Systems and methods for drug 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 medical condition or treatment of a user. The program defines a notification scheme for creating a notification associated with a medical condition or treatment of the user. The system generates different types of notifications based on the occurrence of the first level trigger event, the second level trigger event, and the third level trigger event. The notifications are displayed on a graphical user interface provided by an operating system of the program or user device. The content of the notifications may vary according to the user's experience level. The system may also start a timer to allow the medicament in the medicament delivery device to reach room temperature in response to a user's interaction with a particular notification.

Description

Technical Field

[0001] This specification relates to systems and methods for drug and disease management, and more particularly to a computer-implemented system and method for providing timely and relevant notifications to patients to assist in the management of disease progression and drug regimens. Background Art

[0002] A significant obstacle to high-quality treatment outcomes is patient engagement and adherence to prescribed drug regimens, as well as patient understanding of factors that affect their disease progression and overall health.

[0003] Current systems fail to effectively engage users or provide appropriate and timely messaging and reminders. Instead, providing users with too much information can overwhelm them and cause them to stop paying attention to the messaging.

[0004] Accordingly, there is a need for systems and methods for effective and timely messaging regarding a user's disease management and drug regimen to improve user engagement and adherence, and ultimately improve the user's treatment outcomes. Summary of the Invention

[0005] A first aspect of the present disclosure provides a non-transitory computer-readable storage medium including instructions that, when executed by a computer, cause the computer to:

[0006] Execute a program for managing a user's medical condition or treatment, the program defining a notification scheme for creating notifications associated with the user's medical condition or treatment;

[0007] When a first-level trigger event occurs, generate a silent notification configured to be displayed on a graphical user interface provided by the program when the user accesses the program for managing the user's medical condition or treatment;

[0008] When a second-level trigger event occurs, generate an indication that the user has at least one batch notification and cause the indication to be displayed; and

[0009] When a third-level trigger event occurs, generate a push notification and cause the push notification to be displayed,

[0010] 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 including the computer.

[0011] In some embodiments, the graphical user interface provided by the operating system of the user device is the lock screen of the user device. In other embodiments, the graphical user interface provided by the program for managing the user's medical condition or treatment is the main screen of the program for managing the user's medical condition or treatment.

[0012] In some embodiments, the second-level trigger event has a higher priority than the first-level trigger event, and the third-level trigger event has a higher priority than the second-level trigger event.

[0013] In some embodiments, the first batch notification defines a threshold time for interacting with the first batch notification, and if the first batch notification is not interacted with within the threshold time, the computer is caused to generate a push notification related to the first batch notification.

[0014] In some embodiments, the content of the silent notification and / or the push notification varies according to the user's experience level.

[0015] In some embodiments, the first push notification reminds the user to remove the medicament 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 allow the medicament in the medicament delivery device to reach room temperature.

[0016] In some embodiments, the first-level trigger event, the second-level trigger event, or the third-level trigger event includes the time remaining before the next medicament administration expires.

[0017] In some embodiments, the first-level trigger event, the second-level trigger event, or the third-level trigger event includes the time remaining before an appointment or a call.

[0018] In some embodiments, the first-level trigger event, the second-level trigger event, or the third-level trigger event includes a prompt to create a diary entry regarding disease symptoms and / or overall health.

[0019] In some embodiments, the first-level trigger event, the second-level trigger event, or the third-level trigger event includes the time remaining before a prescription period is about to end.

[0020] A second aspect of the present disclosure provides a computer-implemented method, the computer-implemented method comprising: executing a program for managing the user's medical condition or treatment, the program defining a notification scheme for causing notifications associated with the user's medical condition or treatment to be created;

[0021] When a first-level trigger event occurs, generating a silent notification configured to be displayed on a graphical user interface provided by the program when the user accesses the program for managing the user's medical condition or treatment;

[0022] When a second - level trigger event occurs, generate an indication that the user has at least one bulk notification and cause the indication to be displayed; and

[0023] When a third - level trigger event occurs, generate a push notification and cause the push notification to be displayed,

[0024] 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 the user device.

[0025] The first - level trigger event, the second - level trigger event, or the third - level trigger event may each be selected from the group consisting of: (i) the time remaining before the next medication administration is due; (ii) the time remaining before an appointment or call; (iii) a prompt to create a diary entry regarding disease symptoms and / or overall health; and (iv) the time remaining before a prescription period is about to end.

[0026] A third aspect of the present disclosure provides a user device, the user device including processing circuitry configured to:

[0027] Execute a program for managing a user's medical condition or treatment, the program defining a notification scheme for causing notifications associated with the user's medical condition or treatment to be created;

[0028] When a first - level trigger event occurs, generate a silent notification configured to be displayed on a graphical user interface provided by the program when the user accesses the program for managing the user's medical condition or treatment;

[0029] When a second - level trigger event occurs, generate an indication that the user has at least one bulk notification and cause the indication to be displayed; and

[0030] When a third - level trigger event occurs, generate a push notification and cause the push notification to be displayed,

[0031] 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 the user device. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] To enable a more complete understanding of the general concepts set forth in the foregoing, embodiments thereof will be described with reference to the accompanying drawings, in which:

[0033] Figure 1 An overall architecture of a system in which a computer program runs is shown;

[0034] Figures 2a through 2d show exemplary screenshots related to silent push notifications displayed by a computer program;

[0035] Figures 3a and 3b show additional exemplary screenshots related to bulk notifications displayed by a computer program;

[0036] Figures 4a and 4b show additional exemplary screenshots related to push notifications displayed by a computer program;

[0037] Figures 5a and 5b show a first notification option screen and a second notification option screen;

[0038] Figure 5c shows an injection routine control screen;

[0039] Figure 5d shows a connection device management screen;

[0040] Figure 5e shows an additional notification option screen;

[0041] Figure 6 Schematically shows a user device for running a computer program; and

[0042] Figure 7 is a flowchart showing steps of a computer-implemented method. DETAILED DESCRIPTION

[0043] This disclosure relates to an application program that can run on a user device and assist the user in tracking their health and disease progress and managing all aspects of their treatment. In particular, the application program encourages and motivates the user to maintain their treatment routine through a series of notifications regarding various aspects of the user's treatment, such as creating journal entries, recording received treatments, and generating reports prior to doctor appointments.

