Therapeutic Content Delivery and Progress Tracking System

Abstract

The apparatus and associated methods relate to a Dynamic Incentive Package Generation System (DIPGS). In an exemplary instance, the DIPGS may include at least one valid Digital Therapy (DTx), a user profile, and a media profile associated with wild media content. The DIPGS may include, for example, an evaluation engine configured to generate or update a user profile based on a journal of user inputs and observations of user behavior. The DIPGS may include a Medical Media Package Generation Engine (MMPGE) configured to generate a Dynamic Incentive Media Package (DIMP). In the incentive mode, the DIMP can periodically play the wild media content selected by the user. After transitioning from the incentive mode to the therapy mode, the MMPGE generates Intervention Monitoring Content (IMC) that includes a valid DTx to administer a therapeutic treatment to the user. Various embodiments can advantageously provide continuous medical guidance and progress monitoring to the user.

Description

Technical Field

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 268,905, titled "FDA-Compliant Therapeutic Game Selection and Delivery Platform," filed on March 4, 2022, by Ryan J. Douglas; U.S. Provisional Application No. 63 / 362,497, titled "Digital Platform for Delivery And Tracking of DTX Video Games," filed on April 5, 2022, by Ryan J. Douglas; U.S. Provisional Application No. 63 / 363,639, titled "Media Delivery Tool for Self-Assessment of Physical and Mental State," filed on April 26, 2022, by Ryan J. Douglas; and U.S. Provisional Application No. 63 / 366,521, titled "Therapeutic Game Selection and Delivery Engine," filed on June 16, 2022, by Ryan J. Douglas.

[0002] This application incorporates by reference the entire contents of the aforementioned applications herein.

[0003] The subject matter of this application may have inventors' requirements common to the following subject matter and / or may be related to the following subject matter. · PCT Patent Application No. PCT / US2021 / 071585, titled "Immersive Medicine Translational Engine for Development and Repurposing of Non-Verified and Validated Code," filed on September 24, 2021, by Ryan J. Douglas, ·U.S. Patent No. 11,295,261, titled "FDA COMPLIANT QUALITY SYSTEM TO RISK-MITIGATE, DEVELOP, AND MAINTAIN SOFTWARE-BASED MEDICAL SYSTEMS", filed by Ryan J. Douglas on May 28, 2019, ·U.S. Patent No. 11,531,949, titled "FDA COMPLIANT QUALITY SYSTEM TO RISK-MITIGATE, DEVELOP, AND MAINTAIN SOFTWARE-BASED MEDICAL SYSTEMS", filed by Ryan J. Douglas on March 1, 2022, and ·U.S. Patent Application No. 18 / 055,754, titled "FDA COMPLIANT QUALITY SYSTEM TO RISK-MITIGATE, DEVELOP, AND MAINTAIN SOFTWARE-BASED MEDICAL SYSTEMS", filed by Ryan J. Douglas on November 15, 2022.

[0004] This application incorporates by reference the entire contents of the aforementioned applications herein.

[0005] Various embodiments generally relate to systems and methods for delivering regulated digital therapy media in an unregulated media content delivery network.

Background Art

[0006] Medical therapies can include various acts and / or devices. A patient can receive medical therapy under the supervision of a caregiver (e.g., a doctor, a therapist). Medical therapies can be performed, for example, in a medical facility (e.g., a hospital, a clinic) and / or in a home environment.

[0007] A medical device may include, for example, software components. The software components may be regulated by one or more regulatory agencies such as the US Food and Drug Administration, the European Medicines Agency (EMA), the European Food Safety Authority (EFSA), the UK Veterinary Medicines Directorate (VMD), Health Canada, the Canadian Food Inspection Agency (CFIA), the Australian Pesticides and Veterinary Medicines Authority (APVMA), the National Medical Products Administration (NMPA) of China, the Taiwan Food and Drug Administration (FDA), the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, the Ministry of Health, Labour and Welfare (MHLW) of Japan, and / or the Ministry of Food and Drug Safety (MFDS) of South Korea. The medical device software components may be required to be inspected in accordance with regulatory standards prior to being put on the market.

[0008] Non-medical therapies may include, for example, health and / or behavior enhancement. For example, various supplements and / or processes may be created to enhance behavior and / or health. Such non-medical therapies may be unregulated or may be subject to less restrictive legal requirements.

[0009] For example, digital assets may be available from one or more repositories and / or platforms (e.g., bidirectional). Digital assets may also be available from, for example, game platforms. Digital assets may also be available from, for example, software developers. Digital assets may also be available from, for example, book publishers and / or retailers. Digital assets may also be available from, for example, music and / or video publishers or retailers.

Prior Art Documents

Patent Documents

[0010]

Patent Document 1

Summary of the Invention

[0011] The apparatus and associated methods relate to a dynamic inducement package generation system (DIPGS). In an exemplary instance, the DIPGS can include at least one effective digital therapeutics (DTx), a user profile, and a media profile associated with wild media content. The DIPGS can include, for example, an evaluation engine configured to generate or update a user profile based on a journal of user input and observations of user behavior. The DIPGS can include a medical media package generation engine (MMPGE) configured to generate a dynamic inducement media package (DIMP). In the stimulation mode, the DIMP can periodically play the wild media content selected by the user. After transitioning from the stimulation mode to the therapy mode, the MMPGE generates interventive monitoring content (IMC) including effective DTx to administer a therapeutic treatment to the user. Various embodiments can advantageously provide continuous medical guidance and progress monitoring to the user.

[0012] Various embodiments can achieve one or more advantages. For example, some embodiments can advantageously provide a history and / or an immediate assessment regarding a user's mental and / or physical health. Some embodiments can be configured to monitor, for example, advantageously, a user's ongoing media usage. For example, some embodiments can include, advantageously, a medical expert interface for enabling an expert's insights to the user and / or for enabling direct interaction with a patient. Some embodiments can, for example, advantageously assist self-care patients by providing a dynamically generated immersive therapy mechanism-based monitoring and tracking mechanism in an unregulated media content environment. For example, some embodiments can advantageously provide ordinary people with a simple tool for assisting a user's health state based on the user experience regardless of the environment without being tilted towards a game or a specific media. Some embodiments can, for example, advantageously automatically verify updates for effective DTx.

[0013] Details of various embodiments are described in the accompanying drawings and the following description. Other features and advantages will become apparent from the description and drawings, and from the claims.

Brief Description of the Drawings

[0014]

Fig. 1A

Fig. 1B

Fig. 2

Fig. 3

Fig. 4

Fig. 5

Fig. 6

Fig. 7

Fig. 8

Fig. 9

Fig. 10

DETAILED DESCRIPTION OF THE INVENTION

[0015] Like reference symbols in the various drawings indicate like elements.

[0016] To facilitate understanding, this document is organized as follows. First, a dynamic incentive package generation system (DIPGS) is introduced with reference to FIGS. 1A - 3 to help introduce the discussion of various embodiments. Second, this introduction leads to an explanation regarding FIGS. 4 - 5 for some exemplary embodiments of the risk assessment and delivery characteristics of DIPGS. Third, with reference to FIGS. 6 - 8, the digital game cloud in the context of an exemplary implementation of DIPGS is described. Fourth, with reference to FIGS. 9 - 10, this document describes exemplary devices and methods useful for updating and delivering effective digital therapy modalities. Finally, the document discusses further embodiments, exemplary uses, and aspects related to dynamic incentive package generation and application.

[0017] Digital therapy media, such as audio or video content, can be used to treat various health conditions, including, for example, mental health disorders, chronic pain, and addictions. The delivery of such media is, in some instances, traditionally restricted to regulated channels, such as telemedicine platforms and / or medical devices approved by regulatory authorities (e.g., the US Food and Drug Administration (FDA)), which may limit patient accessibility and scalability. Unregulated media content delivery networks, such as streaming services or social media platforms, may sometimes offer greater reach and flexibility. However, these platforms may sometimes lack the management of regulations required to distribute digital therapy media.

[0018] In some implementations, digital therapy media can be delivered through various means, such as mobile applications, virtual reality platforms, and / or web - based portals. Such platforms can provide patients with a convenient and accessible way to receive treatment, for example, outside of traditional treatment rooms and regardless of their location.

[0019] In some examples, digital therapy media can be used to train patients to perform unconscious actions (e.g., breathing). For example, these unconscious actions can improve mental health. In an exemplary example, breathing exercises can be an effective treatment for various mental health conditions including anxiety and depression. Traditional methods of training patients to perform these exercises are, for example, time-consuming and expensive. Sometimes, in a treatment room environment, for example, patients may feel even more stressed. By using digital therapy media, for example, patients can receive training at home, at their own pace, and without the need for a therapist or other healthcare provider.

[0020] Figures 1A and 1B depict an exemplary dynamic incentive package generation system (DIPGS) that includes a medical media package platform (MMPP) and a dynamic incentive package state machine (DIPSM) in an exemplary use case scenario. In the example shown in Figure 1A, DIPGS 100 includes a self-treatment user (STU 105). For example, STU 105 may be using device 106 (e.g., a tablet, a gaming console, a personal computer) to search for media (e.g., games). Device 106 is running a medical media delivery application (MMDA 110: medical media delivery application) (e.g., in response to an input from STU 105). For example, MMDA 110 can help STU 105 select a game that has therapeutic benefits for STU 105. For example, device 106 may be a gaming station, a computer, a phone, or some combination thereof.

[0021] As shown in the illustration, DIPGS100 includes a wild media platform (WMP115) and a medical media package platform (MMPP120). MMPP120 includes an evaluation engine 125, a medical media package generation engine (MMPGE130), and a data store 135, as depicted. The data store 135 can store, for example, inputs from STU105. The data store 135 can store, for example, media information (e.g., profiles of a wide range of available media). The data store 135 can store, for example, (predetermined) caregiver profiles.

[0022] In the described example, the data store 135 includes a user profile 140. The user profile 140 can be embodied as a digital data structure having an association with a given digital metadata of a corresponding patient (e.g., STU105), for example. For example, the user profile can include attributes (e.g., motivation attributes, morbidity attributes, kinetic pathology state attributes), and / or a temporally distributed (activity) history of STU105. For example, the user profile 140 can include a player type that can be generated based on the extended Bartle model.

[0023] In the described example, the data store 135 includes a media profile 145. For example, the media profile 145 can be embodied as a digital data structure corresponding to a specific media object (e.g., digital media, games, game components). The media profile 145 can define, for example, predetermined attributes of the associated media object. For example, MMPP120 can select and / or filter games appropriate for the user based on predetermined attributes of the associated media object.

[0024] WMP115 includes various wild games 150. For example, the wild games 150 may not be medically regulated. For example, the wild games 150 may include games, music, and / or videos developed for normal use (e.g., entertainment). For example, the wild games 150 may be uploaded to WMP115 by game developers. In some examples, DIPGS100 may include games pre-loaded in WMP115. In some embodiments, WMP115 and MMPP120 may be of an integrated architecture and / or may be connected via a communication network. In some embodiments, WMP115 may include, for example, other unregulated digital media. For example, the unregulated media may include books. In some embodiments, the unregulated media may include, for example, movies. In some implementations, the unregulated media may include, for example, audio. The unregulated media may function as an attraction mechanism to draw a user (e.g., STU105) to continue therapy and / or evaluation.

[0025] MMPP120 can categorize STU105 using, for example, the user profile 140. MMPP120 can categorize the wild games 150 using, for example, the media profile 145. MMPP120 can, for example, compare the categories and summarize the therapeutic journey of STU105 through one or more of the wild games 150. For example, MMPP120 can propose the game and treatment flow. In some examples, MMPP120 may enable a patient to individually propose the flow in treatment.

[0026] In an exemplary embodiment, MMPP 120 can recommend, for example, a therapy based on stress relief. For example, if STU 105 indicates that STU 105 was in a scenario that was difficult for STU 105 to escape from, MMPP 120 can propose a role-playing game through corresponding scenarios that enable the patient to respond to each and / or control the scenario.

[0027] Data store 135 includes several digital therapy modules (DTx module 155). For example, DTx module 155 may include effective therapy media content. For example, DTx module 155 may include therapeutic effects and mechanisms approved by regulatory organizations (e.g., the U.S. Food and Drug Administration, the U.S. Federal Communications Commission). In some implementations, DTx module 155 can be stored in data store 135 only after being activated by MMPP 120. Various examples for activating and managing DTx module 155 are described with reference to FIG. 6.

[0028] In various embodiments, DTx module 155 may include, for example, a therapy action profile, source code, digital media (e.g., audio, video, images, text), an interaction sequence (e.g., an interaction profile), or some combination thereof. Various embodiments include, for example, therapy modalities, therapy mechanics, treatment mechanics, treatment modalities, game mechanics, or some combination thereof, as described throughout U.S. Application No. 63 / 202,881, titled "Immersive Digital Therapy," filed on June 28, 2021, by Ryan J. Douglas, the entire contents of which are incorporated herein by reference. For example, at least paragraphs

[0017] -

[0026] and

[0030] -

[0063] discuss various implementations using therapy action profiles, game execution profiles, game attribute profiles, therapy mechanics, therapy modalities, game mechanics, scaling and / or adaptation management systems, and combinations thereof.

