Regulating digital heatlh technolgies with transparency: the case for dynamic and multi stakeholder evaluation

BMC Medicine
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Regulating digital heatlh technolgies with transparency: the case for dynamic and multi stakeholder evaluation

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  • The unmet need for psychiatric services has accelerated interest in mobile apps to bridge the mental health gap. Innovative apps for therapy, medication adherence, and mindfulness are now a few clicks away for billions of people around the world. While digital health tools may serve the unmet needs of tech savvy people well, they may not meet the needs of those who are not technology-literate. Ensuring digital health equity and realizing the potential of increased access and innovation with mental health apps present a novel challenge for regulation. This strategy narrows the scope of mobile applications the FDA oversees and approves.

  • In the case of mental health, this approach excludes many or most mental health-related resources from evaluation. The UK's National Health Service (NHS) has taken a different approach by developing its own digital health apps library. Each organization is currently piloting novel approaches that iterate on initial program designs. The NHS has published a digital health app library, but disclaimers on its website state that developers are ultimately responsible for the efficacy and safety of the applications they build. The FDA similarly revised its approach to medical app regulation to hinge heavily on the role and credibility of the developer.

  • As part of the Digital Health and Innovation Plan, the FDA introduced a "Pre-Certification" program in 2017 for pilot in 2019. In an effort to move innovation forward, the FDA has piloted a program that accredits developers and software companies—not the technology itself. Independent ratings, decided and published by a range of reviewers, have emerged to measure the value and safety of mobile health and wellness apps. These assessments are widely available and often published without further review or commentary.
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