System and method for digital access consent management

Abstract

The present technology may relate to electronic consent services (1630) such as using application programming interfaces (APIs), and their use. The consent services and APIs may be configured to allow different services providers to obtain and manage consent to share data with one another. A consent service may provide consent management of user data by querying a consent repository for a consent resource associated with a consent policy and a user of a client application. When the consent resource does not indicate an active consent status, the consent service obtains the consent repository for a consent template corresponding to the consent policy, obtains a consent notice indicated by the consent template for display in the client application, receives a consent response from the client application based on display of the consent notice, and generates a new consent resource in the consent repository based on the response. Additional implementations are described.

Description

RMDDHI(23)SYSTEM AND METHOD FOR DIGITALACCESS CONSENT MANAGEMENT0. CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of United States Provisional Patent Application No. 63 / 713,406, filed October 29, 2024, the entire content of which is incorporated herein by reference, therapy.1 BACKGROUND OF THE TECHNOLOGY1.1 FIELD OF THE TECHNOLOGY

[0002] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and amelioration of respiratory-related disorders. The present technology’ also relates to medical devices or apparatus, and their use. The present technology also relates to consent services and application programming interfaces (APIs), and their use allowing different services providers to obtain and manage consent to share data with one another.1.2 DESCRIPTION OF THE RELATED ART1.2.1 Human Respiratory System and its Disorders

[0003] The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of a patient. The airways include a series of branching tubes, which become narrower, shorter and more numerous as they penetrate deeper into the lung. The prime function of the lung is gas exchange, allowing oxygen to move from the inhaled air into the venous blood and carbon dioxide to move in the opposite direction. The trachea divides into right and left main bronchi, which further divide eventually into terminal bronchioles. The bronchi make up the conducting airways, and do not take part in gas exchange. Further divisions of the airways lead to the respiratory bronchioles, and eventually to the alveoli. The alveolated region of the lung is where the gas exchange takes place, and is referred to as the respiratory zone. See "Respiratory Physiology” , by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0004] A range of respiratory disorders exist. Certain disorders may be characterized by particular events, for example, apneas, hypopneas, and hyperpneas. Examples of respiratory' disorders include Obstructive Sleep Apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory’ insufficiency, Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) and Chest yvall disorders. Otherwise healthy individuals may take advantage of systems and devices to prevent respiratory’ disorders from arising.1.2.2 Diagnosis and Therapies

[0005] Patients’ interaction with the health system generally comprises two main stages or phases - a diagnostic stage and a treatment (also referred to as “therapy”) stage.RMDDHI(23)

[0006] During the diagnostic stage a patient is tested and the patient’s condition is diagnosed. In the area of sleep and respiratory disorders, the diagnostic providers, as well as the therapy providers can be qualified medical practitioners, also referred to as physicians or doctors, or assisting practitioners referred to as clinicians. Instead of conducting a sleep test in a sleep lap or sleep clinic, a diagnostic providers increasingly use portable take home testing devices to diagnose patients with sleep disorder breathing. Once the patient is diagnosed, they may be put on a suitable therapy.

[0007] The application of the respirator}' therapy defines the therapy stage, during which the patient is treated for the purpose of managing the patient’s condition and / or ameliorating its symptoms. The services to supply the CPAP devices used for such therapy and monitor the progress of the patient’s therapy may be provided by a therapy provider organization, such as a Home Medical Equipment (HME) company. A therapy provider from the therapy provider company, such as a therapy clinician, may configure the device as per directions from the prescription, and put the patient on a program to monitor their ongoing adherence to therapy and the patient’s therapy progress. For example, patients suffering from sleep apnea may be diagnosed via a Home Sleep Test by a diagnostic provider and prescribed a therapy device, such as a continuous positive airway pressure ("CPAP") device, for home respiratory therapy that is prescribed to operate at a particular pressure. The therapy provider for this patient will provide the device and set the required pressure and other settings. Alternatively, the therapy device may be configured for automatic initial setup, based on the prescription settings in the diagnostic prescription issued by the diagnostic provider.

[0008] Thus, the therapy provider may be responsible for setting the patient for therapy. This may involve selection of a treatment mask, humidifier, conduits and other accessories, which may or may not be specified in the prescription issued by the diagnostic provider. Apart from the initial setup, the therapy provider will also monitor the therapy data from the patient therapy sessions. If the patient's therapy progress is unsatisfactory' or there are other problems with the therapy, the therapy provider may refer the patient back to the diagnostic provider for review and modification to the therapy.

[0009] Insurance companies, or other assessing or reimbursing entity computer 103, often require evidence that the patient has been diagnosed in an appropriate manner before paying for the diagnosis. In order for a determination to be made of whether a patient was appropriately diagnosed, a diagnostic provider will need to present the appropriate data from a Home Sleep Test device (which will also be referred to herein as a diagnostic device 101 ) and a diagnosis needs to be made available that is signed by a qualified physician. Furthermore, insurance companies often want to track whether a patient once diagnosed with a medical condition successfully proceeds toRMDDHI(23) and remains on the therapy for which they are prescribed. This process can be inefficient and time consuming, with very poor patient traceability during the transfer of the patient between the diagnostic and therapy provider. The transfer may be inconvenient and disruptive, because multiple records of the patient (e.g. one during the diagnostic stage patient management and another one during the therapy stage) are being created on different software packages and in different software environments. The communication between the two stages also currently involves paper records and / or faxed documents. This may cause inconvenience to the patients and the diagnostic and therapy service providers, as well as cause errors in the patient’s record.1.2.2.1 Respiratory pressure therapies

[0010] Respiratory pressure therapy is the application of a supply of air to an entrance to the airways at a controlled target pressure that is nominally positive with respect to atmosphere throughout the patient’s breathing cycle (in contrast to negative pressure therapies such as the tank ventilator or cuirass). Various respiratory therapies, such as continuous positive airway pressure (CPAP) therapy, bi-level positive airway pressure (BiPAP), automatic positive airway pressure (APAP), positive expiratory pressure (PEP), non-invasive ventilation (NIV), invasive ventilation (IV), and high flow therapy (HFT) have been used to treat one or more of the above respiratory disorders.

[0011] CPAP therapy has been used to treat OSA. The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and may prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy may be voluntary, and hence patients may elect not to comply with therapy if they find devices used to provide such therapy one or more of: uncomfortable, difficult to use. expensive and aesthetically unappealing.

[0012] NIV provides ventilatory support to a patient through the upper airways to assist the patient breathing and / or maintain adequate oxygen levels in the body by doing some or all of the work of breathing. The ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure, in forms such as OHS, COPD, NMD and Chest Wall disorders. In some forms, the comfort and effectiveness of these therapies may be improved.

[0013] IV provides ventilatory support to patients that are no longer able to effectively breathe themselves and may be provided using a tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these therapies may be improved.1.2.3 Respiratory Therapy Systems

[0014] Respirator}7therapies may be provided by a respirator}’ therapy system or device. Such systems and devices may also be used to screen, diagnose, or monitor a condition without treatingRMDDHI(23) it. A respiratory therapy system may comprise a Respiratory Pressure Therapy (RPT) device, an air circuit, a humidifier, a patient interface, an oxygen source, and data management.1.2.3.1 Patient Interface

[0015] A patient interface may be used to interface respiratory equipment to its wearer, for example by providing a flow of air to an entrance to the airways. The flow of air may be provided via a mask to the nose and / or mouth, a tube to the mouth or a tracheostomy tube to the trachea of a patient. Depending upon the therapy to be applied, the patient interface may form a seal, e.g., with a region of the patient's face, to facilitate the delivery7of gas at a pressure at sufficient variance with ambient pressure to effect therapy, e.g., at a positive pressure of about 10 cmPfO relative to ambient pressure. For other forms of therapy, such as the delivery of oxygen, the patient interface may not include a seal sufficient to facilitate delivery to the airways of a supply of gas at a positive pressure of about 10 cmFDO. For flow7therapies such as nasal HFT, the patient interface is configured to insufflate the nares but specifically to avoid a complete seal. One example of such a patient interface is a nasal cannula.1.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0016] An RPT device may be used individually or as part of a system to deliver one or more of a number of therapies described above, such as by operating the device to generate a flow7of air for delivery to an interface to the airways. The flow of air may be pressure-controlled (for respiratory pressure therapies) or flow-controlled (for flow therapies such as HFT). Thus, RPT devices may also act as flow therapy devices. Examples of RPT devices include CPAP devices and a ventilators.1.2.3.3 Air circuit

[0017] An air circuit is a conduit or a tube constructed and arranged to allow, in use, a flow of air to travel between two components of a respiratory therapy system such as the RPT device and the patient interface. In some cases, there may be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb air circuit is used for both inhalation and exhalation.1.2.3.4 Humidifier

[0018] Delivery of a flow of air without humidification may cause drying of airways. The use of a humidifier with an RPT device and the patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases patient airw ay comfort. In addition, in cooler climates, warm air applied generally to the face area in and about the patient interface is more comfortable than cold air.RMDDHI(23)1.2.3.5 Vent technologies

[0019] Some forms of treatment systems may include a vent to allow the washout of exhaled carbon dioxide. The vent may allow a flow of gas from an interior space of a patient interface, e.g., the plenum chamber, to an exterior of the patient interface, e.g., to ambient.1.2.4 Screening, Diagnosis, and Monitoring Systems

[0020] Polysomnography (PSG) is a conventional system for diagnosis and monitoring of cardio-pulmonary disorders, and typically involves expert clinical staff to apply the system. PSG typically involves the placement of 15 to 20 contact sensors on a patient in order to record various bodily signals such as electroencephalography (EEG), electrocardiography (ECG), electrooculograpy (EOG), electromyography (EMG), etc. PSG for sleep disordered breathing has involved two nights of observation of a patient in a clinic, one night of pure diagnosis and a second night of titration of treatment parameters by a clinician. PSG is therefore expensive and inconvenient. In particular, it is unsuitable for home screening / diagnosis / monitoring of sleep disordered breathing.

[0021] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically gives a true / false result indicating whether or not a patient's SDB is severe enough to warrant further investigation, while diagnosis may result in clinically actionable information. Screening and diagnosis tend to be one-off processes, whereas monitoring the progress of a condition can continue indefinitely. Some screening / diagnosis systems are suitable only for screening / diagnosis, whereas some may also be used for monitoring.

[0022] Clinical experts may be able to screen, diagnose, or monitor patients adequately based on visual observation of PSG signals. However, there are circumstances where a clinical expert may not be available, or a clinical expert may not be affordable. Different clinical experts may disagree on a patient’s condition. In addition, a given clinical expert may apply a different standard at different times.2 BRIEF SUMMARY OF THE TECHNOLOGY

[0023] The present technology relates to the diagnosis and treatment of sleep disorder breathing patients and related respiratory insufficiencies. Currently, the diagnostic stage and the therapy stage systems of electronic patient data management are somewhat disconnected and incoherent. What is needed is an integrated electronic system which links the data access for multiple devices, such as diagnostic provider devices and therapy provider devices to the same patient database system, and allows for easy generation, management, access, evaluation, use and / or transfer of a patient’s diagnostic and / or therapy information, such as directly to the prescribed flow generator (which will also be referred to in herein as a therapy device) or other patient devices, such as patient’s portable computing devices (e.g., smart phones and / or tablets),RMDDHI(23) in accordance with patient digital consent controls. One or more operations, such as output, of any of the systems, diagnostic and / or therapy devices and / or computing device(s) described herein may be changed or controlled based on such digital consent controls that are described herein.

[0024] Some versions of the present technology may relate to a method and system for an integrated processing and management of the patient data during the diagnostic and therapy stages. In particular, the described system provides diagnostic providers and therapy device providers with a simple and fast way to generate a clinical diagnosis from a diagnostic device and to transfer that patient’s record and diagnostic data directly to the therapy provider responsible for the patient’s ongoing care.

[0025] In accordance with one aspect of the technology, a server contains memory configured to store medical device data, and a processor in communication with the memory. The processor is configured to receive diagnostic and therapy data for a plurality of medical device users, and to process diagnostic report data and therapy device usage data. A successful download of data may be based on whether the received diagnostic data from the device contains a predetermined duration of recording information and conforms to acceptable clinical ranges. Therapy compliance may be based on whether the received medical device usage data satisfies predetermined usage criteria, such as a number of hours of continuous usage or another predetermined criterion. The processor is also configured to receive a request from the diagnostic provider or health providers for the diagnostic stage, as well as a compliance status for one or more of the patients using medical devices, and to transfer access to those patients from one provider to another.

[0026] In accordance with another aspect of the technology, a medical device can either be a Diagnostic Home Sleep Testing Device or a Therapy Device (e.g. a Flow Generator) used for respiratory therapy. In addition, the memory of the server may be further configured to store device identifiers, e.g., a unique ID number, wherein the medical device data for each of the plurality of medical device users includes a device identifier, which may be a unique device identifier, and wherein the processor of the server is further configured to associate the medical device usage data with a medical device user based on the received device identifiers.

[0027] In accordance with another aspect of the technology, the medical devices may be or include any one or more of a smart watch, a temperature sensor, an electrocardiogram (ECG / EKG) device, a respiratory pressure medical device (e.g., an RPT device, HFT device, etc.), a finger sensor device, a biopotential measurement device, a health tracker, a blood monitor (e.g., a glucose meter, lactic acid meter / analyzer, and / or the like), flow sensors and / or flow rate sensors, pressure sensors, motion sensors, image capture devices (e g., cameras), a smartphone, sonar sensors and / or microphones, among other possibilities.RMDDHI(23)

[0028] In another aspect of the technology, the server’s processor is further configured to regenerate medical device diagnostic data from at least one of the plurality of medical device users, based on a user determined change in analysis parameters.

[0029] In another aspect, a clinical diagnostic summary report may be provided, the report being of a format that allows an assessing entity’ to accept the report as verification of diagnosis. For example, the report may contain summary statistics from the diagnostic test data, a physician’s interpretation of the test results and an electronic signature, as proof of review or acceptance.

[0030] In another aspect, a prescription based on a clinical diagnostic report may be provided. The prescription may be of a format that allows a therapy provider to supply a device, configure it for therapy and begin monitoring a schedule for reimbursement. For example, the prescnption may contain a specified therapy’ device (e g. CPAP), an itemized list of accessories (e g. mask ty pe), pressure settings for the device and an electronic signature. This document may be used by a Therapy Provider to legally supply the patient with the listed therapy items.

[0031] In another aspect of the technology, diagnostic and compliance indications are generated and displayed as selectable icons on the screen of a user.

[0032] In another aspect, a compliance report may be provided. The report may be of a format that allows an assessing entity7to accept the report as verification of compliance. For example, the report may contain a numerical or graphical indication of compliance.

[0033] In another aspect of the technology, a healthcare professional associated with a diagnostic provider may access a website and select on the website one or more medical device users (patients) for which diagnostic information is available. The user may then select a therapy provider from a list of eligible organizations (orgs) within the system and send the selected patients’ diagnostic information to the selected org. A user within the therapy provider will then receive a notification of the availability7of diagnostic information for each of the one or more transferred medical device users, as well as the prescription information required to set up the patients on therapy.

[0034] In accordance with another aspect, a method for patient data processing during diagnosis and therapy of sleep disorder breathing may be performed. The method may include generating, by one or more computing devices, an electronic patient record for a patient; during a diagnostic stage of the patient, storing, by the one or more computing devices, diagnostic-related data in the electronic patient record; providing, by the one or more computing devices, a diagnostic medical practitioner with access to the electronic patient record; during a therapy stage of the patient, providing, by the one or more computing devices, a treating medical practitioner with access to the electronic patient record; and updating, by the one or more computing devices, the electronic patient record to include therapy-related data.RMDDHI(23)

[0035] In another aspect, the method may include storing at least one of reports and prescriptions, generated during either the diagnostic stage or the therapy stage, in the electronic patient record. When the diagnostic stage is at an end, the treating medical practitioner is notified and provided access to at least one of diagnostic data and prescription data of the patient. Therapy settings from a therapy prescription may be retrieved from the electronic patient record and used to automatically configure a therapy device for the patient. The automatic configuration may be effected by way of a network connection or a memory card. In addition, the data storage, processing, and access during the diagnostic stage and the therapy stage are performed on a single software platform and on a single physical system of servers.

[0036] Once the electronic patient record is created, medical practitioners associated with either the diagnostic stage or the therapy stage may be provided access to the electronic patient record during both the diagnostic stage and the therapy stage. In addition, the diagnostic stage may include receiving data from a diagnostic device and the therapy stage may include receiving data from a therapy medical device, the therapy medical device being a flow generator for respiratory- therapy.

[0037] In accordance with another aspect, a disclosed method may include any one or more of receiving, by one or more computing devices, medical device data for a plurality of medical device users; storing, by the one or more computing devices, the medical device data; determining, by the one or more computing devices, whether to process the medical device data as diagnostic information or as compliance information, based on a predetermined criterion related to identification data of the medical devices; if the medical device data is processed as diagnostic data, generating, by the one or more computing devices, diagnostic information based on predetermined analysis criteria; enabling, by the one or more computing devices, an electronic transfer of at least one of an clinical diagnosis report to an associated therapy provider, wherein the diagnosis report is based on the diagnostic information; and transmitting, by the one or more computing devices, a therapy settings to a therapy device associated with the diagnosis report.

[0038] In accordance with another aspect, receiving the medical device data further comprises receiving a signal that one of the medical devices has data available for uploading. In addition, the medical device may be a home sleep testing device or a flow generator used for respiratory therapy.

[0039] A generated diagnostic report may contain statistical indications which assist diagnosis and provide an area where a healthcare professional may input their clinical interpretation. The diagnostic report may also include a prescription for therapy that identifies one or more therapy devices and one or more therapeutic settings to be used by a patient. The diagnostic report for therapy may be displayed within a web browser, within one or more UI elements of a web app orRMDDHI(23) mobile app, or as an electronic document, such as HTML, JSON, XML, and / or a Portable Document Format (PDF) document.

[0040] The method may also include assigning a therapy provider to a patient that is ready for therapy; transferring diagnostic information for the patient to the assigned therapy provider; and electronically importing therapy settings from the diagnostic information onto the therapy device to be used by the patient.

[0041] In another aspect, an apparatus for integrated electronic management of diagnostic and therapy data of a plurality' of sleep disorder breathing patients may include: a memory' configured to store medical data, and one or more processors in communication with the memory. The one or more processors may be configured to receive medical device data for a plurality of medical device users; associate the received medical device data with a corresponding patient records; determine whether received medical device data is diagnostic or usage data; update the patient records in accordance with the determination of whether the received medical device data is diagnostic or usage data; store a list of therapy providers within a system of therapy providers; receive a request to display the list from a diagnostic provider; receive diagnostic data from the plurality of medical devices; generate summary statistics by processing the diagnostic data using a set of predetermined analysis criteria; receive a request generated by a clinical user; and / or transmit, in response to the request, a diagnostic report comprising the summary statistics.

[0042] The processors may also be configured to store a list of medical devices and accessory items; receive a request to display the list by a clinical user; receive clinical settings information generated by the clinical user; receive text generated by the clinical user; transmit a prescription for therapy report displaying a selected item manifest and clinical settings; securely allow access to diagnostic and prescription data of a patient record by the selected therapy provider; dynamically update the therapy provider’s available patient list with at least one patient record; display the additional patient record in the patient list; securely display patient information, diagnostic reports and prescription for therapy reports as selected by a therapy provider user; receive a request to assign a patient with a therapy device ID that corresponds to the prescription; and automatically transfer clinical settings information into the memory from the prescription.

[0043] The present technology, such as optionally with any of the aforementioned features, may also relate to consent services for managing consent related aspects of user data. The consent service may provide an API for managing the collection of consent-related resources, and may provide service subscribers with functions to record patient (or user) consent for any use or use cases, such as disclosure of their personal health information (PHI), compliance with data privacy laws (e.g., HIPAA, GDPR, etc.), and / or any other suitable purpose. The consent service mayRMDDHI(23) integrate with a consent repository for persisting all consent resources recorded by the consent service.

[0044] Some versions of the present technology may relate to a method for operating a consent service to provide consent management of user data, the method may include: query ing, by one or more computing devices, a consent repository for a consent resource associated with a consent policy and a user of a client application; and when the consent resource does not indicate a consent status of active: obtaining, by the one or more computing devices, the consent repository for a consent template corresponding to the consent policy; obtaining, by the one or more computing devices, a consent notice indicated by the consent template for display in the client application; receiving, by the one or more computing devices, a consent response from the client application based on display of the consent notice; and generating, by the one or more computing devices, a new consent resource in the consent repository based on the consent response.

[0045] In accordance with one aspect of the technology, the method further include: generating consent-related resources in the consent repository.

[0046] In accordance with one aspect of the technology, the consent related resources may include the consent template, the consent policy, and / or the consent resource. In another aspect, the consent template may be a data structure representing a consent agreement and may include the consent policy and the consent notice. In another aspect, the consent template may include a reference to a location where the consent notice is stored. In another aspect, the consent policy may be a data structure representing a policy for obtaining consent for a specified purpose. In another aspect, the user data may be collected by the client application and / or a medical device, and the specified purpose is to share the user data with a service provider platform separate from the consent service.

[0047] In accordance with one aspect of the technology, the service provider platform may be a first service provider platform, and the client application or the medical device may consume services provided by a second sendee provider platform. In another aspect, the user data may be diagnostic data, and the second service provider platform may collect the diagnostic data from the client application and / or the medical device. In another aspect, the specified purpose may be to share the diagnostic data wdth the first sendee provider platform to provide analysis and / or therapy services through another medical device or service.

[0048] In accordance with one aspect of the technology, the consent resource may be a data structure representing a record of a consent status, wherein the consent status may be one of consented, withheld, revoked, or expired. In accordance wdth one aspect of the technology, the new consent resource may be a data structure representing a record of a consent status indicated by the consent response, wherein the consent status indicated by the consent response may be oneRMDDHI(23) of consented, withheld, revoked, and expired. In another aspect, the consent resource and the new consent resource include a user identifier associated with the user or an application identifier associated with the client application. In another aspect, the consent resource and the new consent resource may include an effective field indicating a time period when the consent status is active.

[0049] In accordance with one aspect of the technology’, the method may further include: determining whether the consent resource indicates an active, revoked, or expired status. In another aspect, the method may further include determining that the consent resource does not indicate a consent status of active when the consent status is revoked or expired. In another aspect, the method further comprises determining that the consent resource does not indicate a consent status of active when no consent resource is stored in the consent repository based on the querying.

[0050] In accordance with one aspect of the technology', the method may further include: generating a notification including the consent status indicated by the consent response. In another aspect, the notification may be an email message, and the method may include: causing the email to be sent to the client application and / or a service provider platform that hosts a service consumed by the client application. In another aspect, the notification may be a database record, and the method may include: storing the database record in the consent repository in association w ith the new' consent resource.

[0051] Some versions of the present technology may relate to a computer-readable medium encoded with computer-readable instructions, which when executed by one or more processors implement the method of any of the previously described methods.

[0052] Some versions of the present technology' may relate to a system for operating a consent service to provide consent management of user data. The system may include one or more servers comprising one or more databases including the user data. The user data may include device related usage data generated by a plurality' of devices for a user. The one or more servers may be configured to access and execute the computer-readable instructions of the aforementioned computer-readable medium.

