On Thursday, lawmakers with the House Energy & Commerce Committee and health IT stakeholders convened on the Hill to once again discuss the role of health information technology in improving patient care. Among the topics of conversation was the future of clinical decision support and whether such technology needs to be legislated, or if anticipated guidance from the U.S. Food and Drug Administration--due out by the end of September--will suffice from a regulatory standpoint.
Brad Thompson, a health attorney with Epstein Becker Green who represents five groups on the matter--including the CDS Coalition, the CDS Consortium, the Continua Health Alliance, the mHealth Regulatory Coalition and the Wireless-Life Sciences Alliance--earlier this month called for less regulation of CDS tools in comments submitted about the FDA's health IT risk-based regulatory framework. A distinction between man and machine, he said, must be made when assessing such risk.
In an exclusive interview with FierceHealthIT, Thompson elaborates on his position and what legislation for CDS could mean.
FierceHealthIT: What would you like to see lawmakers doing instead of trying to create CDS statutes?
Brad Thompson: One of the conversations I've been having much more recently is about whether Congress should legislate a timetable for resolving these issues, because there are a number of open issues left. One of the things that folks are talking about generally and on Capitol Hill is whether Congress should really be directive to FDA to say 'look, this is really what industry needs in the way of guidance, and we'd like you to proceed on this timetable in order to complete it.' That's a relatively new discussion, and it's an interesting one to me because the FDA has to juggle lots of different priorities, and I think it is useful for Congress to weigh in on occasion about what those priorities ought to be.
FHIT: What is the likelihood of that scenario coming to fruition?
Thompson: To me, it's good policy, so whenever there's potentially good policy like this, I think it has a chance. I'm not a political expert, though, and I recognize that there is this enormous gridlock on Capitol Hill. You have to be skeptical that any legislation certainly would pass this year. Next year is a different dynamic. We all have to be skeptical that frankly Congress will overcome the gridlock.
To me, it would potentially have bipartisan support; it would have support from many of the stakeholders outside of the government. I read recently that patient groups are expressing a good bit of anxiety over this push to deregulate and to really change FDA's approach to approving products. I would think the patient groups would be comfortable with the idea of 'let's just agree on a time table for FDA providing the guidance that is necessary.'
FHIT: How will politics impact these efforts?
Thompson: Politics is always going to play a role in everything that happens on Capitol Hill. One of the nice things about the topic is that it stays away from the Affordable Care Act. Politics gets most intense the closer you get to the Affordable Care Act, and it seems to me that clearing the way for these efforts to flourish--avoiding modifying ACA and approaching more technical issues from a prioritization standpoint--would politically stand a better chance of being enacted.
Politics are going to be there, and politics at a high level, frankly, just impede good cooperation between parties. It's unfortunate, but I think what I just described at least minimizes the political obstacles.
FHIT: What do you anticipate will happen next?
Thompson: This year, I think, the ink is pretty well dry on what's going to be enacted in this area. You're going to see legislation in 2014. I think what you'll see is a significant continued discussion on these issues through the fall. To me, the big wild card is, will FDA come out with its guidance on CDS in a timely manner--hopefully before the end of September.
I think if FDA does that, it changes the political dynamic quite a bit. Then, all of a sudden, you have a framework and people can start responding to it concretely. I have no idea whether what FDA comes out with will be good or bad, but let's say that it does a really good job of both clearly dividing it and doing so in a way that doesn't unduly impede innovation. To me, that takes the steam out of the push for legislation. Once that's out there, on the one hand, I predict it'll be complicated, and so it won't lend itself to ready translation into a statute. And the fact that it's out there means that a lot of the impetus or the drive for the need for clarity will have been satisfied.
FHIT: What are some of the consequences if CDS does wind up being legislated?
Thompson: The challenge with legislation is two-fold. Number one, it's getting the line right, meaning appropriately dividing high risk from low risk. The other aspect of legislation is to do so clearly, without ambiguities that we spend a lot of time afterward arguing about and trying to figure out. Both of those are huge challenges for the people who are crafting this legislation.
With regard to getting it right, there are so many pieces of software out there right now that do very important job--such as assist a radiologist in evaluating whether images suggest cancer or not. You have software at the high end that does very important jobs and the task is to make sure that that stuff that is high risk remains regulated. If they don't get the legislation right, what they'll do, unfortunately, is cause some high-risk software to not be subject to FDA regulation, and the risk is that it won't work right and somebody gets hurt.
The other difficulty in this area is the enormous intellectual challenge of expressing whatever the rule is clearly in a way that doesn't create ambiguities. Every version of the legislation I've seen so far fails in that regard. It actually introduces new concepts, new wording, new thoughts that frankly haven't been vetted very well or thought through very well, that create all sorts of ambiguities. The risk is that not only might software that deserves to be regulated find itself unregulated, but that we actually find ourselves in worse shape because we're now arguing about brand new concepts and new language and we have to restart the whole FDA process to interpret this new language.
The ambiguity that's been the sand in the ears of innovation is actually made worse, not better. I haven't seen much progress in tackling either of those challenges.
Editor's Note: This interview has been edited for clarity and content.