Systems and methods for medication and disease tracking

Abstract

[0001] The present disclosure relates to systems and methods for medication and disease tracking management, and more particularly to a computer-implemented method for triggering prompts to complete a journal entry using environmental and / or user-specific health information. [0002] According to a first aspect of the present disclosure, a non-transitory computer-readable storage medium is described that includes instructions, when executed by a computer, to cause the computer to run a program for tracking a user's medical condition; acquire environmental information and user-specific information; determine that a trigger condition is met based on the acquired environmental information or the user-specific health information; and, in response to determining that the trigger condition is met, generate a notification to be displayed on a user device that prompts the user to enter data into a medical journal entry in the program.

Description

[Technical Field]

[0001] The present specification relates to systems and methods for medication and disease tracking management, and in particular to computer-implemented systems and methods for using environmental and / or user-specific health information to trigger prompts to complete diary entries. [Background technology]

[0002] A major challenge to achieving quality treatment outcomes is active patient engagement and adherence to prescribed medication regimens, as well as patient understanding of factors that influence the progression of their disease and their overall health.

[0003] Conventional systems do not substantially actively engage users or provide appropriate and timely messaging and reminders. Conventional systems do not provide sufficient opportunities for users to input symptom and treatment-related information in a timely manner and do not fully utilize this information to make informed treatment and lifestyle decisions. Summary of the Invention [Problem to be solved by the invention]

[0004] Therefore, there is a need for a system and method that provides an effective symptom and treatment diary system that encourages patient engagement and adherence, ultimately resulting in improved patient treatment outcomes. [Means for solving the problem]

[0005] When the first aspect of the present disclosure is executed by a computer, the computer Execute a program to track the user's medical condition; acquiring environmental information or user-specific health information, and if the acquired environmental information or user-specific health information indicates a possible deterioration of the user's medical condition; determining that a trigger condition is met based on the acquired environmental information or user-specific health information; In response to determining that the trigger condition is met, generating a notification to be displayed on the user device prompting the user to enter data into a medical diary within the program. The present invention provides a non-transitory computer-readable storage medium including instructions for causing the

[0006] In some embodiments, the program is configured to track a plurality of different medical conditions of the user. The computer can be part of a user device, and the instructions can be further configured to cause the computer to obtain environmental information using one or more sensors forming part of the user device.

[0007] The sensors may include one or more of a thermometer, a barometer, and / or a hygrometer. Alternatively or additionally, the computer may obtain environmental information from a weather application running on the user device. The environmental information may include one or more of temperature, humidity, barometric pressure, pollen count, pollution index, NO2 readings, air quality index, UV index, and / or weather conditions or weather forecasts.

[0008] The trigger conditions may include one or more of an upper temperature threshold, a lower temperature threshold, an upper humidity threshold, an upper pollen count threshold, an upper NO2 measurement threshold, a threshold air quality index score, and / or one or more sets of predefined weather conditions.

[0009] The computer may obtain user-specific health information from one or more sensors on the user device, which may include an optical sensor.

[0010] The computer can obtain user-specific health information from one or more external devices. The one or more external devices can include wearable devices selected from a list including a smart watch, a pedometer, a glucose meter, and a pulse oximeter. The user-specific health information can include one or more of heart rate, respiratory rate, body temperature, blood pressure, blood oxygen level, number of steps taken during a specific period, sleep duration, and / or sleep patterns.

[0011] The trigger conditions may include one or more of upper and / or lower heart rate thresholds, upper / lower blood pressure thresholds, lower blood oxygen concentration thresholds, upper / lower body temperature thresholds, upper / lower respiratory rate thresholds, lower step count thresholds during a particular period of time, and / or deviation from an established or predefined sleep pattern.

[0012] The user-specific health information may include one or more of calorie intake, fat intake, and / or salt intake. The generated notification may provide an alert regarding the environmental information or user-specific health information that triggered the generation of the notification.

[0013] The computer can be part of a user device, and the instructions can be further configured to cause the computer to display the generated notification on the user device as a push notification to a lock screen of the user device. The instructions can also cause the computer to programmatically create a journal entry containing information about symptoms of the user's medical condition reported by the user.

[0014] The information regarding symptoms of the user's medical condition may include information regarding symptoms of a plurality of different medical conditions. The instructions may further cause the computer to compare the information regarding symptoms of the user's medical condition reported by the user with contemporaneous environmental information or user-specific health information to identify one or more correlations. Based on the identified one or more correlations, the computer may determine that the current environmental information or user-specific health information is indicative of a risk factor for the user's medical condition. In response, the computer may generate a notification to be displayed on the user device, alerting the user to the current environmental information or user-specific health information and / or risk factor.

[0015] A second aspect of the present disclosure is executing a program for tracking a user's medical condition; Obtaining environmental information or user-specific health information; determining that a trigger condition is met based on the acquired environmental information or user-specific health information; In response to determining that the trigger condition is met, generating a notification to be displayed on the user device prompting the user to enter data into a medical diary within the program. The present invention provides a computer-implemented method, comprising:

[0016] A third aspect of the present disclosure provides a user device comprising a processing circuit configured to generate and display a notification on a display of the user device, the notification prompting the user to enter data into a medical journal within a program. The user device can receive user input selecting one or more health conditions to which the journal entry relates, display one or more questions related to the first selected health condition, and display an option to complete a questionnaire related to the first selected health condition after completion of the journal entry related to the first selected health condition.

[0017] The one or more questions about the first selected health condition can include a request to specify a time and / or location associated with an episode of the first health condition. The one or more questions about the first selected health condition can include a request to specify a location on the body where the medical condition is occurring.

[0018] After completing the journal entry related to the first selected health condition, the user device may display one or more questions related to the second selected health condition. After completing the journal entry related to the first selected health condition, the user device may display an option to set a reminder to complete a subsequent journal entry.

[0019] A fourth aspect of the present disclosure provides a user device comprising processing circuitry configured to execute a program for tracking a user's medical condition, acquire environmental information and user-specific information, determine that a trigger condition is met based on the acquired environmental information or user-specific health information, and, in response to determining that the trigger condition is met, generate a notification for display on the user device prompting the user to enter data into a medical journal within the program.

[0020] A fifth aspect of the present disclosure provides a computer-implemented method including: executing a program for creating journal entries to track a user's medical condition; creating journal entries in a profile including information about symptoms of the user's medical condition reported by the user; associating environmental conditions and user-specific health information with the journal entries; identifying risk factors for the user's medical condition by correlating the symptoms of the user's medical condition with the associated environmental conditions and / or user-specific health information; and generating a notification to be displayed on a user device alerting the user to the risk factors for the user's medical condition.

[0021] The method may further include obtaining information regarding the new environmental conditions and / or new user-specific health information, determining that the new environmental conditions and / or the new user-specific health information correlate with identified risk factors for the user's medical condition, and generating a notification to be displayed on the user device, alerting the user to the new environmental information or the new user-specific health information and / or risk factors.

[0022] The method may further include creating a plurality of diary entries in the program, each diary entry including information regarding symptoms of the user's medical condition as reported by the user; associating environmental conditions and user-specific health information with each of the plurality of diary entries; identifying risk factors for the user's medical condition by correlating the symptoms of the user's medical condition with the associated environmental conditions and / or user-specific health information for each of the plurality of diary entries; and amalgamating each identified risk factor.

