Systems and methods for medication and disease management and patient notification

Abstract

A non-transitory computer-readable storage medium includes instructions that, when executed by a computer, cause the computer to execute a program for managing a user's medical condition or treatment. The program defines a notification scheme for generating notifications related to the user's medical condition or treatment. The system generates different types of notifications based on the occurrence of first, second, and third level trigger events. These notifications are displayed on a graphical user interface provided by the program or the operating system of the user device. The content of the notifications can be modified depending on the user's level of experience. The system can also start a timer to allow medication in the medication delivery device to reach room temperature in response to the user's interaction with a particular notification.

Description

[Technical Field]

[0001] The present specification relates to systems and methods for medication and disease management, and in particular to computer-implemented systems and methods for providing timely and appropriate notifications to patients to assist in managing disease progression and medication regimens. [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 engage users or provide relevant and timely messaging and reminders, and conversely, providing users with too much information can overwhelm them and lead to them not engaging with messaging. Summary of the Invention [Problem to be solved by the invention]

[0004] Therefore, there is a need for systems and methods that provide effective and timely messaging regarding a user's disease management and medication regimen, which improves user engagement and adherence, and ultimately leads to improved treatment outcomes for the user. [Means for solving the problem]

[0005] When the first aspect of the present disclosure is executed by a computer, the computer Implementing a program for managing a user's medical condition or treatment, the program defining a notification scheme for generating notifications related to the user's medical condition or treatment; generating, upon occurrence of a first level trigger event, a silent notification on a graphical user interface provided by the program for managing a medical condition or treatment of a user, configured to be displayed when the program is accessed by the user; generating an indication that the user has at least one mass notification when a second level trigger event occurs, and displaying the indication; When a third-level trigger event occurs, generate a push notification and display the push notification. 1. A non-transitory computer-readable storage medium comprising instructions for causing: A non-transitory computer-readable storage medium is provided in which an indication that a user has at least one bulk notification and a push notification are displayed on a graphical user interface provided by an operating system of a user device equipped with a computer.

[0006] In some embodiments, the graphical user interface provided by the operating system of the user device is a lock screen of the user device, while in other embodiments, the graphical user interface provided by the program for managing a user's medical condition or treatment is a home screen of the program for managing a user's medical condition or treatment.

[0007] In some embodiments, second level trigger events have a higher priority than first level trigger events, and third level trigger events have a higher priority than second level trigger events.

[0008] In some embodiments, the first mass notification defines a threshold time for interacting with the first mass notification, and if the first mass notification is not interacted with within the threshold time, the computer is configured to generate a push notification associated with the first mass notification.

[0009] In some embodiments, the content of the silent and / or push notifications varies depending on the user's experience level.

[0010] In some embodiments, the first push notification reminds the user to remove the medication delivery device from a cold environment, and in response to the user interacting with the first push notification, the computer starts a timer to leave the medication in the medication delivery device until it reaches room temperature.

[0011] In some embodiments, the first, second, or third level trigger event comprises the time remaining until the next medication administration.

[0012] In some embodiments, the first, second, or third level trigger event includes the time remaining until an appointment or call.

[0013] In some embodiments, the first, second, or third level trigger event comprises a prompt to complete a diary entry regarding disease symptoms and / or general health.

[0014] In some embodiments, the first, second, or third level trigger event comprises the time remaining until the end of the prescription period.

[0015] A second aspect of the present disclosure is Executing a program for managing a user's medical condition or treatment, the program defining a notification scheme for generating notifications related to the user's medical condition or treatment; generating, when a first level trigger event occurs, a silent notification on a graphical user interface provided by the program for managing a medical condition or treatment of a user, the silent notification configured to be displayed when the program is accessed by the user; generating an indication that the user has at least one mass notification when a second level trigger event occurs, and displaying the indication; When a third-level trigger event occurs, a push notification is generated and displayed. A computer-implemented method comprising: A computer-implemented method is provided in which an indication that a user has at least one batch notification and a push notification are displayed on a graphical user interface provided by an operating system of a user device.

[0016] The first level trigger event, the second level trigger event, or the third level trigger event may each be selected from the group including: (i) the time remaining until the next medication dose; (ii) the time remaining until an appointment or phone call; (iii) a prompt to complete a diary entry regarding disease symptoms and / or general health; and (iv) the time remaining until the end of the prescription period.

