As part of the 21st Century Cures Acts proposed reform of regulations governing health software, Representatives Marsha Blackburn (R-Tenn.) and Gene Green (D-Tex.) have reintroduced a new version of the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act. Whether the version is an improvement is up for debate.
First introduced by Blackburn in October 2013, the latest iteration of the SOFTWARE Act, contained in the 21st Century Cures Act, is an attempt to categorize health IT based upon the level of risk and create regulatory certainty for innovators by removing the lowest risk software from the purview of the Food and Drug Administration.
In a statement at yesterdays House Energy and Commerce Committee meeting, Blackburn called the SOFTWARE Act the linchpin of the 21st Century Cures Act which tailors the authority of the FDA to the realities of twenty-first century health IT. She argued that the bill provides for common sense oversight that focuses the FDAs regulation on software products that pose the greatest risk to patients, providing regulatory certainty to software developers while not stifling health IT innovation.
But, in a written statement the Healthcare Information and Management Systems Society expressed its concern that the definition of clinical decision support (CDS) software may be negatively impacted by the current legislation. Likewise, Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green who counsels medical device companies on regulatory issues, voiced his concern that the legislative language in the latest draft of the SOFTWARE Act does not go far enough in clarifying and providing regulatory certainty in its definition of CDS and FDA oversight.
While the latest proposed legislation lists four factorsdown from six in an earlier draftthat FDA could take into consideration in its discretion to decide what CDS to regulate, the bill still simply says that FDA should take these factors into account and the regulatory agency will make the decision of what software meets the overarching criteria of poses a significant risk to patient safety, according to Thompson.
The final criteria still simply considers the intended use. That is incredibly open-ended, he complained. So, while FDA should consider the transparency of the software, the legislation certainly does not say that transparent software should always be unregulated. It is still simply one factor that FDA should take into account.
With regard to CDS, some stakeholders have been advocating that FDA jurisdiction should be limited to software that lacks transparency, meaning: FDA would not regulate software if the user can see through the software to the original data and clinical intelligence and make the decision for themselves. But, according to Thompson, that doesnt appear to be the case with the SOFTWARE Act andby extensionwith the 21st Century Cures Act.
As a result, Thompson makes the case that the legislation in the end only serves to maintain the regulatory status quo. The bill does not create a roadmap for innovators to discern whether a given piece of software is regulated or not, he concludes. It simply provides some guidance to FDA for it to make the decision. We need legislation that is self-executingthat provides the software development community with clear delineation as to whats in and whats out.
The House Energy and Commerce Committee announced that the markup of the 21st Century Cures Act will reconvene on Thursday, May 21. It had previously been scheduled for May 20.
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