Draft U.S. legislation would curb FDA
medical software oversight
Send a link to a friend
[November 25, 2014] By
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
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.
[to top of second column]
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
(Reporting By Christina Farr; Editing by Cynthia Osterman)
[© 2014 Thomson Reuters. All rights
Copyright 2014 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.