[0017] A third aspect of the present disclosure comprises: Implementing a program for managing a user's medical condition or treatment, the program defining a notification scheme for generating notifications related to the user's medical condition or treatment; generating, upon occurrence of a first level trigger event, a silent notification on a graphical user interface provided by the program for managing a medical condition or treatment of a user, configured to be displayed when the program is accessed by the user; generating an indication that the user has at least one mass notification when a second level trigger event occurs, and displaying the indication; When a third-level trigger event occurs, generate a push notification and display the push notification. 1. A user device comprising a processing circuit configured to: A user device is provided in which an indication that the user has at least one batch notification and the push notification are displayed on a graphical user interface provided by an operating system of the user device.

[0018] 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]

[0019] [Figure 1] It shows the overall architecture of the system on which the computer program runs. [Figure 2A-2B] 10 shows an exemplary screenshot displayed by a computer program for silent push notifications. [Figures 2C-2D] 10 shows an exemplary screenshot displayed by a computer program for silent push notifications. [Figure 3A-3B] 10 shows further exemplary screenshots displayed by a computer program for mass notification; [Figure 4A-4B] 10 shows further exemplary screenshots displayed by a computer program regarding push notifications. [Figure 5A-5B] 1 shows first and second notification option screens. [Figure 5C-5D] Figure 5C shows the infusion routine control screen, and Figure 5D shows the connected device management screen. [Figure 5E] 1 shows an additional notification options screen. [Figure 6] 1 shows a schematic representation of a user device for running a computer program; [Figure 7] 1 is a flowchart illustrating steps of a computer-implemented method. DETAILED DESCRIPTION OF THE INVENTION

[0020] The present disclosure relates to an application that can run on a user device and assists the user in tracking their health and disease progression and managing all aspects of their treatment. In particular, the application encourages and prompts the user to maintain their treatment routine through a series of notifications regarding various aspects of treatment, such as completing a journal entry, recording treatments received, and generating reports before doctor's appointments.

[0021] 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.

[0022] 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.

[0023] The application may additionally assist users in accessing treatment, such as accessing insurance coverage, managing medication delivery, and providing educational support. The application may also help 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 may also provide access to learning materials, including instructional articles and videos, as well as motivational articles and challenges, and provide connectivity to other connected devices, such as activity trackers and heart rate monitors, to provide holistic care by continuously updating and learning about the user's behavior. The application may also collect and combine information from other programs, such as environmental monitoring apps or weather forecasts.

[0024] Referring to Figure 1, an overall architecture 100 of a disease management and medication regimen management 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.

[0025] One of the functional modules is a diary module 102. The diary module 102 is configured to enable a user to keep a diary related to the user's one or more medical conditions. The diary may include multiple diary entries detailing episodes of one or more medical conditions, including 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 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.

[0026] The diary may also keep track of a user's adherence to a treatment regimen, such as a medication regimen. For example, diary entries may include records, such as an infusion log, that record the doses of medication taken by the user (e.g., scheduled doses). The records may form a dose record that includes various information related to the doses administered by the user. The records may be stored as part of the diary entries or separately from the diary entries.

[0027] 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 linked to the cloud to remotely store the journal entries.

[0028] 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.

[0029] One of these functional modules is a user management module 110 that is responsible for retrieving user settings and generating notifications for output on the user device 104. The data required for the notification scheme may be stored in a local database 106 of the user device 104. The user management module 110 may also update the information held in the database 106 as the application is used. The architecture 100 also shows how the application run by the user device 104 may interact with other service providers to enhance the information that may be provided to the user via the application.

[0030] 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 has three main notification types: (i) silent notifications, (ii) bulk summary notifications, and (iii) push notifications.

[0031] Silent notifications may be silently pushed to the application. The user is presented with silent notifications within the app, for example, on the app'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. Bulk summary notifications may relate to several different reminders and other notifications. The user can interact with the bulk summary notification to expand and view individual notifications. The bulk summary notification indicates the number of notifications available for the user to view. Push notifications may relate to a single notification and are pushed to the lock screen or home screen of the user device 104. 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.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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 124 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.

[0038] 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.

[0039] 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.

[0040] 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.

[0041] 2a-2d, exemplary screenshots displayed by the present application are shown. The screenshots in Figures 2a-2d relate to silent notifications that are displayed only within the present application.

[0042] In the first screenshot 200 shown in FIG. 2a, the Home Screen tab 202 is selected. The application displays several user-selectable tabs at the bottom of the screen, including at least two of Home Screen, Treatment, Journal, Learn, and Account (or Settings). The Home Screen has a notification area where silent notifications are displayed. A first silent notification 204 is displayed, reminding the user of an upcoming doctor's appointment and indicating the appointment date and time. Interacting with the first silent notification 204 may open a notification center (see FIG. 3b), where further details about the notification and any other notifications waiting for the user's viewing can be viewed. A graphic containing recommended actions is displayed at the top of the Home Screen. The recommended actions vary depending on the user's proximity to their next dose / infusion, doctor's appointment, prescription renewal / delivery date, etc. In the example of the first screenshot 200, the user's doctor's appointment is more than several days away (e.g., four or more days), so the recommended actions are related to completing a journal entry rather than the appointment.