[0023] In order that the general concepts set forth in the preceding sections may be more fully understood, embodiments thereof will now be described with reference to the accompanying drawings. [Brief explanation of the drawings]

[0024] [Figure 1] 1 shows a schematic diagram of the overall architecture of a disease management and medication regimen management system. [Figure 2a-2b] Shown are three different ways the application can prompt the user to make a journal entry. [Figure 2c] Shown are three different ways the application can prompt the user to make a journal entry. [Figure 2d] 10 shows alternative home page and journal page GUIs. [Figure 2e] 10 shows alternative home page and journal page GUIs. [Figure 3a]1 illustrates an exemplary process for making selections to create a diary entry related to atopic dermatitis and the steps involved in making that entry. [Figure 3b-3c] 1 illustrates an exemplary process for making selections to create a diary entry related to atopic dermatitis and the steps involved in making that entry. [Figure 3d-3e] 1 illustrates an exemplary process for making selections to create a diary entry related to atopic dermatitis and the steps involved in making that entry. [Figure 4a-4b] 1 illustrates an exemplary process for making selections to create an asthma-related diary entry and the steps involved in making that entry. [Figure 4c-4d] 1 illustrates an exemplary process for making selections to create an asthma-related diary entry and the steps involved in making that entry. [Figure 4e] 1 illustrates an exemplary process for making selections to create an asthma-related diary entry and the steps involved in making that entry. [Figure 5] 1 illustrates an exemplary process for making selections to create a journal entry related to general health and a single page containing entry options. [Figure 6a-6b] 3d, 4e, and / or 5 in the respective processes, showing examples of screens showing insights into general health and environmental data. [Figure 6c-6d] 3d, 4e, and / or 5 in the respective processes, showing examples of screens showing insights into general health and environmental data. [Figures 6e-6f] 1 shows an example screen that provides the option to launch a clinically approved questionnaire. [Figure 7] 1 illustrates a schematic diagram of a user device according to some embodiments. [Figure 8] 1 shows a flowchart of an exemplary method for triggering a journal notification. [Figure 9]1 shows a flowchart of an exemplary method for identifying risk factors for a user's medical condition. DETAILED DESCRIPTION OF THE INVENTION

[0025] The present disclosure relates to an application that can run on a user device to assist users in tracking their health and disease progression and managing all aspects of their treatment. In particular, the application encourages and prompts users to keep a journal and document their treatment progress (symptoms, flare-ups, mood, sleep, anything related to their condition).

[0026] The application may be used to manage a wide range of diseases treated with a variety of different medications. While some of the specific embodiments below are described in connection with the treatment of atopic dermatitis and / or asthma using a single medication, the application is not so limited. Various other immunological indications, one or more of which may be treated using a single medication approved for use in treating one or more immunological indications, may also be managed by the application. Such single medications may include, for example, different dosages containing the same API, different volumes or concentrations of the same API, or different formulations containing the same API. In some embodiments, the single medication may include an anti-IL-4 receptor monoclonal antibody (e.g., dupilumab). Furthermore, a wide range of immunological conditions may be managed by the application. A user may be prescribed one or more medications, and the application provides personalized support to the user depending on the user's particular medication regimen and health profile. For example, the application may be configured to provide support for several diseases caused by type 2 inflammation. In relation to dermatology, this may include atopic dermatitis, prurigo nodularis, bullous pemphigoid, urticaria (e.g., chronic idiopathic urticaria or cold urticaria), hand and foot disease, or pruritus, each of which may be treated by injection of Dupixent® or other injectable medications, but may also be treated by any oral or topical medication. In relation to respiratory diseases, this may include asthma, nasal polyps, sinusitis (e.g., chronic sinusitis with or without nasal polyps), allergic bronchopulmonary aspergillosis (ABPA), or allergic fungal rhinosinusitis (AFRS) (which may be treated by injection of Dupixent® or other injectable medications, but may also be treated by any oral medication), and chronic obstructive pulmonary disease (COPD), which may be treated by injection of Dupixent® or other injectable medications.In relation to gastroenterology, this may include inflammatory bowel disease (IBD), eosinophilic esophagitis (EoE), eosinophilic gastroenteritis (EGE), or ulcerative colitis, which may be treated by injection of Dupixent® or other injectable medications, but may also be treated by any oral medication.

[0027] One or more medications may be administered by infusion. As used herein, the term infusion or self-infusion is intended to encompass intravenous infusion, intramuscular infusion, infusion, or any needle-based infusion system as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based infusion systems can be broadly divided into multi-dose container systems and single-dose (partial or total discharge) container systems. The container can be a replaceable container or an integrated, non-replaceable container.

[0028] The application helps users manage their disease, such as by providing a tracking diary that allows users and their healthcare providers to monitor treatment use and progress by recording simple diary entries about symptoms and medication use and generating reports based on the collected information. The application also encourages and prompts users to maintain their treatment routine through a series of notifications for various aspects of their treatment, such as reminders to take medication, reminders for doctor appointments and reminders to report in advance to such appointments, reminders for phone calls and reminders to properly prepare for such calls, and reminders for medication delivery or prescription completion. The application can additionally assist users in accessing treatment, such as accessing insurance coverage, managing medication delivery, and providing educational support. The application also provides access to learning materials, including instructional articles and videos, as well as motivational articles and challenges, and may provide connectivity to other connected devices, such as activity trackers and heart rate monitors, to continuously update and learn about the user's behavior, thereby providing holistic care. The application can also collect and combine information from other programs, such as environmental monitoring apps or weather forecasts.

[0029] The application allows users to keep a journal to document their treatment progress (symptoms, flare-ups, mood, sleep, anything related to their condition). As described below in connection with Figures 3-6, the application may track a user's progress by: (a) Presenting a set of questions to a user based on whether the user indicates that they have one or more medical conditions of a set of medical conditions, e.g., whether they have disease A or B or both. For example, the set of questions presented to a user who indicates that they have disease A may be different from the set of questions presented to a user who indicates that they have disease B. The questions may be related to the user's current symptoms and the severity of those symptoms. (b) Journal entries are saved as the user answers a series of questions, or at various times while the user is answering the questions. The user may be asked to set periodic (e.g., daily, weekly) journal reminders. (c) Users may have the ability to enter free-form text into the journal. (d) Near the end of the process of creating the diary entry, the application may share some statistics about environmental conditions (e.g., current air quality index in the patient's area) and recent personal health indicators (e.g., average hours of sleep for the week, number of steps) for the user's review.

[0030] The application may further provide a clear insight into the user's medical condition(s) and assist the user in better managing the medical condition(s), for example, by: (a) Leverage diary entries and understanding of triggers to predict upcoming flares and manage symptoms. For example, based on previous diary entries about sudden flares (worsening unpleasant symptoms) and environmental or other data related to the diary entries (e.g., pollen count or humidity at the time of the flare), the application attempts to predict a flare / episode before it occurs. The application may then notify the user about the predicted flare / episode. The application may suggest steps the user can take to prevent or mitigate the flare / episode. (b) The Application allows / encourages users to be specific about their symptoms (e.g., identifying which parts of the body are improving / worsening). The Application may encourage users to add photos of their skin / rash or other outward manifestations of the condition.

[0031] The application may also proactively present relevant information to patients based on information shared in their diary entries.

[0032] The application may further encourage the patient to make additional journal entries to record potentially relevant events / health changes. For example, the application may access the patient's fitness data from another application and note that the patient is not sleeping well. The application then encourages the patient to note this change and begin a journal entry to provide additional information that may be relevant.

[0033] Referring to FIG. 1, a schematic diagram of an overall architecture 100 for a disease management and medication regimen administration system is shown. The system architecture 100 shows several functional modules and the data links between them. The system architecture 100 includes a user device 104 running an application that includes several functional modules, shown in the center box. The architecture 100 also shows how the application run by the user device 104 interacts with other service providers to enhance the information that may be provided to the user via the application. For example, information may be enhanced by communicating with insurance / benefit provider systems and pharmacies.

