System and method for reservation preparation and diary entries

Abstract

Systems and methods for reservation preparation and diary entries provide a non-transitory computer-readable storage medium, method, and user device configured to execute a procedure for managing a medical condition or treatment of a user. The program displays a user interface that includes user-selectable options for preparing a report for an appointment with a healthcare professional, the report including information associated with managing or treating a medical condition of the user. Responsive to a user's interaction with the user-selectable option, the program determines whether a diary entry associated with managing or treating a medical condition of the user is stored within a memory accessible to the program. In response to determining that the diary entry is stored within the memory, the program generates a report including the diary entry associated with the medical condition of the user and transmits the report to the healthcare professional.

Description

Technical Field

[0001] This specification relates to systems and methods for the management of medicines and diseases, and more particularly to computer-implemented systems and methods, as well as user devices, for facilitating the preparation of appointments between users and healthcare professionals. Background Technology

[0002] A major obstacle to high-quality treatment outcomes is patient engagement and adherence to the prescribed medication regimen, as well as patients' understanding of the factors that influence their disease progression and overall health.

[0003] In particular, some patients may have chronic medical conditions whose symptoms may vary in their occurrence and intensity (spatial and temporal). Some patients may find it difficult to manage these systems effectively and will benefit from better interaction with healthcare professionals and ongoing support from them.

[0004] Current systems are ineffective in allowing patients to monitor their symptoms and adhere to medication regimens in a convenient manner. Therefore, there is a need for systems and approaches that provide effective and timely assistance and ongoing support to patients in monitoring and reporting changes in medical conditions and treatment, thereby improving patient engagement and adherence, and ultimately, improving treatment outcomes. Summary of the Invention

[0005] A first aspect of this specification provides a non-transitory computer-readable storage medium comprising instructions that, when executed by a computing device, cause the computing device to: execute a program for managing a user's medical condition or treatment; display a user interface including user-selectable options for preparing a report for an appointment with a healthcare professional (HCP), the report including information associated with managing or treating the user's medical condition; in response to user interaction with the user-selectable options, determine whether a diary entry associated with managing or treating the user's medical condition is stored in memory accessible to the program; in response to determining that the diary entry is stored in the memory, generate a report including the diary entry associated with the user's medical condition; and transmit the report to the HCP.

[0006] The information associated with the management or treatment of the user's medical condition may include one or more of the following: the user's patient information, one or more medical conditions, prescription information, the user's registered physician and / or medical practice, one or more diary entries, and the results of one or more clinical questionnaires.

[0007] The memory can be the memory of the computing device or external memory.

[0008] These instructions can be further configured, when executed by the computing device, to cause the computing device to: generate a notification reminding the user to prepare for an appointment with the HCP; and, in response to the user's interaction with the notification, display a user interface including user-selectable options for preparing the report.

[0009] The notification may be generated in response to a triggering event.

[0010] The triggering event can include one or more of the following: scheduled appointments, new appointments, and reminders.

[0011] The user-selectable option can be an option to choose one or more medical conditions of the user to be included in the report.

[0012] These instructions can be further configured, when executed by the computing device, to cause the computing device to: in response to receiving a user's selection of the one or more medical conditions, determine whether a diary entry for each of the selected one or more medical conditions is stored in the memory; and in response to determining that a diary entry for each of the selected one or more medical conditions is stored in the memory, generate a report including a diary entry for each of the selected one or more medical conditions.

[0013] These instructions can be further configured to, when executed by the computing device, cause the computing device to: in response to generating the report, display a user interface including one or more user-selectable options for editing the report by modifying, adding, or removing information included in the report.

[0014] The one or more user-selectable options for editing the report include options for completing the diary entries to be included in the report.

[0015] These instructions can be further configured, when executed by the computing device, to cause the computing device to: in response to user interaction with the user-selectable options for completing the diary entry, display one or more user interfaces including one or more of the following: questions, environmental data, user-selectable options for uploading files to be included in the diary entry, and user-selectable options for completing clinical questionnaires to be included in the diary entry.

[0016] These files may include one or more of the following: documents, PDFs, audio files, video files, and image files.

[0017] The one or more user-selectable options for editing the report may include options for completing a clinical questionnaire.

[0018] These instructions can be further configured, when executed by the computing device, to cause the computing device to: in response to user interaction with the user-selectable options for completing the clinical questionnaire, display one or more user interfaces including one or more questions related to the current state of the user's medical condition.

[0019] These instructions can be further configured to, when executed by the computing device, cause the computing device to: in response to determining that the diary entry is not stored in the memory, generate another notification prompting the user to complete the diary entry.

[0020] These instructions can be further configured, when executed by the computing device, to cause the computing device to: determine whether a clinical questionnaire associated with monitoring the control of the user's medical condition is stored in the memory; and in response to determining that the clinical questionnaire is not stored in the memory, generate another notification prompting the user to complete the clinical questionnaire.

[0021] These instructions can be further configured to, when executed by the computing device, cause the computing device to: automatically or in response to user input that transmits the report to the HCP.

[0022] A second aspect of this specification provides a computer-implemented method comprising: executing a program for managing a user's medical condition or treatment; displaying a user interface including user-selectable options for preparing a report for an appointment with a healthcare professional (HCP), the report including information associated with managing or treating the user's medical condition; determining, in response to user interaction with the user-selectable options, whether a journal entry associated with managing or treating the user's medical condition is stored in memory accessible to the program; generating, in response to determining that the journal entry is stored in the memory, a report including the journal entry associated with the user's medical condition; and transmitting the report to the HCP.

[0023] The computer-implemented method may further include, in response to generating the report, displaying a user interface including one or more user-selectable options for editing the report by modifying, adding, or removing information included in the report.

[0024] The one or more user-selectable options for editing the report may include options for completing the diary entries to be included in the report.

[0025] The computer-implemented method may further include, in response to user interaction with user-selectable options for completing a diary entry, displaying one or more user interfaces including one or more of the following: questions, environmental data, user-selectable options for uploading files to be included in the diary entry, and user-selectable options for completing a clinical questionnaire to be included in the diary entry.

[0026] A third aspect of this specification provides a user device including a processing circuitry system configured to: execute a program for managing a user's medical condition or treatment; display a user interface including user-selectable options for preparing a report for an appointment with a healthcare professional (HCP), the report including information associated with managing or treating the user's medical condition; in response to user interaction with the user-selectable options, determine whether a diary entry associated with managing or treating the user's medical condition is stored in memory accessible to the program; in response to determining that the diary entry is stored in the memory, generate a report including the diary entry associated with the user's medical condition; and transmit the report to the HCP.

[0027] The processing circuitry can be further configured to display a user interface, including one or more user-selectable options for editing the report by modifying, adding, or removing information included in the report, in response to the generation of the report.

[0028] The one or more user-selectable options for editing the report include options for completing the diary entries to be included in the report.

[0029] The processing circuitry can be further configured to display one or more user interfaces, including one or more of the following, in response to user interaction with the user-selectable options for completing a diary entry: questions, environmental data, user-selectable options for uploading files to be included in the diary entry, and user-selectable options for completing a clinical questionnaire to be included in the diary entry.

[0030] The processing circuitry can be further configured to generate another notification prompting the user to complete the diary entry in response to determining that the diary entry is not stored in the memory. Attached Figure Description

[0031] To gain a more comprehensive understanding of the general concepts set forth in the foregoing sections, embodiments thereof will be described with reference to the accompanying drawings, in which:

[0032] Figure 1 The overall architecture of the system in which computer programs run is shown;

[0033] Figures 2a to 2g show exemplary screenshots displayed by a computer program related to helping users prepare for appointments with healthcare professionals;

[0034] Figures 3a to 3h show exemplary screenshots related to control tools associated with atopic dermatitis, displayed by a computer program;

[0035] Figures 4a to 4g show exemplary screenshots related to asthma-related control tools displayed by a computer program;

[0036] Figure 5 This shows an example of the content of a report created by a computer program;

[0037] Figures 6a and 6b show exemplary screenshots related to diary entries displayed by a computer program;

[0038] Figures 7a to 7d show exemplary screenshots related to creating a new diary entry, displayed by a computer program;

[0039] Figures 8a to 8f show exemplary screenshots displayed by a computer program related to adding additional data to a diary entry;

[0040] Figures 9a and 9b show exemplary screenshots displayed by a computer program in relation to identifying body areas affected by a user's medical condition;

[0041] Figures 10a and 10b show exemplary screenshots related to environmental data displayed by a computer program;

[0042] Figure 11a shows an exemplary screenshot of a control tool associated with atopic dermatitis, displayed by a computer program;

[0043] Figure 11b shows an exemplary screenshot related to asthma control tools displayed by a computer program;

[0044] Figures 12a and 12b show exemplary screenshots displayed by a computer program in relation to confirming the completion of a diary entry;

[0045] Figure 13 A flowchart illustrating the process for recording diary entries, as described in this article, is shown;

[0046] Figure 14a shows a flowchart illustrating an example of the appointment preparation process;

[0047] Figure 14b shows a flowchart illustrating another example of the appointment preparation process; and

[0048] Figure 15 A user device based on an example described herein is illustrated schematically. Detailed Implementation

[0049] This disclosure relates to an application that runs on a user's device and assists the user in managing and treating one or more medical conditions. Specifically, the application prompts the user to prepare for appointments with a doctor, nurse, or other healthcare professional, during which support is provided for the management and treatment of one or more of the user's medical conditions. The application provides the user with a convenient way to track treatment events and create a health diary related to one (or more) conditions being treated. The application assists the user in recording this information and adhering to their prescribed medication regimens. The application also provides a simple and efficient way to report this information to healthcare professionals as a means of supporting the user and assisting healthcare professionals in monitoring the user's treatment and / or disease progression.

