Senate Bill Reintroduced to Limit, Clarify FDA Software Regulation

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Senators Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah) on Monday reintroduced a bill to exempt low-risk medical software and mobile apps from regulation by the U.S. Food and Drug Administration in an attempt to provide “greater certainty regarding what software will be regulated by the agency to protect consumers.”

The bipartisan Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act seeks to amend the Federal Food, Drug, and Cosmetic Act to limit and clarify the FDA’s role regarding the regulation of administrative and financial software, wellness and lifestyle products, certain aspects of electronic health records, and decision support software.

According to the senators, their bill takes a“risk-based approach” to ensure that medical software developers understand the regulatory “rules of the road” to provide safe and innovative products to consumers as quickly as possible.

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“Some tools, whether a calorie counter or an activity tracker to monitor your exercise routines, are low risk and don’t require in-depth oversight by the government,” said Bennet in a written statement. “Our bill provides certainty for innovators in the life sciences and the FDA by clarifying which devices and software should be monitored to keep consumers safe.”

The senators first introduced the MEDTECH Act in December 2014 during the lame-duck session of the 113th Congress. But, according to Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green who counsels medical device companies on regulatory issues, the legislative language in this latest draft includes additional types of software to exclude from FDA regulation such as business analytics and communication.

“FDA never intended to regulate those things, but it certainly doesn’t hurt to explicitly exclude them,” said Thompson, who observes that the bill’s sponsors also added a new section for wellness software. “It seems that they were probably trying to implement FDA’s draft January guidance on wellness. The legislative language is pretty cryptic, so the draft guidance will remain important.”

He argues that the section on electronic health records is more precisely stated. “A nice change is that no longer do EHR developers have to use some ill-defined validation of the kind expected by FDA in a premarket submission, but rather they must comply with the ONC’s voluntary certification process,” Thompson comments. “That seems much more sensible and clear.”

When it comes to laboratory information systems, he asserts that the legislative language has been “tightened up” to “allow for the deregulation of software used to generate reports or move data around, but does not exempt from FDA regulation software used to interpret or analyze clinical laboratory data.” That has been a sensitive topic with FDA, Thompson says.

In its treatment of decision support software, he concludes that the bill “does a nice job of striking the balance where software that analyzes medical information, to help a doctor, but presents the information in a way that does not force the doctor to rely on the software, would be unregulated by FDA. That’s the right approach.”

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