A bipartisan group of house members led by Rep. Marsha Blackburn, R-Tenn introduced the SOFTWARE Act on October 22, 2014. The bill will redefine the regulation of health information technology, with the probable effect of deregulating much of the sector.
There has been much debate over the role of the FDA in regulating mobile medical apps and other health IT products. In September, the agency recently finalized a guidance document on the regulation of medical application – emphasizing a hands-off enforcement discretion approach to a majority of apps. However, many in the health IT community remain concerned that FDA is asking for too much authority.
The bill, which has undergone significant changes since the July daft version, divides health IT into three categories:
- Medical Software
- Clinical Software
- Health Software
Under the bill, the health software category is the only one under the jurisdiction of the FDA, specifically CDRH, although it is defined as a separate category from a medical device. In fact, the bill excludes all three software categories from being defined as a medical device. This would exclude these health IT products from the much debated medical device tax.
Obviously, the bill has broad support from the health IT community who want the FDA to slow down its effort to build a regulatory framework for mobile apps. Janet Marchibroda, director of the Bipartisan Policy Center’s health innovation initiative provided this comment: “The Software Act provides important clarity regarding how different types of health information technology should fit with a risk-based approach for oversight and regulation.”
Conversely, there is opposition to the bill. Bradley Thompson, an attorney for Epstein, Becker & Green has concerns with the bill. He disagrees with the segmentation of software into three categories. “There is an inherent challenge in trying to segment out software into three distinct categories when in fact the development of software is going precisely the opposite direction, toward greater convergence.” He is also concerned about Congress making decisions about regulation of clinical and health software.
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