[0053] Some versions of the present technology may relate to a system for operating a consent service to provide consent management of user data. The system may include one or more database systems and one or more computing devices. The one or more database systems may be configured to store the user data. The one of more computing devices may be configured to access the one or more database systems and configured with one or more consent services. The one or more consent services may be configured to: query a consent repository for a consent resource associated with a consent policy and a user of a client application; and when the consent resource does not indicate a consent status of active: obtain the consent repository' for a consent template corresponding to the consent policy; obtain a consent notice indicated by the consent template for display in theRMDDHI(23) client application; receive a consent response from the client application based on display of the consent notice; and generate anew consent resource in the consent repository based on the consent response.

[0054] In accordance with one aspect of the technology, the one or more database systems comprise the consent repository for storage of one or more consent-related resources.

[0055] In accordance with one aspect of the technology, the one or more consent services may be further configured to: generate consent-related resources in the consent repository. In another aspect, the consent related resources may include the consent template, the consent policy, and / or the consent resource. In another aspect, the consent template may be a data structure representing a consent agreement and may include the consent policy and the consent notice. In another aspect, the consent template may include a reference to a location where the consent notice is stored. In another aspect, the consent policy may be a data structure representing a policy for obtaining consent for a specified purpose. In another aspect, the user data may be collected by the client application and / or a medical device, and the specified purpose is to share the user data with a service provider platform separate from the consent service.

[0056] In accordance with one aspect of the technology, the service provider platform may be a first service provider platform, and the client application or the medical device consume sendees provided by a second senice provider platform. In another aspect, the user data may be diagnostic data, and the second service provider platform may collect the diagnostic data from the client application and / or the medical device. In another aspect, the specified purpose may be to share the diagnostic data with the first service provider platform to provide evaluation and / or therapy services through another medical system or device.

[0057] In accordance with one aspect of the technology, the consent resource is a data structure representing a record of a consent status, wherein the consent status may be one of consented, withheld, revoked, or expired. In accordance with one aspect of the technology, the new consent resource may be a data structure representing a record of a consent status indicated by the consent response, wherein the consent status indicated by the consent response may be one of consented, withheld, revoked, or expired. In another aspect, the consent resource and the new consent resource may include a user identifier associated with the user or an application identifier associated with the client application. In another aspect, the consent resource and the new consent resource may include an effective field indicating a time period when the consent status is active.

[0058] In accordance with one aspect of the technology, the one or more consent services may be further configured to: determine whether the consent resource indicates an active, revoked, or expired status.

[0059] In accordance with one aspect of the technology, the one or more consent services mayRMDDHI(23) be further configured to: determine that the consent resource does not indicate a consent status of active when the consent status is revoked or expired.

[0060] In accordance with one aspect of the technology, the one or more consent services may be further configured to: determine that the consent resource does not indicate a consent status of active when no consent resource is stored in the consent repository based on the querying.

[0061] In accordance with one aspect of the technology, the one or more consent services may be further configured to: generate a notification including the consent status indicated by the consent response. In another aspect, the notification is an email message, and wherein the one or more consent services may be configured to: cause the email to be sent to the client application or a service provider platform that hosts a service consumed by the client application. In another aspect, the notification may be a database record, and wherein the one or more consent services may be configured to: store the database record in the consent repository in association with the new consent resource.

[0062] The methods, systems, devices and apparatus described may be implemented so as to improve the functionality of a processor, such as a processor of a specific purpose computer, respiratory monitor and / or a respiratory therapy apparatus. Moreover, the described methods, systems, devices and apparatus can provide improvements in the technological field of automated management, monitoring and / or treatment of respiratory conditions, including, for example, sleep disordered breathing. Portions of the aspects may form sub-aspects of the present technology. Also, various ones of the sub-aspects and / or aspects may be combined in various manners and also constitute additional aspects or sub-aspects of the present technology. Other features of the technology will be apparent from consideration of the information contained in the following detailed description, abstract, drawings and claims.3 BRIEF DESCRIPTION OF THE DRAWINGS

[0063] The present technology is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings, in which like reference numerals refer to similar elements including:3. 1 RESPIRATORY THERAPY SYSTEMS

[0064] Fig. 1 A shows a system including a patient 1000 wearing a patient interface 3000, in the form of nasal pillows, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown. The patient is sleeping in a supine sleeping position.

[0065] Fig. IB shows a system including a patient 1000 wearing a patient interface 3000, in the form of a nasal mask, receiving a supply of air at positive pressure from an RPT device 4000.RMDDHI(23)Air from the RPT device is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000.

[0066] Fig. 1C shows a system including a patient 1000 wearing a patient interface 3000, in the form of a full-face mask, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000. The patient is sleeping in a side sleeping position.3.2 RESPIRATORY SYSTEM AND FACIAL ANATOMY

[0067] Fig. 2A shows an overview of a human respiratory system including the nasal and oral cavities, the larynx, vocal folds, oesophagus, trachea, bronchus, lung, alveolar sacs, heart and diaphragm.

[0068] Fig. 2B shows a view of a human upper airway including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostril, lip superior, lip inferior, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, oesophagus and trachea.

[0069] Fig. 2C is a front view of a face with several features of surface anatomy identified including the lip superior, upper vermillion, lower vermillion, lip inferior, mouth width, endocanthion, a nasal ala, nasolabial sulcus and cheilion.3.3 PATIENT INTERFACE

[0070] Fig. 3 shows an example patient interface in the form of a nasal mask in accordance with one form of the present technology.3.4 RPT DEVICE

[0071] Fig. 4A shows an RPT device in accordance with one form of the present technology.

[0072] Fig. 4B is a schematic diagram of the pneumatic path of an RPT device in accordance with one form of the present technology. The directions of upstream and downstream are indicated with reference to the blower and the patient interface. The blower is defined to be upstream of the patient interface and the patient interface is defined to be downstream of the blower, regardless of the actual flow direction at any particular moment. Items which are located within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0073] Fig. 4C is a schematic diagram of the electrical components of an RPT device in accordance with one form of the present technology7.

[0074] Fig. 4C-1 is a schematic diagram illustrating the interconnection of various electrical components of the RPT device.

[0075] Fig. 4D is a schematic diagram of the processing implemented in an RPT device in accordance with one form of the present technology.RMDDHI(23)

[0076] Fig. 4E is a flow chart illustrating a method carried out by the therapy engine module of Fig. 4D in accordance with one form of the present technology.3.5 HUMIDIFIER

[0077] Fig. 5A shows an isometric view of a humidifier in accordance with one form of the present technology.

[0078] Fig. 5B shows an isometric view of a humidifier in accordance with one form of the present technology, showing a humidifier reservoir 5110 removed from the humidifier reservoir dock 5130.3.6 BREATHING WAVEFORMS

[0079] Fig. 6 shows a model typical breath waveform of a person while sleeping.3.7 SCREENING, DIAGNOSIS, AND MONITORING SYSTEMS AND DATA MANAGEMENT SYSTEMS

[0080] Fig. 7A shows an environment in which aspects of the present disclosure may be practiced.

[0081] Fig. 7B shows a system that may be used in diagnosing and treating a patient's sleep disorder breathing.

[0082] Fig. 7C is a schematic diagram of the components of a screening / diagnosis / monitoring device that may be used to implement a Respiratory polygraphy (RPG) headbox in an RPG screening / diagnosis / monitoring system concentrator in accordance with one form of the present technology.

[0083] Figs. 8-14 are various user interfaces that may be displayed in accordance with aspects of the present technology.

[0084] Fig. 15 depicts an example method for practicing aspects of the present technology.3.8 ACCESS CONSENT MANAGEMENT ASPECTS

[0085] Fig. 16 shows an example consent domain environment in accordance with aspects of the present technology.

[0086] Fig. 17 depicts an example consent management in accordance with aspects of the present technology.4 DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY

[0087] Before the present technology is described in further detail, it is to be understood that the technology is not limited to the particular examples described herein, which may vary. It is also to be understood that the terminology7used in this disclosure is for the purpose of describing only the particular examples discussed herein, and is not intended to be limiting.

[0088] The following description is provided in relation to various examples which may share one or more common characteristics and / or features. It is to be understood that one or more featuresRMDDHI(23) of any one example may be combinable with one or more features of another example or other examples. In addition, any single feature or combination of features in any of the examples may constitute a further example.4.1 THERAPY

[0089] In one form, the present technology comprises a method for treating a respiratory- disorder comprising applying positive pressure to the entrance of the airw ays of a patient 1000.

[0090] In certain examples of the present technology-, a supply of air at positive pressure is provided to the nasal passages of the patient via one or both nares.

[0091] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.4.2 RESPIRATORY THERAPY SYSTEMS

[0092] In one form, the present technology- comprises a respiratory- therapy system for treating a respiratory disorder. The respiratory- therapy system may comprise an RPT device 4000 for supplying a flow of air to the patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.4.3 PATIENT INTERFACE

[0093] A non-invasive patient interface 3000, such as that shown in Fig. 3, in accordance with one aspect of the present technology- comprises the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, one form of connection port 3600 for connection to air circuit 4170, and a forehead support 3700. In some forms a functional aspect may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use the sealforming structure 3100 is arranged to surround an entrance to the airways of the patient so as to maintain positive pressure at the entrance(s) to the airways of the patient 1000. The sealed patient interface 3000 is therefore suitable for delivery- of positive pressure therapy.4.4 RPT DEVICE

[0094] An RPT device 4000 in accordance with one aspect of the present technology comprises mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300, such as any of the methods, in w hole or in part, described herein. The RPT device 4000 may be configured to generate a flow of air for delivery- to a patient's airw ays, such as to treat one or more of the respiratory conditions described elsewhere in the present document.

[0095] In one form, the RPT device 4000 is constructed and arranged to be capable of delivering a flow- of air in a range of -20 L / min to + 150 L / min w-hile maintaining a positive pressure of at least 4 cmH20, or at least 10cmH2O, or at least 20 ctnH2O.RMDDHI(23)

[0096] The RPT device may have an external housing 4010, formed in two parts, an upper portion 4012 and a lower portion 4014. Furthermore, the external housing 4010 may include one or more panel (s) 4015. The RPT device 4000 comprises a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0097] The pneumatic path of the RPT device 4000 may comprise one or more air path items, e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 capable of supplying air at positive pressure (e.g., a blower 4142), an outlet muffler 4124 and one or more transducers 4270, such as pressure sensors 4272 and flow rate sensors 4274.

[0098] One or more of the air path items may be located within a removable unitary structure which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be located within the external housing 4010. In one form a pneumatic block 4020 is supported by, or formed as part of the chassis 4016.

[0099] As shown in Fig. 4C, the RPT device 4000 may have an electrical power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, memory 4260, transducers 4270, data communication interface 4280 and one or more output devices 4290. Electrical components 4200 may be mounted on a single Printed Circuit Board Assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.4.4.1 RPT device mechanical & pneumatic components

[0100] An RPT device may comprise one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be located as respective separate units.4.4.1.1 Air filter(s)

[0101] An RPT device in accordance with one form of the present technology may include an air fdter 4110, or a plurality7of air fdters 4110.

[0102] In one form illustrated in Fig. 4B, an inlet air filter 4112 is located at the beginning of the pneumatic path upstream of a pressure generator 4140.

[0103] In one form illustrated in Fig. 4B, an outlet air filter 41 14, for example, an antibacterial filter, is located between an outlet of the pneumatic block 4020 and a patient interface 3000 or 3800.4.4.1.2 Muffler(s)

[0104] An RPT device in accordance with one form of the present technology may include a muffler 4120, or a plurality of mufflers 4120.

[0105] In one form of the present technology (see e.g., Fig. 4B), an inlet muffler 4122 is located in the pneumatic path upstream of a pressure generator 4140.RMDDHI(23)

[0106] In one form of the present technology, an outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and a patient interface 3000 or 3800.4.4.1.3 Pressure generator

[0107] In one form of the present technology, a pressure generator 4140 for producing a flow, or a supply, of air at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers. The impellers may be located in a volute. The blower may be capable of delivering a supply of air, for example at a rate of up to about 120 liters / minute, at a positive pressure in a range from about 4 cmH20 to about 20 cmH20, or in other forms up to about 30 cmH20 when delivering respiratory pressure therapy. The blower may be as described in any one of the following patents or patent applications the contents of which are incorporated herein by reference in their entireties: U.S. Pat. No. 7,866,944; U.S. Pat. No. 8,638,014; U.S. Pat. No. 8,636,479; and Infl Pat Pub. W 2013 / 020167.

[0108] The pressure generator 4140 may be under the control of the therapy device controller 4240. In other forms, a pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high pressure source (e.g. compressed air reservoir), or a bellows.4.4.1.4 Transducer(s)

[0109] Transducers may be internal of the RPT device, or external of the RPT device. External transducers may be located for example on or form part of the air circuit, e.g., the patient interface. External transducers may be in the form of non-contact sensors such as a Doppler radar movement sensor that transmit or transfer data to the RPT device.

[0110] In one form of the present technology (see e.g., Fig. 4B), one or more transducers 4270 are located upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate signals representing properties of the flow of air such as a flow rate, a pressure or a temperature at that point in the pneumatic path. Additionally or alternatively, one or more transducers 4270 may be located proximate to the patient interface 3000 or 3800. Additionally or alternatively, a signal from a transducer 4270 may be filtered, such as by low-pass, high-pass or band-pass filtering.4.4.1.4.1 Flow rate sensor

[0111] A flow rate sensor 4274 in accordance with the present technology may be based on a differential pressure transducer, for example, an SDP600 Series differential pressure transducer from SENSIRION.

[0112] In one form of the present technology, a signal generated by the flow rate sensor 4274 and representing a flow rate is received by the central controller 4230.RMDDHI(23)4.4.1.4.2 Pressure sensor

[0113] A pressure sensor 4272 in accordance with the present technology is located in fluid communication with the pneumatic path. An example of a suitable pressure sensor is a transducer from the HONEYWELL ASDX series. An alternative suitable pressure sensor is a transducer from the NPA Series from GENERAL ELECTRIC.

[0114] In one form of the present technology, a signal generated by the pressure sensor 4272 and representing a pressure is received by the central controller 4230.4.4.1.4.3 Motor speed transducer

[0115] In one form of the present technology, a motor speed transducer 4276 is used to determine a rotational velocity of the motor 4144 and / or the blower 4142. A motor speed signal from the motor speed transducer 4276 may be provided to the therapy device controller 4240. The motor speed transducer 4276 may, for example, be a speed sensor, such as a Hall effect sensor.4.4.1.5 Anti-spill back valve

[0116] As shown in Fig. 4B. one form of the present technology, an anti-spill back valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-spill back valve is constructed and arranged to reduce the risk that water will flow upstream from the humidifier 5000, for example to the motor 4144.4.4.2 RPT device electrical components4.4.2.1 Power supply

[0117] A power supply 4210 may be located internal or external of the external housing 4010 of the RPT device 4000.

[0118] In one form of the present technology, power supply 4210 provides electrical power to the RPT device 4000 only. In another form of the present technology, power supply 4210 provides electrical power to both RPT device 4000 and humidifier 5000.

[0119] As illustrated in Fig. 4C-1, the power supply 4210 may provide electrical power to the input device 4220, the central controller 4230, the output device 4290, and the pressure generator 4140. The power supply 4210 may also provide electric energy to other components of the RPT device 4000 (or the humidifier 5000, as described above).4.4.2.2 Input devices

[0120] In one form of the present technology7, an RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches or dials to allow a person to interact with the device. The buttons, switches or dials may be physical devices, or software devices accessible via a touch screen. The buttons, switches or dials may, in one form, be physically connected to the external housing 4010, or may, in another form, be in wireless communication with a receiver that is in electrical connection to the central controller 4230.RMDDHI(23)

[0121] In one form, the input device 4220 may be constructed and arranged to allow a person to select a value and / or a menu option.4.4.1.3 Central controller

[0122] In one form of the present technology, the central controller 4230 is one or a plurality' of processors suitable to control an RPT device 4000. The central controller 4230 is show in Figs. 4C and 4C-1.

[0123] Suitable processors may include an x86 INTEL processor, a processor based on ARM® Cortex®-M processor from ARM Holdings such as an STM32 series microcontroller from ST MICROELECTRONIC. In certain alternative forms of the present technology, a 32-bit RISC CPU, such as an STR9 series microcontroller from ST MICROELECTRONICS or a 16-bit RISC CPU such as a processor from the MSP430 family of microcontrollers, manufactured by TEXAS INSTRUMENTS may also be suitable.

[0124] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0125] In one form, the central controller 4230 is an application-specific integrated circuit (ASIC), field-programmable gate arrays (FPGA), digital signal processors (DSP), and / or the like. In another form, the central controller 4230 comprises discrete electronic components.

[0126] The central controller 4230 may be configured to receive input signal(s) from one or more transducers 4270, one or more input devices 4220. and / or the humidifier 5000.

[0127] The central controller 4230 may be configured to provide output signal(s) to one or more of an output device 4290, a pressure generator 4140, a therapy device controller 4240, a data communication interface 4280, and / or the humidifier 5000.

[0128] In some forms of the present technology, the central controller 4230 is configured to implement the one or more methodologies described herein, such as the one or more algorithms 4300 which may be implemented with processor-control instructions, expressed as computer programs stored in a non-transitory computer readable storage medium, such as memory 4260. In some forms of the present technology, the central controller 4230 may be integrated with an RPT device 4000. However, in some forms of the present technology, some methodologies may be performed by a remotely located device. For example, the remotely located device may determine control settings for a ventilator or detect respiratory related events by analysis of stored data such as from any of the sensors described herein.4.4.2.4 Clock

[0129] The RPT device 4000 may include a clock 4232 that is connected to the central controller 4230.RMDDHI(23)4.4.2.5 Therapy device controller

[0130] In one form of the present technology, therapy device controller 4240 is a therapy control module 4330 that forms part of the algorithms 4300 executed by the central controller 4230.

[0131] In one form of the present technology, therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one form a MC33035 brushless DC motor controller, manufactured by ONSEMI is used.4.4.2.6 Protection circuits

[0132] The one or more protection circuits 4250 in accordance with the present technology may comprise an electrical protection circuit, a temperature and / or pressure safety circuit.4.4.2.7 Memory

[0133] In accordance with one form of the present technology the RPT device 4000 includes memory' 4260, e.g., non-volatile memory. In some forms, memory 4260 may include battery' powered static RAM. In some forms, memory 4260 may include volatile RAM.

[0134] Memory 4260 may be located on the PCBA 4202. Memory74260 may be in the form of EEPROM, or NAND flash.

[0135] Additionally, or alternatively, RPT device 4000 includes a removable form of memory' 4260. for example a memory card made in accordance with the Secure Digital (SD) standard.

[0136] In one form of the present technology, the memory- 4260 acts as a non-transitory computer readable storage medium on which is stored computer program instructions expressing the one or more methodologies described herein, such as the one or more algorithms 4300.4.4.2.8 Data communication systems

[0137] In one form of the present technology, a data communication interface 4280 is provided, and is connected to the central controller 4230 (see e.g., Fig. 4C). Data communication interface 4280 may be connectable to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 may be connectable to a remote external device 4286. The local external communication network 4284 may be connectable to a local external device 4288.

[0138] In one form, data communication interface 4280 is part of the central controller 4230. In another form, data communication interface 4280 is separate from the central controller 4230, and may comprise an integrated circuit or a processor.

[0139] In one form, remote external communication network 4282 is the Internet. The data communication interface 4280 may use wired communication (e.g. via Ethernet, or optical fiber) or a wireless protocol (e.g. CDMA, GSM, LTE) to connect to the Internet.RMDDHI(23)

[0140] In one form, local external communication network 4284 utilizes one or more communication standards, such as Bluetooth, or a consumer infrared protocol.

[0141] In one form, remote external device 4286 is one or more computers, such as one or more servers, for example a cluster of networked computers. In one form, remote external device 4286 may be virtual computers, rather than physical computers. In either case, such a remote external device 4286 may be accessible to an appropriately authorized person such as a clinician.

[0142] The local external device 4288 may be a personal computer, mobile phone, tablet or remote control.4.4.2.9 Output devices including optional display, alarms

[0143] An output device 4290 in accordance with the present technology may take the form of one or more of a visual, audio and haptic unit. A visual display may be a Liquid Crystal Display (LCD) or Light Emitting Diode (LED) display.4.4.2.9.1 Display driver

[0144] A display driver 4292 receives as an input the characters, symbols, or images intended for display on the display 4294, and converts them to commands that cause the display 4294 to display those characters, symbols, or images.4.4.2.9.2 Display

[0145] A display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 may be an eight-segment display, in which case the display driver 4292 converts each character or symbol, such as the figure “0”, to eight logical signals indicating whether the eight respective segments are to be activated to display a particular character or symbol.4.4.3 RPT device algorithms

[0146] As mentioned above, in some forms of the present technology, the central controller 4230 may be configured to implement one or more processes according to algorithms 4300 that are expressed as computer programs stored in a non-transitory computer readable storage medium, such as memory 4260. The algorithms 4300 are generally grouped into groups referred to as modules.

[0147] In other forms of the present technology, some portion or all of the processes of algorithms 4300 may be implemented by a controller of an external device such as the local external device 4288 or the remote external device 4286. In such forms, data representing the input signals and / or intermediate algorithm outputs necessary for the portion of the processes of algorithms 4300 to be executed at the external device may be communicated to the external device via the local external communication network 4284 or the remote external communication network 4282. In such forms, the portion of the processes of algorithms 4300 to be executed at the externalRMDDHI(23) device may be expressed as computer programs, such as with processor control instructions to be executed by one or more processor(s), stored in a non-transitory computer readable storage medium accessible to the controller of the external device. Such programs configure the controller of the external device to execute the portion of the processes of algorithms 4300.

[0148] In such forms, the therapy parameters generated by the external device via the therapyengine module 4320 (if such forms part of the portion of the algorithms 4300 executed by the external device) may be communicated to the central controller 4230 to be passed to the therapy control module 4330.4.4.3.1 Pre-processing module

[0149] A pre-processing module 4310 in accordance with one form of the present technology receives as an input a signal from a transducer 4270, for example a flow rate sensor 4274 or pressure sensor 4272, and performs one or more process steps to calculate one or more output values that will be used as an input to another module, for example a therapy engine module 4320.

[0150] In one form of the present technology, the output values include the interface pressure Pm, the vent flow rate Qv, the respiratory flow rate Qr, and the leak flow rate QI.

[0151] In various forms of the present technology, the pre-processing module 4310 comprises one or more of the following algorithms: interface pressure estimation 4312, vent flow rate estimation 4314, leak flow rate estimation 4316. and respiratory flow rate estimation 4318.4.4.3.1.1 Interface pressure estimation

[0152] In one form of the present technology, an interface pressure estimation algorithm 4312 receives as inputs a signal from the pressure sensor 4272 indicative of the pressure in the pneumatic path proximal to an outlet of the pneumatic block (the device pressure Pd) and a signal from the flow rate sensor 4274 representative of the flow rate of the airflow leaving the RPT device 4000 (the device flow rate Qd). The device flow rate Qd, absent any supplementary gas 4180, may be used as the total flow rate Qt. The interface pressure algorithm 4312 estimates the pressure drop AP through the air circuit 4170. The dependence of the pressure drop AP on the total flow rate Qt may be modelled for the particular air circuit 4170 by a pressure drop characteristic AP(Q). The interface pressure estimation algorithm, 4312 then provides as an output an estimated pressure, Pm, in the patient interface 3000 or 3800. The pressure, Pm, in the patient interface 3000 or 3800 may be estimated as the device pressure Pd minus the air circuit pressure drop AP.4.4.3.1.2 Vent flow rate estimation

[0153] In one form of the present technology, a vent flow rate estimation algorithm 4314 receives as an input an estimated pressure, Pm, in the patient interface 3000 or 3800 from the interface pressure estimation algorithm 4312 and estimates a vent flow rate of air, Qv, from a ventRMDDHI(23) 3400 in a patient interface 3000 or 3800. The dependence of the vent flow rate Qv on the interface pressure Pm for the particular vent 3400 in use may be modelled by a vent characteristic Qv(Pm).4.4.3.1.3 Leak flow rate estimation

[0154] In one form of the present technology, a leak flow rate estimation algorithm 4316 receives as an input a total flow rate, Qt, and a vent flow rate Qv, and provides as an output an estimate of the leak flow rate QI. In one form, the leak flow rate estimation algorithm estimates the leak flow rate QI by calculating an average of the difference between total flow rate Qt and vent flow rate Qv over a period sufficiently long to include several breathing cycles, e.g. about 10 seconds.

