Regulation of Mobile Medical Apps as Medical Devices

Recently I wrote an article on FDA Regulation of Mobile Medical Apps that was featured on IBM developerWorks.  My intent was to translate for developers some of the highlights of the FDA clearance and approval processes and how they might be applied to mobile medical apps.  Currently the FDA has only provided draft guidance and many other federal agencies are interested in this space.  I explore those issues here and impress upon our developers that mobile medical apps are tools just as scalpels.  This is not just about the fear of new regulations impeding creativity but on efficacy and safety for truly good solutions to change health and healthcare.

The full article can be found here, but below I copy the introduction:

Close to a million mobile health apps are now available from 62 app stores. Many of them might soon be regulated as medical devices. In response to the ever-growing marketplace of health and wellness applications for mobile platforms, the U.S. Food and Drug Administration (FDA) issued Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications in July 2011 (see Resources for a link). That document proposes that some mobile applications intended for medical use be considered medical devices and placed under FDA scrutiny before they can be marketed.

Mobile medical apps are apparatuses, like scalpels and stethoscopes. These apps have great power to help diagnose, treat, or heal — but they can also fail, and failure can have detrimental consequences for the user. Even seemingly simple apps are complex instruments of code, with complex implications for health. They deserve the same attention to safety and efficacy as all medical devices, both during the development life cycle and after release.

Final guidance from the FDA is forthcoming, but in the meantime, many mobile medical app developers have already sought FDA clearance or approval. As more mobile medical apps are created, regulation will tighten — whether that regulation comes from the FDA, the Federal Trade Commission (FTC), the Office for National Coordinator for Health IT (ONC), the Federal Communications Commission (FCC), and especially the Department of Health & Human Services (HHS) Office for Civil Rights (OCR). The requirements set forth in the Draft Guidance (and most likely in future regulation) consistently ask mobile medical app developers to ensure safety and efficacy, particularly in processes such as verification and validation, as well as in specific design protocols that address user needs.

This article’s goal is to help mobile app developers understand the FDA Draft Guidance and its implications for their work. If medical mobile apps are subject to regulation, significant changes in development processes might be needed that could affect the time and cost involved in taking such apps to market. For example, a development team might need to change its development methodology, document proof of verification and validation (among other controls), or apply for clearance or approval by the FDA. Also, an understanding of the Draft Guidance can help mobile medical app developers understand client needs in detail and state those requirements in such a way that clearly distinguishes the end product as either a medical application or as a general health and wellness app not meant to diagnose, cure, mitigate, treat, or prevent diseases.

For another interesting read on this issue, I recommend this article on The Health Care Blog – What Do mHealth Leaders Need Most from Our Government? Clarity. by Jonathan Spalter


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