[0044] The application can be used to manage multiple diseases treated with various different medicaments. Although some of the following specific embodiments are described with respect to treating atopic dermatitis and / or asthma using a single medicament, the application is not limited thereto. The application can also manage various other immunological indications, where one or more of these immunological indications can be treated by using a single medicament approved for treating one or more immunological indications. Such a single medicament can include, for example, different dosages, different volumes or concentrations of the same API, or different formulations containing the same API. In some embodiments, the single medicament can include an anti-IL-4R mAb (e.g., Dupilumab). Further, the application can manage multiple immune disorders. A prescription for one or more drugs can be issued to a user, and the application provides personalized support to the user based on the user's (multiple) specific drug prescriptions and health profile. For example, the application can be configured to provide support for many diseases caused by type 2 inflammation. In the context of dermatology, this can include atopic dermatitis, prurigo nodularis, bullous pemphigoid, urticaria (e.g., chronic spontaneous urticaria or cold-induced urticaria), hand-foot disease, or pruritus, each of which can be treated by injection or other injectable drugs, but can also be treated with some oral and topical medications. In the context of respiratory diseases, this can include asthma, nasal polyps, sinusitis (e.g., chronic rhinosinusitis with or without nasal polyps), allergic bronchopulmonary aspergillosis (ABPA), or allergic fungal rhinosinusitis (AFRS) (which can be treated by injection or other injectable drugs, but can also be treated with some oral medications) and chronic obstructive pulmonary disease (COPD) (which can be treated by injection or other injectable drugs). In the context of gastroenterology, this can include inflammatory bowel disease (IBD), eosinophilic esophagitis (EoE), eosinophilic gastroenteritis (EGE), or ulcerative colitis, which can be treated by injection or other injectable drugs, but can also be treated with some oral medications.

[0045] One or more medicaments can be administered by injection. As used herein, the term injection or self-injection is intended to cover intravenous injection, intramuscular injection, infusion, or any 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 classified into multi-dose container systems and single-dose (partially or fully emptied) container systems. The container can be a replaceable container or an integrated non-replaceable container.

[0046] The application can additionally assist the user in accessing treatment (including accessing insurance coverage), managing the delivery of medications, and providing educational support. The application can also assist the user in managing their disease, such as by providing a tracking diary, in which the user and their healthcare provider can monitor treatment use and progress by recording quick diary entries about symptoms and medication use and by generating reports based on the information collected. The application can also provide holistic care by providing access to learning materials (including instructional articles and videos as well as motivational articles and challenges) and by providing connections to other connected devices (such as activity trackers and heart rate monitors) to continuously update and understand the user's behavior. The application can also collect and combine information from other programs (such as environmental monitoring apps or weather forecasts).

[0047] Reference Figure 1 , shows the overall architecture 100 of a disease management and medication regimen management system. The system architecture 100 shows multiple functional modules and the data links between these functional modules. The system architecture 100 includes a user device 104 that runs an application with multiple functional modules, which are shown in the central box. The architecture 100 also shows how the application run by the user device 104 can interact with other service providers to enhance the information that can be provided to the user through the application. For example, by communicating with insurance / benefits provider systems and pharmacies.

[0048] One of the functional modules is the diary module 102. The diary module 102 is configured to allow the user to maintain a diary related to one or more medical conditions of the user. The diary can include multiple diary entries that detail the onset of one or more medical conditions, such as symptoms, user-specific health data, context information, etc. The diary can be used to monitor the patterns of one or more medical conditions and to identify potential trigger conditions for the onset of the one or more medical conditions. The diary module 102 can communicate with an external service called adverse events. The diary module can transmit patient information associated with the onset of one or more medical conditions to the adverse events service.

[0049] The diary can further maintain a record of the user's compliance with a treatment regimen (such as a medication regimen). For example, a diary entry can include a record of the dose of medication (e.g., a scheduled dose) that the user has taken, such as an injection log. The record can form a dose record that includes various information associated with the dose administered by the user. The record can be stored as part of a diary entry or independently of the diary entry.

[0050] The functional module may further include a memory module or a database 106. The memory module 106 is configured to store the diary entries generated by the user via the diary module 102 for later retrieval and / or analysis. In some embodiments, the memory module 106 may be linked to the cloud and store the diary entries remotely.

[0051] In some embodiments, the functional module may further include a weather module 108. The weather module 108 is configured to determine and / or record the weather conditions at the user's location. The user location may be determined, for example, by the GPS function of the user device. The weather module 108 may, for example, access an online weather forecasting system to obtain the current weather conditions, previous weather conditions, and / or predicted future weather conditions. The weather module 108 may provide the weather conditions to the diary module 102 to include them in the diary entries. There are also weather conditions such as general weather conditions, temperature, humidity, air pressure, and UV index. The weather module may additionally obtain air quality information such as pollen count, pollution index, NO 2 count and / or air quality index.

[0052] One of these functional modules is the user management module 110, which is responsible for obtaining user preferences and for generating notifications for output on the user device 104. The necessary data for the notification scheme may be stored on the local database 106 of the user device 104. The user management module 110 may also update the information stored in the database 106 when using the application. Architecture 100 also shows how the applications running on the user device 104 can interact with other service providers to enhance the information that can be provided to the user through the application.

[0053] 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 types of notifications; (i) silent notifications; (ii) bulk summary notifications; and (iii) push notifications.

