Abstract
BackgroundThe prevalence of smartphones today, paired with the increasing precision and therapeutic potential of digital capabilities, offers unprecedented opportunity in the field of digital medicine. Smartphones offer novel accessibility, unique insights into physical and cognitive behavior, and diverse resources designed to aid health. Many of these digital resources, however, are developed and shared at a faster rate than they can be assessed for efficacy, safety, and security—presenting patients and clinicians with the challenge of distinguishing helpful tools from harmful ones.Main textLeading regulators, such as the FDA in the USA and the NHS in the UK, are working to evaluate the influx of mobile health applications entering the market. Efforts to regulate, however, are challenged by the need for more transparency. They require real-world data on the actual use, effects, benefits, and harms of these digital health tools. Given rapid product cycles and frequent updates, even the most thorough evaluation is only as accurate as the data it is based on.ConclusionsIn this debate piece, we propose a complementary approach to ongoing efforts via a dynamic self-certification checklist. We outline how simple self-certification, validated or challenged by app users, would enhance transparency, engage diverse stakeholders in meaningful education and learning, and incentivize the design of safe and secure medical apps.
Highlights
Leading regulators, such as the Food and Drug Administration (FDA) in the USA and the National Health Service (NHS) in the UK, are working to evaluate the influx of mobile health applications entering the market
With worldwide ownership of smartphones already at 2.5 billion [1], the opportunity to utilize these devices to screen, assess, monitor, and even intervene in psychiatric conditions is unprecedented. The potential for this new generation of accessible, affordable, and accurate digital mental health tools has already attracted the attention of the public, large technology companies, and national healthcare regulators
Mental health apps available for immediate download on the iTunes and Android stores [2] offer a concrete representation of the rapid pace of development
Summary
Steps to regulate Growing pressure to inform the public around the safety and efficacy of new innovations in apps and other digital health technologies has prompted initial evaluation efforts. Available online and accessible outside the UK, the NHS App Library models an organized effort to influence the selection and use of mobile health applications It does not regulate development or enforce data security standards. The APA app evaluation framework customized to local needs offers potential, its use requires that app data presented in the marketplaces and scientific literature is accurate, accessible, and upto-date This is not always the case, with recent studies demonstrating that many mental health apps do not disclose accurate information on how they handle, secure, or store patient data [8]. A self-certification program would offer ongoing education and teaching Both patients and clinicians would learn which app features are most appealing, how to flag concerning apps for additional review, and what ways other users are utilizing apps to improve health. Any app that completes self-certification is subject to review by the FDA without
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