[0050] This application can be used to manage multiple diseases treated with various different agents. While some embodiments in the following specific examples are described with respect to the use of a single agent for the treatment of atopic dermatitis and / or asthma, the application is not limited thereto. The application can also manage various other immunological indications or other indications, wherein one or more of these immunological indications or other indications can be treated with a single agent approved for the treatment of that one or more immunological indications or other indications. Such a single agent may include, for example, different doses, different volumes or concentrations of the same API, or different formulations containing the same API. In some embodiments, the single agent may include an anti-IL-4R mAb (e.g., dupilumab). Furthermore, the application can manage multiple immune disorders or other conditions. Prescriptions for one or more medications can be issued to the user, and the application provides personalized support to the user based on the user's specific medication prescription and health profile. For example, the application can be configured to provide support for many diseases caused by type 2 inflammation. In the context of dermatology, this can include atopic dermatitis, nodular prurigo, bullous pemphigoid, urticaria (e.g., chronic spontaneous urticaria or cold-induced urticaria), hand-foot disease, or pruritus, each of which can be treated with injectable Dupixent® or other injectable medications, but may also be treated with some oral and topical medications. In the context of respiratory diseases, this can include asthma, nasal polyps, sinusitis (e.g., chronic sinusitis with or without nasal polyps), allergic bronchopulmonary aspergillosis (ABPA) or allergic fungal sinusitis (AFRS) (which can be treated with injectable Dupixent® or other injectable medications, but may also be treated with some oral medications), and chronic obstructive pulmonary disease (COPD) (which can be treated with injectable Dupixent® or other injectable medications). In the context of gastroenterology, this can include inflammatory bowel disease (IBD) and eosinophilic esophagitis (EoE), eosinophilic gastroenteritis (EGE), or ulcerative colitis, which can be treated with injections of Dupixent® or other injectable medications, but may also be treated with some oral medications.

[0051] refer to Figure 1This diagram illustrates a schematic overview of the overall architecture 100 of a disease management and medication protocol management system. System architecture 100 shows numerous functional modules and the data links between them. System architecture 100 includes user devices 104 running applications with numerous functional modules, shown in the central box. Architecture 100 also demonstrates how the applications running on user devices 104 can interact with other service providers to enhance the information available to users through the applications. For example, through communication with insurance / benefit provider systems and pharmacies.

[0052] One of these functional modules is the diary module 102. The diary module 102 is configured to allow a user to maintain a diary related to one or more medical conditions. The diary can include multiple entries that describe in detail the onset of one or more medical conditions, such as symptoms, user-specific health data, contextual information, etc. The diary can be used to monitor patterns in one or more medical conditions and to identify potential triggers for the onset of those conditions. The diary module 102 can communicate with an external service (adverse events). The diary module can transmit patient information associated with the onset of one or more medical conditions to the adverse event service.

[0053] A diary can further maintain a record of a user's adherence to a treatment plan, such as a medication regimen. For example, a diary entry may include a record of the dosage of medication the user has taken (e.g., a pre-determined dose), such as an injection log. The record may form a dosage record, which includes various information associated with the dosage administered by the user. The record may be stored as part of a diary entry or independently of the diary entry.

[0054] The functional module may further include a storage module or a database 106. The storage module 106 is configured to store diary entries generated by the user via the diary module 102 for later retrieval and / or analysis. In some embodiments, the storage module 106 may be linked to the cloud and remotely store diary entries.

[0055] In some embodiments, the functional module may further include a weather module 108. The weather module 108 is configured to determine and / or record weather conditions at the user's location. The user's location may be determined, for example, via the GPS function of the user's device. The weather module 108 may, for example, access an online weather forecast system to obtain current weather conditions, previous weather conditions, and / or predicted future weather conditions. The weather module 108 may provide weather conditions to the log module 102 to include them in log entries. Other weather conditions include, for example, general weather conditions, temperature, humidity, air pressure, and UV index. The weather module may also obtain air quality information such as pollen count, pollution index, NO2 count, and / or air quality index.

[0056] Another module in the functional modules is the user management module 110. The user management module 110 is responsible for obtaining user preferences and generating notifications to be output on the user device 104. The necessary data for the notification scheme can be stored in the memory module 106. The user management module 110 can also update the information stored in the memory module 106 when the application is used.

[0057] User management module 110 can define and assist in implementing notification schemes that determine when and how notifications should be generated and output on user device 104. Notification schemes can have three main notification types: (i) silent notifications; (ii) batch summary notifications; and (iii) push notifications.

[0058] In some embodiments, silent notifications can be silently pushed into an application and can only be viewed within the application. Silent notifications within the application can be presented to the user, for example, on the application's home screen. In some embodiments, silent notifications are presented to the user when certain requirements are met and no user action is required. Bulk summary notifications can involve several different alerts and other notifications. Users can interact with bulk summary notifications to expand and display individual notifications. Bulk summary notifications can indicate the number of notifications available for the user to view. Push notifications can involve 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 and actionable items that require immediate user attention. They are reserved for actions related to the user's regular treatment or as a follow-up action that may affect the user's access to treatment / medication.

[0059] Notifications can be escalated, meaning the notification type can be upgraded based on the user's action (or the absence of that action). For example:

[0060] a. When a user has 5 days until their next dose, their next dosing reminder will be displayed as a silent notification in the app, such as below a carousel on the app's home screen.

[0061] b. A few days before administration, the application will push bulk notifications to users to view instructional videos, schedule calls with nurses, or view self-administration instructions.

[0062] c. On the day of administration and one hour before the scheduled time, the application will send a notification to the user to take their dose. If the user's medication is stored in the refrigerator, the notification will instruct the user to remove it from the refrigerator. Interacting with this notification will trigger a warm-up timer set for the user's medication dose.

[0063] Another module in the functional modules is the Health / Assessment Module 112. The Health / Assessment Module 112 is responsible for importing users and obtaining detailed information about their medical conditions and the medications used to treat them. The Health / Assessment Module 112 can also collect information about user prescriptions and manage medication delivery.

[0064] Another module in the functional modules is the Healthcare Professionals (HCP) Services module. The HCP Services module facilitates communication with nurses, doctors, or other healthcare professionals, including scheduling reminders related to appointments and calls, prompting users to create reports or otherwise prepare for upcoming appointments or calls, initiating voice or video calls, providing follow-up notifications after calls or appointments, and initiating journal entries after calls or appointments. The HCP Services module interacts with the internet-based patient support program. Healthcare professionals also have access to certain aspects and information stored by the patient support program to facilitate communication with users and monitor their treatment and / or disease progression.

[0065] Another module among these functional modules is the consent module, which, in conjunction with other aspects of the system, is responsible for managing consent and permission to access patient-specific information, such as the user's health-related data. The memory module 106 can be configured to store user IDs and role information, as well as consent templates for use by the consent module. The memory module 106 can also store consent and permission information entered by the user via the consent module, including any time limits set for consent and permission.

[0066] The consent module can communicate with an external service known as the consent management service. Consent and permission information generated by the consent module can be stored or copied to the consent management service. The consent management service can also be responsible for sending patient-specific information to third parties when permitted by associated consent instructions.

[0067] Another module in the functional modules is the content module. The content module is responsible for receiving and recording personalized content and / or preferences set by the user. The content module can communicate with an external service called content management. The content management service is responsible for providing patient-specific content or settings from external users, such as healthcare professionals. The content module can interact with the storage module 106 to store personalized content and / or settings.

[0068] Another module in the functional modules is the benefits module, which, in conjunction with other aspects of the system, is responsible for managing patient access to healthcare. The benefits module may include pharmacy integration services and / or benefits integration services. Information generated by the benefits module can be used to send patient-specific information to third parties to instruct patients on access to healthcare services. The benefits module can interact with external services, such as benefits provider systems and pharmacy services.

