Dynamic Inducement Package Generation for Regulated Digital Therapeutics
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Solution Overview
Problem
Existing digital therapeutic media delivery systems are limited by regulatory restrictions, making it difficult to provide accessible and scalable treatment options for patients, while non-regulated media content delivery networks lack the necessary regulatory controls.
Innovation Solution
A dynamic inducement package generation system (DIPGS) that integrates validated digital therapeutics (DTx) with user profiles and media profiles, generating a dynamic inducement media package (DIMP) that transitions from an inducement mode to a therapeutic mode, providing continuous medical guidance and progress monitoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If regulated digital therapeutic media delivery systems are used, then regulatory compliance and medical guidance quality are improved, but accessibility and scalability are limited
Solution Approach 1:
The system segments the delivery network into regulated components (assessment engine, treatment recommendation engine) and unregulated components (media content delivery). This allows the regulated parts to ensure compliance while the unregulated parts provide broad accessibility and scalability through existing content delivery infrastructure.
Solution Approach 2:
The system introduces an intermediary regulated platform that sits between patients and treatment providers. This platform assesses patient needs, recommends FDA-cleared treatments, and monitors progress, thereby enabling scalable access while maintaining regulatory compliance through the intermediary's controlled functions.
2Adaptability or versatility
If non-regulated media content delivery networks are used, then accessibility and scalability are improved, but regulatory controls are lacking
Solution Approach 1:
The system segments functionality so that only critical functions (assessment, treatment recommendation, progress monitoring) are regulated, while content delivery remains unregulated. This enables the system to leverage scalable unregulated infrastructure for delivery while maintaining compliance through regulated control functions.
Solution Approach 2:
The system dynamically adjusts the level of regulation applied to different components based on their function. Regulated components handle patient assessment and treatment recommendations, while unregulated components handle content delivery. This dynamic allocation allows scalability without compromising compliance where needed.
3Reliability
If traditional medical therapy delivery is used, then medical guidance quality is improved, but patient convenience and home-based accessibility are limited
Solution Approach 1:
The system enables patients to self-assess their needs through the assessment engine and access recommended treatments at home without requiring direct physician involvement for each interaction. This self-service model maintains medical guidance quality through automated recommendations while dramatically improving patient convenience and accessibility.
Solution Approach 2:
The system performs preliminary assessment and treatment recommendation actions before patients need direct medical intervention. By pre-assessing patient needs and recommending appropriate FDA-cleared treatments in advance, the system provides convenient home-based access while maintaining quality through pre-established medical guidance protocols.
Data Source
AI summary
Apparatus and associated methods relate to a dynamic inducement package generation system (DIPGS). In an illustrative example, the DIPGS may include at least one validated digital therapeutics (DTx), user profiles, and media profiles associated with wild media content. The DIPGS, for example, may include an assessment engine configured to generate or update a user profile based on a journal of user input and observation of user behavior. The DIPGS may include a medical media package generation engine (MMPGE) configured to generate a dynamic inducement media package (DIMP). In an inducement mode, the DIMP may play the user-selected wild media content regularly. After transitioning from the inducement mode to a therapeutic mode, the MMPGE generates an interventive monitoring content (IMC) comprising a validated DTx to provide therapeutic treatment to the user. Various embodiments may advantageously provide continuous medical guidance and progress monitoring to a user.