Congress must wait for FDASIA report

Congressional hearings are supposed to be opportunities for congressional committees to collect and analyze information in the early stages of their legislative policymaking, so that they can make informed decisions about whether to pursue legislation. In theory, witnesses with different perspectives and points of view are brought before the committee and questioned by members of Congress in order to gain better insight into the issues. However, in practice, that is not usually how it works.

Case in point: last week's hearing held by the House Energy and Commerce Subcommittee on Health examining federal regulation of mobile medical apps and other health software. At the Nov. 19 hearing, a panel of industry witnesses with similar agendas testified in support of the SOFTWARE Act and urged Congress to pass the proposed legislation, which seeks to limit the FDA's authority to regulate mobile medical apps and other software that function as medical devices.

Not surprisingly, some of these witnesses are affiliated with the Bipartisan Policy Center (BPC), the organization that proposed three software categories in an early 2013 report that mirror those outlined in the SOFTWARE Act. "This legislation, similar to BPC's recommendations, identifies three categories of health IT based on levels of risk, including medical software, which constitutes the highest level of risk; clinical software, which is used to inform care delivery, such as electronic health records; and health software, such as software used for administrative or population health purposes," states a BPC press release issued last month in support of the SOFTWARE Act. Coincidence? I think not.

Conspicuously absent from the witness list at last week's hearing (other than Robert Jarrin, Qualcomm's Senior Director of Government Affairs) were voices of dissent from industry who might have testified against passage of the SOFTWARE Act. Personally, I would liked to have seen Bradley Merrill Thompson, general counsel for both the Clinical Decision Support Coalition and mHealth Regulatory Coalition, included in the panel of witnesses representing industry.

Thompson, who has been an outspoken critic of the SOFTWARE Act, contacted the committee's staff and inquired whether the organizations he represents could testify at the hearing. However, Thompson was rebuffed by committee staffers who said they had enough witnesses. So, he filed written comments to be included as part of the record. But, they were not accepted by the committee. It should be noted, however, that a whole host of industry letters supporting the SOFTWARE Act were entered into the record at the hearing.

Nevertheless, it's important to hear Thompson's arguments against the SOFTWARE Act. The day before the hearing Thompson sent a letter to the committee on behalf of the mHealth Regulatory Coalition arguing that the "fundamental design of the legislation, that is parsing health information technology into three separate categories--medical, clinical and health software--is misdirected" and "we do not see a clear, conceptual distinction between medical device software and clinical software that will last into the future."

At the same time, Thompson sent a letter to the committee on behalf of the Clinical Decision Support Coalition asserting that "it seems inconsistent for Congress to move forward with legislation to address the regulation of [clinical decision support software]," when a FDASIA-mandated report to Congress on a risk-based regulatory framework for health IT (including clinical decision support software, which was not addressed by the FDA's final guidance on mobile medical apps) is expected in early 2014.

"We do not understand why Congress, after directing this work to be done, would proceed with the SOFTWARE bill now, before the FDASIA process is complete," he wrote. "We think it is important to first hear what the federal experts on health information technology recommend before proceeding to develop legislation."

Moreover, as Thompson points out, the SOFTWARE Act runs contrary to the recommendations of the FDASIA advisory committee in regulating high-risk clinical decision support apps such as computer-aided diagnosis. "The proposed legislation's category of 'clinical software' casts its net too widely, and therefore removes from FDA regulation some software and hardware that really should not be removed," he wrote to the committee.  

The FDA has long had a role in overseeing software apps that meet the definition of a medical device. Now, some members of Congress would like to severely limit the agency's ability to apply discretionary regulatory oversight to certain apps, regardless of the risks to patient safety. It's time for Congress to take a step back from its efforts to push through the SOFTWARE Act and give the FDA, working with the FCC and ONC, the opportunity to report its comprehensive strategy for regulating health IT including clinical decision support software. - Greg (@Slabodkin)