[0069] Another module in the functional modules is the analysis module. The analysis module, in conjunction with other modules (such as the diary module 102, the user management module 110, and the health assessment module 112), can be responsible for analyzing patient information related to the status and / or treatment of a user's medical condition.

[0070] Another module in the functional modules is the messaging system. The messaging system can communicate with the analytics module. For example, if the analytics module identifies an onset or triggering condition of one or more medical conditions in a user, the messaging system outputs a message conveying this result. The messaging system can also communicate with external services known as the information hub. The information hub can store data received from the messaging system. The information hub can also interact with other service providers to enhance the information about the user that can be stored through the application. This includes communication with patient support programs, insurance / benefit provider systems and pharmacies, adverse event services, etc.

[0071] Referring now to Figures 2a through 2g, screenshots are shown demonstrating an application that helps users prepare for an appointment with HCP.

[0072] The application assists users in creating reports and / or otherwise preparing for upcoming appointments or calls with a doctor, nurse, or other healthcare professional, where support is provided for the management, treatment, and / or progression of one or more of the user's medical conditions. Hereafter, the term healthcare professional is used to encompass all such professionals. The application prompts users to prepare for upcoming or requested appointments with the HCP. Specifically, the application prompts users to create reports and transmit these reports to the HCP or external devices accessible to the HCP. Reports may include patient information and / or detailed descriptions of recorded treatments and / or disease progression recorded by the user.

[0073] In the first screenshot 200 shown in Figure 2a, a screen is displayed where the treatment tab 202 is selected. The application displays several user-selectable tabs at the bottom of the screen, including at least two of Home Screen, Treatment, Journal, Learning, and Settings. The Treatment screen has a notification area where silent notifications are displayed. A first silent notification 204 reminds the user that their next dose is due today. Alternatively, the first silent notification could remind the user of their upcoming appointment with the HCP. Interacting with the first silent notification 204 opens the notification center, where any further details related to the notification and any other notifications awaiting the user's attention can be seen. At the top of the home screen, a second silent notification or a graphic with suggested actions is displayed. The content of the suggested action changes based on the proximity of the user's next scheduled dose, doctor's appointment, prescription renewal / delivery date, etc. In the example of the first screenshot 200 in Figure 2a, the suggested action is preparing a report for an upcoming appointment. A user-selectable option 206 prompting the user to prepare a report is provided.

[0074] When the user interacts with the user-selectable option 206, a second screenshot 208 of Figure 2b or a third screenshot 214 of Figure 2c is displayed.

[0075] If the application is assisting a user in managing and / or treating more than one disease, a second screenshot 208 of Figure 2b is shown. In other words, if the user is a comorbid user, a second screenshot 208 of Figure 2b can be shown. The screen includes multiple (two or more) user-selectable options 210, each associated with a particular medical condition of the user. The user can select one or more of these icons, such that an entry for each medical condition in the selected medical condition will be included in the report. When the user selects one or more of these icons, a user-selectable option 212 that allows the user to choose to continue can be activated or otherwise made optional. The user can choose to continue preparing the report or cancel the action. When the user interacts with the user-selectable option 212, a third screenshot 214 of Figure 2c is shown.

[0076] Alternatively, when the application assists the user in managing and / or treating a single medical condition, the third screenshot 214 of Figure 2c is shown. In this example, when the user interacts with the user-selectable icon 206 shown in Figure 2a, the second screenshot of Figure 2b is omitted and the third screenshot 214 of Figure 2c is shown immediately.

[0077] In Figure 2c, a third screenshot 214 shows a report summary screen displaying numerous areas providing various information, including patient information and / or detailed descriptions of recorded treatments and / or disease progression by the user. For example, these areas may include detailed descriptions of one or more of the following: the time period covered by the report, patient information, medical conditions, prescription information, and the registered user's medical practices and / or physician. Similarly, other information may be provided or omitted in various combinations. For example, in the example shown in Figure 2c, two medical conditions are shown, but the user may also have a single medical condition or more than two. The report summary screen includes a diary area where one or more user-selectable icons 216 representing diary entries are displayed. Interacting with a user-selectable icon 216 opens the selected diary entry. The diary area may also include user-selectable options (not shown) for completing diary entries. Diary entries and the process of completing diary entries will be discussed in more detail below.

[0078] The report summary screen includes a control tools area, which displays one or more user-selectable icons 218 representing control tool questionnaire entries. The control tool questionnaire provides scores associated with the control or progression of a user's medical condition. Interacting with user-selectable icons 218 opens a report detailing the selected control tool questionnaire entry. An example report is shown in the fourth screenshot 222 of Figure 2d. The control tools area may also include user-selectable icons 220 that provide information about the control tool questionnaire. The icon can be represented by "i," but other graphics can also be used. Interacting with user-selectable icons 220 opens a screen including a control tool information area, such as the screen shown in the fifth screenshot 224 of Figure 2e. The control tool information area provides further information explaining the purpose and function of the questionnaire and scores associated with the control tool. The screen may also display additional links to provide users with access to additional information about the tool. Referring back to Figure 2c, the control tools area may also include additional user-selectable options 226 for completing the control tool questionnaire.

[0079] In Figure 2c, the report summary screen also includes a user-selectable option 228 for allowing the user to choose to download the report. Interacting with the user-selectable option 228 provides confirmation from the user that the report is ready to be downloaded, and in response, the application downloads the report. A sixth screenshot 230 of Figure 2f can be shown when the user interacts with the user-selectable option 228. The sixth screenshot 230 includes a graphic confirming that the report has been downloaded. The application records, saves, or otherwise stores the report. The application may store the report in the memory of the user's device. Alternatively, the application may be linked to the cloud, and the report may be stored remotely.

[0080] In response to a user's selection to download a report, the application can automatically transmit the report. In another example, once the report has been downloaded, the application can transmit the report only in response to confirmation from a user who has selected to transmit the report to the HCP. Confirmation can be provided in advance by the user, for example, through consent permissions or preferences set by the user via one of the system's functional modules. For example, through the user management module 110, the health / assessment module 112, the HCP service module 114, etc. Alternatively, the application can display a notification prompting the user to select whether to transmit the report (or not) to the HCP. In response to an affirmative user interaction with the notification selecting to transmit the report, the application transmits the report to the HCP (or vice versa). The application can transmit the report to the HCP directly or via the cloud or other external devices accessible to the HCP. In response to a negative user interaction with the notification, the application does not transmit the report.

[0081] In another example, Figure 2g shows a seventh screenshot 232, which illustrates an alternative report summary screen. Similar to Figure 2c, the report summary screen displays multiple areas providing various information, including patient information and / or detailed descriptions of treatments and / or disease progression recorded by the user. Here, one area of ​​the report summary screen shows that the user only has one medical condition managed by the application, but this is just an example. The report summary screen includes a diary area and a control tool area. In this example, the diary area and control tool area indicate that the user has not yet completed any diary entries or control tool questionnaires. In the diary area, a graphic with suggested actions is displayed. In this example, the suggested action is to add a new diary entry, and the graphic includes user-selectable options 234 for completing the diary entry. In the control tool area, a graphic with suggested actions is displayed. In this example, the suggested action is to add a control tool entry, and the graphic includes user-selectable options 236 for completing the control tool questionnaire.

[0082] In Figure 2g, the report summary screen also includes a user-selectable option 238 for allowing the user to choose to download the report summary. In this example, user-selectable option 238 is disabled. In some embodiments, the option to download the report is disabled until the journal entry and / or control tool questionnaire entry is recorded. When the journal entry and / or control tool questionnaire entry is completed, user-selectable option 238 is activated to allow the user to choose to download the report summary. Once the report summary is downloaded, the application can transmit the report to the HCP in the same manner as described above with respect to Figure 2c.

[0083] However, it should be understood that this is merely an example, and the application could also provide user-optional features allowing users to choose to download reports that describe detailed patient information without including diary entries or control tool questionnaire entries. For example, if a user has not yet completed diary entries because they have just started treatment, the patient information could form the basis of the initial report sent to the HCP at the start of the medication regimen or treatment process.

[0084] Referring now to Figures 3a through 3h, screenshots are shown illustrating the entries for a control tool, more specifically a control tool questionnaire. The control tool questionnaire comprises a series of clinical questions used to monitor and / or detect disease progression. The questionnaire may be referred to as a control tool questionnaire, a clinical questionnaire, etc.