[0155] In one form, the leak flow rate estimation algorithm 4316 receives as an input a total flow rate Qt, a vent flow rate Qv, and an estimated pressure, Pm, in the patient interface 3000 or 3800, and provides as an output a leak flow rate QI, by calculating a leak conductance, and determining a leak flow rate QI to be a function of leak conductance and pressure, Pm. Leak conductance is calculated as the quotient of low pass filtered non-vent flow rate equal to the difference between total flow rate Qt and vent flow rate Qv, and low pass filtered square root of pressure Pm, where the low pass filter time constant has a value sufficiently long to include several breathing cycles, e.g. about 10 seconds. The leak flow rate QI may be estimated as the product of leak conductance and a function of pressure. Pm.4.4.3.1.4 Respiratory flow rate estimation

[0156] In one form of the present technology, a respiratory flow rate estimation algorithm 4318 receives as an input a total flow rate, Qt, a vent flow rate, Qv, and a leak flow rate, QL and estimates a respiratory flow rate of air, Qr, to the patient, by subtracting the vent flow rate Qv and the leak flow rate QI from the total flow rate Qt.4.43.2 Therapy Engine Module

[0157] In one form of the present technology', a therapy engine module 4320 receives as inputs one or more of a pressure, Pm, in a patient interface 3000 or 3800, and a respiratory flow rate of air to a patient, Qr, and provides as an output one or more therapy parameters.

[0158] In one form of the present technology, a therapy parameter is a treatment pressure Pt.

[0159] In one form of the present technology, therapy parameters are one or more of an amplitude of a pressure variation, a base pressure, and a target ventilation.

[0160] In various forms, the therapy engine module 4320 comprises one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation determination 4323, inspiratory flow limitation determination 4324, apnea / hypopnea determination 4325, snore determination 4326, airway patency determination 4327, target ventilation determination 4328, and therapy parameter determination 4329.RMDDHI(23)4.4.3.2.1 Phase determination

[0161] In one form of the present technology, the RPT device 4000 does not determine phase.

[0162] In one form of the present technology, a phase determination algorithm 4321 receives as an input a signal indicative of respiratory flow rate, Qr. and provides as an output a phase cp of a current breathing cycle of a patient 1000.

[0163] In some forms, known as discrete phase determination, the phase output cp is a discrete variable. One implementation of discrete phase determination provides a bi-valued phase output cp with values of either inhalation or exhalation, for example represented as values of 0 and 0.5 revolutions respectively, upon detecting the start of spontaneous inhalation and exhalation respectively. RPT devices 4000 that “trigger” and “cycle” effectively perform discrete phase determination, since the trigger and cycle points are the instants at which the phase changes from exhalation to inhalation and from inhalation to exhalation, respectively. In one implementation of bi-valued phase determination, the phase output cp is determined to have a discrete value of 0 (thereby “triggering” the RPT device 4000) when the respiratory flow rate Qr has a value that exceeds a positive threshold, and a discrete value of 0.5 revolutions (thereby “cycling” the RPT device 4000) when a respirator}' flow rate Qr has a value that is more negative than a negative threshold. The inhalation time Ti and the exhalation time Te may be estimated as typical values over many respiratory cycles of the time spent with phase cp equal to 0 (indicating inspiration) and 0.5 (indicating expiration) respectively.

[0164] Another implementation of discrete phase determination provides a tri-valued phase output cp with a value of one of inhalation, mid-inspiratory pause, and exhalation.

[0165] In other forms, known as continuous phase determination, the phase output cp is a continuous variable, for example varying from 0 to 1 revolutions, or 0 to 277 radians. RPT devices 4000 that perform continuous phase determination may trigger and cycle when the continuous phase reaches 0 and 0.5 revolutions, respectively. In one implementation of continuous phase determination, a continuous value of phase > Dis determined using a fuzzy logic analysis of the respiratory flow rate Qr. A continuous value of phase determined in this implementation is often referred to as “fuzzy phase”. In one implementation of a fuzzy phase determination algorithm 4321, the following rules are applied to the respirator}’ flow rate Qr:1. If Qr is zero and increasing fast then cp is 0 revolutions.2. If Qr is large positive and steady then cp is 0.25 revolutions.3. If Qr is zero and falling fast, then cp is 0.5 revolutions.4. If Qr is large negative and steady then cp is 0.75 revolutions.5. If Qr is zero and steady and the 5-second low-pass filtered absolute value of Qr is large then cp is 0.9 revolutions.RMDDHI(23)6. If Qr is positive and the phase is expiratory, then cp is 0 revolutions.7. If Qr is negative and the phase is inspiratory, then cp is 0.5 revolutions.8. If the 5 -second low-pass filtered absolute value of Qr is large, cp is increasing at a steady rate equal to the patient’s breathing rate, low-pass filtered with a time constant of 20 seconds.

[0166] The output of each rule may be represented as a vector whose phase is the result of the rule and whose magnitude is the fuzzy7extent to which the rule is true. The fuzzy7extent to which the respiratory flow rate is “large”, “steady”, etc. is determined with suitable membership functions. The results of the rules, represented as vectors, are then combined by some function such as taking the centroid. In such a combination, the rules may be equally weighted, or differently weighted.

[0167] In another implementation of continuous phase determination, the phase cp is first discretely estimated from the respiratory7flow- rate Qr as described above, as are the inhalation time Ti and the exhalation time Te. The continuous phase cp at any instant may be determined as the half the proportion of the inhalation time Ti that has elapsed since the previous trigger instant, or 0.5 revolutions plus half the proportion of the exhalation time Te that has elapsed since the previous cycle instant (whichever instant was more recent).4.4.3.2.2 Waveform determination

[0168] In one form of the present technology, the therapy parameter determination algorithm 4329 provides an approximately7constant treatment pressure throughout a respiratory cycle of a patient.

[0169] In other forms of the present technology, the therapy control module 4330 controls the pressure generator 4140 to provide a treatment pressure Pt that varies as a function of phase cp of a respiratory cycle of a patient according to a waveform template n(cp).

[0170] In one form of the present technology, a waveform determination algorithm 4322 provides a waveform template n(ip) with values in the range [0, 1] on the domain of phase values <p provided by the phase determination algorithm 4321 to be used by the therapy parameter determination algorithm 4329.

[0171] In one form, suitable for either discrete or continuously-valued phase, the waveform template n(cp) is a square-w ave template, having a value of 1 for values of phase up to and including 0.5 revolutions, and a value of 0 for values of phase above 0.5 revolutions. In one form, suitable for continuously-valued phase, the waveform template n(<p) comprises two smoothly curved portions, namely a smoothly curved (e.g. raised cosine) rise from 0 to 1 for values of phase up to 0.5 revolutions, and a smoothly curved (e.g. exponential) decay from 1 to 0 for values of phase above 0.5 revolutions. In one form, suitable for continuously-valued phase, the waveformRMDDHI(23) template n(cp) is based on a square wave, but with a smooth rise from 0 to 1 for values of phase up to a “rise time” that is less than 0.5 revolutions, and a smooth fall from 1 to 0 for values of phase within a “fall time” after 0.5 revolutions, with a “fall time” that is less than 0.5 revolutions.

[0172] In some forms of the present technology, the waveform determination algorithm 4322 selects a waveform template fl(<p) from a library of waveform templates, dependent on a setting of the RPT device. Each waveform template n(cp) in the library may be provided as a lookup table of values Pt against phase values cp. In other forms, the waveform determination algorithm 4322 computes a waveform template EI(cp) “on the fly” using a predetermined functional form, possibly parametrized by one or more parameters (e.g. time constant of an exponentially curved portion). The parameters of the functional form may be predetermined or dependent on a current state of the patient 1000.

[0173] In some forms of the present technology, suitable for discrete bi-valued phase of either inhalation (cp = 0 revolutions) or exhalation (cp = 0.5 revolutions), the waveform determination algorithm 4322 computes a waveform template n “on the fly” as a function of both discrete phase cp and time t measured since the most recent trigger instant. In one such form, the waveform determination algorithm 4322 computes the waveform template fl(q>, t) in two portions (inspiratory and expiratory ) as follows: o = o0 = 0.5

[0174] where fli(t) and fle(t) are inspiratory7and expiratory7portions of the waveform template n((p, t). In one such form, the inspiratory7portion fli(t) of the waveform template is a smooth rise from 0 to 1 parametrized by a rise time, and the expiratory portion ne(t) of the waveform template is a smooth fall from 1 to 0 parametrized by a fall time.4.4.3.2.3 Ventilation determination

[0175] In one form of the present technology, a ventilation determination algorithm 4323 receives an input a respiratory flow rate Qr, and determines a measure indicative of current patient ventilation. Vent.

[0176] In some implementations, the ventilation determination algorithm 4323 determines a measure of ventilation Vent that is an estimate of actual patient ventilation. One such implementation is to take half the absolute value of respiratory flow rate, Qr, optionally filtered by low-pass filter such as a second order Bessel low-pass filter with a comer frequency of 0. 11 Hz.

[0177] In other implementations, the ventilation determination algorithm 4323 determines a measure of ventilation Vent that is broadly proportional to actual patient ventilation. One such implementation estimates peak respiratory7flow rate Qpeak over the inspiratory7portion of the cycle. This and many other procedures involving sampling the respiratory flow rate Qr produceRMDDHI(23) measures which are broadly proportional to ventilation, provided the flow rate waveform shape does not vary very much (here, the shape of two breaths is taken to be similar when the flow- rate waveforms of the breaths normalized in time and amplitude are similar). Some simple examples include the median positive respiratory flow rate, the median of the absolute value of respiratory flow rate, and the standard deviation of flow rate. Arbitrary linear combinations of arbitrary’ order statistics of the absolute value of respiratory flow rate using positive coefficients, and even some using both positive and negative coefficients, are approximately proportional to ventilation. Another example is the mean of the respiratory’ flow' rate in the middle K proportion (by time) of the inspiratory portion, where 0 < K < 1. There is an arbitrarily large number of measures that are exactly proportional to ventilation if the flow rate shape is constant.4.4.3.2.4 Determination of Inspiratory Flow Limitation

[0178] In one form of the present technology, the central controller 4230 executes an inspiratory flow limitation determination algorithm 4324 for the determination of the extent of inspiratory flow limitation.

[0179] In one form, the inspiratory flow’ limitation determination algorithm 4324 receives as an input a respiratory’ flow rate signal Qr and provides as an output a metric of the extent to which the inspiratory’ portion of the breath exhibits inspiratory flow’ limitation.

[0180] In one form of the present technology’, the inspiratory portion of each breath is identified by a zero-crossing detector. A number of evenly spaced points (for example, sixty -five), representing points in time, are interpolated by’ an interpolator along the inspiratory flow rate-time curv e for each breath. The curve described by the points is then scaled by a scalar to have unity' length (duration / period) and unity area to remove the effects of changing breathing rate and depth. The scaled breaths are then compared in a comparator with a pre-stored template representing a normal unobstructed breath, similar to the inspiratory portion of the breath shown in Fig. 6. Breaths deviating by more than a specified threshold (typically 1 scaled unit) at any time during the inspiration from this template, such as those due to coughs, sighs, swallows and hiccups, as determined by a test element, are rejected. For non-rejected data, a moving average of the first such scaled point is calculated by the central controller 4230 for the preceding several inspiratory events. This is repeated over the same inspiratory events for the second such point, and so on. Thus, for example, sixty -five scaled data points are generated by the central controller 4230, and represent a moving average of the preceding several inspiratory events, e.g., three events. The moving average of continuously updated values of the (e.g., sixty -five) points are hereinafter called the "scaled flow rate ", designated as Qs(t). Alternatively, a single inspiratory event can be utilized rather than a moving average.RMDDHI(23)[01811 From the scaled flow rate, two shape factors relating to the determination of partial obstruction may be calculated.

[0182] Shape factor 1 is the ratio of the mean of the middle (e.g. thirty -two) scaled flow rate points to the mean overall (e.g. sixty-five) scaled flow rate points. Where this ratio is in excess of unity, the breath will be taken to be normal. Where the ratio is unity or less, the breath will be taken to be obstructed. A ratio of about 1.17 is taken as a threshold between partially obstructed and unobstructed breathing, and equates to a degree of obstruction that would permit maintenance of adequate oxygenation in a ty pical patient.

[0183] Shape factor 2 is calculated as the RMS deviation from unit scaled flow rate, taken over the middle (e.g. thirty -two) points. An RMS deviation of about 0.2 units is taken to be normal. An RMS deviation of zero is taken to be a totally flow-limited breath. The closer the RMS deviation to zero, the breath will be taken to be more flow limited.

[0184] Shape factors 1 and 2 may be used as alternatives, or in combination. In other forms of the present technology, the number of sampled points, breaths and middle points may differ from those described above. Furthermore, the threshold values can be other than those described.4.4.3.2.S Determination of apneas and hypopneas

[0185] In one form of the present technology, the central controller 4230 executes an apnea / hypopnea determination algorithm 4325 for the determination of the presence of apneas and / or hypopneas.

[0186] In one form, the apnea / hypopnea determination algorithm 4325 receives as an input a respiratory flow' rate signal Qr and provides as an output a flag that indicates that an apnea or a hypopnea has been detected.

[0187] In one form, an apnea will be said to have been detected when a function of respiratory flow rate Qr falls below a flow rate threshold for a predetermined period of time. The function may determine a peak flow' rate, a relatively short-term mean flow' rate, or a flow rate intermediate of relatively short-term mean and peak flow' rate, for example an RMS flow' rate. The flow rate threshold may be a relatively long-term measure of flow rate.

[0188] In one form, a hypopnea will be said to have been detected when a function of respiratory flow rate Qr falls below' a second flow rate threshold for a predetermined period of time. The function may determine a peak flow', a relatively short-term mean flow rate, or a flow' rate intermediate of relatively short-term mean and peak flow rate, for example an RMS flow rate. The second flow rate threshold may be a relatively long-term measure of flow rate. The second flow rate threshold is greater than the flow' rate threshold used to detect apneas.RMDDHI(23)4.4.3.2.6 Determination of snore

[0189] In one form of the present technology, the central controller 4230 executes one or more snore determination algorithms 4326 for the determination of the extent of snore.

[0190] In one form, the snore determination algorithm 4326 receives as an input a respiratory flow rate signal Qr and provides as an output a metric of the extent to which snoring is present.

[0191] The snore determination algorithm 4326 may comprise the step of determining the intensity of the flow rate signal in the range of 30-300 Hz. Further, the snore determination algorithm 4326 may comprise a step of filtering the respiratory flow rate signal Qr to reduce background noise, e.g.. the sound of airflow in the system from the blower.4.4.3.2. 7 Determination o f airway patency

[0192] In one form of the present technology', the central controller 4230 executes one or more airway patency determination algorithms 4327 for the determination of the extent of airway patency.

[0193] In one form, the airway patency determination algorithm 4327 receives as an input a respiratory flow rate signal Qr, and determines the power of the signal in the frequency range of about 0.75 Hz and about 3 Hz. The presence of a peak in this frequency range is taken to indicate an open airway. The absence of a peak is taken to be an indication of a closed airway.

[0194] In one form, the frequency range within which the peak is sought is the frequency of a small forced oscillation in the treatment pressure Pt. In one implementation, the forced oscillation is of frequency 2 Hz with amplitude about 1 cmH20.

[0195] In one form, airway patency determination algorithm 4327 receives as an input a respiratory flow rate signal Qr, and determines the presence or absence of a cardiogenic signal. The absence of a cardiogenic signal is taken to be an indication of a closed airway.4.4.3.2.8 Determination of target ventilation

[0196] In one form of the present technology7, the central controller 4230 takes as input the measure of current ventilation, Vent, and executes one or more target ventilation determination algorithms 4328 for the determination of a target value Vtgt for the measure of ventilation.

[0197] In some forms of the present technology, there is no target ventilation determination algorithm 4328, and the target value Vtgt is predetermined, for example by hard-coding during configuration of the RPT device 4000 or by manual entry through the input device 4220.

[0198] In other forms of the present technology, such as adaptive servo-ventilation (ASV), the target ventilation determination algorithm 4328 computes a target value Vtgt from a value Vtyp indicative of the typical recent ventilation of the patient.RMDDHI(23) ro 1991 In some forms of adaptive servo-ventilation, the target ventilation Vtgt is computed as a high proportion of, but less than, the typical recent ventilation Vtyp. The high proportion in such forms may be in the range (80%, 100%), or (85%, 95%), or (87%, 92%).

[0200] In other forms of adaptive servo-ventilation, the target ventilation Vtgt is computed as a slightly greater than unity multiple of the typical recent ventilation Vtyp.

[0201] The typical recent ventilation Vtyp is the value around which the distribution of the measure of current ventilation Vent over multiple time instants over some predetermined timescale tends to cluster, that is, a measure of the central tendency of the measure of current ventilation over recent history. In one implementation of the target ventilation determination algorithm 4328, the recent history is of the order of several minutes, but in any case should be longer than the timescale of Cheyne-Stokes waxing and waning cycles. The target ventilation determination algorithm 4328 may use any of the variety of well-known measures of central tendency to determine the typical recent ventilation Vtyp from the measure of current ventilation, Vent. One such measure is the output of a low-pass filter on the measure of current ventilation Vent, with time constant equal to one hundred seconds.4.4.3.2.9 Determination of therapy parameters

[0202] In some forms of the present technology, the central controller 4230 executes one or more therapy parameter determination algorithms 4329 for the determination of one or more therapy parameters using the values returned by one or more of the other algorithms in the therapy engine module 4320.

[0203] In one form of the present technology, the therapy parameter is an instantaneous treatment pressure Pt. In one implementation of this form, the therapy parameter determination algorithm 4329 determines the treatment pressure Pt using the equation

[0204] where:• A is the amplitude,• n(cp,t) is the waveform template value (in the range 0 to 1) at the current value cp of phase and t of time, and• Po is a base pressure.

[0205] If the waveform determination algorithm 4322 provides the waveform template II(cp,t) as a lookup table of values fl indexed by phase cp, the therapy parameter determination algorithm 4329 applies equation (1) by locating the nearest lookup table entry to the current value cp of phase returned by the phase determination algorithm 4321, or by interpolation between the two entries straddling the current value cp of phase.RMDDHI(23)

[0206] The values of the amplitude A and the base pressure P0 may be set by the therapy parameter determination algorithm 4329 depending on the chosen respiratory pressure therapy mode in the manner described below.

[0207] The therapy parameter determination algorithms may include any or all of the algorithms for adjusting therapy that are described herein, such as those described in relation to Figs. 8A to 16.4.4.3.2.10 Mask-off determination

[0208] It can be helpful to assess whether a patient is compliant with respiratory7pressure therapy, i.e. whether they wear or remove the patient interface while sleeping. Accordingly, the therapy control module 4330 may periodically query the leak flow rate estimation algorithm 4316, which uses an estimate of pressure at the patient interface to determine how much air is leaking from the interface. In case the patient is not wearing / using the patient interface while the RPT device is operating, the leak flow rate will exceed a threshold value, and the therapy control module 4330 may assess a “mask-off’ event. It should be understood that “mask-off’ is a term of convenience and that the determination equally is applicable to other patient interfaces, e.g., nasal pillows. A mask-on event may be determined similarly such as by detecting a low leak flow rate or patient respiratory flow via the mask.4.4.3.3 Therapy Control module

[0209] The therapy control module 4330 in accordance with one aspect of the present technology receives as inputs the therapy parameters from the therapy parameter determination algorithm 4329 of the therapy engine module 4320, and controls the pressure generator 4140 to deliver a flow of air in accordance with the therapy parameters.

[0210] In one form of the present technology, the therapy parameter is a treatment pressure Pt, and the therapy control module 4330 controls the pressure generator 4140 to deliver a flow of air whose interface pressure Pm at the patient interface 3000 or 3800 is equal to the treatment pressure Pt.4.4.3.4 Detection of fault conditions

[0211] In one form of the present technology7, the central controller 4230 executes one or more methods 4340 for the detection of fault conditions. The fault conditions detected by the one or more methods 4340 may include at least one of the following:• Power failure (no power, or insufficient power)• Transducer fault detection• Failure to detect the presence of a component• Operating parameters outside recommended ranges (e g. pressure, flow rate, temperature, PaO2)RMDDHI(23)• Failure of a test alarm to generate a detectable alarm signal.

[0212] Upon detection of the fault condition, the corresponding algorithm 4340 signals the presence of the fault by one or more of the following:• Initiation of an audible, visual & / or kinetic (e.g. vibrating) alarm• Sending a message to an external device• Logging of the incident4.5 AIR CIRCUIT

[0213] An air circuit 4170 in accordance with an aspect of the present technology is a conduit or a tube constmcted and arranged to allow, in use, a flow of an to travel between two components such as RPT device 4000 and the patient interface 3000 or 3800.

[0214] In particular, the air circuit 4170 may be in fluid connection with the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air deliverytube. In some cases there may be separate limbs of the circuit for inhalation and exhalation. In other cases a single limb is used.

[0215] In some forms, the air circuit 4170 may comprise one or more heating elements configured to heat air in the air circuit, for example to maintain or raise the temperature of the air. The heating element may be in a form of a heated wire circuit, and may comprise one or more transducers, such as temperature sensors. In one form, the heated wire circuit may be helically w ound around the axis of the air circuit 4170. The heating element may be in communication with a controller such as a central controller 4230. One example of an air circuit 4170 comprising a heated wire circuit is described in U.S. Pat. No. 8,733.349, which is hereby incorporated byreference in its entirety.4.5.1 Supplementary gas delivery

[0216] In one form of the present technology, supplementary- gas, e.g. oxygen, 4180 is delivered to one or more points in the pneumatic path, such as upstream of the pneumatic block 4020. to the air circuit 4170, and / or to the patient interface 3000 or 3800.4.6 HUMIDIFIER4.6.1 Humidifier overview

[0217] In one form of the present technology there is provided a humidifier 5000 (e.g. as shown in Fig. 5A) to change the absolute humidity of air or gas for delivery to a patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity and increase the temperature of the flow- of air (relative to ambient air) before delivery to the patient’s airways.