[0054] Silent notifications can be pushed silently into the application. For example, silent in-app notifications will be presented to the user on the app's home screen. In some embodiments, a silent notification can be presented to the user when certain requirements are met and no action on the user's part is required. Batch summary notifications can relate to several different reminders and other notifications. The user can interact with the batch summary notification to expand and show individual notifications. The batch summary notification indicates the number of notifications available for the user to view. A push notification can relate to a single notification and is pushed to the lock screen or home screen of the user device 104. A push notification is a time-sensitive and actionable item that requires the user's immediate attention. They are reserved for actions related to the user's regular treatment or as follow-up actions for actions that may affect the user's access to treatment / medication.

[0055] Notifications can be escalated, i.e., the notification type can be promoted based on the user's actions (or lack thereof). For example:

[0056] a. When the user is 5 days away from their next medication dose, their next dosing reminder will be shown as a silent notification in the application, e.g., below the carousel on the App home page.

[0057] b. A few days before the administration, the application will push a batch notification to the user to view a guidance video, schedule a call with a nurse, or view self-administration instructions.

[0058] c. One hour before the administration on the day of administration and at the scheduled time, the application will push a notification to the user to take the medication. If the user's medication is stored in the refrigerator, the notification will instruct the user to take their medication out of the refrigerator. Interacting with this notification will trigger a preheat timer that is set to the user's medication dose.

[0059] Another module in the functional module is the Health / Assessment module 112. The Health / Assessment module 112 is responsible for importing the user and obtaining detailed information about the user's medical conditions and the medications used to treat these conditions. The Health / Assessment module 112 can also collect information about the user's prescriptions and manage the delivery of medications.

[0060] Another module in the functional module is the Healthcare Professional (HCP) Services module. The HCP Services module is responsible for facilitating connections with nurses, doctors, or other healthcare professionals, including scheduling reminders related to appointments and calls, prompting the user to create reports or otherwise prepare for upcoming appointments or calls, initiating voice or video calls, providing follow-up notifications after a call or appointment, and initiating a diary entry after a call or appointment. The HCP Services module interacts with an internet-based patient support program. Healthcare professionals can also access certain aspects and information saved by the patient support program to facilitate connections with the user and monitor the user's treatment and / or disease progression.

[0061] Another module among these functional modules is the consent module (also known as the consent management module), which, in combination with other aspects of the system, is responsible for managing consents and permissions for accessing patient-specific information (such as the user's health-related data). The memory module 106 can be configured to store user IDs and role information, as well as consent templates for use by the consent module. The memory module 106 can also store consent and permission information input by the user via the consent module, including any time limits set for the consents and permissions.

[0062] The consent module can communicate with an external service called the consent management service. The consent and permission information generated by the consent module can be stored or copied to the consent management service. The consent management service can also be responsible for sending patient-specific information to a third party when the associated consent directives permit.

[0063] Another module among the functional modules is the content module. The content module is responsible for receiving and recording personalized content and / or preferences set by the user. The content module 124 can communicate with an external service called content management. The content management service is responsible for providing patient-specific content or settings from external users (such as healthcare professionals). The content module can interact with the memory module 106 to store the personalized content and / or settings.

[0064] Another module among the functional modules is the benefits module, which, in combination with other aspects of the system, is responsible for managing a patient's access to healthcare. The benefits module can include pharmacy integration services and / or benefits integration services. The information generated by the benefits module can be responsible for sending patient-specific information to a third party to indicate the patient's access to healthcare services. The benefits module can interact with external services (such as benefits provider systems and pharmacy services).

[0065] Another module among the functional modules is the analysis module. The analysis module is responsible for analyzing patient information associated with the status and / or treatment of the user's medical condition.

[0066] Another module among the functional modules is the messaging system. The messaging system can communicate with the analysis module. For example, if the analysis module identifies the onset or onset trigger conditions of one or more of the user's medical conditions, the messaging system outputs a message conveying this result. The messaging system can communicate with an external service called the information hub. The information hub can store the data received from the messaging system. The information hub can also interact with other service providers to enhance the information about the user that can be stored in the application. For example, by communicating with patient support programs, insurance / benefits provider systems and pharmacies, adverse event services, etc.

[0067] Referring now to FIGS. 2a through 2d, exemplary screenshots displayed by the application are shown. The screenshots in FIGS. 2a through 2d relate to silent notifications that are only displayed within the application.

[0068] In a first screenshot 200 shown in FIG. 2a, a home screen label 202 is selected. The application shows a number of user-selectable labels at the bottom of the screen, which include at least two of home screen, treatment, diary, learning, and account (settings). The home screen has a notification area where a silent notification is shown. A first silent notification 204 is shown, reminding the user that they have a doctor's appointment and indicating the date and time of the appointment. Interacting with the first silent notification 204 opens the notification center (see FIG. 3b), where any further details related to the notification and any other notifications waiting for the user to view can be seen. At the top of the home screen, a graphic with a suggested action is displayed. The content of the suggested action changes according to the proximity of the user's next medication / administration, doctor's appointment, prescription renewal / delivery date, etc. In the example of the first screenshot 200, since there are still several days (e.g., more than three days) until the user's doctor appointment, the suggested action does not relate to the appointment but rather to a daily diary entry.

[0069] In a second screenshot 206 shown in FIG. 2b, the home screen label 202 is again shown. A second silent notification 208 is shown, reminding the user that they have a doctor's appointment and indicating the date and time of the appointment. Since there are only two days until the doctor's appointment, the time remaining before the appointment is more prominently shown as part of the second silent notification 208. Additionally, the suggested action shown at the top of the home screen relates to the upcoming doctor appointment, specifically reminding to prepare a report for the doctor to review during the appointment. In this way, the application provides relevant and timely notifications and associated suggested actions to the user.

