Devices, systems and methods for physiological monitoring

Abstract

Devices, systems, and methods for physiological monitoring are provided. Software applications, devices, systems, and methods are provided for monitoring, recording, and tracking cardiac health related metrics using associated computing devices. Software applications may monitor, record, and track physiological data such as electrocardio activity, heart rate, and blood pressure. Data transmission between a patient and a health care provider may also be implemented via the software application disclosed herein.

Description

[0001] This application is a divisional application of the application filed on August 31, 2017, with application number 201780067224.6 and entitled "Apparatus, System and Method for Physiological Monitoring". Technical Field

[0002] This application relates to devices, systems, and methods for physiological monitoring. Background Technology

[0003] The use of smartphones, tablets, wearable computers, and "smart" accessories is becoming increasingly widespread. Smartphones are virtually ubiquitous in high-income countries and are gaining popularity in low- and middle-income countries as production costs decrease and internet access becomes more readily available. This increased availability of computing power and devices offers numerous opportunities for improvements in how health is monitored and how health management is given greater patient control.

[0004] Cardiovascular disease is a leading cause of death worldwide and is prevalent in both high- and low-income countries. Heart rate measurement, blood pressure measurement, and electrocardiogram (ECG) are widely used techniques for diagnosing patients' cardiovascular health. Summary of the Invention

[0005] This document describes software, systems, apparatus, and methods for connecting patients with healthcare providers to provide effective healthcare, thereby improving the efficiency of healthcare providers. In some embodiments, the software described herein includes one or more integrated applications on a single platform for connecting patients with healthcare providers.

[0006] This document describes a platform comprising: a patient application including: a software module for receiving sensing data from sensors configured to sense physiological parameters of a patient; a software module for transmitting one or more of the sensing data and patient communications to a healthcare provider; and a software module for receiving healthcare provider communications; and a healthcare provider application including: a software module for receiving the sensing data and one or more of the patient communications; and a software module for generating the healthcare provider communications and transmitting the healthcare provider communications to the patient; wherein the healthcare provider communications are automatically generated and transmitted in response to or referencing one or more of the sensing data; wherein the healthcare provider communications refer to the sensing data; and wherein the healthcare provider communications include a marker indicating that the healthcare provider communications were generated by the healthcare provider. In some embodiments, the physiological parameters include the patient's vital signs. In some embodiments, the physiological parameters include the patient's heart sounds. In some embodiments, the patient communications are transmitted around the time the physiological parameters are sensed. In some embodiments, the patient communications include audio recordings of the patient. In some embodiments, the patient communications include video recordings of the patient. In some embodiments, the patient communications are recorded in real time and transmitted to the healthcare provider application. In some embodiments, the platform includes the sensor, and the sensor is configured to operate to connect to a mobile computing device. In some embodiments, the sensor is integrated with the mobile computing device. In some embodiments, the sensor includes two ECG electrodes. In some embodiments, the healthcare provider communication includes personalized messages of encouragement or congratulations for the patient. In some embodiments, the marker includes an image of the healthcare provider and one or more logos associated with the healthcare provider. In some embodiments, the healthcare provider application includes a database comprising data sensed from multiple patients, and the healthcare provider application includes software modules for organizing and separating data for each of the multiple patients. In some embodiments, the patient application and the healthcare provider application each include software modules for real-time video communication between the patient and the healthcare provider. In some embodiments, at least a portion of the patient application is unlocked using a received electronic prescription.This document describes a computer-implemented method comprising: sensing a patient's physical parameters using a sensor; transmitting the physical parameters and one or more patient communications referencing the physical parameters; transmitting an automatically generated communication to the patient in response to the transmitted physical parameters and one or more patient communications; wherein the automatically generated communication refers to the physical parameters and one or more of the communications; and wherein the automatically generated communication includes a marker indicating that the automatically generated communication was sent by a healthcare provider. In some embodiments, the physical parameters include the patient's vital signs. In some embodiments, the physical parameters include the patient's heart sounds. In some embodiments, the patient communications are transmitted around the time the physical parameters are sensed. In some embodiments, the patient communications include audio recordings of the patient. In some embodiments, the patient communications include video recordings of the patient. In some embodiments, the patient communications are recorded in real time and transmitted to the healthcare provider. In some embodiments, the sensor is configured to operate to connect to a mobile computing device. In some embodiments, the sensor is integrated with the mobile computing device. In some embodiments, the sensor includes two ECG electrodes. In some embodiments, the automatically generated communication includes a personalized message of encouragement or congratulations for the patient. In some embodiments, the marker includes an image of the healthcare provider and one or more logos associated with the healthcare provider. In some embodiments, the method includes receiving data sensed from multiple patients by the healthcare provider, and using a database to organize and separate the data for each of the multiple patients. In some embodiments, real-time video communication is transmitted between the patients and the healthcare provider. In some embodiments, the step of sensing the bodily parameters requires first receiving an electronic prescription from the healthcare provider. Attached Figure Description

[0007] The novel features of the subject matter disclosed herein are particularly set forth in the appended claims. A better understanding of the features and advantages of the subject matter disclosed herein can be obtained by referring to the following detailed description of illustrative embodiments utilizing the principles of the subject matter disclosed herein, wherein:

[0008] Figure 1 Typical embodiments of a platform including a digital processing device, as disclosed herein, are shown.

[0009] Figure 2A This illustrates an example of the initial home screen interface encountered by a patient before he or she has logged into a patient application running on a computing device as described herein.

[0010] Figure 2B~E shows a screenshot of a typical patient app interface that a patient would see once logged in. Figure 2B A screenshot of a typical interface used for sensing ECG is shown; Figure 2C A screenshot showing a typical interface used to sense a patient's heart rate; Figure 2D A screenshot showing a typical interface used to sense a patient's blood pressure; Figure 2E A screenshot shows a typical interface used to sense a patient's weight.

