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Channeling Inigo Montoya at the mHealth Summit

by Dan Haley, SVP and General Counsel

This week I had the pleasure of speaking at the 5th annual mHealth Summit, on a panel entitled, “An Industry Perspective: Impacts of FDA Oversight.” I wrote about the issue back in August, specifically about the potential Food and Drug Administration (FDA) regulation of health IT, including mHealth. Quite a bit has happened since then, including the FDA’s release of their “final” mhealth guidance, which provides every bit as much ‘regulatory certainty’ as any document bearing the header “contains nonbinding recommendations” on every single page), and last month’s filing of the SOFTWARE Act by a bipartisan group of Members of Congress interested in putting parameters in place around the FDA.

Disclaimer: athenahealth is on record as supporting the SOFTWARE Act. (Hey, even if we weren’t, you’ve gotta hand it to the drafters for their dedication to the art of the legislative acronym.)

Both the guidance and the Act came up repeatedly during our lively panel discussion. Here are some of my big takeaways:

  1. The dividing line is clear. FDA regulation of health IT is complicated, but dividing proponents and opponents is not: you either trust the FDA to exercise its near-limitless “enforcement discretion” with a deft-enough touch to both protect patients and innovators… or you don’t.

    While I am big fan of giving the benefit of the doubt in my day-to-day life, there is simply no historical support for the proposition that the FDA is capable of regulating gently. However, there is plenty of recent evidence for the opposite proposition (see, e.g., the once-thriving-now-virtually-nonexistent domestic medical device industry).

    One of my co-panelists suggested that you’d need a scalpel to carefully separate those technologies that should be regulated from those that shouldn’t be. I agree. But the FDA doesn’t work with a scalpel. It works with a sledgehammer.
  2. Regulators are from Mars, innovators are from Venus. I freely admit that I do not understand people, like at least one co-panelist, who thinks it is a *good* idea for the FDA to get more heavily involved in regulating health IT. As I see it, health IT is one of the relatively few thriving industries in our struggling economy, and a veritable wellspring of innovations that improve patient care (and even save lives) while creating relatively few legitimate risks to patient safety. Their arguments are counter-intuitive, their reasoning ahistorical, and their conclusions illogical. By the same token, I believe my co-panelist (an attorney who makes his living parsing FDA regulations) was genuinely flummoxed when he exclaimed at one point, “I just don’t understand the arguments against an FDA role here.” We sat and spoke together about a single topic for an hour, but mostly talked past each other—like we were speaking different languages, or living in different realities.
  3. Everybody talks about innovation. Read the FDA’s final mhealth guidance. Watch the FDA’s Jeffrey Shuren, MD testify before the Energy & Commerce Committee (E&C). The most oft-seen/heard word (okay, other than “the”) is “innovation.” Everyone wants to encourage/foster/spur/increase “innovation” in health IT.

    Despite the panel’s rather profound disagreements, this was a point on which we found common cause; but I’m not sure we were talking about the same thing. At that E&C hearing, as Dr. Shuren of the FDA uttered “innovation” over and over, I found myself thinking of that great Inigo Montoya line from the movie The Princess Bride: “You keep using that word. I do not think it means what you think it means.”

    There are infinite ways to foster innovation in health IT, where it’s currently flourishing—including leaving it alone. Subjecting low-risk technologies to the enormous burdens of the FDA’s medical device regulation regime isn’t high on the list.
  4. Everyone understands the implications of increased regulation. For me, this is maybe the most important takeaway. One of my summit co-panelists is a consultant who helps clients navigate the FDA approval process. Despite his obvious pecuniary interest in having an entire industry subject to that process, he seemed genuinely troubled when he quantified the “huge” up-front investment that health IT start-ups should probably make in “regulatory research and compliance” to guard against the possibility of FDA regulation.

    That point, more than any other, underscored the danger that overzealous regulation poses to innovation in health IT. Simply stated, “huge” amounts invested to comply with regulatory requirements are “huge” amounts not invested in new technologies—and “huge” barriers to entry for entrepreneurs who start out without enormous resources at their disposal.

This brought me back to that E&C hearing, where Dr. Shuren casually highlighted the implications of FDA regulation. Asked by a committee member to address fears that mHealth regulation could extend to popular mhealth devices, Dr. Shuren was unequivocal: “I don’t want anyone regulating my iPad. I like my iPad.”

Now replace Dr. Shuren’s singular opinion with that of the millions of doctors and patients who currently benefit from the use of low-risk health IT functionality, and substitute “health IT” for “iPad.” You’ll have a good encapsulation of what’s at stake in the debate over appropriate regulatory oversight of health IT.

I would love to continue this conversation and get your thoughts on my takeaways. Share your point of view on FDA’s regulation of health IT in the comments below.

Check out Dan Haley's Google+ Profile. Follow @DanHaley5 on Twitter.

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