Reactions from industry groups to the SOFTWARE Act, which seeks to "provide regulatory clarity regarding mobile medical applications, clinical decision support, electronic health records and other healthcare related software" have been quick, but not all positive.
In a statement, the Software & Information Industry Association (SIIA), a Washington-based group representing the software and digital content industries, voiced its support for the SOFTWARE Act, calling it an effective regulatory framework for medical software that will promote safety while advancing innovation.
"The SOFTWARE Act takes necessary steps to establish regulatory framework for medical software without compromising safety," said SIIA president Ken Wash in a written statement. "Specifically, the SOFTWARE Act would create a bright line that delineates when the Food and Drug Administration should regulate medical software, and when it should not, calling for FDA regulation of software only when it has the ability to change the end user's current state of physiology with limited or no opportunity for informed human intervention."
However, Bradley Merrill Thompson (pictured right), general counsel for the mHealth Regulatory Coalition (MRC), expressed concerns with some of the bill's concepts and the language used.
"There is an inherent challenge in trying to segment out software into distinct categories when in fact the development of software is going precisely the opposite direction, toward greater convergence," Thompson told FierceMobileHealthcare. "A larger conceptual concern is that the legislation is really only half done. The legislation seeks a way to separate out various types of software based on functionality, explains how one of the three categories would be regulated, but then ends abruptly without finishing the story. The legislation doesn't explain how clinical and health software would be regulated."
The SOFTWARE Act 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. Last month, the FDA issued its own final guidance on mobile medical apps. The SOFTWARE Act would amend Section 201 of the Federal Food, Drug, and Cosmetic Act to regulate medical software and to provide guidance to the FDA about mobile medical app regulations.
"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 said. "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."
"...We face the very real potential of having to deal with two different agencies trying to regulate the gray area in between," he said. "Personally, as I said, I think we need to view software collectively as a system and figure out a more unified approach, as opposed to trying to create distinctions and separations that lead to regulatory overlap and conflict."