[0029] In some implementation forms, in response to a request to play a game from STU105, MMPGE130 can generate a Dynamic Incentive Media Package (DIMP) by integrating one of the Wild Games 150 with one or more of the DTx modules 155. For example, each of the Media Profiles 145 can correspond to one of the Wild Games 150. The Media Profile 145 can include, for example, DTx transition points for integrating the Wild Game 150. In some implementation forms, the Media Profile 145 can also include metadata for suggesting which type of DTx module 155 can be integrated at each of the software insertion points. In some implementation forms, at the software insertion point, the DTx module 155 may be inserted such that the software jumps during runtime to execute an instruction in the DTx module 155.

[0030] As a non-limiting exemplary example, the Evaluation Engine 125 can operate according to user input from STU105 to determine one or more proposed games for play. The Evaluation Engine 125 can determine several games from the Wild Games 150, for example, based on user input, the User Profile 140, and the Media Profile 145. For example, the proposed games may be displayed on the MMDA110 for user selection. According to one of the proposed games, for example, MMPGE130 can generate a DIMP based on the user selection. For example, the DIPGS100 can directly deliver the generated DIMP from the MMPP120 to the device 106. For example, the DIMP may be delivered to the device 106 via the WMP115.

[0031] In this example, the MMDA 110 executes the received DIMP on a Dynamic Incentive Package State Machine (DIPSM 160). As shown, the DIPSM 160 includes a therapy state and an incentive state. In the incentive state, the DIPSM 160 can execute, for example, a selected wild game 150. For example, the selected wild game 150 can be executed normally. In some examples, the selected wild game 150 can be executed with adjusted parameters (e.g., game speed, control mechanism). For example, the adjusted parameters can be determined based on the user profile 140 and the media profile 145.

[0032] In the therapy state, for example, the DIPSM 160 can pause game play by executing a Therapeutic Immersive Medical Package (TIMP 190). In some implementations, the MMPGE 130 can dynamically generate a set of state transition metrics based on the selected wild game 150 and the integrated DTx module 155, based on the user profile 140 and the media profile 145. For example, in a state transition, the MMPGE 130 can generate the TIMP 190 based on the DTx module 155, the user profile 140, and the media profile 145.

[0033] When a transition measure is reached in an identified instance in the wild game 150, in some implementations, the DIPSM 160 can switch to a therapy state, and the MMPGE 130 can identify one of the DTx modules 155 based on the user profile 140 to generate intervention monitoring content (IMC 165) to be played in the therapy state. For example, the MMDA 110 can execute the IMC 165 to display the TIMP 190. The TIMP 190 can include, for example, guidance to the user in the identified instance. For example, the TIMP 190 can include a warning to the user in the identified instance. For example, the TIMP 190 can include a list of questions to the user in the identified instance. For example, the list of questions may be generated to access / track the therapy state of the STU 105. In some implementations, the TIMP 190 may be generated based on the user profile 140 and the media profile of the wild game 150.

[0034] As shown in this example, in the therapy state of the DIPSM 160, the IMC 165 can stimulate the MMDA 110 to display the therapy interface 170. For example, the therapy interface 170 can include valid media content to be presented to the STU 105. As a non-limiting exemplary example, an exemplary therapy interface 170 is shown in FIG. 1B. For example, the therapy interface 170 can display a list of questions 175 for the STU 105 to answer. For example, the therapy interface 170 can include guidance 180. For example, the guidance 180 can include cautions, warnings, explanations, or combinations thereof about information (e.g., mental health information, physical health information). The list of questions 175 may be generated from the DTx module 155 based on, for example, the current progress of the wild game 150 and the user profile 140.

[0035] In some implementations, STU105 is prompted for a response to therapy. For example, STU105 may be asked how it feels (e.g., an absolute mood, a mood just before the media is delivered). STU105 may be required to provide feedback related to, for example, its medical condition, motivation, experience, the media being delivered, or some combination thereof. The queries may include, for example, selections (e.g., choosing a smiley face or a frowning face), ratings, sentence completion, free responses, or some combination thereof. In some implementations, additional micro-journaling prompts may be provided.

[0036] After STU105 interacts with the therapy interface 170, as shown in FIG. 1A, MMDA110 can send the response 185 to MMPP120. The evaluation engine 125 can, for example, process the response and update the user profile 140. Various examples of updating the user profile 140 and other exemplary methods for processing the response 185 are discussed below with reference to FIGS. 3-4.

[0037] In an exemplary aspect, DIPGS100, which includes various wild media content (e.g., wild game 150), can be configured to generate DIMP based on a user profile generated from a journal of user input. During the execution time of DIMP, DIPGS100 can use MMPGE130 to generate TIMP during the playback of the selected media content. For example, MMPGE130 can generate TIMP based on a set of state transition metrics. Based on the received response of TIMP (e.g., response 185), the user profile (e.g., of the user) may be updated.

[0038] In some implementations, MMPGE130 can dynamically generate a set of state transition metrics based on selected media content, user profiles, and identified therapy instances within the DIMP. In some examples, the generated DIMP can include a recommended set of valid media content (e.g., DTx module 155) for each of the identified instances based on the media profile 145 of the media content (e.g., Wild Game 150) and the user profile 140.

[0039] In some implementations, the user profile 140 may be generated based on a journal of user input received from MMDA110 (e.g., the user's initial profile, input from healthcare providers, responses received during the media playback process 185). For example, based on the journal of user input, DIPGS100 can advantageously provide a history and immediate assessment of the mental and / or physical health of STU105.

[0040] In various implementations, IMC165 can include guidance and warnings to the user presented at a predetermined time based on a set of state transition metrics. For example, the guidance (e.g., guidance 180) can include instructions for stimulating self-regulatory functions using voluntary actions required when playing the DIMP.

[0041] As an illustrative example without limitation, many people may rely on the media as a means of reducing mental and / or physical health problems. However, such users may sometimes lack guidance on which media is most suitable for their problems. Such users may not even have subjective criteria, for example, on whether the media is appropriate for the user and / or whether the user's specific condition / situation requires more prescriptive care. Moreover, such users may find it difficult to track whether the media they are using has a positive effect on their condition and / or to determine whether further assistance is required.

[0042] In various embodiments, the DIPGS 100 may be configured, for example, advantageously, to monitor the ongoing media use of the STU 105. The DIPGS 100 may be able to determine, for example, (by the evaluation engine 125) whether a deterioration in well-being during the media time has been detected (e.g., based on a journal of user input). In some implementations, the DIPGS 100 may be used to attempt and address concerns (e.g., during media use and during the days, weeks, months, and / or years in which an individual is interacting with the media about specific health concerns). In some implementations, by way of example and not limitation, the DIPGS 100 may be configured as a media delivery therapy companion system. In some implementations, the DIPGS 100 may be able to incorporate a media platform.

[0043] In some embodiments, the DIPGS 100 may be configured, for example, as a companion code to a (digital) media asset. The DIPGS 100 may be configured, for example, as a wrapper application (e.g., software). By way of example and not limitation, the DIPGS 100 may be configured as a supplementary app (e.g., a mobile app, a gaming console app, the MMDA 110). The DIPGS 100 may be directly integrated, for example, into a media delivery system that delivers media.

[0044] In an exemplary and non-limiting example, if a user requests an in-game health assessment, the user may have to be created by a medical professional trained for medical advice. The trained medical professional may be required to study a set of media (e.g., games, songs, videos) before providing any medical advice. (e.g., watching a 10-minute video several times, studying a transcript of the video, etc.) After all the media has been fully studied, the medical profession can identify appropriate break points and create guidance at each of the break points based on the detailed medical records associated with the user. Thus, the medical profession should be able to easily spend days, if not weeks, just to prepare a specialist program for one media for one user.

[0045] To perform self-assessment, the user should have to pause themselves at the identified times. This should be very difficult and only trained users may be able to do it. On the other hand, the user can play the media accompanied by a medical professional in order to be paused during playback and to perform medical guidance to the user. Thus, the cost of playing the media should be prohibitively high. Furthermore, after the user gets bored with the media with the specialist program, expanding the media library should require the same expensive process.

[0046] When using the DIPGS100, the STU105 can automatically enjoy the valid media content generated by the MMPGE130. The evaluation engine 125 can, for example, advantageously provide medical guidance and monitor the progress of the STU105. In some implementations, as described with reference to FIGS. 6-9, the media content delivered to the STU105 may be regulated. For example, the delivered content may comply with the regulation rules.

[0047] FIG. 2 is a block diagram depicting an exemplary MMPP (e.g., MMPP 120). In this example, MMPP 120 includes a therapy media generation and monitoring engine TMGAME 200. Engine TMGAME 200 includes a processor 205. Processor 205 may include, for example, one or more processors. Processor 205 is operatively coupled to a communication module 210. Communication module 210 may include, for example, wired communication. Communication module 210 may include, for example, wireless communication. In the depicted example, communication module 210 is operatively coupled to MMDA 110 and WMP 115. In the depicted example, communication module 210 is operatively coupled to a medical expert interface 215 and medical enablement rules 220. For example, medical expert interface 215 may enable a medical expert to adjust data when stored in MMPP 120. For example, medical expert interface 215 may enable a medical expert to perform a medical input to MMPP 120. Medical expert interface 215 provides, for example, a communication channel between a medical expert and a patient. For example, a medical expert may ask, via medical expert interface 215, "How did you feel about this game? This game was accidentally set up according to the 7 stages of sadness." Thus, a medical expert can advantageously provide insight to a patient and / or directly interact with the patient.

[0048] In some implementations, DIPGS 100 may enable a medical expert to propose a treatment flow and / or "homework" to a user. For example, a medical expert may instruct that MMPP 120 should focus heavily on anxiety for a specified user for a while. For example, a medical expert may instruct that after anxiety is addressed, the post-traumatic stress issue will be addressed later.

[0049] Memory module 225 can be used, for example, to activate media content transmitted by MMPP 120. For example, MMPP 120 can automatically verify the generated IMC or DIMP using memory module 225.

[0050] Processor 205 is operatively coupled to memory module 225. Memory module 225 can include, for example, one or more memory modules (e.g., random access memory (RAM)). Processor 205 includes storage module 230. Storage module 230 can include, for example, one or more storage modules (e.g., non-volatile memory). In the depicted example, storage module 230 includes evaluation engine 125 and MMPGE 130.

[0051] MMPGE 130 can determine, for example, interface 170 that will be generated and displayed on STU 105. Evaluation engine 125 can update user profile 140, for example, based on input from the user.

[0052] Media analysis engine 235 can analyze media objects (e.g., wild game 150, other media content associated with WMP 115), for example, to determine attributes. For example, in some implementations, media analysis engine 235 can be configured to generate media profile 145. In some implementations, media analysis engine 235 can include a machine learning model configured to automatically redefine and / or update weightings associated with the attributes of media objects based on user input (e.g., micro-journaling, changes in the medical profile, caregiver input, input from an authorized expert).

[0053] In the described example, the storage module 230 includes a treatment analysis engine 240. For example, the treatment analysis engine 240 can generate an output based on data stored in the data store 135. The data store 135 is operatively coupled to the processor 205. The data store 135 includes, as described, a media profile 145, a user profile 140, a treatment profile 250, and a microjournal 255.

[0054] The microjournal 255 can be embodied as a digital data structure having, for example, an association of predetermined digital metadata to a particular user (e.g., to the user profile 140). The microjournal 255 can store, by way of non-limiting example, a corresponding user's historical response (e.g., a raw summary evaluation of a raw response) to a therapy (e.g., to the presented media).

[0055] In various embodiments, the microjournal 255 can include, by way of non-limiting example, pre- and post-game play inputs with an associated database correlating played games, durations, frequencies, and / or emotional states as represented by information input by the user and / or estimated by the system. Such information can include, by way of non-limiting example, an emotional rating scale (e.g., 1 - 5, emojis), language associations, sentence completion (e.g., related to the current symptom state), free-form input, gratitude journal, experience journal, or a combination thereof.

[0056] The user profile 140 includes a morbidity profile 260, a motivation profile 265, a predetermined caregiver 270, and a dynamic state profile 275. The motivation profile 265 can be embodied as a digital data structure having, for example, an association of predetermined digital metadata to a predetermined motivation type. The motivation profile 265 can define, for example, the attributes of the motivation type.

[0057] For example, the motivation profile 265 may include one or more profiles based on the above model. The motivation analysis engine 240 can generate, for example, a motivation profile 265 for a user as a weighted variance of multiple motivation types.

[0058] Exemplary examples of self - evaluations that can be used to determine whether a user is suffering from mild to moderate stress, anxiety, and / or symptoms of depression may include, but are not limited to, the Patient Health Questionnaire (PHQ - 9). The PHQ - 9 is, for example, a valid screening measure to assist in the diagnosis and evaluation of the severity of depressive symptoms and can function, for example, as a symptom severity tracker for monitoring the effectiveness of a treatment plan. In some implementations, by way of example and not limitation, the MMPP 120 can be configured to use valid assessment scales to better "understand" (e.g., generate a disease profile 260, generate a treatment profile 250) the core symptoms for each state of a disorder / symptom. In the case of depression, for example, SIGECAPS (a mnemonic device that outlines symptoms characteristic of depression as listed in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM - 5)) can be implemented as a framework.

