Bipartisanship in Congress is rare these days. So it was refreshing to see three Democratic and three Republican members of the House co-sponsor the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act of 2013.
In theory, they should be applauded for bridging the political divide in Washington and their attempt--misguided as it might be--to "provide regulatory clarity regarding mobile medical applications, clinical decision support, electronic health records and other healthcare related software."
However, upon closer examination, the bill (H.R. 3303) that these congressmen introduced is counterproductive and potentially damaging to the FDA's "tailored approach" to mobile medical applications embodied in the regulatory agency's final guidance issued late last month that strikes an appropriate balance between innovation and patient safety.
The SOFTWARE Act got a mixed response from industry groups. While the Software & Information Industry Association, was quick to voice its support for the proposed legislation, calling it "an effective regulatory framework for medical software that will promote safety while advancing innovation,"
Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition (MRC), got it right when he said "the act of separating the software is fraught with challenges" which might "produce some unexpected outcomes."
The bill outlines three categories of software--clinical software, health software and medical software--with the two former not subject to regulation under the proposed legislation. Yet, as the MRC's Thompson points out, these legislators are trying to "separate out software into distinct buckets" in a way that just doesn't work.
As an example, he points to computer aided diagnosis (CAD), a software package that takes an x-ray image and applies complex algorithms to evaluate whether there might be an abnormality that a radiologist should look at more closely.
"Presently, the riskiest versions of this software are class III medical devices regulated by FDA," Thompson told FierceMobileHealthcare. "If I read this legislation correctly, it would put this CAD in the category of clinical software, to be unregulated until the future as-of-yet unspecified regulatory system is put in place. I don't think the drafters intend for that outcome."
To say that the language in the SOFTWARE Act needs a major revision is an understatement. The proposed legislation is so loosely constructed it leaves the details on how clinical and health software would be regulated unspecified--to be defined in future legislation. Moreover, it flies in the face of the FDASIA workgroup's recommendation last month that software in these categories require regulation.