Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in Pharma & MedTech Business Intelligence’s The Gray Sheet, in “Industry: New SOFTWARE Act Provides Certainty,” by Ferdous Al-Faruque.
Following is an excerpt:
“Originally, the authors of the bill were addressing all health information technology and trying to divide it into three different buckets…But over the last year, the sponsors of the bill apparently changed their mind and instead are much more focused on drawing a sharper line around FDA regulation,” said Thompson. “So that’s a much different exercise than was originally envisioned. Thus, the bill has the more modest goal of simply trying to put ambiguous software on either one side of the line.” …
“In effect, this idea of substantial dependence is a way to distinguish between software that is used simply within the practice of medicine, and software that functions as a regulated medical device,” said Thompson. “The Hatch and Bennet legislation addresses this criterion of transparency, and we’d love to see that embraced in the house bill as well. We believe there is broad support for using this concept of transparency to draw the line around FDA jurisdiction of CDS.”
He also says he does not think risk should be the only criterion determining what FDA regulates. In general he says FDA should not regulate the practice of medicine and says medical software can often take on elements of the practice of medicine when physicians use them to gather information in their decision-making.
“Even if the physician’s decision involves a risky therapy, fundamentally physician decision-making is part of the practice of medicine and should be regulated by the state boards of medicine, not FDA,” said Thompson. “So it is this additional principle, beyond risk, which needs to be spelled out more specifically in the statute.”