Background

Digital Therapeutics (DTx)

Digital Therapeutics (DTx)

Digital therapeutics (DTx) are evidence-based therapeutic interventions delivered through software programs to prevent, manage, or treat medical disorders or diseases. These interventions are designed to spur changes in patient behavior and are often used as standalone treatments or in conjunction with conventional therapies like pharmacological or in-person therapy. DTx products are held to the same standards of evidence, regulatory oversight, patient centricity, privacy, and quality as traditional medical treatments.

Market Overview

Foundational principles of digital therapeutics include:

  • Incorporate design, manufacture, and quality best practices
  • Engage end users in product development and usability processes
  • Incorporate patient privacy and security protections
  • Apply product deployment, management, and maintenance best practices
  • Publish trial results inclusive of clinically meaningful outcomes in peer-reviewed journals
  • Be reviewed and cleared or certified by regulatory bodies as required to support product claims of risk, efficacy, and intended use
  • Make claims appropriate to clinical evaluation and regulatory status
  • Collect, analyze, and apply real-world evidence and/or product performance data

Technical Details

Along with our collaborative university research partners, Biomojo® has been researching and developing DTx applications for suicide prevention. AI-CARE (Artificial Intelligence for Crisis Assistance, Resilience, and Empowerment) is a conversational AI clinical co-pilot tailored specifically to veteran suicide prevention. AI-CARE will assist mental health professionals in assessing, understanding, and intervening effectively during mental health crises. Designed to support both text-based and audio interactions, AI-CARE provides veterans with the flexibility to communicate in the format that best suits their needs. By leveraging advanced large language models (LLMs) fine-tuned with veteran-specific data and guided by mental health subject matter experts (SMEs), AI-CARE ensures accurate, clinically appropriate, and empathetic responses that resonate with veterans' unique experiences.

Applications

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Optimize clinical and health economic outcomes – ;

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Deliver high quality therapies to underserved populations – ;

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Easily scale and be accessible through patient-owned devices – ;

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Offer at-home convenience and privacy – ;

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Transform how patients understand, manage, and engage in their healthcare – ;

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Extend clinicians' ability to care for patients – ;

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Support healthcare teams in settings with varying degrees of health care infrastructure – ;

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Lower overall costs of care – ;

References

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