[0070] In a third screenshot 210 shown in FIG. 2c, the home screen label 202 is again shown. 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 silent notifications are of a different type than the first and second silent notifications described previously. The third silent notification 212 relates to the scheduled time for the user's next medication dose. The date and time of the scheduled dose are indicated in the third silent notification 212, although these details may have been set by the user (see FIG. 5c). Since there are only two days remaining until the scheduled medication administration event, the remaining time is more prominently shown at the top of the third silent notification 212. Since the notification relates to a scheduled medication administration, the suggested action shown at the top of the home screen relates to supporting the user in administering the medication. In particular, the suggested action can be to schedule a call with a healthcare professional.

[0071] The fourth silent notification 214 relates to an upcoming pharmaceutical delivery. The fourth silent notification 214 indicates the date and time window of the delivery. Interacting with the third silent notification 212 or the fourth silent notification 214 opens the notification center (see Figure 3b), where any further details related to the notification and any other notifications waiting for the user to view can be seen.

[0072] Some silent notifications can be shown in other user-selectable tabs at the bottom of the screen. In the fourth screenshot 216 shown in Figure 2d, the treatment tab 218 is selected. The treatment screen also has a notification area showing silent notifications, but the range of notifications that may appear here is more limited compared to the main screen. For example, only notifications related to doctor appointments and scheduled dosing events can be shown on the treatment screen. The fifth silent notification 220 is shown, reminding the user that they have a doctor appointment and indicating the date and time of the appointment. Interacting with the fifth silent notification 220 opens the notification center (see Figure 3b), where any further details related to the notification and any other notifications waiting for the user to view can be seen. Similar to the main screen, the treatment screen also uses the top of the treatment screen to display graphics with suggested actions. The suggested actions shown at the top of the treatment screen relate to supporting the user in administering the pharmaceutical. In particular, the suggested actions are links to information and / or instructional videos for self-administration of the pharmaceutical.

[0073] The silent notifications described with respect to Figures 2a to 2d are only examples of the types of information that can be communicated to the user via silent notifications. The silent notifications can be shown in decreasing order of urgency. For example, if the most urgent action is the user's next scheduled dose, that reminder can appear first in the silent notification list or can be the only silent notification. The content of the silent notifications can also depend on the specific tab shown. For example, when the home tab 202 is selected, the most urgent silent notifications can be shown. When the diary tab is selected, notifications related to the user's next appointment can be shown even if they are not the most urgent. When the treatment tab is selected, notifications related to the user's next scheduled dose can be shown even if they are not the most urgent. A more complete but non-exhaustive list of notifications that can be provided to the user via silent notifications is presented in Table 1 below.

[0074] In the notification center, options are available to change certain aspects of the notification, such as the time of an appointment or a scheduled dosing event. In cases where the notification relates to pharmaceutical delivery, a link to contact the carrier / transport company can be provided so that the date and time of the delivery can be changed.

[0075] Referring now to FIGS. 3a and 3b, additional exemplary screenshots are shown. The screenshots in FIGS. 3a and 3b relate to batch notifications. The fifth screenshot 300 shown in FIG. 3a is the lock screen of a user device running an application. The lock screen displays a batch notification 302 indicating that the user has a number of notifications from the application waiting for them to view. In this way, the user is not overwhelmed with a number of individual notifications where these notifications are not time-critical or do not require immediate user action. Useful information about the number and source of the notifications is presented to the user, and then the user can 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 for them to view.

[0076] Interacting with the batch notification 302 opens the notification center, as shown in the sixth screenshot 304 in FIG. 3b. These notifications are shown individually. The user can interact with any of the notifications displayed in the notification center to navigate to a new page where appropriate actions can be performed.

[0077] The batch notifications described with respect to FIGS. 3a and 3b are only examples of the types of information that can be conveyed to the user via batch notifications. More complete but non-exhaustive lists of notifications that can be provided to the user via batch notifications are presented in Tables 1 and 2 below.

[0078] Referring now to FIGS. 4a and 4b, additional exemplary screenshots are shown. The screenshots in FIGS. 4a and 4b relate to push notifications. The seventh screenshot 500 shown in FIG. 4a is the lock screen of a user device running an application. The lock screen displays a push notification 502 indicating that the user has a call with a nurse in 5 minutes and includes some instructions for preparing for the call. The time remaining before 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 1 hour before the call is about to start. Then the displayed time before the call can be updated, for example, in 5-minute increments. Interacting with the push notification 502 can navigate the user to information that assists the user in preparing for an injection or to the most recent diary entry related to their health.

[0079] As can be appreciated, the push notification 502 has a time-sensitive nature and requires user action. In this way, 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 for such time-sensitive tasks. Therefore, the user is less likely to ignore any such notifications and is better prepared for medication events and appointments, and is more likely to comply with their prescribed medication regimen. The appearance of a push notification can also be accompanied by an audible and / or tactile output on the user device.

[0080] The eighth screenshot 504 shown in FIG. 4b presents another example of a push notification 506. In this example, the push notification 506 is a reminder to complete a journal entry. In particular, the application receives information that the user did not sleep well, for example, from an external monitoring device or via another application running on the user device that shares information with the application. Interacting with the push notification 506 can navigate the user to the starting page of the journal entry within the application.

[0081] Displaying the notification in a timely manner can prompt the user to create a journal entry, which is a time-sensitive task. For example, by prompting the user to create a journal entry immediately after the user experiences symptoms, the journal entry may be more accurate because memories related to acute events may fade over time. In this way, the user is prompted to create useful records related to their disease progression and overall health, thus providing more and better-quality information for healthcare professionals.

[0082] The push notifications described with respect to FIGS. 4a and 4b are only used as examples of the types of information that can be sent to the user via push notifications. More complete but non-exhaustive lists of notifications that can be provided to the user are presented in Tables 1 and 2 below.

