Systems and methods for drug and disease management

Abstract

A non-transitory computer-readable storage medium, a user device, and a method configured to execute a program for managing multiple medical conditions treated by a first medication, provide a user interface that allows a user to specify the first medical condition and a second medical condition treated by the first medication, provide treatment access information related to the first medication, provide at least one of information about the first medical condition, a journal that facilitates entry of symptoms related to the first medical condition, and notifications related to the first medical condition, and provide at least one of information about the second medical condition, a journal that facilitates entry of symptoms related to the second medical condition, and notifications related to the second medical condition.

Description

[Technical Field]

[0001] FIELD OF THE INVENTION This specification relates to systems and methods for drug and disease management, and in particular to computer-implemented systems and methods for assisting a user in managing one or more diseases that can be treated by one or more drugs. [Background technology]

[0002] Significant barriers to quality treatment outcomes are patient engagement and adherence to prescribed drug regimens, and patient understanding of factors that influence disease progression and overall health.

[0003] Current systems do not effectively enable patients with complex medical conditions to conveniently manage multiple health conditions. Current systems also do not allow patients to effectively track the progress of multiple health conditions or easily access information and guidance about these conditions. 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 beneficial assistance to patients in managing their health conditions, which will improve patient engagement and compliance and ultimately improve patient outcomes. [Means for solving the problem]

[0005] A first aspect of the present specification provides a computer-implemented method, the method comprising: executing a program for managing a plurality of medical conditions treated by the first medication; providing a user interface that allows a user to specify a first medical condition to be treated by a first medication; providing a user interface that allows a user to specify a second medical condition to be treated by the first medication; providing treatment access information regarding the first medication; providing at least one of information regarding the first medical condition, a journal that facilitates entry of symptoms related to the first medical condition, and notifications related to the first medical condition; providing at least one of information regarding the second medical condition, a journal facilitating entry of symptoms related to the second medical condition, and a notice related to the second medical condition; Includes.

[0006] Providing a user interface may include providing a single user interface display that allows a user to specify both a first medical condition treated by the first medication and a second medical condition treated by the first medication. The user interface may allow a user to specify an additional medication to be used to treat the first medical condition, the second medical condition, or the additional medical condition. In a particular example, the first medical condition is atopic dermatitis and the second medical condition is asthma.

[0007] The method may further include pairing the program for managing the plurality of medical conditions treated by the first medication with one or more external devices and receiving user-specific data from the one or more external devices. The user-specific data may be physiological data and / or activity data.

[0008] The method may further include receiving environmental information and displaying the environmental information.

[0009] The method may further include determining that approval is required to customize the information about the first medical condition and / or the information about the second medical condition, and presenting a user interface for obtaining approval. The approval may be to access the user's location.

[0010] The method may further include providing a dose support screen having a call scheduling element configured to initiate a call scheduling process with a healthcare professional when selected. The method may further include providing a pre-call instruction screen, the pre-call instruction screen including instructions for preparing and / or administering the first medication and an initiation call element configured to initiate the call and open a phone application when selected. The method may further include providing a post-call screen including a body representation having a plurality of predetermined regions for indicating a location for an injection.

[0011] The method may further include providing a reminder system configured to allow input of medication administration reminder parameters and to generate a reminder for display on a graphical user interface provided by the program for managing multiple medical conditions being treated by the first medication or to generate a reminder for display as a push notification on a locked screen of the user device.

[0012] The method may further include providing a prescription management system configured to allow entry of collection or delivery details for the first medication, display status updates regarding the collection or delivery details for the first medication, and generate one or more push notifications regarding the collection or delivery details for the first medication.

[0013] The method may further include providing a user interface that facilitates input of insurance and / or financial information regarding access to the first medication, transmitting the insurance and / or financial information to a third party, and displaying a notification of the insurance and / or financial status regarding access to the first medication.

[0014] The method may further include scanning a code on the injection device to check the expiration date of the medication in the injection device and outputting a warning via the program if the medication in the injection device is determined to be expired.

[0015] The method may further include scanning a code associated with the new injection device or new batch of injection devices, launching a program and determining that the user is a registered user of the program, and displaying a user interface asking the user to confirm receipt of the new injection device or batch of injection devices.

[0016] The method may further include causing a refill reminder in the program to be reset in response to receiving a user input confirming that a new injection device or batch of injection devices has been received.

[0017] A second aspect of the present specification provides a non-transitory computer-readable storage medium containing instructions, which when executed by a computer, cause the computer to executing a program for managing a plurality of medical conditions treated by the first medication; providing a user interface that allows a user to specify a first medical condition to be treated by a first medication; providing a user interface that allows a user to specify a second medical condition to be treated by the first medication; providing treatment access information regarding the first medication; providing at least one of information regarding the first medical condition, a journal that facilitates entry of symptoms related to the first medical condition, and notifications related to the first medical condition; providing at least one of information regarding the second medical condition, a journal facilitating entry of symptoms related to the second medical condition, and notifications related to the second medical condition; Make them do so.

[0018] The instructions can cause the computer to provide a single user interface display that allows the user to specify both a first medical condition to be treated by the first medication and a second medical condition to be treated by the first medication.

[0019] The instruction may cause the computer to determine that approval is required to customize the information about the first medical condition and / or the information about the second medical condition and to present a user interface for obtaining approval. The approval may be to access the user's location.

[0020] This instruction enables the computer to receive and display the environmental information.

[0021] A third aspect of the present specification is executing a program for managing a plurality of medical conditions treated by the first medication; providing a user interface that allows a user to specify a first medical condition to be treated by a first medication; providing a user interface that allows a user to specify a second medical condition to be treated by the first medication; providing treatment access information for the first drug; providing at least one of information regarding the first medical condition, a journal that facilitates entry of symptoms related to the first medical condition, and notifications related to the first medical condition; providing at least one of information about the second medical condition, a journal that facilitates entry of symptoms related to the second medical condition, and notifications related to the second medical condition; The present invention provides a user device including a processing circuit configured to:

[0022] The processing circuitry may be further configured to pair the program for managing the plurality of medical conditions treated by the first medication with one or more external devices and to receive user-specific data from the one or more external devices, where the user-specific data may be physiological data and / or activity data.

[0023] The processing circuitry may be further configured to control a camera of the user device to scan a code on the injection device, check the expiration date of the medication in the injection device based on the scanned code, and programmatically output an alert if the medication in the injection device is determined to be expired.

[0024] The processing circuitry may be further configured to control a camera of the user device to scan a code associated with the new injection device or new batch of injection devices, launch the program, determine that the user is a registered user of the program, and display a user interface asking the user to confirm that they have received the new injection device or batch of injection devices. The processing circuitry may be further configured to reset a refill reminder in the program in response to receiving user input confirming that they have received the new injection device or batch of injection devices.

[0025] 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, in which: [Brief explanation of the drawings]

[0026] [Figure 1A] It shows the overall architecture of the system on which the computer program runs. [Figure 1B] 1 shows a flowchart illustrating the overall process of creating a user account and logging in. [Figure 1C] 1 shows screenshots illustrating the user account creation process. [Figure 1D-E] 1 shows screenshots illustrating the user account creation process. [Figure 1F-G] 1 shows screenshots illustrating the user account creation process. [Figure 1H] 1 shows screenshots illustrating the user account creation process. [Figure 1I-K]1 shows screenshots illustrating the user account creation process. [Figure 2A-C] 1 shows screenshots illustrating the application customization process. [Figure 2D-F] 1 shows screenshots illustrating the application customization process. [Figure 2G-I] 1 shows screenshots illustrating the application customization process. [Figure 2J-L] 1 shows screenshots illustrating the application customization process. [Figure 2M] 1 shows screenshots illustrating the application customization process. [Figure 2N] 1 shows a data flow diagram of the application customization process. [Figure 3A-B] Figure 3A shows the dosage support screen of the application, and Figure 3B shows the user interface for entering the user's contact preferences. [Figure 4A-C] Figure 4A shows an example of a push notification for an upcoming call, Figure 4B shows an instruction screen for the upcoming call, and Figure 4C shows an injection location screen that appears after the call. [Figure 5] 1 shows an example of an application home screen. [Figure 6] 1 shows an example of a user profile in an application. [Figure 7] 1 shows an injection routine control screen. [Figure 8] 1 shows an example of a graphical user interface that includes an in-application notification prompting a user to create a journal entry. [Figure 9] Show a push notification to the locked screen of the user device, prompting the user to create a journal entry. [Figure 10A] 1 shows the application health entry screen. [Figure 10B-C] Figure 10B shows the photo entry screen, and Figure 10C shows the activity tracker data selection screen. [Figure 11] FIG. 1 is a data flow diagram showing categories of data and movement of data. [Figure 12A] The Treatment tab screen is shown. [Figure 12B] The report screen is shown. [Figure 12C] The report screen is shown. [Figures 13A-13B] Figure 13A shows an exemplary journal tab screen, and Figure 13B shows an alternate journal tab screen. [Figure 14] 1 shows an exemplary Learning tab screen. [Figures 15A-15B] Figure 15A shows an example Accounts tab screen, and Figure 15B shows a Settings tab screen. [Figure 15C] The settings tab screen is shown. [Figure 16] Indicates environmental information. [Figure 17] Shows the user's physiological and activity data. [Figures 18A-18B] 16 and user physiological and activity data in FIG. 17 show how they may be displayed within the application. [Figures 19A-19C] This application shows how the user can assist with medication collection or delivery. [Figures 20A-20C] Illustrate how the application assists users in associating their insurance details with the application and / or making insurance claims. [Figure 21] 1 shows a schematic representation of a user device for executing a computer program; [Figure 22] 1 is a flowchart illustrating steps of a computer-implemented method. DETAILED DESCRIPTION OF THE INVENTION

[0027] The present disclosure relates to an application that can run on a user device and assists users in managing multiple health conditions while facilitating access to medications, learning resources, and financial guidance related to medications. The application provides a wide range of resources and features to assist users in a single program. For example, the application can provide a customized onboarding process related to two or more diseases / health conditions, which then presents information about those health conditions, provides notifications, inputs symptoms, and provides a journal for tracking disease progression and treatment regimens related to those health conditions. The application also assists users in managing appointments and calls with healthcare professionals and provides appropriate reminders and summary reports. The application also assists users in obtaining medications by guiding and managing the insurance plan approval process, and by guiding and managing the prescription renewal and medication delivery or withdrawal processes.