[0034] One of these functional modules is the diary module 102. The diary module 102 is configured to enable a user to keep a diary related to one or more medical conditions of the user. The diary may include multiple diary entries detailing episodes of one or more medical conditions, such as symptoms, user-specific health data, and contextual information. The diary may be used to monitor patterns of one or more medical conditions and identify potential precipitating factors for episodes of one or more medical conditions. The diary may also keep a record of the user's adherence to a treatment regimen, such as a medication regimen. For example, the diary entries may include a record, such as an infusion log, that records the dosages (e.g., scheduled dosages) of a medication taken by the user. The record may form a dosage record that includes various information related to the dosages administered by the user. The record may be stored as part of the diary entries or independently of the diary entries. The diary module 102 may communicate with an external service called an adverse events service. The diary module may send patient information related to episodes of one or more medical conditions to the adverse events service.

[0035] The functional modules may further include a memory module or database 106. The memory module 106 is configured to store journal entries made by a user via the journal module 102 for later retrieval and / or analysis. The memory module 106, in some embodiments, may be cloud-connected to remotely store the journal entries.

[0036] In some embodiments, the functional modules may further include a weather module 108. The weather module 108 is configured to determine and / or record weather conditions at the user's location. The user's location may be determined, for example, by the GPS functionality of the user device. The weather module 108 may access an online weather forecasting system, for example, to obtain current weather conditions, previous weather conditions, and / or predicted future weather conditions. The weather module 108 provides weather conditions to the logbook module 102 for inclusion in the logbook entries. In addition to weather conditions such as general weather conditions, temperature, humidity, barometric pressure, and UV index, the weather module may additionally obtain air quality information such as pollen count, pollution index, NO2 measurements, and / or air quality index.

[0037] Another functional module is the user management module 110. The user management module 110 is responsible for obtaining user settings and generating notifications for output on the user device 104. The data required for the notification scheme may be stored in the memory module 106. The user management module 110 may also update the information held in the memory module 106 as the application is used.

[0038] The user management module 110 may define and help implement a notification scheme that determines when notifications should be generated and how they should be output on the user device 104. The notification scheme may have three main notification types: (i) silent notifications, (ii) bulk summary notifications, and (iii) push notifications.

[0039] In some embodiments, silent notifications may be silently pushed to the application and only viewable within the application. The user may be presented with silent notifications within the application, for example, on the application's home screen. In some embodiments, silent notifications are made apparent to the user when certain requirements are met and do not require any action on the user's part. A consolidated summary notification may be associated with several different reminders and other notifications. The user can interact with the consolidated summary notification to expand and view individual notifications. The consolidated summary notification may indicate the number of notifications present for the user to view. A push notification may be associated with a single notification and is pushed to the lock screen or home screen of the user device 104. In some embodiments, push notifications are time-sensitive, actionable items that require immediate user attention. They are reserved for actions related to the user's treatment routine or as follow-up to actions that may affect the user's access to treatment / medication.

[0040] Notifications can be escalated, i.e. moved up a notification type, depending on user action (or lack thereof). For example: a. If the user has 5 days until their next medication dose, the application will display their next dose reminder as a silent notification, for example, below the carousel on the app homepage. b. In the days leading up to administration, the application will push a mass notification to the user to either watch an instructional video, schedule a call with a nurse, or view instructions for self-administration. c. One hour before the scheduled time on the day of administration, the application will push a notification to the user to take their medication. If the user's medication is stored in the refrigerator, the notification will instruct the user to remove their medication from the refrigerator. Interacting with this notification will trigger the warm-up timer set for the user's medication administration.

[0041] Another functional module is the health / assessment module 112. The health / assessment module 112 is responsible for orienting the user and obtaining details about the user's medical conditions and the medications used to treat them. The health / assessment module 112 may also collect information about the user's prescriptions and manage medication delivery.

[0042] Another functional module is the Healthcare Professional (HCP) Services module. The HCP Services module facilitates communication with nurses, doctors, or other healthcare professionals, such as scheduling reminders for appointments and phone calls, prompting users to generate reports or prepare for upcoming appointments or calls, initiating voice or video calls, providing follow-up notifications after calls or appointments, and initiating diary entries after calls or appointments. The HCP Services module interacts with an internet-based patient support program. Healthcare professionals can also access certain aspects and information maintained by the patient support program to facilitate communication with users and monitor the user's treatment and / or disease progression.

[0043] Another functional module is a consent module (also referred to as a consent management module) that, among other aspects of the system, is responsible for managing consents and permissions for accessing patient-specific information, such as a user's health-related data. The memory module 106 may be configured to store user identification and role information, as well as consent templates for use by the consent module. The memory module 106 may also store consent and permission information entered by a user via the consent module, including any time limits set for the consent and permission.

[0044] The consent module may communicate with an external service called a consent management service. The consent and permission information generated by the consent module may be stored or copied to the consent management service. The consent management service may also be responsible for transmitting patient-specific information to third parties if the associated consent indicates this is permitted.

[0045] Another functional module is the content module. The content module is responsible for receiving and recording personalized content and / or settings set by a user. The content module may communicate with an external service called content management. The content management service is responsible for providing patient-specific content or settings from an external user, such as a healthcare professional. The content module may interact with the memory module 106 to store the personalized content and / or settings.

[0046] Another functional module is a benefits module that is responsible for managing patient access to healthcare in conjunction with other aspects of the system. The benefits module may include a pharmacy integration service and / or a benefits integration service. Information generated by the benefits module may be responsible for transmitting patient-specific information to third parties to indicate the patient's access to healthcare services. The benefits module may interact with external services such as benefit provider systems and pharmacy services.

[0047] Another functional module is the analysis module, which is responsible for analyzing patient information related to the status and / or treatment of a user's medical condition.

[0048] Another functional module is a messaging system. The messaging system may communicate with the analysis module. For example, if the analysis module identifies an episode or trigger for one or more medical conditions in the user, the messaging system outputs a message conveying this result. The messaging system may communicate with an external service called an information hub. The information hub may store data received from the messaging system. The information hub may also interact with other service providers to enhance the information that may be stored about the user via the application. For example, information may be enhanced by communicating with patient support programs, insurance / benefit provider systems and pharmacies, adverse event services, etc.

[0049] Figures 2a, 2b and 2c show three different ways in which the application may prompt the user to make a journal entry.

[0050] FIG. 2a shows a push notification 202 to a user device's lock screen 204 prompting the user to make a journal entry based on detected environmental conditions or user-specific health information.

[0051] The application monitors environmental conditions in the user's environment and triggers a notification 202 when one or more environmental threshold conditions are met. The notification 202 may provide a prompt to the user to make a journal entry and, in some embodiments, a warning regarding the environmental condition that triggered the notification. The application may monitor environmental conditions using one or more sensors present on the user's device, such as a thermometer, barometer, or hygrometer. Alternatively or additionally, the application may monitor environmental conditions using one or more other services, such as a weather application on the device or environmental information from the internet.

[0052] Examples of environmental conditions include one or more of temperature, humidity, barometric pressure, pollen count, pollution index, NO2 reading, air quality index, UV index, and / or weather conditions / forecasts. Environmental threshold conditions may include upper thresholds above which a notification is triggered and / or lower thresholds below which a notification is triggered. For example, environmental thresholds may include one or more of an upper temperature threshold, a lower temperature threshold, an upper humidity threshold, an upper pollen count threshold, an upper NO2 reading threshold, a threshold air quality index score, and / or one or more sets of predefined weather conditions.

[0053] Alternatively or additionally, the application may monitor user-specific health information and trigger a notification when one or more health thresholds are met. The notification may provide a prompt for the user to complete a journal entry and, in some embodiments, a warning regarding the health information that triggered the notification. The user-specific health information may be entered into the device by the user, for example, through the device's GUI. Alternatively or additionally, the user-specific health information may be collected by one or more sensors on the device, for example, the user's pulse may be measured by an optical sensor on the device. Alternatively or additionally, the user-specific health information may be collected from one or more external devices. For example, the application may access data collected by the user's wearable device, such as a smartwatch, and / or a medical device used by the user to monitor health conditions, a pulse oximeter, or a device for monitoring the user's breathing, such as a peak flow meter or spirometer.