[0059] The treatment profile 250 can be embodied, for example, as a digital data structure corresponding to a specific treatment. One or more treatment profiles 250 may be linked, for example, to the disease profiles 260 of one or more patients, and / or vice versa. The treatment profile 250 can define, by way of example and not limitation, predetermined treatment attributes (e.g., breathing profile, duration, indicated symptoms, indicated disease state).

[0060] In some implementations, the treatment analysis engine 240 may be configured to operate according to the user profile 140, by way of example and not limitation, to determine an association between a user and one or more medical conditions. For example, the treatment analysis engine 240 may generate a medical condition profile 260 based on data associated with one of the user profiles 140 and / or data retrieved from one of the user profiles 140. For example, the medical condition profile 260 may be generated corresponding to attributes defined by one or more medical condition definitions. For example, the treatment analysis engine 240 may generate a medical condition profile 260 that includes one or more weightings associated with each of a plurality of medical condition definitions.

[0061] For example, a medical condition definition may be embodied as a digital data structure corresponding to a particular medical condition (e.g., depression, cardiomyopathy, post-traumatic stress disorder), for example. A medical condition definition may define, for example, predetermined attributes of the corresponding medical condition (e.g., associated symptoms, associated therapies). In some implementations, a medical condition definition may define one or more states of a medical condition and associated attributes. In some implementations, a medical condition definition may be accessible in an external database using the communication module 210. In some implementations, a medical condition definition may be pre-loaded into the data store 135.

[0062] In this example, the data store 135 also includes the DTx module 155. As shown, each of the DTx modules 155 may include a therapy profile 280. For example, the therapy profile 280 may include attributes and parameters of the corresponding DTx module 155. For example, the MMPGE 130 may generate a DIMP from the DTx module based on the therapy profile 280.

[0063] In some implementation forms, the treatment analysis engine 240 can operate according to the user profile 140 (for example, the patient's disease profile 260 retrieved from and / or associated with the user profile) according to the treatment profile 250 to generate, for example, an associated patient treatment profile (not shown). For example, the treatment analysis engine 240 can determine the proposed media content based on the user profile 140 according to, for example, the treatment profile 250, the media profile 145, and / or the motivation profile 265 of the user profile 140. The treatment analysis engine 240 can include, for example, a machine learning model configured to automatically redefine and / or update the weighting associated with the attributes of the patient treatment profile based on user input (for example, micro-journaling, changes to the disease profile, changes to the media profile, caregiver input, input from authorized experts).

[0064] In some implementation forms, the evaluation engine 125 can operate according to the user profile 140 and / or the micro-journal 255 to determine, for example, the current state of the associated user. In some implementation forms, by way of example and not limitation, the evaluation engine 125 can operate according to the user profile 140 and / or the micro-journal 255 associated with a patient (for example, STU105) to determine the current state of the user (for example, in the disease process) according to the treatment profile 250. In some implementation forms, the evaluation engine 125 can operate according to the user profile 140 and / or the micro-journal 255 to determine, for example, the current state of the associated user. In some implementation forms, by way of example and not limitation, the evaluation engine 125 can operate according to the user profile 140 associated with a patient (for example, STU105) and / or the motivation profile 265 to determine the motivation profile 265 of the user.

[0065] In some implementations, when it is determined that direct in-person intervention is required, the evaluation engine 125 can generate a message to the healthcare professional interface 215 and / or a designated caregiver 270. For example, the evaluation engine 125 can be configured to generate a dynamic state profile 275 about the user using, by way of example and not limitation, the SIGECAPS (Sleep, Interest, Guilt, Energy, Concentration, and Appetite, Psychomotor, and Suicidal ideation) framework to access the user's current mental health. For example, the evaluation engine 125 can determine to contact a designated caregiver 270 based on the updated dynamic state profile 275.

[0066] FIG. 3 is a flowchart illustrating an exemplary runtime method 300 of an exemplary DIPGS. For example, the MMPP 120 can be used to implement the method 300. The method 300 begins at step 305, at which time an input is received from the user device. For example, the device 106 can send the input from the STU 105 to the MMPP 120. In some embodiments, the MMPP 120 can include an ongoing evaluation engine configured, by way of example and not limitation, to assist in determining the effectiveness of the game, a list of recommended games, and whether the user should be directed to a higher level of personal care (e.g., rather than self-treatment).

[0067] For example, STU105 can send user input, including self - evaluation micro - journal entries, to MMPP120 using MMDA110. At decision point 310, it is determined whether the user is a new user. If the user is a new user, at step 315, a new user profile is generated based on the received input. For example, the new user profile can be stored in user profile 140. If the user is not a new user, at step 320, the existing user profile is updated based on the received input. For example, evaluation engine 125 can update the micro - journal 255 within user profile 140 based on the user input.

[0068] For example, the input made at step 305 can include responses to a predetermined set of questions presented to STU105. In some implementations, the set of questions can be retrieved from data store 135 and presented to STU105. In some implementations, the set of questions can be dynamically generated, for example, based on responses from STU105. In some implementations, the set of questions can be provided to STU105 by a third party (e.g., STU105 can be directed to the set of questions and / or a signal representing the results from the third - party set of questions can be sent to MMPP120).

[0069] After step 315 or step 320, at decision point 325, it is determined whether method 300 should end. For example, STU105 can close MMDA110 after completing micro - journaling. If method 300 should end, method 300 ends.

[0070] If method 300 should not be terminated, in step 330, a media proposal is generated based on the user profile. For example, MMPGE 130 can generate a list of wild games 150 proposed to the user based on the user's user profile 140. Next, in step 335, the proposed media is distributed. In some implementations, the media may be distributed, for example, from and / or via WMP 115. For example, MMPP 120 can distribute a link to the proposed media in WMP 115 to STU 105. For example, MMPP 120 can distribute a DIMP including the proposed media to STU 105. For example, the media analysis engine 235 can operate according to the user profile 140 to generate the proposed media according to, by way of example and not limitation, the media profile 145, the disease profile 260, the treatment profile 250, the motivation profile 265, the evaluation engine 125, the patient's disease profile 260, and / or the dynamic state profile 275.

[0071] In step 340, within the stimulated state of the media, the user response is recorded by a background process. For example, DIPSM 160 can send the user profile 140 based on the user's interaction within the wild game 150 in the stimulated state. The response may be sent, for example, periodically. The response may be sent, for example, when a predetermined measure is met.

[0072] At decision point 345, it is determined whether a state transition should be performed. For example, DIPSM160 can determine that a transition from a stimulation state to a therapy state should be performed when a set of predetermined metrics generated by MMPGE130 is satisfied. If the state transition should not be performed, step 340 is repeated. If the state transition should be performed, in step 350, the media is temporarily interrupted, and digital therapy (e.g., TIMP190) is delivered to the user (e.g., to MMDA110), and step 305 is repeated. For example, DTx module 155 can include, by way of non-limiting example, therapy proposals and / or instructions (such as attention via therapy interface 170 as disclosed, for example, with at least reference to FIG. 1B). For example, the response of STU105, media proposals and / or the history of the selected media, the history of the interaction with the delivered media, or some combination thereof may be stored (e.g., in micro journal 255) in association with, for example, user profile 140.

[0073] After step 320, the user profiles 140 of other users are updated (e.g., media profile 145, medical condition profile 260, treatment profile 250, motivation profile 265). For example, user profile 140 may be updated based on the actual actions and / or responses of similar users to improve accuracy rather than relying solely on the initial self-assessment.

[0074] In various implementations, DIPSM160, which is configured to identify one of the therapy instances within DIPGS during the execution time of DIPGS, interrupts the execution time of DIPGS, presents one or more therapy modalities to the user, and updates the user profile and DIPGS based on the results of the therapy modalities.

[0075] Figure 4 depicts an exemplary architecture 400 of an exemplary risk assessment engine for DIPGS. In the depicted example, the guidance and warning layer 405 can, for example, provide media and / or prompts to the user and / or receive input from the user. The observation layer 410 can generate metrics corresponding to a given scale, for example, based on input from the guidance and warning layer 405. The risk assessment layer 415 can generate instructions and / or messages corresponding to referrals based on the metrics. In some implementations, the guidance and warning layer 405, the observation layer 410, and the risk assessment layer 415 can be included in the assessment engine 125.

[0076] Without limitation, as shown in the exemplary example of FIG. 4, the STU 105 may self-treat, for example, using the media in the WMP 115. The observation layer 410 can receive input (e.g., via a display layer module) corresponding to the use of media by the STU 105 and / or progress regarding the monitoring status.

[0077] As an exemplary example, the observation layer 410 can be configured to collect information about health metrics (e.g., prompt the user to enter a rating). For example, the user may be seeking self-treatment for pain and / or range of motion limitations. The user can rate, for example, pain and / or range of motion. A game may be proposed and / or delivered that stimulates the user to move incrementally in a manner that can address pain and / or range of motion limitations. The observation engine can prompt the user to provide periodic feedback. Based on the feedback, the assessment engine can make recommendations (e.g., continue playing, play another game, seek further assistance). For example, a "referral" recommendation may be generated based on a given metric (e.g., a pain scale and / or an increase in pain metric exceeding a given referral scale).

[0078] Accordingly, the observation layer 410 can advantageously help the user to better recognize a given factor (e.g., pain, depression, etc.). In some implementations, the observation layer 410 can observe the user's actions (e.g., being in a game play, being away from a game play) to collect health metric information. For example, based on the collected information, the observation layer 410 can request a response from the user (e.g., propose a game, send a questionnaire). For example, in an exemplary use case related to depression, if the user rates their mood as corresponding to mild / moderate depression and if the user is in a better mood after playing, the recommendation layer and / or engine can generate a message recommending playing again tomorrow. If the user is in a worse mood, a message recommending that the user play a different game may be generated. If the user shows additional stress factors and / or a significant worsening, a message and / or instruction prompting the user to seek help (e.g., a given caregiver) may be generated.

[0079] In some embodiments, the observation layer and / or engine can monitor the user's physical attributes. For example, physical monitoring can include biological sensors (e.g., heart rate, temperature, blood pressure). In some embodiments, physical monitoring can include, for example, a camera. For example, the camera can be configured to detect posture. In some embodiments, the metric can include response speed (e.g., while playing a game). The recommendation can be determined, for example, based on the physical attributes.

[0080] The risk assessment layer 415 can operate according to the metrics determined by the observation layer 410 from the input. The risk assessment layer 415 can compare the metrics to a predetermined measure related to progress and / or risk. The risk assessment layer 415 can generate a signal for changing the visible mark presented to the STU 105 according to the metrics and the predetermined measure (e.g., risk scale). The guidance and warning layer 405 can, for example, cause a (dynamic) mark 435 to be generated in response to a signal from the risk assessment layer 415. For example, the mark may be displayed on the therapy interface 170 as shown in FIGS. 1A-1B.

[0081] As an illustrative example, the risk assessment layer 415 can include a risk assessment and / or notification engine configured to generate an alert, remind the player, and / or instruct the player to seek additional care while attempting to use a game as a coping mechanism. For example, by way of non-limiting example, the player may be instructed to seek additional assistance when the player is self-assessing beyond a level of mild to moderate symptoms, when the player's mood has shifted in a negative direction while playing the game, or when the player's mental state has a tendency to be more negative over a period of time when relaxation or at least stability is expected. In some implementations, the assessment engine 125 can be further configured to direct the individual to appropriate resources for the individual's health concerns (e.g., mental, physical) based on one or more factors (including, for example, self-assessment, self-assessment and interaction with the gaming system).

[0082] In this example, a visible marker 420 is presented to the STU105. In some implementations, the marker 420 may include an assistance button. For example, the STU105 can self-identify assistance using the assistance button. For example, the STU105 can click the assistance button to enhance the recognition of a caregiver 430 (such as a predetermined caregiver, a proposed caregiver, etc.) for potential problems. In some implementations, the assistance button can change its shape and / or color based on the risk intensity. For example, when the risk level is low, the assistance button 425a may be gray and have a rectangular shape as represented in the depicted example. When the risk level increases, for example, the assistance button 425a can be changed to the assistance button 425b from gray to green, and its shape can be changed from a rectangle to a circle. In this example, when the risk level further increases to medium-high risk, for example, the assistance button 425b can increase in size and change its color to yellow as shown in the assistance button 425c. When the risk level is high, as an illustrative example, the assistance button 425d may be even larger in size, its text may change to red, and it may blink.

[0083] In various embodiments, the evaluation engine 125 may include a security mechanism configured such that a referral to a predetermined caregiver 430 (such as stored in a predetermined caregiver 270 in the data store 135) is made in all cases where the media is not useful or does not continue to be useful to the individual in dealing with the individual's health condition. The predetermined caregiver 430 may include, for example, a family member. The predetermined caregiver 430 may include, for example, an expert service or other similar help line. This referral may, for example, help the individual to self-evaluate and / or recognize that a higher level of care is required. The referral can, for example, provide a proposed access point for care.