[0085] Figure 3a shows a first screenshot 300 of the Control Tool Items screen, which displays the first question of the questionnaire. The Control Tool Items screen asks users to rate the symptoms of their medical condition using qualitative descriptions (e.g., “none,” “mild,” “severe,” etc.). Figure 3b shows a second screenshot 302 of the Control Tool Items screen, which asks users to indicate how many episodes they have experienced associated with their medical regulator using a numerical scale. Figure 3c shows a third screenshot 304 of the Control Tool Items screen, which asks users to indicate the degree of distress they experience from their medical condition using qualitative descriptions (e.g., “none,” “mild,” “severe,” etc.). Figure 3d shows a fourth screenshot 306 of the Control Tool Items screen, which asks users to indicate whether they experience problems at night due to their medical condition using a numerical scale. Figure 3e shows a fifth screenshot 308 of the Control Tool Items screen, which asks users to indicate the degree of impact their medical condition has on their daily activities using qualitative descriptions (e.g., “none,” “moderate,” “very severe,” etc.). Figure 3f shows a sixth screenshot 310 of the control tool entries screen, which asks users to indicate the degree to which their medical condition affects their emotional state using qualitative descriptions (e.g., “not at all,” “moderate,” “very much,” etc.).

[0086] In the examples above, the questions require users to provide qualitative or quantitative answers. However, for each question, any other suitable method of indication can be used, such as qualitative descriptions, quantitative descriptions, or graphical indicators, such as emojis.

[0087] The control tool entry screen may also include a back button and / or a continue button. The continue button, when selected, causes the next control tool entry screen to appear. Conversely, the back button, when selected, causes the previous control tool entry screen to appear. In the examples shown in Figures 3a to 3f, qualitative descriptions ("continue" and "back") are used. However, any other suitable indication method can be used to allow the user to switch back and forth between screens, such as numerical or graphical indicators (e.g., arrows, checkmarks, crosses, emojis, etc.) indicating subsequent and / or previous question numbers.

[0088] One or more of these control tool entry screens may also include a graph showing the number of questions in the questionnaire to be completed and / or the user's progress in completing the questionnaire. This graph can be reproduced on each control tool entry screen to indicate that questions are being completed and / or the questionnaire is progressing. In the examples shown in Figures 3a to 3f, the graph displays each question as a number in a circle, and when a question is completed, that number is replaced by a checkmark. Any other suitable indication method, such as a progress bar, may be used. Although the graph is displayed at the top of the screen, any other suitable location on the screen may be used. The graph may also be implemented as a user-selectable option that allows the user to choose which specific questions to view, jump forward to, or return to.

[0089] Furthermore, in the examples shown in Figures 3a to 3f, the questionnaire includes six questions, but any other suitable number of questions can be implemented. Additionally, the questions shown relate to an exemplary medical condition, namely atopic dermatitis. However, this application is not limited to this medical condition. Any other questions suitable for users registering with the application for other medical conditions can be provided.

[0090] When a user completes the questionnaire, the screen shown in the seventh screenshot 312 of Figure 3g or the screen shown in the eighth screenshot 314 of Figure 3h is displayed. The screens displayed in the seventh screenshot 312 and the eighth screenshot 314 of Figures 3g and 3h may include graphs indicating questionnaire completion. The screens may also include graphs indicating scores associated with the questionnaire. This may be referred to as a control tool score, status score, control status score, etc. The graphs may also include suggested statuses for the user's medical condition. The content of the suggested status changes based on the control status score. In the screen shown in the seventh screenshot 312 of Figure 3g, the suggested status is that the condition is likely well controlled. In the screen shown in the eighth screenshot 314 of Figure 3h, the suggested status is that the condition is likely not well controlled. The graphs may also include suggested actions, such as contacting the HCP to discuss the medical condition and / or treatment options.

[0091] The application determines a control status score. For each question, a value (e.g., points) is assigned to each of the user's selectable response options. The application determines the value associated with each response selected by the user and calculates a final score upon completion of the questionnaire. Based on the calculated final score, the application determines that the user's medical condition is well controlled, as shown in Figure 3g, or that the application determines that the user's medical condition is poorly controlled, as shown in Figure 3h. The application stores records of completed questionnaires and associated scores. The score provides an indication of the control status or the state of the user's medical condition at a specific point in time (i.e., when the questionnaire is completed).

[0092] Because control tool questionnaires can be completed more than once, the application can record, monitor, and detect changes in a user's medical condition status over time. For example, the application can monitor changes in control status scores and detect whether a user's condition has improved or worsened, or whether the user's condition has been aggravated by a specific environment or user-specific condition. If the application determines a high control status score or a significant change in control status score, it can prompt the user to request an appointment with the HCP or create and / or send a report to the HCP. For example, a change in control status score of five points or more can indicate a clinically relevant change in the user's health status. Similarly, a "high" control status score can be 10 points or more above a threshold.

[0093] By monitoring and recording the control status of a user's medical regulator, the application can assist the user and HCP in managing and treating the user's medical conditions. Furthermore, by improving support and patient care through the application, users are more likely to adhere to the medication regimens used to treat their medical conditions.

[0094] The control tool and control tool questionnaire have been described above. In the examples shown in Figures 3a to 3f, the control tool questionnaire questions relate to an exemplary medical condition, namely atopic dermatitis. However, this application is not limited to this medical condition. It should be understood that the control tool can target other medical conditions registered by the user with the application. Therefore, the control tool questionnaire may include any other questions suitable for assessing another medical condition registered by the user with the application.

[0095] For example, referring to Figures 4a to 4g, screenshots are shown of entries displaying control tools, and more specifically, control tool questionnaires for asthma medical conditions.

[0096] Figures 4a to 4e show exemplary screenshots 400 to 408 of the screens, which include example questions from a control tool questionnaire for different medical conditions (i.e., asthma). Similarly, screenshot 410 of Figure 4f shows a screen where the application determines the condition is well controlled after the user has completed the asthma questionnaire, and screenshot 412 of Figure 4g shows a screen where the application determines the condition is not well controlled.

[0097] Additionally, in the examples shown in Figures 3a to 3f, the questionnaire includes six questions, but any other suitable number of questions can be implemented. For example, in the exemplary screenshots shown in Figures 4a to 4e, the questionnaire includes five questions.

[0098] Now for reference Figure 5 The image shows an exemplary page of a report created by an application. As described above, the report includes various patient information and / or detailed descriptions of recorded treatments and / or disease progression recorded by the user. The report may detail the number of entries and questionnaires completed by the user and / or general information, such as the dates, times, and time periods associated with the data included in the report. The report may include information associated with all of the user's medical conditions, or a separate report may be generated for each medical condition. The report may be created in various formats, such as PDF, Word documents, image files, etc. The report may be stored in the user's device's storage module. Alternatively, the storage module may be linked to the cloud, and the report may be stored remotely. The user can access and view the report via the user's device. The application may automatically or in response to user input transmit the report to the HCP (as discussed above with respect to Figure 2c).

[0099] Referring now to Figures 6a and 6b, screenshots of a diary and an application that facilitates diary entries are shown.

[0100] In the first screenshot 600 shown in Figure 6a, the Home Screen tab 602 is selected. The application displays several user-selectable tabs at the bottom of the screen, including at least two of Home Screen, Treatment, Journal, Learning, and Settings. The Home Screen has a notification area where silent notifications are displayed. A first silent notification 604 reminds the user that their next dose is due today. Interacting with the first silent notification 604 opens the Notification Center, where any further details related to the notification and any other notifications awaiting the user's attention can be seen. At the top of the Home Screen, a graphic with suggested actions is displayed. The content of the suggested actions changes based on the proximity of the user's next scheduled dose, doctor's appointment, prescription renewal / delivery date, etc. In the example of the first screenshot 600 in Figure 6a, the suggested action is to add a new journal entry. A user-selectable icon 606 is provided to prompt and enable the user to add a new journal entry.

[0101] In the second screenshot 608 shown in Figure 6b, the Diary tab 610 is selected from the user-selectable tabs at the bottom of the screen. The Diary screen has a recording area that displays one or more graphics 612 showing previous diary entries. Interacting with the graphics 612 opens the displayed diary entry. In the top portion of the main screen, a graphic with suggested actions is displayed, similar to the graphic shown in the first screenshot 600 of Figure 6a. In the Diary tab 610, the suggested action is to add a new diary entry. A user-selectable icon 606 is provided to prompt and enable the user to add a new diary entry.

[0102] Referring now to Figures 7a to 7d, screenshots are shown illustrating the means for creating new diary entries.

[0103] In many embodiments, when a user interacts with the user-selectable icon 606 of FIG. 6a or FIG. 6b, a first screenshot 700 of FIG. 7a or a second screenshot 706 of FIG. 7b is shown.

