Sens. Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah) re-introduced a bill (S 1101) that would exempt certain medical software and mobile applications from FDA regulation, Health Data Management reports.

The Medical Electronic Data Technology Enhancement for Consumers' Health -- or MEDTECH -- Act (S 2977) was first introduced in December 2014.

Bill Details

The reintroduced bill seeks to revise the definition of medical devices in the Federal Food, Drug and Cosmetic Act to limit and clarify FDA's role in overseeing administrative and financial software, certain parts of electronic health records, clinical decision-support software and wellness and lifestyle products. The senators said the bill will use a "risk-based approach" for such tools.

According to Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, the new version of the bill includes more types of software that would be exempted from FDA oversight (Slabodkin, Health Data Management, 4/28). For example, the new bill would bar FDA from regulating software that is used for:

• Appointment scheduling;
• Business analytics and communication;
• Patient population and laboratory workflow process information;
• Maintaining healthy lifestyles; and
• Maintenance of financial records (Gold et al., "Morning eHealth," Politico, 4/28).

Other exempted software would include tools that are used to:

• Analyze and support the display of patient data for diagnostics, prevention and treatment recommendations; and
• Format, organize and present clinical lab test report data prior to analysis, as well as laboratory test report findings and related patient education data (iHealthBeat, 12/5/14).

Merrill Thompson said that under the bill FDA would maintain regulation of software that is used to interpret clinical lab data (Health Data Management, 4/28).

Meanwhile, an aide to Hatch said that the bill also clarifies how "products with multiple functionality" would be regulated and would require that device accessories be regulated based on their independent risk levels ("Morning eHealth," Politico, 4/28).

In addition, Merrill Thompson said that under the latest bill EHR vendors would only have to comply with the Office of the National Coordinator for Health IT's voluntary certification process.

Comments

In a statement, Bennet said, "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" (Health Data Management, 4/28).

Meanwhile, Hatch called the bill "a commonsense approach to give medical software pioneers the certainty they need to continue developing new technology that will benefit both health care professionals and consumers alike" (Sen. Bennet release, 4/27).

However, Merrill Thompson cautioned that "[t]he language they use [in the legislation] is very complicated," noting that it must be read "carefully to understand whether we're talking about something that is regulated or something that is not regulated" ("Morning eHealth," Politico, 4/28).