The Food and Drug Administration is taking steps to regulate mobile medical applications intended to perform a medical device function regardless of the hardware or platforms associated with a mobile device. But the initiative is by no means a solo effort by FDA; six other federal agencies will be significantly involved.
Walking industry stakeholders through the seven-agency oversight of aspects of mobile health is the topic of education session #10, “Federal mHealth Policy 101,” at HIMSS13 in New Orleans. Jessica Jacobs, an Oak Ridge Institute for Science & Education Fellow on assignment at the FDA, will present the session on March 4 at 9:45 a.m. She will be presenting as a Fellow and not an official FDA representative.
Jacobs hopes to answer a core question that providers have about mobile regulation: “What do I have to worry about?” And there isn’t a simple answer, she acknowledges. “There’s really a lot of levels people have to be looking at.”
To start, FDA is only one of four agencies of the Department of Health and Human Services with influence in the coming regulations. The others are the Centers for Medicare and Medicaid Services, Office of the National Coordinator for Health Information Technology and Office for Civil Rights. They’ll be joined by the National Institute of Standards and Technology, the Federal Communications Commission and the Federal Trade Commission. Jacobs will walk through the entities within each organization that will play a role and why they have authority over certain aspects of the regulations.
But she’ll emphasize that the regulations need not be scary and advises stakeholders to contact pertinent agencies with questions early in the development and implementation stages.
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