[0028] The application may also provide access to learning materials, including instructional articles and videos, motivational articles and challenges, and provide connectivity to other connected devices, such as activity trackers and heart rate monitors, to continuously update and learn from the user's behavior to provide comprehensive care. The application may also collect and combine information from other programs, such as environmental monitoring apps or weather forecasts.

[0029] This application can 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 with respect to the treatment of atopic dermatitis and / or asthma using a single medication, application is not so limited. Various other immunological indications may also be managed by the present application, and one or more of these immunological indications may be treated using a single medication approved for use in treating one or more immunological indications. Such a single medication 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-4R mAb (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 specific medication regimen and health profile. For example, the application may be configured to provide support for several diseases caused by type 2 inflammation. In the context of dermatology, this can include atopic dermatitis, prurigo nodularis, cholecystic pemphigoid, urticaria (e.g., chronic spontaneous urticaria or cold-induced urticaria), hand and foot disease, or prurigo, each of which can be treated with injections of Dupixent® or other injectable medications, but also with several oral and topical medications. In the context of respiratory diseases, this can include asthma, nasal polyps, sinusitis (e.g., chronic sinusitis with or without nasal polyps), allergic bronchopulmonary aspergillosis (ABPA), or allergic fungal rhinosinusitis (AFRS), which can be treated with injections of Dupixent® or other injectable medications, but also with several oral medications, and chronic obstructive pulmonary disease (COPD, which can be treated with injections of Dupixent® or other injectable medications).In the gastroenterology context, this can include inflammatory bowel disease (IBD) and eosinophilic esophagitis (EoE), eosinophilic gastroenteritis (EGE), or ulcerative colitis, which can be treated with Dupixent® or other injectable drugs, but also with several oral agents.

[0030] Medication may be administered by injection. As used herein, the term injection or self-injection is intended to encompass 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 divided into multi-dose container systems and single-dose (partial or full discharge) container systems. The container may be a replaceable container or an integrated, non-replaceable container.

[0031] Referring to FIG. 1a, a schematic diagram of an overall architecture 100 for a disease management and medication regimen management system is shown. The system architecture 100 illustrates several functional modules and the data links between them. The system architecture 100 includes a user device 104 running an application with a number of functional modules, shown in the center box. The architecture 100 also illustrates 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, such as communicating with insurance and benefit provider systems and pharmacies.

[0032] One of these functional modules is the journal module 102. The journal module 102 is configured to enable a user to maintain a journal related to one or more medical conditions of the user. The journal may include multiple journal entries detailing episodes of one or more medical conditions, such as symptoms, user-specific health data, contextual information, etc. The journal may be used to monitor patterns of one or more medical conditions and identify potential triggers for episodes of one or more medical conditions. The journal may further maintain a record of the user's adherence to a treatment regimen, such as a medication regimen. For example, the journal entries may include a record, such as an injection log, that records the dosages (e.g., scheduled doses) of medication taken by the user. The record may form a dosage record that includes various information related to the dosage administered by the user. The record may be stored as part of the journal entry or independently of the journal entry. The journal module 102 may communicate with an external service called an adverse events service. The journal module may send patient information related to episodes of one or more medical conditions to the adverse events service.

[0033] The functional modules may further include a memory module 106. The memory module 106 is configured to store journal entries created 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.

[0034] 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 a user's location. The user's location may be determined, for example, by a GPS function of the user device. The weather module 108 may access an online weather forecasting system to obtain, for example, current weather conditions, previous weather conditions, and / or predicted future weather conditions. The weather module 108 may provide the weather conditions to the journal module 102 for inclusion in a journal entry. 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 count, and / or air quality index.

[0035] Another of the functional modules is the user management module 110. The user management module 110 is responsible for retrieving user settings and generating notifications for output on the user device 104. The necessary data for the notification schemes may be stored in the memory module 106. The user management module 110 may also update the information held in the memory module 106 as applications are used. The user management module 110 may define and assist in the implementation of notification schemes that determine when notifications should be generated and how they should be output on the user device 104. The notification schemes may have three main notification types: (i) silent notifications, (ii) batched summary notifications, and (iii) push notifications.

[0036] In some embodiments, silent notifications may be silently pushed to an application and may be viewable only within the application. The user may be presented with silent notifications within the application, for example, on the application's home screen. In some embodiments, silent notifications are surfaced to the user when certain requirements are met and do not require any action on the user's part. Batched summary notifications may be associated with several different reminders and other notifications. The user can interact with the batched summary notifications to expand and view individual notifications. The batch summary notification may indicate the number of notifications present for the user to review. Push notifications may be associated with a single notification and are pushed to the lock screen or home screen of the user device 104. In some embodiments, push notifications are time-sensitive, actionable items that require the user's immediate 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.

[0037] Notifications can be escalated, i.e. moved up a notification type, depending on the user's action (or lack thereof). For example: a. If the user is 5 days away from their next medication dose, the next dose reminder will appear as a silent notification within the application, for example below the carousel on the app homepage. b. With days until administration, the application pushes a batch notification to the user to review the instructional video, schedule a call with a nurse, or review instructions for self-administration. c. On the day of administration and one hour before the scheduled time, the application pushes a notification to the user to take the dose. If the user's medication is stored in the refrigerator, the notification instructs the user to remove the medication from the refrigerator. Interacting with this notification triggers a warm-up timer and sets it to the medication dose.

[0038] Another of the functional modules is the health / assessment module 112. The health / assessment module 112 is responsible for onboarding users and obtaining details about the user's medical conditions and medications used to treat them. The health / assessment module 112 may also collect information about the user's prescriptions and manage medication delivery.

[0039] Another of the functional modules is a healthcare professional (HCP) services module. The HCP services module is responsible for facilitating communication with nurses, doctors, or other healthcare professionals, such as scheduling reminders for appointments and calls, prompting the user to create reports or prepare for upcoming appointments or calls, initiating voice or video calls, providing follow-up notifications after a call or appointment, and initiating journal entries 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 maintained by the patient support program to facilitate communication with the user and monitor the user's treatment and / or disease progression.

[0040] Another of these functional modules is a consent module (also referred to as a consent management module) that is responsible for managing consents and permissions to access patient-specific information, such as a user's health-related data, along with other aspects of the system. The memory module 106 may be configured to store user ID 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 consents and permissions.

[0041] The consent module can communicate with an external service called a 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 transmitting patient-specific information to third parties if the associated consent indicates this is permitted.

[0042] Another of the functional modules is the content module, which is responsible for receiving and recording personalized content and / or settings set by a user. The content module may communicate with an external service called content management, which is responsible for providing patient-specific content or settings from external users, such as healthcare professionals. The content module 124 may interact with the memory module 106 to store the personalized content and / or settings.

[0043] Another of the functional modules is a benefits module that is responsible for managing patient access to medical care 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 patient access to medical services. The benefits module may interact with external services such as benefit provider systems and pharmacy services.

[0044] Another of the functional modules is an analysis module, which may be responsible for analyzing patient information related to the status and / or treatment of a user's medical condition.

[0045] Another functional module is a messaging system. The messaging system may communicate with the analytics module. For example, if the analytics module identifies an episode or trigger of one or more medical condition episodes in the user, the messaging system may output a message communicating 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 stored about the user through the application. For example, this may be accomplished by communicating with patient support programs, insurance and benefit provider systems, pharmacies, adverse event services, etc.

[0046] Referring to Figure 1b, a flow chart illustrating the overall process of creating a user account and logging in is shown.

[0047] At step 120, the user accesses the application via a Patient Support Portal (PSP) invitation. In this scenario, the user is already registered with the Patient Support Portal and receives an application invitation code via either email or SMS. At step 122, the application displays an onboarding page, for example, by displaying the screenshot of FIG. 1c. At step 124, the application determines whether the user has chosen to create an account using an invitation code. For example, the user provides input indicating that they have received an invitation code (Yes at step 124). In this case, the flow proceeds to step 126, where the application displays a page prompting the user to enter the invitation code. If the user does not enter a valid invitation code (No at step 126), the application may provide the user with the option to contact a Patient Support Portal representative at step 128.

