Health IT, Policy

FCC + FDA: Working together to regulate digital health

The FCC and FDA are working together to regulate digital health - meeting every four months to discuss interoperability, cybersecurity and wireless health.

How is medical device interoperability regulated? And, when it comes to mobile health apps, what should be regulated?

As medical devices converge with wireless technologies, the FCC along with the FDA is beginning to take an active role in regulating mobile health and device interoperability. This relationship between the two agencies was discussed at this week’s AdvaMed 2015 conference in San Diego.

The fact remains, after all, that the government must provide regulatory oversight for medical devices that communicate remotely – to preserve users’ privacy and security, and to ensure these devices actually work. And it’s a constant question over what should be regulated, and what should not.

“We make choices about which products to scrutinize, and which to not scrutinize,” said Bakul Patel, associate center director for digital health at FDA.  “That comes from the inherent heterogeneity of medical devices.”

 

The FDA and FCC have worked together since 2010, after signing a memorandum of understanding around how medtech is converging with wireless. Since, the two agencies have met every four months or so to discuss this interconnectivity, Patel said. They’ve talked internally to streamline approval processes, said Michael Gibbons, chief health innovation officer at the FCC.

Notably, FDA has melded wireless health, interoperability and cybersecurity into a single digital health page – indicating that this convergence is top priority.

“One thing we learned over the mobile apps guidance process – we couldn’t stay static,” Patel said. “We had to stay current, and learn what questions people had as we evolved.”

 

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