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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
@the_sy_guy
sayak.mukherjee@fortune.com
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DIGITAL HEALTH

Digital health firm OWKIN launches AI-powered medical network. OWKIN, a digital health upstart backed by groups like GV (formerly Google Ventures) and Otium Venture, announced this week the launch of an AI-powered research system that connects nearly three dozen medical institutes, the company announced. Ok, so a whole lot of companies are entering the red-hot, buzzword filled world of machine learning and artificial intelligence for drug development. What sets OWKIN apart? The mission of using such technology to break down data silos, according to CEO and co-founder Thomas Clozel.

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INDICATIONS

Johnson & Johnson in the hot seat. Shares of drug giant Johnson & Johnson slipped a staggering 10% in Friday trading following an explosive Reuters investigation suggesting the company may have known about its talc products' alleged health risks—including asbestos contamination—for years. J&J has been facing a slew of class action suits over the issue and, despite several high profile losses, has also managed to prevail upon appeals to expensive jury decisions. The firm has yet to comment on Reuter's findings. (Fortune)

Court orders unsealed records in OxyContin case. An appellate court in Kentucky may have opened up the first real avenue to getting the notoriously tight-lipped Sackler clan—which controls privately held Purdue Pharma, manufacturer of the controversial opioid OxyContin—on the official record. The court ruled that secret testimony from former president Richard Sackler must be unsealed on Friday; Purdue will appeal the decision. (Courier Journal)

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THE BIG PICTURE

Obamacare enrollment lags sharply. Obamacare enrollment appears to be dropping off significantly in the first full year of the individual mandate's repeal. The federal Healthcare.gov enrollment period, which (for the most part) ends tomorrow night, has seen a nearly 20% dropoff in signups compared to one year ago, according to government figures. The Trump administration has severely slashed outreach and advertising funding for the health law and propped up shorter-term health care plans that contain less comprehensive health coverage. (Fortune)

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REQUIRED READING

The FDA Wants to Let You Know That You Shouldn't Eat Glitterby Chris Morris

This Is How Amazon Is Helping Jersey City Police Catch 'Porch Pirates'by Renae Reints

Commentary: Tomorrow's CEOs Will Come from an Unlikely Place—The Supply Chainby Nader Mikhail

Concentric CEO: Connect With Society at All Levels of Businessby Damanick Dantes

Produced by Sy Mukherjee
@the_sy_guy
sayak.mukherjee@fortune.com

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