[0054] Examples of user-specific health information may include physiological data associated with the user. For example, the user-specific health information may include one or more of heart rate, respiration rate or other respiratory condition, body temperature, blood pressure, sleep patterns, physical activity, skin condition, etc. The user-specific health information may include dietary information such as calorie intake, fat intake, salt intake, vitamin / nutrient intake, etc. The health condition thresholds may include an upper threshold above which a notification is triggered and / or a lower threshold below which a notification is triggered. The health condition threshold conditions may include, for example, one or more of upper and / or lower heart rate thresholds, upper / lower blood pressure thresholds, upper / lower body temperature thresholds, upper / lower respiration rate thresholds, deviation from an established or predefined sleep pattern, etc.

[0055] When triggered, notification 202 may be pushed to the graphical user interface (GUI) of the device on which the application is running. In the illustrated example, notification 202 is pushed to the lock screen of the user's device. Notification 202 may alternatively or additionally be pushed to a notification bar on the home screen of the device GUI. Notification 202 may suggest to the user that they make a journal entry. In some embodiments, notification 202 may provide a reason for the request, such as "It seems you haven't slept well this past week." The user may select notification 202 to open the application. The application may open on the home screen or directly to the journal module.

[0056] FIG. 2b shows an example of the application's graphical user interface 206, including an in-application notification 208 prompting the user to create a journal entry. The notification may be triggered when the user launches the application if no journal entries have been made for that day, prompting the user to begin their daily journal entry. Alternatively or additionally, the notification may be triggered by the user entering the application via a lock screen notification, as described above in connection with FIG. 2a. The notification may include a GUI element, such as a button 210, that may be selected by the user to open the journal module for that day's entry. In the illustrated example, the GUI button for accessing the journal is labeled "Add Entry."

[0057] The GUI 206 may further include one or more reminders for upcoming health-related events, such as appointments with a healthcare provider, scheduled medication times, and / or scheduled health monitoring times (e.g., peak flow meter, pulse oximeter, or spirometer check times). The reminders may include links to the application's calendar feature. Alternatively or additionally, the GUI may include one or more links to content (e.g., articles, web pages, videos, etc.) related to the user's medical condition. In other embodiments, one or more additional applications may track or determine the user's medical condition. For example, audio biomarkers may provide an indication of the severity of the user's current or future asthma condition.

[0058] FIG. 2c shows an example of the application's graphical user interface 206, including an in-application notification 212 prompting the user to make a journal entry. The notification may be triggered when the user launches the application in response to determining that the user is experiencing a medical condition flare-up. The application may determine that the user is experiencing a medical condition flare-up based on one or more previous journal entries in the application and / or user-specific health information accessible by the application. The notification may include a GUI element, such as a button 214, that may be selected by the user to open the journal module for that day's entry. Otherwise, the GUI may include the same elements as the GUI of FIG. 2b.

[0059] 2d and 2e show alternative views of the application's home page GUI 216 and journal page GUI 222, respectively. FIG. 2d shows the home page GUI 216. At the bottom of the page are several selectable tabs used to navigate to various areas of the application. The home page tab 218 is selected. The home page GUI 216 includes an in-application notification 219 prompting the user to make a journal entry. The notification 219 is one of several notifications that may be displayed in this section of the GUI. The notification 219 may include a GUI element, such as a button 220, which may be selected by the user to open the journal module for that day's entry. In the example shown in FIG. 2d, the GUI button 220 for accessing the journal is labeled "Add a New Entry." The home page GUI 216 may display other information, such as the date (and optionally the time) of the next scheduled medication and the date (and optionally the time) of any upcoming appointments or phone calls.

[0060] FIG. 2e shows the journal page GUI 222. At the bottom of the page are several selectable tabs used to navigate to various areas of the application. The journal page tab 224 is selected. The journal page GUI 222 includes an in-application notification 225 prompting the user to make a journal entry. The notification 225 is one of several notifications that may be displayed in this section of the GUI. The notification 225 may include a GUI element, such as a button 226, which may be selected by the user to open the journal module for that day's entry. In the example shown in FIG. 2e, the GUI button 226 for accessing the journal is labeled "Add a New Entry." The journal page GUI 222 may display other information, such as the date and health status, associated with the most recent journal entry.

[0061] Figures 3a-3d illustrate the process of making selections to create a diary entry related to atopic dermatitis and the steps involved in making that entry.

[0062] In FIG. 3 a, a user selects one or more health conditions 302 to which the journal entry pertains from a health condition selection page 304. Selection of one or more health conditions 302 may be performed by clicking an associated checkbox, as shown in FIG. 3 a. Alternatively, or additionally, one or more medical conditions 302 may be selected from one or more drop-down lists and / or entered manually. In the illustrated example, the medical conditions for the journal entry include atopic dermatitis and asthma, as well as a general “overall health” condition. In the illustrated example, the user has selected atopic dermatitis as the associated medical condition. Once the user has selected one or more medical conditions 302 to pertain to the journal entry, the user may select a “Next” button 306 to proceed to the next portion of the journal entry. The information requested in subsequent journal entry screens depends on the selected medical condition (in this case, atopic dermatitis).

[0063] In FIG. 3b, a user provides location and time details associated with an episode of a medical condition (in this example, atopic dermatitis). The user may enter the date and / or time 308 that the atopic dermatitis episode occurred. The date may be selected from a calendar. The user may further indicate the location 310 where the event occurred, for example, by entering an address, selecting from a list of predefined locations (e.g., "home," "work," etc.), and / or selecting a location on a map, or selecting a location suggested by the user's device's location services (e.g., GPS). In the illustrated example, the user indicates that the episode occurred on March 22, 2021, at 9:45 AM at 1255 Rarlton Road, New York. In some embodiments, the location box is omitted. The application may display a similar GUI asking the user to "Select the date to add an entry," providing only the date and time boxes.

[0064] In some embodiments, the GUI includes a progress indicator 312 that indicates how far the user has progressed toward completing the journal entry. In the illustrated example, the progress indicator 312 is located at the top of the GUI and includes a row of numbered icons, each corresponding to a page of the journal entry. The current page of the journal entry is highlighted in the progress indicator 312. As the user completes each page of the journal entry, the progress indicator 312 may mark the corresponding icon with an indication that it is complete, such as a check mark. In some embodiments, the icons in the progress indicator 312 may additionally be used as shortcuts to the corresponding journal pages. The progress indicator 312 may alternatively be in the form of a progress bar and / or a numerical progress indicator (e.g., a percentage complete).

[0065] Once the user has entered the details of the date and location of the episode, the user may proceed to the next part of the diary entry by clicking the "Next" button 306. Alternatively, to return to the health condition selection page, the user may select the back button 314.

[0066] In FIG. 3c, the user is provided with one or more questions 316 regarding a health condition. In the illustrated example, the questions 316 relate to atopic dermatitis. The questions 316 may be answered by selecting a symbolic score (e.g., a face) or a numerical score (e.g., a number from 0 to 4 or 0 to 5) from a set of possible scores. In the illustrated example, the selection is performed by selecting one of the displayed numbers, although other methods of score entry may alternatively be used, such as a drop-down box, text entry, slider, etc. In some embodiments, one or more of the questions may be in the form of a "yes / no" or "true / false" statement.