[0084] In various implementations, the media can advantageously serve to engage individuals in assessing their personal levels of physical / mental health and to stay on a path of self-discovery that can lead to seeking additional care. In an exemplary instance, video games and / or other people with mental health states can have the ability to access information online through a peer network or to engage in self-discovery that video games can be a source of alleviating symptoms of mental health. Still, in making this self-determination by selecting and playing these games, they may not choose what is right or best for them. Additionally, the use of video gaming for certain conditions may not be considered appropriate and / or may cause additional harm if an individual does not find the relief they are seeking. The very act of self-determining that the need for support or care is an important step can be, for example, an on-ramping process for those seeking care, especially for those who do not receive care and / or do not have the bandwidth for care.

[0085] In some instances, a situation can exist where, upon self-identifying that an individual has had mental health concerns, the individual may not have the motivation to continue self-monitoring and evaluating to determine whether the selected game is helpful for their condition or whether the condition is overall becoming more severe beyond the gaming experience.

[0086] Advising on the use of video games to address mental health states can remove an important option as a coping mechanism at home and does not represent a practical approach to addressing current mental health support and treatment environments or how individuals will continue to access other sources of games and media as support for health and personal improvement. Thus, method 300 advantageously can solve the technical problem of assisting self - treating patients by providing STU105 with a dynamically generated immersive - therapy - mechanism - based monitoring and tracking mechanism in an unregulated media - content environment.

[0087] In some implementations, DIPSM160 can be configured to adjust a set of predetermined runtime parameters of DIMP based on TIMP190, and the therapy profile of DTx module 155 within TIMP190, and user profile 140.

[0088] As an illustrative example, a patient can download MMDA110. MMDA110 can prompt the patient to answer several questions upon registration. For example, in response to receiving user input, evaluation engine 125 can determine, in response to the questions, that the patient is not in a good mood (e.g., is in a depressed mood, is in a bad mood). Evaluation engine 125 can determine that the patient is associated with post - traumatic stress disorder, anxiety, and / or trauma. For example, evaluation engine 125 can determine (e.g., automatically based on input from a therapist) that the patient is in a depressive mood due to trauma and that depression is thus linked to the trauma and that the trauma must be addressed before other issues.

[0089] The evaluation engine 125 can determine that a mood-changing exercise is necessary (e.g., based on input from the patient and / or therapist, or based on the results of the history from other patients having statistically similar responses within a predetermined confidence interval). The MMPP 120 can recommend a Tetris-based game ("Tetris"). The patient can obtain Tetris (e.g., buy it, download it) (e.g., purchase a stand-alone game on the WMP 115). The patient can log in to the Tetris game in a manner that notifies the evaluation engine 125 that access to Tetris has been completed.

[0090] In response to the notification, the MMPP 120 can cause the MMDA 110 to generate an interface with cautions and warnings (e.g., as mandated by FDA regulations). The MMPP 120 can cause the interface to be generated in an app (e.g., "From the data you provided, I want to visualize for you the time you had a traumatic event and what it was that scared you about the traumatic event"). The DIPGS 100 can then prompt the user to play Tetris (e.g., "Please try playing Tetris for 20 minutes"). After the proposed time and / or when the MMPP 120 is notified that the user has stopped playing, the MMPP 120 can cause the app to generate an interface (e.g., the therapy interface 170) that asks the patient one or more questions (e.g., 1 - 2 simple questions) about how the patient is feeling now. The MMPP 120 can then propose subsequent actions (e.g., "You should do this again tomorrow").

[0091] Thus, DIPGS100 can, by way of example and not limitation, use playing Tetris to stimulate the patient to re-associate the thoughts of an individual associated with mental trauma. DIPGS100 may, for example, not change the game at all from a “normal” non-medical implementation form. DIPGS100 can use Tetris as a tool in medical therapy by suggesting what the patient is thinking about while the patient is playing Tetris.

[0092] DIPGS100 may, for example, monitor and / or collect and / or analyze feedback data to understand why the patient is depressed. DIPGS100 may, for example, line up the patient through a group of games that can help the patient treat this depression. DIPGS100 may, for example, add therapy elements (such as labeling, suggestions, etc.) to these games. DIPGS100 may, for example, track the patient's behavior over time within the user profile 140 (for example, to provide patient and / or physician feedback to gain insights into how well the patient is doing and / or how well the therapy is working).

[0093] In some embodiments, DIPGS100 may be configured, for example, to enable the patient to perform self-care. In the above illustration, for example, if the patient responds that they do not want to play Tetris, MMPP120 can suggest other puzzle games. If the patient does not want to play puzzle games and prefers action games, MMPP120 can suggest action games.

[0094] For example, the patient can play an action game. If the patient's anxiety is slightly reduced, the evaluation engine 125 can return again and propose that the patient think about these moments of mental trauma for a while and try going to play some Tetris. After playing for a while, the patient may indicate that they are bored with playing Tetris. The evaluation engine 125 can encourage the patient while performing therapy actions (such as first thinking about mental trauma) and propose another puzzle game. In some such examples, the game may not need to be changed for "commercial" non-therapy use. In some embodiments, a kernel may be provided (for example, a check-in module).

[0095] In some implementations, the guidance and warning layer 405 can further include general wellness software functions to facilitate, track, and / or recommend choices that can help live well with or reduce the risks of certain chronic psychiatric disorders or conditions as part of a healthy lifestyle. The connection between living well and reducing the risks or impact of chronic psychiatric disorders or medical conditions is well understood. For example, chronic psychiatric conditions can include depression, anxiety, obsessive-compulsive disorder, autism, attention deficit hyperactivity disorder. The platform can also provide physical wellness and comprehensive health treatments and guidelines.

[0096] In some examples, the general wellness software functions can provide statements such as "Device X provides a daily reminder of motivation to perform physical activities that can help a patient with chronic depression live a good life" or "Device Y provides mindfulness and meditation activities that can help a patient with chronic anxiety live a good life".

[0097] In some implementations, the general wellness software functionality can help patients with diagnosed psychiatric conditions maintain their behavioral coping abilities by providing "Skills of the Day" behavioral techniques or voice messages that are accessible to users when experiencing increased anxiety related to the COVID-19 public health emergency.

[0098] In some implementations, the general wellness software functionality can be used to teach users to "simply acknowledge," accept, and embrace thoughts and moods that are difficult or previously unnecessary during the COVID-19 public health emergency, so that the user learns to accept these unpleasant moods and not overreact to them, or avoid situations that trigger them. In some examples, the general wellness software functionality can display images or other messages to physical users who want to stop addictive behaviors due to increased anxiety during the COVID-19 public health emergency at appropriate times.

[0099] In some examples, the general wellness software functionality can help patients or users self-manage their illness or condition without performing a specific treatment or treatment recommendation. In some examples, the general wellness software functionality can use a checklist or questionnaire about common signs and symptoms of psychiatric disorders (e.g., anxiety due to waiting orders) to provide a list of possible medical conditions and advice on when to consult a healthcare provider. In some examples, the general wellness software functionality can guide the user through a questionnaire about the signs and symptoms of psychiatric disorders (e.g., anxiety or stress due to waiting orders) to provide recommendations about the type of healthcare facility that is most appropriate for the user's needs.

[0100] Figure 5 depicts an exemplary use case scenario for delivering an exemplary independent digital therapeutics (IDTx) modality. In this example, STU105 can be in an environment 500 not suitable for gaming. For example, STU105 may be working in an office where gaming is not playable. Nevertheless, as shown in Figure 5, STU105 may desire to receive respiratory assistance. In this example, STU105 can use MMDA110 to send an assistance signal specifying that assistance is needed. For example, the assistance signal can indicate that STU105 needs respiratory assistance. For example, the assistance signal can indicate that STU105 is having an anxiety attack.

[0101] After receiving the assistance signal, MMPGE130 can process the assistance signal to determine, for example, that presenting DIMP is not appropriate based on environmental limitations. In some implementations, MMPGE130 can determine an environment 500 not suitable for gaming based on the user profile 140 of STU105 and the location of STU105.

[0102] In this example, MMPGE130 determines to generate a respiration-related IDTx 505 that will be delivered based on the user profile 140 of STU105. For example, the respiration-related IDTx 505 may be a simplified DIMP. For example, MMPGE130 can access the micro journal 255, the motivation profile 265, and the dynamic state profile 275. For example, MMPGE130 can determine the respiration-related IDTx 505 based on user feedback and historical game play on the history of STU105 and / or similar users.

[0103] As shown, the respiratory-related IDTx505 includes a respiratory DTx510 and details 515. For example, the respiratory DTx510 may be generated based on TIMPs previously played by the STU105. For example, the details 515 may be dynamically generated based on the respiratory DTx510 and the user profile 140. In some implementations, the details 515 may include instructions and warnings for guiding the user. In this example, the details 515 may include guidance for the user during a breathing exercise. For example, the guidance may be generated by artificial intelligence based on the respiratory DTx510, the user profile 140, and the media profile 145.

[0104] Upon receiving the details 515, the MMDA110 generates a virtual treatment room 525. In some implementations, the virtual treatment room 525 can provide the user with an immersive treatment experience of short duration. As an illustrative example, the virtual treatment room 525 can provide the user with a 3-minute breathing exercise accompanied by anti-anxiety music and / or video.

[0105] In various implementations, when the DIPGS100 determines that presenting the DIMP is not appropriate based on environmental limitations or upon receiving a user request, the DIPGS100 can generate a simplified DIMP with a TIMP190 based on the user profile and the history of played DIMPs. Thus, the DIPGS100 advantageously provides a solution for providing the general public with a simple tool for assisting in the user's health state based on a user experience that is not attributable to, for example, a game or a specific media and is environment-independent. For example, the DIPGS100 can function as an "assistant" for health self-assessment (e.g., physical, mental).

[0106] FIG. 6 depicts an exemplary Digital Game Cloud (DGC600) for delivering DTx games employed in an exemplary use case scenario. For example, user 610 can receive DTx game 605 from game platform 615.

[0107] In some implementations, DGC600 may include MMPP120 to conveniently enable an integrated platform for the customization, planning, coordination, tracking, and / or delivery of video games as a digital therapy. For example, DTx game 605 may include DIMPs generated by MMPGE130. DGC600 can operate on, for example, one or more supported game platforms (e.g., WMP115). DGC600 can, for example, enable user 610 to play the game in the native location of the game. DGC600 can, for example, remove the regulatory burden from individual games and enable the games to be played as originally intended. For example, DGC600 can advantageously perform the regulatory operations (e.g., all regulatory operations) required to ensure the safe and effective delivery of mental health treatment for games delivered using DGC600.

[0108] As further discussed with reference to FIGS. 7-8, DGC600 manages the regulatory burden by, for example, delivering games that are already approved as medical devices, delivering games that make wellness claims associated with approved games, and / or delivering games for which DGC600 performs regulatory operations including, but not limited to, labeling, therapy setup, and / or follow-up (pre- and / or post-game play messaging, monitoring, or questionnaires).

[0109] In various implementations, the DGC600 can receive usage information from the game platform 615. For example, the DGC600 can identify from the data provided by the game platform 615 that the user 610 is playing a specific game at a specific time. In some implementations, an interconnection between the game platform 615 and the DGC600 can be provided by incorporating a digital connection between the wild game of the game platform 615 and the DGC600. For example, in some implementations, the DGC600 can be provided with at least a signal identifying which game and when the user is playing. In some implementations, when such a connection may not exist, the DGC600 can enable the user 610 to manually report usage information (e.g., game usage and play duration).

[0110] Figure 7 is a block diagram depicting an exemplary DGC. In this example, the DGC600 includes an initial self - assessment tool 705 and a journaling module 710. For example, the initial self - assessment tool 705 can help the user 610 determine which games are most suitable for the user's health concerns and the current state of dysfunction. For example, the initial self - assessment tool 705 can use the evaluation engine 125 to evaluate the user's current state and recommend the most suitable game.

[0111] In some implementations, the initial self - assessment tool 705 can include points of an entry self - assessment tool configured to help a user determine whether a DGC is suitable for the player's needs. For example, the entry self - assessment tool can determine (e.g., based on profiles in the data store 135) whether the instructions of the currently approved platform for use (e.g., morbidity profiles, treatment profiles, and / or instructions for a given approval associated with a kinetic pathology state) match the user's needs and current profile. For example, when approved for mild to moderate symptoms of stress, anxiety, and depression, the self - assessment tool can be configured to help the user self - determine, for example, whether the user has the appropriate symptoms and whether those symptoms actually conform to the form of the disease state from mild to moderate. The DGC 600 can be configured such that such information can also form a basis or baseline for further self - and / or system - based evaluations.

[0112] In some implementations, the initial self - assessment tool 705 can help a player determine which game is most suitable for the player's motivation / play type (e.g., the evaluation engine 125), morbidity (e.g., mental health concerns) (e.g., the patient's morbidity profile 260), and the current state of dysfunction with respect to the morbidity (e.g., the dynamic state profile 275).