[0043] In a second screenshot 206 shown in FIG. 2b, the home screen tab 202 is again selected. A second silent notification 208 is shown reminding the user of an upcoming doctor's appointment and indicating the date and time of the appointment. Because the doctor's appointment is only two days away, the time remaining until the appointment is more prominently displayed as part of the second silent notification 208. Also, the recommended actions displayed at the top of the home screen relate to the upcoming doctor's appointment, specifically a reminder to prepare a report for the doctor to view at the time of the appointment. In this way, the application provides the user with appropriate and timely notifications and associated recommended actions.

[0044] In a third screenshot 210 shown in FIG. 2c, the home screen tab 202 is again selected. In this example, a third silent notification 212 and a fourth silent notification 214 are shown in the notification area of ​​the home screen. These are of a different type than the first and second silent notifications described above. The third silent notification 212 relates to the scheduled time of the user's next medication administration. The date and time of the scheduled administration are shown in the third silent notification 212, although these details may be set by the user (see FIG. 5c). Because only two days remain until the scheduled administration event, the remaining time is more prominently displayed at the top of the third silent notification 212. Because the notification relates to a scheduled medication administration, the recommended action displayed at the top of the home screen relates to supporting the user with administering the medication. In particular, the recommended action may be to schedule a call with a healthcare professional.

[0045] The fourth silent notification 214 is for an upcoming delivery of medication. The fourth silent notification 214 indicates the date and time window for delivery. Interacting with the third silent notification 212 or the fourth silent notification 214 may open a notification center (see FIG. 3b) where further details about the notification and any other notifications waiting for the user's viewing can be seen.

[0046] Some silent notifications may appear on other user-selectable tabs at the bottom of the screen. In the fourth screenshot 216 shown in FIG. 2d, the Treatment tab 218 is selected. The Treatment screen also has a notification area where silent notifications are displayed, but here, the range of notifications may be more limited compared to the Home screen. For example, only notifications regarding doctor appointments and scheduled administration events may be displayed on the Treatment screen. A fifth silent notification 220 is shown reminding the user of an upcoming doctor's appointment and indicating the appointment date and time. Interacting with the fifth silent notification 220 may open a notification center (see FIG. 3b), where further details about the notification and any other notifications waiting for the user's viewing can be viewed. Like the Home screen, the Treatment screen also allocates the upper portion of the Treatment screen to display graphics containing recommended actions. The recommended actions displayed at the top of the Treatment screen are related to supporting the user with medication administration. In particular, the recommended actions may be links to information and / or instructional videos for self-administering medication.

[0047] The silent notifications described with respect to FIGS. 2a-2d are used only as examples of the types of information that may be conveyed to a user by silent notifications. Silent notifications may be displayed in order of decreasing urgency. For example, if the most urgent action is the user's next scheduled dose, this reminder may appear first in the list of silent notifications or may be the only silent notification. The content of the silent notification may also depend on the particular tab that is displayed. For example, when the Home tab 202 is selected, the most urgent silent notification may be displayed. When the Diary tab is selected, a notification regarding the user's next appointment may be displayed, even if this is not the most urgent notification. When the Treatment tab is selected, a notification regarding the user's next scheduled dose may be displayed, even if this is not the most urgent notification. A non-exhaustive, but more complete, list of notifications that may be provided to a user by silent notifications is set forth in Table 1 below.

[0048] In the notification center, options may be accessible to change some aspects of the notification, such as the time of the appointment or scheduled administration event. If the notification is for medication delivery, a link may be provided to contact the carrier / shipping company so that the date and time of delivery may be changed.

[0049] 3a and 3b, further exemplary screenshots are shown. The screenshots in FIGS. 3a and 3b relate to batch notifications. A fifth screenshot 300 shown in FIG. 3a is of the lock screen of a user device running the application. A batch notification 302 is displayed on the lock screen, indicating to the user that there are several notifications from the application waiting for the user to view. This prevents the user from being overwhelmed with many separate notifications that are not time-critical or require immediate user action. The user is presented with useful information regarding the number and source of notifications and can then choose when to interact with the batch notification 302. In the example of the fifth screenshot 300 shown in FIG. 3a, the user has three notifications waiting to be viewed.

[0050] Interacting with the bulk notification 302 may open a notification center, as shown in the sixth screenshot 304 in FIG. 3b, where the notifications are displayed individually. The user can interact with any of the displayed notifications in the notification center to be taken to a new page where the appropriate action can be taken.