[0218] The humidifier 5000 may comprise a humidifier reservoir 5110, a humidifier inlet 5002 to receive a flow of air, and a humidifier outlet 5004 to deliver a humidified flow of air. In some forms, as shown in Fig. 5A and Fig. 5B, an inlet and an outlet of the humidifier reservoirRMDDHI(23) 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004 respectively. The humidifier 5000 may further comprise a humidifier base 5006, which may be adapted to receive the humidifier reservoir 5110 and comprise a heating element 5240.4.7 BREATHING WAVEFORMS

[0219] Fig. 6 shows a model typical breath waveform of a person while sleeping. The horizontal axis is time, and the vertical axis is respiratory flow rate. While the parameter values may vary, a typical breath may have the following approximate values: tidal volume Vt 0.5L, inhalation time Ti 1.6s, peak inspiratory flow rate Qpeak 0.4 L / s, exhalation time Te 2.4s, peak expiratory’ flow rate Qpeak -0.5 L / s. The total duration of the breath, Ttot. is about 4s. The person typically breathes at a rate of about 15 breaths per minute (BPM), with Ventilation Vent about 7.5 L / min. A ty pical duty cycle, the ratio of Ti to Ttot, is about 40%.4.8 SCREENING, DIAGNOSIS, MONITORING SYSTEMS4.8.1 Respiratory polygraphy

[0220] Fig. 7C illustrates a screening / diagnosis / monitoring device 7200 that may be used to implement an RPG headbox in an RPG screening / diagnosis I monitoring system. The screening / diagnosis / monitoring device 7200 receives the three RPG channels mentioned above (a signal indicative of thoracic movement, a signal indicative of nasal flow rate, and a signal indicative of oxygen saturation) at a data input interface 7260. The screening / diagnosis / monitoring device 7200 also contains a processor 7210 configured to carry out encoded instructions. The screening / diagnosis / monitoring device 7200 also contains a non-transitory computer readable memory / storage medium 7230.

[0221] Memory 7230 may be the screening I diagnosis / monitoring device 7200's internal memory, such as RAM, flash memory or ROM. In some implementations, memory 7230 may also be a removable or external memory linked to screening / diagnosis / monitoring device 7200, such as an SD card, server, USB flash drive or optical disc, for example. In other implementations, memory’ 7230 can be a combination of external and internal memory. Memory’ 7230 includes stored data 7240 and processor control instructions (code) 7250 adapted to configure the processor 7210 to perform certain tasks. Stored data 7240 can include RPG channel data received by data input interface 7260, and other data that is provided as a component part of an application. Processor control instructions 7250 can also be provided as a component part of an application program. The processor 7210 is configured to read the code 7250 from the memory 7230 and execute the encoded instructions. In particular, the code 7250 may’ contain instructions adapted to configure the processor 7210 to carry out methods of processing the RPG channel data provided by the interface 7260. One such method may be to store the RPG channel data as data 7240 in theRMDDHI(23) memory 7230. Another such method may be to analyze the stored RPG data to extract features. The processor 7210 may store the results of such analysis as data 7240 in the memory 7230.

[0222] The screening / diagnosis / monitoring device 7200 may also contain a communication interface 7220. The code 7250 may contain instructions configured to allow the processor 7210 to communicate with an external computing device (not shown) via the communication interface 7220. The mode of communication may be wired or wireless. In one such implementation, the processor 7210 may' transmit the stored RPG channel data from the data 7240 to the remote computing device. In such an implementation, the remote computing device may be configured to analyze the received RPG data to extract features. In another such implementation, the processor 7210 may transmit the analysis results from the data 7240 to the remote computing device.

[0223] Alternatively, if the memory 7230 is removable from the screening / diagnosis / monitoring device 7200, the remote computing device may be configured to be connected to the removable memory' 7230. In such an implementation, the remote computing device may be configured to analyze the RPG data retrieved from the removable memory 7230 to extract the features.4.9 RESPIRATORY THERAPY MODES

[0224] Various respiratory' therapy modes may be implemented by the disclosed respiratory' therapy system.4.9.1 CPAP therapy

[0225] In some implementations of respiratory pressure therapy, the central controller 4230 sets the treatment pressure Pt according to the treatment pressure equation (1) as part of the therapy parameter determination algorithm 4329. In one such implementation, the amplitude A is identically zero, so the treatment pressure Pt (which represents a target value to be achieved by the interface pressure Pm at the current instant of time) is identically equal to the base pressure P0 throughout the respiratory' cycle. Such implementations are generally grouped under the heading of CPAP therapy. In such implementations, there is no need for the therapy engine module 4320 to determine phase cp or the waveform template n(cp,t).

[0226] In CPAP therapy, the base pressure P0 may be a constant value that is hard-coded or manually entered to the RPT device 4000. Alternatively, the central controller 4230 may repeatedly compute the base pressure P0 as a function of indices or measures of sleep disordered breathing returned by the respective algorithms in the therapy engine module 4320, such as one or more of flow limitation, apnea, hypopnea. patency, and snore. This alternative is sometimes referred to as APAP therapy.

[0227] Fig. 4E is a flow chart illustrating a method 4500 carried out by the central controller 4230 to continuously compute the base pressure P0 as part of an APAP therapy implementation ofRMDDHI(23) the therapy parameter determination algorithm 4329, when the pressure support A is identically zero.

[0228] The method 4500 starts at step 4520, at which the central controller 4230 compares the measure of the presence of apnea / hypopnea with a first threshold, and determines whether the measure of the presence of apnea / hypopnea has exceeded the first threshold for a predetermined period of time, indicating an apnea / hypopnea is occurring. If so, the method 4500 proceeds to step 4540; otherwise, the method 4500 proceeds to step 4530. At step 4540, the central controller 4230 compares the measure of airway patency with a second threshold. If the measure of airway patency exceeds the second threshold, indicating the airway is patent, the detected apnea / hypopnea is deemed central, and the method 4500 proceeds to step 4560; otherwise, the apnea / hypopnea is deemed obstructive, and the method 4500 proceeds to step 4550.

[0229] At step 4530, the central controller 4230 compares the measure of flow limitation with a third threshold. If the measure of flow limitation exceeds the third threshold, indicating inspiratory flow is limited, the method 4500 proceeds to step 4550; otherwise, the method 4500 proceeds to step 4560.

[0230] At step 4550, the central controller 4230 increases the base pressure P0 by a predetermined pressure increment AP, provided the resulting treatment pressure Pt would not exceed a maximum treatment pressure Pmax. In one implementation, the predetermined pressure increment AP and maximum treatment pressure Pmax are 1 cmH20 and 25 cmH20 respectively. In other implementations, the pressure increment AP can be as low as 0. 1 cmH20 and as high as 3 cmH20, or as low as 0.5 cmH20 and as high as 2 cmH20. In other implementations, the maximum treatment pressure Pmax can be as low as 15 cmH20 and as high as 35 cmH20, or as low as 20 cmH20 and as high as 30 cmH20. The method 4500 then returns to step 4520.

[0231] At step 4560, the central controller 4230 decreases the base pressure P0 by a decrement, provided the decreased base pressure P0 would not fall below a minimum treatment pressure Pmin. The method 4500 then returns to step 4520. In one implementation, the decrement is proportional to the value of PO-Pmin, so that the decrease in P0 to the minimum treatment pressure Pmin in the absence of any detected events is exponential. In one implementation, the constant of proportionality is set such that the time constant T of the exponential decrease of P0 is 60 minutes, and the minimum treatment pressure Pmin is 4 cmH20. In other implementations, the time constant r could be as low as 1 minute and as high as 300 minutes, or as low as 5 minutes and as high as 180 minutes. In other implementations, the minimum treatment pressure Pmin can be as low as 0 cmH20 and as high as 8 cmH20, or as low as 2 cmH20 and as high as 6 cmH20. Alternatively, the decrement in P0 could be predetermined, so the decrease in P0 to the minimum treatment pressure Pmin in the absence of any detected events is linear.RMDDHI(23)4.9.2 Bi-level therapy

[0232] In other implementations of this form of the present technology, the value of amplitude A in equation (1) may be positive. Such implementations are known as bi-level therapy, because in determining the treatment pressure Pt using equation (1) with positive amplitude A, the therapy parameter determination algorithm 4329 oscillates the treatment pressure Pt between two values or levels in synchrony with the spontaneous respiratory effort of the patient 1000. That is, based on the typical waveform templates n(q>,t) described above, the therapy parameter determination algorithm 4329 increases the treatment pressure Pt to Po + A (known as the IPAP) at the start of, or during, or inspiration and decreases the treatment pressure Pt to the base pressure PO (known as the EPAP) at the start of, or dunng, expiration.

[0233] In some forms of bi-level therapy, the IPAP is a treatment pressure that has the same purpose as the treatment pressure in CPAP therapy modes, and the EPAP is the IPAP minus the amplitude A, which has a “small” value (a few cmH20) sometimes referred to as the Expiratory' Pressure Relief (EPR). Such forms are sometimes referred to as CPAP therapy with EPR, which is generally thought to be more comfortable than straight CPAP therapy. In CPAP therapy with EPR, either or both of the IPAP and the EPAP may be constant values that are hard-coded or manually entered to the RPT device 4000. Alternatively, the therapy parameter determination algorithm 4329 may repeatedly compute the IPAP and I or the EPAP during CPAP with EPR. In this alternative, the therapy parameter determination algorithm 4329 repeatedly computes the EPAP and / or the IPAP as a function of indices or measures of sleep disordered breathing returned by the respective algorithms in the therapy engine module 4320 in analogous fashion to the computation of the base pressure P0 in APAP therapy described above.

[0234] In other forms of bi-level therapy, the amplitude A is large enough that the RPT device 4000 does some or all of the w ork of breathing of the patient 1000. In such forms, known as pressure support ventilation therapy, the amplitude A is referred to as the pressure support, or swing. In pressure support ventilation therapy, the IPAP is the base pressure P0 plus the pressure support A, and the EPAP is the base pressure P0.

[0235] In some forms of pressure support ventilation therapy, known as fixed pressure support ventilation therapy, the pressure support A is fixed at a predetermined value, e.g. 10 cmH20. The predetermined pressure support value is a setting of the RPT device 4000, and may be set for example by hard-coding during configuration of the RPT device 4000 or by manual entry through the input device 4220.

[0236] In other forms of pressure support ventilation therapy, broadly known as servoventilation. the therapy parameter determination algorithm 4329 takes as input some currently measured or estimated parameter of the respiratory cycle (e.g. the current measure Vent ofRMDDHI(23) ventilation) and a target value of that respiratory parameter (e.g. a target value Vtgt of ventilation) and repeatedly adjusts the parameters of equation (1 ) to bring the current measure of the respiratory parameter towards the target value. In a form of servo-ventilation known as adaptive servoventilation (ASV), which has been used to treat CSR, the respiratory' parameter is ventilation, and the target ventilation value Vtgt is computed by the target ventilation determination algorithm4328 from the typical recent ventilation Vtyp, as described above.

[0237] In some forms of servo-ventilation, the therapy parameter determination algorithm4329 applies a control methodology to repeatedly compute the pressure support A so as to bring the current measure of the respiratory parameter towards the target value. One such control methodology is Proportional-Integral (PI) control. In one implementation of PI control, suitable for ASV modes in which a target ventilation Vtgt is set to slightly less than the ty pical recent ventilation Vty p, the pressure support A is repeatedly computed as:A = G^(Vent -Vtgt)dt

[0238] where G is the gain of the PI control. Larger values of gain G can result in positive feedback in the therapy engine module 4320. Smaller values of gain G may permit some residual untreated CSR or central sleep apnea. In some implementations, the gain G is fixed at a predetermined value, such as -0.4 cmH2O / (L / min) / sec. Alternatively, the gain G may be varied between therapy sessions, starting small and increasing from session to session until a value that substantially eliminates CSR is reached. Conventional means for retrospectively analyzing the parameters of a therapy session to assess the severity of CSR during the therapy session may be employed in such implementations. In yet other implementations, the gain G may vary depending on the difference between the current measure Vent of ventilation and the target ventilation Vtgt.

[0239] Other servo-ventilation control methodologies that may be applied by the therapy parameter determination algorithm 4329 include proportional (P), proportional-differential (PD), and proportional-integral-differential (PID).

[0240] The value of the pressure support A computed via equation (2) may be clipped to a range defined as [Amin, Amax], In this implementation, the pressure support A sits by default at the minimum pressure support Amin until the measure of current ventilation Vent falls below the target ventilation Vtgt, at which point A starts increasing, only falling back to Amin when Vent exceeds Vtgt once again.

[0241] The pressure support limits Amin and Amax are settings of the RPT device 4000, set for example by hard-coding during configuration of the RPT device 4000 or by manual entry through the input device 4220.

[0242] In pressure support ventilation therapy modes, the EPAP is the base pressure P0. As with the base pressure P0 in CPAP therapy, the EPAP may be a constant value that is prescribedRMDDHI(23) or determined during titration. Such a constant EPAP may be set for example by hard-coding during configuration of the RPT device 4000 or by manual entry through the input device 4220. This alternative is sometimes referred to as fixed-EPAP pressure support ventilation therapy. Titration of the EPAP for a given patient may be performed by a clinician during a titration session with the aid of PSG, with the aim of preventing obstructive apneas, thereby maintaining an open airway for the pressure support ventilation therapy, in similar fashion to titration of the base pressure P0 in constant CPAP therapy.

[0243] Alternatively, the therapy parameter determination algorithm 4329 may repeatedly compute the base pressure P0 during pressure support ventilation therapy. In such implementations, the therapy parameter determination algorithm 4329 repeatedly computes the EPAP as a function of indices or measures of sleep disordered breathing returned by the respective algorithms in the therapy engine module 4320, such as one or more of respiratory events of flow limitation, apnea, hypopnea, patency, and snore. Because the continuous computation of the EPAP resembles the manual adjustment of the EPAP by a clinician during titration of the EPAP. this process is also sometimes referred to as auto-titration of the EPAP, and the therapy mode is known as auto-titrating EPAP pressure support ventilation therapy, or auto-EPAP pressure support ventilation therapy.4.10 ADDITIONAL THERAPY, ASPECTS

[0244] In some forms of the present technology, a respiratory therapy system, which may comprise an RPT device 4000 for supplying a flow of air to the patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800, is configured or otherwise embodied to incorporate further potential changes to therapy settings, such as those discussed in Int’l App. No. PCT / AU2024 / 050572 filed on 31 May 2024 (‘572), the contents of which are hereby incorporated by reference in its entirety and for all purposes.

[0245] In some forms of the present technology, a respiratory therapy system, which may comprise an RPT device 4000 for supplying a flow of air to the patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800, is configured or otherwise embodied as an auto-adjusting pressure device (or self-adjusting device) comprising advanced event detection and auto-adjusting mechanisms, such as those discussed in ‘572.4.11 COMMUNICATION AND DATA MANAGEMENT SYSTEM

[0246] Figs. 7A-7B depict an example system 700 configured to implement the technology- discussed herein, such as in relation to devices used in the diagnostic and / or therapy stages previously described which may occur withing the same timeframe such that the stages may overlap. In particular, Fig. 7A is a block diagram and Fig. 7B is a functional diagram of example system 700 that includes client systems 1605 (including client systems 1605-1 to 1605-x, where xRMDDHI(23) is a number), service provider platforms (SPPs) 1602 (including SPPs 1602-1 to 1602 -y. where y is anumber), and consent platform 1640 (also referred to as “consent system 1640”), each of which may communicate over a network 150, which may involve multiple networks. The examples of Figs. 7A-7B should not be considered as limiting the scope of the disclosure or usefulness of the features described herein.

[0247] The diagnostic devices 101 may include, for example, a smart watch 101a, ECG / EKG device 101b, a finger sensor device 101 f (such as a photoplethy smogram (PPG), or pulse oximeter and / or peripheral arterial tone sensor), a biopotential measurement device lOle, a monitoring device 7200 of Fig. 7C. health tracker, fitness tracker, a blood monitor (e.g., a glucose meter, lactic acid meter / analyzer, and / or the like), flow sensors and / or flow rate sensors, pressure sensors, motion sensors, image capture devices (e.g., cameras), sonar sensors, and / or microphones, among other possibilities. The therapy devices 105 may include, for example, a respiratory pressure medical device 105asuch as an RPT device and / or HFT, which may include CPAP devices, BiPAP devices, APAP devices, PEP devices, oxygen concentrators, portable ventilators, and / or the like. The therapy devices 105 can also include, for example, nerve or muscle stimulator such as a transcutaneous electrical nene stimulation (TENS) units, nebulizers, dialysis devices, compression therapy devices, ultrasound therapy devices, traction devices, cry otherapy devices, and / or the like. In an example, the therapy device 105 may include the RPT device 4000, humidifier 5000, and patient interface 3000 described herein. Additionally or alternatively, the medical devices, such as diagnostic devices 101 and / or therapy devices 105, may be or include any of the devices discussed in U.S. Prov. App. No. 63 / 662,455, EP Pat. No. 3,593,707, U.S. Pat. Pub. 2020 / 0015737, U.S. Pat. Pub. 2021 / 0275056, U.S. Pat. Pub. 2022 / 0007965, U.S. Pat. Pub. 2014 / 0024917. Infl App. No. PCT / EP2017 / 070773, U.S. Pat. Pub. 2018 / 0239014, the entire disclosures of each of which are hereby incorporated herein by reference for all purposes.

[0248] The client systems 1605 include physical and / or virtual hardware devices and software components capable of accessing content and / or services provided by SPPs 1602 and / or consent platform 1640. Each SPP 1602 may represent an entity that provides services and / or content to consumers. Each of the SPPs 1602 include one or more physical and / or virtualized systems (e.g., one or more servers, data storage systems, etc.) for providing content, applications (apps), and / or services to one or more clients (e.g., client system 1605, diagnostic devices 101, therapy devices 105, etc.) over the network 150. Users and / or client systems 1605 that utilize, obtain, or consume apps, content, and / or services provided by that SPP 1602 may be referred to as “subscribers” of that SPP 1602.

[0249] For example, the SPP 1602-1 may provide diagnostic services to one or more users of one or more diagnostic device(s) 101 and SPP 1602-2 may provide therapy services to one or moreRMDDHI(23) users of one or more therapy device(s) 105. In this example, the diagnostic services may include sleep study services, wherein the SPP 1602-1 collects sensor data from one or more diagnostic devices 101, such as while users are asleep, and monitors the sensor data to detect sleep disruption events, such as apneas, cessation of breath, and the like. The sleep study sendees may also include analytics functionality based on the sensor data. In this example, the therapy services may include controlling various settings of the therapy device(s) 105 to provide respiratory therapy to users of those therapy device(s) 105. In some examples, some patients may be users of diagnostic devices 101 and therapy devices 105, and thus, such users may be subscribers of multiple SPPs 1602.

[0250] The consent platform 1640 also includes one or more physical and / or virtualized systems (e.g., server(s) 1645 and / or database system(s) 1646 discussed infra with respect to Fig. 16) for providing content, apps, and / or services to its clients and / or subscribers, which may be the SPP 1602 in this example. An SPP 1602 (or users and / or client systems 1605 associated with an SPP 1602) that utilize, obtain, or consume apps and / or services provided by the consent platform 1640 may be referred to as "subscribers7' of the consent platform 1640 or "consent platform subscribers7’.

[0251] The physical and / or virtualized systems of the SPPs 1602 and / or consent platform 1640 may include one or more logically or physically connected servers, such as servers 201, 1645, and / or data storage devices, such as databases 1646, centrally located and / or distributed across one or more geographic locations (e.g., within one or more data center networks and the like). In some examples, the SPPs 1602 and / or consent platform 1640 may be part of a cloud computing service or edge network. Each of the client system 1605, SPPs 1602, and / or consent platform 1640 components may have the same or similar components as those discussed infra with respect to Figs. 7B and 7C.

[0252] In some cases, two or more SPPs 1602 may integrate their sen ices with one another or otherwise share data. In a first example, the diagnostic SPP 1602-1 may be requested to share data with another SPP 1602, which may provide GUI sen-ices or other analysis service for healthcare providers such as hospital or doctor's office and / or to the patient users. In a second example, the diagnostic services provided by SPP 1602-1 may be integrated with the therapy services of therapy app 1610, which may be provided by SPP 1602-2. In this example, the diagnostic data collected by SPP 1602-1 from diagnostic devices 101 may be stored in its own data storage system. However, legal or regulatory requirements, such as HIPAA requirements, may prevent SPP 1602-1 from sharing its diagnostic data with other SPPs 1602 without informed consent. Thus, in order to satisfy these legal or regulatory requirements, such as HIPAA requirements, the subscribers of SPP 1602-1 would need to provide their consent to share their diagnostic data with SPP 1602-2 so that that SPP 1602-2 could tailor their diagnostic and / orRMDDHI(23) therapy experience in the app 1610 for their evaluation and / or treatment such as a respiratory therapy.

[0253] As discussed in more detail infra, the services provided by the consent platform 1640, such as sendees 1620, 1630 of Fig. 16, are capable of collecting and recording user consent on behalf of individual SPPs 1602. The services provided by the consent platform 1640. such as services 1620, 1630 of Fig. 16, include providing consent and / or permission related services to various SPPs 1602 so that those SPPs 1602 can share user / client data with one another to better refine their ability to provide their own content, apps, and / or services to their subscribers. For instance, the consent platform 1640 may integrate with the apps and / or services provided by SPP 1602 to obtain consent from their subscribers to share data with other SPPs 1602. For example, a subscriber of SPP 1602-1 may provide consent to the SPP 1602-1 through the consent platform 1640 to allow SPP 1602-1 to share the subscriber’s diagnostic data with SPP 1602-2 such as with a first device. Here, the SPP 1602-2 may utilize the shared diagnostic data to enhance or refine the therapy provided to that subscriber and / or other users of other devices, such as therapy devices 105. In another example, a subscriber of SPP 1602-1 may provide consent to the SPP 1602-1 through the consent platform 1640 to allow SPP 1602-1 to share the subscriber’s diagnostic data with one or more other SPPs 1602, such as analytics platforms, artificial intelligence and / or machine learning platforms, marketing platforms, and / or the like. Here, the one or more other SPPs 1602 may use the shared diagnostic data to enhance or refine the content, apps, and / or services provided to their own subscribers.

[0254] Although various example embodiments are described in relation to sharing diagnostic data for providing therapy services to individual users, the consent services discussed herein can be used for a wide variety of purposes and / or use cases for recording permissions and / or consent, such as on a device-by-device basis, for a variety of different data sharing and data privacy purposes, such as to implement sharing of data originating from different devices, different service providers, and / or other data sources.

[0255] As shown by Fig. 7B, each of the computing devices 101, 102, 103, 104, and 105 may include one or more processors, memory, data and instructions. Some or all of the computing devices 101, 102, 103, 104, and 105 may also include communication interfaces, output device(s), and / or input device(s). Each of the computing devices 101, 102, 103, 104, and 105 may correspond to one or more of the client systems 1605-1 to 1605-x of Fig. 7A.

[0256] The system 700 is compatible with, and capable of processing data from medical devices, such as diagnostic device(s) 101 and / or therapy device(s) 105. As provided supra, the diagnostic device(s) 101 may be one or more monitoring devices, such as any sleep testing device used in connection with diagnosis of the patient's sleep-related breathing disorder. Therapy deviceRMDDHI(23) 105 may be any device used in connection with providing therapy for the patient's sleep-related breathing disorder. Examples of the diagnostic device(s) 101 and therapy device(s) 105 are mentioned previously with respect to Fig. 7A.

[0257] Thus, when receiving data from a medical device, the system may be configured to not only associate the received medical device data with a corresponding patient record, but also determine whether the received medical device data is diagnostic usage data or therapy usage data and update the patient records accordingly, based on predetermined one or more criteria. The data identification may be associated with the data itself or with a device ID from which it is received. If the medical device data is determined as diagnostic data, the system may be configured to process the diagnostic data and to generate a diagnostic report and / or a prescription based on predetermined analysis criteria. The system may be further configured to display the diagnostic report and / or the prescription to a diagnostic provider for review and to enable an electronic transfer of a diagnosis report or a therapy prescription, based on the diagnostic data, to a therapy provider.