[0011] Figure 3 This is a screenshot showing a typical patient interface encountered by a patient during an ECG scan.

[0012] Figure 4A A screenshot shows a typical patient interface during the sensing of physiological parameters, including blood pressure measurement.

[0013] Figure 4B This is a typical screenshot of the patient interface, showing blood pressure measurements recorded over a period of time.

[0014] Figure 5 The image shows a typical screenshot of a patient interface 500 displaying multiple historical physiological measurements, including analysis and / or insights related to the physiological parameters.

[0015] Figure 6 The screenshot shows a typical patient application, illustrating typical healthcare provider communications.

[0016] Figure 7 The screenshot shows a typical patient interface on a patient application, where the patient is assigned tasks corresponding to a patient care plan.

[0017] Figure 8 This screenshot shows a typical healthcare provider communication sent in response to received patient data.

[0018] Figure 9A This screenshot shows a typical initial home screen interface of the Health Care Provider app that a health care provider will see when using the app to browse his or her patient list.

[0019] Figure 9B This screenshot shows a typical interface of a healthcare provider app that displays the received data.

[0020] Figure 9C This screenshot shows a typical interface of a healthcare provider application that allows healthcare providers to select descriptors of received patient ECGs.

[0021] Figure 9DThis screenshot shows a typical interface of a healthcare provider app that allows healthcare providers to type annotations related to the received patient ECG. Detailed Implementation

[0022] As used herein, the term "patient" refers to a person who can use the software platform disclosed herein. These terms do not require or limit situations characterized by (e.g., continuous or intermittent) supervision by a healthcare provider (e.g., a physician, registered nurse, nurse practitioner, healthcare provider's assistant, caregiver, or hospice worker).

[0023] The terms “sensor” and “sensing device” include any hardware configured to sense patient parameters, including standalone sensors as well as sensors that contain a processor or additional computing and / or hardware components (e.g., a transmitter or display).

[0024] The term "that operation to connect" includes connections made through operation. Such connections can also include physical integration of components or reversible connections. Alternatively, such connections can be made between completely physical components.

[0025] platform

[0026] This document describes software platforms (or "platforms"), systems, devices, and methods for providing effective healthcare to patients while improving the efficiency of healthcare providers. The platform provides effective healthcare to patients by, but not limited to, monitoring patients' physical parameters and treatment goals. Furthermore, the platform is configured to provide communication between patients and healthcare providers. The platform is configured to provide patients with more direct and timely access to healthcare providers, while automating a large number of monitoring tasks and / or communications from healthcare providers to patients, thereby saving healthcare providers time and increasing their efficiency.

[0027] The platform includes one or more custom software applications (or "applications") configured to interact with each other. Applications on the platform as described herein are configured to provide monitoring and communication features.

[0028] In some embodiments of the platform, the platform includes one or more hardware components (e.g., one or more sensing devices).

[0029] In some embodiments, the platform is configured to operate with one or more devices and / or one or more systems. That is, in some embodiments, the devices described herein are configured to use a built-in processor to run applications of the platform, and in some embodiments, the platform is used by a system comprising one or more computing devices that interact with or run one or more applications of the platform. The methods described herein include, for example, the step of using the platform described herein to enable communication between patients and healthcare providers.

[0030] The platform includes one or more applications, at least one of which includes a patient application and one application includes a healthcare provider application. In some embodiments, the platform includes additional monitoring applications (i.e., applications other than the patient and healthcare provider applications) located on a computing device at a remote monitoring location. For example, in some embodiments, a third party has a monitoring application that allows the third party to monitor and / or interact with one or more applications of the platform. For example, a monitoring service that monitors patient data would utilize a monitoring application.

[0031] Figure 1 A typical embodiment of a platform including a digital processing device 101 as described herein is shown. The digital processing device 101 includes a patient application or physician application as described herein. The device 101 is configured to run the application. The digital processing device 101 includes a central processing unit (CPU, also referred to herein as a “processor” and “computer processor”) 105, wherein the central processing unit is a single-core or multi-core processor, or multiple processors for parallel processing. The digital processing device 101 also includes memory or storage location 110 (e.g., random access memory, read-only memory, flash memory, etc.), electronic storage unit 115 (e.g., hard disk), power supply 125, communication interface 120 for communicating with one or more other systems (e.g., network adapter), and peripheral devices 135. The memory 110, storage unit 115, interface 120, and remote devices 135 are configured to communicate with the CPU 105 via a communication bus (solid line) such as a motherboard. In some embodiments, the digital processing device 101 is operatively connected to a computer network (“network”) 130 via a communication interface 120. In some embodiments, the network 130 includes the Internet. In some embodiments, the network 130 is a telecommunications and / or data network.

[0032] CPU 105 is configured to execute machine-readable instructions embodied in a software application or module. These instructions can be stored in a storage location such as memory 110.

[0033] In some embodiments, storage unit 115 is configured to store files such as user data (e.g., user preferences) and user programs.

[0034] Some of the methods described herein are implemented by machine-executable code (e.g., a computer processor) stored in an electronic storage location on digital processing device 101, such as memory 110 or electronic storage unit 115. The machine-executable code or machine-readable code is provided in the form of a software application or software module. During use, the code is executed by processor 105. In some cases, code is retrieved from storage unit 115 and stored in memory 110 for access by processor 105. In some cases, electronic storage unit 115 is excluded, and machine-executable instructions are stored in memory 110.

[0035] In some embodiments, the remote device 135 is configured to communicate with the digital processing device 101 and includes any mobile computing device, wherein non-limiting examples of the mobile computing device include a tablet computer, a laptop computer, a smartphone, or a smartwatch. In some embodiments, the remote device 135 includes a physiological sensor.