[0051] The mass notifications described with respect to Figures 3a and 3b are used only as examples of the types of information that may be conveyed to users by mass notifications. A more complete, but not exhaustive, list of notifications that may be provided to users by mass notifications is provided in Tables 1 and 2 below.

[0052] 4a and 4b, further exemplary screenshots are shown. The screenshots in FIGS. 4a and 4b relate to push notifications. A seventh screenshot 500, shown in FIG. 4a, is of the lock screen of a user device running the application. The lock screen displays a push notification 502 indicating that the user will receive a call from a nurse in five minutes and including some instructions for preparing for the call. The remaining time until the event, displayed as a push notification, can be actively updated. For example, a notification of an upcoming call with a nurse can be displayed one hour before the start of the call. The displayed time until the call can then be updated, for example, in five-minute increments. Interacting with the push notification 502 can direct the user to information to assist in preparing for an infusion or to a recent journal entry about their health.

[0053] As can be appreciated, the push notification 502 is time-sensitive in nature and requires action by the user. In this manner, urgent or time-sensitive tasks are prioritized by the notification system, and the user learns to trust that the application will only display push notifications regarding such time-sensitive tasks. Thus, the user is less likely to ignore such notifications and is more likely to be better prepared for administration events and appointments and to follow prescribed administration regimens. The appearance of the push notification may also be accompanied by an audible and / or haptic output on the user's device.

[0054] An eighth screenshot 504, shown in FIG. 4b, illustrates a further example of a push notification 506. In this example, the push notification 506 is a prompt to complete a journal entry. In particular, the application has received information that the user had a poor night's sleep, for example from an external monitoring device or via another application running on the user's device that shares information with the application. Interacting with the push notification 506 may take the user to the start page of the journal entry within the application.

[0055] Displaying this notification in a timely manner can prompt the user to complete the diary entry, a time-sensitive task. For example, prompting the user to complete the diary entry immediately after experiencing symptoms is likely to result in a more accurate diary entry, given that memories of acute events fade over time. In this way, the user is prompted to create useful records regarding disease progression and overall health, providing more and better quality information to medical professionals.

[0056] The push notifications described with respect to Figures 4a and 4b are used only as examples of the types of information that may be conveyed to a user by a push notification. A more complete, but not exhaustive, list of notifications that may be provided to a user by a push notification is provided below in Tables 1 and 2.

[0057] The application may provide users with various options for customizing the types of notifications they receive and the timing of any reminders to take their medications. FIG. 5a shows a first notification options screen 508. The first notification options screen 508 has several user-selectable elements that allow the user to specify whether they want to be notified about specific events. The list of events may include upcoming doctor appointments, medication deliveries, administration event reminders such as infusion reminders, nurse call notifications, news and articles, and challenges and new habits. FIG. 5b shows a second notification options screen 510 that allows the user to select an area of ​​interest. The user may be presented with notifications related to the selected area of ​​interest. Allowing users to specify the notifications they want to receive and the areas they want to hear about increases the level of customization the notification system offers, improving user engagement and satisfaction.

[0058] FIG. 5c shows the infusion routine control screen 512. The infusion routine control screen 512 allows the user to specify the time of day that they normally take their infusion, so that they can be reminded at the appropriate time. The user can also use this screen to specify how long before the scheduled infusion time they would like to be reminded about their infusion, for example, one day in advance. There is also a selectable option as to whether or not to provide a step-by-step guide as part of the infusion reminder. This option may be toggled to "yes" by default until the user specifies otherwise. While this screen is described in terms of infusion reminders, the application can also assist users in managing other forms of medication administration, such as oral and topical medications.

[0059] The timing of notifications, particularly push and bulk notifications, may be initially defined by the application. However, the application may also dynamically adjust the timing of notifications as the user engages with the application. The application may learn about a particular user's behavior and track when the user is most active and most likely to open the application. The application may then adjust the timing of notifications accordingly to obtain maximum impact and maximum user engagement.

[0060] 5d shows the Manage Connected Devices screen 514. This screen lists connected devices that are wirelessly capable and associated with the user. The user can use this screen to pair a new device, such as an injector or inhaler, with the application to manage the user's medical condition or treatment, or to remove an unwanted device.

[0061] FIG. 5e shows an additional notification options screen 516. The additional notification options screen 516 may be displayed by the application instead of or in addition to the notification options screen 508 of FIG. 5a. The alternative notification options screen 516 has a different list of notification types that the user may enable or disable. The list of notifications may include infusion reminders, prescription refill reminders, other medication reminders (where the user has specified in the application what other medications they are taking and on what schedule), and administration event reminders such as diary reminders. Some of the notification options on the alternative notification options screen 516 may have links that allow the user to edit various associated reminders set in the application or choose to view upcoming reminders.