[0048] If the user enters a valid invitation code (Yes at step 126), then at step 130 the application provides the option to enable biometric login controls, such as fingerprint or facial recognition. However, biometric login is not required. At step 132, the application displays a screen summarizing the information received by the application for the PSP, which may include, for example, the user's name, email, date of birth, and gender. At this step, the application also presents options for the user to confirm that the information is correct or indicate that the information is incorrect. If the application indicates that some aspect of the profile information is incorrect (No at step 132), then at step 134 the application may provide the user with the option to contact a patient support portal representative.

[0049] If the user confirms that the information is correct (Yes at step 132), then at step 136, the application displays one or more screens prompting the user to enter information about the prescription. In some embodiments, this may be a single screen with several GUI elements through which the user can enter information. In another example, the application may present a screen similar to that of FIG. 1d that allows the user to select from a list of medical conditions for which they have a prescription. After receiving user input selecting a first medical condition, the application may display a screen similar to that of FIG. 1e, asking the user if they have a second medical condition and allowing the user to select from a list of medical conditions they have. After receiving user input specifying a medical condition and any secondary medical conditions, the application may display a screen similar to that of FIG. 1f that allows the user to select a prescribed injection method and dosage. After receiving user input selecting a prescribed injection method and dosage, the application may display a screen similar to that of FIG. 1g that allows the user to specify whether they have started taking the medication. If the user indicates that they have started taking the medication, the screen may display additional GUI elements for the user to indicate when their next scheduled dose is. In this manner, a current medication dosage schedule can be set in the application during account creation.

[0050] After collecting the additional prescription information, the application collects the necessary permissions to send user notifications and monitor the location of the user device at step 138. At this point, the application may also collect the necessary permissions to hold or process the user's personal data in accordance with the laws of the local jurisdiction. At step 140, the application displays a registration completion page.

[0051] In another account creation process, at step 142, the user accesses the application without an invitation. In this scenario, the user is not registered with the patient support portal. At step 143, the application displays an onboarding page, for example, by displaying the screenshot of FIG. 1c. At step 144, user input is received indicating that the user does not have an invitation code. In response, at step 146, the application prompts the user to select a verification method, which may be either an email or a mobile phone number. For example, the application may display a screen similar to that of FIG. 1h. The process may also reach step 146 if the user was invited to access the app using an invitation code from a PSP but selected not to have the code at step 124 (e.g., because they lost or never received the code).

[0052] After successfully completing the verification process via email or mobile phone number (Yes at step 146), the application provides the option to enable biometric login controls, such as fingerprint or facial recognition, in the same manner as at step 130. At step 150, the application displays one or more screens prompting the user to enter profile information by entering personal information such as the user's name, email, date of birth, and gender. After entering this information, the process proceeds to step 136 as described above.

[0053] FIG. 1b also shows a process flow for logging back into the application. At step 152, the user attempts to log back into the application at some point after account creation. At step 154, the application checks whether there have been any updates to the application's privacy policy / settings. If there have been changes (Yes at step 154), the application displays a page providing a link to the updated policy and prompts the user to consent to the storage and processing of data in accordance with the new policy at step 156. If the user agrees to the new privacy policy / settings or there are no updates, the process proceeds to step 158, where the application performs the login process. At step 160, the application checks whether the user has indicated that they have forgotten their password. If the user has not forgotten their password (No at step 160), the process proceeds to the login page at step 162. If the user indicates that they have forgotten their password (Yes at step 160), the application initiates the password reset process at step 164.

[0054] When the application is first installed and run by a user, an application registration and profile creation routine is performed. This routine may include, among other things, the user creating an account by entering an email and password. A verification code may be sent to the user's email that must be entered into the application to complete account creation. The application may also be configured for biometric login and may ask the user whether they would like to use stored biometric login information (e.g., fingerprint or facial recognition) as their primary means of logging into the application. After creating an account, the user may be guided through the process of creating a profile that includes personal and contact details, diagnosed medical conditions, and dates of these diagnoses.

[0055] Figures 1c-1h show screenshots illustrating the application's account creation process. Figure 1c shows an application invitation screen 166. This screen appears the first time a user accesses the application and asks the user whether they received an invitation code and through which channel. If the user is already registered with a patient support portal (PSP) related to their prescribed medication or medical condition, the user can generate an invitation code through the PSP (or a healthcare professional or PSP operator can initiate the generation of the invitation code). The application invitation screen 166 has three selectable options for indicating whether the user received the invitation code via email, (ii) the user received the invitation code via SMS, or (iii) the user did not receive an invitation code. If the user selects either option (i) or (ii), they are prompted to enter the code. The application may communicate with the PSP to verify the entered code. Any personal information held by the PSP may be communicated to the application to avoid the user having to manually enter this information. If the user selects option (iii), the application may prompt the user to enter an email address or mobile phone number that can carry out a verification process.

[0056] Once the user is verified, a condition selection screen 168 is displayed, as shown in FIG. 1d. The condition selection screen 168 may include a list of conditions treated by the first medication, and the user may select any of the conditions for which they have a prescription. The list of conditions may include asthma, atopic dermatitis (eczema), chronic rhinitis with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU), eosinophilic esophagitis, and prurigo nodularis. Not all of these conditions may be included in the list, and the list is not exhaustive. In some embodiments, the user may select multiple conditions on the condition selection screen 168. After selecting and continuing, the application displays a secondary condition selection screen 170, as shown in FIG. 1e. The secondary condition selection screen 170 may include the same list of conditions as the condition selection screen 168, but does not include any that the user has already selected. The secondary condition selection screen 170 may also include an option for the user to indicate that they have no more conditions.

[0057] After indicating the medical condition they have, the application displays an injection method and dosage selection screen 172, as shown in FIG. 1f. The medication prescribed to the user may be provided in various dosages and delivery methods, which may be represented by selectable graphical icons, images, and / or wording. The four delivery methods shown in FIG. 1f are merely exemplary. A subset of these or different delivery devices may be displayed depending on the medical condition selected by the user. After selecting the method and dosage for which they are prescribed, the application displays a treatment start screen 174, as shown in FIG. 1g. The treatment start screen 174 includes an option for the user to indicate whether they have already started taking the treatment / medication or have not yet started taking the medication. If the user selects the option to indicate that they have already started taking their medication, a further GUI element may be displayed or accessible, allowing the user to enter the date of their next scheduled dose. In this way, the current administration schedule can be set in the application during the account creation process. If the user selects the option to indicate that they have not yet started taking the medication, a further GUI element may be displayed or accessible, allowing the user to enter the date they plan to take their first dose. Each of the prescription information collection screens shown in Figures 1d-1g may display links to important or useful information, such as safety information about the drug.

[0058] After entering the above information, the application will display a summary screen (not shown) containing information about the user's dose, method of administration, date of next scheduled dose, and dose frequency. This page may provide the user with the option to contact support services if any of the information seems inaccurate.

[0059] After displaying the summary screen, the application may display a first authorization screen 178, as shown in FIG. 1i. The first authorization screen 178 is for receiving air quality updates via the application. Because air quality can have a direct impact on a user's symptoms, providing this information via the application can help the user manage their condition. If the user chooses to allow the application to provide air quality information, the application may request access to the user's device's location, which the user can approve (for the current session or always) or deny. Air quality and location represent examples of information that may be customized according to the health condition being managed. Other types of information that may be useful or valuable for the user to know, such as weather information or traffic data, may also be communicated. The application may determine that certain information may be valuable to the user based on the particular health condition the user is managing and may need access to the user's location data or some other protected data stored on the user's device or related to the user's health condition to customize the information presented. The application can then present a user interface requesting approval to access the protected data so that the information can be customized.

[0060] After receiving user input regarding the air quality information, the application may display a second consent screen 180, as shown in FIG. 1j. The second consent screen 180 relates to receiving notifications from the application regarding the user's medical condition and treatment. If the user chooses to allow the application to provide notifications, the application may display a notification consent screen 182, as shown in FIG. 1k. The notification consent screen 182 may display several user-selectable options 184 for different types of notifications. The user-selectable options 184 may be toggle buttons switchable between "yes" and "no" and may include topics such as "upcoming GP visits," "medication deliveries," "injection reminders," "nurse call notifications," "news and articles," and "challenges and new habits." Selecting the "yes" toggle for any of these options 184 may enable the application to send the user push notifications regarding the associated topic. The push notifications may be displayed on the locked screen of the user device 104. After selecting a notification option, the user may be presented with various policy statements, such as a privacy policy statement. The user's permission to collect and store personal data in certain ways may also be obtained at this point.

[0061] 2a-2h, screenshots illustrating the application customization process are shown.