[0036] Applications described herein (i.e., patient applications, healthcare provider applications, and monitoring applications) include one or more software modules. Software modules as described herein include computer-readable and executable code. In various embodiments, a software module includes files, code segments, programming objects, programming structures, or combinations thereof. In other various embodiments, a software module includes multiple files, multiple code segments, multiple programming objects, multiple programming structures, or combinations thereof. In various embodiments, by way of non-limiting example, one or more software modules include web applications, mobile applications, and standalone applications. In some embodiments, a software module is in one computer program or application. In other embodiments, a software module is in more than one computer program or application. In some embodiments, a software module is hosted on one machine. In other embodiments, a software module is hosted on more than one machine. In other embodiments, a software module is hosted on a cloud computing platform. In some embodiments, a software module is hosted on one or more machines in one location. In other embodiments, a software module is hosted on one or more machines in more than one location.

[0037] The computing devices described herein include an operating system that enables them to run the software applications of this invention. Non-limiting examples of such operating systems include: Android, iOS, Chrome, Windows 10 Mobile, Blackberry 10, Firefox OS, Sailfish OS, Tizen, Ubuntu Touch OS, and H5OS. Non-limiting examples of manufacturers producing mobile computing devices compatible with the software applications disclosed herein include: Apple, Samsung, Sony, HTC, LG, and Motorola Mobility.

[0038] Sensing device

[0039] In some embodiments of the platform, one or more sensors (or “sensing devices”) are configured to monitor one or more physiological parameters of an individual. In some embodiments, local sensing devices (e.g., sensing devices located with the patient) are configured to communicate with one or more remote computing devices. As used herein, remote computing devices are devices not located with the patient or not integrated with a computing device running a patient application.

[0040] In some embodiments, the sensing device is integrated with a patient computing device. For example, a sensing device including one or more ECG electrodes is integrated into the housing and / or processor of a computing device such as a smartphone or smartwatch. In some embodiments, the sensing device is operatively coupled to the patient computing device. For example, a sensing device having a connector such as a magnetic or adhesive connector is configured to be coupled to the computing device via said magnetic or adhesive connector. In some embodiments, the sensing device is integrated with the housing of a smartphone's protective case. In some embodiments, the sensing device is integrated with the strap of a smartwatch.

[0041] In some embodiments, the sensing device includes a separate device configured to send data to patient applications and / or healthcare provider applications. Non-limiting examples of sensing devices configured to operate with the platforms described herein include thermometers, heart rate sensors, activity sensors (e.g., accelerometers, gyroscopes), position sensors (including positioning sensors), blood pressure sensors, oxygen saturation sensors, weight sensors (e.g., scales), sweat sensors (e.g., capacitive sensors), respiration sensors, EEG sensors, and ECG sensors.

[0042] Patient application

[0043] The patient application is configured to be operated by the patient, and the healthcare provider application is configured to be operated by the healthcare provider. In some embodiments of the platform, the patient application is located on a computing device that is located near the patient but far from the healthcare provider.

[0044] The platform is configured to enable one or more patient applications to interact with one or more healthcare provider applications. For example, data and communications are sent and received between patients and healthcare providers via one or more applications on the platform. In some embodiments, data received from a patient application results in a computer-generated response from an application within the platform (e.g., a healthcare provider application or a monitoring application).

[0045] The patient application is configured to monitor the patient's health in an occasional or continuous manner. In embodiments where the patient continuously wears, contacts, or otherwise engages with the sensor, one approach is for the patient application to continuously monitor the patient's health.

[0046] The patient application is configured to receive, organize, and / or track patient data, including sensed physiological parameters. For example, in some embodiments, the patient application is configured to receive the patient's heart rate from a heart rate sensor. In other examples, in some embodiments, the patient application is configured to receive sensed ECG data of the patient.

[0047] In some embodiments, the patient application is configured to receive multiple health indicators or physiological parameters. For example, the patient application includes one or more interfaces presented to a patient, wherein these interfaces allow the sensing and receiving of several parameters. Non-limiting examples of the sensed patient parameters received by the patient application include ECG, blood pressure, heart rate, height, weight, age, and physical activity level.

[0048] In some embodiments, the patient application is configured to provide synchronized measurement and sensing of cardiac health data. Additionally, in some embodiments, the patient application is configured to send data (e.g., cardiac health data or notifications) to another application within the platform. In some embodiments of the platform, the sending of sensed data to another application within the platform occurs synchronously with the sensing of the data.

[0049] In some embodiments, the patient application is configured to organize and / or track data received from the sensing device, while in alternative embodiments, this organization and tracking of data received from the sensing device may be done by a remote second application. In some embodiments, organizing the received data on the patient application includes sorting the data in a searchable, interactive patient database. In some embodiments of the patient application, tracking the received data includes monitoring specific data values ​​or ranges within the received data. In some embodiments, the sensing data is sent directly to a healthcare provider application instead of to the patient application.

[0050] The patient application is configured to operate on or in conjunction with a computing device. For example, the first computing device includes one or more sensors (which may or may not be physically integrated with the computing device) configured to sense the patient's physiological parameters. For instance, the patient may use an ECG monitor, blood pressure monitor, or pulse oximeter, along with the patient application, to record and save or store his or her electrical activity and blood pressure. Furthermore, the patient may choose to send the ECG activity and blood pressure data or oxygen saturation data to his or her healthcare provider via the software application of this disclosure. Additionally, in some embodiments, the patient application is configured to simultaneously monitor and / or record multiple physiological parameters.

[0051] Sensing data is transmitted to the platform's applications (e.g., patient applications, healthcare provider applications, monitoring applications) via wired connections or wireless connections such as WiFi transmitters, Bluetooth transmitters, audio or ultrasonic acoustic transmitters.