[0062] Tables 1 and 2 below detail a variety of different notifications that may be generated by the notification system described herein. The "Logic" column specifies the conditions necessary to generate a particular notification. This may take the form of a predetermined time until an event, at the event, or a predetermined time after an event. In some other examples, the logic condition requires that the user have or have not completed a specific task in addition to a time constraint.

[0063] The "New User Copy" column specifies the text that will be displayed as part of the notification for inexperienced users. The "Experienced User Copy" column specifies the text that will be displayed as part of the notification for experienced users. Inexperienced users may be defined as users who have completed fewer than a predetermined number of infusions / medication administrations or who have been using the application for less than a predetermined period of time. In some other embodiments, users may have the option to define whether they are experienced or inexperienced.

[0064] The "Notification Type" column indicates the priority level of the notification. An event that triggers a silent push notification is a first-level trigger event. An event that triggers a bulk notification is a second-level trigger event. An event that triggers a push notification is a third-level trigger event. Some events start at a particular level and can escalate to a higher level if the user does not interact with the notification or complete the task associated with the notification within a specified period of time (see, for example, documents 01-10 in Table 2).

[0065] The "Notification Point" column indicates where the notification can or may be displayed. This typically depends on the type of notification. Push notifications may be displayed on the lock screen of the user's device. Silent push notifications may be displayed anywhere within the application, or in multiple places within the application. For example, a silent notification may appear on the homepage / home screen of the application. The homepage of the application may have a defined area for displaying notifications, or several different areas where notifications may appear. These areas may be called cards (e.g., infusion card, carousel card). In some other embodiments, the infusion card and carousel card are separate pages within the application. If the silent notification is related to the user's treatment, it may also appear on the treatment page of the application.

[0066] Bulk notifications appear individually in the notification center. In this case, notifications that one or more bulk notifications are waiting for the user to view also appear on the lock screen of the user device as described above. In addition, push notifications may also appear individually in the notification center. Silent notifications may optionally appear in the notification center.

[0067] If a particular notification can increase the priority level, only the initial display location of the notification will be shown. The application and notification scheme is applicable to a wide variety of different medications that may be administered by injection, orally, or topically, and that may be associated with a wide range of different diseases and medical conditions. The application and notification scheme can also notify the user simultaneously about several different medical conditions and treatment regimens. In some embodiments, several different instances of the notification scheme may be run on the application, one for each medical condition being managed or each medication being administered.

[0068] The priority level of a notification may also be based on medical conditions that a particular user has. For example, some notifications may have a higher priority (and be displayed, for example, as a push notification) if the user indicates that they have a first medical condition. The first medical condition may be asthma. The same notification may be given a lower priority, for example, displayed as a bulk notification or silent push, if the user indicates that they have a second medical condition but not the first medical condition. The second medical condition may be atopic dermatitis.

[0069] [Table 1]

[0070] [Table 2]

[0071] [Table 3]

[0072] [Table 4]

[0073] [Table 5]

[0074] [Table 6]

[0075] [Table 7]

[0076] [Table 8]

[0077] In one example, some notifications are required for offline operation, specifically notification names "Treatment 06-09", "Missed Medication 01-03", "Diary 01-06", and "Content 01-03".

[0078] There may be prerequisites for at least some notifications to be displayed. For example, a prerequisite for notification "Treatment 02" may be that the user has already signed up for a proprietary patient support program, while a prerequisite for notification "Treatment 03" may be that the user has not signed up for the program. The user may also indicate that they do not need or want to see a particular notification, in which case the associated notification will not be displayed. For example, for notification "Treatment 04," if the user indicates that they do not need a step-by-step guide by toggling the appropriate option in the notification options (see Figure 5a), this notification will not be displayed. For some notifications, the action communicated may also depend on the user's settings. For example, this may be the case for notification "Treatment 07."

[0079] It should be appreciated that the desired outcomes or actions following various notifications can vary, for example, from scheduling a PSP phone call to viewing an infusion guide. Notification "Treatment 06" may trigger a timer countdown for the time required for the medication to warm to room temperature. After notification "Treatment 07," the infusion may be recorded, for example, when the user indicates completion of the treatment. In response to notification "Missed Dose 01," the outcome / action may be that the user has already administered the medication and the user simply removes the medication from the refrigerator and "reminds me later." The outcome for notifications "Appointment 02-05" may be to generate a report or add a journal entry to notifications "Diary 01-06."