[0067] Question 316 may relate to an aspect of the health condition (e.g., for atopic dermatitis, "skin lesion level," "itch level?", "pain level?", "impact on quality of life," "impact on sleep disturbance," etc.) or the user's general state regarding the health condition (e.g., "How are you feeling?").

[0068] Once the user has entered the answers to the questions 316, the user may proceed to the next part of the journal entry by clicking the "Next" button 306. Alternatively, to return to the date and time details page, the user may select the back button 314.

[0069] In FIG. 3d, the user is asked whether they wish to add more details about their symptoms. This page may include a first section 315 for indicating symptoms that have improved and a second section 317 for indicating symptoms that have worsened. The list of symptoms in the first and second sections varies depending on the health condition to which the diary entry pertains. For atopic dermatitis, the list of symptoms may be "skin lesions," "itchiness," and "sleeping problems." Once the user has entered their desired symptom details, they may click the "Next" button 306 to proceed to the next part of the diary entry. Alternatively, to return to the question page, the user may select the back button 314.

[0070] The next portion of the journal entry may include a photo entry page (not shown). This page provides the user with the option to take a photo (or video) of their body to add to the journal. Upon selecting the displayed option to add a photo or video, the application may display an option to open the camera application on the user device to take a new photo, or an option to open the photo gallery application on the user device to select an existing photo.

[0071] In FIG. 3e, a user inputs one or more body locations 318 where a health condition (e.g., atopic dermatitis) is occurring. Such information may only be relevant to a specific health condition, and therefore, this diary page may not be present in all situations. The user may indicate one or more locations 318 where the health condition is occurring / episodes of the health condition are occurring. If the user previously indicated that the health condition is occurring in one or more body locations 318, the user may indicate which locations are worsening. In the illustrated example, the user may indicate one or more locations 318 by selecting one or more predefined locations on a model of the human body. The model may be a rotatable model so that the user can select locations on the ventral, dorsal, left, and right sides of the body. Alternatively, other methods of entering body locations may be used, such as selecting locations from a list or manually entering locations.

[0072] Once the user has entered one or more body locations 318, the user may click the "Next" button 306 to proceed to the next portion of the journal entry. If no other medical conditions were selected in Figure 3a, the application proceeds to Figure 6b. If selected, the method proceeds to Figure 4 or Figure 5 depending on the other condition(s) selected. Alternatively, to return to the symptom details page or photo page, the user may select the back button 314.

[0073] Figures 4a-4e illustrate the process of making selections to create an asthma related diary entry and the steps involved in making that entry.

[0074] In Figure 4a, the user selects one or more health conditions 402 to which the journal entry pertains from a health condition selection page, as described above in connection with Figure 3a. In the illustrated example, the user has selected asthma as the associated medical condition. Once the user has selected one or more associated medical conditions 402 for the journal entry, the user may click the "Next" button 406 to proceed to the next portion of the journal entry. The information requested in subsequent journal entry screens depends on the medical condition selected (in this case, asthma).

[0075] In Figure 4b, the user provides location 408 and time 412 details associated with an episode of a medical condition (asthma in this example). The user enters location 408 and time details 410 as described above in connection with Figure 3b. Once the user has entered the episode date and location details, the user may click the "Next" button 406 to proceed to the next part of the journal entry. Alternatively, to return to the health condition selection page, the user may select the back button 414. In some embodiments, the location box is omitted. The application may display a similar GUI asking the user to "Select the date to add an entry for," and providing only the date and time boxes.

[0076] In some embodiments, the GUI includes a progress indicator 412 that indicates how far the user has progressed towards completing the journal entry, as described above in connection with FIG. 3b.

[0077] In FIG. 4c, the user is provided with one or more questions 416 regarding a health condition. In the illustrated example, the questions relate to asthma. The user may enter answers to the questions 416 in the manner described above in connection with FIG. 3c. The questions 416 may relate to aspects of the health condition (e.g., for asthma, "general symptoms," "level of shortness of breath?", "level of wheezing," "impact on quality of life," "impact on sleep disturbances," etc.) or the user's general state of mind with respect to the health condition (e.g., "how are you feeling?"). Once the user has entered answers to the questions, the user may click the "next" button 406 to proceed to the next part of the journal entry. Alternatively, to return to the date and time page, the user may select the back button 414.

[0078] In FIG. 4d, the user is provided with one or more questions regarding medication for a health condition 418. The medication questions 418 may include identifying the medication and dosage the user has taken to treat the condition. A list of medications for the condition may be provided alongside GUI elements for entering the dosage. In some embodiments, the list of medications may be limited to medications prescribed to the user, while in other embodiments, the list may include a more general list of medications available to treat the condition. The user may manually add additional medications to the list. The GUI may also provide an option to indicate that the medication is not being taken.

[0079] In the illustrated example, the user is provided with the option to select one of two asthma inhalants, namely, Venetrin or Arupent, or to indicate that they are not using an inhalant. The user also has the option to add an additional inhalant. For each inhalant, the user can indicate the number of inhalations of the inhalant.

[0080] Once the user has entered their medication response, they may proceed to the next part of the diary entry by clicking the "Next" button 406. Alternatively, to return to the questions page, the user may select the back button 414.

[0081] In Figure 4e, a user inputs one or more physiological measurements 420 related to a medical condition. The user may manually input the physiological measurements 420 as shown, or may read the physiological measurements 420 from an external device, for example, using the user device's network connection or an RFID reader. In the example shown, the user is asked to input a peak flow measurement that indicates whether the user's airway is narrowed.

[0082] Once the user has entered one or more physiological measurements 420, the user may click the "Next" button 406 to proceed to the next portion of the diary entry. If no other medical conditions were selected in Figure 3a, the application proceeds to Figure 6. If selected, the method may proceed to Figure 5 depending on the other condition(s) selected. Alternatively, to return to the medication page, the user may select the back button 414.

[0083] In addition to the screens described above, in the case of asthma, the application may also display a list of symptoms in a manner similar to that shown in FIG. 3d. The user may then indicate which symptoms are remission or exacerbation. In the case of asthma, an exemplary list of symptoms may be "shortness of breath," "wheezing," and "problems sleeping." The application may also provide the user with the option to take or upload a photo or video or record audio. For certain health conditions, such as asthma, the video or audio may provide an indication of the severity of the user's symptoms.

[0084] FIG. 5 illustrates the process of making selections for creating a journal entry related to general health and a single page containing entry options. The user is presented with one or more questions 602 related to the user's general health. The questions may be answered by selecting a symbolic score (e.g., a face) or a numerical score (e.g., a number between 0 and 5) from a set of possible scores, as described in connection with FIG. 3c. In the illustrated example, the general health questions are "How is your general health?" and "Are you coping with your daily tasks?", although many other examples are possible.

[0085] In some embodiments, the GUI includes a progress indicator 506 that indicates how far the user has progressed towards completing the journal entry, as described above in connection with FIG. 3b.

[0086] Once the user has entered the answers to the questions, the user may proceed to the next part of the journal entry by clicking on the "Next" button 504. The application then proceeds to FIG.

[0087] 6a-6d are examples of screens that may be displayed after FIG. 3d, FIG. 4e, and / or FIG. 5 in the process of providing insight into general health and environmental data, respectively.

[0088] In FIG. 6a, the user is presented with one or more overall health perspectives 602. The perspectives 602 are provided to assist the user in identifying causes / triggers of health episodes / flare-ups. The health perspectives 602 may be based on physiological data collected from the user and / or answers to the questions provided in FIGS. 3-5. In the illustrated example, the user is presented with daily step counts for the past seven days, which may indicate the amount of activity the user engaged in. The step counts are presented in the form of a bar graph. The user is also provided with a sleep indicator that indicates the amount of sleep the user was able to achieve during the past seven days. Records of the information presented in the health perspectives may be recorded and associated with journal entries. Once the user views a health perspective, the user may click a "Next" button 606 to proceed to the next portion of the journal entry.