[0052] Patient applications include one or more interfaces (e.g., graphical, audio, or video interfaces). One or more patient interfaces of a software application enable patients to: obtain physiological information, for example, from sensing devices or other health-based software applications (e.g., Apple Health); store sensing data from sensing devices; send and receive communications; track task completion; and / or send physiological, audio, and visual data to a healthcare provider.

[0053] In some embodiments of the patient application, the patient application is configured to communicate with another application running within the platform described herein, and in some embodiments, it is also configured to communicate with software applications that are not part of the platform to send and / or receive data from sensing devices (such as height, weight, age, physical activity level, heart rate, blood pressure, and / or ECG data). For example, in some embodiments, the patient sends and / or receives data from other health-based software applications (including, but not limited to, Apple Health, Google Fit, S Health, and / or Fitbit) and saves the data to his or her cardiac monitoring device.

[0054] The patient application provides the patient with one or more patient interfaces, which allow the patient to select specific data to be sent to the healthcare provider, and / or data that can be automatically sent from the patient application to the healthcare provider. Data sent from the patient application to the healthcare provider application includes, for example, height, weight, age, physical activity level, heart rate, blood pressure, and ECG data.

[0055] Figure 2A This illustration shows an example of the initial home screen interface encountered by a patient before he or she has logged into a patient application running on a computing device as described herein. The patient application typically includes a login feature 200, which prompts the patient to provide, for example, his or her email address and password, in order to log in.

[0056] In some embodiments, the entire patient application or a portion thereof is provided to the patient in a locked state, wherein in order to operate the application or a portion thereof, the patient must first be authorized to access it by another party (e.g., a healthcare provider, hospital, employer, or insurance provider). For example, a healthcare provider grants access to the patient application by providing the patient with a traditional or electronic prescription containing an access code or password, thereby granting the patient access to the locked patient application or a locked portion thereof by entering a password as a username and / or password in login feature 200. In some embodiments of the application described herein, the electronic prescription includes an email sent from the healthcare provider to the patient (or sent by the healthcare provider application to the patient) containing an access code or password for accessing the software. In another example, the healthcare provider provides an electronic prescription including a hyperlink, which unlocks the patient application or its locked portion upon being clicked by the patient. In yet another example, the healthcare provider sends a text message to the patient containing a link or code that the patient uses to unlock the patient application or a portion thereof. In some embodiments of the platform, the platform automatically grants access to the patient application in response to a request from the healthcare provider.

[0057] In another example, a healthcare provider gives a patient an electronic prescription for a health monitoring device that utilizes and / or includes a patient application as described herein. For instance, the healthcare provider gives a patient a prescription for a device configured to run a patient application as described herein. In other examples, a cardiologist gives a patient an electronic prescription for a device including electrodes configured to sense the patient's ECG and engage with a patient application that also prescribes the medication to the patient.

[0058] Once a patient accesses the patient application by entering an access code or password provided by another party (e.g., a healthcare provider, hospital, employer, or insurance provider), in some embodiments, the patient application displays images associated with the healthcare provider, such as an image of the healthcare provider and / or one or more logos associated with the healthcare provider and / or the healthcare provider's practices and / or the hospitals associated with the healthcare provider.

[0059] Figure 2B ~E shows a screenshot of a typical patient app interface that a patient would see once logged in. Figure 2B and 2C A patient interface component 204 is shown, which uses, for example, an ECG sensing device 200 configured to interact with a software application to provide a patient with the ability to select recording an ECG or heartbeat. In some embodiments, the patient interface component 204 includes touchscreen buttons.

[0060] In some embodiments of the patient application, the patient interface includes a dashboard 210 and / or an interface 204, wherein the patient contacts the dashboard 210 and / or the interface 204 to perform tasks, such as using sensing devices to sense, for example, one or more physiological parameters, such as resting heart rate. Figure 2C ),blood pressure( Figure 2D Physical activity and body mass index (BMI) Figure 2E In some embodiments, when in contact with a patient, interface 204 enables the sensing of the patient's physiological parameters (described in...) via sensing devices 200, 206, or 208. Figure 2B(Screenshot of the patient application in a typical embodiment of ~E). The first sensing device 200 includes a smartphone operatively coupled to one or more ECG electrodes (not shown). As described herein, in some embodiments, the patient application operates on the first sensing device 200. The second sensing device 206 includes a blood pressure cuff, and the third sensing device 208 includes a scale. As described herein, in some embodiments, the patient application receives sensing data from sensing devices on which it does not operate (such as embodiments of the second sensing device 206 and the third sensing device 208).

[0061] Figure 3 A screenshot of a typical patient interface encountered by a patient during ECG sensing using an ECG sensing device (displayed at point 300 on the interface) is shown. In some embodiments of the patient application, the patient can select options in the patient interface, for example, using a touchscreen button 306, which allows the patient to record audio and / or video using a computing device (e.g., a smartphone running the patient application as an app) that is interacting with the patient application. For example, the patient can use the ECG sensing device to sense an ECG, send the sensed ECG to a processor on a computing device (e.g., a smartphone or smartwatch), and record audio and / or video, which is associated with the sensed ECG by the patient application. For example, the patient can record an audio recording stating "I have chest pain" along with the sensed ECG. The patient application is configured to associate the sensed ECG with the recorded audio and / or video recordings and store them locally on the computing device interacting with the patient application and / or send the ECG and audio and / or video recordings together to another computing device (e.g., a computing device belonging to a healthcare provider or monitoring service). The patient interface component can prompt the patient to verbally state any annotations that the patient must add, for example, by engaging with the patient interface at 306 via a touchscreen interface at 306. Once engaged at 306, the patient verbally describes any symptoms he or she is experiencing, for example, during the day or at the time of ECG sensing. This verbal description (e.g., video or audio) is recorded by the patient application and sent to the physician application and / or monitoring application and / or stored. The verbal annotations added by the patient to the ECG data provide a correlation between symptoms and cardiac health indicators. In some embodiments, the heart rate displayed on the typical interface at 304, along with other ECG data-specific parameters (such as filtering, gain, and velocity), is displayed on the ECG measurement interface at 302, or provided as metadata.