[0080] [Table 9]

[0081] [Table 10]

[0082] [Table 11]

[0083] The application may also receive data from external devices or from other applications running on the user device. For example, connected devices such as activity trackers and heart rate monitors may be paired with the application. The application may also collect and combine information from other programs, such as environmental monitoring apps or weather forecasts. Several additional notifications may be generated based on information obtained from these external devices or services. For example, notifications regarding high pollen counts, high air pollution, high UV index, high or low humidity, or specific weather conditions may be generated based on information obtained from the environmental monitoring app or weather forecast. The priority level of these notifications may depend on the medical conditions of a particular user. For example, if a user has asthma, notifications regarding high pollen counts and high air pollution may be high priority and displayed as push notifications. On the other hand, if a user has atopic dermatitis but does not have asthma, these notifications may be displayed with a lower priority, such as bulk notifications or silent pushes, or may not be displayed at all.

[0084] Notifications may also be generated based on a user's activity level as determined by data from external devices such as smartwatches and other activity trackers. For example, if the data obtained indicates that the user is sleeping poorly, a notification may be generated asking if the user would like to make a journal entry related to this, as shown in FIG. 4b. Because such notifications are time-sensitive (as they relate to recent user activity), they may be given high priority and displayed as push notifications. General notifications about environmental conditions that may worsen a user's medical condition, such as certain weather conditions or a high UV index, but that do not suggest time-dependent action on the user's part, may be displayed as bulk or silent push notifications.

[0085] The application may combine information from both the activity tracker and the environmental monitor. For example, the application may use step counts to determine when a user is taking a walk. This may be cross-referenced with pollen and / or air pollution data from the environmental monitor to determine that the user regularly takes walks when pollen and / or pollution levels are high. A notification may then be generated advising the user that this may exacerbate or trigger a medical condition and advising them to take a walk at a different time. This notification may be considered time-independent because it relates to long-term behavioral changes, and therefore may be displayed as a bulk or silent push notification, for example, on the Learning tab screen of the application.

[0086] The application may also be connected to other smart devices in the home, such as a smart refrigerator, a smart TV, a tablet computing device, a connected storage device for storing the user's medications, or a connected needle collection container. Notifications may be generated based on data received from these devices. For example, if the application is notified by a smart refrigerator that the user has opened the door within a certain window to access medication, a notification may be generated asking the user if they would like to start a warm-up timer. Some medications must be stored in the refrigerator but must be brought up to room temperature for comfortable injection. Generating a warm-up timer reminder when the user opens the refrigerator door helps remind the user of this, and is a timely and useful reminder that the application can provide the user with a warm-up timer. Because this is a time-sensitive notification, it may be displayed as a push notification.

[0087] As a further example, if the application receives data from a connected storage device that the user has removed an infusion device from the storage device, the application may generate a notification asking the user if they would like to view a step-by-step guide for self-injection. Because this is a time-sensitive notification, it may be displayed as a push notification. Such a notification may be displayed the first time the user removes the infusion device from the storage device, or the first few times, or every time. In another example, if data from a connected storage device indicates that there are no more (or only one) infusion devices left on the storage device, the notification may relate to ordering more medication or renewing a prescription.

[0088] As a further example, if the application receives data from a connected smart collection container indicating that the user has discarded the injection device in a needle collection container, the application may generate a notification asking the user whether they would like to schedule their next injection. Such a notification may only be displayed if an injection schedule has not been set in the application. In another example, a notification may ask the user whether they would like to complete a journal entry or speak with a healthcare professional about their medical condition or treatment.

[0089] By utilizing data received from external devices and services in this manner, the Application can provide more timely and relevant notifications to the user, thereby significantly improving the Application's ability to assist the user in managing their health condition and may also improve user satisfaction and adherence to prescribed medications.

[0090] It can be seen that some of the notifications provide confirmation to the user that input, such as a document, has been received, while other notifications prompt the user to take action.

[0091] FIG. 6 schematically illustrates a user device 400 according to some embodiments. The user device 400 may be a mobile phone or a tablet computer. The user device 400 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 400 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 WiFi (IEEE 802.11). The user device 400 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 400 and the host computer may be configured to communicate data.

[0092] The user device 400 may comprise hardware including a processing circuit 401. The processing circuit 401 may comprise a processor 402 and a memory 404. The user device 400 may also comprise a wireless transceiver 406, a user input 408, a display 412, a camera 410, a microphone 416, an RFID reader 418, and a speaker 414. The wireless transceiver 406 may be configured to set up and maintain a wireless connection to a network node. The wireless transceiver 406 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 401 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 402 may be configured to read from and / or write to the memory 404. The memory 404 may include volatile and / or non-volatile memory, such as cache, RAM (random access memory), and / or ROM (read only memory).

