Reintroduced MEDTECH Act exempts more non-diagnostic software from FDA regulation

The Medical Electronic Data Technology Enhancement for Consumers’ Health Act aims to cut red tape at the Food and Drug Administration and promote health IT innovation.

A bipartisan bill reintroduced in Congress last week would exclude more types of medical software from FDA regulation.

Bill sponsors Sens. Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah) said in an announcement that the Medical Electronic Data Technology Enhancement for Consumers’ Health, or MEDTECH, Act cuts red tape at the Food and Drug Administration and will promote health IT innovation.

Their announcement didn’t specify how the new version of MEDTECH Act varies from the version they introduced in December. They described the bill as limiting and clarifying the FDA’s role in regulating medical administrative and financial software, wellness and lifestyle products, “certain aspects” of electronic health records and software used to formulate treatment recommendations.

“As the rate of innovation rapidly increases in the medical technology field, this bill provides greater clarity to ensure that businesses understand the rules of the road and safe and effective products reach consumers as soon as possible,” according to the announcement, posted on Bennet’s website.

Bradley Merrill Thompson, a Washington, D.C.-based attorney specializing in medical device regulatory issues, told Health Data Management that the updated bill calls for EHR developers to meet requirements under the voluntary certification process outlined by the Office of the National Coordinator for Health IT rather than “some ill-defined validation of the kind expected by FDA in a premarket submission.”

The reintroduced bill also deregulates software used to generate reports and transfer data, but leaves in place FDA regulation of software for analyzing clinical laboratory data, he said in the article. The bill’s approach to clinical decision-support software strikes a good balance, he added.

Bennett noted in his statement that consumer health IT tools such as calorie counters and activity trackers “are low risk and don’t require in-depth oversight by the government.”

The MEDTECH Act builds on an FDA Safety Innovation Act Workgroup report commissioned by the two senators in a 2012 FDA reform law, according to their announcement.

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