[0083] The application can provide the user 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 a number of user-selectable elements that allow the user to specify whether they want to receive notifications about specific events. The list of events can include upcoming doctor appointments, medication deliveries, medication administration event reminders (such as injection 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 areas of interest. Notifications related to the selected areas of interest can be presented to the user. Allowing the user to specify which notifications they will receive and which areas they are interested in learning about increases the level of customization provided by the notification system and increases user engagement and satisfaction.

[0084] FIG. 5c shows an injection routine control screen 512. The injection routine control screen 512 allows the user to specify what time of day they typically perform their injections, so the user can be reminded at the appropriate time. The user can also use this screen to specify how long before the scheduled injection time (e.g., 1 day before) they want to be reminded of the injection time. There is also an optional option regarding whether to provide step-by-step guides as part of the injection reminder. This option can be toggled to 'yes' by default until the user specifies otherwise. Although this screen is described from the perspective of injection reminders, the application is also capable of assisting the user in managing other forms of medication administration, such as oral and topical medications.

[0085] The timing of notifications (specifically push notifications and batch notifications) can initially be defined by the application. However, when the user engages with the application, the application can also dynamically adjust the timing of the notifications. The application can learn about specific user behaviors and can track when the user is most active and when they are most likely to open the application. The application can then adjust the timing of the notifications accordingly to achieve maximum impact and maximum user engagement.

[0086] Figure 5d shows the connected device management screen 514. This screen lists any connected devices that are capable of wireless communication and are associated with the user. The user can use this screen to pair a new device (such as a syringe or inhaler) with the application for managing the user's medical condition or treatment, or to remove any unwanted devices.

[0087] Figure 5e shows the additional notification options screen 516. Instead of or in addition to the notification options screen 508 of Figure 5a, the application can display the additional notification options screen 516. The alternative notification options screen 516 has a list of different notification types that the user can enable or disable. The notification list can include administration event reminders, such as injection reminders, prescription refill reminders, other medication reminders (where the user has indicated in the application which other medications they are taking and on what schedule), and diary reminders. Some of the notification options on the alternative notification options screen 516 can have links that the user can select to edit the various related reminders set in the application or to view upcoming reminders.

[0088] The following Tables 1 and 2 detail the various different notifications that can be generated by the notification system described herein. The Logic column specifies the conditions required to generate a particular notification. This can take the form of a predefined time before the event, at the time of the event, or a predefined time after the event. In some other examples, in addition to the time constraint, the logical condition also requires that the user has completed or not completed a specific task.

[0089] The copy for novice users specifies the text that will be displayed as part of the notification for novice users. The copy for experienced users specifies the text that will be displayed as part of the notification for experienced users. Novice users can be defined as users who have completed fewer than a predefined number of injections / drug administrations or who have used the application for less than a predefined period of time. In some other embodiments, the user can have an option to define whether they are experienced or novice.

[0090] The notification type column indicates the priority of the notification. Any event that triggers a silent push notification is a first-level trigger event. Any event that triggers a bulk notification is a second-level trigger event. Any 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 completes the task involved in the notification within a given time period (see, for example, Document 01-10 in Table 2).

[0091] The notification point column indicates where the notification can or may be displayed. This will typically depend on the notification type. A push notification can be displayed on the lock screen of the user device. A silent push notification is displayed somewhere within the application or in multiple places within the application. For example, a silent notification can appear on the home page / home screen of the application. The home page of the application can have a defined area for displaying notifications or several different areas where notifications may appear. These areas can be referred to as cards (e.g., injection card, carousel card). In some other embodiments, the injection card and the carousel card are separate pages within the application. If the silent notification relates to the user's treatment, it can also appear in the treatment page of the application.

[0092] Bulk notifications appear separately in the notification center. In this case, one or more bulk notifications that are waiting for the user to view also appear on the lock screen of the user device, as previously described. Additionally, push notifications can also appear separately in the notification center. Silent notifications can optionally appear in the notification center.

[0093] In cases where a particular notification can have its priority escalated, only the initial location where the notification is to be displayed is indicated. The application and the notification scheme are applicable to a variety of different medicaments that can be administered via injection, orally, or topically and can relate to a variety of different diseases and medical conditions. The application and the notification scheme are also capable of notifying the user simultaneously about several different medical conditions and treatment regimens. In some embodiments, several different instances of the notification scheme can run on the application, relating to each of the medical conditions being managed or each of the medicaments being administered.

[0094] The priority of the notification can also be based on the medical conditions that a particular user has. For example, if a user has indicated that they have a first medical condition, some notifications can have a higher priority (and, for example, be displayed as a push notification). The first medical condition can be asthma. If the user has indicated that they have a second medical condition instead of the first medical condition, the same notification may be given a lower priority and, for example, be displayed as a bulk notification or a silent push. The second medical condition can be atopic dermatitis.

[0095]

[0096]

[0097]

[0098]

[0099]

[0100]

[0101]

[0102]

[0103] Table 1.

[0104] In the example, offline operation requires many notifications, especially notifications with names "Treatment 06 - 09", "Omission 01 - 03", "Diary 01 - 06", "Content 01 - 03".

[0105] There may be prerequisites for displaying at least some of the notifications. For example, for the notification "Treatment 02", the prerequisite may be that the user has registered

[0106] a dedicated patient support program, while for the notification "Treatment 03", the prerequisite may be that the user has not registered for the program. The user can also indicate that they do not need or do not wish to see a particular notification, and in such cases, the relevant notification will not be shown. For example, for the notification "Treatment 04", if the user has indicated that they do not need step - by - step guidance by toggling the appropriate option in the notification options (see Figure 5a), then that notification will not be shown. For some notifications, the actions conveyed can also depend on user preferences. For example, this may be the case for the notification "Treatment 07".

