By Sy Mukherjee
December 14, 2018

Happy Friday, readers!

Back in 2016, Congress passed a major health care overhaul called the 21st Century Cures Act. Championed by drug developers but divisive among patient advocacy groups, the law, among its many provisions, changes the approval process for certain non-medical device products such as software—i.e., digital health apps.

The Cures Act’s purpose is in part to streamline these products’ path to market and nix some of the more severe regulatory burdens that full-on medical devices (say, something like an implanted heart or glucose monitor) face. But the law also mandates regular reviews of such products’ entry to the marketplace. And on Thursday, the Food and Drug Administration (FDA) issue its first such report on digital health apps’ impact on patient health and safety.

So what did the agency conclude? In large part, it’s (preliminary) good news.

“In general, the FDA’s analysis found more benefits than risks to patient safety and health from the use of these digital products. The report also details best practices for health care providers, patients and developers related to implementation and training that could promote safety, education and use of the devices,” it wrote in a press release.

FDA Commissioner Scott Gottlieb echoed those sentiments while cautioning that this is very much an on-going process, and software that helps store patient records, collect data, or deliver personalized advice must continue to be monitored.

“While we believe that the benefits of these products generally outweigh the risks to patients, we still encourage consumers and health care providers who use these technologies to stay informed about the benefits and risks of these and any digital health products they are considering using or recommending for their patients,” said Gottlieb. “Moving forward, the FDA will continue to update this report to ensure the agency is striking the right balance in our approach to digital health.”

You can read the agency’s full report here.

Read on for the day’s news, and have a great weekend.

Sy Mukherjee


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