[0113] The journalling module 710 may include, for example, a continuous self - assessment tool that can help the user 610 determine which games are most suitable for the user 610's health concerns and current state of dysfunction. In some implementations, journalling can be achieved as a micro - journalling tool that can provide context to short, documented comments by the user 610 using AI and up - to - date / situation awareness. In some implementations, the journalling module can advantageously reduce the need for the user to spend a lot of time on mood journalling or explanations. In some implementations, the journalling tool may include ways to enable the user 610 to rate the user 610's current state before, during, and after play. These ways include, but are not limited to, choosing from a list of words associated with the game the player is experiencing or the current physical or mental health state, recording spoken words for translation into written words, and using short or small texts all tied to the most recent game - play experience (situation awareness) that helps provide context to the information captured from the patient / player.

[0114] In this example, DGC600 further includes a game selection module 715. For example, user 610 can use game selection module 715 to select a game based on the intended or associated usage of user 610. In some implementations, game selection module 715 can generate a proposed play list of games. For example, the list of games may be compiled by instructions regarding usage, associated usage, action mechanisms, genres, platforms, and / or other similar user recommendations. In some implementations, game selection module 715 can generate a proposed list of games to play next. For example, the proposed list of games to play next may be generated based on initial user input and / or standard treatment protocols, and / or in response to user experience associated with previously played games, or updates to user self-assessment tools or diagnostic tools, based on a predetermined treatment policy.

[0115] In some examples, the game selection module can propose additional games based on the response of user 610 and the measured progress. For example, user 610 can make an independent selection from a pre-selected group of games. In some implementations, the recommended games may be successful games recorded from the game history of user 610. In some examples, the therapy mechanisms used in the recommended games may be shown to user 610. In some implementations, game selection module 715 can advantageously promote more neural engagement to potentially achieve a higher rate of success, based on past gaming history, and / or the preferences of user 610 regarding games, or statistics regarding the preferences of other players having similar traits (including but not limited to health problems, similar responses to treatment, or other similar preferences regarding treatment). Further, the user may be connected such that game options from other platform users that the user follows are presented, or the user can choose from similar gaming / treatment policies.

[0116] In this example, the DGC600 includes a notice and warning distribution module 720. For example, the notice and warning distribution module 720 can distribute notices and warnings as required by the relevant regulatory agencies. In some implementations, the DGC600 can provide guidance to the user 610 before, during, and / or after the game to help focus on the therapeutic intent of the DTx game 605. In some implementations, the warning distribution module 720 may be executed in the guidance and warning layer 405 described with reference to FIG. 4. In some implementations, 720 can distribute preamble and / or postscript explanations and / or suggestions on how to receive increased benefits from play and / or therapy based on the guidance for game play and / or the use of the game as a motivational tool for therapeutic use.

[0117] The DGC600 includes a platform communication module 725 for connecting the DGC600 to the game platform 615. In some implementations, the DGC600 may be connected to the game platform 615 by a software and / or middleware-based connection. For example, the connection may enable the DGC600 to know which game the user 610 is playing and for how long.

[0118] DGC600 includes a game feedback module 730 and a feedback analysis module 735. In some implementations, the game feedback module 730 can recommend games for use based on the user 610's experience of using games for therapeutic use. In some implementations, the feedback analysis module 735 tracks the user 610's game play and resulting self-evaluations, including surveys, (micro) journaling, and other forms of self-reflection and reporting, and can use the data collected, for example, to improve the proposed treatment regimens for specific DGC users. In some examples, the feedback analysis module 735 can use the data collected to improve the proposed treatment regimens for other DGC users having similar needs, histories, and / or other enumerated characteristics.

[0119] In some implementations, DGC600 includes a healthcare professional module 740 (e.g., in the healthcare professional interface 215) for providing an interface for a healthcare provider and / or related healthcare professional (e.g., a therapist) to view the game play history, self-evaluations of DGC users, and other relevant reporting including, but not limited to, journaling, micro-journaling, user associations, or any other information that may help a healthcare professional understand the user's current mental and / or physical health. For example, the healthcare professional module 740 can include means for a therapist to shape or propose games, treatment mechanisms, themes, or directions of treatment, or to control other parts of the platform to improve the user treatment experience and outcome. In some implementations, a therapist can use the healthcare professional module 740 to assign homework or other ancillary tasks along with a patient's treatment plan to create a coordinated treatment approach. A therapist can also use the information from the platform to create a more complete patient profile or understanding for the development of a more coordinated treatment plan.

[0120] In some implementation forms, users may be provided with control rights over data privacy regarding logged data and / or journaling data. For example, users may be provided with the option to use the medical expert module 740 to send raw logged data and / or journaling data to treatment experts. In some examples, users may be provided with the option to send (e.g., manually or automatically) summaries and / or redacted logged data and / or journaling data to treatment experts. In some implementation forms, by way of example and not limitation, users may be provided with a customized display of historical data (e.g., logged data, journaling). For example, the DGC600 can generate different (e.g., customized) displays of historical data for treatment experts.

[0121] In this example, the DGC600 includes a revenue module 745 for determining the contractual obligations and calculations for a shared revenue agreement with a wide range of potential partners including, but not limited to, game developers / publishers, treatment experts, complementary platforms, and other treatment or gaming-related tools and services, and is a source for appropriate game purchase and play recommendations that meet the contractual obligations. For example, the revenue module 745 can determine that the DTx game 605 previously recommended by the DGC600 to the user 610 has been played. For example, the revenue module can track usage data and charge for access to the DGC600. In some examples, the revenue module 745 can determine that a portion of the sales revenue from purchasing individual games may be chargeable.

[0122] In this example, the DGC600 addresses regulatory requirements using the regulatory module 750. In some implementations, the regulatory module 750 advantageously minimizes the impact on game developers and (e.g., centralizes around a web - based platform for intake and labeling, and other required regulatory functions that require ongoing verification and validation) minimizes the ongoing verification and validation requirements of the game platform. For example, when the DGC600 is distributing the DTx game 605, there may be regulatory requirements for all digital therapy games that make therapeutic claims not individually approved as medical devices.

[0123] Figure 8 depicts an exemplary regulatory module for addressing regulatory requirements for DTx games. For example, the DGC600 can use the regulatory module 750 to meet at least some of the regulatory requirements for DTx games that make therapeutic claims not individually approved as medical devices.

[0124] As shown in the illustration, the regulatory module 750 includes a software inspection module 805, a cybersecurity module 810, a labeling module 815, and a user consent formulator 820. For example, the software inspection module 805 can perform software verification, validation, and threat analysis to ensure that the device is implemented as intended for the therapy model. The cybersecurity module 810 can provide appropriate cybersecurity protection compliant with authorities (such as FDA pre-market and post-market recommendations), for example. For example, the labeling module 815 may include user guidance for instructing the patient to contact the physician before using the device. The user consent formulator 820 may be prompted to approve recommendations, for example, to contact the physician before use. For example, the user consent formulator 820 can provide a stand-alone checkbox separate from the end-user license agreement. In some implementations, the end-user license agreement may include an explicit statement that the patient can contact the physician before using the device even if the device is directly marketed to consumers.

[0125] In some implementations, the end - user license agreement may include user guidance for providing information on how to access additional resources related to the treatment of mental states. In some examples, the guidance for use may include images showing how to interact with the device. For example, the state may include a reference to recommendations for the general public made by medical professional organizations (such as the American Psychiatric Association or other associations). In some implementations, the end - user license agreement can provide a clear description of the device's instructions, including the mental states / disorders the device is intended to treat, and a description of the intended patient population (such as type of symptoms, duration, severity, and the age range expected to be effective (adults vs. children / young people), etc.). In some implementations, the labeling module 815 can provide a description of the therapeutic methods (behavioral therapy, cognitive restructuring, etc.). In some implementations, the end - user license agreement can provide a clear description of the recommended duration and frequency of use.

[0126] In some implementations, the end - user license agreement can provide an overview of the clinical tests performed by the device. In various implementations, the overview may include a summary of the available clinical performance tests, including the methods (such as the clinical endpoints studied, type of study, sample size, etc.) and results (such as group / responder analysis, performance goals, etc.). In some implementations, the overview may include a statement that the device has not been clinically tested and thus may have unknown benefits and risks.

[0127] An end-user license agreement can provide, for example, a description of how to determine any treatment recommendations. In some examples, the end-user license agreement can provide, when applicable, an important notice to both the patient and the healthcare provider that the recommendations provided by the device are adjunct (supportive) and need not rely solely or primarily on treating a psychiatric condition. In some implementations, the end-user license agreement can provide a warning that the device does not substitute for a patient's medications. In some examples, the end-user license agreement can provide a statement as to whether the device is available regardless of the presence or absence of a prescription. In some examples, the end-user license agreement can include guidance as to when (under what circumstances, how frequently) the user should consult a healthcare provider. The end-user license agreement can also, in some examples, include a clear statement as to what to do if symptoms have not improved and for what period improvement should be expected. For example, the end-user license agreement can include guidance as to what to do in the event of a medical emergency. The end-user license agreement can include, for example, a clear identification of any device instructions / functions that are not FDA-approved.

[0128] In some implementations, the DGC600 can deliver games as non-medical devices that recommend a healthy lifestyle, which is not related to the specific diagnosis, cure, alleviation, prevention, or treatment of a disease or condition. For example, the DGC600 can include general wellness software functions that are not related to a specific disease or condition, such as promoting rest, mindfulness, meditation, and / or reducing stress, fatigue, or mood caused by the COVID-19 public health emergency or other situations that create isolation or potential isolation for the user. For example, the DGC600 can include general wellness software functions related to sleep, such as promoting sufficient sleep, improving your sleep experience, getting a more calm or peaceful sleep, sleeping through the night, or sleeping all night. For example, the DGC600 can include general wellness software functions related to mental health or psychiatric conditions, such as providing motivation secrets by the DGC600 through text and other messages intended to help the user have a good life during the COVID-19 public health emergency or in general or potential isolation situations, and promoting a positive mental attitude to reduce stress.

[0129] As an illustrative example, the DGC600 can include a label display engine (e.g., in the guidance and warning layer 405) configured to generate (digital) label displays to help an individual understand the cautions and warnings associated with playing a game with an expectation of alleviating symptoms of mild / moderate depression, anxiety, or stress.

[0130] In various embodiments, when a change is accepted in one of the DTx games 605, the therapy profile 280 of the changed media content is updated based on a predetermined set of activation rules, and thus the changed media content complies with the activation rules and conforms to the therapeutic intent.

[0131] Figure 9 depicts an exemplary method 900 for enabling a wild game to become a DTx game. For example, method 900 may be implemented by a regulation module 750. In this example, method 900 begins at step 905 when an update of a valid DTx (e.g., DTx module 155 within data store 135) is received from the game platform. For example, game platform 615 can notify DGC 600 of the update using the interconnect between game platform 615 and DGC 600. For example, a game developer can change a part of an unregulated game (e.g., the background color of one of the displays), such as wild game 150.

[0132] At step 910, an enabling rule is retrieved. For example, regulation module 750 can retrieve the enabling rule from medical enabling rule 220. Next, at step 915, the updated DTx is evaluated based on the retrieved enabling rule. For example, software inspection module 805 can test the updated components against the enabling rule.

[0133] At decision point 920, it is determined whether the updated DTx complies (e.g., with the regulation rules). If it complies, at step 925, an updated therapy profile for the DTx is generated and method 900 ends. For example, therapy profile 280 can be updated based on the changes to the DTx. For example, label display module 815 can generate appropriate labels based on the updated components to generate the updated DTx. Thus, the DTx can advantageously be verified to conform to the therapeutic intent.

[0134] If not compliant, at step 930, an error report is generated, the update is rejected, and method 900 ends. For example, the error report may include the reason for the rejection. Various embodiments for inspecting and validating non-medical digital components of medical digital assets are described in PCT Patent Application No. PCT / US2021 / 071585, entitled "Immersive Medicine Translational Engine for Development and Repurposing of Non-Verified and Validated Code," filed by Ryan J. Douglas on September 24, 2021, the entire contents of which are incorporated herein by reference.

[0135] Figure 10 depicts an exemplary method 1000 for delivering a dynamic stimulus media package (DIMP) and providing ongoing monitoring to a user. For example, MMPP 120 may be configured to implement method 1000. Method 1000 begins at step 1005 when a signal corresponding to a user request for media is received. For example, the requested media may be an unregulated game (e.g., wild game 150). At step 1010, the user is prompted to answer a predetermined question. For example, the evaluation engine 125 can send the question to device 106.

[0136] Next, at step 1015, the user profile is updated based on the received answer. For example, the evaluation engine 125 can update the user profile 140 based on the received answer from the sent question. After the user profile is updated, at step 1020, a transition metric corresponding to the requested media is dynamically generated. For example, MMPGE 130 can generate a state transition metric for the wild game selected by the user. At step 1025, a DIMP is generated based on the requested media and one or more DTx.

