The FDA is not going to kill health 2.0

Summary:Medical app makers face a much lighter burden than device makers ever faced before, just as their business starts to take off. A 510(k) clearance is a hassle, but it's a very minor inconvenience when, at the end of it, you have immunity from lawsuits.

Attorney Bradley Merrill Thompson, a rainmaker at Epstein Becker Green (from which this picture is taken), is out today with a specious claim that the FDA is aiming to kill health 2.0 with regulation.

It's a charge even Thompson, who has been involved in health regulation for over a decade, knows is not true.

Just last year he wrote a three-part series for MobiHealth News on FDA device regulation.

"It’s more likely a cell phone or related software might end up as a regulated accessory, than a stand alone medical device," he wrote then. "Merely being a medical device is by no means the end of the world."

It's true the FDA is tightening up on medical device regulation, but it has to.

The Bush-era head of its medical device regulation unit resigned amid scandal. The Supreme Court has ruled that the FDA's device regulation is the end of the road for consumers -- most lawsuits against approved devices are forbidden under Riegel vs. Medtronic.

Imagine if the current Administration were ignoring the need for regulation as its predecessor did. It would be giving all medical device makers a license to kill.

That said, the FDA is a big supporter of connected medical devices, of apps and medical body area networks. It is working with the FCC and the West Wireless Health Institute to assure these devices get their shot at the market.

Thompson knows how to get apps approved as accessories to medical devices. Most, he knows, can be approved through an expedited process like an abbreviated 510(k) pre-clearance. I'm willing to call his "warning" simple marketing, and to recommend him to you if you have concerns.

But what alternative do we have?

In a recent dissertation on the subject, Raakhee Kumar called the FDA's present course "ideal." A mobile health chip that just transmits data, like Motorola's HealthPal, is properly seen as an accessory to the measurement device itself. Motorola is on top of the regulatory process on behalf of its customers. Apple's app contracts already require medical app makers to get this light approval.

A 510(k) clearance is a hassle, but it's a very minor inconvenience when, at the end of it, you have immunity from lawsuits. And if you were on the other side of the transaction, isn't it the least you would expect as well?

For medical apps that exist mainly to take data off chips and send them along to a doctor, or the software that doctor uses to analyze those results, it might be easier to just assume everything works and let the plaintiff's bar prove a malfunction. But that's not how the Supreme Court has things set up. The role of the bar has been eliminated.

The result is a much lighter burden than device makers ever faced before, just in time for the world of medical apps to take off. And it will take off -- the FDA has no intention of stopping it, no matter how much business lawyers may lose as a result.

This post was originally published on

Topics: Innovation


Dana Blankenhorn has been a business journalist since 1978, and has covered technology since 1982. He launched the Interactive Age Daily, the first daily coverage of the Internet to launch with a magazine, in September 1994.

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