[0062] In some embodiments, the patient application is accessed via a patient interface (such as...) Figure 3The typical interface shown in the image displays the sensed patient data. One or more health indicators are displayed in the patient interface in graphical or textual form. The patient interface can also display ECG at position 300 and heart rate recording at position 304 over a period of time; ECG, heart rate recording, and time can be displayed graphically or in textual form.

[0063] The patient interface can also display, for example, the status of ECG measurements, which can be labeled as "normal" for normal ECG measurements and "atrial fibrillation" for abnormal ECG measurements. In other aspects, the patient dashboard interface allows patients to add annotations to the recorded health indicators.

[0064] In some embodiments of the patient application, data in the patient interface of the patient application can also be viewed through the healthcare provider application. That is, in a platform where both the healthcare provider and the patient are running software applications on their respective computing devices, in some embodiments of this platform, the healthcare provider can use the healthcare provider application running on the healthcare provider's computing device to view the patient's patient interface as seen by the patient. Optionally, the data can be viewed in the healthcare provider application after it has been acquired.

[0065] Figure 4A A screenshot of a typical patient interface during the sensing of physiological parameters, including blood pressure measurement, is shown. In some embodiments, the sensing device includes a blood pressure monitor, which includes an electronic blood pressure monitor configured to sense the patient's blood pressure and transmit the sensed blood pressure to a patient application. In some embodiments, the patient is prompted to record the blood pressure measurement via the patient application by sending a warning or alarm 400 displayed on the interface or otherwise sent via a computing device coupled to the patient application. In some embodiments, the blood pressure record from the blood pressure device is then prompted to transmit it to the patient application, for example, by engaging a touchscreen button 402. Furthermore, the patient can store the blood pressure record on the computing device via the patient application; however, in some embodiments, the storage and transmission of the sensed parameters are done automatically.

[0066] like Figure 4B (As shown in the typical screenshot of the patient interface) the patient can view blood pressure records stored over a period of time, as depicted at position 404. Figure 4B The patient interface shown also displays the latest record to the patient at point 406 by marking it as "new" and including the time the blood pressure record was saved. Additionally, patients can view other metrics sensed over a period of time, such as weight and BMI records stored over that period.

[0067] Figure 5The diagram shows a typical screenshot of a patient interface 500 displaying multiple historical physiological measurements, including analysis and / or insights related to the physiological parameters. For example, in some embodiments, the interface 500 is configured to display a graphical representation of one or more physiological parameters sensed over time. For example, in some embodiments, the interface 500 is configured to display an assessment of the sensed physiological parameters, such as whether the sensed parameters are normal or abnormal.

[0068] Figure 6 The screenshot shows a typical patient application, illustrating typical healthcare provider communication 602. Communication to the patient via the platform is either sent directly from the healthcare provider or automatically generated, and includes a tag 600 indicating that the communication was generated by the healthcare provider (even if it is automatically generated).

[0069] The automatically generated communications described herein are computer-generated communications, but they have markers indicating that they have been created and sent by a healthcare provider. In this way, the patient is given the impression that the computer-generated communications were created and generated by the healthcare provider. Examples of computer-generated communications include communications congratulating a patient on successfully completing a task (e.g., losing 5 pounds). In some embodiments of the platform described herein, the computer-generated communications include markers indicating that the communications were generated and sent by a healthcare provider, such as electronic messages containing an image of the healthcare provider or a logo associated with the healthcare provider. It is highly beneficial to automatically generate (i.e., computer-generated) such communications rather than having the healthcare provider generate them, as this saves the healthcare provider time in monitoring and responding to changes in routine patient monitoring. Simultaneously, the markers indicating that the communications originated from the healthcare provider provide an emotional benefit to the patient. Computer-generated communications are one way the platform described herein is used as an assistant or helper for healthcare providers, thereby saving healthcare providers time while providing valuable patient monitoring and feedback.

[0070] The application of this invention also provides a patient interface, in which tasks provided by a healthcare provider are received and displayed. In this case, such as Figure 6 As shown, healthcare providers have offered patients care plans that include recording his or her weight.

[0071] The software application also provides an interface in which push notifications sent by healthcare providers are received and displayed. In some embodiments, additional interface components allow patients to track or confirm the completion of various health-related tasks, such as physical activity or medication administration.

[0072] Figure 7The screenshot shows a typical patient interface on a patient application, where the patient is assigned a patient care plan (in this case, a...). Figure 6 The corresponding task 700 is the care plan. Once the patient is connected to the scale, in some embodiments, pressing the touchscreen button 702 causes data to be sent from the scale (while in other embodiments, the scale does this automatically), or alternatively, the patient enters weight data into the interface and confirms the data by selecting a button.

[0073] In some embodiments, the healthcare provider application is configured to use received patient data to generate a comprehensive patient care plan. The patient care plan is sent to the patient application, for example, and is configured to monitor, record, and / or track multiple health indicators of the patient, such as ECG, blood pressure, weight, physical activity level, BMI, and medication adherence.

[0074] In some embodiments, the healthcare provider app described herein is configured to provide patients with the ability to perform an exercise stress test to detect the presence of heart disease. For example, the patient app instructs the patient to exercise (such as walking on a treadmill for 20 minutes) for a set period of time while in contact with an ECG sensing device that communicates with the patient app, wherein, in some embodiments, the patient app sends the data to the healthcare provider app for analysis.