[0137] After DIMP is generated, at step 1030, the user actions during the execution time of the requested media are observed. For example, the observation layer 410 can observe the user actions while the wild game 150 is being played. At the decision point 1035, it is determined whether the state transition measure is satisfied. If the state transition measure is not satisfied, step 1030 is repeated.

[0138] If the state transition measure is satisfied, at step 1040, effective therapy content is presented. For example, DIPSM 160 can transition DIMP from the stimulation state to the therapy state, and MMPGE 130 can generate a therapy interface 170 that will be presented on the device 106. At step 1045, the user's progress is evaluated. For example, the evaluation engine 125 can evaluate the responses received from the therapy interface 170.

[0139] At the decision point 1050, it is determined whether the user's health state has improved. For example, the evaluation engine 125 can specifically evaluate the user's anxiety. If the user's health state has improved, at step 1055, a notification message is generated and step 1030 is repeated. If the user's health state has not improved, at step 1060, a proposal is generated. For example, the guidance and warning layer 405 can generate several proposals based on the user's dynamic state profile 275.

[0140] At the decision point 1065, it is determined whether an intervention is required. For example, the risk assessment layer 415 can determine in the evaluation step that an intervention is required when the user's condition falls below a predetermined intervention threshold. If an intervention is not required, step 1030 is repeated.

[0141] If an intervention is required, at step 1070, an intervention is generated. For example, the risk assessment layer 415 can generate a message to a predetermined caregiver 270 to check on the user.

[0142] Although various embodiments have been described with reference to the figures, other embodiments are possible. In some implementations, the DGC 600 can, for example, (using an app as a "wrapper" for delivering medical therapies associated with, for example, non-medical / non-regulated games), advantageously enable a retailer to distribute and return a catalog game with minimal intervention from the developer. The DGC 600 can, for example, provide an existing game developer with a new revenue source. The DGC 600 can, for example, enable a game developer to permanently associate a game. The DGC 600 can, for example, enable the delivery of a powerful therapy to a patient.

[0143] In some embodiments, the DGC 600 can monitor the environmental conditions of the gaming. In some embodiments, the DGC 600 can propose games that are also available as stand-alone medical devices outside of the app environment.

[0144] As an illustrative example, a game (e.g., "GameX") can be provided through the system's platform. The diagnostic engine of the DGC600 (e.g., part of the MMPGE130 that collaborates with the selection engine) can suggest that the user has a particular problem. The system can suggest that GameX is associated with the highest historical success rate when dealing with a particular problem (e.g., based on diagnostic factors, environmental factors, personality). GameX can be recommended. The DGC600 can enable users of GameX associated with medical therapy (e.g., GameX may not be medically approved and / or distributed) by implementing label display and / or therapy input and / or monitoring associated with playing GameX. The DGC600 can monitor how the interaction with GameX proceeds (e.g., through an API, through user input). For example, the system can have feedback information from GameX. In some embodiments, by way of example and not limitation, the information can include at least (a) whether the user signed in to the game (e.g., to confirm that the user played the game), and (b) the duration of play (e.g., when the user started and stopped playing the game).

[0145] In some embodiments, MMDA110 may not be a medical device. For example, MMDA110 may be configured to operate as a collection device. MMDA110 can cause device 106 to send data (e.g., unchanged) to DGC600 (e.g., a cloud server). Thus, MMDA110 or device 106 may not need to be enabled as a medical device. The medical device may be embodied, for example, in a cloud server (e.g., MMPP120 or DGC600). A server-based system (including, for example, a diagnostic engine, a selection engine, a monitoring engine) may be maintained, verified, and / or enabled (e.g., in response to regulatory control). Thus, for example, wild game 150 may be a "free game" and / or the app may be a "free app on the phone" that does not require ongoing activation. As an illustrative example, a distributed network of servers may be managed for regulatory compliance (e.g., compliance with ISO 13485).

[0146] In some implementations, MMDA110 and / or wild game 150 may be configured such that it is impossible to break the treatment mechanism. For example, the treatment mechanism may advantageously depend substantially entirely on a server-based system. The system can receive information from the game and / or from the patient, analyze the information, and / or respond to the information. The system can interact with the patient, for example, through an app. The system can send information to the game (e.g., to generate a display, to prompt a report of play time, etc.).

[0147] The cloud server may, for example, execute a program of instructions for recommending games (e.g., via a diagnostic engine and / or a selection engine), monitor when a game is completed (e.g., via a monitoring engine), recommend that the patient perform an action therapeutically, and / or seek and check what has functioned for the patient. For example, the DGC600 can provide an interface to the patient and / or the therapist (e.g., via an app, via a web interface, etc.). The DGC600 can monitor who, which game, and why a recommendation was made.

[0148] In some embodiments, the DGC600 can make direct recommendations (e.g., "Hey, you seem like the kind of person who should play GameX"). The DGC600 can recommend means for playing GameX (e.g., "By the way, there's a really great place here for you to go play GameX"). The DGC600 can prompt for feedback (e.g., "Hey, you played GameX. What do you think of it now?"). The DGC600 can prompt for self-evaluation (e.g., "Hey, are you enjoying what you're doing. Also, what do you think of it?"). The responses may be stored, for example, in a structure associated with the game, the user, and / or the disorder. The game selection module 715 can update recommendations for the user and / or other users based on the feedback. Thus, the recommendations, by way of example and not limitation, can advantageously become more therapeutic and / or make already performed user actions (e.g., playing a game the user enjoys) more therapeutic.

[0149] In some implementation forms, DGC600 can, for example, generate promising proposals (e.g., "Did you know that you showed that our mood improved significantly within three weeks from these moods in a similar scenario?"). DGC600 can, for example, associate promising proposals with the proposed actions (e.g., "By the way, this is what you did when you felt like this, and did your mood start to improve after you did this?"). DGC600 can make non-pressure proposals (e.g., "You are ready, you can start as soon as you remember, these are games and they are fun. You had a great time. This is one of the things you like. Do you remember this game that you really liked? Why not try this for 20 minutes?").

[0150] In some implementation forms, DIPGS100 may not be associated with the source code of the game. DIPGS100 can provide, for example, codes and / or links (e.g., via visible markers such as logos, icons, etc.). When the codes and / or links are activated, patients can be directed to the selected games compiled by DIPGS100. The patients may, for example, already own the games and / or have purchased them from a third party (e.g., a game platform).

[0151] In various embodiments, a game (e.g., a wild game 150, a DTx game 605) may be available on one or more platforms. For example, the game may be available through a third-party platform. The selection engine can instruct the user as to one or more platforms available for accessing the game. The selection engine can generate an identifier associated with the user and / or recommendation. When the user accesses the game, the monitoring engine can associate the identifier with the user and / or recommendation. The monitoring engine can determine attributes associated with game play based on input received from an engine associated with the game (e.g., a third-party game engine), and / or user input. The attributes can include, by way of example and not limitation, a game start time, a play duration, a game end time, or some combination thereof.

[0152] The monitoring engine can interact with the user before, during, and / or after game play. For example, the monitoring engine can provide the user with notices, warnings, and / or regulatory information at the start of game play. In some examples, the monitoring engine can provide the user with guidance regarding game play (e.g., at the start of game play). The monitoring engine can, for example, collect feedback from the user. For example, the monitoring engine can prompt the user for feedback regarding the user's experience, mood, current state, noticed improvements, or some combination thereof. The monitoring engine can, for example, provide the feedback to the selection engine. Accordingly, the selection engine can dynamically update recommendations and / or metadata associated with the game based on feedback received from the user and / or others.

[0153] The DGC600 can propose games that should be played at therapeutically appropriate intervals. The DGC600 can require the player to think about and / or do things (e.g., prompt via an app) while playing the game. The DGC600 can check (e.g., via a prompt) to monitor whether the user is following the proposal. Thus, the DGC600 can advantageously stimulate a change in the user's attitude. For example, the DGC600 and the process result in a therapeutic treatment effect.

[0154] Such embodiments can be integrated with a game at one or more levels, for example, advantageously, to (optionally) apply the game to stimulate a positive therapeutic effect. For example, the system can receive feedback (e.g., through an app such as by user input, through an API associated with the system and the game) regarding when and for how long the patient played the game. The system can retrieve, for example, a list of games already integrated with the system. In some embodiments, one or more games may be hosted and / or accessible via a platform associated with the system. At least some of the games may be accessible by the user, for example, via the native environment of the game (e.g., X-Box, Playstation, Wii). For example, the game may not be required to be hosted on a platform provided by the system that will be therapeutically selected, delivered, and / or monitored. Such an implementation can be carried out, for example, with little or no integration burden for the game developer. Thus, various such embodiments can advantageously provide expanded access to patients.

[0155] In various embodiments, the evaluation engine 125 can retrieve, generate, and / or store information about a user's personality based on profiling (e.g., performed during setup, performed periodically, provided by a therapist). The evaluation engine 125 can, for example, direct the patient to the game that best suits the patient's medical problem. For example, the evaluation engine 125 can record usage data so that, for example, the patient can "guide themselves" through the app. In some embodiments, a third party (e.g., a professional therapist, a doctor) can provide input to guide the selection of the game.

[0156] In various embodiments, information about a proposal, feedback, response, engagement, play duration, or some combination thereof may be recorded in a data structure (e.g., associated with the patient, associated with the disorder, associated with the game). The information may be analyzed for diagnosis and improvement in treatment (e.g., using an artificial intelligence model such as a neural network).

[0157] Although an exemplary system has been described with reference to the figures, other implementations may be deployed in other industrial, scientific, medical, commercial, and / or residential applications.

[0158] In some implementations, the regulatory requirements may include a clear statement that the patient should contact a physician before using the device even if the device is directly marketed to consumers. The regulatory requirements may include labeling with user guidance that provides information on how to access additional resources regarding the treatment of psychiatric conditions, such as references to general population recommendations made by healthcare provider organizations, or to the American Psychiatric Association or other societies. The regulatory requirements may include a clear description of the device's intended use for the psychiatric condition / disorder being treated by the device, as well as a description of the intended patient population (type of symptoms, duration, severity, and age range expected to be effective (adult vs. child / young person), etc.).

[0159] For example, the regulatory requirements may include a description of a therapeutic method (e.g., cognitive behavioral therapy, etc.). For example, the regulatory requirements may include a clear description of the recommended duration and frequency of use. For example, the regulatory requirements may include instructions for use, including an image showing how to interact with the device. For example, the regulatory requirements may include an overview of the clinical tests by the device. For example, the regulatory requirements may include a description of how to determine any treatment recommendations. For example, the regulatory requirements may include, when applicable, an important notice to both the patient and the healthcare provider that the recommendations provided by the device are ancillary (supportive) and should not solely or primarily rely on treating the psychiatric condition. For example, the regulatory requirements may include a warning that the device does not substitute for a patient's medication. For example, the regulatory requirements may include a statement about whether the device is available regardless of the presence or absence of a prescription. For example, the regulatory requirements may include instructions on when (in what situations, how frequently) the user should consult a healthcare provider. For example, the regulatory requirements may include a clear statement about what to do if the symptoms have not improved and for what period improvement should be expected. For example, the regulatory requirements may include instructions on what to do in the event of a medical emergency. For example, the regulatory requirements may include a clear identification of any device instructions / functions not approved by the FDA.

[0160] In some implementations, by way of example and not limitation, various systems (e.g., DIMP generation, delivery, and / or monitoring systems) can be configured to manage stimulation, except for the actual administration of therapy. For example, DIPGS (e.g., as disclosed herein) can manage the delivery of stimulation, the monitoring of stimulation, and / or the monitoring of ambient stimulation (e.g., to determine when to trigger stimulation, how to modify stimulation, and when to end stimulation). By way of example and not limitation, DIPGS may not actually deliver therapy. For example, a separate therapy delivery module may deliver therapy. DIPGS can, for example, generate a stimulation package. DIPGS can, for example, deliver stimulation. DIPGS can, for example, transfer discretion to a therapy module and / or a human. DIPGS can, for example, receive the results of therapy. DIPGS can, for example, generate an updated stimulation package (e.g., DIMP) based on the results of therapy and / or stimulation.

[0161] (e.g., as depicted herein) MMPGE can, for example, package stimulation and therapy. In some implementations, by way of example and not limitation, MMPGE can operate, for example, except for the delivery of therapy. For example, MMPGE can generate packaged medical media and non-medical stimulation (e.g., non-medical media) and provide the resulting media package for delivery. In some implementations, by way of example and not limitation, MMPGE can, for example, monitor delivery. MMPGE can, in some implementations, receive the results of therapy delivery from a separate module (e.g., a therapy module, DIPGS). For example, in some implementations, DIPGS and / or MMPGE can dynamically create and / or adjust a media package (e.g., DIMP) based on the results of therapy and / or stimulation without delivering and / or performing therapy.

[0162] A computer program product may include a set of instructions that, when executed by a processor device, cause the processor to perform prescribed functions. These functions may be performed in conjunction with a controlled device operating in communication with the processor. A computer program product that may include software may be stored in a data store tangibly embedded in a storage medium such as an electronic, magnetic, or optical storage device, which may be fixed or removable (e.g., hard disk, floppy (registered trademark) disk, thumb drive, CD, DVD).