[0104] If the application is assisting a user in managing and / or treating more than one disease, a first screenshot 700 of Figure 7a is shown. In other words, if the user is a comorbid user, a first screenshot 700 of Figure 7a can be shown. The screen includes multiple (two or more) user-selectable icons 702, each associated with a medical condition of the user. The user can select one or more of these icons 702 such that each of the selected medical conditions will be included in the diary entry. The screen may include a user-selectable icon 704 that allows the user to choose to continue adding diary entries. When the screen is initially displayed, the user-selectable icon 704 may be deactivated or otherwise provided such that it is unselectable. When the user interacts with one or more of the icons 702 to select one or more medical conditions to include in the diary entry, the user-selectable icon 704 may be activated or otherwise implemented as selectable. The user can choose to continue the diary entry. The user-selectable icon 704 may also provide the user with an option to cancel the action. When the user interacts with the user-selectable icon 704, a second screenshot 706 of Figure 7b is shown.

[0105] Alternatively, in another example, a second screenshot 706 of Figure 7b is shown when the application assists the user in managing and / or treating a single medical condition. In this example, the first screenshot 700 of Figure 7a is omitted, and the second screenshot 706 of Figure 7b is shown when the user interacts with the user-selectable icon 606 of Figure 6a or Figure 6b.

[0106] In the second screenshot 706 of Figure 7b, the application shows a screen that includes a user-selectable option 708 for entering and / or confirming the date of a diary entry, and an optional user-selectable option 710 for entering and / or confirming the time of a diary entry. The screen may further include a user-selectable icon 704 for allowing the user to choose to continue with the diary entry. Although not shown, the user-selectable icon 704 may also provide the user with an option.

[0107] In the third screenshot 712 of Figure 7c, the diary entry screen is shown. The screen displays one or more questions to be included in the diary entry, related to its medical condition. These questions can be general about the state of the overall symptoms and / or specific about the state of a particular symptom. For example, questions could assess the impact on the user's sleep, lifestyle, mood, etc. Similarly, questions could ask the user to rate the state of a specific symptom (such as the presence and / or state of skin lesions). The questions will vary depending on the specific medical condition the diary entry is for. The diary entry screen asks the user to rate the symptoms of their medical condition using a numerical scale. When the user chooses to continue the diary entry, a diary entry screen is displayed, such as the screen shown in the fourth screenshot 716 of Figure 7d. Here, the diary entry screen asks the user to indicate which symptoms have worsened and which have improved using user-selectable options.

[0108] Referring now to Figures 8a through 8f, screenshots are shown illustrating a screen for adding additional data to a diary entry.

[0109] When the user selects to continue a diary entry from the diary entry screen 716 of Figure 7d, a first screenshot 800 of Figure 8a is shown. In the first screenshot 800 of Figure 8a, the application displays the diary entry screen, which includes an annotation area 802 and user-selectable options 804 for adding additional data to the diary entry. The annotation area 802 can be an open text area. Interacting with the annotation area 802 can open a text box and / or keyboard area, allowing the user to provide open text entries to be included in the diary entry. The annotation area 802 can provide a means for the user to provide additional details and / or more detailed annotations about their medical condition. The user can provide further information that may not be included in the questions in the diary entry. The user can also ask questions or include annotations for the HCP to view. The annotation area 802 enables the application to record a wider range of information to be provided to the HCP to assist in monitoring and managing the user's medical condition. However, the annotation area 802 is not required and can be omitted.

[0110] In the screen of Figure 8a, user-selectable option 804 indicates that the user can add photos or videos. However, other forms of data can be included just as well. In some embodiments, the user may also be able to add data in the form of audio. Any other suitable form of media and file type, such as documents, PDFs, etc., can also be added. Interacting with user-selectable option 804 can open another screen, such as the screen shown in the second screenshot 806 of Figure 8b, where the user can navigate to the data to be added to the diary entry. The application enables the user to collect additional data in real time (e.g., by accessing a data repository on the device or remotely (e.g., via the cloud)) or by operating the device's sensors (e.g., a camera). In the example shown in the second screenshot 806 of Figure 8b, user-selectable options are presented to the user for turning on the camera on the user's device or selecting from a library accessed via the user's device. In the example shown, user-selectable options including qualitative descriptions ("Turn on camera" and "Select from library") are shown. However, any other suitable method of indication, such as graphical indication, can be used.

[0111] When the user selects to open a library, the application opens the library from which the user can select files (not shown). When the user selects to open the camera, the application activates the camera, allowing the user to capture images, such as the image shown in the third screenshot 808 of Figure 8c. Alternatively or additionally, the user can record video, such as the video shown in the fourth screenshot 810 of Figure 8d. The video may include sound and / or multiple images. In another example, the application may also activate the user device's microphone, allowing the user to record audio files in conjunction with video or independently as audio-only files.

[0112] When the user has selected additional data, such as by selecting a file, capturing an image, recording a video, or recording an audio file, the fifth screenshot 812 of Figure 8e or the sixth screenshot 816 of Figure 8f can be displayed.

[0113] In the fifth screenshot 812 of Figure 8e, the screen is substantially the same as the screen in the first screenshot 800 of Figure 8a; however, the application additionally displays a graph 814 on the journal entry screen, indicating that the application has uploaded additional data or otherwise included additional data in the journal entry. Graph 814 may also include user-selectable icons for allowing the user to view, delete, or remove the additional data. If the user selects multiple data files, the application may display graph 814 for each file. In the fifth screenshot 812 of Figure 8e, the screen also shows an annotation area 802 including open text entries entered by the user.

[0114] If the application is unable to upload user-selected additional data or otherwise include such data in the journal entry, the application displays a modified version of the journal entry screen of Figure 8a, wherein the journal entry screen includes a graphic 818 (such as graphic 818 shown in the sixth screenshot 816 of Figure 8f), which indicates or warns that the additional data has not been uploaded or otherwise included in the journal entry. Graphic 818 may indicate that the additional data was not uploaded due to an error. For example, this could be because the data file size exceeds the file size limit, the data file is corrupted in some way, or the data file is incompatible with the application. Graphic 818 may also include a user-selectable icon for allowing the user to edit and / or delete or remove the erroneous additional data.

[0115] Referring now to Figures 9a and 9b, screenshots are shown of a screen displaying a screen used to identify body areas affected by a user's medical condition.

[0116] In Figures 9a and 9b, the application displays a diary entry screen showing a human body model (e.g., a mannequin) with multiple identified body regions. The application displays two user-selectable labels at the top of the screen: a front label 904 and a back label 906. In the first screenshot 900 of Figure 9a, the screen shows the selection of the front label 904 and a view of the human body from the front. In the second screenshot 902 of Figure 9b, the screen shows the selection of the back label 906 and a view of the human body from the back. Interacting with the front label 904 and the back label 906 allows the user to switch between a front view and a back view of the human body. The displayed body regions relate to common and predefined body regions that may be affected by the user's medical condition. In the first screenshot 900 and the second screenshot 902, the screen prompts the user to indicate one or more body regions affected by a medical condition or showing symptoms of a medical condition. This allows both the user and the HCP to track the location and potential spread or reduction of the disease over time.

[0117] Referring now to Figures 10a and 10b, screenshots of the display screen showing environmental data are shown.

[0118] In the first screenshot 1000 shown in Figure 10a, a screen providing environmental data is displayed. The environmental data may be provided, for example, by the weather module 108 of a user device accessing an online weather forecast system to obtain current weather conditions, previous weather conditions, and / or predicted future weather conditions. The environmental data may include one or more of the following: general weather conditions, temperature, humidity, air pressure, and UV index. The weather module may also obtain air quality information such as pollen count, pollution index, NO2 count, and / or air quality index. In the first screenshot 1000 of Figure 10a, the screen includes graphics illustrating the weather conditions, including temperature, humidity, and air quality index. The screen may also display a map of the user's location, and the weather conditions are associated with the user's location. In another example, as shown in the second screenshot 1002 of Figure 10b, the screen displays pollution levels (e.g., major pollutants) and pollen levels or pollen counts.

[0119] In screenshots 1000 and 1002 of Figures 10a and 10b, the screen includes a user-selectable option 1004 for the user to choose whether to include environmental data in the log entries. Environmental conditions can affect the symptoms of certain medical conditions. Including environmental conditions in the recording of a user's medical condition can help identify environmental conditions that may be used to improve the user's symptoms or that may cause these symptoms to worsen (e.g., an outbreak). This allows both the user and the HCP to track the impact of environmental conditions on the user's symptoms over time.

[0120] Referring back to Figures 7a-7d, 8a-8f, 9a, 9b, 10a, and 10b, the journal entry screen may also include a back button and / or a continue button. The continue button, when selected, causes the next journal entry screen to appear. The back button, when selected, causes the previous journal entry screen to appear. In the examples shown, qualitative descriptions ("continue" and "back") are used. However, any other suitable indication method may be used, such as numerical or graphical indicators (e.g., arrows, checkmarks, crosses, emojis, etc.) indicating subsequent and / or previous question numbers.