[0062] After the profile is completed, the application may allow the user to perform a customization process. The customization process may be accessed from a notification on the application's home screen or may start automatically after profile creation. FIG. 2a illustrates a first initial screen 200 of the customization process. The first initial screen 200 may be displayed when the user indicates during account creation that they are managing one health condition. In the example shown in FIG. 2a, the user selects atopic dermatitis. FIG. 2b illustrates a second initial screen 202 of the customization process. If the application is configured to manage multiple health conditions for the user and the user indicates during account creation that they are managing multiple health conditions, the second initial screen 202 of the customization process may be displayed instead of the first initial screen 200. For clarity, although the application can handle multiple health conditions, the user may select only one of the health conditions the application is configured to handle, in which case the application will support only the selected health condition. In the example shown in FIG. 2b, the second initial screen 202 notifies the user that the application requests information about both atopic dermatitis and asthma. As previously explained, the application can be programmed to manage a range of immunological or other medical conditions that are treated by a particular drug or group of drugs.

[0063] FIG. 2c shows the first screen of a customization process for atopic dermatitis. The first screen has a list of trigger conditions 204 and asks the user to select those they consider to be triggers for atopic dermatitis. The user can select as many trigger conditions 204 as desired. There may also be an "Other" option and a box for entering free text associated with this option. The customization process may then ask the user what steps they currently take to minimize trigger conditions by presenting a list of options for user selection and / or allowing free text entry. The customization process may then ask the user what topics they would like to learn about by again presenting a list of options for user selection and / or allowing free text entry. User selection of these topics may inform the content displayed on the "Learn" tab screen of the application (see FIG. 14).

[0064] FIG. 2d shows an additional medication question screen 206 in which the user is asked if they are using any other medications to manage their atopic dermatitis, with selectable options of "yes" and "no." If the user selects "yes," the additional medication selection screen of FIG. 2e is displayed. The additional medication selection screen includes a list of additional medications 208, with each entry in the list having an associated check box. The list may display some common medications at the top, followed by an alphabetical list of medications. The additional medication selection screen also includes a search box 210 that allows the user to search the list of additional medications 208.

[0065] If the user is managing only atopic dermatitis, the customization process proceeds to a prompt screen on the connected device, as shown in Figure 2i. If the user is managing multiple health conditions, after the user selects any additional medications they are using for the first health condition, the customization process displays a second medical condition prompt screen 212, as shown in Figure 2f. The second medical condition prompt screen 212 displays a notification prompting the user to customize the application in relation to the second medical condition (in this embodiment, asthma). If the user chooses to end the customization process at this point, a notification prompting the user to customize the application in relation to the second medical condition may be prominently displayed on the application's home screen.

[0066] As the user continues the customization process, the first screen of the asthma customization process is displayed, as shown in FIG. 2g. This screen includes a list of trigger conditions 214, prompting the user to select those they believe are triggers for their asthma. The user can select as many trigger conditions 214 as desired. There may also be an “Other” option and a box for entering free text associated with this option. FIG. 2h shows an additional medication question screen 216, which asks the user if they are taking any other medications to manage their asthma, providing selectable options of “Yes” and “No.” If the user selects “Yes,” an additional medication selection screen with similar functionality to that of FIG. 2e is displayed. Additional screens (not shown) may be displayed during the asthma customization process, prompting the user to specify which preventer inhaler and which reliever inhaler they use. The application may then ask the user if they are taking any medications other than the prescribed medications administered by the application and their inhalers to manage their asthma.

[0067] Similar to the process described above, if the user indicates that they are prescribed medications to manage chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU), eosinophilic esophagitis, and / or prurigo nodularis, a separate customization process may occur for each selected health condition in which the application displays a screen asking the user what triggers the condition (similar to the screens in Figures 2c and 2g), a screen asking the user if they are using other medications to treat the condition (similar to the screens in Figures 2d and 2h), and a screen providing a list of other medications for the user to select (similar to the screen in Figure 2e). The list of triggering conditions and the list of other medications may be different for each health condition.

[0068] Upon selecting any additional medications used to manage each of the user's health conditions, the customization process displays a connected device prompt screen, as shown in FIG. 2i. The connected device prompt screen may include options 218 to add a connected device or skip this portion of the customization process. The connected device prompt screen may also include a selectable link 220 to information about which connected devices are compatible with the application. Selecting the link may navigate to such information within the application, or in some embodiments, may be a URL link configured to open an internet browser.

[0069] When the user selects option 218 to add a connected device, a connected device management screen 222 is displayed, as shown in FIG. 2j. This screen lists connected devices that are capable of wireless communication and 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 an unwanted device. The connected device management screen 222 includes a user-selected option 224 to scan for a new device, for example, using the user device's Bluetooth interface or NFC protocol. Alternatively, the user's syringe or inhaler may have a scannable code, such as a QR code (or similar barcode) printed on a label affixed to the device, or otherwise printed or etched on the device. When the user selects the option to connect a new device, the application may provide an option to open the user device's camera app. The user device's camera can then be used to capture the scannable code, such as the QR code. The type and dosage of the syringe or inhaler can then be checked against the information entered during the account creation process. Alternatively, this step may replace manual entry of injection device information during account creation. By scanning the QR code on the injection device, the application can check the expiration date of the medication in the injection device. If the medication has expired, this can be communicated to the user via an alert in the application.

[0070] The QR code may serve the additional purpose of directing the user to the application or automatically initiating the account creation process. After being prescribed medication and receiving the injection device, the user can scan the QR code with their device. If the application is not installed on the user's device, scanning the QR code may open an app store on the user's device and take them to an application store page where they can download and install the application. Alternatively, a page may be displayed informing the user that the application is available and providing a link to open the app store. If the application is already installed on the user's device, scanning the QR code may automatically launch the application and initiate the account creation and customization process described herein. If the user is an existing user of the application and scans a new injection device, the application may automatically launch and prompt the user to confirm that they have received a new injection device or batch of injection devices. This may reset the application's refill reminders.

[0071] Instead of providing a QR code (or similar barcode) on a label on the injection device, a QR code (or similar barcode) may be provided on the box that houses the injection device, and the actions resulting from scanning the label on the box may be the same as those described above.

[0072] The application may continue the customization process by displaying an appointment entry screen 238, as shown in FIG. 2k. The appointment entry screen 238 prompts the user to enter details of the scheduled doctor's appointment so that a reminder can be generated. The screen 238 may have multiple free text entry boxes for entering the doctor's name, city, and state / region. The screen 238 may have a selectable soft button to initiate a doctor search and an option to skip the appointment entry process. Once the user enters information in at least one box and presses the search button, the search is performed and a search results screen 240, as shown in FIG. 2l, is displayed. The search results screen 240 may include several search results and a filter for setting the distance (radius) of the search. The search results screen 240 allows the user to select one of the search results and continue. The search results screen 240 also provides an option to manually enter doctor details. Once a doctor is selected or details are manually entered, the process proceeds to an appointment detail entry screen 242, as shown in FIG. 2m. This screen may have data entry boxes for the date and time of the appointment. After saving the appointment details, the customization process is complete.

[0073] Referring now to FIG. 2n, a data flow diagram 226 is shown, illustrating a request for user data input in an oval box in the center of the diagram and the movement of data (labeled arrows) between the application and external systems and services. The "Digital Immunology App" 228 is the user-facing end of the application. An application programming interface gateway is programmed into the application to exchange data with functional modules, such as the health / assessment module 112 described with reference to FIG. 1. The user interacts with the Digital Immunology App 228 to begin the onboarding process (also referred to as the customization process), as described above with reference to FIGS. 2a and 2b. In step 230, the application prompts the user to "Enter Primary Condition Trigger." In the above embodiment, the application shows the screen of FIG. 2c, which asks the user about the trigger conditions for atopic dermatitis (the primary condition). The process then asks the user what steps they currently take to minimize the trigger conditions for the primary condition by presenting a list of options for user selection and / or allowing free text entry. Next, the process again asks the user what topics they would like to learn about regarding their primary medical condition by presenting a list of options for user selection and / or allowing free text entry. The information entered by the user at each of these steps is communicated to an external account management service 236, which may include a data server that stores user-specific health information.

[0074] At step 234, the application asks the user to "Enter Medications Being Taken." In the embodiment described above, the application shows the screens of Figures 2d and 2e, asking the user if they are taking other medications to manage their primary medical condition, and what these medications are. As shown in data flow diagram 226, the list of medications may be provided by an external "Medication Management System." This allows the list of medications presented in Figure 2e to be kept up to date without the need to provide updates to the application.

[0075] As shown in data flow diagram 226, an additional step may be performed: "Capture any medication conflicts." Details of medication conflicts may also be stored in the external medication management system. If medication conflicts are found, a warning may be displayed to the user as part of the customization process. The warning may advise the user to contact a healthcare provider to discuss the potential conflict.

[0076] After collecting information about other medications the user is taking, the process proceeds to step 232, where the application asks the user to "Enter Secondary Condition Triggers." In the above embodiment, the application shows the screen of FIG. 2g, asking the user about asthma trigger conditions (secondary conditions). The process then cycles back, asking the user what steps they are currently taking to minimize secondary condition trigger conditions by presenting a list of options for user selection and / or allowing free text entry. Next, the process again asks the user what topics they would like to learn about regarding secondary conditions by presenting a list of options for user selection and / or allowing free text entry. The information entered by the user at each of these steps is again communicated to the external account management service 236.