[0163] Examples of systems that may be portable have been described with reference to the above figures, but other implementation forms may be deployed in other processing applications such as desktop and networked environments.

[0164] Temporary auxiliary energy input may be received from, for example, a rechargeable or single-use battery, enabling use in portable or remote applications. Some embodiments may be operable with other DC voltage sources, such as a 9V battery. For example, an alternating current (AC) input, which may be provided from a 50 / 60Hz power port or from a portable generator, may be received via a rectifier and appropriate scaling. The supply of an AC (e.g., sine wave, square wave, triangular wave) input may include a line frequency converter to provide voltage step-up, voltage step-down, and / or isolation.

[0165] Although specific features of the architecture have been described, other features may be incorporated to improve performance. For example, caching (e.g., L1, L2, …) techniques may be used. For example, random access memory may be included to provide a scratch pad memory and / or to load executable code or parameter information stored for use during run-time operation. Other hardware and software may be provided to perform operations such as network or other communication using one or more protocols, wireless (e.g., infrared) communication, stored operating energy and power (e.g., battery), switching and / or linear power circuits, software maintenance (e.g., self-test, upgrade), and the like. One or more communication interfaces may be provided to support data storage and related operations.

[0166] As a computer system that can be used with various implementations, several systems may be implemented. For example, the various implementations may include digital circuit devices, analog circuit devices, computer hardware, firmware, software, or combinations thereof. The apparatus can be implemented in a computer program product tangibly embodied in an information carrier, for example, within a machine-readable storage device, for execution by a programmable processor, and the method can be performed by a programmable processor executing a program of instructions to perform the functions of the various embodiments by operating on input data to produce output. The various embodiments can advantageously be implemented in one or more computer programs that are executable on a programmable system including at least one programmable processor coupled to receive data and instructions from, and to transmit data and instructions to, a data storage system, at least one input device, and / or at least one output device. A computer program is a set of instructions that can be used, directly or indirectly, in a computer to perform a particular activity or to cause a particular result. The computer program can be written in any form of programming language, including compiled or interpreted languages, and the computer program can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment.

[0167] Processors suitable for the execution of a command program may include, by way of example, general and special-purpose microprocessors, which may include a single processor of any type of computer or one of a plurality of processors. Generally, a processor will receive instructions and data from a read-only memory or a random access memory, or both. Indispensable elements of a computer are a processor for executing instructions and one or more memories for storing instructions and data. Generally, a computer will also include or be operatively connected to communicate with one or more mass storage devices for storing data files, such devices including magnetic disks such as internal hard disks and removable disks, magneto-optical disks, and optical disks. Storage devices suitable for tangibly embodying computer program instructions and data include all forms of non-volatile memory, including, by way of example, semiconductor memory devices such as EPROM, EEPROM, and flash memory devices, magnetic disks such as internal hard disks and removable disks, magneto-optical disks, and CD-ROM and DVD-ROM disks. The processor and memory can be supplemented or incorporated by an ASIC (application specific integrated circuit).

[0168] In some implementations, each system may be programmed with the same or similar information and / or initialized with substantially the same information stored in volatile and / or non-volatile memory. For example, one data interface may be configured to perform auto-configuration, auto-download, and / or auto-update functions when connected to a suitable host device such as a desktop computer or a server.

[0169] In some implementation forms, one or more user-interface features may be custom-configured to perform a specific function. In a computer system including a graphical user interface and / or an Internet browser, various embodiments may be implemented. To provide interaction with a user, some implementation forms may be implemented on a computer having a display device. The display device may include, for example, an LED (light-emitting diode) display. In some implementation forms, the display device may include, for example, a CRT (cathode ray tube). In some implementation forms, the display device may include, for example, an LCD (liquid crystal display). The display device (e.g., a monitor) may be used, for example, to display information to the user. Some implementation forms may include, for example, a keyboard and / or a pointing device (e.g., a mouse, a trackpad, a trackball, a joystick) such that a user can input to the computer.

[0170] In various implementations, the system can communicate using appropriate communication methods, devices, and techniques. For example, the system can use point-to-point communication where messages are transported directly from a source to a receiver via a dedicated physical link (e.g., an optical fiber link, point-to-point wiring, daisy chain) to communicate with compatible devices (e.g., devices capable of transferring data to and from the system). Components of the system can exchange information by any form or medium of analog or digital data communication, including packet-based messages on a communication network. Examples of communication networks include, for example, LAN (Local Area Network), WAN (Wide Area Network), MAN (Metropolitan Area Network), wireless and / or optical networks, computers and networks forming the Internet, or some combination thereof. Other implementations can transport messages by broadcasting to all or substantially all devices connected together by a communication network, such as by using an omnidirectional radio frequency (RF) signal. Yet other implementations can transport messages characterized by high directivity, such as an RF signal transmitted using a directional (i.e., narrow beam) antenna, or an infrared signal optionally used with a focusing optical system. Without being intended to be limiting, additional other implementations are possible using appropriate interfaces and protocols such as USB2.0, Firewire, ATA / IDE, RS-232, RS-422, RS-485, 802.11a / b / g, Wi-Fi, Ethernet®, IrDA, FDDI (Fiber Distributed Data Interface), token-ring network, multiplexing techniques based on frequency, time, or code division, or some combination thereof. Some implementations can optionally incorporate features such as error checking and correction (ECC) for data integrity, or security measures such as encryption (e.g., WEP) and password protection.

[0171] In various embodiments, a computer system may include Internet of Things (IoT) devices. IoT devices may include electronic devices, software, sensors, actuators, objects embedded with these, and network connections that enable these objects to collect and exchange data. IoT devices may be used with wired or wireless devices by sending data through an interface to another device. IoT devices can collect useful data and then autonomously flow the data among other devices.

[0172] Various examples of modules may be implemented using circuitry that includes various electronic hardware. By way of example and not limitation, the hardware may include transistors, resistors, capacitors, switches, integrated circuits, other modules, or some combination thereof. In various examples, a module may include analog logic, digital logic, individual components, traces and / or memory circuits fabricated on a silicon substrate that include various integrated circuits (e.g., FPGAs, ASICs), or some combination thereof. In some embodiments, a module may include execution of pre-programmed instructions, software executed by a processor, or some combination thereof. For example, various modules may include both hardware and software.

[0173] In an exemplary aspect, a Dynamic Incentive Package Generation System (DIPGS) (e.g., 100) may include, for example, a data store. The data store may include, for example, valid digital therapies (e.g., 155), therapy profiles (e.g., 280) each associated with one of the valid therapies, user profiles (e.g., 140) associated with a user, and media profiles (e.g., 145) associated with wild video games (e.g., 150).

[0174] DIPGS can include, for example, an evaluation engine (e.g., 125) configured to be coupled to a data store and generate a user profile based on a journal of user input (e.g., 255).

[0175] DIPGS can include, for example, a medical media package generation engine (e.g., 130) coupled to a data store, and the medical media package generation engine can be configured to generate, for example, a dynamic incentive media package (DIMP). The DIMP can include, for example, one or more of effective digital therapies based on a user profile, a therapy profile, and a media profile associated with a wild video game selected by the user. The DIMP can include, for example, a state transition metric generated based on the user profile and the effective digital therapies in the DIMP, and when the state transition metric is satisfied, the operating state of the DIMP can transition, for example, from an incentive mode to a therapy mode.

[0176] DIMP can be configured to be executed, for example, on a user device (e.g., 106) remotely coupled to a dynamic incentive package generation system. During the execution time of the DIMP, in the incentive mode, the wild video game selected by the user can be played, for example, periodically. When the execution time condition satisfies the state transition metric, the DIMP can transition, for example, from the incentive mode to the therapy mode, and the medical media package generation engine can generate, for example, a therapy immersion media package (TIMP). The TIMP can include, for example, a recommended set of effective media content based on a therapy profile of an effective digital therapy and a user profile. The recommended set of effective media content can be presented, for example, at a therapy interface on the user device.

[0177] In therapy mode, the medical media package generation engine can generate, for example, intervention monitoring content (IMC). The IMC can include, for example, TIMP such that when the DIMP switches from a user-selected wild video game execution to an effective digital therapy. When a response to the IMC is received, the evaluation engine can update, for example, the user profile based on the received response so that medical guidance and progress monitoring are continuously and automatically performed on the user.

[0178] Effective media content can include, for example, a set of questions.

[0179] The DIPGS can further include, for example, a dynamic stimulus package state machine (e.g., DIPSM) configured to, during the execution time of the DIMP: (a) identify at least one transition point within the DIMP; (b) transition the execution time of the DIMP from a stimulation mode to a therapy mode; (c) present the TIMP on the user device; and (d) send a signal to the evaluation engine to update the user profile based on the results of the TIMP.

[0180] The DIPSM can be further configured to adjust a set of predetermined execution time parameters of the DIMP based on, for example, the TIMP, and the therapy profile of the effective media content within the TIMP, and the user profile.

[0181] The switch from a user-selected wild video game execution to an effective digital therapy can include, for example, inserting guidance within the wild video game.

[0182] The switch from a user-selected wild video game execution to an effective digital therapy can include, for example, temporarily interrupting the execution time of the DIMP during the play of the wild video game.

[0183] The DIPGS can further include, for example, an observation layer, which can be configured to, for example, observe the user's behavior to collect health metric information and request a response from the user based on the collected information.

[0184] When the presentation of the DIMP is not appropriate, for example, the medical media package generation engine can be configured to generate a simplified DIMP. The DIMP can include, for example, a TIMP based on the user profile and the history of the played DIMP.

[0185] The TIMP can include, for example, guidance and warnings to the user. The guidance and warnings may be determined to be presented, for example, based on a state transition scale. The guidance and warnings can include, for example, guidance for stimulating self-regulatory functions using the voluntary actions required when playing the DIMP.

[0186] The DIPGS may further include, for example, a regulation module. The regulation module may be configured to update the therapy profile of the changed digital therapy based on a predetermined set of activation rules so that, for example, when a change to one of the valid digital therapies is received, the changed digital therapy can be verified to conform to, for example, the therapeutic intent. In an exemplary aspect, the Dynamic Incentive Package Generation System (DIPGS) (e.g., 100) may include, for example, a data store. The data store may include, for example, valid digital therapies (e.g., 155), user profiles (e.g., 140) associated with users, and media profiles (e.g., 145) associated with wild media content. The DIPGS may include, for example, an evaluation engine (e.g., 125) coupled to the data store and configured to generate a user profile based on a journal of user input (e.g., 255). The DIPGS may include, for example, a medical media package generation engine (e.g., 130) coupled to the data store, and the medical media package generation engine may be configured to generate a dynamic incentive media package (e.g., DIMP) based on, for example, the user profile and the media profile associated with the wild media content selected by the user.

[0187] The DIMP may include, for example, a state transition scale, and the DIMP may be configured to be executed, for example, on a user device remotely coupled to the dynamic incentive package generation system such that the DIMP operates in a stimulation mode and / or a therapy mode during the execution time of the DIMP.

[0188] In the stimulation mode, the wild media content selected by the user may be played periodically, for example. When the execution time condition meets the state transition measure, DIMP can transition from the stimulation mode to the therapy mode, for example. In the therapy mode, the medical media package generation engine generates intervention monitoring content (e.g., IMC). IMC may include, for example, at least one of a plurality of effective digital therapies so that DIMP switches from executing the wild media content selected by the user to an effective digital therapy. When receiving the response of IMC, the evaluation engine can update the user profile based on the received response, for example, so that medical guidance and progress monitoring are continuously and automatically performed for the user. The medical media package generation engine is configured to, for example, dynamically generate a state transition measure based on the user profile and the effective digital therapies within DIMP, and identify at least one transition point within DIMP, where at each transition point, the execution time of DIMP transitions from the stimulation mode to the therapy mode, and generate a therapy immersion type media package (e.g., TIMP). TIMP may include, for example, a recommended set of effective media content at each of the identified transition points based on the therapy profile of the effective digital therapy and the user profile. The recommended set of effective media content may be configured to be presented (e.g., automatically) at the therapy interface on the user device.

[0189] The effective media content may include, for example, a set of questions.

[0190] DIPGS may further include, for example, a dynamic incentive package state machine (e.g., DIPSM) configured to, during the execution time of DIMP, (a) identify at least one transition point within DIMP, (b) transition the execution time of DIMP from an incentive mode to a therapy mode, (c) present TIMP on a user device, and (d) send a signal to an evaluation engine to update a user profile based on the results of TIMP.

[0191] DIPSM may be further configured to adjust a set of predetermined execution time parameters of DIMP, for example, based on TIMP, and a therapy profile of valid media content within TIMP, and a user profile.

[0192] Switching from executing wild media content selected by a user to an effective digital therapy may include, for example, inserting guidance within the wild media content.

[0193] Switching from executing wild media content selected by a user to an effective digital therapy may include, for example, temporarily interrupting the execution time of DIMP during the play of the wild media content.

[0194] DIPGS may further include, for example, an observation layer configured to, for example, observe a user's behavior to collect health metric information and request a response from the user based on the collected information.