[0121] One or more of these journal entry screens may also include a graphic showing the number of pages or entries to be completed and / or the user's progress in completing the journal entries. This graphic can be reproduced on each journal entry screen to indicate the page being completed and / or the progress of the journal entry process. In the example shown, the graphic displays each page as a number in a circle, and when a page is completed, that number is replaced by a checkmark. Any other suitable indication method, such as a progress bar, can be used. Although the graphic is displayed at the top of the screen, any other suitable location on the screen may be used.

[0122] Additionally, in the example shown, the diary entry comprises six pages, but any other suitable number of pages can be implemented. The order of the presented pages can also be varied. Furthermore, the diary entry shown relates to exemplary medical conditions, namely atopic dermatitis and asthma. However, this application is not limited to these medical conditions. Suitable entries can be provided that include any other medical conditions registered by the user with the application.

[0123] Referring now to Figures 11a and 11b, screenshots show a control tool. The control tool is associated with the user's medical condition and provides a questionnaire containing a series of clinical questions for monitoring and / or detecting disease progression. The questionnaire may be referred to as a control tool questionnaire or a clinical questionnaire, etc.

[0124] In screenshot 1100 of Figure 11a, a screen with a silent notification area or a graphic with suggested actions is shown. The suggested actions notify the user that they can complete the control tool questionnaire to be included in the diary entry. A first user-selectable option 1102 is provided to prompt the user to complete the questionnaire. Interacting with the first user-selectable option 1102 opens the first screen of the control tool questionnaire. The questionnaire is substantially the same as the questionnaire described with respect to Figures 3a to 3h, so the corresponding description will be omitted.

[0125] In screenshot 1100 of Figure 11a, a second user-selectable option 1104 is also provided to allow the user to choose not to complete the control tool questionnaire at that time. In this case, including the control tool questionnaire in the diary entries at this stage is optional.

[0126] In screenshot 1100 of Figure 11a, the screen shows the control tool for the medical condition of atopic dermatitis. However, as stated above, this application is not limited to this specific medical condition. Figure 11b shows another exemplary screenshot 1106, in which the control tool relates to a different medical condition, namely asthma. However, in other respects, the screen is substantially the same as the screen shown in Figure 11a and functions in the same way, such that corresponding descriptions will be omitted. In this example, the questionnaire is substantially the same as the questionnaire described in Figures 4a to 4g, such that corresponding descriptions will be omitted. The control tool can be implemented in this way for various different medical conditions registered by the user with the application.

[0127] Referring now to Figures 12a and 12b, a screenshot showing the completion of a diary entry is displayed.

[0128] When the user has completed the control tool questionnaire or selected to interact with the second user-selectable option 1104 of Figure 11a or Figure 11b, a first screenshot 1200 of Figure 12a and / or a second screenshot 1202 of Figure 12b are shown. In the first screenshot 1200 of Figure 12a, a screen including a notification area is displayed, showing a silent notification 1204 or graphic indicating that a diary entry has been completed and / or has been recorded, saved, or otherwise stored by the application. The user can choose to close the screen of Figure 12a by interacting with the user-selectable option.

[0129] The second screenshot 1202 of Figure 12b shows the application's main screen. At the top of the main screen, a second silent notification 1206 or graphic indicating that a journal entry has been completed and / or has been recorded, saved, or otherwise stored by the application is displayed. The second screenshot 1202 of Figure 12b can be displayed independently of the screen 1200 of Figure 12a. Alternatively, the second screenshot 1202 of Figure 12b can be shown when the user chooses to close the screen of Figure 12a.

[0130] Figures 12a and 12b indicate the end of the process of recording diary entries. Although the screenshots of Figures 12a and 12b are described as following the options for completing the control tool questionnaire as shown in Figure 11a or 11b, this order is not required. The diary entry screen can be displayed in various different orders or sequences.

[0131] The journal entries stored by the application can be included in reports created when preparing for an appointment with HCP, as discussed above.

[0132] Now for reference Figure 13 A flowchart 1300 is shown illustrating the process for recording diary entries.

[0133] The application can create, complete, and store journal entries in a variety of different ways. For example, at step 1302, when creating, viewing, or otherwise editing a report in preparation for an appointment with HCP, options for creating journal entries are provided, for example, as shown in screenshots of Figures 2c and 2g. In another example, at step 1304, options for creating journal entries are provided from a journal screen, which can be accessed from the journal tab on the application's home page, for example, as shown in screenshots of Figures 6a and 6b.

[0134] When a user chooses to create a diary entry, at step 1306, the user can select one or more medical conditions to include in the diary entry. For example, as shown in the screenshots of Figure 2b or Figure 7a. Step 1306 is optional and can be omitted. For example, if the user has only one medical condition managed through the application, rather than multiple medical conditions associated with a comorbid user, step 1306 can be omitted.

[0135] Following step 1306, or if step 1306 is omitted, the user is directed to a diary entry screen at step 1308 after step 1302 or 1304 to complete questions related to the current state of their medical condition. This is illustrated, for example, in screenshots of Figures 7b-7d and Figures 9a and 9b. The options for completing the diary entry in step 1308 are not limited to those prior to step 1310. Additional diary entries may be completed after step 1310 (e.g., as described with respect to Figures 9a and 9b) and / or after step 1312 and / or after step 1314.

[0136] At step 1310, the user can choose to provide additional data to be included in the journal entry. Additional data can be included, as described above with respect to the screenshots of Figures 8a through 8f. At step 1312, the user can choose to include environmental data, such as the data shown and described above with respect to the screenshots of Figures 10a and 10b.

[0137] At step 1314, the user may choose to include a control tool entry in the diary entry. For example, as shown in the example screenshot of Figure 11, the user may be prompted to complete a control tool questionnaire associated with the user's medical condition. In response to positive user input at step 1314, the user is guided to complete a clinical questionnaire for the control tool at step 1316. For example, the user may complete a questionnaire such as the one shown and described above with respect to screenshots of Figures 3a through 3h. In response to negative user input at step 1314 or completion of the control tool questionnaire at step 1316, the user receives confirmation that the diary entry has been completed and / or stored. For example, the confirmation provided may be shown and described above with respect to screenshots of Figures 12a and 12b.

[0138] Referring now to Figures 14a and 14b, Figure 14a shows a flowchart 1400 illustrating the appointment preparation process, and Figure 14b shows a flowchart 1410 illustrating an appointment preparation process that includes some optional steps.

[0139] In Figure 14a, a report is generated at step 1402. The report is generated in response to an appointment with HCP. The report may describe patient information in detail and / or details of recorded treatment and / or disease progression recorded by the user. For example, the report may include one or more diary entries and / or control tool questionnaires.

[0140] Reports can be generated in response to one or more different trigger conditions. Reports can also be generated in response to user input that selects to generate a report. Alternatively and / or additionally, reports can be automatically generated in response to a pre-booked appointment or a new appointment request with HCP. For example, an application can be configured to monitor the current appointment schedule set within the application. Thus, the application can determine when an appointment is scheduled. For example, the application can determine the existence of an appointment based on a calendar entry. The calendar entry can be associated with one or more of the appointment's date, day, or time. In some examples, reports can be generated in response to a scheduled reminder. The reminder can be associated with or independent of the scheduled appointment. The reminder can be set in advance by the user. In another example, the application can also determine the time remaining before the appointment. This time can be measured in minutes, hours, or days. The application generates a report in response to determining that the time remaining before the appointment is less than a threshold time. The threshold time can be measured in minutes, hours, or days. The threshold time can be preset in the application or set by the user.

[0141] At operation 1404, the program transmits the report to the HCP. Once a report is generated, it is automatically or in response to user input and transmitted to the HCP. The process of transmitting the report is essentially the same as that discussed above with respect to Figure 2c, so the corresponding description should be omitted.

[0142] Referring now to Figure 14b, at step 1412, a notification is generated prompting the user to prepare for their appointment with the HCP. The appointment may be booked by the HCP and / or the user, or a new request may be made. In one example, the notification may be a push notification pushed to the user's device's lock screen or home screen. In another example, the notification may be a silent notification. A silent notification may be pushed silently to the screen and can only be viewed within that screen. A silent notification may be displayed on the screen as a reminder or suggestion to the user to prepare for their upcoming appointment with the HCP. For example, the screen may be the application's home screen, such as home screen 602 shown in the first screenshot 600 of Figure 6a. Alternatively or additionally, the screen may be treatment screen 202, as shown in the first screenshot 200 of Figure 2a.

[0143] The notification prompts the user to prepare for an appointment by preparing a report. The report can detail patient information and / or information recorded by the user regarding treatment and / or disease progression. The user can choose to prepare for an appointment with HCP by interacting with the notification. In response to interaction with the push notification, the application can open a new screen to prepare the report. For example, the application can display the treatment screen shown in the first screenshot 200 of Figure 2a or the main screen shown in the first screenshot 600 of Figure 6a.

