The 21st Century Cures bill passed by the House last week provides much-needed clarification on the regulation of medical software.

The legislation, which now heads to the Senate for consideration, identifies five specific categories of medical software that—given certain conditions—will not be regulated as a medical device by the Food and Drug Administration based on their low level of risk to patients.

The five categories of medical software include: administrative and operational, such as appointment software; wellness, such as apps for tracking exercise; electronic health records; software for transferring, storing or displaying medical device data such as lab data; and clinical decision support software.

Bradley Merrill Thompson, an attorney at the Washington-based law firm of Epstein Becker Green, says that the vendor community has been waiting years for this kind of clarity on the type of clinical decision support software the FDA should regulate.

Bradley Merrill Thompson
Bradley Merrill Thompson

Thompson, who counsels medical device companies on regulatory issues, contends that there has been a cloud over the industry because of the uncertain regulatory environment.

“FDA says that they regulate high-risk clinical decision support software, but not low-risk software. That’s great, but how is a company supposed to discern high from low risk?” he says. “Companies have to know the answer to that question because it is fundamental to both the cost and timelines associated with product development.”

An FDA spokesperson said the agency does not comment on proposed or pending legislation.

Also See: FDA seeks input on clinical evaluation of software as a medical device

“Health software companies are working on exciting technologies that help doctors do a more thorough job in both the diagnosis and treatment decision making process,” adds Thompson. “We are delighted to see that Republicans and Democrats have come together over these concepts to provide industry with the needed clarity.”

According to Thompson, clinical decision support software can analyze patient data quickly and—by referring to the literally millions of peer reviewed articles and clinical guidelines—make recommendations to physicians, which serve the purpose of helping ensure that doctors have thought of all potentially relevant treatments for their patients. As such, he argues that the function of CDS software is to support the clinical judgment of a healthcare professional, not replace it.

Section 3060 of the 21st Century Cures Act “incorporates the common-sense notion that if a physician has access to all of the underlying information—such that the physician can double check the basis for any recommendation—then the software is really simply supporting the physician in his or her practice,” Thompson concludes. In those cases, such software “should not be FDA regulated, and the legislation reinforces that point.”

However, at the same time, the bill provides the FDA with the authority to regulate software in these categories if safety concerns emerge, such as causing serious adverse health consequences.

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