Name
Placing Global Guardrails on Digital Therapeutics for Mental Health
Time
11:10 AM - 11:20 AM (EST)
Description

This highlights the significant advancements in digital therapeutics (DTx) for mental health, including a variety of tools such as mobile apps, AI chatbots, and VR therapies. With an estimated 10,000 to 20,000 mobile health apps readily available, it's clear that this landscape currently lacks consistent global regulation, safety standards, and ethical oversight. To address this critical gap, the IEEE is establishing the Global Standardized Medical Mobile Health Apps Registry. This initiative will create a global framework of guardrails specifically for therapeutic mobile health apps, initially focusing on mental health. Unlike existing industry app repositories, the IEEE Registry employs a standardized framework comprising three key categories: ethics, technical aspects, and clinical efficacy. These criteria have been developed through a consensus-driven approach by an international committee of 35 multidisciplinary experts. This registry has the potential to harmonize regulatory standards worldwide and assist governments in developing their own guidelines for reviewing medical mobile health apps. By providing a trusted source of information, the registry offers significant benefits to all stakeholders, including patients, clinicians, payers, technologists, and regulators, fostering greater confidence in the use of these digital tools. Furthermore, the IEEE has a global initiative dedicated to supporting policy development for the regulation of Generative AI in digital therapeutics for mental health. This work is being conducted within its tech policy collaborative program, where government regulatory representatives can share best practices and work towards harmonizing trends. The aim is to support innovation in DTx for mental health while implementing necessary safeguards. Notably, the IEEE is uniquely positioned as the only technical standards development organization taking this comprehensive approach to support innovation while prioritizing the security, privacy, and safety of patients in the realm of DTx for mental health.

Maria Palombini
Location Name
Pier-2 Room