[0093] The user device 400 may include software stored, for example, in memory 404. The software may be executable by the processing circuitry 401. 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.

[0094] The processing circuitry 401 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 401, cause the processing circuitry 401 to perform the methods described herein.

[0095] The memory 404 may include both program memory, which stores program code (e.g., software or firmware), and main memory, which stores data. The processing circuit 401 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 400. 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).

[0096] The user device 400 includes one or more user inputs 408, such as a touchscreen, a keypad or keyboard, an accelerometer or gyroscope, a mouse, or a microphone 416 for receiving voice commands. The user device 400 may also include a camera 410 configured to capture images of the user and of labels, codes, etc. visible on the medication administration device, packaging, or storage solution. The user device 400 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 410 or the RFID reader 418. The term "scanning" as used with respect to the user device 400 may refer to using either of these components to read information provided externally or internally to the medication administration device.

[0097] The notification scheme outlined above provides several key benefits: Predictability: There is a consistent approach to how notifications are presented to the user, prioritizing urgent notifications and clearly indicating the action required by the user. For example, notifications that require the user to perform a time-sensitive action are sent as a push notification indicating the action the user needs to take. Users learn that they will not receive a push notification for every notification, and that push notifications from the app are associated with importance and require action on their part. Reliability: Notifications are consistent and reliable, thus demonstrating trustworthiness to the user. Users learn to trust the application to guide them through their treatment and present the right resources at the right time. Context-aware: Notifications are context-aware (i.e., take into account the user's situation, preferences, and level of experience). Notifications are delivered at the right time and with the right priority.

[0098] 7 is a flowchart illustrating steps of a computer-implemented method. In step 700, the method calls for executing a program defining a notification scheme for generating notifications related to a user's medical condition or treatment. The program is an application described above for managing a user's medical condition or treatment. The program executes at least in part on a user device, and the notifications are displayed on a display of the user device.

[0099] In step 702, the method calls for generating, when a first-level trigger event occurs, a silent notification on a graphical user interface provided by the program for managing a user's medical condition or treatment configured to be displayed when the user accesses the program. The silent notification may be displayed on a home screen of the program for managing a user's medical condition. In some other embodiments, the silent notification may be displayed on a treatment page of the program for managing a user's medical condition in addition to the home screen, depending on the subject of the notification.

[0100] In step 704, the method requests that, when a second-level trigger event occurs, the user generate and display an indication that the user has at least one mass notification. Interacting with the mass notification can open a notification center where the content of the individual notifications can be viewed and further interacted with. The mass notification can be displayed on a graphical user interface provided by the operating system of the user device. This graphical user interface can be the lock screen of the user device.

[0101] In step 706, the method calls for generating a push notification and displaying the push notification when a third-level trigger event occurs. By interacting with the push notification, the program for managing the user's medical condition or treatment can open and navigate to a user interface where an action can be taken related to the subject of the push notification. The push notification can be displayed on a graphical user interface provided by the operating system of the user device. This graphical user interface can be the lock screen of the user device.

[0102] 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.

[0103] 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.

[0104] 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.

[0105] 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).

[0106] 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.

[0107] 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).

[0108] 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.

[0109] It will be understood by those skilled in the art that modifications (addition and / or deletion) of various components of the APIs, formulations, devices, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the invention, and that the 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 may be broadly divided into multi-dose container systems and single-dose (with partial or complete evacuation) container systems. The container may be an exchangeable container or an integrated, non-exchangeable container.

[0110] 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).

[0111] 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: executing a program for managing a user's medical condition or treatment, said program defining a notification scheme for generating notifications related to the user's medical condition or treatment; generating, upon occurrence of a first level trigger event, a silent notification on a graphical user interface provided by the program for managing a user's medical condition or treatment, the silent notification configured to be displayed when the user accesses the program; generating an indication that the user has at least one batch notification when a second-level trigger event occurs, and displaying the indication; If a third-level trigger event occurs, generate a push notification and display the push notification.

1. A non-transitory computer-readable storage medium comprising instructions for causing: A non-transitory computer-readable storage medium, wherein the indication that the user has at least one bulk notification and the push notification are displayed on a graphical user interface provided by an operating system of a user device equipped with the computer.

2. The non-transitory computer-readable storage medium of claim 1 , wherein the graphical user interface provided by an operating system of a user device is a lock screen of the user device.

3. 10. The non-transitory computer-readable storage medium of claim 1, wherein the graphical user interface provided by the program for managing a user's medical condition or treatment is a home screen of the program for managing a user's medical condition or treatment.

