Washington signals possible FDA regulation of mHealth

By: Brian Dolan | Feb 26, 2010        

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Bradley Merrill ThompsonBy Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C.

“Under the Federal, Food, Drug, and Cosmetic Act, HIT software is a medical device.” That’s according to Dr. Jeff Shuren, the new director of the Device Center within FDA. Yikes. Dr. Shuren testified yesterday at a hearing of the HIT Policy Committee, Adoption/Certification Workgroup. The workgroup invited numerous speakers from different sectors to discuss the safety of HIT, and possible regulatory approaches.

Dr. Shuren’s conclusion portends a new and perhaps more demanding regulatory environment for mHealth. Over the last several months, I’ve written a series of articles in MobilHealthNews to outline FDA requirements that might apply, depending on the circumstances, to the hardware and software used in mHealth. Notice how I qualified that. I’ve suggested that manufacturers should be aware of certain nuances in FDA law related to intended use claims and other limits on the scope of FDA regulation.

But in his written statement, Dr. Shuren did not equivocate. He did not limit his conclusions, for example, depending on the specific intended uses for the HIT. He just swept it all into FDA regulation and moved on. I don’t know whether Dr. Shuren and I would truly disagree on the scope of FDA regulation if we discussed it, but he seems to want to move quickly past that to talking about how FDA should regulate this area.

On the eve of the hearing, Sen. Grassley, the ranking Republican on the powerful Senate Finance Committee, sent out letters revealing his interest in FDA regulating HIT. The events of this week are significant enough that I want to depart from the planned schedule of articles to discuss what happened, and its implications for mHealth.

What happened?

At the hearing yesterday, after expressing his view that HIT software is a medical device, Dr. Shuren observed FDA has “largely refrained from enforcing our regulatory requirements with respect to HIT devices.” That, Dr. Shuren suggests, is about to change. In explaining the change of heart, he revealed FDA has received 260 voluntary reports of HIT-related malfunctions with the potential for patient harm. Of those reports, 44 included injuries and six even reported deaths. In a table attached to his written testimony, he provided de-identified examples of these reports, several of which involved one patient’s data being substituted for another’s. Since FDA at this juncture only relies on voluntary reports, Dr. Shuren asserted this might be the tip of an iceberg.

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  • http://mhealthnews.wordpress.com/2010/03/01/washington-signals-possible-fda-regulation-of-mhealth/ Washington signals possible FDA regulation of mHealth « mHealth News Summary
  • http://www.telecareaware.com/ Steve Hards

    Bradley,

    I read this, and your previous article with interest and have referred them to several people. Especially for device manufacturers in the UK unfamiliar with the FDA and its approach, but who may have to deal with it, the explanations are clear and helpful. Is there any chance that when the series is complete Wireless Health will publish them all together as an ebook? I’d love to be able to direct Telecare Aware readers to it.

    Regards,
    Steve

  • http://mobihealthnews.com Brian Dolan

    Hi Steve,

    Bradley and the MobiHealthNews team have already discussed that and plan to republish the series as a downloadable PDF report or eBook as you described it. Look for it in the coming months!

    Brian

  • http://www.healthcare311.com Greg Judd

    Here’s hoping Brad means it when he says, in item 7 of his 7 observations,

    …it all starts and ends with concern for the patient. Whatever approach emerges, whether it’s FDA regulation or a voluntary industry code that allows for self-regulation, it needs to have as its essence a focus on protecting the patient.

    (my emphases)

    Why? Because people are people first, and only then, and not continuously in most cases, patients. So FDA regs dealing with, say, cellphones, will need to be particularly flexible to contend with users’ transitory statuses.

    And no, I do not anticipate that that will be easy :-)

  • jamadan

    Why would cellphones that receive and display medical data be considered a medical device any more than the Dell or HP Desktop is today? Does the FDA want to go back to the day where HIT vendors have branded, dedicated hardware (desktops and servers) that costs 10 times what it should in order to pass the FDA audit? Regulating software makes sense to me, because that’s where the logic is. But regulating hardware will drive up costs and drive out competitors. Not sure anyone really wants it or that it’s necessary from a patient safety perspective.

  • http://mobihealthnews.com/7322/will-the-fda-regulate-mhealth-care-providers/ Will the FDA regulate mHealth care providers? | mobihealthnews

    [...] and provided some background on what the regulatory framework looks like. In my last article, I noted that recent activity at FDA suggests the agency is preparing to expand its scope to most areas of HIT, and by implication into [...]

  • http://healthcare.zdnet.com/?p=3669 How will the FDA regulate health IT? | ZDNet

    [...] CompassX Group of Irvine, Calif. told the AMA a regulated device will cost three times more than an unregulated one to develop. The estimate seems reasonable. But pre-approval does not appear to be what Jeffrey Shuren (above, from the FDA), who heads the FDA’s device regulation unit, is looking at. [...]

  • http://mobihealthnews.com/8358/update-mhealth-regulatory-coalitions-first-meeting/ Update: mHealth Regulatory Coalition’s first meeting | mobihealthnews

    [...] 3. Software. FDA has a term for certain software called “standalone” software, which is software that is not acting as an accessory to the device. Part of this discussion is included in the MDDS proposal — systems of systems — that the FDA never made a final ruling on. The group is going to try to come up with an appropriate approach for which software gets regulated and what doesn’t. (more on FDA regulation of software) [...]