[0089] In FIG. 6b, the user is presented with one or more environmental conditions 604 at or near the time of the medical episode. These may assist the user in identifying triggers for the medical episode / flare-up. The environmental conditions 604 may include, for example, atmospheric conditions, such as the air quality index, NO2 values, pollen counts, humidity, temperature, and / or weather conditions. Once the user views the environmental conditions 604, the user may click a "Next" button 606 to proceed to the next portion of the journal entry. The screen presenting the environmental conditions 604 may also include an option (e.g., a checkbox) to add the environmental condition information to the user's journal entry. In this manner, the environmental condition information may be associated with the user's symptoms and used to better inform the user of environmental conditions that may affect them, provide more timely notifications for future journal entries, or alert the user to current or forecasted environmental conditions at their location or to locations they are traveling to.

[0090] In some embodiments, the application (or a remote system receiving information from the application) may automatically determine one or more risk factors for the user's medical condition by correlating symptoms of the user's medical condition with associated external / environmental conditions and / or other relevant user-specific health information, such as sleep patterns or duration or physical activity. Using data from multiple diary entries, the application may identify recurring external / environmental conditions (or user-specific health information) that occur in association with episodes of the user's medical condition. In some embodiments, identification may be based on the relative frequency of a set of external / environmental conditions (or user-specific health information) occurring within a predefined time period of the episode. Alternatively, one or more medical condition-specific rules may be applied to identify one or more risk factors from the environmental or health information.

[0091] In FIG. 6c, the user is notified that the journal entry has been saved to the device's memory (or to the cloud, if cloud functionality is enabled). The user may select and complete one or more questionnaires 608. The questionnaires may include a series of further questions about the user's health status and may facilitate free-form text entry. A disease control score may be presented to the user at the end of the questionnaire, along with recommended actions or links to further information and support. The user may also be presented with the option to set a reminder 610 to complete the journal entry. If the user selects this option, the user may be presented with the screen shown in FIG. 6c. Alternatively, the user may select the "Finish" GUI element 612 to complete the journal entry process.

[0092] 6d shows the screen that is displayed if the user selects Set Entry Reminder Text 610 in FIG. 6c. Through this screen, the user may set a recurring alarm to remind the user to make a journal entry. The user may select a reminder time 614 and a recurrence frequency 616 (e.g., daily, weekly, etc.). Once the alarm time 614 and recurrence frequency 616 are selected, the user may confirm the alarm by selecting a "Set Reminder" GUI element 618, e.g., a button. The alarm may push a notification to the user device when the alarm time arrives, for example, as described in connection with FIG. 2a.

[0093] Figure 6e shows an alternative screen 620 that may be displayed after completing the main diary entry related to atopic dermatitis. This screen 620 gives the user the option to complete an Atopic Dermatitis Control Status (ADCT) questionnaire. Screen 620 has the option to start the questionnaire or skip the questionnaire. Figure 6f shows an alternative screen 622 that may be displayed after completing the main diary entry related to asthma. This screen 622 gives the user the option to complete an Asthma Control Test (ACT) questionnaire. Screen 620 has the option to start the questionnaire or skip the questionnaire.

[0094] While FIGS. 3a and 4a illustrate the selection of a single health condition, the user may select more than one health condition at this point in the journal entry process. For example, the user may select both atopic dermatitis and asthma. In that case, the application would go through the process of creating a journal entry related to atopic dermatitis followed by a journal entry related to asthma. For example, the application may go through the journal entry process described in connection with FIGS. 3b-3d and then the journal entry process described in connection with FIGS. 4b-4e. If "general health" is also selected, the process described in connection with FIG. 5 would then be performed. Other sorting configurations are possible depending on the range of health conditions managed by the application. After the journal entry process for all selected health conditions is complete, the application may display the general health perspective screen of FIG. 6a and the environmental conditions screen of FIG. 6b, as described above.

[0095] FIG. 7 schematically illustrates a user device 700 according to some embodiments. The user device 700 may be a mobile phone or a tablet computer. The user device 700 is an example of a wireless communication device. The user device may alternatively be referred to as a communication device, a computer, a computing device, or a mobile device, and is not necessarily associated with a single user. The user device 700 is configured to wirelessly communicate with a communication network using a wireless communication protocol, such as, but not exclusively, 3GPP LTE and / or New Radio (NR) or Wi-Fi (IEEE 802.11). The user device 700 may also be configured to communicate using Bluetooth, NFC, ZigBee, ultra-wideband, IrDa, etc. The communication network may include one or more network nodes. The communication network may be further connected via a core network and / or intermediate networks to a host computer (not shown), which may be embodied in hardware and / or software of a standalone server, a cloud-implemented server, or a distributed server. The user device 700 and the host computer may be configured to communicate data.

[0096] The user device 700 may comprise hardware including a processing circuit 701. The processing circuit 701 may comprise a processor 702 and a memory 704. The user device 700 may also comprise a wireless transceiver 706, a user input 708, a display 712, a camera 710, a microphone 716, an RFID reader 718, and a speaker 714. The wireless transceiver 706 may be configured to set up and maintain a wireless connection to a network node. The wireless transceiver 706 may comprise one or more wireless transmitters and one or more wireless receivers. The display may be a touch-sensitive display and may be based on capacitive or resistive sensing technology. The processing circuit 701 may include, for example, a microprocessor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), etc. The processor 702 may be configured to read from and / or write to the memory 704. The memory 704 may include volatile and / or non-volatile memory, such as cache, RAM (random access memory), and / or ROM (read only memory).

[0097] The user device 700 may include software stored, for example, in memory 704. The software may be executable by the processing circuitry 701. The software may include the application. In some embodiments, a host computer may communicate with the application. The application may request data from the host computer and / or provide user data to the host computer.

[0098] The processing circuitry 701 may be configured to perform or cause to be performed any of the methods described herein. In some embodiments, software / programs may include instructions that, when executed by the processing circuitry 701, cause the processing circuitry 701 to perform the methods described herein.

[0099] The memory 704 may include both program memory, which stores program code (e.g., software or firmware), and main memory, which stores data. The processing circuit 701 may be configured to execute program code stored in the program memory and to read, write, and delete data from the main memory. In some embodiments, the program code may be an application that can be downloaded and installed on the user device 700. The application may be a disease and treatment management and tracking tool for use by the patient. The program memory may be, for example, read-only memory (ROM), and the main memory may be, for example, random access memory (RAM).

[0100] The user device 700 includes one or more user inputs 708, such as a touchscreen, a keypad or keyboard, an accelerometer or gyroscope, a mouse, or a microphone 716 for receiving voice commands. The user device 700 may also include a camera 710 configured to capture an image of the user and an image of a label, code, or the like visible on the medication administration device, packaging, or storage solution. The user device 700 may be configured to scan a medication administration device (such as an injection device or inhaler) using a scanning device. The scanning device may refer to either the camera 710 or the RFID reader 718. The term "scanning" as used with respect to the user device 700 may refer to using either of these components to read information provided externally or internally to the medication administration device.

[0101] Figure 8 shows a flowchart of an exemplary method for triggering a diary notification. The method may be performed by a computing device / system such as that described in connection with Figure 7. The computing device / system may be a user device.

[0102] In operation 800, a program (also called an application) for tracking a user's medical condition is executed on a computing device / system.

[0103] Environmental data and / or user-specific health information is acquired by a computing device / system in operation 802. The acquired environmental information and / or user-specific health information is indicative of a potential deterioration in the user's medical condition.