[0077] At step 234, the application again prompts the user to "Enter Medications Being Used" in connection with the secondary medical condition. In the embodiment described above, the application displays the screen of FIG. 2h and a screen similar to FIG. 2e but adapted for asthma, asking the user if they are taking other medications to manage the secondary medical condition and what these medications are. As shown in dataflow diagram 226, the list of medications may be provided by an external "Medication Management System." This allows the list of medications presented in FIG. 2e to be kept up to date without having to provide updates to the application.

[0078] At the end of the process, the applicant may ask for the user's consent to store the information entered as part of the customization process. A dedicated external "consent management" system may handle this aspect of the process and store evidence of the consent requests presented to the user and their responses.

[0079] 3a shows a dose support screen of the application. The dose support screen provides information regarding the user's scheduled medication doses. The dose support screen may include one or more reminders / notifications of upcoming events related to one or more of the user's medications. For example, the dose support screen may display one or more reminders / notifications for scheduled medication doses 302. The reminders for scheduled medication doses 302 may include the medication identity and the time (e.g., date and time) when the medication dose should be administered. Alternatively or additionally, the dose support screen may display one or more reminders / notifications for scheduled medication deliveries 304. The reminders for scheduled medication doses 304 may include the medication identity and the time (e.g., date and time) when the medication is scheduled to be delivered.

[0080] The dose support screen may further include an interface for a call scheduling function 306. The call scheduling function 306 facilitates scheduling a call between a user and a healthcare professional, e.g., a nurse, and guides the user through the administration of a medication, e.g., preparing and administering an injection. The user may select a GUI element, e.g., a button, to initiate the call scheduling function 306. Once the call scheduling function is initiated, the process proceeds to Figure 3b.

[0081] As shown in FIG. 3b, after initiating the call scheduling function 306, the user enters their contact preferences. The contact preferences provide details regarding the user's preferred method of being contacted. The contact preferences may include, for example, a preferred contact date 308, a preferred contact time (or time window) 310, and a preferred contact method 312 (e.g., in-app video call, phone call, external app video call, etc.). In some embodiments, the user may also provide an input 314 indicating how they feel about their upcoming medication dose. Once the details are provided, the user can activate a confirmation GUI element 316 to save and send the preferences to the analytics platform. Alternatively, instead of the screen shown in FIG. 3b, the user can request an immediate support call. In response, the application may check whether the support service is currently operating (e.g., within operating hours). In this case, the application can ask the user for the nature of the call so that the user can be directed to the appropriate person for support. The application then opens the user's phone application (or another communications program) on the user's device and dials the appropriate number to immediately initiate the support call.

[0082] FIG. 4a shows an example of a notification 318 regarding an upcoming call with a healthcare professional. The notification is pushed to the lock screen of the user device. The notification provides a reminder of the time remaining until the call and the identity of the caller (e.g., "Video call with nurse in 60 minutes"). The notification may further provide instructions for actions the user should take before the call, such as retrieving medication from storage at a predetermined time before the call, such as "retrieve dose from refrigerator now." The user can select the notification to open an application on the user device.

[0083] Upon selecting the notification or opening the app and navigating to the call function, the user may be presented with an instruction screen, such as that shown in FIG. 4b. The instruction screen provides instructions 320 for preparing the medication dose before the scheduled call with the healthcare professional. The instructions may include picture instructions and / or text instructions. In some implementations, video instructions 322 may also be provided. When the call time arrives, the user selects the “Proceed to Call” 324 element to proceed with the call, during which the user administers the medication under the remote supervision of the healthcare professional.

[0084] After the call, the application may display a notification asking the user if they took their medication during the call. If the user indicates that they have not taken their medication, they may be presented with the option to set a reminder to take their medication later. If the user indicates that they have taken their medication, the user may be prompted to enter additional data regarding the administration of the medication. For example, as shown in FIG. 4c, the user may select injection location 326 from a set of predetermined locations to indicate the location where the user administered the injection.

[0085] FIG. 5 shows an example of the application's home screen. The home screen displays a reminder 502 that prominently indicates that today is the day the user should take their medication. A calendar notification 504 is also provided, providing a time window for taking the medication. Selecting either the reminder 502 or the calendar notification 504 can initiate a medication dose support process, and the application presents a step-by-step administration guide, e.g., a step-by-step injection guide. The medication dose support process can also include reminding the user to remove their medication from the refrigerator and providing a warm-up period countdown timer. Additionally, the application can display a push notification on the lock screen of the user device 104 at the scheduled time for the next dose. Selection of this push notification can also initiate the medication dose support process by the application when the user device is unlocked.

[0086] FIG. 6 shows an example of a user profile in an application. The user profile includes user identity 602 (e.g., the user's name, the user's gender 604, the user's date of birth 606, multiple medical conditions of the user 608, one or more medications taken by the user 610, one or more reports regarding the medical condition 612, and / or medication start date 614). As can be seen, the profile indicates that the application is assisting the user in managing a primary medical condition (atopic dermatitis) and a secondary medical condition (asthma). Additional conditions, such as the immunological conditions mentioned above, may also be managed by the application. The profile also indicates that the user may be using multiple medications to manage their medical condition. In the embodiment of FIG. 6, five medications are shown (610). The user can select an entry in the profile to view details about the entry, such as a list of individual medications. The profile information can be later viewed and edited by the user. The user's treatment details, such as which health conditions they are managing, what other medications they are taking, symptom triggers, and which injection method and dosage they use, can also be later viewed and edited.

[0087] FIG. 7 shows an injection routine control screen 702. The injection routine control screen 702 allows the user to specify the time of day that the user would normally administer an injection, allowing for appropriate reminders. The user can also use this screen to specify how long before the scheduled injection time, for example, one day in advance, they would like to be notified about the injection. There is also a selectable option for whether to provide a step-by-step guide as part of the injection reminder. This option may be toggled to "yes" by default and is enabled until the user specifies otherwise. The option to skip the step-by-step guide may not be available, or may not be available until the application determines that the user has sufficient experience, for example, after the user has completed a certain number of doses. While this screen is described in terms of injection reminders, the application can also assist the user in managing other forms of medication administration, such as oral and topical medications.

[0088] The timing of notifications, particularly push and batch 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 can learn the behavior of a particular user and track when the user is most active and most likely to open the application. The application can adjust the timing of notifications accordingly to achieve maximum impact and maximum user engagement.

[0089] 8 shows an example of a graphical user interface for an application that includes an in-application notification 802 prompting the user to create a journal entry. This notification can be triggered when the user launches the application if a daily journal entry has not been created for that day, prompting the user to begin a daily journal entry. Alternatively or additionally, the notification can be triggered by the user entering the application via a lock screen notification, as described below with respect to FIG. 9. The notification can include a GUI element, such as a button 804, that the user can select to open the journal module with the current day's entries. In the example shown, the GUI button for accessing the journal is marked "Add Entry."

[0090] FIG. 9 illustrates a push notification 902 to the locked screen of a user device, prompting the user to create a journal entry based on detected environmental conditions or user-specific health information.

[0091] The application monitors environmental conditions of the user's environment and triggers a notification 902 when one or more environmental threshold conditions are met. The notification 902 may provide a prompt to the user to create a journal entry and, in some embodiments, a warning regarding the environmental condition that triggered the notification. The application may monitor the environmental conditions using one or more sensors present on the user's device, such as a thermometer, barometer, or hygrometer. Alternatively or additionally, the application may monitor the environmental conditions using environmental information from one or more other services, for example, a weather application on the device or on the Internet.

[0092] The occurrence or parameters of this notification may further be determined in part by whether the user pre-selected an environmental-related trigger (e.g., hot weather, cold weather, and / or environmental allergies) for the user's primary or secondary medical condition (e.g., in steps 204, 214, 230, and / or 232). For example, a "hot weather" notification may be presented more urgently if the user indicated that "hot weather" triggers the user's asthma than if the user did not.

[0093] Alternatively or additionally, the application can monitor user-specific health information and trigger a notification when one or more health status thresholds are met. The notification may prompt the user to create a journal entry and, in some embodiments, provide a warning regarding the health information that triggered the notification. The user-specific health information may be entered into the device by the user, for example, via the device's GUI. Alternatively or additionally, the user-specific health information may be collected by one or more sensors on the device; for example, the user's pulse may be measured by an optical sensor on the device. Alternatively or additionally, the user-specific health information may be collected from one or more external devices. For example, the application may access data collected by the user's wearable device, such as a smartwatch, and / or a medical device used by the user to monitor a health condition, such as a pulse oximeter, or a device for monitoring the user's respiration, such as a peak flow meter or spirometer.

[0094] The occurrence or parameters of this notification may further be determined in part by whether the user pre-selected a health-related trigger (e.g., stress) for the user's primary or secondary medical condition (e.g., at steps 204, 214, 230, and / or 232). For example, a "high pulse" notification may be presented more urgently if the user indicated that "stress" triggers the user's asthma than if the user did not.

[0095] FIG. 10a shows the health condition entry screen of the application. A user selects one or more health conditions 1002 to which the journal entry is associated from a health condition selection page. Selection of one or more health conditions 1002 may be performed by clicking the associated checkboxes, as shown. Alternatively, or additionally, one or more medical conditions 1002 may be selected from one or more drop-down lists and / or entered manually. In the example shown, the medical conditions for the journal entry include atopic dermatitis and asthma, as well as a general "overall health" condition. In the example shown, the user has selected atopic dermatitis as the associated medical condition. Once the user has selected one or more associated medical conditions 1002 for the journal entry, the user can select a "Next" button to proceed to the next portion of the journal entry.

