In a new legislative proposal, the Clinical Decision Support (CDS) Coalition charges that a bipartisan bill introduced in October 2013 to amend the Federal Food, Drug, and Cosmetic Act "goes too far" in deregulating CDS software that requires regulation to ensure the health and safety of patients.
The SOFTWARE Act, which limits the U.S. Food and Drug Administration's authority, 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. As a result, the CDS Coalition argues in their document that given the way the SOFTWARE Act is currently written very little CDS software would in fact be regulated by the FDA.
"Our position is that FDA should regulate certain high risk CDS where the intended user is expected to be substantially dependent on the software," states the CDS Coalition's legislative proposal. "Thus we believe, in order to avoid putting patients at risk, the act should be modified to provide for FDA regulation of certain CDS."
For instance, the Coalition advises that the FDA should regulate CDS for which the intended use of the software "provides a diagnosis of a serious or life threatening disease or other such condition, or directs a specific cure, mitigation, treatment, or prevention of such disease."
At a Nov. 19 hearing held by the House Energy and Commerce Subcommittee on Health, Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, testified that the SOFTWARE Act takes out from FDA authority "the ability to assure the safety and effectiveness of devices that we currently regulate including some high risk devices" such as blood glucose meters and software that is used to analyze pap smear slides.
"On the basis of FDA testimony, there seemed to be agreement that there were unintended deregulatory consequences to the current draft," states the CDS Coalition proposal. "Indeed, on the basis of our own analysis of the language, it appears that the current draft would remove from FDA regulation a large number of software products traditionally regulated by FDA such as many forms of software used in diagnostic laboratory testing or with radiological images such as MRI and x-ray."
A FDASIA-mandated report to Congress on an overall risk-based regulatory framework for health IT, expected in the first quarter of 2014, will include CDS software--a topic that wasn't addressed by the FDA's September 2013 release of its final guidance on mobile medical apps. In November, the CDS Coalition sent a letter to several key congressmen asserting that "it seems inconsistent for Congress to move forward with legislation to address the regulation of CDS software," when the FDASIA-mandated report to Congress is slated for early 2014.
"The 2013 draft of SOFTWARE Act separates FDA-regulated from unregulated CDS based on distinctions that do not reflect the real risk factors," concludes the Coalition's legislative proposal. "Instead, we would urge the sponsors of legislation to look carefully at the work done by the federal advisory committee established under section 618 of FDASIA."
To learn more:
- read the legislative proposal