As the late Paul Harvey was famous for, I want to share ?the rest of the story? with your readers. I think your readers deserve a bit more context.
First, I hope they bother to click on the link to the article you're citing. I don?t say anything close to the ominous statement you attribute to me.
Second, what I said was entirely consistent with your own May 24th post on ?How will the FDA regulate health IT?? Some FDA regulation, you assert there, could be a good thing for certain software used in health applications. That doesn?t mean THE DEATH OF ALL SOFTWARE AS WE KNOW IT.
Third, the reporter called me to understand the dividing line between what FDA regulates and what they don't. Then he asked me whether the agency was monitoring the situation, and I said yes. This issue of mHealth has gotten quite a bit of attention in the media and in the industry, so naturally FDA is watching it. And yes, literally they can and do sit at their computers and surf the web just like anybody else, checking out the claims that people are making around these products. Honestly, I think that's a fairly unremarkable observation on my part.
If you are interested in what I think, read my ENTIRE book on FDA Regulation of mHealth (its not that long), and you?ll know my view really is that FDA is constructively analyzing the policy options with an eye toward figuring out how to encourage innovation in mobile health, while fulfilling its public health role of protecting the American citizen. Personally I think they are doing an admirable job of approaching this in a very thoughtful way. All I ask is that you don?t translate that into ?rainmaker device lawyer expresses undying love for FDA?.
Brad Thompson
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.