[0258] System 700 has the ability to seamlessly transfer a patient’s health information (including demographic and medical data) directly from diagnosis through to patient therapy within the same system within a single patient record and permit or restrict integrated evaluation of data from multiple devices of a patient based on one or more of a patient’s electronic consent record(s), where a consent record, such as consent records based on consent resources 1653 discussed infra, may be linked to the data emanating from a particular device, such as where different consent records of a patient exist for different devices of the patient. To facilitate this workflow, system 700 may have the following functional features:

[0259] The ability to upload and analyze therapy management data within the same software system as the diagnostic data, allowing for a single software system for both diagnostic and therapy management users. This may be helpful in avoiding formatting problems when transitioning between different software applications.

[0260] The ability to share the patient’s diagnostic record with therapy management users, thus enabling them to save a patient’s therapy and compliance data directly to the common patient record having the patient’s diagnostic report and prescription data.

[0261] The ability of therapy provider to access the diagnostic data, as well as therapy settings information from the initial prescription data, as saved in the patient’s record, or even for the therapy device to be automatically configured via a cable connection, wireless connection, or a memory card, by accessing this record.

[0262] As the patient uses medical diagnostic device 101, diagnostic data 111 may be recorded on a storage medium 112, also referred to as memory 112. Diagnostic data 111 mayRMDDHI(23) include any data relating to the patient’s sleep test, such as date, time and duration of test, as well as physiological data obtained during the test, such as recorded respiratory flow data, respiratory effort data, oximetry and pulse data, or other clinical information. Memory 112 may be of any non-transitory type capable of storing information accessible by a processor, including a computer- readable medium, or other medium that stores data that may be read with the aid of an electronic device, such as read-only memory (ROM), random access memory (RAM), non-volatile RAM (NVRAM), flash memory, solid-state storage, memory cards, magnetic disk storage mediums, phase change memory, optical storage mediums such as CDs and DVDs, as well as other write- capable and read-only memories. Systems and methods may include different combinations of the foregoing, whereby different portions of the instructions and data are stored on different types of media.

[0263] Computing device(s) 201 may represent one or more servers and / or other physical and / or virtual computing device(s) that provide access to a pool of physical and / or virtual resources, data, services, and / or programs to other computer device(s), such as computer device(s) 101, 102, 103, 104, and 105, over a network, such as network 150. The server(s) 201 may be implemented as application servers, web servers, database servers, storage servers, file servers, proxy servers, email servers, media servers, content distribution network (CDN) serv ers, cloud servers, edge servers, virtualization servers (e.g., hypervisors, virtual machines monitors (VMMs), etc.), and / or some other remote infrastructure. The server(s) 201 may run virtual machines (VMs), virtualization containers (or simply “containers”), applications, and / or other executable code. Additionally or alternatively, the serv er(s) 201 may include any one of a number of virtual serv ers, services, and capabilities such as, for example, any of those discussed herein. The server(s) 201 may represent a cluster of servers, a load balanced server farm, a cloud computing service / architecture, an edge computing network / architecture, and / or other grouping or pool of servers, which may be located in one or more datacenters and / or other sites. Additionally, the servers 802 may be interconnected with one another using any suitable networking and / or interconnection technologies, such as Ethernet, fiber channel, data center interconnect, virtual extensible LAN, InfiniBand, switch fabrics, and / or the like. As mentioned previously, each of the SPPs 1602 may include one or more servers 201.

[0264] Each of the one or more servers 201 includes one or more processors 210 and memory 220 for storing data 230 and instructions 234. Memory 220 stores information accessible by the processor(s) 210, including instructions 234 that may be executed or otherwise used by the processor 21. The memory 220 may be of any non-transitory type capable of storing information accessible by the processor, including a computer-readable medium, or other medium that stores data that may be read with the aid of an electronic device, such as a hard-drive, memory' card,RMDDHI(23)ROM, RAM. NVRAM, flash memory, solid-state storage, memory cards, magnetic disk storage mediums, phase change memory, optical storage mediums such as CDs and DVDs, as well as other write-capable and read-only memories. Systems and methods may include different combinations of the foregoing, whereby different portions of the instructions and data are stored on different types of media.

[0265] The instructions 234 may be any set of instructions to be executed directly (such as machine code) or indirectly (such as scripts) by the processor(s) 210. For example, the instructions may be stored as computer code on the computer-readable medium. In that regard, the terms "instructions" and "programs" may be used interchangeably herein. The instructions may be stored in object code format for direct processing by the processor(s) 210, or in any other computer language including scripts or collections of independent source code modules that are interpreted on demand or compiled in advance. Functions, methods, and routines of the instructions are explained in more detail infra. Instructions 234 may also contain instructions for operating one or more applications, virtual servers, and / or services (or microservices), such as communication (Comm) server 240, easy care online (ECO) server 250, communication abstraction layer (CAL) server 260, outreach sendee 1620, and consent service 1630. The outreach service 1620 and the consent service 1630 are discussed in more detail infra. In some implementations, individual instances of each of the services 240, 250, 260, 1620, 1630 may be implemented within one or more VMs, one or more containers, and / or using some other virtualization technology.

[0266] The Comm service 240 is responsible for communicating with wireless or wired medical devices, such as diagnostic devices 101 and / or therapy devices 105, and validating their output(s). The core responsibilities of the Comm service 240 may include, for example, communicating with medical devices via a communication module, inbuilt communications device, and / or internal or external network interface circuitry; validating the incoming data, such as wireless data, obtained from medical devices; and converting the obtained data, such as wireless data, into a format that can be read by the CAL service 260.

[0267] The CAL service 260 is responsible for communicating with medical devices, such as diagnostic devices 101 and / or therapy devices 105. The CAL service 260 may provide a simplified and standardized interface for communication between different systems, components, or layers, abstracting away the complexities of the underlying communication protocols or mechanisms, such as those provided by Comm service 240. This CAL service 260 may act as an intermediary between the Comm service 240 and services 250. 1620, 1630, and / or other services provided by server(s) 201 that allows different systems or components to communicate with each other without requiring them to know the specifics of how the underlying communication protocols and / or communication hardware being used. Thus, the CAL service 260 may allow system componentsRMDDHI(23) and / or services to interact with the medical devices and / or other client system 1605 using a simplified interface and / or APT(s). The CAL service 260 may also allow system components and / or sendees to interact with the consent platform 1640 using a simplified interface and / or API(s), such as the consent service API 1633 discussed infra. The responsibilities of the CAL service 260 may include, for example, obtaining daily summary data for active patients; retrieving and changing therapy device settings, such as settings of therapy device(s) 105; and converting raw therapy device data, obtained from therapy device(s) 105, into an easily digestible format, such as formats that can be consumed by ECO service 250 and / or services 1620, 1630.

[0268] The ECO service 250 is responsible for application functionality within the system. The responsibilities of the ECO service 250 may include, for example, presenting patient and device information within a user interface (UI); writing and managing patient health information; and running application related processes.

[0269] The data 230 may be retrieved, stored or modified by processor(s) 210 in accordance with the instructions 234. For instance, although the system and method is not limited by any particular data structure, the data may be stored in computer registers, in a relational database as a table having a plurality of different fields and records, electronic documents (e.g., XML, JSON, Protobufs, YAML, etc.), and / or flat files. The data may also be formatted in any computer-readable format. The data may comprise any information useful in identifying the relevant information, such as numbers, descriptive text, proprietary codes, references to data stored in other areas of the same memory or different memories (including other locations accessible through other network connections) or information that is used by a function to calculate the relevant data. Data 230 may include one or more databases, including a Comm database 231 , CAL database 232, ECO database 233, HST database 235, and consent database 1646. Various types of data may be saved in these databases. For example, the Comm database 231, CAL database 232 and the ECO database 233 may store data associated with the respective servers, as described supra. The HST database 235 may store diagnostic data received from diagnostic devices 101. Aspects of the consent database / repository 1640 is discussed in more detail infra.

[0270] The processor(s) 210 may be embodied as or include one or more general-purpose processors, which may be processor(s) designed to perform a wide variety of tasks and / or processor(s) capable of running a broad range of applications and programs efficiently. Additionally or alternatively, the processor(s) 210 may be embodied as or include one or more special-purpose processors, which may be processor(s) designed to perform specific tasks or functions with relatively high efficiency and / or processor(s) optimized for particular applications or workloads. By way of example, the one or more processors may include any number and / or combination of the following: central processing units (CPUs), graphical processing units (GPUs),RMDDHI(23) accelerated processing units (APUs). data processing units (DPUs), network processors or network processing units, microcontrollers, neural processing units (NPUs), tensor processing units (TPUs), hardware accelerators, p-bit devices, ASICs, FPGAs, DSPs, programmable logic devices (PLDs), quantum processing units (QPUs), crypto-processors, and / or any other hardware-based processor. The processor(s) 201 and memory 220 may be or provide virtualization infrastructure and / or provide compute, storage, and network resources to applications and / or services, such as those mentioned herein. References to a processor or processor(s) should be understood to include references to a single processor or a collection of processors that may or may not operate in parallel.

[0271] Although not shown by Fig. 7B, server(s) 201 and / or computers 101-105 may include additional or alternative hardware elements than those shown, such as network interfaces, input / output (I / O) and / or peripheral component interfaces, I / O devices, near-field communication (NFC) circuitry, trusted execution environment and / or trusted platform module, batteries and / or charging circuitry, sensor circuitry (which may be specific to a specific medical device and / or the type diagnostic data 111 and / or usage data 1 13 being collected), among many other elements. Additionally, although Fig. 7B functionally illustrates the processor(s) 210, memory 220, and other elements of server(s) 201 as being within the same block, it should be understood by those of ordinary skill in the art that the processor(s) 210 and memory 220 may comprise multiple processors and / or memories that may or may not be stored within the same physical housing. For example, memory 220 (or some memory devices making up memory 220) may comprise a hard drive or other storage media located in a housing different from that of server(s) 201. Additionally or alternatively, some of the processors 210 may be part of a hardware accelerator pool external to the housing of the server(s) 201. Additionally or alternatively, the server(s) 201 may be communicatively connected to an external switch fabric through which it communicates with network 150 and / or devices 101, 102, 103, 104, 105. Accordingly, references to a processor or computer will be understood to include references to a collection of processors or computers or memories that may or may not operate in parallel or even be located at the same site. Rather than using a single processor to perform the steps described herein some of the components, such as steering components and deceleration components, may each have their own processor that only performs calculations related to the component's specific function. Thus, server(s) 201 may be referred to as both a system and an apparatus.

[0272] The network 150 may represent any type of network, or combination of networks and / or network connections, such as the Internet, a transmission control protocol (TCP) / Intemet Protocol (IP)-based network, a data network, a local area network (LAN), a wide area network (WAN), a wireless LAN (WLAN), a wireless wide area network (WWAN) including proprietaryRMDDHI(23) and / or enterprise networks for a company or organization, a cellular network, and / or combinations thereof. The network 150 may comprise computers, network connections among the computers, and software routines to enable communication between the computers over network connections. In this regard, the network 150 may comprise one or more network elements that may include one or more processors, communications systems (e.g., including network interface controllers, one or more transmi tters / receivers connected to one or more antennas, and the like), and computer readable media. Examples of such network elements may include wireless access points (WAPs), home / business servers (with or without RF communications circuitry), routers, switches, hubs, radio beacons, base stations, picocell or small cell base stations, backbone gateways, and / or any other like network device. Connection to the network 150 may be via a wired or a wireless connection using suitable communication protocol(s), including any of those discussed herein. More than one network 150 may be involved in a communication session between the illustrated devices.

[0273] Computers 102, 103. 104, and 105 may include all of the components normally used in connection with a computer, such as one or more processors (e.g., CPU, GPU, APU, and / or any other type of processor such as any of those mentioned herein), memory (e.g., ROM, RAM, intemal / extemal hard drives, and / or any other ty pe of memory devices such as any of those mentioned herein) for storing data 120 and 121 and instructions 130 and 131 (e.g., a client such as a web browser, email client, mobile app, native app, and / or the like; desktop apps, native apps; a portable document format (PDF) reader; etc.), output devices 110 and 115 (e g., a monitor or display device having a screen, touchscreen, and / or any other electrical device that is operable to display information, speakers and / or audio output devices, actuators and / or haptic feedback devices, one or more sensors, etc.), and user input devices 160 and 161 (e.g., mouse, keyboard, touchscreen device, touchpad device, microphone, cameras and / or image capture devices, one or more sensors, etc.).

[0274] The memory 112 may be internal to diagnostic device 101 which may be accessed by connecting a peripheral component interface, such as a USB data cable and / or the like, to a separate computer. The memory 114 may be internal to therapy device 105 which may be accessed by connecting a peripheral component interface, such as a USB data cable and / or the like, to a separate computer. Accordingly, the term “medical device” in such a case may be interpreted broadly to include a personal computer, such as a desktop or mobile computer, which contains medical data, such as diagnostic data 111 and / or usage data 113, collected from a medical device, such as a diagnostic device 101 (e g., a home sleep testing device and / or the like) and / or a therapy device 105. In addition, while Fig. 2 illustrates server 201 and computers 101-105 as being connected viaRMDDHI(23) a network 150. each two or more devices within system 700 may be connected via a separate network or via the Internet.

[0275] In one example, any one of the ECO service 250 and its associated ECO database 233, the Comm service 240 and its associated Comm database 231, the CAL service 260 and its associated CAL database 232, the outreach service 1620, consent service 1630 and its associated consent database 1646 may reside on a device at a location that is remote from the remaining servers. In addition, at least two of these servers, such as the Comm service 240, Comm database 231, CAL service 260, CAL database 232, outreach service 1620, consent service 1630, and consent database 1646 may exist on a single device. In other examples, the ECO service 250, ECO database 233, Comm service 240, Comm database 231, CAL service 260, and CAL database 232 may be distributed over any number of servers and / or data storage systems, which may or may not be distributed over multiple locations.4.12 EXAMPLE METHODS

[0276] In order for a patient to undergo a test, the patient may need to be issued with a diagnostic order by the patient’s treating physician. The patient is referred to a sleep test where the patient may be issued a diagnostic device 101 for sleep testing. The diagnostic device 101 may collect any one of the following types of data Polysomnography (PSG) data, polygraphy data, oximetry data, pneumatic or Respiratory Inductance Plethysmography (RlP)-based respiratory’ effort data, respiratory flow data, audio signal data, body position data etc.

[0277] The patient’s record is first created during the diagnostic stage, when the patient is approved for running a diagnostic test. The patient’s record may comprise any data that is associated with the patient or with the patient’s condition, such as the patient’s personal details (name, gender, age. address, contact details etc.), symptoms, treating physician, insurance provider, type of insurance cover etc. From diagnostic provider’s computer 104, where the patient’s record is created, it is transferred to the ECO database of server 201. It should be appreciated that computer 104 may not be a personal computer, but an administration computer used at the diagnostic provider clinic. As such, this computer may be operated, at least partially, not by the specific diagnostic physician responsible for the testing and diagnosis of the respective patient, but by a data administrator on the site. For example, it can be envisaged that such an administrator may be responsible for creating the patient’s record.

[0278] During the actual test, the diagnostic device collects diagnostic data indicating any respiratory condition that the patient may have, as well as other information, such as the type and model of the diagnostic device, the patient’s details, including these of the referring diagnostic physician, time and dates of usage etc.RMDDHI(23)

[0279] During the actual test, the diagnostic device saves the diagnostic test data 111 in memory 1 12. A user of system 700, such as a user of diagnostic provider computer 104, may have a remote access to the memory 112 of the medical diagnostic device 101. Alternatively, user of diagnostic provider computer 104 may extract the portable memory card of device 101 and download the data to computer 104. An addition, one can connect the device 101, e.g. via a USB cable, to the diagnostic provider computer 104 to access the device memory 112. A web browser 131 on the diagnostic provider computer 104 may then be used to contact server 201 and upload diagnostic data 111 to one or more of the databases 231, 232, 233 and 235.

[0280] The diagnostic data 111 provided to server 201 from diagnostic device 101 may be stored in a CAL database 232, which may identify the type of patient device from which it came. For example, each diagnostic device 101 may be assigned a device ID, which is provided to server 201 along with the diagnostic data. The diagnostic data may then be stored by server 201 in a database that uses the device ID to associate the received data with the appropriate patient diagnostic device 101. The usage data from therapy device 105 may be processed in a similar manner.

[0281] In some instances, a patient is required to use a medical diagnostic device for a set duration and exhibit certain clinical symptoms in order to be eligible to qualify for therapy of the patient's sleep disorder breathing. For example, a patient who has been ordered a home sleep test may be required to use the diagnostic device for at least four hours and exhibit an Apnea-Hypopnea Index (AHI) of greater than 5 in order for a physician to write a prescription for CPAP therapy. The prescription (also referred to as prescription data or prescription information) may be saved in the HST database 235). System 700 may be used to track whether the patient has been compliant in using the diagnostic device and may assist a physician in making a diagnosis.

[0282] Once the patient is tested, a diagnosis may be issued by the sleep provider and may be based on the diagnostic information produced by system 700, and more specifically by the testing / diagnostic device 101. Depending on the patient’s diagnosis, a diagnostic provider, and more specifically a diagnostic physician, may issue a prescription for therapy. The diagnostic provider may input his or her clinical interpretation of diagnostic data into the patient's record. In addition, the ECO database may contain a list of clinical options for a number of therapy devices 105 which the diagnostic physician may assign to a patient, as they see appropriate. In assigning these devices, ECO service 250 may select the appropriate pre-set of settings from the ECO database and then allow the diagnostic provider to input the clinical values into the appropriate fields. The data corresponding to the patient and device type may then be stored on server 201, such as in the ECO database 233.RMDDHI(23)

[0283] In some cases, the testing compliance criteria is usually defined by the reimbursing authority and may be set in the system 700 by a user, such as the sleep physician or clinician in the diagnostic site (a user of diagnostic computer 104). For example, usage data from diagnostic device 101 may demonstrate that a patient was tested for at least 4 hours and had an Obstructive Sleep Apnea with an AHI of 20, and therefore may be a candidate for CPAP therapy. A qualified healthcare professional, such as a sleep physician, may use computer 104 to write a prescription within a web browser 131 for therapy for a CPAP device at a pressure of 14cmH20. Diagnostic computer 104 may transmit the prescription data to server 201, wherein it will be stored in a database, such as in the ECO database 233, to become a part of the patient's record.

[0284] Patients prescribed for therapy will need to open new records with their diagnostic provider, e.g. on diagnostic computer 104. Instead, the proposed system allows access to their record, including any usage and settings data, to a therapy provider computer 102 so that the patients can be supplied and set up with a therapy device. For example, the patient diagnosed with Obstructive Sleep Apnea will need to have their patient information and prescription sent to an assigned therapy provider who can supply them with a CPAP device. System 700 may be used to facilitate the assignment, access, and transfer of data from the diagnostic provider to a trusted therapy provider. Instead of creating a new patient record, the patient’s record may be electronically transferred. Furthermore, instead of transferring the patient record, the system may allow the therapy provider to access the present patient record, as created and updated during the diagnostic stage. Depending on the arrangement, the therapy provider may be allowed access either to the entire patient record, or only to some of the patient identification data, diagnostic data, diagnostic report, therapy prescription and initial device setting data. Also, the access to the respective data may be open access with full functionality, or only limited access. Such a limited access, for example, may involve the capability to view and / or download the diagnostic data, but not to modify it.

[0285] The therapy provider may be allow ed to modify the access of the diagnostic provider. For example, after the record is made accessible to the therapy provider, the therapy provider may allow continuous access by the diagnostic provider to the patient’s record. Depending on the arrangement, the diagnostic provider may be allowed access either to the entire patient record, or only to some of the patient data, such as the patient’s identification data, diagnostic data, but not to the patient’s therapy data. Also, the access to the respective data may be open access with full functionality, or only limited access. Such a limited access, for example, may involve the capability to view and / or download the therapy data, but not to modify it.RMDDHI(23)

[0286] Thus, once the electronic patient record is created, medical practitioners associated with either the diagnostic stage or the therapy stage may be provided various level of access to the electronic patient record during both the diagnostic stage and the therapy stage.

[0287] A health care professional at a diagnostic provider location may monitor the status of their patient’s diagnostics data and forward their prescription to a therapy provider by contacting server 201 via a website accessed on diagnostic computer 104. For example, the healthcare professional may access patient data via webpage 800 (the ‘dashboard’) shown in Fig. 8. Webpage 800 may contain a list of active patients who are currently proceeding through home sleep testing, including status indicators that indicate the status of the patient's diagnostic tests. The various icons indicate the different status of the patient. For example - the bed-like icons indicate that the patient is still in testing phase. The physician profile-like icon indicates that the patient has moved to the diagnostic report phase. Different color, for example, may be used to indicate whether the report has or has not being issued yet. Similarly, the Rx icon indicates that the patient’s diagnostic report is ready and the patient has moved to the prescription stage. Again, different color may be used to indicate whether the prescription has or has not being issued yet. Finally, icon 871 may indicate that the patient is in the “patient record being finalized” phase.

[0288] As shown in Fig. 9, the patient Noemy Harber has completed her testing, diagnostic report and prescriptions stages. The icon Rx indicates that Noemy’s diagnostic report and prescription are ready. As indicated by status indicator 872, the patient’s record has undergone even the final checks and is now ready to be sent. Such final checks may involve verification of the patient’s name, phone number and insurance provider details.

[0289] Once a diagnostic provider associated with diagnostic computer 104 has determined that the patient needs to go onto therapy, the diagnostic provider may click on the icon 871. As shown in Fig. 9, pop-up window 973 may appear when icon 871 is selected. Pop-up window7973 may then be used to send patient information to a selected therapy provider that is to be associated with the therapy of the patient. The diagnostic provider may select a particular therapy provider from a list of therapy providers using drop-down menu 974. For that purpose, the diagnostic provider computer 104 may send a transmission to the ECO service 250 requesting data for available therapy providers within the system of therapy providers. ECO service 250 will then provide data responsive to the request, which will populate menu 974 within the web brow ser 131. By clicking on send button 976 the healthcare professional can instantly confirm their choice and initiate a command to the ECO service 250 to transfer ownership of the patient record to the therapy provider nominated in menu 974. Clicking on send button 976 transfers ownership of the patient to the therapy provider and changes the status of the patient within the dashboard to "Results Sent." In this way, healthcare professionals may quickly and easily transfer their patientsRMDDHI(23) directly into the therapy provider’s inbox without having to manually transfer paper records via fax, mail or via the patient.

[0290] In some instances, ECO service 250 may automatically provide therapy provider computer 102, by way of web browser (e.g. instructions 130) and via the network 150, with the usage and therapy settings data required to set up a patient on therapy device 105 as directed by the diagnostic provider physician’s prescription. For example, a therapy provider may be notified by the ECO service 250 when a diagnosis and prescription for therapy has been created on the server by a diagnostics provider and assigned to them. This allows the therapy provider to be immediately informed of a patient’s transfer into their care and ensures that a patient is supplied with the correct therapy device having the required therapeutic settings. The settings data can be automatically transferred directly to therapy device 105, such as via an internet connection, or manually inputted via an SD card or the therapy device’s interface.