[0195] When the presentation of DIMP may be inappropriate (e.g., based on one or more predetermined fitness measures, at the discretion and / or input of the user), the medical media package generation engine may be configured to generate, for example, a simplified DIMP. The simplified DIMP may include, for example, a TIMP based on the user profile and the history of played DIMPs.

[0196] The TIMP can include, for example, guidance and warnings to the user, and the guidance and warnings are determined to be presented based on a state transition measure. The guidance and warnings can include, for example, guidance for stimulating an autonomous function using the voluntary actions required when playing the DIMP.

[0197] The DIPGS can further include, for example, a regulation module that can be configured to update the therapy profile of the changed digital therapy based on a predetermined set of validation rules so that when receiving a change to one of the valid digital therapies, the changed digital therapy can be verified to conform to the therapeutic intent, for example.

[0198] A dynamic stimulus package generation system as described in claim 12, wherein the wild media content can include, for example, video games. In an exemplary embodiment, the computer-executable method may be implemented by at least one processor to automatically provide a dynamically generated immersive therapy mechanism-based monitoring and tracking mechanism in an unregulated media content environment. The method may include, for example, receiving a signal corresponding to a user request to play wild media content (e.g., 1005). The method may include, for example, dynamically generating a set of transition metrics based on a user profile and a therapy profile of the requested media content (e.g., 1020). The method may include, for example, observing user behavior during the execution time of the media content (e.g., 1030). The method may include, for example, transitioning the execution time of the media content from a stimulus mode to a therapy mode when a set of transition metrics is satisfied (e.g., 1035). The method may include, for example, dynamically generating effective therapy content including questions and guidance generated based on a user profile in a therapy mode (e.g., 1040). The method may include, for example, evaluating the user's progress based on responses received from the effective therapy content and the observed user behavior (e.g., 1045). The method may include, for example, generating an intervention when the user's progress falls below an intervention threshold so that medical guidance and progress monitoring of the therapy process are continuously performed (e.g., 1065).

[0199] In an exemplary aspect, a computer program product (e.g., CPP) can include a program of instructions tangibly embodied in, for example, a non-transitory computer-readable medium, which when executed by a processor, causes the processor to perform dynamic stimulus media package generation and presentation operations to automatically provide a dynamically generated immersive therapy mechanism-based monitoring and tracking mechanism in an unregulated media content environment. The operations can include, for example, receiving a signal corresponding to a user request to play wild media content (e.g., 1005). The operations can include, for example, dynamically generating a set of transition metrics based on, for example, a user profile and a therapy profile of the requested media content (e.g., 1020). The operations can include, for example, observing user behavior during the runtime of the media content (e.g., 1030). The operations can include, for example, transitioning the runtime of the media content from a stimulus mode to a therapy mode when a set of transition metrics is met (e.g., 1035). The operations can include, for example, dynamically generating effective therapy content including questions and guidance generated based on a user profile in a therapy mode (e.g., 1040). The operations can include, for example, evaluating a user's progress based on a response received from the effective therapy content and the observed user behavior (e.g., 1045). The operations can include, for example, generating an intervention when the user's progress can fall below, for example, an intervention threshold so that medical guidance and progress monitoring of the therapy process are continuously performed (e.g., 1065).

[0200] Some implementations have been described. Nevertheless, it will be understood that various modifications can be made. For example, advantageous results can be achieved even if the steps of the disclosed techniques are performed in a different sequence, or if the components of the disclosed system are combined in a different manner, or if other components are supplemented to the components. Accordingly, other implementations are envisioned within the scope of the following claims.

Claims

Claim 1 A dynamic stimulation package generation system (100) comprising: A data store comprising a plurality of effective digital therapies (155), a plurality of therapy profiles (280) each associated with one of said effective therapies, a user profile (140) associated with a user, and a plurality of media profiles (145) associated with a plurality of wild video games (150); An evaluation engine (125) coupled to said data store and configured to generate said user profile based on a journal (255) of user input; A medical media package generation engine (130) coupled to said data store, said medical media package generation engine comprising: One or more of said plurality of effective digital therapies based on said user profile, said plurality of therapy profiles, and a media profile associated with a wild video game selected by the user; A state transition metric generated based on said user profile and said effective digital therapy within a dynamic stimulation media package (DIMP), wherein when said state transition metric is satisfied, an operating state of said DIMP transitions from a stimulation mode to a therapy mode; Comprising: Said DIMP is configured to be executed on a user device (106) remotely coupled to said dynamic stimulation package generation system, and during execution of said DIMP, In said stimulation mode, a wild video game selected by said user is periodically played; When an execution time condition satisfies said state transition metric, said DIMP transitions from said stimulation mode to a therapy mode, and said medical media package generation engine generates a therapy immersion media package (TIMP) comprising a recommended set of effective media content based on a therapy profile of said effective digital therapy and said user profile, and said recommended set of effective media content is presented at a therapy interface on said user device; In the therapy mode, the medical media package generation engine generates intervention monitoring content (IMC) comprising the TIMP such that the DIMP switches from executing the wild video game selected by the user to the effective digital therapy, Upon receiving a response to the IMC, the evaluation engine updates the user profile based on the received response such that medical guidance and progress monitoring are continuously and automatically performed for the user. A medical media package generation engine (130) configured to generate the DIMP A dynamic stimulation package generation system (100) comprising. **Claim 2** The dynamic stimulation package generation system according to claim 1, wherein the effective media content includes a set of questions. **Claim 3** During the execution time of the DIMP, (a) identifying at least one transition point within the DIMP; (b) transitioning the execution time of the DIMP from the stimulation mode to the therapy mode; (c) presenting the TIMP on the user device; (d) sending a signal to the evaluation engine to update the user profile based on the results of the TIMP The dynamic stimulation package generation system according to claim 1, further comprising a dynamic stimulation package state machine (DIPSM) configured to perform. **Claim 4** The dynamic stimulation package generation system according to claim 3, wherein the DIPSM is further configured to adjust a set of predetermined execution time parameters of the DIMP based on the TIMP, the therapy profile of the effective media content within the TIMP, and the user profile. **Claim 5** The dynamic stimulation package generation system according to claim 1, wherein the switch from executing the wild video game selected by the user to the effective digital therapy includes inserting guidance within the wild video game. **Claim 6** The dynamic stimulation package generation system according to claim 1, wherein the switch from executing the wild video game selected by the user to the effective digital therapy includes temporarily interrupting the execution time of the DIMP during play of the wild video game. **Claim 7** further comprising an observation layer, wherein the observation layer observes the user's behavior to collect health metric information, and requests a response from the user based on the collected information The dynamic stimulus package generation system according to claim 1, which is configured to perform.

8. The medical media package generation engine is configured to generate a simplified DIMP including the TIMP based on the user profile and the history of the played DIMP when the presentation of the DIMP is not appropriate. The dynamic stimulus package generation system according to claim 1.

9. The dynamic stimulus package generation system according to claim 2, wherein the TIMP includes guidance and warnings to the user, and the guidance and warnings are determined to be presented based on the state transition scale.

10. The dynamic stimulus package generation system according to claim 9, wherein the guidance and warnings include guidance for stimulating an autonomous function using a spontaneous action required when playing the DIMP.

11. further comprising a regulation module, When the regulation module receives a change to one of the effective digital therapies, based on a predetermined set of activation rules, the therapy profile of the changed digital therapy is updated so that the changed digital therapy is verified to conform to the therapeutic intention. The dynamic stimulus package generation system according to claim 3.

12. A dynamic stimulus package generation system (100) comprising: a data store comprising a plurality of effective digital therapies (155), a user profile (140) associated with a user, and a plurality of media profiles (145) associated with a plurality of wild media contents; an evaluation engine (125) coupled to the data store and configured to generate the user profile based on a journal (255) of user input; A medical media package generation engine (130) connected to the data store, wherein the medical media package generation engine is configured to generate a dynamic incentive media package (DIMP) based on the user profile and a media profile associated with wild media content selected by the user. The DIMP includes a state transition metric and is configured to be executed on a user device remotely connected to the dynamic incentive package generation system. During the execution time of the DIMP, In the incentive mode, the wild media content selected by the user is periodically played. When the execution time condition meets the state transition metric, the DIMP transitions from the incentive mode to the therapy mode. In the therapy mode, the medical media package generation engine generates intervention monitoring content (IMC) including at least one of the plurality of effective digital therapies so as to switch from executing the wild media content selected by the user to the effective digital therapy. When receiving a response to the IMC, the evaluation engine updates the user profile based on the received response so that medical guidance and progress monitoring are continuously and automatically performed for the user. A medical media package generation engine (130) and A dynamic incentive package generation system (100) comprising.

13. The medical media package generation engine Generating the state transition metric based on the user profile and the effective digital therapy within the DIMP; and Identifying at least one transition point within the DIMP, at each of the transition points, the execution time of the DIMP transitions from the incentive mode to the therapy mode; and Generating a therapy immersion media package (TIMP) comprising a recommended set of effective media content at each of the identified transition points based on the therapy profile of the effective digital therapy and the user profile, wherein the recommended set of effective media content is presented at a therapy interface on the user device. The dynamic stimulus package generation system according to claim 12, configured to perform dynamically.

14. The dynamic stimulus package generation system according to claim 13, wherein the effective media content includes a set of questions.

15. During the execution time of the DIMP, (a) identifying at least one transition point within the DIMP; (b) transitioning the execution time of the DIMP from the stimulation mode to the therapy mode; (c) presenting the TIMP on the user device; (d) sending a signal to the evaluation engine to update the user profile based on the results of the TIMP The dynamic stimulus package generation system according to claim 13, further comprising a dynamic stimulus package state machine (DIPSM) configured to perform the above.

16. The dynamic stimulus package generation system according to claim 15, wherein the DIPSM is further configured to adjust a set of predetermined execution time parameters of the DIMP based on the TIMP, the therapy profile of the effective media content within the TIMP, and the user profile.

17. The dynamic stimulus package generation system according to claim 12, wherein switching from executing the wild media content selected by the user to the effective digital therapy includes inserting guidance within the wild media content.

18. The dynamic stimulus package generation system according to claim 12, wherein switching from executing the wild media content selected by the user to the effective digital therapy includes temporarily interrupting the execution time of the DIMP during the playback of the wild media content.

19. Further comprising an observation layer, the observation layer being observing the user's behavior to collect health metric information; requesting a response from the user based on the collected information The dynamic stimulus package generation system according to claim 12, configured to perform the above.

20. The dynamic stimulation package generation system according to claim 13, wherein the medical media package generation engine is configured to generate a simplified DIMP including the user profile and the TIMP based on the history of the played DIMP when the presentation of the DIMP is not appropriate.

21. The dynamic stimulation package generation system according to claim 13, wherein the TIMP includes guidance and warnings to the user, and the guidance and warnings are determined to be presented based on the state transition scale.

22. The dynamic stimulation package generation system according to claim 21, wherein the guidance and warnings include guidance for stimulating self-regulatory functions using spontaneous actions required when playing the DIMP.

23. Further comprising a regulation module, wherein when the regulation module receives a change to one of the effective digital therapies, the therapy profile of the changed digital therapy is updated based on a predetermined set of activation rules so that the changed digital therapy is verified to conform to the therapeutic intention. The dynamic stimulation package generation system according to claim 14.

24. The dynamic stimulation package generation system according to claim 12, wherein the wild media content includes video games.

25. A computer-executed method implemented by at least one processor for automatically providing a dynamically generated immersive therapy mechanism-based monitoring and tracking mechanism in an unregulated media content environment, comprising: receiving a signal corresponding to a user request to play wild media content (1005); dynamically generating a set of transition scales based on a user profile and a therapy profile of the requested media content (1020); observing user behavior during the execution time of the media content (1030); when the set of transition scales is satisfied, transitioning the execution time of the media content from a stimulation mode to a therapy mode (1035); dynamically generating effective therapy content including questions and guidance generated based on the user profile in the therapy mode (1040); evaluating the user's progress (1045) based on the response received from the effective therapy content and the observed user actions; generating an intervention (1065) when the user's progress falls below an intervention threshold so that medical guidance and progress monitoring of the therapy process are continuously performed A method comprising: **Claim 26** A computer program product (CPP) comprising a program of instructions tangibly embodied on a non-transitory computer-readable medium, wherein when the instructions are executed by a processor, the processor provides a dynamically generated immersive therapy mechanism-based monitoring and tracking mechanism in an unregulated media content environment by performing dynamic stimulus media package generation and presentation operations, the operations comprising: receiving a signal corresponding to a user request to play wild media content (1005); dynamically generating a set of transition metrics based on a user profile and a therapy profile of the requested media content (1020); observing user actions during the execution time of the media content (1030); transitioning the execution time of the media content from a stimulus mode to a therapy mode when the set of transition metrics is satisfied (1035); dynamically generating effective therapy content including questions and guidance generated based on the user profile in the therapy mode (1040); evaluating the user's progress (1045) based on the response received from the effective therapy content and the observed user actions; generating an intervention (1065) when the user's progress falls below an intervention threshold so that medical guidance and progress monitoring of the therapy process are continuously performed A computer program product (CPP) comprising:

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