Wireless/Mobile Apps

Coalition asks FDA to rework mobile health app guidance

The mHealth Regulatory Coalition has submitted a letter urging FDA to develop a mobile health framework that promotes innovation and gets rid of unnecessary regulations, Becker’s Hospital Review reports.

The letter comes in response to FDA’s recently released set of proposed guidelines on the regulation of certain mobile medical applications.

According to FDA officials, oversight is necessary for mobile medical apps that pose risks for patients if they do not work as designed. FDA officials said that only a small number of the thousands of mobile apps would face agency scrutiny under the draft guidelines. In its letter, the coalition said it supports FDA’s “step toward appropriate regulation of mobile health technologies,” but added that further work is needed.

The coalition recommended that FDA:
Commit to promoting investment and innovation within the mobile health industry;
Focus its regulations on moderate- to high-risk mobile health apps and exempt low-risk products;
Provide more detailed information about how it plans to regulate mobile health products; and
Reconsider and clarify which entities are in charge of mobile health-related regulatory activities. In related news, the Healthcare Information and Management Systems Society also submitted a comment letter on FDA’s draft guidance.

The letter encouraged FDA to educate health systems, hospitals, health care providers and software developers about the agency’s policies. HIMSS noted that many such groups lack experience with being regulated by FDA as a mobile health device manufacturer

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