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FDA mHealth app regulation: A developer's perspective

Joseph Cafazzo of the University of Toronto represents both a healthcare provider and an mHealth app developer. His reaction to the FDA's approach to the U.S. app market: What's safe for the patient?

BOSTON -- With the FDA indicating its mobile health (mHealth) app regulation will be mostly hands-off, with a small minority of apps subject to clinical trials and premarket approval, who can healthcare provider CIOs trust to provide safe apps for their patients and care workflows?

Joseph Cafazzo, lead for the University of Toronto's Centre for Global eHealth Innovation, offered the perspective of both an app developer and healthcare provider who has worked for Bant, a teenage diabetes management app, and worked on clinical trials measuring its safety and efficacy. We spoke with him at the mHealth and Telehealth World 2014 conference.

Joseph CafazzoJoseph Cafazzo

Cafazzo and his organization, of course, want to eventually bring the mHealth app to market in the United States. He has a unique perspective on the value of clinical trials for apps, which take years to conduct and publish the findings. He offered his take on how apps should and shouldn't be regulated, and provided CIOs with a few pointers on choosing patient apps for their organizations in what is a mostly unregulated market.

Let us know what you think about the story; email Don Fluckinger, news director or contact @DonFluckinger on Twitter.

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