4. 4. The non-transitory computer-readable storage medium of claim 1, wherein the second-level trigger events have a higher priority than the first-level trigger events, and the third-level trigger events have a higher priority than the second-level trigger events.

5. 5. The non-transitory computer-readable storage medium of claim 1, wherein a first bulk notification defines a threshold time for interacting with the first bulk notification, and if the first bulk notification is not interacted with within the threshold time, the computer is configured to generate a push notification associated with the first bulk notification.

6. The non-transitory computer-readable storage medium of claim 1 , wherein the content of the silent notification and / or the push notification is changed depending on the experience level of the user.

7. 7. A non-transitory computer-readable storage medium as described in any one of claims 1 to 6, wherein a first push notification reminds a user to remove a medication delivery device from a low-temperature environment, and in response to the user interacting with the first push notification, the computer starts a timer to leave the medication in the medication delivery device until it reaches room temperature.

8. 8. The non-transitory computer-readable storage medium of claim 1, wherein the first, second, or third level trigger event comprises a time remaining until the next drug administration.

9. 9. The non-transitory computer-readable storage medium of claim 1, wherein the first, second, or third level trigger event comprises the time remaining until the next appointment or phone call.

10. 10. The non-transitory computer-readable storage medium of claim 1, wherein the first, second, or third level trigger event comprises a prompt to complete a diary entry regarding disease symptoms and / or general health.

11. 11. The non-transitory computer-readable storage medium of claim 1, wherein the first, second, or third level trigger event comprises time remaining until the end of a prescription period.

12. executing a program for managing a user's medical condition or treatment, said program defining a notification scheme for generating notifications related to the user's medical condition or treatment; generating, upon occurrence of a first level trigger event, a silent notification on a graphical user interface provided by the program for managing a user's medical condition or treatment, the silent notification configured to be displayed when the user accesses the program; generating an indication that the user has at least one batch notification when a second level trigger event occurs, and displaying the indication; generating a push notification when a third-level trigger event occurs and displaying the push notification; A computer-implemented method comprising: A computer-implemented method, wherein the indication that the user has at least one batch notification and the push notification are displayed on a graphical user interface provided by an operating system of a user device.

13. 13. The computer-implemented method of claim 12, wherein the graphical user interface provided by an operating system of a user device is a lock screen of the user device, and the graphical user interface provided by the program for managing a user's medical condition or treatment is a home screen of the program for managing a user's medical condition or treatment.

14. 14. The computer-implemented method of claim 12 or 13, wherein a first bulk notification defines a threshold time for interacting with the first bulk notification, and if the first bulk notification is not interacted with within the threshold time, the method further comprises generating a push notification associated with the first bulk notification.

15. a first push notification reminding the user to remove the medication delivery device from the cold environment; 15. The computer-implemented method of claim 12, further comprising: in response to the user interacting with the first push notification, starting a timer to allow the medication in the medication delivery device to reach room temperature.

16. 16. The computer-implemented method of claim 12, wherein the first level trigger event, the second level trigger event, or the third level trigger event is selected from the group comprising: (i) time remaining until the next medication administration; (ii) time remaining until an appointment or phone call; (iii) a prompt to complete a diary entry regarding disease symptoms and / or general health; and (iv) time remaining until the end of a prescription period.

17. executing a program for managing a user's medical condition or treatment, said program defining a notification scheme for generating notifications related to the user's medical condition or treatment; generating, upon occurrence of a first level trigger event, a silent notification on a graphical user interface provided by the program for managing a user's medical condition or treatment, the silent notification configured to be displayed when the user accesses the program; generating an indication that the user has at least one batch notification when a second-level trigger event occurs, and displaying the indication; If a third-level trigger event occurs, generate a push notification and display the push notification.

1. A user device comprising a processing circuit configured to: The user device, wherein the indication that the user has at least one notification batch and the push notification are displayed on a graphical user interface provided by an operating system of the user device.

18. 18. The user device of claim 17, wherein the graphical user interface provided by the operating system of the user device is a lock screen of the user device, and the graphical user interface provided by the program for managing a user's medical condition or treatment is a home screen of the program for managing a user's medical condition or treatment.

19. 19. The user device of claim 17 or 18, wherein a first bulk notification defines a threshold time for interacting with the first bulk notification, and wherein if the first bulk notification is not interacted with within the threshold time, the user device is configured to generate a push notification related to the first bulk notification.

20. 20. The user device of claim 17, wherein a first push notification reminds a user to remove the medication delivery device from a low-temperature environment, and wherein, in response to the user interacting with the first push notification, the user device is configured to start a timer to leave the medication in the medication delivery device until it reaches room temperature.

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