[0096] The process of creating a journal entry may include the user providing location and time details regarding an episode of a medical condition and answering one or more queries regarding the health condition. The queries may be answered by selecting a symbolic score (e.g., a face) or a numeric score (e.g., a number between 0 and 5) from a set of potential scores. The selection may be performed using a slider, although other methods of entering a score, such as a drop-down box, text entry, etc., may alternatively be used. In some embodiments, one or more of the queries may be in the form of a "yes / no" or "true / false" statement. The queries may relate to aspects of the health condition (e.g., for atopic dermatitis, "How itchy is it?", "How painful is it?", etc.) or the user's general state regarding the health condition (e.g., "How are you feeling?", "How did you sleep last night?"). If the user is creating a journal entry for asthma, the queries may be different, such as "What is your level of shortness of breath?", or the user's general state regarding the health condition, such as "How am I feeling right now?" After providing an answer to the query, the journal entry process may display a model of the human body, which may be used to indicate specific body locations where a health condition, e.g., atopic dermatitis, is occurring. The model may be a rotatable model that allows the user to select front, back, and side body locations. Such information may only be relevant to a specific health condition, and thus this journal page may not be present in all situations (e.g., for asthma). The user may indicate one or more locations where the health condition is occurring / health condition episodes are occurring. If the user has previously indicated that the health condition is occurring in one or more body locations, the user may indicate which locations are worsening.

[0097] Two additional steps may be part of the journal entry process. FIG. 10b shows a photo entry screen 1004. For a particular health condition, e.g., atopic dermatitis, the journal entry process may ask the user if they would like to add a photo of their skin to better illustrate and track the severity of the condition. The photo entry screen 1004 may display thumbnails of any photos already uploaded as part of the journal entry and include a button to add a photo. Upon selecting the button, the user may be presented with the option to open a camera application on the user device or a gallery application on the user device to capture or select a photo to add. A separate free-text entry screen may also be presented to the user as part of the journal entry process.

[0098] As part of the journal entry process, the user may be asked about their sleep quality and may enter a numerical score, a symbolic score, or a free-text entry. The user may also be presented with the option to add sleep quality data. Selecting this option may cause the application to display an activity tracker data selection screen 1006, as shown in FIG. 10c. In this embodiment, the activity tracker is “Google Fit,” but the device may be any suitable activity monitoring device. The device may have been paired with the application during the customization process (see FIG. 2j). If an activity tracker device has not previously been paired, selecting the option to add sleep quality data may open a connected device pairing screen to search for nearby devices. On the activity tracker data selection screen 1006, the user may be presented with a list of time periods to associate with the journal entry, which may include, for example, “today,” “yesterday and today,” “last 7 days,” or any other appropriately defined time period. By associating activity data with the journal entry, the application may derive further insights into the user's health, correlate activity with symptoms, and present this information to the user at a later time.

[0099] After answering a query about a first health condition (and optionally indicating one or more locations on the body model), the user may be asked about a second health condition if the user so selects using the input in Figure 10a. In this way, journal entries for multiple health conditions treated by a drug can be made in a single process.

[0100] After completing a journal entry, the user is presented with a journal reminder screen where the user can set a date and time for a reminder to make further journal entries. The application stores a record of the user's journal entry, which the user can access and view from the Journal tab (see Figures 13a and 13b).

[0101] In describing features of the above application, reference has been made to various external systems and devices with which the application communicates and exchanges data. FIG. 11 is a data flow diagram 1100 showing categories of data within oval boxes in the central section 1104 of the diagram and the movement of data (labeled arrows) between the application and external systems and services. The "Digital Immunology App" 1102 is the user-facing end of the above application. An application programming interface gateway is programmed into the application to exchange data with functional modules such as the user management module 110 and health / assessment module 112 described with reference to FIG. 1. Users can interact with the Digital Immunology App 1102 to manage their accounts and can manage their accounts by selecting the "Account" tab in the application (see, e.g., FIG. 15).

[0102] Within the account management section of the application, various categories of data can be viewed and edited, as represented by the oval boxes in the central section 1104 of the figure. These may include, but are not limited to, injection routine, account, areas of interest, profile, connected apps, medication delivery, legal and privacy, notifications, licenses, settings, health center, and payments. Information entered by the user for several categories is communicated to an external account management service 1106, which may include a data server that stores user-specific health information. Information regarding payments may be exchanged with a patient support portal (PSP). Information regarding connected apps and / or devices is exchanged directly with those apps and devices (e.g., Google Fit or Apple Health). Information regarding medication delivery may be exchanged with one or more medication delivery systems, such as a connected injection device or a connected inhalation device (see FIG. 2j). The medication management system may store and provide, when queried, a list of medications and information regarding medication conflicts.

[0103] The application also assists users in preparing for appointments related to treatment, such as doctor appointments. FIG. 12a shows the Treatment tab screen 1200, which appears within the application when the Treatment tab 1202 is selected. The Treatment tab screen 1200 includes a notification 1204 that reminds the user of an upcoming doctor's appointment and provides several details about the appointment. The Treatment tab screen 1200 also includes a suggested action graphic 1206, which in this embodiment is to access a step-by-step injection guide. Selecting a button within the suggested action graphic 1206 may navigate to information within the application, such as video or graphical instructions, or may open a web browser on the user device and navigate to the information. In this way, users can better prepare for appointments related to the treatment of their medical condition. This section of the Treatment tab may also display other types of suggested action graphics, such as a notification to prepare a re-pot for an upcoming doctor's appointment. The type of notification shown may depend on whether a scheduled dose or a scheduled appointment is earliest.

[0104] The Therapies tab screen 1200 may also provide access to prescription and delivery information, allowing the user to track new delivery deadlines for medications. The Therapies tab screen 1200 may also provide access to administration history, such as injection history, allowing the user to view a complete list of all injection events entered or otherwise recorded in the application.

[0105] Selecting notification 1204 opens a new screen providing more detailed information about the appointment, for example, a monthly check, and may also provide a selectable option to prepare a report before the appointment. Figures 12b and 12c show report screens (1208-1, 1208-2) that may be generated by the application. The report may include a summary of the user's journal entries and completed questionnaires to detail the progression of their health condition. The summary may relate to a specific time period. By default, the time period may begin the day after the user's previous doctor's appointment and end on the current day. The time period may be adjustable by the user. Below the summary of journal entries, report screen 1208-1 may individually display the most recent journal entries and indicate which medical condition or conditions they relate to. For example, the three most recent journal entries may be displayed. The user can select any individual journal entry to view all entries. Report screen 1208-1 may also provide a "View All" selection, allowing the user to view a complete list of their journal entries. Below the journal entries, report screen 1208-2 may display a list of the user's most recent questionnaire scores. In the example shown, these are Atopic Dermatitis Control Tool (ADCT) scores. A summary of the results of each questionnaire, such as "well controlled" or "may not be well controlled," may also be provided, as well as the date and time the questionnaire was completed. For example, the last three completed questionnaires may be shown. An option may be provided to complete additional questionnaires. Finally, a selectable GUI element is provided to download the report. The report may then be shared with the user's physician or other healthcare professional.

[0106] Both the journal entries and the questionnaires are disease-specific. Thus, if a user has multiple health conditions managed by the application, each journal entry may relate to one or more health conditions and show the results of different questionnaires. For example, if a user has asthma, the questionnaire may relate to the Asthma Control Tool (ACT). If a user has Prurigo Nodularis, the questionnaire may relate to the Prurigo Nodularis Control Tool (PCT). If a user has Chronic Spontaneous Urticaria, the questionnaire may relate to the Urticaria Control Tool (UCT). Some diseases, such as chronic rhinitis with nasal polyps (CRSwNP) or eosinophilic esophagitis, may not have specific questionnaires associated with them; in this case, the summary report may omit the questionnaire section shown in FIG. 12c.

[0107] Correlations noted between the user's reported symptoms and other information in the journal entry (e.g., environmental conditions, sleep, or user activity data) may also form part of the report. In this way, the application can collect and present therapeutically useful information to the user and their healthcare provider at appropriate times. The user can generate, view, and comment on reports at other times. Generating a report may also include the user answering a short questionnaire about current symptoms for each health condition managed by the application. The application may offer the option to send the report directly to a physician in electronic format after it has been generated.

[0108] FIG. 13a shows an exemplary journal tab screen 1300 that is displayed when the journal tab 1302 is selected within the application. The journal tab screen 1300 may include a notification about the most recent journal entry made by the user. The user can select this notification to view the journal entry or view all journal entries. The notification may also have a separate selectable element for viewing a list of all journal entries. The application may also automatically generate graphs and charts from the numerical information contained in the journal entries to graphically illustrate the user's treatment, symptom, and / or disease progression. These graphs and charts may additionally or alternatively be generated on demand. The journal tab screen 1300 may also include suggested action graphics related to journaling, such as for preparing reports to share with healthcare professionals. The journal tab screen 1300 may also include a selectable option for adding connected devices so that data collected as part of journaling can be enriched with data from external sources.