[0144] The application can be configured to display a notification in response to one or more different trigger conditions. The trigger conditions can be the same as those discussed above with respect to Figure 14a, so their corresponding descriptions should be omitted.

[0145] The notification provided in step 1412 is optional and can be omitted. In some examples, the user can independently choose to prepare for an appointment with HCP by preparing a report without receiving a notification. For example, the user can interact with user-selectable option 206 shown in the first screenshot 200 of Figure 2a.

[0146] At step 1414, user input for selecting one or more medical conditions to be included in the report is detected. For example, the user can select one or more of the user-selectable options 210, as shown in the second screenshot 208 of Figure 2b. This step is optional and can be omitted. For example, this step can be omitted if the user only has one medical condition being treated.

[0147] At step 1416, a screen displaying a report summary of the selected medical condition is shown. The report summary may correspond to the summary shown in the third screenshot 214 of Figure 2c. The report summary indicates the information to be included in the report. The report summary provides the user with options to view and / or edit the information to be included in the report.

[0148] At step 1418, the user can choose to edit the report. Step 1418 is optional, and the user can choose not to edit the report. The user can edit the report by modifying, adding, or removing information. For example, the user can add additional information to include in the report by completing diary entries and / or control tool questionnaires. The user can complete a diary entry, for example, by selecting a user-selectable option (not shown) from the screen in the third screenshot 214 of Figure 2c or by selecting user-selectable option 234 shown on the screen in the seventh screenshot 232 of Figure 2g. The process of completing a diary entry can correspond to the process described above.

[0149] Alternatively or additionally, the user can complete the control tool entry, for example, by selecting the user-selectable option 226 shown on the screen in the third screenshot 214 of Figure 2c, or by selecting the user-selectable option 236 shown on the screen in the seventh screenshot 232 of Figure 2g. The process of completing the control tool questionnaire can correspond to the process described above, for example, with respect to Figures 3a to 3h, Figures 4a to 4g, and Figure 11.

[0150] At step 1420, the report is completed or finally completed. The report can be finally completed in response to the detection of user input to download the report. User input can be selected from user-selectable option 228 shown on the screen in the third screenshot 214 of Figure 2c, or by selecting user-selectable option 238 shown on the screen in the seventh screenshot 232 of Figure 2g. The process of downloading the report is essentially the same as that described above with respect to Figures 2c and 2g, therefore the corresponding descriptions should be omitted.

[0151] At step 1422, optionally, in response to detecting that the report has been finally completed, a record of the report is stored. The application stores the record of the report. The application may store the report in the memory of the user device. Alternatively, the application may be linked to the cloud, and the report may be stored remotely.

[0152] At step 1424, the application transmits the report to the HCP. The application may transmit the report automatically, for example, in response to a user's selection to download the report. Alternatively, the program may transmit the report in response to user input. The process of transmitting the report is essentially the same as that described above with respect to Figures 2c and 2g, and therefore the corresponding descriptions should be omitted.

[0153] HCP can receive reports directly or access them via a remote database. HCP can receive or access reports based on user consent.

[0154] The above text describes an application, but an application can also be called a program. A program used to manage a user's medical conditions or treatments can execute on a computing device. A computing device can refer to a user device, such as... Figure 1 The system shown below Figure 15 The user device described in the document.

[0155] Now for reference Figure 15 A schematic diagram of a user device 1500 according to some examples described herein is shown. The user device may correspond to... Figure 1 User device 104 shown in the system.

[0156] exist Figure 15In this context, user device 1500 may be a mobile phone or a tablet computer. User device 1500 is an example of a wireless communication device. The user device may alternatively be referred to as a communication device, computer, computing device, or mobile device, and is not necessarily associated with a single user. User device 1500 is configured to communicate wirelessly with a communication network using wireless communication protocols (e.g., but not exclusively, 3GPP LTE and / or New Radio (NR) or WiFi (IEEE 802.11)). User device 1500 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 further be connected to a host computer (not shown) via a core network and / or intermediate networks, which may be embodied in the hardware and / or software of a standalone server, a cloud-implemented server, or a distributed server. User device 1500 and the host computer may be configured to transmit data.

[0157] User device 1500 may include hardware including processing circuitry system 1501. Processing circuitry system 1501 may include processor 1502 and memory 1504. User device 1500 may also include wireless transceiver 1506, user input 1508, display 1512, camera 1510, microphone 1516, RFID reader 1518, and speaker 1514. Wireless transceiver 1506 may be configured to establish and maintain a wireless connection to a network node. Wireless transceiver 1506 may include one or more radio transmitters and one or more radio receivers. The display may be a touch-sensitive display and may be based on capacitive or resistive sensing technology. Processing circuitry system 1501 may include, for example, a microprocessor, digital signal processor (DSP), application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), etc. Processor 1502 may be configured to read from and / or write to memory 1504. The memory 1504 may include volatile and / or non-volatile memory, such as cache, RAM (random access memory) and / or ROM (read-only memory).

[0158] User device 1500 may include software, for example, stored in memory 1504. The software may be executed by processing circuitry 1501. The software may include application programs, such as those described above. In some embodiments, the host computer may communicate with the application program. The application program may request data from the host computer and / or provide user data to the host computer.

[0159] The processing circuitry system 1501 may be configured to perform or cause to perform any of the methods described herein. In some embodiments, the software / program may include instructions that, when executed by the processing circuitry system 1501, cause the processing circuitry system 1501 to perform the methods described herein.

[0160] Memory 1504 may include both program memory for storing program code (e.g., software or firmware) and main memory for storing data. Processing circuitry 1501 may be configured to execute program code stored in program memory and to read, write, and delete data from main memory. In some embodiments, the program code may be an application program that can be downloaded and installed on user device 1500. The application program may be a disease and treatment management and tracking tool for patient use. Program memory may be, for example, read-only memory (ROM), and main memory may be, for example, random access memory (RAM).

[0161] User device 1500 includes one or more user inputs 1508, such as a touchscreen, keypad or keyboard, accelerometer or gyroscope, mouse, or microphone 1516 for receiving voice commands. Microphone 1516 can also be used more generally to record user voice input and noise or sound input. User device 1500 may also include a camera 1510 configured to capture images of the user and images of labels, codes, etc., visible on the medication delivery device, packaging, or storage solution. User device 1500 may be configured to use a scanning device to scan a medication delivery device (such as an injection device or inhaler). The scanning device may refer to camera 1510 or RFID reader 1518. The term "scanning" as used with respect to user device 1500 may refer to reading information provided externally or internally on a medication delivery device using any of these components.

[0162] The examples above describe various types of "screens". A "screen" can also be viewed entirely as a user interface or graphical user interface, which is displayed to the user and the user can interact with it.

[0163] The terms “drug” or “pharmaceutical” are used synonymously herein and describe pharmaceutical preparations comprising one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally pharmaceutically acceptable carriers. In the broadest sense, an active pharmaceutical ingredient (“API”) is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical preparation is used to treat, cure, prevent, or diagnose a disease or to otherwise enhance physical or mental health. Drugs or pharmaceutical preparations may be used for a limited duration or periodically for chronic disorders.

[0164] As described below, a drug or pharmaceutical agent may include at least one API or combination thereof in different types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules with a molecular weight of 500 Da or less; polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids (such as antisense DNA and RNA), small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also considered.

[0165] Drugs or pharmaceutical preparations may be contained in primary packaging or "drug containers" suitable for use with drug delivery devices. Drug containers may be, for example, cartridges, syringes, reservoirs, or other robust or flexible vessels configured to provide suitable chambers for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chambers may be designed to store the drug for at least one day (e.g., from 1 day to at least 30 days). In some cases, the chambers may be designed to store the drug for about one month to about two years. Storage may be carried out 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, drug containers may be or may include dual-chamber cartridges configured to separately store two or more components (e.g., API and diluent, or two different drugs) of a pharmaceutical preparation to be administered, one component in each chamber. In such cases, the two chambers of a dual-chamber cartridge may be configured to allow mixing between the two or more components before and / or during administration to a human or animal. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., through a conduit between the two chambers), allowing the user to mix the two components as needed before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing during dispensing of the components into a human or animal. Drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical disorders.

[0166] As used herein, the terms "analyte" and "derivative" refer to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide by the deletion and / or exchange of at least one amino acid residue present in the peptide and / or by the addition of at least one amino acid residue. The added and / or exchanged amino acid residues may be coding amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Specifically, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide, wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may have been deleted and / or substituted with other amino acids (including non-coding amino acids), or amino acids (including non-coding amino acids) may have been added to the naturally occurring peptide.