[0104] The environmental data may include current environmental data regarding the current state of the user's environment. The computer may obtain environmental information using one or more sensors forming part of the user device, such as a thermometer, barometer, or hygrometer. Alternatively or additionally, the environmental information may be obtained from a weather application running on the user device. The environmental data may include, for example, weather data. The weather data may include one or more of temperature, air pressure, humidity, UV index, and / or weather conditions (e.g., "rainy," "sunny," "stormy," etc.). Alternatively or additionally, the environmental data may include one or more measures of air quality, such as an air quality index, NO2 levels, pollen counts, etc.

[0105] The user-specific health information may include an indication of a possible deterioration in the user's medical condition. The user-specific health information may include one or more physiological measurements obtained from the user. The physiological measurements may include, for example, one or more of heart rate, blood pressure, blood glucose level, body temperature, blood oxygen level, etc. The user-specific health information may alternatively or additionally include one or more activity-related measurements, for example, step counts, sleep patterns, distance traveled, etc. The user-specific health information may alternatively or additionally include one or more diet-related measurements, for example, calorie intake, fat intake, and / or salt intake.

[0106] One or more sets of user-specific health information may be manually entered into the computing device / system by a user. Alternatively or additionally, one or more sets of user-specific health information may be captured by the computing device / system using one or more on-device sensors, such as optical sensors. Alternatively or additionally, one or more sets of user-specific health information may be entered into the computing device / system from an external device, such as a smartwatch, pedometer, glucose meter, or pulse oximeter, via a network interface, such as Wi-Fi, Bluetooth, and / or an RFID tag reader.

[0107] In operation 804, the computing device / system determines whether one or more trigger conditions are met based on the acquired environmental information and / or user-specific health information. The trigger conditions may be based on one or more thresholds related to the environmental data and / or user-specific health information.

[0108] The one or more trigger conditions may include one or more of an upper temperature threshold, a lower temperature threshold, an upper humidity threshold, an upper pollen count threshold, an upper NO2 measurement threshold, a threshold air quality index score, and / or one or more sets of predefined weather conditions. The one or more trigger conditions may alternatively or additionally include one or more of an upper and / or lower heart rate threshold, an upper / lower blood pressure threshold, a lower blood oxygen concentration threshold, an upper / lower body temperature threshold, an upper / lower respiration rate threshold, a lower step count threshold during a specified period, and / or a deviation from an established or predefined sleep pattern.

[0109] In operation 806, in response to determining that the trigger condition has been met, the computing device / system generates a notification to be displayed on the user device prompting the user to enter data into the medical journal within the program. The notification may provide information related to the trigger that caused the notification to be generated. The notification may be provided, for example, as a push notification on the lock screen of the user device.

[0110] The user may respond to the notification by creating a journal entry within the program that includes information about the symptoms of the user's medical condition reported by the user, for example, as described above in connection with Figures 3-6. The journal entry may relate to one or more medical conditions, for example, multiple medical conditions.

[0111] The application may compare information about the user's medical condition symptoms reported by the user in the diary entry with contemporaneous environmental information or user-specific health information to identify one or more correlations. Based on the identified correlations, the system may determine that the current environmental information or user-specific health information is indicative of a risk factor for the user's medical condition. In response, the system may generate a notification to be displayed on the user device, drawing the user's attention to the current environmental information or user-specific health information and / or risk factor.

[0112] FIG. 9 illustrates a flowchart of an exemplary method for identifying risk factors for a user's medical condition.

[0113] In operation 900, a program (also called an application) for tracking a user's medical condition is executed on a computing device / system. The method may be performed by a computing device / system such as that described in connection with FIG.

[0114] At operation 902, a journal entry containing information about symptoms of the user's medical condition as reported by the user is created within the program. The journal entry may be created using, for example, any of the methods described in connection with FIGS. 3-6.

[0115] In operation 904, one or more external / environmental conditions are associated with the journal entry, for example as described in connection with FIG.

[0116] In operation 906, one or more risk factors for the user's medical condition are identified by correlating symptoms of the user's medical condition with associated external / environmental conditions. The correlation may be based on the frequency of the external / environmental conditions occurring within a predefined period of a flare-up / episode of the medical condition. The correlation may be determined based on multiple diary entries.

[0117] In operation 908, a notification is generated for display on the user device alerting the user to risk factors related to the user's medical condition.

[0118] In some embodiments, the method may further include predicting when one or more additional flare-ups / episodes may occur based on identifying that one or more current external / environmental conditions correspond to the identified risk factors. If it is determined that one or more current external / environmental conditions correspond to the identified risk factors, a warning notification may be provided to the user via the GUI of the computing device / system. The warning may provide recommended preventative measures to avoid a flare-up / episode under the current conditions. To this end, the method may obtain information regarding the new environmental conditions and / or new user-specific health information. The system then determines that the new environmental conditions and / or new user-specific health information correlate with the identified risk factors for the user's medical condition. The system then generates a notification for display on the user device, alerting the user to the new environmental information or user-specific health information and / or risk factors.

[0119] The terms "drug" or "medicament" are used synonymously herein to refer to a formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in the broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medications are used to treat, cure, prevent, or diagnose disease or otherwise improve physical or mental well-being. Drugs or medications may be used for a limited period of time or periodically for chronic conditions.

[0120] As described below, drugs or pharmaceutical agents can include at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs include small molecules having a molecular weight of 500 Da or less, polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0121] The drug or agent may be contained within a primary package or "drug container" adapted for use with a drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber may be designed to store the drug for about one month to about two years. Storage may occur at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container may be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during administration to a human or animal body. For example, the two chambers may be configured so that they are in fluid communication with each other (e.g., by a conduit between the two chambers), allowing the user to mix the two components if desired prior to administration. Alternatively or additionally, the two chambers may be configured to allow mixing upon administration of the components into the human or animal body. Drugs or agents contained in drug delivery devices as described herein may be used in the treatment and / or prevention of many different types of medical disorders.

[0122] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain antigen-binding ability. An antibody may be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single-chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, antibody fragment, or mutant that does not support Fc receptor binding, e.g., with a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable region antibody-like binding proteins with a crossover binding region orientation (CODV).

[0123] The term "fragment" or "antibody fragment" refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to antigen. Antibody fragments may include truncations of the full-length antibody polypeptide, although the term is not limited to such truncated fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, such as bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, such as bivalent, trivalent, tetravalent, and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0124] The term "complementarity-determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences but are primarily responsible for maintaining the proper positioning of the CDR sequences to enable antigen binding. Although the framework region itself typically does not directly participate in antigen binding, as is known in the art, certain residues within the framework region of a particular antibody can be directly involved in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen. Examples of antibodies include anti-PCSK-9 monoclonal antibodies (e.g., alirocumab), anti-IL-6 receptor monoclonal antibodies (e.g., sarilumab), and anti-IL-4 receptor monoclonal antibodies (e.g., dupilumab).

[0125] Pharmaceutically acceptable salts of any of the APIs described herein are also contemplated for use with the drugs or medicaments in the drug delivery devices. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0126] It will be understood by those skilled in the art that modifications (additions and / or deletions) to various components of the APIs, formulations, apparatus, methods, systems, and embodiments described herein may be made without departing from the full scope and spirit of the present invention, and that the present invention encompasses such modifications and any and all equivalents thereof. An exemplary drug delivery device may include a needle-based injection system as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems can be broadly divided into multi-dose container systems and single-dose (with partial or complete evacuation) container systems. The container may be an interchangeable container or an integrated, non-interchangeable container.

[0127] As further described in ISO 11608-1:2014(E), a multi-dose container system may include a needle-based injection device with replaceable containers. In such a system, each container holds multiple doses and may be fixed or variable in size (pre-set by the user). Another multi-dose container system may include a needle-based injection device with integrated non-replaceable containers. In such a system, each container holds multiple doses and may be fixed or variable in size (pre-set by the user).

