Echoing the position of the U.S. Food and Drug Administration, the mHealth Regulatory Coalition (MRC) has drafted and approved a policy proposal urging Congress not to pass legislation that regulates health information technology, including mHealth.
Instead, the MRC argues that lawmakers should wait for a FDASIA-mandated report to Congress on an overall risk-based regulatory framework for health IT, including mobile medical applications, that the FDA, working with the Federal Communications Commission and the Office of the National Coordinator for Health IT, is expected to complete early this year.
"The time is not right to pursue legislative changes to the federal regulation of [health IT], including mobile health," states the MRC proposal. "At a minimum, Congress should wait until the federal agencies have had an opportunity to publish their proposed regulatory strategy mandated by section 618 of FDASIA. We also believe the stakeholders have not yet had enough time to critically consider the alternatives, and that rushing legislation through could produce substantial, detrimental impacts on both safety and innovation."
At issue is the SOFTWARE Act, a bipartisan bill that was introduced in October 2013 to amend the Federal Food, Drug, and Cosmetic Act and to limit the FDA's authority. Bradley Merrill Thompson, MRC's general counsel, has been an outspoken critic of the SOFTWARE Act, which defines three classification levels of software--clinical software, health software and medical software--in which both clinical and health software would not be subject to regulation under this proposed legislation.
"One of my biggest concerns is that I know many of the private stakeholder proponents of this legislation want to take regulatory responsibility for these categories of software away from FDA," Thompson told FierceMobileHealthcare in October. "They express great frustration with the agency, and think that Congress should come up with a new regulatory scheme and the new regulator. I do not share that view. I think the act of separating the software is fraught with challenges that will leave any legislative articulation subject to much interpretation."
Similarly, Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, testified at a Nov. 19 hearing held by the House Energy and Commerce Subcommittee on Health that the SOFTWARE Act "takes out from our authority the ability to assure the safety and effectiveness of devices that we currently regulate including some high risk devices" such as blood glucose meters and software that is used to analyze pap smear slides. Though Shuren said it was Congress' "prerogative" to pass legislation, in his opinion it was "just simply premature" for Congress to pursue legislation like the SOFTWARE Act on the heels of the FDA's September 2013 release of its final guidance on mobile medical apps.
Likewise, the MRC document asserts that "we as a nation are simply not ready to start talking about legislation." However, the organization does provide an outline in its policy proposal of the key elements of a "new regulatory paradigm" for health IT.
"Whenever the time is right, any new, legislatively-created regulatory paradigm for HIT needs to balance the goals of assuring public safety and encouraging innovation," states the MRC. "Protecting patients is of paramount importance here just as it is anywhere in healthcare. Patients come first. But we frankly see potential opportunities down the road, after these issues have percolated a bit, to both increase patient protections while simultaneously decreasing the regulatory burdens on those who innovate in this space, producing public health advancements. That's because right now the present regulatory oversight is in some cases fragmented and even misdirected. Thus, in the future, we may have an opportunity to increase both public health protections and innovation."
Among other technology areas, the FDASIA-mandated report to Congress expected in the first quarter of 2014 will cover clinical decision support (CDS) software, which wasn't addressed by the FDA's final guidance on mobile medical apps. Thompson, who is also general counsel for the Clinical Decision Support Coalition, told FierceMobileHealthcare that the organization is currently working on a policy proposal which is focusing specifically on the definition of CDS. In November, he sent a letter to several key congressmen 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 the FDASIA-mandated report to Congress is slated for early 2014.
To learn more:
- read the MRC policy proposal