[0167] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, antibodies have effector functions and can immobilize complement. In some embodiments, the ability of an antibody to bind to an Fc receptor is reduced or absent. For example, an antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to an Fc receptor, for example, its Fc receptor-binding region has been mutagenized or deleted. The term "antibody" also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable-region antibody-like binding proteins with cross-binding region orientation (CODV).

[0168] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not contain the full-length antibody polypeptide but still contains at least a portion of the full-length antibody polypeptide capable of binding to an antigen. Antibody fragments may contain cleaved portions of the full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments that can be used in this invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (e.g., bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., double-chain, triple-chain, and quadruple-chain antibodies)), monovalent or multivalent antibody fragments (e.g., bivalent, trivalent, quadruvalent, and multivalent antibodies), microantibodies, chelated recombinant antibodies, tri- or bivalent antibodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camel-derived antibodies, and antibodies containing VHH. Further examples of antigen-binding antibody fragments are known in the art.

[0169] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "frame region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides; it is not a CDR sequence and is primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although frame regions, as is known in the art, typically do not directly participate in antigen binding, certain residues within the frame region of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0170] Examples of antibodies are anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6R mAb (e.g., sarilumab), and anti-IL-4R mAb (e.g., dupilumab).

[0171] It is also considered that a pharmaceutically acceptable salt of any API described herein may be used in a drug or pharmaceutical preparation in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0172] Those skilled in the art will understand that modifications (additions and / or removals) can be made to the different components, formulations, devices, methods, systems, and embodiments of the API described herein without departing from the full scope and spirit of the invention, which covers such modifications and any and all equivalents thereof.

[0173] Example drug delivery devices may involve needle-based injection systems, as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems can be broadly categorized into multiple-dose container systems and single-dose (partially or completely emptied) container systems. The container may be a replaceable container or an integral, non-replaceable container.

[0174] As further described in ISO 11608-1:2014(E), a multiple-dose container system can relate to a needle-based injection device with replaceable containers. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user). Another multiple-dose container system can relate to a needle-based injection device with an integral, non-replaceable container. In such a system, each container holds multiple doses, the size of which can be fixed or variable (preset by the user).

[0175] As further described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device having a replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In another example, each container contains a single dose, in which a portion of the deliverable volume is discharged (partially emptied). Also as described in ISO 11608-1:2014(E), a single-dose container system can relate to a needle-based injection device having an integral, non-replaceable container. In one example of such a system, each container contains a single dose, in which the entire deliverable volume is discharged (completely emptied). In another example, each container contains a single dose, in which a portion of the deliverable volume is discharged (partially emptied).

Claims

1. A non-transitory computer-readable storage medium comprising instructions that, when executed by a computing device, cause the computing device to: To execute procedures used to manage a user's medical conditions or treatments; The user interface displays user-selectable options for preparing reports for appointments with healthcare professionals (HCPs), which include information related to the management or treatment of the user's medical condition; In response to user interaction with the user's optional options, determine whether diary entries associated with the management or treatment of the user's medical condition are stored in memory accessible to the program; In response to determining that the diary entry is stored in the memory, a report is generated that includes the diary entry related to the user's medical condition; and The report is then transmitted to the HCP.

2. The non-transitory computer-readable storage medium according to claim 1, wherein, The information associated with the management or treatment of the user's medical condition includes one or more of the following: the user's patient information, one or more medical conditions, prescription information, the user's registered physician and / or medical practice, one or more diary entries, and the results of one or more clinical questionnaires. Optionally, the memory is the memory of the computing device or external memory.

3. The non-transitory computer-readable storage medium according to claim 1 or 2, wherein, These instructions are further configured as follows: Generate a notification to remind the user to prepare for their appointment with the HCP; and In response to user interaction with the notification, the user interface is displayed, including user-selectable options for preparing the report.

4. The non-transitory computer-readable storage medium according to claim 3, wherein, This notification is generated in response to a triggering event, and Optionally, the triggering event includes one or more of the following: pre-booked appointment, new appointment, and reminder.

5. The non-transitory computer-readable storage medium according to any one of the preceding claims, wherein, This user-selectable option is used to choose which one or more medical conditions of the user should be included in the report.

6. The non-transitory computer-readable storage medium according to claim 5, wherein, These instructions are further configured as follows: In response to receiving a user's selection of one or more medical conditions, determine whether a diary entry for each of the selected medical conditions is stored in the memory; and In response to determining that a diary entry for each of the selected one or more medical conditions is stored in the memory, a report is generated that includes a diary entry for each of the selected one or more medical conditions.

7. The non-transitory computer-readable storage medium according to any one of the preceding claims, wherein, These instructions are further configured to display a user interface, including one or more user-selectable options for editing the report by modifying, adding, or removing information included in the report, in response to the generation of the report.

8. The non-transitory computer-readable storage medium according to claim 7, wherein, The one or more user-selectable options for editing the report include options for completing the diary entries to be included in the report, and These instructions are configured to display one or more user interfaces, including one or more of the following, in response to user interaction with the user-selectable options for completing the diary entry: questions, environmental data, user-selectable options for uploading files to be included in the diary entry, and user-selectable options for completing clinical questionnaires to be included in the diary entry.

9. The non-transitory computer-readable storage medium according to claim 8, wherein, These files include one or more of the following: documents, PDFs, audio files, video files, and image files.

10. The non-transitory computer-readable storage medium according to claims 7 to 9, wherein, The one or more user-selectable options for editing the report include options for completing a clinical questionnaire, and These instructions are configured to display one or more user interfaces, including one or more questions related to the current state of the user's medical condition, in response to the user's interaction with the user-selectable options used to complete the clinical questionnaire.

11. The non-transitory computer-readable storage medium according to any one of the preceding claims, wherein, These instructions are further configured to generate another notification prompting the user to complete the diary entry in response to determining that the diary entry is not stored in the memory.

12. The non-transitory computer-readable storage medium according to any one of the preceding claims, wherein, These instructions are further configured as follows: Determine whether clinical questionnaires associated with monitoring the control of the user's medical condition are stored in the memory; and In response to the determination that the clinical questionnaire is not stored in the memory, another notification is generated prompting the user to complete the clinical questionnaire.

13. The non-transitory computer-readable storage medium according to any one of the preceding claims, wherein, These instructions are further configured to automatically or in response to user input that transmits the report to the HCP.

14. A computer-implemented method, the method comprising: To execute procedures used to manage a user's medical conditions or treatments; The user interface displays user-selectable options for preparing reports for appointments with healthcare professionals (HCPs), which include information related to the management or treatment of the user's medical condition; In response to user interaction with the user's optional options, determine whether diary entries associated with the management or treatment of the user's medical condition are stored in memory accessible to the program; In response to determining that the diary entry is stored in the memory, a report is generated that includes the diary entry related to the user's medical condition; as well as The report is then transmitted to the HCP.

15. The computer-implemented method of claim 14, further comprising, in response to generating the report, displaying a user interface including one or more user-selectable options for editing the report by modifying, adding, or removing information included in the report.

16. The computer-implemented method according to claim 15, wherein, The one or more user-selectable options for editing the report include options for completing the diary entries to be included in the report, and The method further includes, in response to user interaction with user-selectable options for completing a diary entry, displaying one or more user interfaces including one or more of the following: questions, environmental data, user-selectable options for uploading files to be included in the diary entry, and user-selectable options for completing a clinical questionnaire to be included in the diary entry.

17. A user equipment, including a processing circuitry system configured to: To execute procedures used to manage a user's medical conditions or treatments; The user interface displays user-selectable options for preparing reports for appointments with healthcare professionals (HCPs), which include information related to the management or treatment of the user's medical condition; In response to user interaction with the user's optional options, determine whether diary entries associated with the management or treatment of the user's medical condition are stored in memory accessible to the program; In response to determining that the diary entry is stored in the memory, a report is generated that includes the diary entry related to the user's medical condition; and The report is then transmitted to the HCP.

18. The user equipment according to claim 17, wherein, The processing circuitry is further configured to display a user interface, including one or more user-selectable options for editing the report by modifying, adding, or removing information included in the report, in response to the generation of the report.

19. The user equipment according to claim 18, wherein, The one or more user-selectable options for editing the report include options for completing the diary entries to be included in the report, and The processing circuitry is further configured to display one or more user interfaces, including one or more of the following, in response to user interaction with the user-selectable options for completing a diary entry: questions, environmental data, user-selectable options for uploading files to be included in the diary entry, and user-selectable options for completing a clinical questionnaire to be included in the diary entry.

20. The user equipment according to claims 17 to 19, wherein, The processing circuitry is further configured to generate another notification prompting the user to complete the diary entry in response to determining that the diary entry is not stored in the memory.

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