[0291] A therapy provider may be automatically alerted that a patient has been referred to them by messaging service, such as E-mail or SMS messaging, or by contacting therapy provider computer 102 via server 201 . For example, the therapy provider or an administrator at the therapy provider’s office may access the transferred patient information described above via webpage 900 shown in Fig. 10. Webpage 900 may contain various data items, such as patient names 970, referring diagnostic providers 982, contact details 983. diagnostic and prescription information 984, insurer data 986, an acceptance status 987, or any other patient information of interest. A therapy provider may use webpage 900 to accept or reject a patient referral. For example, the therapy provider may select a patient having an "accept / reject" status, and then designate the patient's referral as either "accepted" or "rejected." Once the therapy provider has accepted the desired patient, the therapy provider computer 102 may send a transmission to the ECO service 250 requesting additional patient health information from the ECO database for the relevant patient ID. ECO service 250 will then provide patient demographic and therapy settings data responsive to the request, which once available will be used to pre-populate data fields required for a setup of the new patient with a therapy device. Thus, the system is configured to dynamically update the therapy provider's available patient list the record of the new patient, as w ell as to start displaying the additional patient record in the patient list of the therapy provider. For example, Fig. 11 shows webpage 910 in which the patient Noemy Harber may be automatically assigned various therapy devices in accordance with her prescription. The healthcare professional may alter the assigned devices or identify additional therapy devices or components in field 1102 and have those devices or components assigned to the patient by selecting the Add icon 1 104.

[0292] As shown in Fig. 10, Noemy Harber’s patient record details are now visible to the administrative staff using therapy provider computer 102. After contacting the patient, such as byRMDDHI(23) the website, e-mail, or phone, the administrator may schedule a time for a therapy provider to meet with the patient. For example, the administrator may click on Accept and use dialogue box 985 to assign the patient to a clinical user and transfer the new patient into the therapy provider’s work queue. The therapy provider's work queue is shown in Fig. 12 as w ebpage 920. The work queue webpage may show compliance icons 1202 and noncompliance icons 1204 to indicate whether a patient is currently compliant with his or her prescribed therapy. The work queue may also indicate the last time the compliance data w as updated, as well as statistics regarding the patient's usage of the therapy device. The work queue of webpage 920 may be securely accessed by a clinician, an administrator, or both. Secure access may include some form of protection to prevent unauthorized individuals from access patient data. For example, server 201 of Fig. 7 may require a password before transmitting patient data. Server 201 may also encrypt the transmitted data so as to prevent unauthorized devices from displaying the data.

[0293] A healthcare professional may also assign and configure Noemy Harber’s therapy device via webpage 920 shown in Fig. 12, and set her up for ongoing monitoring by clicking on her name and opening the patient record shown in Fig. 13 as webpage 930. As seen on webpage 930 within the patient record section, the patient information required to set up a patient for ongoing monitoring may be already pre-populated from the ECO database 233 with any patient data available from the diagnostic provider including patient demographics, insurance information and device therapy settings. As described above, a prescribed CPAP therapy device with a humidification unit is may be automatically assigned to the patient. In this way, healthcare professionals may quickly and easily set up patients on therapy without having to re-enter the patient data manually from paper prescriptions as well as reducing the percentage of patient who fail to present at the therapy provider for therapy. All therapy notes, prescriptions, and diagnostic reports may be viewed within the notes section of the patient record as shown in w ebpage 940 of Fig. 14.

[0294] Returning to Fig. 7B, a therapy healthcare professional who accesses server 201 via therapy provider computer 102 may provide diagnostic and compliance summary reports, which have been generated by server 201, to the respective assessing entities. This can be performed by transmitting the diagnostic and / or compliance reports from therapy provider computer 102 to an external party, such as the reimbursing entity computer 103, via network 150. The diagnostic and / or compliance reports may be transmitted in any number of ways, including as part of an E- mail transmission. Alternatively, the diagnostic and / or compliance reports may be saved either at therapy provider computer 102 or server 201 and the assessing entity may send, via the reimbursing entity computer 103, a request for diagnostic and / or compliance reports to either computer 102 or server 201.RMDDHI(23)

[0295] Fig. 15 shows an example process for practicing aspects described supra. As seen in Fig. 15, a single patient record may be created, saved to a single data platform, updated and accessed by using a single software system, regardless of whether the patient is the diagnostic or the therapy stage of the patient management. In addition, the data platform may reside on multiple remote servers or on a single physical system of servers so as to allow for integrated electronic management of data relating to both the diagnostic stage and therapy stage. Medical practitioners or evaluation and / or analytical software from both the diagnostic management stage and the therapy management stage may be provided access to this record and can save and access relevant data associated with at least one of general patient data, diagnostic data, device usage data, compliance data, device parameters, diagnostic report, device prescription etc. This reduces the time and effort involved in creating multiple records, as well as minimizes the likelihood of errors. The described system has the following features:

[0296] The capability to download to. upload from, view and analyze diagnostic data within the same software management tools and. in some cases, physical set of servers, as the therapy management stage data. This makes it much more convenient for both the diagnostic providers and the therapy providers, as they have a single point of access to the patient’s data and do not need to use two different data platforms, have two different passwords etc. Here the term data platform is used broadly in relation to at least one of the hardware setup and the used software. The service providers from the reimbursement entity 103 also need to access both the diagnostic and the therapy data of the patient to evaluate whether the patient is compliant with the prescribed diagnostic or therapy requirements. Thus, they also benefit from the single password, the single point of entry and the use of a single data platform used for accessing both types of data.

[0297] The capability to upload diagnostic data, diagnostic reports, prescription information, as well as a therapy device usage and compliance data, directly into the original patient’s therapy record created and populated in the diagnostics data management stage.

[0298] The capability to send device settings data from a prescription issued by a sleep physician directly to the diagnostic patient record, where it can be accessed and downloaded by the therapy provider without the need of manual rewriting or electronic re-creating of the record. This contrasts with the current practice of the patient having to personally take their prescription to the therapy provider or, at best, the diagnostic provider faxing or otherwise transferring the prescription to the therapy provider who then has to read the prescription and manually input the settings into the device. The proposed system allows the diagnostic provider to save the prescription in the patient record from where it is directly accessed by the therapy provider. Those settings can also be automatically downloaded to a card or sent wirelessly to the device upon device setup.RMDDHI(23)

[0299] A system based on the consent services described herein is illustrated in Fig 16. Consent related resources, such as a Template 1651, ConsentPolicy 1652, Consent 1653, PolicyResource, Notice resources (e.g., LocalizedText, LocalizedString, etc.), and / or other resources, are created for collecting user consent for a consent policy in the consent repository 1646. As an example, the consent policy may be a HIPAA authorization policy allowing a diagnostic service provider 1602-1 share diagnostic data with a therapy service provider 1602-2. In some implementations, this functionality can be provisioned as part of deploying the consent service 1630. In other implementations, clients or SPPs 1602 may be able to perform these interactions. For example, the consent related resources may be created during an account setup process or user registration process with the diagnostic service provider 1602-1 or the therapy service provider 1602-2.

[0300] At some point later, the app 1610 queries for a consent record 1653 for the user 1601 through an SPP 1602 that hosts the app 1610 and the consent service 1630. In some implementations, this may take place during a user onboarding process or first-time user experience (FTUE) flow, which may take place when the user 1601 operates the app 1610 for the first time, or when the user 1601 uses the app 1610 to setup / configure a medical device.

[0301] If a consent record 1653 is found, then the app 1610 may return or continue with its normal operating processes. In some implementations, an indication may be sent to the relevant SPPs 1602 indicating that the SPPs 1602 may share the type of data specified by the consent record 1653.

[0302] If no consent record 1653 is found, or the user’s consent has expired or has been revoked, the app 1610 queries for the consent template 1651 related to the consent policy via the consent service 1630. The consent service 1630 queries consent platform 1640 (or the consent repository 1646) for the data comprising the consent template 1651. The consent content, such as the notices and / or descriptions included in the template 1651 and / or consent policy 1652, is provided to the app 1610 via the consent service 1630. The consent content is then displayed by the app 1610 to the user, such as within one or more UI elements 1615. to collect the user’s 1601 response 1611, which may indicate granting consent or not granting consent.

[0303] The user’s response 161 1 is captured as a consent resource 1653. Here, a user input indicating the consent causes a request to be generated and sent to the consent sendee 1630 to create the consent resource 1653. The consent service 1630 creates a consent receipt in the consent repository 1646 representing the consent resource 1653. The consent receipt may indicate whether the user 1601 granted their consent or did not grant their consent.

[0304] The subject, such as user 1601, identified in the consent receipt may capture a user ID and potentially other information, such as an app ID, user’s 1601 email address, and / or otherRMDDHI(23) information related to the user 1601. In some implementations, this other information is only recorded if the user 1601 provides their consent.

[0305] If the user provides their consent (i.e., grants consent), the outreach service 1620 and / or consent service 1630 may generate a message, such as an email or the like, containing the contents of the same revision of the ConsentPolicy 1652 and the notice(s) the user 1601 has consented to. The message may also contain a signature (e.g., full name, date, digital signature, and / or the like) entered when the user 1601 provided their consent in the app 1610. This message may then be sent to the user via the outreach service 1620 4.13 ACCESS CONSENT MANAGEMENT

[0306] Fig. 16 depicts an example consent domain environment 1600 in accordance with aspects of the present technology. The consent domain environment 1 00 supports collecting permission and / or consent, such as HIPAA Authorization consent, from diagnostics and / or therapy device users, such as user 1601. The consent domain environment 1600 also provides an API 1633 for SPP 1602 software products to view and record users’ consent to collect and process their personal data for a specific provision or purpose. Thus, the consent domain environment 1600 may abstract away some or all interactions with the consent platform 1640 in the SPP 1602 software products, such as app 1610.

[0307] In the example of Fig. 16, a user 1601 operates a client system 1605 to obtain services from at least one SPP 1602. The consent system 1640 provides services 1620 and 1630 to one or more SPPs 1 02 to obtain consent from the user 1 01. The consent may include permission to share data among two or more SPPs 1602. The client system 1605 operates a client application (app) 1610 to access the content, services, data, and / or other resources provided by one or more SPPs 1602. The client app 1610 may be a general-purpose app used to access resources provided by multiple SPPs 1602, a special -purpose app that is specially tailored to access and / or interact with an individual SPP 1602, or a hybrid app that has functionality of both general -purpose and special-purpose apps. The client app 1610 may be athick / rich client, a thin client, and / or a diskless node. Additionally or alternatively, the client app 1610 may be specifically adapted for a hardware platform or configuration, for example, where the client app 1610 is embodied as a desktop app for a desktop, workstation, or laptop; embodied as a native or hybrid mobile app for a mobile device (e.g., smartphone, tablet, wearable device, and / or the like), and / or the like. As examples, the client app 1610 can be an HTTP client such as a web browser (or simply “browser’), a browser extension or plug-in, an email client / app. videoconferencing app, file sharing client / app. command line interface, and / or the like.

[0308] The client app 1610 may display UI element(s) 1615, which may represent an individual webpage, website, web app, mobile app, data, media content, graphical UI (GUI),RMDDHI(23) and / or other resources. Additionally or alternatively, the UI element(s) 1615 1615 may represent one or more web components, GUI elements, plug-ins, browser extensions, web workers, and / or the like, some or all of which may be provided by different service providers or developers. In these examples, the UI element(s) 1615 can be used to control different aspects of one or more applications and / or services, cause different functions to be performed, and / or otherwise allow the client system 1605 to interact with medical devices and / or an SPP 1602. As examples, the UI element(s) 1615 may include the GUIs of Figs. 8-14.

[0309] The client system 1605 may generate and display the UI element(s) 1615 by sending appropriate HTTP messages (or other suitable messages) to an SPP 1602 via a network connection. In response to the HTTP messages, the server-side app(s) operated by the SPP 1602 may (dynamically) generate and / or provide assets or resources in the form of code, scripts, markup language documents, data, media content, etc., to the client system 1605, which is then used by the client system 1605 to render and display the UI element(s) 1615 in the app 1610. In some implementations, the app 1610 and / or UI element(s) 1615 include program code, markup, and / or script(s) that call APIs, web services (WS), connectors, and / or other suitable mechanisms to access data and / or sendees provided by SPP(s) 1602 and / or services 1620, 1630 provided by the consent system 1640. Furthermore, individual UI elements 1615 may be implemented as respective web components or using a suitable sandboxing technology’.

[0310] The UI element(s) 1615 may be or include hosted elements and / or embedded elements. Hosted elements may be content / objects served or otherwise provided by7an SPP. The embedded elements include content / objects served by a third party' platform that are embedded or othenvise included in or with UI element(s) 1615 hosted by SPP 1602. In some examples, first UI element(s) 1615 can be used to display notice text and second UI element(s) 1615 can be input fields for a user 1601 to provide their consent to the SPP 1602 and / or consent platform 1640. The input fields may be check boxes, text fields, etc., which allow the user 1601 to input a signature or otherwise indicate whether the user 1601 provides their consent. The input fields may also include submission buttons or the like, which allow the user 1601 to submit their consent to the system. In this example, the second UI element(s) 1615 may be hosted or embedded elements, and the first UI element(s) 1615 can be embedded elements that are hosted by the consent platform 1640 through the app 1610. As discussed in more detail infra, the notice text may be obtained from stored templates 1651 and / or consent policies 1652.

[0311] In an example, the app 1610 may be a therapy app that can control or interact with a respiratory therapy device, such as therapy device 105, to provide therapy support experience to the user 1601. The user 1601 of such a therapy device 105 and / or app 1610 may also be referred to as a “patient” or the like. The therapy app 1610 may be a mobile app, desktop app, wearableRMDDHI(23) device app. and / or the like. According to various embodiments, the user 1601 views and provides their consent to data privacy policies, such as those defined by consent policy resources 1652 and / or consent resources 1653, via the app 1610.

[0312] The outreach service 1620 is a service used to send messages 1621 to users, such as user 1601, such as by electronic delivery, such as by email and / or via the therapy app 1610. For example, the outreach service 1620 may provide the consent forms / text to the app 1610, which may be served as or within one or more hosted UI elements 1615 and / or embedded UI elements 1615. Additionally or alternatively, the messages 1621 may be in the form of in-app notifications (e.g., banners, pop-ups, modals, etc.), local notifications, badge notifications, push notifications, rich media notifications, wearable device-specific notifications, and / or the like. Additionally or alternatively, the outreach service 1620 may send the messages 1621 through alternative messaging means. For example, the messages 1621 may be in the form of emails, short message service (SMS) messages, and / or the like, that are obtained and displayed by the client system 1605 using a separate email client. SMS client, web browser, and / or the like.

[0313] The app 1610 retrieves 1631 privacy policy information, such as those defined by consent policy resources 1652 and / or consent resources 1653, from the consent system 1640 using the consent service 1630. The app 1610 records and / or stores 1631 the user’s 1601 consent 1611 to policies 1652 in the consent system 1640 using the consent service 1630. The user's 1601 consent 1611 to policies 1652 may be recorded in a corresponding consent resource 1653.

[0314] The consent domain service 1630 (also referred to as “consent service 1630” and / or the like) provides a consent service API 1633 to store and retrieve 1643 consent information about patients, such as user 1601, and orgs, which may be stored in corresponding consent resources 1653. The consent service 1630 sends messages 1632 to the app 1610 (or to another app or client) using the outreach service 1620 via the consent service API 1633. The consent service 1630 provides the ability for different apps 1605 provided by different SPPs 1602 to query' the consent platform 1640 (or consent repository 1646) for consent information, such as any of those discussed herein.

[0315] The consent sendee API 1633 may be defined by an API definition 1636 and API permissions 1635. The API permissions 1635 may define control and access aspects for specific data and functionality' using the API 1633. The API permissions 1635 may be managed through API keys, Open Authorization (OAuth) tokens, or role-based access controls (RBAC), allowing granular control, such as read-only access for some users / subscribers and full access for other users / subscribers. The API definition 1636 may provide a description of the API 1633, specifying its structure, available endpoints, request / response formats, supported methods, response status codes, and / or other relevant information. In some implementations, the API 1633, or any otherRMDDHI(23)API discussed herein, may be defined or specified according to OpenAPI standards, such as those discussed in OpenAPI Specification, version 3.1.1, OPENAPI INITIATIVE (24 Oct. 2024), https: / / spec.openapis.Org / oas / v3.l.l.html, the contents of which is hereby incorporated by reference in its entirety. In some implementations, the API 1633, or any other API discussed herein, may be defined or specified according to RESTful API Modeling Language (RAML) specifications, such as those discussed in RAML Version 1.0: RESTful API Modeling Language, version 1.0 (09 Apr. 2021), https: / / github.com / raml-org / raml-spec / blob / master / versions / raml- 10 / raml-10.md / , the contents of which is hereby incorporated by reference in its entirety7.

[0316] In some embodiments, the consent domain service 1630 is implemented as a Java Spring Boot app (or multiple apps) that provides an API, such as API 1633, for managing the collection of consent resources, which are discussed in more detail infra. Additionally or alternatively, other suitable frameworks may be used to build apps that can provide the consent domain service 1630, such as Java Spring, Jakarta EE, Micronaut, Quarkus, Dropwizard, or Ktor (Kotlin). It should be noted that the outreach sen ice 1620 can also be implemented as one or more apps that can be built using the same or similar frameworks. The consent service 1630 may offer clients, such as client app 1610, with functions to record patient, such as user 1601, consent for any use and / or disclosure of their PHI, for compliance with data privacy laws (e.g., HIPAA, GDPR, etc.) in jurisdictions where the app 1610 mays operate, or for other purpose(s).

[0317] The consent system 1640 provides storage and retneval services for storing and retrieving consent information, such as resources 1651, 1652, 1653, and / or other resources, among other user data and / or system data. The consent repository 1646 stores consent information about users / patients, such as user 1601, and orgs. The consent service 1630 stores consent information in the consent repository 1646 using a repository API 1643. The consent service 1630 also retrieves 1643 consent information from the consent repository 1646 using the repository API 1643.

[0318] The consent repository' 1646 may be implemented using one or more data storage systems, which act as a repository for persistently storing and managing collections of data according to one or more predefined or configured database structures. The data storage systems include one or more primary storage devices, secondary storage devices, tertiary storage devices, non-linear storage devices, and / or any other suitable data storage devices. The data storage systems may also include scrver(s) 1645, which implement a suitable database management system (DBMS), such as a relational database management system (RDBMS), an object database management system (ODBMS), anon-relational DBMS (e.g., NoSQL), and / or some other DBMS, to store, retrieve, update, and manage data in the databases making up the repository 1 46. The DMBS may include one or more query' engines that utilize one or more data query' languages to store and retrieve information in / from the databases, such as structured query language (SQL),RMDDHI(23)Structured Object Query Language (SOQL), GraphQL. MongoDB Query Language (MQL), and / or any other suitable query language. The data storage systems can also utilize a database acceleration or database caching senice, such as Cloudflare® Hyperdrive™. Suitable implementations for the database systems and storage devices are known or commercially available, and are readily implemented by persons having ordinary skill in the art.

[0319] In some implementations, the consent system 1640, consent service 1630, and the outreach sen-ice 1620 may be provided by the same sendee provider, such as consent platform 1640. In these implementations, the repository API 1643 may be part of the consent sen ice API 1633, or the consent senice API 1633 may provide the same services and / or functionality as the repository API 1643.

[0320] In some implementations, the consent repository 1646, or the entire consent platform 1640, may be a sen ice provided by a third party privacy and data protection platform, such as the Universal Consent and Preference Management™ platform provided by OneTrust®, TrustArc® Consent & Preference Manager™, BigID® consent governance and / or data rights management modules, and / or the like. In these implementations, the consent service 1630 integrates with the third party privacy and data protection platform for persisting consent resources recorded by the consent service 1630. In these implementations, the repository' API 1643 may be provided by the third party privacy and data protection platform. In these implementations, the specific third party’ privacy and data protection platform can be changed, for example, by migrating data to a new platform, without having to update or change the consent service API 1633.

[0321] In some implementations, the consent service 1630 manages the collection of consent through the following domain resources: template resources 1651 (referred to herein as “Template” or “Templates”), consent policy resources 1652 (referred to herein as “ConsentPolicy” or “ConsentPolicies”), and consent resources 1653 (referred to herein as “Consent” or “Consents”).

[0322] A Template is a digital record representation of a consent agreement containing specific privacy policies and privacy notice text. Additionally or alternatively, Templates represent a privacy agreement in a client's (e.g., an SPP 1602) digital product (e.g., app 1610) where the patient, such as user 1601, is required to provide their consent to use and / or disclosure or their personal health information. The template resource 1651 contains the information necessary to: display the consent agreement (e.g., privacy notice text, consent policy text, etc.); how to collect user consent (e.g., opt-in, opt-out, signature required, etc.), data collection mechanisms (e.g., app 1610, web form, device types for client systems 1605, etc.), the type and / or amount of patient identifiable information (PH) to collect along with their consent response(s), the duration the userRMDDHI(23) consent is applicable for, the jurisdiction(s) the consent applies to, and / or the like. An example

[0323] A Templates API, which is part of the consent API 1633, of the consent domain service1630 may support the operations on a template resource 1651 summarized in table IB, and example attributes of the template resource 1651 are summarized in table 1C.Table IB: Template API OperationsTable 1C: Template Attributes_ Table ID: Localized Text AttributesAttributeType | DescriptionRMDDHI(23)

[0324] In some implementations, the Template may additionally or alternatively include an "identifiers7’ attribute of type “Id[] ”, which includes one or more SPP-specified identifiers for the Template. Additionally or alternatively, the Template may define collection point aspects, such as data collection methods (e.g., through forms, using cookies, etc.), the t pe of data to be captured (e.g., consent responses and / or the like), and any applicable legal requirements or consent language. Additionally or alternatively, the Template may define purpose related aspects, such as an intent or rationale behind the data collection. Each purpose may be mapped to a collection point and a legal basis for data processing (e.g., consent, legitimate interest, or contractual necessity).

[0325] In the example of table 1 A, the Template.notices element (e.g., “notices” in table 1 A) is an array of privacy notice elements. In general, the notice may include any applicable legal requirements or consent language, which may be tailored to applicable jurisdictions indicated by the jurisdictions attribute. In some implementations, the privacy notice text could be included directly within the element itself. In other implementations, a reference or pointer to a location of the privacy notice text on separate, publicly accessible platform, such as a server of an SPP 1602, may be used to provide the privacy notice text. This reference or pointer may be in the form of a URL, path, or other network address / ID of a resource containing the privacy notice text. In these implementations, a reference / pointer may be included for each listed jurisdiction so that a different privacy notice text can be displayed for respective jurisdictions. As an example, a localized text resource (LocalizedText) may be used to represent a relatively longer text string and associated language. An example of such LocalizedText includes the attributes in table ID. In this example, the textUrl element is populated with a URI of localized privacy notice text hosted on separate, publicly accessible system / platform.

[0326] A consent policy resource 1652 (ConsentPolicy) may define a policy for collecting or obtaining consent. A policy may be a set of rules or plan of action expected to be fulfilled or followed. A policy may specify a goal or purpose for which consent is to be collected or obtained and the manner in which consent is to be collected or obtained. A policy can cover a range of topics, such as access control, data sharing parameters such as the type of data to be shared and with whom the data will be shared, conditions of treatment, and / or the like. A policy may also specify the duration that collected consent is applicable for, once it is collected. A policy may apply to a party regardless of preference. For example, a patient privacy policy may establish the appropriate disclosure and / or uses of a patient’s health information and / or PII. A consent policy 1652 is one that may be selectively applied. In some embodiments, consent policies may be opt- in or opt-out. Opt-in policies are policies that are applicable on assent or acceptance by a user, andRMDDHI(23) opt-out policies are policies that are applicable unless refused or decline by a user. It should be understood that the consent domain service 1630 does not enforce the behavior described by specific policies. Rather, the consent domain service 130 is a system of record for consent to the specific policies. An example consent policy resource 1652 is shown by table 2A.