[0128] As further described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device with replaceable containers. In one example of such a system, each container holds a single dose, thereby discharging the entire deliverable amount (full discharge). In a further example, each container holds a single dose, thereby discharging a portion of the deliverable amount (partial discharge). Also as described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device with integrated non-replaceable containers. In one example of such a system, each container holds a single dose, thereby discharging the entire deliverable amount (full discharge). In a further example, each container holds a single dose, thereby discharging a portion of the deliverable amount (partial discharge).

Claims

1. When executed by a computer, the computer: Execute a program to track the user's medical condition; acquiring environmental information or user-specific health information, the acquired environmental information or user-specific health information indicating a possibility of a worsening medical condition of the user; determining that a trigger condition is met based on the acquired environmental information or user-specific health information; In response to determining that the trigger condition is met, generating a notification to be displayed on the user device prompting the user to enter data into a medical journal within the program. A non-transitory computer-readable storage medium comprising instructions to cause

2. The non-transitory computer-readable storage medium of claim 1 , wherein the program is configured to track a plurality of different medical conditions of the user.

3. 3. The non-transitory computer-readable storage medium of claim 1, wherein the computer is part of a user device, and the instructions are further configured to cause the computer to obtain the environmental information using one or more sensors that form part of the user device.

4. The non-transitory computer-readable storage medium of claim 3 , wherein the sensor comprises one or more of a thermometer, a barometer, and / or a hygrometer.

5. 10. The non-transitory computer-readable storage medium of claim 1, wherein the computer is part of a user device, and the instructions are further configured to cause the computer to obtain the environmental information from a weather application running on the user device.

6. The environmental information includes temperature, humidity, atmospheric pressure, pollen count, pollution index, NO ２ 6. The non-transitory computer-readable storage medium of claim 1, comprising one or more of a measurement, an air quality index, a UV index, and / or weather conditions or weather forecasts.

7. The trigger conditions include an upper temperature threshold, a lower temperature threshold, an upper humidity threshold, an upper pollen count threshold, an upper NO ２ 7. The non-transitory computer-readable storage medium of claim 1, comprising one or more of a measurement threshold, a threshold air quality index score, and / or one or more set of predefined weather conditions.

8. 8. The non-transitory computer-readable storage medium of claim 1, wherein the computer is part of a user device and the instructions are further configured to cause the computer to obtain the user-specific health information from one or more sensors of the user device.

9. The non-transitory computer-readable storage medium of claim 8 , wherein the one or more sensors include an optical sensor.

10. 10. The non-transitory computer-readable storage medium of claim 1, wherein the instructions are further configured to cause the computer to obtain the user-specific health information from one or more external devices.

11. 11. The non-transitory computer-readable storage medium of claim 10, wherein the one or more external devices comprise a wearable device selected from the list comprising a smart watch, a pedometer, a glucose meter, and a pulse oximeter.

12. 12. The non-transitory computer-readable storage medium of claim 1, wherein the user-specific health information comprises one or more of heart rate, respiratory rate, body temperature, blood pressure, blood oxygen level, number of steps taken during a specific period of time, sleep duration, and / or sleep patterns.

13. 13. The non-transitory computer-readable storage medium of claim 12, wherein the trigger conditions include one or more of upper and / or lower heart rate thresholds, upper / lower blood pressure thresholds, lower blood oxygen concentration thresholds, upper / lower body temperature thresholds, upper / lower respiration rate thresholds, lower step count thresholds during a specified period of time, and / or deviation from an established or predefined sleep pattern.

14. 14. The non-transitory computer-readable storage medium of claim 1, wherein the user-specific health information comprises one or more of calorie intake, fat intake, and / or salt intake.

15. 15. The non-transitory computer-readable storage medium of claim 1, wherein the generated notification provides a warning regarding the environmental information or the user-specific health information that triggered the generation of the notification.

16. 16. The non-transitory computer-readable storage medium of claim 1, wherein the computer is part of a user device, and the instructions are further configured to cause the computer to display the generated notification on the user device as a push notification to a lock screen of the user device.

17. 17. The non-transitory computer-readable storage medium of any one of claims 1 to 16, wherein the instructions are further configured to cause the computer to create a journal entry within the program that includes information regarding symptoms of the user's medical condition reported by the user.

18. 20. The non-transitory computer-readable storage medium of claim 17, wherein the information regarding symptoms of the user's medical condition includes information regarding symptoms of a plurality of different medical conditions.

19. The instructions cause the computer to: comparing the information regarding symptoms of the user's medical condition as reported by the user with contemporaneous environmental information or user-specific health information to identify one or more correlations; Identifying, based on the one or more correlations, that current environmental information or user-specific health information indicates a risk factor for the user's medical condition; In response, generating a notification to be displayed on the user device that alerts the user to the current environmental information or user-specific health information and / or the risk factors.

20. The non-transitory computer-readable storage medium of claim 17, further configured to cause

20. executing a program for tracking a user's medical condition; Obtaining environmental information or user-specific health information; determining that a trigger condition is met based on the acquired environmental information or user-specific health information; and In response to determining that the trigger condition is met, generating a notification to be displayed on a user device prompting the user to enter data into a medical journal within the program.

20. A computer-implemented method comprising:

21. A user device, comprising: generating and displaying a notification on a display of the user device, the notification prompting the user to enter data into a medical diary within the program; receiving a user input selecting one or more health conditions to which the diary entry relates; displaying one or more questions related to the first selected health condition; After completing a journal entry related to the first selected health condition, display an option to complete a questionnaire related to the first selected health condition. a user device comprising a processing circuit configured to:

22. 22. The user device of claim 21, wherein the one or more questions regarding a first selected health condition include a request to specify a time and / or location associated with an episode of the first health condition.

23. 23. The user device of claim 21 or 22, wherein the one or more questions regarding a first selected medical condition include a request to specify a location on the body where the medical condition is occurring.

24. 24. The user device of claim 21, wherein after completion of the diary entry related to the first selected health condition, the user device is configured to display one or more questions related to a second selected health condition.

25. 25. The user device of claim 21, wherein after the completion of the journal entry related to the first selected health condition, the user device is configured to display an option to set a reminder to complete a subsequent journal entry.

26. A user device, comprising: Execute a program to track the user's medical condition; Obtaining environmental information or user-specific health information, determining that a trigger condition is met based on the acquired environmental information or user-specific health information; In response to determining that the trigger condition is met, generating a notification to be displayed on the user device prompting the user to enter data into a medical journal within the program. a user device comprising a processing circuit configured to:

27. executing a program to generate diary entries for tracking a user's medical condition; creating a diary entry within the program containing information regarding symptoms of the user's medical condition as reported by the user; Associating environmental conditions and / or user-specific health information with said diary entries; identifying risk factors for the user's medical condition by correlating the symptoms of the user's medical condition with the associated environmental conditions and / or user-specific health information; generating a notification to be displayed on a user device alerting the user to the risk factors related to the user's medical condition; 20. A computer-implemented method comprising:

28. obtaining information regarding new environmental conditions and / or new user-specific health information; determining that the new environmental conditions and / or new user-specific health information correlate with identified risk factors for the user's medical condition; generating a notification to be displayed on the user device, alerting the user to the new environmental information or the user-specific health information and / or the risk factors; 28. The computer-implemented method of claim 27, comprising:

29. creating a plurality of diary entries within the program, each diary entry including information regarding symptoms of the user's medical condition as reported by the user; associating environmental conditions and / or user-specific health information with each of the plurality of diary entries; identifying risk factors for the user's medical condition by correlating the symptoms of the user's medical condition with the associated environmental conditions and / or user-specific health information for each of the plurality of diary entries; and amalgamating each identified risk factor.

28. The computer-implemented method of claim 27, comprising:

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