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October 30, 2013

Bipartisan House Bill Attempts To Limit FDA's HIT Oversight

  Inside Health Reform

By Stephanie Beasley

A bipartisan House bill introduced late Tuesday (Oct. 22) aims to clarify FDA's authority over health information technology by amending the Federal Food, Drug and Cosmetic Act so that the agency will only regulate mobile medical applications that change the physiology of a patient and with little opportunity for human intervention. The move was applauded by industry and patient groups that see the bill as the first step in implementing a recommendation from a federal working group to re-focus FDA.

While some people may see the legislation as limiting the agency's role in mobile health oversight, it will actually strengthen the agency by allowing it to focus specifically on its area of expertise -- medical devices -- said one patient advocate.

An industry attorney, however, said the bill's "piecemeal" approach of stratifying health information technology and exempting some software from FDA regulation without outlining what the alternative regulatory framework would be could have adverse outcomes.

The Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act was introduced by Rep. Marsha Blackburn (R-TN) and co-sponsored by a bipartisan group of House lawmakers, including Republicans Phil Gingrey (GA) and Greg Walden (OR) as well as Democrats Diana DeGette (CO) and G.K. Butterfield (NC). The bill comes less than a month after FDA released finalized guidance for mobile medical applications that laid out a strategy of using enforcement discretion on low-risk devices.

The SOFTWARE Act would go a step further by codifying language that would exempt clinical and health software from FDA regulation. Clinical software is defined in the legislation as clinical decision support software or other software that captures, analyzes, changes or presents clinical data but that does not change the structure or the function of the body. Health software would be any software that is not medical software or clinical software but still captures clinical data and acts as a platform for secondary data, according to the bill. The lawmakers said the bill would address concerns that under current law FDA could regulate a wide array of software as medical devices.

"As new technologies emerge, it's important that federal regulatory agencies like the FDA are properly equipped to provide a common sense level of oversight of medical software," Green said in a statement. "This bill builds on the steps forward made by FDA in their recently released guidance and focuses federal resources on the medical software that pose a risk to patients and should be trusted to be safe and effective by patients and providers alike."

Joel White, executive director of Health IT Now, praised the bill during an Institute for Policy Innovation event this week, saying it created a "bright line" that made it clear that apps like health information technology management tools were beyond FDA's purview.

"The bill will clarify how new technologies are regulated," he said. "(It) says that new technologies that are a device in nature, that those would go through the FDA process. For things and apps that are more information technology management tools, clinical decision support tools and things like that, those would fall outside of the FDA structure."

He said that clarification was key since a federal workgroup charged with making recommendation on federal mHealth oversight included clinical decision support software, electronic health records and health information exchanges within its definition of health IT. If the old framework continues to be applied, those apps could be subject to FDA regulation, White said.

The FDA Safety and Innovation Act requires FDA, the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission to submit to Congress a report outlining a tri-agency, risk-based framework for health IT by January. The FDASIA workgroup submitted recommendations for that framework to ONC in September and also identified several key inter-agency issues that should be addressed (see FDA Week, Aug. 23).

Jim Bialick, executive director of the Newborn Coalition, also applauded the bill for addressing those parts of the law that the workgroup identified as "broken."

"[I]t's the first crack at looking at what the FDASIA (workgroup) report said around focusing FDA a little bit," he said. "It doesn't take anything away from them as much as it just says that (FDA is) working on medical devices and then kind of takes a step back so that when the final report does come out, we have a better view of what to do with everything else."

Bialick said while he anticipates there will be some who will argue that the legislation limits FDA, it is actually strengthening the agency by allowing it to focus on those apps that function as medical devices and "push their resources in the right direction," he said.

Yet, Bialick, who worked with House members to draft the bill, also emphasized that this was just the first step in the legislative process and said he expected Congress to continue to press the issue next year through subsequent legislation.

"This is not the magic bullet," he said. "This is certainly an iterative process. I think that from the offices that I've discussed this with, they're seeing this as too important an issue to try and solve in like one omnibus."

However, Bradley Merrill Thompson, an attorney with Epstein, Becker and Green, took issue with the legislation's "piecemeal" approach, saying it could have adverse effects. He said while bipartisan support if health IT innovation is welcome, the lawmakers seeming intent to follow the recommendation of the Bipartisan Policy Center and stratify health IT into three different layers -- administrative or non-clinical software; clinical software; and medical device software -- is questionable. There is an inherent challenge in trying to segment software when the development of software is going in the opposite direction, toward convergence, he said.

"The fact of the matter is that software operates like connective tissue holding together different parts of the health care system," Thompson said. "Thus, if we were to follow the lead of the technology, we would not try to separate out software into distinct bucket, but rather look for a more holistic way to approach software that creates large systems of care delivery."

He also raised concerns that the legislation was only "half done" since it does not explain how clinical and health software would be regulated, if not under FDA. The FDASIA workgroup was fairly clear in its recommendation that software in these categories would require regulation, said Thompson, who was a member of the workgroup. He highlighted computer-aided diagnosis, which takes x-rays and applies algorithms that identify abnormalities, as an example of why clinical software oversight was needed. Currently, the riskiest versions of the software are class III devices regulated by FDA, but the legislation would place the software in the category of clinical software, to be unregulated "until the future as of yet unspecified regulatory system is put in place." While the legislators appear to have reached consensus around the problem, they have not been able to develop a solution that would address such an outcome, he said.

"Personally, I would encourage them to continue their internal discussions to reach the point of a solution," said Thompson. "We should not approach this in a piecemeal fashion, first only agreeing as to somehow separating the types of software without completing the work to decide how the categories would, in fact, be regulated."


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