[0107] It will be understood that the desired results or actions after various notifications will vary, for example from scheduling a PSP call to viewing injection instructions. The notification "Treatment 06" can trigger a timer countdown related to the time required to pre - heat the medication to room temperature. After the notification for "Treatment 07", once the user indicates that the treatment is complete, for example, an injection can be recorded. In response to the notification "Omission 01", the result / action can be results / actions such as the user has taken the dose, the user has just taken the dose out of the refrigerator, remind me later, etc. The result from the notifications "Appointment 02 - 05" can be to generate a report, or the result from the notifications "Diary 01 - 06" can be to add a diary entry.

[0108]

[0109]

[0110]

[0111] Table 2.

[0112] The application can 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 can be paired with the application. The application can also collect and combine information from other programs such as environmental monitoring apps or weather forecasts. Some additional notifications can be generated based on the information obtained from these external devices or services. For example, notifications regarding high pollen count, high air pollution, high UV index, high humidity or low humidity, or specific weather conditions can be generated based on the information obtained from environmental monitoring apps or weather forecasts. The priority of these notifications can depend on the medical conditions suffered by a particular user. For example, if a user has asthma, notifications related to high pollen count and high air pollution can have a high priority and be displayed as push notifications. If the user has atopic dermatitis but not asthma, these notifications can be displayed with a lower priority, such as batch notifications or silent pushes, or not displayed at all.

[0113] Notifications can also be generated based on the 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 has had poor sleep, a notification can be generated asking the user if they wish to create a diary entry related to this, as shown in Figure 4b. Thus, the notification is time-sensitive (since it relates to recent user activity), it can be given a high priority and be displayed as a push notification. General notifications related to environmental conditions (such as certain weather conditions or high UV index) that may exacerbate the user's medical condition but do not recommend some time-sensitive action on the user's part can be displayed as batch notifications or silent push notifications.

[0114] The application can combine information from both the activity tracker and the environmental monitor. For example, the application can use the number of steps to determine when the user takes a walk. This can be cross-referenced with pollen and / or air pollution data from the environmental monitor to determine that the user regularly takes a walk when the pollen level and / or pollution level is high. A notification can then be generated that informs the user that this may exacerbate or trigger their medical condition and recommends taking a walk at other times. The notification can be considered non-time-sensitive as it relates to long-term behavior changes and is thus displayed as a batch notification or a silent push notification, for example, in the learning tab screen of the application.

[0115] The application can also be connected to other smart devices around 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 sharps container. Notifications can be generated based on the data received from these devices. For example, if the smart refrigerator notifies the application that the door has been opened within a predefined window for the user to take their medications, a notification can be generated asking the user if they wish to start a preheating timer. Some medications must be stored in the refrigerator but need to be warmed to room temperature for comfortable injection. Generating a preheating timer reminder when the user opens the refrigerator door can help remind the user of this, and the reminder is a timely and useful reminder that the application can provide to the user for the preheating timer. Since the reminder is a time-sensitive notification, it can be displayed as a push notification.

[0116] As another example, if the application receives data from the connected storage device that the user has removed an injection device from the storage device, the application can generate a notification asking the user if they wish to view step-by-step instructions for self-injection. Since the reminder is a time-sensitive notification, it can be displayed as a push notification. Such a notification can be displayed when the user first removes an injection device from the storage device, or on the first few or every occasion. In another example, if the data from the connected storage device indicates that there are no injection devices left in the storage device (or only one injection device), the notification can relate to ordering more medications or extending the prescription period.

[0117] As another example, if the application receives data from the connected smart container indicating that the user has deposited an injection device into the sharps container, the application can generate a notification asking the user if they wish to schedule their next injection. Such a notification can be displayed only when there is no injection schedule set in the application. In another example, the notification can ask the user if they wish to create a diary entry or if they wish to talk to a healthcare professional about their medical condition or treatment.

[0118] By leveraging the data received from external devices and services in this way, the application can provide the user with more timely and relevant notifications, which greatly enhances the application's ability to assist the user in managing their health condition and also improves user satisfaction and compliance with their prescription medications.

[0119] It can be seen that some notifications provide the user with confirmation of the receipt of inputs such as documents, while other notifications prompt the user to perform an action.

[0120] Figure 6Schematically shows a user device 400 according to some embodiments. The user device 400 can be a mobile phone or a tablet computer. The user device 400 is an example of a wireless communication device. The user device can 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 can also be configured to communicate using Bluetooth, NFC, Zigbee, ultra-wideband, IrDa, or the like. The communication network can include one or more network nodes. The communication network can further be connected to a host computer (not shown) via a core network and / or an intermediate network, and the host computer can be embodied in the hardware and / or software of a stand-alone server, a cloud-implemented server, or a distributed server. The user device 400 and the host computer can be configured to transfer data.

[0121] The user device 400 can include hardware including processing circuitry 401. The processing circuitry 401 can include a processor 402 and a memory 404. The user device 400 can also include a wireless transceiver 406, a user input 408, a display 412, a camera 410, a microphone 416, and an RFID reader 418 and a speaker 414. The wireless transceiver 406 can be configured to establish and maintain a wireless connection to a network node. The wireless transceiver 406 can include one or more radio transmitters and one or more radio receivers. The display can be a touch-sensitive display and can be based on capacitive or resistive sensing technology. The processing circuitry 401 can 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 can be configured to read from and / or write to the memory 404. The memory 404 can include volatile and / or non-volatile memory, such as a cache, RAM (random access memory), and / or ROM (read-only memory), etc.

[0122] The user device 400 can include software, for example, stored in the memory 404. The software can be executed by the processing circuitry 401. The software can include application programs. In some embodiments, the host computer can communicate with the application programs. The application programs can request data from and / or provide user data to the host computer.

[0123] The processing circuitry 401 can be configured to execute or cause to execute any method described herein. In some embodiments, the software / program can include instructions that, when executed by the processing circuitry 401, cause the processing circuitry 401 to execute the methods described herein.

