Draft U.S. legislation would curb FDA medical software oversight

SAN FRANCISCO (Reuters) - A draft U.S. bill is circulating in Washington D.C. that would curb the U.S. Food and Drug Administration's regulatory oversight over electronic medical records and some clinical support software, according to a copy of the legislation seen by Reuters.

The Medical Electronic Data Technology Enhancement for Consumers’ Health Act or Medtech Act would limit the FDA's jurisdiction over medical technology that it classifies as posing low risks to patient safety. It builds on previous efforts in the U.S. Senate and House of Representatives.

The bill is being developed by Republican Senator of Utah Orrin Hatch and Democratic Senator of Colorado Michael Bennet and proposes that some software should not be regulated as medical devices. This includes software for administrative support of hospitals, according to a copy of the draft bill.

The FDA is currently working in concert with other federal agencies to propose a strategy for a risk-based regulatory framework for health IT that balances innovation and patient safety.

The FDA declined to comment on pending or proposed legislation.

Some industry experts say the bill would bring clarity to the health IT sector, which is still a regulatory gray area.

"The lack of clear regulation makes it very difficult to plan for the future," said Dan Haley, vice president of government affairs for electronic medical-records company AthenaHealth.

"The act takes a straightforward and clean approach and as a result is less likely to have unintended consequences," added Bradley Merrill Thompson, an FDA-specialist with the Washington D.C.-based legal firm Epstein Becker & Green.

Merrill Thompson said the bill would retain FDA oversight over medium-risk or high-risk software, and technology that serves as an accessory to a medical device. But the bill does not propose any specific body or agency that would be charged with determining levels of risk.

AthenaHealth, IBM and other IT companies publicly declared support for the PROTECT Act, a previous effort to prevent FDA from regulating some health technology. The PROTECT act was introduced in February of 2014.

It not yet clear if or when the law will be formally introduced in Congress.