A bill that would minimize federal regulation of health information technology for safety may be added to a bipartisan package of House legislation intended to spur medical innovation.
A modified version of the SOFTWARE Act is under consideration for the 21st Century Cures legislative package from the House Energy & Commerce Committee, a committee source confirmed. The bill is under discussion by representatives from committee Chairman Fred Upton's office, as well as Reps. Gene Green (D-Texas) and Marsha Blackburn (R-Tenn.) The bill sets up a conflict between the federal legislative and executive branches on their vision for oversight of the emerging health IT sector.
The House Energy and Commerce Committee held a series of hearings over the spring and summer to solicit ideas for stimulating medical innovation in areas from pharmaceuticals to genomics, and has received bipartisan committee support for the initiative. GOP control of both houses of the legislature is expected to boost the package's chances at eventual passage.
The first version of the SOFTWARE Act, introduced in October 2013 by Blackburn, and then co-sponsored by a bipartisan group including Reps. Diana DeGette (D-Colo.), Greg Walden (R-Ore.), and G.K. Butterfield (D-N.C.), was intended to clarify the regulatory structure for health IT, and in particular, to keep the Food and Drug Administration in charge of oversight for high-risk devices and software, instead of relatively low- and medium-risk software used for electronic health records and administrative and billing tasks.
A companion for the bill was introduced in the Senate by Deb Fischer (R-Neb.), Angus King (I-Maine) and Marco Rubio (R-Fla.).
But the bill was criticized for perceived problems with its language. The legislation separated software into three categories, with the highest-risk category placed under FDA supervision. However, some argued that the bill's definitions for the three categories would place high-risk software—such as computer-assisted diagnosis—in the middle-risk category. The middle-risk category specifies that it pertains to software that “captures, analyzes, changes or presents patient or population clinical data or information and may recommend courses of clinical action.” And the bill did not specify how low- or medium-risk software would be overseen, or by what agency.
Additionally, because the bill removed software from the medical-device category, it would exempt it from the medical-device excise tax.
By contrast, the FDA—along with Federal Communications Commission and HHS' Office of the National Coordinator for Health Information Technology—unveiled a draft framework in the spring that would keep tighter oversight over the health IT sector, as well as keeping medical software eligible for the medical device excise tax.
Initial drafts of the revised bill would split the oversight framework into three parts, according to sources familiar with the negotiations. High-risk software that directly controls a regulated medical device would be placed under FDA’s jurisdiction and regulated as a medical device.
High-risk clinical decision-support software would be overseen by FDA but in its lowest-risk category. Clinical decision-support software offers diagnoses and treatment recommendations to doctors, and regulation might be focused on software that isn’t transparent to its users—that is, software that offers recommendations but doesn’t disclose how the recommendations are crunched.
A third, low-risk category of software would be exempt from FDA regulation. That category may include a tier that’s subject to a certification scheme.
The bill may also address the problem of software updates. Current FDA guidance generally requires manufacturers to apply for new clearance or approval when a device is modified. Software, however, is frequently modified and patched.
A source in Blackburn’s office said some of these details regarding the drafts of the bill were not quite right but declined to discuss any details. He emphasized that discussions and development of drafts are ongoing.
Follow Darius Tahir on Twitter: @dariustahir