[0124] The memory 404 may include both a program memory that stores program code (e.g., software or firmware) and a main memory that stores data. The processing circuitry 401 may be configured to execute the program code stored in the program memory and read, write, and delete data from the main memory. In some embodiments, the program code may be an application program that may be downloaded and installed on the user device 400. The application program may be a disease and treatment management and tracking tool for use by a patient. The program memory may be, for example, a read-only memory (ROM), and the main memory may be, for example, a random access memory (RAM).

[0125] The user device 400 includes one or more user inputs 408, such as a touch screen, keypad or keyboard, accelerometer or gyroscope, mouse, or microphone 416 for receiving voice commands. The user device 400 may also include a camera 410 configured to capture images of the user and images of labels, codes, etc. visible on a medicament administration device, package, or storage solution. The user device 400 may be configured to scan a medicament administration device (such as an injection device or inhaler) using a scanning device. The scanning device may refer to the camera 410 or an RFID reader 418. The term "scan" as used with respect to the user device 400 may refer to reading information provided externally or internally on a medicament administration device using any of these components.

[0126] The notification scheme outlined above provides several key advantages. Predictability: The way notifications are presented to the user is consistent, prioritizing urgent notifications and clearly indicating any actions required of the user. For example, any notification that requires the user to take a time-sensitive action will be sent as a push notification and will indicate the action the user needs to take. Push notifications are not sent to the user for all notifications, and the user learns to associate push notifications from the app as being of high importance and requiring their own action. Reliability: The notifications are consistent and reliable and thus demonstrate trustworthiness to the user. The user learns to trust the application to guide them through their treatment and present the right resources at the right time. Situational awareness: The notifications are context-aware (i.e., taking into account the user's situation, preferences, and level of experience). The notifications are delivered at the appropriate time with the appropriate priority.

[0127] Figure 7 is a flowchart showing the steps of a computer-implemented method. At step 700, the method requires executing a program that defines a notification scheme for enabling the creation of notifications associated with a user's medical condition or treatment. The program is the application program previously described for managing the user's medical condition or treatment. The program is executed at least in part on the user device, and the notifications are displayed on the display of the user device.

[0128] At step 702, the method requires that when a first-level trigger event occurs, a silent notification is generated, which is configured to be displayed on a graphical user interface provided by a program for managing a user's medical condition or treatment when the user accesses the program. The silent notification can be displayed on the main screen of a program for managing a user's medical condition. In some other embodiments, depending on the subject of the notification, in addition to the main screen, the silent notification can also be displayed on a treatment page of a program for managing a user's medical condition.

[0129] At step 704, the method requires that when a second-level trigger event occurs, an indication that the user has at least one batch notification is generated and the indication is caused to be displayed. Interacting with the batch notification opens a notification center, where the content of individual notifications can be seen and further interacted with. The batch notification can be displayed on a graphical user interface provided by the operating system of the user device. The graphical user interface can be the lock screen of the user device.

[0130] At step 706, the method requires that when a third-level trigger event occurs, a push notification is generated and the push notification is caused to be displayed. Interacting with the push notification causes the program for managing a user's medical condition or treatment to open and navigate to a user interface where an action related to the subject of the push notification can be taken. The push notification can be displayed on a graphical user interface provided by the operating system of the user device. The graphical user interface can be the lock screen of the user device.

[0131] The terms "drug" or "medicament" are used synonymously herein and describe a pharmaceutical preparation that contains one or more active pharmaceutical ingredients or a pharmaceutically acceptable salt or solvate thereof and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on a human or animal. In pharmacology, a drug or medicament is used to treat, cure, prevent, or diagnose a disease or to otherwise enhance physical or mental health. A drug or medicament can be used for a limited duration or regularly for a chronic disorder.

[0132] As described below, a medicament or pharmaceutical agent can include at least one API or a combination thereof in various types of formulations for treating one or more diseases. Examples of APIs can 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; and 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). A mixture of one or more medicaments is also contemplated.

[0133] The medicament or pharmaceutical agent can be contained in a primary packaging or “drug container” suitable for use with a drug delivery device. The drug container can be, for example, a cartridge, syringe barrel, reservoir, or other rigid or flexible vessel configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more medicaments. For example, in some cases, the chamber can be designed to store the medicament for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber can be designed to store the medicament for about 1 month to about 2 years. Storage can be at room temperature (e.g., about 20 °C) or at refrigerated temperature (e.g., about -4 °C to about 4 °C). In some cases, the drug container can be or can 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 medicaments), one in each chamber. In such a case, the two chambers of the dual-chamber cartridge can be configured to allow mixing between the two or more components before and / or during dispensing into a human or animal body. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., via a conduit between the two chambers) and allow mixing of the two components when needed by the user before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing when the components are dispensed into a human or animal body. The medicament or pharmaceutical agent contained in a drug delivery device as described herein can be used for treating and / or preventing many different types of medical disorders.

[0134] 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, which retain the ability to bind antigen. Antibodies can be polyclonal, monoclonal, recombinant, chimeric, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., murine) antibodies, or single-chain antibodies. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the ability of the antibody to bind to Fc receptors is reduced or absent. For example, the antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., its Fc receptor-binding region has been mutagenized or deleted. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable domain antibody-like binding proteins with cross-over binding domain orientation (CODV).

[0135] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but still includes at least a portion of the full-length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can include cleaved portions of the full-length antibody polypeptide, although the term is not limited to such cleaved 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, tribodies, tetrabodies)), monovalent or multivalent antibody fragments (such as divalent, trivalent, tetravalent, and multivalent antibodies), minibodies, chelating recombinant antibodies, triabodies or diabodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and antibodies comprising VHHs. Additional examples of antigen-binding antibody fragments are known in the art.