[0327] A Consent Policies API, which is part of the consent API 1633, of the consent domain service 1630, may support the operations on ConsentPolicy resources summarized in table 2B. Example attributes of the ConsentPolicy resource are summarized in table 2C.Table 2B: ConsentPolicy API OperationsTable 2C: ConsentPolicy Attributes

[0328] In some implementations, the ConsentPolicy may additionally or alternatively include an ' identifiers'’ attribute of type “Id[]”, which includes one or more SPP-specified identifiers for the ConsentPolicy. In the example of table 2A, the ConsentPolicy. descriptions element (e.g., “descriptions” in table 2A) may include consent text in the “text” field. In this example, the consent text is included directly within the descriptions element / field itself. In other implementations, another resource, such as a localized string resource (LocalizedString), may be used to represent aRMDDHI(23) relatively short text string and associated language(s). An example of such LocalizedString includes the attributes in table 2D.Table 2D: LocalizedString Attributes

[0329] The content of a LocalizedString resource is / are typically short text descriptions of a consent policy. Thus, the content of a LocalizedString resource is not usually stored externally, unlike the content of the LocalizedText resource. However, in some implementations, aLocalizedText resource may be used to store the text description of a consent policy instead of the LocalizedString resource, such as when a subscriber of the consent platform 1640 would like to use longer text to describe the consent policy. In other implementations, a reference or pointer to a location of the consent text (e g., LocalizedString) on separate, publicly accessible platform, such as a server of an SPP 1602, may be used to provide the consent text in a same or similar manner as discussed previously with respect to the LocalizedText of table ID.

[0330] A consent resource 1653 (Consent) may represent a record of consent response(s) for a data subject, such as a patient or user 1601, that applies to a specific Template and one or more ConsentPolicies. In addition to the consent response for one or more policies, the consent resource 1653 may include any required identifiable information for the data subject necessary for processing and / or retrieving the Consent at a later time. In some embodiments, a consent resource 1653 is immutable. Thus, if an SPP 1602 wants to update a data subject's consent to a policy as previously recorded, a new Consent must be created instead. An example consent resource 1653 is shown by table 3A.Table 3A: Example Consent ResourceRMDDHI(23)

[0331] A Consent API, which is part of the consent API 1633, of the consent domain service 1630, may support the operations on consent resources 1653 summarized in table 3B. Example attributes of consent resources 1653 are summarized in table 3C.Table 3B: Consent API OperationsTable 3C: Consent Attributes

[0332] In the example of table 3A. the “identifiers" field may include a discriminator element, a scheme element, and a scheme agency (schemeAgency) field. The discriminator element may be used to differentiate between types of identifiers, ensuring that different ty pes of identifying information are organized and interpreted correctly. The scheme field element specifies the naming convention or format for the identifier, and the scheme agency field designates the organization or agency responsible for issuing or regulating the identifier scheme. In some embodiments, the consent resource 1653 may also include geolocation coordinates of where the user 1601 or client system 1605 is located, such as the geolocation where the consent was granted. In these embodiments, the geolocation coordinates may be in World Geodetic System 1984 (WGS 84) format or some other suitable format.

[0333] In the example of table 3A, the policyRecords. action (e.g., "action" in table 3A) may indicate an action taken by the user 1610 as indicated by a consent response 1611. For example, the possible policyRecords. action (e.g., "action" in table 3A) values may include “consented", “withheld", “revoked", and “expired". The “consented" state may indicate that the data subjectRMDDHI(23) provided their consent to the policy or that the data subject accepted the policy terms. The ■‘withheld” state may indicate that the data subject withheld their consent to the policy or that the data subject declined the policy terms. The “revoked” state may indicate that the data subject revoked their previously provided consent to the policy. The “expired” state may indicate that the data the duration the subject’s consent was valid for has elapsed.

[0334] In some implementations, a policy record (policyRecords) may be represented by a policy resource (Policy Resource). A Policy Record represents a record of a state change for consent to a given policy. Thus, in some implementations, the policyRecords. action attribute may be inherited or otherwise obtained from the action attribute from a corresponding Policy Resource. A PolicyResource may include the attributes summarized in table 4.Table 4; PolicyResource Attributes

[0335] In the example of table 3A, the Consent. subject element (e.g., the “subject” in tables3A and 3C) may include information about a data subject, such as user 1601. In this example, the subject information is included directly within the subject element / field itself. In other implementations, another resource, such as a subject resource (Subject), may be used to represent or contain the subject’s information. The Subject resource may include relevant or desired details about a subject, such as user 1601, at the time of consent. Thus, in some implementations, the subject attribute(s) may be inherited or otherwise obtained from the subject resource. A Subject resource may include the attributes summarized in table 5.Table 5: Subject Attributes

[0336] In the example of Table 5, the subject attribute(s) includes a name attribute to store a name of the subject, an identifiers attribute to store one or more identifiers associated with the subject, an email attribute to store an email address of the subject, a geolocation attribute to store geolocation coordinates (“geocoordinate”) of where the user 1601 or client system 1605 is located at the time consent was granted. The subject attribute(s) may also include zero or more custom attributes, which may be defined by the user / subscribers of the consent platform 1640. For example, the custom attributes may store specific types of information related to the consent to beRMDDHI(23) obtained and / or as defined by relevant laws or regulations. It should also be noted that additional types of attributes and data can be defined for the subject attribute(s).

[0337] Fig. 16 also shows an example API flow between the illustrated components, such as app 1610, outreach service 1620, consent service 1630, and consent system 1640, involved in displaying a consent request (e.g., a HIPAA authorization request) and processing the user’s 1601 response. The interactions involved in recording the user’s 1601 consent may be as follows.

[0338] Consent related resources, such as a Template 1651, ConsentPolicy 1652, Consent 1653, PolicyResource, Notice resources (e.g., LocalizedText, LocalizedString, etc.), and / or other resources, are created for collecting user consent for a consent policy in the consent repository’ 1646. As an example, the consent policy may be a HIPAA authorization policy allowing a diagnostic sendee provider 1602-1 share diagnostic data, such as from a diagnostic device 101, with a therapy service provider 1602-2. In some implementations, this functionality can be provisioned as part of deploying the consent service 1630. In other implementations, clients or SPPs 1602 may be able to perform these interactions. For example, the consent related resources may be created during an account setup process or user registration process with the diagnostic service provider 1602-1 or the therapy service provider 1602-2.

[0339] At some point later, the app 1610 queries for a consent record 1653 for the user 1601 through an SPP 1602 that hosts the app 1610 and the consent service 1630. In some implementations, this may take place during a user onboarding process or first-time user experience (FTUE) flow, which may take place when the user 1601 operates the app 1610 for the first time, or when the user 1601 uses the app 1610 to setup / configure a medical device. In some implementations, this my take place when the app 1610 seeks to access certain device related data such as to provide information based on the accessed data.

[0340] If a consent record 1653 is found, then the app 1610 may return or continue with its normal operating processes. In some implementations, an indication may be sent to the relevant SPPs 1602 indicating that the SPPs 1602 may share the ty pe of data specified by the consent record 1653.

[0341] If no consent record 1653 is found, or the user’s consent has expired or has been revoked, the app 1610 queries for the consent template 1651 related to the consent policy via the consent sendee 1630. The consent service 1630 queries consent platform 1640 (or the consent repository' 1646) for the data comprising the consent template 1651. The consent content, such as the notices and / or descriptions included in the template 1651 and / or consent policy 1652. is provided to the app 1610 via the consent service 1630, and in some implementations, via the outreach service 1620. The consent content is then displayed by the app 1610 to the user, such asRMDDHI(23) within one or more UI elements 1615, to collect the user’s 1601 response 1611, which may indicate granting consent or not granting consent.

[0342] The user's response 1611 is captured as a consent resource 1653. Here, a user input indicating the affirmative consent causes a request to be generated and sent to the consent service 1630 to create the consent resource 1653. The consent sendee 1630 creates a consent receipt in the consent repository 1646 representing the consent resource 1653. The consent receipt may indicate whether the user 1601 granted their consent or did not grant their consent such as in the case of denied consent.

[0343] The subject, such as user 1601, identified in the consent receipt may capture a user ID and potentially other information, such as an app ID of app 1610, user’s 1601 email address, geolocation of the client system 1605 when consent given, and / or other information related to the user 1601. In some implementations, this other information is only recorded if the user 1601 provides their consent.

[0344] If the user provides their consent (i.e.. grants consent), the outreach service 1620 and / or consent sen-ice 1630 may generate a message, such as an email or the like, containing the contents of the same revision of the ConsentPolicy 1652 and the notice(s) the user 1601 has consented to. The message may also contain a signature (e.g., full name, date, digital signature, and / or the like) entered when the user 1601 provided their consent in the app 1610. This message may then be sent to the user via the outreach service 1620.4.14 ADDITIONAL EXAMPLE METHODS

[0345] Fig. 17 shows an example process 1700 for consent management, which may be performed by the various entities shown by Fig. 16, such as app 1610, outreach service 1620, consent service 1630, and consent system 1640,

[0346] Process 1700 begins at operation 1701 where the consent service 1630 creates consent related resources for a given user 1601 in the consent repository 1646. The consent related resources may include the template resource 1651, consent policy resource 1652, consent resource 1653. policy resources, notice resources (e.g., LocalizedText, LocalizedString, etc.), and / or other resources for collecting user consent.

[0347] At operation 1702, the consent service 1630 queries for a consent record 1653 in the consent repository 1646 for the user 1601. The consent service 1630 may perform the query in response to commands / instructions obtained from an app 1610 hosted by the SPP 1602. For example, these commands / instructions may be obtained from the app 1610 when the user 1601 reaches a certain point during a registration or setup process for a medical device, or when the user 1601 logs into the app 1610 to obtain diagnostic or therapy services.RMDDHI(23)

[0348] At operation 1703, the consent sen ice 1630 determines whether a consent record 1653 associated with the user 1601 and a specific policy is active or not (e.g., “revoked” or “expired”). If a consent record 1653 is found in the consent repository 1646 and is active, then the app 1610 may return to perform other app processes. If at operation 1703 the consent record 1653 is not found, the consent has expired, or the consent has been revoked, at operation 1704 a query for the consent template 1651 related to the relevant consent policy 1652 is sent to the consent platform 1640 (or the consent repository 1646). Specifically, the query is driven by the app 1605 requesting the consent template 1651 through the API 1633 provided by the consent service 1630 when consent for the queried policy is no longer active.

[0349] At operation 1705, the consent service 1630 obtains consent content, such as the notices and / or descriptions included in the template 1651 and / or consent policy 1652, and provides the consent content to the app 1610 via the consent service 1630 for display to the user 1601. The consent content is then displayed by the app 1610 to the user 1601. In some implementations, the outreach service 1620 may be involved with the delivery of the consent content.

[0350] At operation 1706, the consent service 1630 obtains a consent response 1611 from the app 1610, and at operation 1707 creates a corresponding consent resource 1653 indicating the consent indicated by the consent response. As mentioned previously, the consent service 1630 may create a consent receipt in the consent repository 1646 representing the consent resource 1653. The consent receipt may indicate whether consent was granted (e.g., “consented”) or not (e.g., “withheld”) and data subject information, such as a user ID and / or additional information, such as an app ID of app 1610, user’s 1601 email address, user’s 1610 geolocation, and / or other information related to the user 1601. In some implementations, the additional information is only- recorded if the user 1601 provides their consent.

[0351] At operation 1708, the consent sendee 1630 generates anotification indicating whether the consent was granted (or not) based on the consent response 1611 and / or the consent resource 1653 stored at operation 1707. The notification may also include consent information such as the user's 1601 full name, date and / or time consent was granted, digital signature, policy ID of the policy the user 1601 consented to, and / or relevant information. In some implementations, the notification is only generated when the user 1601 grants consent. In one example, the notification is an email message or SMS message that is sent by the outreach sen ice 1620 to the user 1601 via a corresponding email service / client or SMS service / client, and / or to the relevant service provider(s) 1602 using a same or similar messaging mechanism. In other examples, the notification may be sent to the user 1601 or client system 1605 using any other type of notification system / service. such as using local notifications, in-app notifications, badge notifications, push notifications, rich media notifications, and / or the like. Additionally or alternatively, theRMDDHI(23) notification may be a database record, and the consent service 1630 may store the database record in a target database object in the consent repository 1646 or in another database system. After receipt of the notification, the relevant service provider(s) 1602 may begin sharing data according to the consented to policy.4.15 GLOSSARY

[0352] For the purposes of the present technology disclosure, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, alternative definitions may apply.4.15.1 General

[0353] Air : In certain forms of the present technology, air may be taken to mean atmospheric air, and in other forms of the present technology air may be taken to mean some other combination of breathable gases, e.g. oxygen enriched air.

[0354] Ambient: In certain forms of the present technology, the term ambient will be taken to mean (i) external of the treatment system or patient, and (ii) immediately surrounding the treatment system or patient. For example, ambient humidity with respect to a humidifier may be the humidity of air immediately surrounding the humidifier, e.g. the humidity in the room where a patient is sleeping. Such ambient humidity may be different to the humidity7outside the room where a patient is sleeping. In another example, ambient pressure may be the pressure immediately surrounding or external to the body. In certain forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room where a patient is located, other than for example, noise generated by an RPT device or emanating from a mask or patient interface. Ambient noise may be generated by sources outside the room.

[0355] Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjustable, e.g. from breath to breath, between minimum and maximum limits, depending on the presence or absence of indications of SDB events.

[0356] Continuous Positive Airway Pressure (CPAP) therapy: Respiratory7pressure therapy in which the treatment pressure is approximately constant through a respiratory cycle of a patient. In some forms, the pressure at the entrance to the airways will be slightly higher during exhalation, and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory7cycles of the patient, for example, being increased in response to detection of indications of partial upper airway obstruction, and decreased in the absence of indications of partial upper airway obstruction.

[0357] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity'. In some cases, a reference to flow rate will be a reference to a scalar quantity7, namely a quantity having magnitude only. In other cases, a reference to flow7rate will beRMDDHI(23) a reference to a vector quantity, namely a quantity having both magnitude and direction. Flow rate may be given the symbol Q. 'Flow rate’ is sometimes shortened to simply ‘flow’ or ‘airflow’.

[0358] In the example of patient respiration, a flow rate may be nominally positive for the inspiratory portion of a breathing cycle of a patient, and hence negative for the expiratory' portion of the breathing cycle of a patient. Device flow rate, Qd, is the flow rate of air leaving the RPT device. Total flow rate, Qt, is the flow rate of air and any supplementary gas reaching the patient interface via the air circuit. Vent flow rate, Qv, is the flow rate of air leaving a vent to allow washout of exhaled gases. Leak flow rate, QI, is the flow rate of leak from a patient interface system or elsewhere. Respiratory flow rate, Qr, is the flow rate of air that is received into the patient’s respiratory system.

[0359] Flow therapy. Respiratory' therapy comprising the delivery of a flow of air to an entrance to the airways at a controlled flow rate referred to as the treatment flow rate that is typically positive throughout the patient's breathing cycle.

[0360] Humidifier'. The word humidifier will be taken to mean a humidifying apparatus constructed and arranged, or configured with a physical structure to be capable of providing a therapeutically beneficial amount of water (H2O) vapor to a flow of air to ameliorate a medical respiratory condition of a patient.

[0361] Leak. The word leak will be taken to be an unintended flow of air. In one example, leak may occur as the result of an incomplete seal between a mask and a patient's face. In another example leak may occur in a swivel elbow to the ambient.

[0362] Noise, conducted (acoustic)'. Conducted noise in the present document refers to noise which is carried to the patient by the pneumatic path, such as the air circuit and the patient interface as well as the air therein. In one form, conducted noise may be quantified by measuring sound pressure levels at the end of an air circuit.

[0363] Noise, radiated (acoustic)'. Radiated noise in the present document refers to noise which is carried to the patient by the ambient air. In one form, radiated noise may be quantified by measuring sound power / pressure levels of the object in question according to ISO 3744.

[0364] Noise, vent (acoustic): Vent noise in the present document refers to noise which is generated by the flow of air through any' vents such as vent holes of the patient interface.

[0365] Oxygen enriched air: Air with a concentration of oxygen greater than that of atmospheric air (21%), for example at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. “Oxygen enriched air” is sometimes shortened to “oxygen”.RMDDHI(23)

[0366] Medical Oxygen Medical oxygen is defined as oxygen enriched air with an oxygen concentration of 80% or greater.

[0367] Patient A person, whether or not they are suffering from a respiratory condition.

[0368] Pressure: Force per unit area. Pressure may be expressed in a range of units, including cmFfcO, g-f / cm2and hectopascal. 1 crnftyO is equal to 1 g-f / cm2and is approximately 0.98 hectopascal (1 hectopascal = 100 Pa = 100 N / m2= 1 millibar ~ 0.001 atm). In this specification, unless otherwise stated, pressure is given in units of cmFfcO.

[0369] The pressure in the patient interface is given the symbol Pm, while the treatment pressure, which represents a target value to be achieved by the interface pressure Pm at the current instant of time, is given the symbol Pt.

[0370] Respiratory Pressure Therapy: The application of a supply of air to an entrance to the airways at a treatment pressure that is typically positive with respect to atmosphere.

[0371] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0372] Seal: May be a noun form ("a seal") which refers to a structure, or a verb form (‘'to seal”) which refers to the effect. Two elements may be constructed and / or arranged to ‘seal’ or to effect ‘sealing’ therebetween without requiring a separate ‘seal’ element per se.

[0373] Shell: A shell will be taken to mean a curved, relatively thin structure having bending, tensile and compressive stiffness. For example, a curved structural wall of a mask may be a shell. In some forms, a shell may be faceted. In some forms a shell may be airtight. In some forms a shell may not be airtight.

[0374] Stiffener: A stiffener will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0375] Strut: A strut will be taken to be a structural component designed to increase the compression resistance of another component in at least one direction.

[0376] Swivel (noun): A subassembly of components configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel may be constructed to rotate through an angle of at least 360 degrees. In another form, the swivel may be constructed to rotate through an angle less than 360 degrees. When used in the context of an air deliver}' conduit, the sub-assembly of components preferably comprises a matched pair of cylindrical conduits. There may be little or no leak flow of air from the swivel in use.

[0377] Optimal: the best or most desirable, favorable, functional, satisfactory, advantageous, efficient, or effective design(s), configuration, arrangement, operation(s), decision(s), condition(s), criteria, parameter(s), allocation(s), variable(s), solution(s), result(s), and / or output(s) considering a set of constraints, criteria, and / or parameters. An “optimum” may refer to an amountRMDDHI(23) or degree to which something is optimal. The term "optimization ’ may refer to an act, process, algorithm, or methodology of making something as optimal as possible. Optimization typically includes mathematical procedures, such as finding the maximum or minimum of a function, or solving one or more loss functions and / or objective functions.4.15.2 Respiratory cycle

[0378] Apnea'. According to some definitions, an apnea is said to have occurred when flow falls below a predetermined threshold for a duration, e.g. 10 seconds. An obstructive apnea will be said to have occurred when, despite patient effort, some obstruction of the airway does not allow air to flow. A central apnea will be said to have occurred when an apnea is detected that is due to a reduction in breathing effort, or the absence of breathing effort, despite the airway being patent. A mixed apnea occurs when a reduction or absence of breathing effort coincides with an obstructed airway.

[0379] Breathing rate'. The rate of spontaneous respiration of a patient, usually measured in breaths per minute.

[0380] Duty cycle'. The ratio of inhalation time, Ti to total breath time, Ttot.

[0381] Effort (breathing): The work done by a spontaneously breathing person attempting to breathe.

[0382] Expiratory portion of a breathing cycle'. The period from the start of expiratory flow to the start of inspiratory flow.

[0383] Flow limitation'. Flow limitation will be taken to be the state of affairs in a patient's respiration where an increase in effort by the patient does not give rise to a corresponding increase in flow. Where flow limitation occurs during an inspiratory portion of the breathing cycle it maybe described as inspiratory flow limitation. |Where flow limitation occurs during an expiratory portion of the breathing cycle it may be described as expiratory flow limitation. Types of flow limited inspiratory waveforms: (i) Flattened: Having a rise followed by a relatively flat portion, followed by a fall; (ii) M-shaped: Having two local peaks, one at the leading edge, and one at the trailing edge, and a relatively flat portion between the two peaks; (iii) Chair-shaped: Having a single local peak, the peak being at the leading edge, followed by a relatively flat portion; and (iv) Reverse-chair shaped: Having a relatively flat portion followed by single local peak, the peak being at the trailing edge.

[0384] Hypopnea. According to some definitions, a hypopnea is taken to be a reduction in flow, but not a cessation of flow. In one form, a hypopnea may be said to have occurred when there is a reduction in flow' below a threshold rate for a duration. A central hypopnea will be said to have occurred when a hypopnea is detected that is due to a reduction in breathing effort. In one form in adults, either of the follow ing may be regarded as being hypopneas: (i) a 30% reductionRMDDHI(23) in patient breathing for at least 10 seconds plus an associated 4% desaturation; or (ii) a reduction in patient breathing (but less than 50%) for at least 10 seconds, with an associated desaturation of at least 3% or an arousal.

[0385] Hyperpnea: An increase in flow to a level higher than normal.

[0386] Inspiratory portion of a breathing cycle: The period from the start of inspiratory flow to the start of expiratory flow will be taken to be the inspiratory portion of a breathing cycle.

[0387] Patency> (airway): The degree of the airway being open, or the extent to which the airway is open. A patent airway is open. Airway patency may be quantified, for example with a value of one (1) being patent, and a value of zero (0), being closed (obstructed).

[0388] Positive End-Expiratory Pressure (PEEP): The pressure above atmosphere in the lungs that exists at the end of expiration.

[0389] Peak flow rate (Qpeak): The maximum value of flow rate during the inspiratory portion of the respiratory flow waveform.

[0390] Respiratory flow rate, patient airflow rate, respiratory airflow rate (Qr): These terms may be understood to refer to the RPT device’s estimate of respiratory flow rate, as opposed to “true respiratory flow rate” or “true respiratory flow rate”, which is the actual respiratory flow rate experienced by the patient, usually expressed in liters per minute.

[0391] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing, when extra effort is not applied. In principle the inspiratory volume Vi (the volume of air inhaled) is equal to the expiratory volume Ve (the volume of air exhaled), and therefore a single tidal volume Vt may be defined as equal to either quantity7. In practice the tidal volume Vt is estimated as some combination, e.g. the mean, of the inspiratory volume Vi and the expiratory volume Ve.

[0392] Inhalation Time (Ti): The duration of the inspiratory portion of the respiratory flow rate waveform.

[0393] Exhalation Time (Te): The duration of the expiratory' portion of the respiratory7flow rate waveform.

[0394] Total Time (Ttot): The total duration between the start of one inspiratory portion of a respiratory flow rate waveform and the start of the following inspiratory7portion of the respiratory flow rate waveform.

[0395] Typical recent ventilation: The value of ventilation around which recent values of ventilation Vent over some predetermined timescale tend to cluster, that is. a measure of the central tendency of the recent values of ventilation.

[0396] Upper airway obstruction (UAO): includes both partial and total upper airway obstruction. This may be associated with a state of flow limitation, in which the flow rate increasesRMDDHI(23) only slightly or may even decrease as the pressure difference across the upper airway increases (Starling resistor behavior).

[0397] Ventilation (Vent): A measure of a rate of gas being exchanged by the patient’s respiratory system. Measures of ventilation may include one or both of inspiratory and expiratory flow, per unit time. When expressed as a volume per minute, this quantity is often referred to as ■‘minute ventilation”. Minute ventilation is sometimes given simply as a volume, understood to be the volume per minute.4.15.3 Ventilation

[0398] Adaptive Servo-Ventilator (ASV): A servo-ventilator that has a changeable, rather than fixed target ventilation. The changeable target ventilation may be learned from some characteristic of the patient, for example, a respiratory characteristic of the patient.