[0075] Exercise stress testing is used to aid in the diagnosis of cardiovascular disease. Specifically, exercise stress testing is performed by a healthcare provider in a specialized clinic or medical center to determine the amount of stress a patient's heart can withstand before evidence of ischemia or arrhythmia appears. Different types of stress tests can include treadmill or exercise stress testing, dobutamine or adenosine stress testing, stress echocardiography, or nuclear stress testing. Exercise stress testing measures the effects of exercise on the heart. Exercise testing performed in a specialized clinic involves monitoring the patient's electrical activity of the heart while the patient walks on a treadmill. The healthcare provider monitors the patient's electrical activity by placing electrodes in ten small areas of the patient's body, where these electrodes are connected to an ECG monitor. The healthcare provider takes baseline measurements of blood pressure, ECG, and heart rate before starting the exercise stress test. The exercise stress test begins when the patient begins walking on the treadmill for a specific period of time. If any abnormal changes occur on the ECG or any chest pain, the test is stopped and the abnormality is noted.

[0076] In some implementations, the patient application described herein can provide a patient with the ability to perform a home exercise stress test to assess heart disease. The patient can monitor their electrical activity, blood pressure, and heart rate using both the cardiac health monitoring device and the patient application while performing the exercise stress test. The patient application can instruct the patient to place the cardiac health monitoring device in contact with their skin and to take a baseline ECG measurement. The interface can also instruct the patient to take a baseline blood pressure measurement before starting the exercise stress test. The patient application can have an interface for prompting the patient to begin the exercise stress test. This interface can prompt the patient to walk for a defined amount of time while in physical contact with the cardiac health monitoring device. For example, the patient may be using a smartphone or other mobile computing device (containing sensing electrodes) as the cardiac health monitoring device to perform the home exercise stress test. Alternatively, the patient can use a smartphone (or other mobile computing device) that includes sensing electrodes and can place their hand on the sensing electrodes while participating in walking as part of the exercise stress test. At the end of the time period, the heart rate is measured within 2 minutes to calculate the time required for the heart to recover from the exercise. The interface may include components that, once the stress test is completed, provide the patient with the option to record, save, and / or send all data collected during the exercise stress test, wherein the data may then be sent via sending components known to those skilled in the art or shared with healthcare professionals in healthcare professional applications.

[0077] Figure 8 This screenshot shows a typical healthcare provider communication sent in response to received patient data. In this case, recording and sending weight has been successfully completed. Figure 6 Patients in care plans such as Figure 7 The congratulatory message was received as shown. As described, such healthcare provider communications are generated and sent by the healthcare provider, or automatically generated and sent, for example, by a healthcare provider application.

[0078] As shown in the figure, marker 800 authenticates the healthcare provider that generates and sends the message, and may include an image or logo of the healthcare provider. In some embodiments, healthcare provider communication 802 is automatically generated when a patient reaches a specific goal as indicated by received sensed physiological data. In this example, congratulatory communication 802 is automatically sent to the patient app once the patient reaches the target weight. In some embodiments, patient communication refers to the achievement of a goal or task, such as a patient sending an email to the healthcare provider app stating that the patient has achieved a weight loss goal. In some embodiments, patient communication referencing the achievement of a specific physiological parameter or task (e.g., weight loss) is analyzed by an algorithm that generates automated healthcare provider communication in response.

[0079] As shown in the figure, in some embodiments, healthcare provider communications reference the received sensing data that triggers the healthcare provider communications. For example, a patient instructed to lose 10 pounds and sent a message indicating that they have successfully done so receives a congratulatory message typically referencing a 10-pound weight loss or weight reduction.

[0080] Generally, healthcare providers can send behavioral notifications to patients they select. Behavioral notifications sent by healthcare providers to patients can be generated automatically. Notifications sent to patients can be personalized push notifications, which are automatically generated and sent to patients when they complete a prescribed task. For example, a healthcare provider's app can automatically generate and send push notifications to patients to congratulate them on completing a prescribed task. Examples of prescribed tasks could be engaging in physical activity, losing weight, reducing BMI, recording ECG data, and / or recording blood pressure measurements.

[0081] Behavioral notifications can also be sent by the patient's family members. The software application of this invention can prompt the patient to "add" another patient and enable them to communicate via the software application. Family members who accept and communicate with the patient can receive notifications when the patient completes a specific task, such as correctly adhering to their prescription regimen. Family members can send behavioral notifications to congratulate the patient on completing their assigned task.

[0082] healthcare providers

[0083] Figure 9A This screenshot shows a typical initial home screen interface of a healthcare provider app that a healthcare provider would see when using the app to browse his or her patient list. In some embodiments of the healthcare provider app, the healthcare provider sorts his or her patient list by the names of other healthcare providers or technicians. In some embodiments of the software application, the initial home screen interface includes, for example, a “virtual stack” 900 displaying all ECGs provided to the healthcare provider. For example, the interface may provide the healthcare provider with the option to select an ECG from the virtual ECG stack and view a 3-second segment of the ECG record. The 3-second segment is displayed next to the reviewer information and diagnostic information on the virtual stack 900. In some embodiments of the healthcare provider app, the 3-second segment is selected as the ECG segment that best represents the diagnosis. The display of the entire ECG is used to quickly identify ECG records (e.g., “All ECGs,” “Abnormal,” “Normal,” “No Analysis,” or “Unreadable”) from lists in different subfolders of the virtual stack.

[0084] In some embodiments, a healthcare provider application is characterized by receiving and displaying patient data, such as... Figure 9AAs shown. Non-limiting examples of such patient data include height, weight, body mass index (BMI), age, physical activity level, heart rate, blood pressure, and / or ECG data. Patient data received by the healthcare provider is stored on a computing device running or connected to the healthcare provider application via the healthcare provider application. Furthermore, the healthcare provider application assists the healthcare provider in analyzing the data. For example, in some embodiments, the healthcare provider application includes audio or video data analysis capabilities.

[0085] Healthcare provider apps are configured to receive, organize, and / or track patient data received from one or more patient apps (e.g., from one or more patients). Figure 9B As shown at 902, the healthcare provider application is configured to analyze and organize the received ECG data (i.e., to indicate whether the analysis reveals any possible anomalies).

