Bradley Merrill Thompson Quoted in “Medical Software Industry Again Calls for Better Regulations”Bloomberg BNA Medical Devices Law & Industry Report March 10, 2016
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg BNA Medical Devices Law & Industry Report, in “Medical Software Industry Again Calls for Better Regulations,” by Michael Williamson.
Following is an excerpt:
However, Thompson said the MEDTECH legislation doesn't exempt all clinical decision support software from FDA oversight. According to Thompson, the bill only exempts CDS if the software is designed to enable doctors to double-check the tool's recommendation.
“If a physician has to blindly rely on the output of the software, that can engender risk,” Thompson said. However, he noted, if a physician can easily see all of the underlying data, and if the doctor can identify the clinical logic or formula the software is applying, he or she is not worse off for having the CDS software.
Overall, uncertainty surrounding the regulation of CDS has left developers unsure how to proceed, Thompson said. “Developers simply cannot afford to proceed with projects where they do not know major variables such as whether compliance with an FDA quality system and FDA preapproval will be required.”