[0399] Backup rate: A parameter of a ventilator that establishes the minimum breathing rate (typically in number of breaths per minute) that the ventilator will deliver to the patient, if not triggered by spontaneous respiratory effort.

[0400] Cycled: The termination of a ventilator's inspiratory phase. When a ventilator delivers a breath to a spontaneously breathing patient, at the end of the inspiratory portion of the breathing cycle, the ventilator is said to be cycled to stop delivering the breath.

[0401] Expiratory positive airway pressure (EPAP): a base pressure, to which a pressure varying within the breath is added to produce the desired interface pressure which the ventilator will attempt to achieve at a given time.

[0402] End expiratory pressure (EEP): Desired interface pressure which the ventilator will attempt to achieve at the end of the expiratory portion of the breath. If the pressure waveform template TT(q>) is zero-valued at the end of expiration, i.e. n(cp) = 0 when cp = 1, the EEP is equal to the EPAP.

[0403] Inspiratory positive airway pressure (IPAP): Maximum desired interface pressure which the ventilator will attempt to achieve during the inspiratory portion of the breath.

[0404] Pressure support: A number that is indicative of the increase in pressure during ventilator inspiration over that during ventilator expiration, and generally means the difference in pressure between the maximum value during inspiration and the base pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure support means the difference which the ventilator aims to achieve, rather than what it actually achieves.

[0405] Servo-ventilator: A ventilator that measures patient ventilation, has a target ventilation, and which adjusts the level of pressure support to bring the patient ventilation towards the target ventilation.RMDDHI(23)

[0406] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the initiation of a breath of a spontaneously breathing patient. If however, the device is unable to detect a breath within a predetermined period of time, the device will automatically initiate delivery of the breath.

[0407] Swing'. Equivalent term to pressure support.

[0408] Triggered. When a ventilator, or other respiratory therapy device such as an RPT device or portable oxygen concentrator, delivers a volume of breathable gas to a spontaneously breathing patient, it is said to be triggered to do so. Triggering usually takes place at or near the initiation of the respiratory portion of the breathing cycle by the patient's efforts.4.15.4 Systems and Software

[0409] Application programming interface (API)', a connection and / or software interface between systems, devices, programs, components, and / or other elements, which may be used to consume and / or offer services to other pieces entities / elements. Additionally or alternatively, an API may be or include a set of rules, definitions, communication protocols, and / or tools for building software and / or for allowing different systems, devices, programs, components, and / or other elements to communicate with each other and exchange data and / or functionality. In some examples, an API may be defined or otherwise used for a web-based system, operating system, database system, computer hardware, software library, and / or the like.

[0410] APIs may define a set of endpoints and methods that enable one system to request data or perform actions in another system. The endpoints may be in the form of network IDs / addresses, universal resource locators (URLs), universal resource identifier (URI), paths, connection strings to a database, memory addresses, ports, function names within a library or framework, and / or the like. The methods may be based on the type of API being used. For example. RESTful APIs may use HTTP methods (or HTTP verbs), such as GET, HEAD, POST, PUT, DELETE, CONNECT, OPTIONS, TRACE, PATCH, and / or the like. In another example, Remote Procedure Call (RPC) APIs may use methods that look like function that may be invoked directly. In another example, GraphQL APIs may use queries and mutations where a single request is sent that specifies desired data and / or operations. When an API call is made, a request is sent to the server providing the API, specifying what information or action is needed. The server processes the request, interacts with its underlying systems, and sends back a response. This allows different applications to interact without sharing their internal code or infrastructure. The requests and responses may be in the form of a structured format, such as JavaScript Object Notation (JSON). Extensible Markup Language (XML), Protocol Buffers (Protobuf), YAML, Apache® Thrift, and / or any other suitable format.RMDDHI(23)

[0411] API specification', a document, standard, or protocol that describes how to build an API connection or interface. A system, device, program, component, and / or other element that meets an API standard is said to implement or expose the API. As used herein, the term “API” may refer to either an API, API specification, and / or to an API implementation.

[0412] Attribute, a property or characteristic of an object, entity, or data structure that holds specific information or values relevant to that object’s definition and behavior. An attribute may also be a data point or piece of information that provides details, context, or functionality for elements or objects, such as collection points and purposes.

[0413] Client', a software element or device capable of requesting and consuming services and / or resources provided by a server and / or other systems in a network. A client may refer to a client system / device or a client application software running on a device in order to utilize functionality and / or services provided by one or more application(s). Examples of clients may include user equipment, web browsers, email clients, FTP clients, gaming clients and / or emulators, mobile apps, native apps.

[0414] Collection point', interface where data subjects can give their consent, set their preferences, or provide data. Examples of collection points may include a custom API, embedded web form, hosted web form, mobile app, and / or any digital touchpoint where user information is captured.

[0415] Component', a modular, self-contained unit of software that encapsulates a set of related functions or services, designed to interact with other components within a larger system through one or more interfaces. Additionally or alternatively, the term “component” may be, or refer to, a group or collection of one or more code elements such as, for example, classes, interfaces, enums, functions, objects, variables, methods, etc. Additionally or alternatively, the term “component” may be, or refer to, a grouping of related functionality encapsulated behind a defined interface. In object-oriented programming language (e.g., Java, C#, C++, etc.) examples, a component is made up of classes and interfaces, such as a collection of implementation classes behind an interface. In procedural programming language (e.g., C) examples, a component may be a number of C files in a particular directory. In ECMAScript (e.g., JavaScript) examples, a component may be a script module that is made up of a number of objects and functions. In functional programming language (e.g., F#, Haskell, etc.) examples, a component may be a module, which is a logical grouping of related functions, types, etc.

[0416] Container', a lightweight, portable, and isolated environment that packages software and its dependencies, enabling it to run consistently across different computing environments. Containers are a form of virtualization that allows applications to be packaged along with all of their dependencies (such as libraries, binaries, and configuration files) into a single, portable unit.RMDDHI(23)Unlike traditional virtual machines, which include an entire operating system, containers share the host system’s OS kernel but operate in isolated user spaces. This makes containers more lightweight and efficient in terms of resource usage. Additionally or alternatively, the term “container’" may refer to, or represent, an application, data store, process, server, or deployable unit. In this context, a container may be a runtime boundary around some code that is being executed or some data that is being stored. Examples of such containers may include a server-side web application (e.g., a Java EE web application running on Apache® Tomcat, an ASP.NET MVC application running on Microsoft® IIS, a Ruby on Rails application running on WEBrick, a Node.js application, etc.), a client-side web application (e.g., a JavaScript application running in a web browser using Angular, Backbone. JSJQuery, etc.), a client-side desktop application (e.g., a Windows® desktop application written using WPF, an OS X desktop application written using Objective-C, a cross-platform desktop application written using JavaFX, a Linux app written using Java or C++, etc.), a mobile app (e g., an Apple® iOS app, an Android app, a Microsoft Windows Phone app, etc.), a server-side console application (e.g.. a standalone or “public static void main” application, a batch process, etc.), a serverless function (e.g., a single serverless function, such as Amazon Lambda, Azure Function, etc.), a database (e.g., a schema or database in a relational database management system, document store, graph database, etc. such as MySQL, Microsoft SQL Server, Oracle Database, MongoDB, Riak, Cassandra, Neo4j, etc.), a blob or content store (e.g., a blob store such as Amazon S3, Microsoft Azure Blob Storage, etc., or content delivery network such as Akamai, Amazon CloudFront, etc.), a file system (e.g., a full local file system or a portion of a larger networked file system such as SAN, NAS, etc.), shell script (e.g., a single shell script written in Bash, etc.), and / or the like.

[0417] Consent', any freely given, specific, informed and unambiguous indication of a data subject’s wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to the data subject.

[0418] Consent string', a standardized, machine-readable carrier of consent information that encodes user consent choices that can be sent to third-party systems and vendors.

[0419] Data element', a fundamental unit of data that represents a single piece of information with a defined structure, type, and / or value within a dataset or data structure. A data element may also represent a data point or piece of additional information about a data subject that is voluntarily provided by the end user themselves.

[0420] Data subject', an identified or identifiable entity, such as a natural person or organization (org), who provides data and grants, withholds, and / or updates consent via an interface.RMDDHI(23)

[0421] Data subject profile', an overall record of the data subject, any identifiers, the purposes they have consented to, transaction history, related data elements, and other details.

[0422] Data subject token', an alphanumeric code that, in combination with a magic link, generates a URL to directly access a preference center.

[0423] Embedded web form', a web form integrated directly into a webpage or application, allowing users to input and submit data, typically interacting with a back-end server for processing or storage. An embedded web form can be a type of collection point that can be customized and directly embedded on a website to collect consent information and automatically send it to a consent platform.

[0424] Geolocation', a physical location, or a process of determining the physical location, of a user, system, or device based on positioning or location information, such as GPS data / coordinates, IP address, Wi-Fi signals, cellular location services, cell tower triangulation, and / or the like. A geolocation is a way to track a data subject’s location using, for example, their IP address and / or the like. Once consent is provided, it is stored in the data subject’s profile and associated consent receipts.

[0425] Hosted web form', a web form that is hosted on or by a third-party service, server, or platform, which allows users to submit data without it being directly embedded or managed on the hosting website’s infrastructure. In some examples, a hosted webform can be a third party web form that can be accessed via link and integrated on a website with or without coding, which collects consent and stores it directly in a consent platform.

[0426] Identifier (ID): a sequence of characters that can be used to identify, refer to, or otherwise indicate the identity of a unique object, element, or entity, such as an application, program, session, object, element, entity, variable, set of data, class, group, data structure, attribute, name, address, index, and / or the like. Here, the sequence of characters, at least in some examples, refers to one or more names, labels, words, numbers, letters, symbols, values, and / or any combination thereof. Additionally or alternatively, an identifier may be a sequence of characters that can be used to identify, refer to. or otherw ise indicate the identity of an individual, such as a name, mailing address, email address, phone number, government issued ID such as a driver’s license number or social security number (SSN), and / or other PII. Additionally or alternatively, the term “identifier” may refer to a unique piece of information used to distinguish and track individual users and their consent choices. Examples of identifiers can include cookie unique ID, network ID (e.g., network address, IP address, MAC address, cellular network address, domain name, port number, socket, etc ), mobile device ID, phone number, flow ID, hash value, index, universally unique ID (UUID), and / or the like.RMDDHI(23)

[0427] Interface: hardware and / or software elements that enable the exchange of information between two or more entities, such as systems, devices, components, etc. An interface may be a point of interaction where information can be collect from data subjects, such as a collection point.

[0428] Mobile app: a software application designed to run on mobile devices, providing users with specific functionality or services, either as native, web-based, or hybrid apps.

[0429] Mobile device: a portable electronic device. A mobile device may additionally or alternatively refer to hardware and associated software and services capable of transmitting, receiving, processing, and / or storing information across a wireless medium. Mobile devices may have a relatively small form factor, such that they are small enough to hold and operate in hand. Mobile devices are typically battery-powered and possess a flat-panel display and one or more built-in input devices, such as a touchscreen or keypad. Mobile devices may also include one or more sensors. Examples include but are not limited to mobile phones, smartphones, tablet computers, laptops, mobile hotspots, mobile printers, mobile projectors, mobile point-of-sale devices, mobile medical devices such as diagnostic and therapy devices, pagers, portable gaming devices, smart watches, fitness trackers, smart glasses, virtual reality headsets, smart TVs, smart appliances, smart home devices, in-vehicle systems, and any other wireless device capable of transmitting, receiving, processing, or storing information, as well as associated software and services.

[0430] Native app: a software application specifically developed to run on a particular operating system (OS) or platform, utilizing the platform's native programming languages, tools, and frameworks. Native apps are designed to take advantage of the device’s hardware, OS features, and performance optimizations, resulting in faster and more responsive user experiences. Typically, some native apps are distributed via official app stores, and sometimes require approval from the platform vendor.

[0431] Personal data or personally identifiable information (PII): information that relates to an identified or identifiable individual, who may be referred to as a “data subject”. Additionally or alternatively, personal data or PII may also refer to information that can be used on its own or in combination with other information to identify, contact, or locate a data subject, or to identify a data subject in context.

[0432] Platform: a collection of hardware and / or software functionality required to run applications on a computing system or infrastructure and enable such applications to provide and / or consume one or more sendees. A platform may be or represent the underlying hardware or software environment that supports and enables the execution of applications, services, or other software systems, often providing frameworks, tools, and resources to users or consumers.RMDDHI(23)

[0433] Policy, a data structure or a machine-readable element that contains rules, instructions, conditions, parameters, and / or criteria. A policy may also represent a set of rules and / or a plan of action that is expected to be fulfilled. For purposes of the present disclosure, the term “policy” may be used interchangeably with the terms “configuration”, “plan”, and / or “ruleset”, unless context dictates otherwise.

[0434] Preference center: an interface where data subjects can manage their consent preferences for specific purposes and purpose preference.

[0435] Purpose: a specific reason why an organization or service provider processes a user’s data for which consent is needed. Example of purposes may include marketing, analytics, personalization, regulatory compliance (e.g.. H1PAA, GDPR, CCPA, etc.), and / or the like.

[0436] Receipt: an unchangeable record that summarizes and includes all relevant information about the data subject's interaction. A receipt may be a timestamped immutable grouping of transactions, data, and metadata belonging to a data subject's single interaction with an interface.

[0437] Service: a distinct, reusable component or unit of functionality that performs a specific task and / or provides a particular capability, often accessible over a network to software systems and / or clients. A service is typically provided via a platform either by the platform itself or by one or more applications.

[0438] Software system: a collection of interconnected or interrelated software elements that work together to perform a specific function or set of functions, often running on a computing platform or infrastructure. A software system may be made up of one or more software elements (e.g., virtual machines, virtualization containers, applications, data stores, engines, modules, etc.), each of which may contain one or more components, which in turn are implemented by one or more code elements (e.g., classes, interfaces, objects, functions, methods, etc.).

[0439] Transaction: individual choice made by a data subject for a single purpose within a given receipt.

[0440] Transaction type: type of action or inaction performed by the data subject for a purpose. Examples may include Confirmed, Expired, Opt-in, Opt-out, and / or the like.

[0441] Visibility rules: Logical conditions that determine which form fields, purposes, or iterations of interfaces appear or are required based on interactions, profile information, geolocation, or other data.

[0442] User: an abstract representation of an entity that is capable of issuing commands, requests, and / or data to a computing system, and / or otherwise consumes or uses services. Users may be or include actors, roles, personas, named individuals, systems, devices, components, and / or the like.RMDDHI(23)104431 Web form', an interactive element on a webpage that allows users to input data through graphical elements, such as fields (e.g., text boxes, checkboxes, dropdowns, etc.), which may then be submitted to a server or service for processing and / or storage.4.16 OTHER REMARKS

[0444] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in Patent Office patent files or records, but otherwise reserves all copyright rights whatsoever.

[0445] Unless the context clearly dictates otherwise and where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limit of that range, and any other stated or intervening value in that stated range is encompassed within the technology. The upper and lower limits of these intervening ranges, which may be independently included in the intervening ranges, are also encompassed within the technology, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the technology.

[0446] Furthermore, where a value or values are stated herein as being implemented as part of the technology, it is understood that such values may be approximated, unless otherwise stated, and such values may be utilized to any suitable significant digit to the extent that a practical technical implementation may permit or require it.

[0447] Furthermore, “approximately”, “substantially”, “about”, or any similar term used herein means + / - 5-10% of the recited value.

[0448] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of the exemplary methods and materials are described herein.

[0449] When a particular material is identified as being used to construct a component, obvious alternative materials with similar properties may be used as a substitute. Furthermore, unless specified to the contrary, any and all components herein described are understood to be capable of being manufactured and, as such, may be manufactured together or separately.

[0450] It must be noted that as used herein and in the appended claims, the singular forms "a", "an", and "the" include their plural equivalents, unless the context clearly dictates otherwise.

[0451] All publications mentioned herein are incorporated herein by reference in their entirety' to disclose and describe the methods and / or materials which are the subject of those publications.RMDDHI(23) The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present technology is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

[0452] The terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.

[0453] The subject headings used in the detailed description are included only for the ease of reference of the reader and should not be used to limit the subject matter found throughout the disclosure or the claims. The subject headings should not be used in construing the scope of the claims or the claim limitations.

[0454] Although the technology herein has been described with reference to particular examples, it is to be understood that these examples are merely illustrative of the principles and applications of the technology. In some instances, the terminology and symbols may imply specific details that are not required to practice the technology7. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to indicate any order but may be utilized to distinguish between distinct elements. Furthermore, although process steps in the methodologies may be described or illustrated in an order, such an ordering is not required. Those skilled in the art will recognize that such ordering may be modified and / or aspects thereof may be conducted concurrently or even synchronously.

[0455] It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the technology7.

Claims

1. RMDDHI(23)CLAIMS1 . A method for operating a consent service to provide consent management of user data, the method comprising: querying, by one or more computing devices, a consent repository for a consent resource associated with a consent policy and a user of a client application; and when the consent resource does not indicate a consent status of active: obtaining, by the one or more computing devices, the consent repository for a consent template corresponding to the consent policy; obtaining, by the one or more computing devices, a consent notice indicated by the consent template for display in the client application; receiving, by the one or more computing devices, a consent response from the client application based on display of the consent notice; and generating, by the one or more computing devices, a new consent resource in the consent repository based on the consent response.

2. The method of claim 1, wherein the method further comprises: generating consent- related resources in the consent repository.

3. The method of claim 2, wherein the consent related resources include the consent template, the consent policy, and the consent resource.

4. The method of claim 3, wherein the consent template is a data structure representing a consent agreement and comprises the consent policy and the consent notice.

5. The method of claim 4, wherein the consent template includes a reference to a location where the consent notice is stored.

6. The method of any one of claims 3 to 5, wherein the consent policy is a data structure representing a policy for obtaining consent for a specified purpose.

7. The method of claim 6, wherein the user data is collected by the client application or a medical device, and the specified purpose is to share the user data with a sendee provider platform separate from the consent sen ice.

8. The method of claim 7, wherein the service provider platform is a first sendee provider platform, and the client application or the medical device consume servicesRMDDHI(23) provided by a second service provider platform.

9. The method of claim 8, wherein the user data is diagnostic data, and the second service provider platform collects the diagnostic data from the client application or the medical device.

10. The method of claim 9, wherein the specified purpose is to share the diagnostic data with the first service provider platform to provides therapy sendees through another medical device.

11. The method of any one of claims 3 to 10, wherein the consent resource is a data structure representing a record of a consent status, wherein the consent status is one of consented, withheld, revoked, or expired.

12. The method of any one of claims 1 to 11, wherein the new consent resource is a data structure representing a record of a consent status indicated by the consent response, wherein the consent status indicated by the consent response is one of consented, withheld, revoked, or expired.

13. The method of any one of claims 11 to 12, wherein the consent resource and the new consent resource include a user identifier associated with the user or an application identifier associated with the client application.

14. The method of any one of claims 1 1 to 13, wherein the consent resource and the new consent resource include an effective field indicating a time period when the consent status is active.

15. The method of any one of claims 1 to 14, wherein the method further comprises: determining whether the consent resource indicates an active, revoked, or expired status.

16. The method of claim 15, wherein the method further comprises: determining that the consent resource does not indicate a consent status of active when the consent status is revoked or expired.

17. The method of claim 15, wherein the method further comprises: determining that the consent resource does not indicate a consent status of activeRMDDHI(23) when no consent resource is stored in the consent repository based on the querying.

18. The method of any one of claims 1 to 17, wherein the method further comprises: generating a notification including the consent status indicated by the consent response.

19. The method of claim 18, wherein the notification is an email message, and the method comprises: causing the email to be sent to the client application or a sendee provider platform that hosts a service consumed by the client application.

20. The method of claim 18, wherein the notification is a database record, and the method comprises: storing the database record in the consent repository in association with the new consent resource.

21. A computer-readable medium encoded with computer-readable instructions, which when executed by one or more processors implement the method of any one of claims 1 to 20.

22. A system for operating a consent service to provide consent management of user data, the system comprising one or more servers communicatively coupled with one or more databases configured to store the user data, wherein the user data comprises device related usage data generated by a plurality of devices for a user, and the one or more servers being configured to access and execute the computer-readable instructions of the computer-readable medium of claim 21.

23. A system for operating a consent service to provide consent management of user data, the system comprising: one or more database systems, the database systems configured to store the user data; and one or more computing devices, the one of more computing devices being configured to access the one or more database systems and being configured with one or more consent services, wherein the one or more consent services are configured to: query a consent repository' for a consent resource associated with a consent policy and a user of a client application; andRMDDHI(23) when the consent resource does not indicate a consent status of active: obtain the consent repository for a consent template corresponding to the consent policy; obtain a consent notice indicated by the consent template for display in the client application; receive a consent response from the client application based on display of the consent notice; and generate a new consent resource in the consent repository based on the consent response.

24. The system of claim 23, wherein the one or more consent services are further configured to: generate consent-related resources in the consent repository.

25. The system of claim 24, wherein the consent related resources include the consent template, the consent policy, and the consent resource.

26. The system of claim 25, wherein the consent template is a data structure representing a consent agreement and comprises the consent policy and the consent notice.

27. The system of claim 26, wherein the consent template includes a reference to a location where the consent notice is stored.

28. The system of any one of claims 25 to 27, wherein the consent policy is a data structure representing a policy for obtaining consent for a specified purpose.

29. The system of claim 28, wherein the user data is collected by the client application or a medical device, and the specified purpose is to share the user data with a sendee provider platform separate from the consent sendee.

30. The system of claim 29, wherein the service provider platform is a first sendee provider platform, and the client application or the medical device consume services provided by a second service provider platform.

31. The system of claim 30, wherein the user data is diagnostic data, and the second service provider platform collects the diagnostic data from the client application or the medical device.RMDDHI(23)32. The system of claim 31, wherein the specified purpose is to share the diagnostic data with the first service provider platform to provides therapy services through another medical device.

33. The system of any one of claims 25 to 32, wherein the consent resource is a data structure representing a record of a consent status, wherein the consent status is one of consented, withheld, revoked, or expired.

34. The system of any one of claims 23 to 33, wherein the new consent resource is a data structure representing a record of a consent status indicated by the consent response, wherein the consent status indicated by the consent response is one of consented, withheld, revoked, or expired.

35. The system of any one of claims 33 to 34, wherein the consent resource and the new consent resource include a user identifier associated with the user or an application identifier associated with the client application.

36. The system of any one of claims 33 to 35, wherein the consent resource and the new consent resource include an effective field indicating a time period when the consent status is active.

37. The system of any one of claims 23 to 36, wherein the one or more consent services are further configured to: determine whether the consent resource indicates an active, revoked, or expired status.

38. The system of claim 37, wherein the one or more consent services are further configured to: determine that the consent resource does not indicate a consent status of active when the consent status is revoked or expired.

39. The system of claim 37, wherein the one or more consent services are further configured to: determine that the consent resource does not indicate a consent status of active when no consent resource is stored in the consent repository based on the querying.

40. The system of any one of claims 23 to 39, wherein the one or more consent servicesRMDDHI(23) are further configured to: generate a notification including the consent status indicated by the consent response.

41. The system of claim 40, wherein the notification is an email message, and wherein the one or more consent services are configured to: cause the email to be sent to the client application or a service provider platform that hosts a service consumed by the client application.

42. The system of claim 40, wherein the notification is a database record, and wherein the one or more consent services are configured to: store the database record in the consent repository in association with the new consent resource.

Images