[0086] Healthcare provider applications are configured to analyze received patient data. For example, in some embodiments, the healthcare provider application is configured to calculate and generate risk scores based on patient population data. For example, a risk score can be calculated to predict an individual's likelihood of developing cardiovascular disease in the future. Such algorithms may use physiological data, such as ECG data, to identify patients based on patient population data or to identify changes in a patient's health based on their historical data. The software application may include machine learning algorithms that improve the analysis of individual data by feeding it into a machine learning algorithm trained to predict the probability of health outcomes for any number of health conditions. Additionally, such algorithms may provide unique identification of individual patients based on the analysis of aggregated data, such as ECG records or measurements. Unique identification of patients using machine learning algorithms may include gender identification, individual identification, identification of health changes, and / or identification of cardiac age. In some embodiments of the software application, cardiac age may be a representative age of the patient's heart, reflecting the overall health of the patient's heart and a general indicator of the patient's cardiac health. Similar to cardiac age, machine learning algorithms can also be used as risk assessment tools to calculate risk scores to predict an individual's likelihood of developing cardiovascular disease in the future or to provide a holistic view of the patient's current cardiac health. Machine learning algorithms can be used to predict risk scores and / or changes in health, whether negative or positive.

[0087] The healthcare provider's inbox interface can contain different folders, such as, but not limited to, a "Categories" folder, a "Healthcare Providers" folder, and a "Confirmed and Archived" folder. Healthcare providers can move and organize data (such as patient data) within these folders.

[0088] If certain data is received, the healthcare provider application can alert the healthcare provider. For example, the interface of the healthcare provider's software application may display a list of notifications showing information such as the patient's name, gender, age, phone number, and corresponding status updates. In some embodiments of the software application, status updates may include notifications related to the patient's ECG records or a percentage of abnormal ECG data for the patient. Other examples of patient status updates that the healthcare provider can choose to activate notifications for include: detection of possible atrial fibrillation, detection of possible atrial fibrillation with a heart rate exceeding a customizable number, a heart rate exceeding a customizable number, a heart rate below a customizable number, and no ECG data received within a customizable number of days. The frequency of sending notifications can be set to different parameters, such as never, once, or always.

[0089] In some embodiments of the software application described herein, the healthcare provider can add interpretations to individual ECG records from available options, such as... Figure 9C As shown, available options include: sinus rhythm, sinus bradycardia, sinus tachycardia, SVT, atrial fibrillation, atrial flutter, pacing, junctional, ventricular tachycardia, or unreadable. As shown, in some embodiments, the highlighting tool 904 allows a healthcare provider to select a specific ECG segment, and the interactive checkbox-formatted list 906 allows the healthcare provider to select an assessment of the highlighted ECG.

[0090] In some embodiments of the healthcare provider application, the healthcare provider can also select, such as Figure 9D The “Add Optional Annotation” option 908 shown is used to add optional annotations to ECG records. The healthcare provider application interface provides healthcare providers with options to adjust and / or select which types of condition updates can be assigned to notifications. The software application interface can display the total number of patients currently using the software application and who have already contacted that healthcare provider. Interface components provide healthcare providers with options to add new patients and send invitation codes via email. Healthcare providers can also send electronic prescriptions for cardiac health monitoring devices or for routine cardiac health monitoring. The software application interface can display the total number of patients currently awaiting an invitation from the healthcare provider to use the software application.

[0091] Notifications can be received not only by healthcare providers, but also sent by them to patients of their choice. Notifications sent to patients can be automatically generated. They can be personalized push notifications, automatically generated and sent to patients upon completion of a prescribed task. For example, a healthcare provider's software application could automatically generate and send a push notification to a patient to congratulate them on completing a prescribed task. Examples of prescribed tasks could be engaging in physical activity, losing weight, reducing BMI, recording ECG data, and / or recording blood pressure measurements.

[0092] Additional interfaces to a healthcare provider's application may include a visual, interactive patient directory or database. This directory or database may include a list of all patients who may currently be waiting for or have already accepted an invitation from the healthcare provider to begin using the heart health monitoring software application. The patient directory may also display patient information such as name, phone number, age, gender, and indications of whether they are in contact and using the heart health monitoring software application. Furthermore, the interface may include components that provide the healthcare provider with options for issuing electronic prescriptions for heart health monitoring devices and / or heart health monitoring. These interface components may be placed near the patient's name for easy access.

[0093] The interface may also include a component that provides healthcare providers with the option to add new patients. This interface component can be displayed in the patient directory interface of the software application. After the healthcare provider makes a selection, the "Add New Patient" interface component opens a new interface. This new interface may prompt the healthcare provider to enter information about the potential new patient, such as the patient's medical record number, first name, last name, email address, mobile phone number, date of birth, and gender. Once the healthcare provider decides to add a new patient, he or she can select from the options displayed on the interface for prescribing the heart health monitoring application. Furthermore, once a prescription for the heart health monitoring application is issued, the software application can automatically generate and send emails and text messages to the new patient, instructing them on how to operate the heart health monitoring software application. The interface may also include a component that provides healthcare providers with the option to select the length of time the healthcare provider will monitor the patient and the monthly fee charged to the patient. The automatically generated email may include an activation code or referral code for the patient to use to gain access to the software application.

[0094] Additional interfaces for healthcare provider applications may include an interactive interface for quickly viewing or scanning the relative distances between RR peaks in an ECG recording. In some embodiments, this interface provides an array of RR peak distances displayed by horizontal lines, which the healthcare provider can interact with by clicking on each horizontal line. When the healthcare provider clicks on a horizontal line representing an RR peak distance, the interface automatically zooms in on the ECG recording segment corresponding to that RR peak distance. In this way, the interactive interface allows the healthcare provider to quickly scan multiple RR peak distances.

