Legislation to curb the FDA’s authority to regulate health IT will pass the Congress in early 2015, predicted Rep. Marsha Blackburn (R-Tenn.), vice chair of the House Energy and Commerce Committee.
Blackburn in October 2013 first introduced the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act. Blackburn’s bill would establish a risk-based regulatory framework for health IT divided into three broad categories of software--clinical, health and medical--with the two former software types not subject to regulation under the proposed legislation. A companion bill, the PROTECT Act, was introduced in the Senate in early 2014. Both the SOFTWARE Act and the PROTECT Act would exempt so-called "clinical software" and "health software" from FDA oversight, leaving the regulatory agency to focus on “medical software”—posing the highest risk to patient safety.
Clinical software is defined as software that: captures, analyzes, changes, or presents patient or population clinical data or information and may recommend courses of clinical action, but does not directly change the structure or any function of the body of man or other animals; and is intended for use only by a health care provider in a health care setting. Health software is defined as software that is not medical software or clinical software and that: captures, analyzes, changes, or presents patient or population clinical data or information or supports administrative or operational aspects of health care and is not used in the direct delivery of care; or has as its primary purpose to act as a platform for a secondary software, to run or act as a mechanism for connectivity, or to store data.
“The goal of the legislation is to develop a regulatory framework for software used in the healthcare setting, including mobile medical apps, that protects patient safety and provides regulatory clarity and certainty,” Blackburn told a Dec. 3 Bipartisan Policy Center forum in Washington, D.C. “We think it’s important enough that we’ve spent about a year and a half working this legislation.”
Joe Ganley, vice president of federal government affairs for health IT vendor McKesson, tells Health Data Management that his company strongly supports the provisions of the SOFTWARE Act. “How we regulate health IT is really one of those interesting bipartisan issues, where everyone largely agrees that we should update the laws and regulations to further define what health IT is and how it’s different from a device in some cases and how it ought to be regulated differently than traditional medical devices,” Ganley says. “Some health IT poses a risk to patient safety and ought to be regulated by the FDA. But, an awful lot of it does not.”
Blackburn concluded her remarks at the Bipartisan Policy Center forum stating that “after a few more tweaks” she will reintroduce a finalized draft of the SOFTWARE Act in January, then “move it on through the Senate” and “have it on the President’s desk in early 2015.” Instead of pushing her original bill forward, the congresswoman claims she has taken the time to “get the legislation right” with several versions modified as a result of input from stakeholder groups and the FDA that has been incorporated in the latest draft.
However, Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition has technical and conceptual concerns with the legislative language in the proposed bill. “The technical concern is it seems there are various gaps in the language that would let some pretty serious software get to market without regulatory oversight,” argues Thompson. “The language is complex and the dividing lines a bit unclear. I’m Not sure if they have cleaned that up since it was first introduced.”
In addition, Thompson makes the case that there is a “conceptual issue” with regard to the SOFTWARE Act’s attempt to “divide all software into three buckets, when software is actually converging into large systems that handle many different tasks.” He adds that the mHealth Regulatory Coalition is “looking to work with Congress including the House Energy and Commerce Committee to come up with sensible solutions that spur innovation while protecting patients.”
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