[0136] The term "complementary determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both the heavy chain polypeptide and the light chain polypeptide that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to the amino acid sequences within the variable regions of both the heavy chain polypeptide and the light chain polypeptide that are not CDR sequences and are primarily responsible for maintaining the correct positioning of the CDR sequences to permit antigen binding. Although framework regions typically do not directly participate in antigen binding as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDRs to interact with an antigen.

[0137] Examples of antibodies are anti-PCSK-9 mAb (e.g., Alirocumab), anti-IL-6R mAb (e.g., Sarilumab), and anti-IL-4R mAb (e.g., Dupilumab).

[0138] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0139] Those skilled in the art will understand that various components, formulations, devices, methods, systems, and embodiments of the APIs described herein can be modified (added and / or removed) without departing from the full scope and spirit of the invention, and the invention encompasses such modifications and any and all equivalents thereof.

[0140] Example drug delivery devices can relate to needle-based injection systems 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 classified into multi-dose container systems and single-dose (partially or fully emptied) container systems. The container can be a replaceable container or an integrated non-replaceable container.

[0141] As further described in ISO 11608-1:2014(E), a multi-dose container system can relate to a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, and the size of these doses can be fixed or variable (predetermined by the user). Another multi-dose container system can relate to a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, and the size of these doses can be fixed or variable (predetermined by the user).

[0142] As further described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device with a replaceable container. In one example of such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (fully emptied). In additional examples, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partially emptied). As also described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device with an integrated non-replaceable container. In one example of such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (fully emptied). In additional examples, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partially emptied).

Claims

1. A non-transitory computer-readable storage medium comprising 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 defining a notification scheme for creating notifications associated with the user's medical condition or treatment; Generate a silent notification when a first-level trigger event occurs, the silent notification being configured to be displayed on a graphical user interface provided by the program when the user accesses the program for managing the user's medical condition or treatment; Generate an indication that the user has at least one bulk notification and cause the indication to be displayed when a second-level trigger event occurs; And Generate a push notification and cause the push notification to be displayed when a third-level trigger event occurs, 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 the operating system of the user device including the computer.

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

3. The non-transitory computer-readable storage medium according to claim 1, Wherein, The graphical user interface provided by the program for managing the user's medical condition or treatment is the main screen of the program for managing the user's medical condition or treatment.

4. The non-transitory computer-readable storage medium according to any one of claims 1 to 3, Wherein, The second-level trigger event has a higher priority than the first-level trigger event, and the third-level trigger event has a higher priority than the second-level trigger event.

5. The non-transitory computer-readable storage medium according to any one of the preceding claims, Wherein, The 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 caused to generate a push notification related to the first bulk notification.

6. The non-transitory computer-readable storage medium according to any one of the preceding claims, Wherein, The content of the silent notification and / or the push notification varies according to the user's experience level.

7. The non-transitory computer-readable storage medium according to any one of the preceding claims, Wherein, The first push notification reminds the user to remove a medicament delivery device from a low-temperature environment, and in response to the user interacting with the first push notification, the computer is caused to start a timer to allow the medicament in the medicament delivery device to reach room temperature.

8. The non-transitory computer-readable storage medium according to any one of the preceding claims, Wherein, The first-level trigger event, the second-level trigger event, or the third-level trigger event includes the time remaining before the next medicament administration expires.

9. The non-transitory computer-readable storage medium according to any one of the preceding claims, Wherein, The first-level trigger event, the second-level trigger event, or the third-level trigger event includes the time remaining before an appointment or a call.

10. The non-transitory computer-readable storage medium according to any one of the preceding claims, Wherein, The first-level trigger event, the second-level trigger event, or the third-level trigger event includes a prompt to create a diary entry regarding disease symptoms and / or overall health.

11. The non-transitory computer-readable storage medium according to any one of the preceding claims, wherein, the first-level trigger event, the second-level trigger event, or the third-level trigger event includes the time remaining before a prescription period is about to end.

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

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

14. The computer-implemented method according to claim 12 or claim 13, wherein, a first batch notification defines a threshold time for interacting with the first batch notification, and if no interaction occurs with the first batch notification within the threshold time, the method further includes generating a push notification related to the first batch notification.

15. The computer-implemented method according to any one of claims 12 to 14, wherein, a first push notification reminds the user to remove a medicament delivery device from a low-temperature environment, the method further includes, in response to the user interacting with the first push notification, starting a timer to allow the medicament in the medicament delivery device to reach room temperature.

16. The computer-implemented method according to any one of claims 12 to 15, wherein, the first-level trigger event, the second-level trigger event, or the third-level trigger event is each selected from the group consisting of: (i) the time remaining before the next medicament administration is due; (ii) the time remaining before an appointment or call; (iii) a prompt to create a diary entry regarding disease symptoms and / or overall health; and (iv) the time remaining before a prescription period is about to end.

17. A user device, comprising processing circuitry configured to: execute a program for managing a user's medical condition or treatment, the program defining a notification scheme for causing notifications associated with the user's medical condition or treatment to be created; When a first-level trigger event occurs, a silent notification is generated, and the silent notification is configured to be displayed on a graphical user interface provided by the program for managing the user's medical condition or treatment when the user accesses the program; When a second-level trigger event occurs, an indication that the user has at least one bulk notification is generated and the indication is caused to be displayed; And When a third-level trigger event occurs, a push notification is generated and the push notification is caused to be displayed, 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 the operating system of the user device.

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

19. The user device according to claim 17 or claim 18, 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 user device is configured to generate a push notification related to the first bulk notification.

20. The user device according to any one of claims 17 to 19, wherein, a first push notification reminds the user to remove a medicament delivery device from a low-temperature environment, and in response to the user interacting with the first push notification, the user device is configured to start a timer to allow the medicament in the medicament delivery device to reach room temperature.

Images