[0109] 13b shows an alternative journal tab screen 1304. The alternative journal tab screen 1304 includes a suggested action graphic related to journaling, in this case, adding a new journal entry. The alternative journal tab screen 1304 includes a list of the most recent journal entries, which can be selected to display all entries or a complete list of past journal entries.

[0110] FIG. 14 shows an exemplary Learn tab screen 1400 that is displayed when the Learn tab 1402 is selected in the application. The Learn tab screen 1400 may include personalized content for the user, selected based on one or more medical conditions the user is managing using the application, according to the profile settings entered in FIG. 2a and topics of interest the user indicated during the customization process. The content may include articles and / or videos. The Learn tab screen 1400 may also include suggested action graphics, such as a suggestion to participate in a challenge. If selected, the application may present information on how the user can adjust their behavior to improve their health, such as dietary information. The application may also help the user track their progress through the challenge. An alternative suggested action may be to view a step-by-step injection guide. The Learn tab screen 1400 may also include a link to view drug safety information and indications.

[0111] Figure 15a shows an exemplary Accounts tab screen 1500 that is displayed when the Accounts tab 1502 is selected in the application. The categories of information that can be viewed and managed on the Accounts tab screen 1500 have been previously described with reference to Figure 11. The Accounts tab screen 1500 may include a link to open a profile management page, such as the page shown in Figure 6. The user's currently connected external devices are displayed on the Accounts tab screen 1500, and links to payment and insurance information may also be displayed.

[0112] 15b and 15c show settings tab screens (1504-1, 1504-2), which may be displayed as an alternative to the account tab screen 1500 of FIG. 15a. The settings tab screen includes several sections for viewing and editing information. The first section is a history section, through which users can view past injections, appointments, journal entries, and generated reports. The second section is a profile section, through which users can view and edit their personal information. For example, selecting "Profile" may display the page shown in FIG. 6. Selecting "Notifications" may display a notification center where messages and reminders are collated. Users may also access their payment and insurance information. The bottom section (1504-2) of the settings tab screen includes a treatment settings section, where users can view treatment details, such as information entered during account creation, and view and adjust injection routines and reminders. The settings tab screen also includes a shared data section, where users can view and adjust permissions granted for data sharing with applications. This data may include the location of the user device, data from other applications such as a weather app, data from an activity monitor or physiological condition monitor, and data from connected devices such as a connected injection device, a connected inhaler, a connected medication storage device, and a connected sharps bin.

[0113] 16 and 17 show example information that may be collected from external sources and displayed in the application. FIG. 16 shows environmental information 1600 obtained from an environmental monitoring application. Environmental information 1600 may include, among other data, current and forecasted weather conditions, NO2 levels, air quality index, and pollen counts. FIG. 17 shows user physiological and activity data 1700 collected by an activity tracker device. User physiological and activity data 1700 may include step count, heart rate, sleep time and duration, and overall activity summary level, as well as other data.

[0114] 18a and 18b are example screens showing how environmental information 1600 and user physiological and activity data 1700 may be displayed within the application.

[0115] The application may also assist the user with medication collection or delivery, as shown in FIGS. 19a-19c. FIG. 19a shows a delivery options screen 1900 including options 1902 for how the user would like to obtain their medication. Options 1902 are to have the medication delivered to their home or to a pharmacy for collection. If the user selects the pharmacy option, a list of nearby pharmacies may be presented. If the user selects the home delivery option, a delivery time selection screen 1904, FIG. 19b, may be displayed. The delivery time selection screen 1904 includes options 1906 for selecting a date and time slot for delivery. Options 1906 may be in the form of a drop-down menu. Selecting a delivery time slot may present a delivery confirmation screen 1908, FIG. 19c, which confirms to the user that the medication will be delivered. It may also provide information regarding medication receipt and / or storage, such as a reminder that the medication should be placed in the refrigerator when received. A delivery confirmation screen 1908 may also be displayed once the user has received the medication and may include selectable buttons to confirm safe receipt of the medication or to report any problems with the medication.

[0116] In addition, the application allows the user to set and edit refill reminders. As a first step, the application may ask the user to specify the number of doses of medication remaining. The application uses the user's dosing frequency and number of remaining doses determined during account creation and customization to determine when the user will run out of doses. Next, the application may ask the user to specify how many days before (or after) the doses run out to display the reminder. If, in the first step, the user indicates that no doses are remaining and the application determines that the number of days remaining before the next scheduled dose is less than the selected reminder period, the application may display a warning advising the user to contact the pharmacy directly to obtain a prescription refill.

[0117] The application may also assist the user in associating insurance details with the application and / or filing an insurance claim to fund the prescription, as shown in FIGS. 20a-20c. FIG. 20a shows an insurance selection screen 2000 including options 2002 for allowing the user to indicate the type of insurance or other payment plan they have for the first medication. In the illustrated embodiment, options 2002 include "Commercial Insurance Plan," "Government Insurance Plan," or "Other Plan." Upon selecting a particular insurance plan option, the program may collect insurance plan details from the user on subsequent screens. After the information is collected, it may be communicated to an external system, such as the patient support portal shown in FIG. 11. While the insurance plan investigation is in progress, the application may display a benefits notification 2006 informing the user that the investigation is in progress. The benefits notification 2006 may be displayed on the application's home screen 2004, as shown in FIG. 20b. Once the benefits investigation is complete, the application may notify the user of the results of the investigation by displaying a push notification 2008 on the lock screen of the user's device. In this way, the application can assist the user in many aspects of obtaining access to and financing a first medication. The insurance selection screen 2000 can be displayed as part of the account creation process or at a later time.

[0118] FIG. 21 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, or the like. 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.

[0119] The user device 400 may include hardware including a processing circuit 401. The processing circuit 401 may include a processor 402 and memory 404. The user device 400 may also include 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 include 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).

[0120] 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 an 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.

[0121] 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.

[0122] 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).

[0123] The user device 400 includes one or more user inputs 408, such as a touch screen, 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 an image of the user and images of labels, codes, etc. that appear on the medication administration device, packaging, or storage device. The user device 400 may be configured to scan the 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 on the medication administration device.

[0124] 22 is a flowchart of an exemplary method for assisting a user in managing multiple medical conditions being treated by medications. In operation 2200, a program (also called an application) for managing multiple medical conditions being treated by a first medication is executed on a computing device / system. The method may be performed by a computing system such as the system described in connection with FIG. 21. Upon execution, the program may perform a customization process associated with two or more medical conditions of the user, as described below.

[0125] In operation 2202, a user interface is provided that allows a user to specify a first medical condition to be treated by a first medication, for example, using the methods described in connection with Figures 2a-2e. In operation 2204, a user interface is provided that allows a user to specify a second medical condition to be treated by the first medication, for example, using the methods described in connection with Figures 2f-2h.

[0126] Providing a user interface that allows a user to specify the first and second medical conditions may include providing a single user interface display that allows a user to specify both the first medical condition to be treated by the first medication and the second medical condition to be treated by the first medication. The user interface may allow a user to specify additional medications to be used to treat the first medical condition, the second medical condition, or the additional medical condition. In some other embodiments, the user interfaces for specifying the first and second (and additional) medical conditions may be presented on separate or consecutive screens.

[0127] In act 2206, therapeutic access information related to the first medication is provided by the program. The therapeutic access information may include information regarding how to obtain the particular medication and / or prescription information communicated to the program by an external source, such as a physician or pharmacy. The therapeutic access information may include retrieval or delivery details for the first medication. The therapeutic access information may include insurance and / or financial information regarding the acquisition of the first medication.

[0128] In operation 2208, the program provides at least one of information about the first medical condition, a journal that facilitates entry of symptoms related to the first medical condition, and a notification related to the first medical condition. The information about the first medical condition may include physiological data of the user and / or activity data of the user. The information about the first medical condition may include environmental information. Providing a notification related to the first medical condition may include displaying a notification within the program or pushing a notification that appears on a lock screen or home screen of a user device running the program. The notification may provide a reminder to perform a specific action related to the first medical condition, such as joining an appointment, joining a call, administering medication, or making a journal entry.

[0129] At operation 2210, the program provides at least one of information about the second medical condition, a journal that facilitates entry of symptoms associated with the second medical condition, and a notification about the second medical condition. The information about the second medical condition may include physiological data of the user and / or activity data of the user. The information about the second medical condition may include environmental information. Because the first medical condition and the second medical condition are different, the user's associated physiological data and / or the user's activity data and associated environmental information may also be different.

[0130] Providing a notification regarding the second medical condition may include displaying a notification within the program or pushing a notification that appears on a lock screen or home screen of a user device running the program. The notification may provide a reminder to perform a particular action related to the second medical condition, such as attending an appointment, joining a call, administering medication, or making a journal entry.

[0131] 22 , the computer-implemented method may further include providing a dose support screen having a call scheduling element configured to initiate a call scheduling process with a healthcare professional when selected. The computer-implemented method may further include providing a pre-call instruction screen including instructions for preparing and / or administering the first medication, and a call initiation element configured to initiate the call by opening a phone application when selected. The computer-implemented method may further include providing a post-call screen including a body representation or model having a plurality of predetermined regions for indicating the location of an injection.