[0095] In some embodiments, the platform offers different payment plans for access to the disclosed software application. For example, a healthcare provider may purchase the software application, while a patient may purchase a health monitoring device associated with the software application, and the healthcare provider may invoice the patient for recurring charges related to the use of the software application. In some embodiments of the software applications, systems, devices, and methods described herein, a healthcare provider purchases the software application, while a patient purchases a health monitoring device associated with the software application, and the company selling the health monitoring device may invoice the patient for recurring charges related to the use of the software application. In some embodiments of the software applications, systems, devices, and methods described herein, an insurance company may offer a free trial period to a patient, whereby the health monitoring device associated with the software application and the software application may be provided to the patient free of charge for a specific period; at the end of the period, the patient may choose to purchase the health monitoring device and the software application. Patients may be offered the option to upgrade to a "Pro" or "Premium" membership plan, where a higher fee may be charged than the normal membership plan fee. The "Pro" or "Premium" plan may include access to a care plan. The care plan may include tasks generated automatically or by the healthcare provider for the patient to complete, and reminders for completing these tasks. These tasks can be based on the patient's current health condition and can provide specific health goals to be achieved.

[0096] Invoice issuance characteristics

[0097] In some embodiments, the platforms, devices, systems, and methods described herein provide payment and billing features for patients and healthcare providers. For example, a healthcare provider may purchase a platform, while a patient may purchase a health monitoring device associated with the platform, and the healthcare provider may bill the patient for recurring charges related to the use of the platform. Some of the payment and billing features described herein provide healthcare providers with the ability to purchase platforms (such as those described herein) while providing patients with the ability to purchase health monitoring devices that include the platform. In this embodiment, a company selling health monitoring devices may, for example, bill patients for recurring charges related to the use of the platform. In some embodiments of platforms with payment and billing features, insurance companies offer patients a free trial period, whereby the health monitoring device associated with the platform and the platform can be provided to the patient free of charge for a specific period; at the end of the period, the patient can choose to purchase the health monitoring device and the platform.

[0098] Platforms, devices, systems, and methods can include different types of payment and billing methods used by patients and healthcare providers. For example, a healthcare provider may purchase a platform, while a patient may purchase a health monitoring device associated with the platform, and the healthcare provider may bill the patient for recurring costs incurred using the platform. Alternatively, a healthcare provider may purchase a platform, while a patient may purchase a health monitoring device associated with the platform, and the company selling the health monitoring device may bill the patient for recurring costs incurred using the platform. In some embodiments of the platform, an insurance company may offer patients a free trial period, during which the health monitoring device associated with the platform and the platform itself may be provided to the patient free of charge for a specific period; at the end of the period, the patient may choose to purchase the health monitoring device and the platform.

[0099] Patients can be offered the option to upgrade to a "Professional" or "Premium" membership plan, which may incur a higher fee than the standard membership plan. The "Professional" or "Premium" plan may include access to a care plan. The care plan platform interface can prompt healthcare providers to automatically or manually generate tasks for patients to complete. The platform can automatically generate reminders for patients to complete these tasks. These tasks may be based on the patient's current health condition and may provide specific health goals to be met. The care plan interface may include options for communicating with family members via the platform, optionally alerting family members to the patient's cardiac health condition, and optionally alerting family members to the patient's task completion status. The care plan platform can enable family members to automatically or manually send behavioral notifications to the patient after successfully completing prescribed tasks (such as correctly adhering to medication dosage regimens).

[0100] While preferred embodiments of the invention have been shown and described herein, it will be apparent to those skilled in the art that these embodiments are provided by way of example only. Many variations, modifications, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in the practice of the invention. The foregoing claims are intended to define the scope of the invention and thereby cover the methods and structures within the scope of these claims and their equivalents.

[0101] Cross-reference to related applications

[0102] This application claims the benefit of U.S. Provisional Application 62 / 382,227, filed August 31, 2016, which is incorporated herein by reference in its entirety.

Claims

1. A system comprising: a. A first computing device for executing patient applications, wherein the first computing device: i. Receive sensing data from sensors configured to sense the patient's physical parameters; ii. Send one or more of the sensing data and patient communications to a healthcare provider; as well as iii. Receive communications from healthcare providers; b. A second computing device that executes applications for healthcare providers, the second computing device: i. Receive one or more of the sensing data and the patient communications; ii. Analyze the sensed data to generate the healthcare provider communications and send the healthcare provider communications to the patient application, wherein the patient application and the healthcare provider application form a software platform through which the sensed data, the patient communications, and the healthcare provider communications are exchanged; The healthcare provider communications are automatically generated and sent in response to one or more of the sensing data or patient communications referencing the sensing data; The healthcare provider communicates with reference to the sensed data; The healthcare provider communications include a tag indicating that the healthcare provider communications were generated by the healthcare provider; The healthcare provider communications include prescribed tasks to be completed by the patient; and The healthcare provider application is configured to automatically generate and send push notifications to the patient when the specified task is completed.

2. The system according to claim 1, wherein, The physical parameters include the patient's vital signs.

3. The system according to claim 1, wherein, The physical parameters include the patient's heart sounds.

4. The system according to claim 1, wherein, The patient communication is sent within a threshold amount of time when the body parameters are sensed.

5. The system according to claim 4, wherein, The patient communications include the patient's audio recordings.

6. The system according to claim 4, wherein, The patient communications include video recordings of the patient.

7. The system according to claim 4, wherein, The patient communications are recorded in real time and sent to the healthcare provider's application.

8. The system of claim 1, further comprising the sensor, wherein the sensor is configured to operate to connect to a mobile computing device.

9. The system according to claim 8, wherein, The sensor is integrated with the mobile computing device.

10. The system according to claim 8, wherein, The sensor includes two ECG electrodes.

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