Lawmakers Considering Draft Bill To Loosen FDA Oversight of EHRs

November 24, 2014 in News

Two senators are circulating a draft measure that would exempt certain electronic health records and clinical decision support software from FDA oversight, Modern Healthcare reports (Tahir, Modern Healthcare, 11/21).

Bill Details

The bill, called the Medical Electronic Data Technology Enhancement for Consumers’ Health — or MEDTECH — Act, is co-sponsored by incoming Senate Finance Committee Chair Orrin Hatch (R-Utah) and Sen. Michael Bennet (D-Colo.) (Slabodkin, Health Data Management, 11/24).

The measure would revise the definition of medical devices in the Federal Food, Drug and Cosmetic Act to remove most clinical decision support software from regulatory oversight by FDA (Modern Healthcare, 11/21).

According to Health Data Management, exempted software would include that which is 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 lab test report findings and related patient education data.

Further, the bill would exempt EHRs — with the exception of diagnostic image data — that are used by health care professionals as long as the EHRs’ software was approved prior to marketing and is in line with federal premarket standards (Health Data Management, 11/24).

However, the bill would allow FDA to maintain its regulatory oversight of software associated with medical devices of medium or high risk (Gold, “Morning eHealth,” Politico, 11/24).

According to Modern Healthcare, it is unclear when the senators plan to introduce the bill.


Dan Haley, vice president of government and regulatory affairs at Athenahealth, said, “We are pleased with any effort to rationalize the oversight framework for health IT to protect patients while encouraging continued innovation. We’re very happy that two influential Senators are engaged on this issue.”

Meanwhile, Bradley Merrill Thompson, a lawyer from Epstein Becker Green, said, “From what I understand of the Hatch/Bennett bill, they are doing a good job of defining software that simply doesn’t merit FDA oversight” (Modern Healthcare, 11/21).

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