[0132] In addition to the operations described above with respect to FIG. 22 , the computer-implemented method may further include providing a reminder system configured to allow input of medication administration reminder parameters and generate a reminder for display on a graphical user interface provided by the program for managing multiple medical conditions being treated by the first medication, or to generate a reminder for display as a push notification on a locked screen of the user device.

[0133] 22 , the computer-implemented method may further include pairing the program for managing the plurality of medical conditions treated by the first medication with one or more external devices and receiving user-specific data from the one or more external devices. The user-specific data may be physiological data and / or activity data. The computer-implemented method may further include receiving environmental information and displaying the environmental information.

[0134] In addition to the operations described above with respect to FIG. 22 , the computer-implemented method may further include providing a prescription management system configured to allow entry of collection or delivery details for the first medication, display status updates regarding the collection or delivery details for the first medication, and generate one or more push notifications regarding the collection or delivery details for the first medication.

[0135] In addition to the operations described above with respect to FIG. 22 , the computer-implemented method may further include providing a user interface that facilitates input of insurance and / or financial information regarding access to the first medication, transmitting the insurance and / or financial information to a third party, and displaying an insurance and / or financial status notification regarding access to the first medication.

[0136] The terms "drug" or "medicament" are used interchangeably herein to describe a pharmaceutical 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.

[0137] 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.

[0138] 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.

[0139] As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that can be formally derived from the structure of a naturally occurring peptide by deleting and / or replacing at least one amino acid residue present in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or replaced amino acid residues can be either codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. In particular, the term "derivative" refers to a polypeptide having a molecular structure that can be formally derived from the structure of a naturally occurring peptide, in which one or more organic substituents (e.g., fatty acids) are attached to one or more amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide can be deleted and / or replaced by other amino acids, including non-codable amino acids, or amino acids, including non-codable amino acids added to the naturally occurring peptide.

[0140] 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 mutations or deletions in 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).

[0141] 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 a 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.

[0142] 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, specific 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 mAbs (e.g., alirocumab), anti-IL-6R mAbs (e.g., sarilumab), and anti-IL-4R mAbs (e.g., dupilumab).

[0143] 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.

[0144] 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 all such modifications and any and all equivalents thereof.

[0145] 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 interchangeable container or may be an integrated, non-interchangeable container.

[0146] 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 integrated with a non-replaceable container. In such a system, each container holds multiple doses and may be fixed or variable in size (pre-set by the user).

[0147] 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 integrated with a non-replaceable container. 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. 1. A computer-implemented method, the method comprising: executing a program for managing a plurality of medical conditions treated by the first medication; providing a user interface that allows a user to specify a first medical condition to be treated by the first medication; providing a user interface that allows a user to specify a second medical condition to be treated by the first medication; providing therapeutic access information regarding the first medication; providing at least one of information regarding the first medical condition, a journal that facilitates entry of symptoms related to the first medical condition, and notifications related to the first medical condition; providing at least one of information regarding the second medical condition, a journal facilitating entry of symptoms related to the second medical condition, and notifications related to the second medical condition; 11. A computer-implemented method comprising:

2. 2. The computer-implemented method of claim 1, wherein providing a user interface comprises providing a single user interface display that enables the user to specify both the first medical condition to be treated by the first medication and the second medical condition to be treated by the first medication.

3. 3. The computer-implemented method of claim 1 or 2, wherein the first medical condition is atopic dermatitis and the second medical condition is asthma.

4. 4. The computer-implemented method of claim 1, wherein the user interface allows a user to specify additional medications to be used to treat the first medical condition, the second medical condition, or the additional medical condition.

5. 5. The computer-implemented method of claim 1, further comprising: pairing the program for managing a plurality of medical conditions treated by a first medication with one or more external devices; and receiving user-specific data from the one or more external devices.

6. The computer-implemented method of claim 5 , wherein the user-specific data is physiological data and / or activity data.

7. The computer-implemented method of any one of claims 1 to 6, further comprising receiving environmental information and displaying the environmental information.

8. determining that approval is required to customize the information related to the first medical condition and / or the information related to the second medical condition; presenting a user interface for obtaining said approval; The computer-implemented method of any one of claims 1 to 7, further comprising:

9. The computer-implemented method of claim 8 , wherein the authorization is to access the user's location.

10. 10. The computer-implemented method of claim 1, further comprising providing a dose support screen having a call scheduling element configured, when selected, to initiate a call booking process with a healthcare professional.

11. providing a pre-call instruction screen, the pre-call instruction screen comprising: instructions for preparing and / or administering said first agent; and A Start Call element configured to start a call and open the Phone application when selected The computer-implemented method of claim 10, comprising:

12. The computer-implemented method of claim 11 , further comprising providing a post-call screen including a body representation having a plurality of predetermined regions for indicating the location of an injection.

13. Allows entry of medication reminder parameters; Generate a reminder for display on a graphical user interface provided by the program for managing a plurality of medical conditions being treated with the first medication, or generate a reminder for display as a push notification on a locked screen of the user device. The computer-implemented method of any one of claims 1 to 12, further comprising providing a reminder system configured to:

14. permitting entry of collection or delivery details for the first medication; displaying a status update regarding collection or delivery details of the first medication; generating one or more push notifications regarding collection or delivery details of the first medication; The computer-implemented method of any one of claims 1 to 13, further comprising providing a prescription management system configured to:

15. providing a user interface that facilitates the entry of insurance and / or financial information regarding access to the first medication; transmitting insurance and / or financial information to third parties; displaying a notice of insurance and / or financial status regarding access to said first medication; The computer-implemented method of any one of claims 1 to 14, further comprising:

16. scanning a code on the injection device to check the expiration date of the medication in the injection device; outputting a warning via the program if the medication in the injection device is determined to be expired; The computer-implemented method of any one of claims 1 to 15, further comprising:

17. scanning a code associated with a new injection device or a new batch of injection devices; launching the program and determining that the user is a registered user of the program; displaying a user interface asking the user to confirm that they have received a new injection device or batch of injection devices; The computer-implemented method of any one of claims 1 to 16, further comprising:

18. resetting a refill reminder within the program in response to receiving a user input confirming receipt of the new injection device or batch of injection devices. The computer-implemented method of claim 17 further comprising:

19. A non-transitory computer-readable storage medium containing instructions, which when executed by a computer, cause the computer to: executing a program for managing a plurality of medical conditions treated by the first medication; providing a user interface that allows a user to specify a first medical condition to be treated by the first medication; providing a user interface that allows a user to specify a second medical condition to be treated by the first medication; providing therapeutic access information regarding the first medication; providing at least one of information regarding the first medical condition, a journal that facilitates entry of symptoms related to the first medical condition, and notifications related to the first medical condition; providing at least one of information regarding the second medical condition, a journal facilitating entry of symptoms related to the second medical condition, and notifications related to the second medical condition; A non-transitory computer-readable storage medium.

20. The instructions, when executed by the computer, cause the computer to: providing a single user interface display that allows the user to specify both the first medical condition to be treated by the first medication and the second medical condition to be treated by the first medication.

20. The non-transitory computer-readable storage medium of claim 19,

21. The instructions, when executed by the computer, cause the computer to: determining that approval is required to customize the information related to the first medical condition and / or the information related to the second medical condition; presenting a user interface for obtaining said approval; 21. The non-transitory computer-readable storage medium of claim 19 or claim 20,

22. 22. The non-transitory computer-readable storage medium of claim 21, wherein the authorization is to access the user's location.

23. 23. The non-transitory computer-readable storage medium of any one of claims 19 to 22, wherein the instructions, when executed by the computer, cause the computer to receive environmental information and display the environmental information.

24. executing a program for managing a plurality of medical conditions treated by the first medication; providing a user interface that allows a user to specify a first medical condition to be treated by said first medication; providing a user interface that allows a user to specify a second medical condition to be treated by the first medication; providing therapeutic access information regarding said first medication; providing at least one of information regarding the first medical condition, a journal that facilitates entry of symptoms related to the first medical condition, and notifications related to the first medical condition; providing at least one of information regarding the second medical condition, a journal that facilitates entry of symptoms related to the second medical condition, and notifications related to the second medical condition; a user device including a processing circuit configured to:

25. the processing circuitry Pairing the program for managing a plurality of medical conditions treated by a first medication with one or more external devices and receiving user-specific data from the one or more external devices.

25. The user device of claim 24, further configured to:

26. The user device of claim 25 , wherein the user-specific data is physiological data and / or activity data.

27. The processing circuitry controlling a camera of the user device to scan a code on an injection device; checking the expiration date of the medication in the injection device based on the scanned code; If the medication in the injection device is determined to be expired, outputting a warning via the program. A user device according to any one of claims 24 to 26, further configured to:

28. The processing circuitry controlling a camera of the user device to scan a code associated with a new injection device or a new batch of injection devices; launching the program and determining that the user is a registered user of the program; Displaying a user interface and prompting the user to confirm receipt of a new injection device or batch of injection devices. A user device according to any one of claims 24 to 27, further configured to:

29. the processing circuitry In response to receiving a user input confirming receipt of the new injection device or batch of injection devices, a refill reminder within the program is reset.

30. The user device of claim 28, further configured to:

Images