The PROTECT Act, a bill introduced this week in the Senate, removes Food and Drug Administration regulation from some high-risk clinical decision support (CDS) software, mobile medical apps and other medical device functionality, the CDS Coalition and mHealth Regulatory Coalition announce in a joint document.
Though a Feb. 10 announcement from Senators Deb Fischer (R-Neb.) and Angus King (I-Maine) asserts that their proposed legislation "boosts patient safety by prioritizing FDA's attention to technologies that pose the greatest health risk," the document released by the two coalitions lists a litany of high-risk CDS softwtare that would no longer be regulated by FDA under the PROTECT Act.
"In looking at this list, it's important to understand that the items on this list are presently regulated by FDA, and have been so since they were first marketed in some cases many years ago," the CDS Coalition/MRC document reads.
Among the list of high-risk CDS software that would no longer be regulated by FDA under the PROTECT Act:
Apps and other software that guide untrained users to make very complex medical decisions--for ex., consumer use melanoma apps, sports concussion injury apps, drug dose calculators and disease managers for patients
Software used in a setting that does not allow a doctor sufficient time to second-guess the software--emergency care predictive analytics software and hospital patient monitoring software
Software that takes a very complicated calculation and presents a result without transparently revealing the basis for the calculation
"A good indicator of risk for CDS is when the user is substantially dependent on the software for clinical decision-making," the document's authors write. "Those situations can arise in many different contexts, but generally involve a serious or life-threatening disease or condition."
The PROTECT Act that was introduced in the Senate is a companion bill to the SOFTWARE Act which was introduced in the House of Representatives in October. Both bills seek to amend the Federal Food, Drug and Cosmetic Act and to limit the FDA's statutory authority in regulating clinical and health software.
The CDS Coalition/MRC document provides some examples of the categories of currently regulated medical devices that would meet the new definitions of either clinical software or health software, including professional use software that captures, analyzes, changes or presents patient and clinical data or information.
To learn more:
- read the document