FDA will play major role in HIT regulation, doc warns

A noted physician informatics specialist is predicting the Food and Drug Administration soon will begin regulating health information technology for the first time.

“Our lives are about to be invaded by the FDA,” Dr. David Classen, associate professor of medicine at the University of Utah and chief medical information officer at Pascal Metrics, a Washington, D.C.-based patient safety software developer and consultancy, said Thursday at the annual Physician-Computer Connection Symposium in Ojai, Calif.

“The wheels have been put in motion and I think it's unstoppable,” he said. “Even Congress can't stop this from happening, so I want to outline for you what it's likely to look like.”

Classen, a longtime health informatics leader, served on an HIT patient safety panel organized by the Bipartisan Policy Center, a Washington, D.C., think tank, that issued a report in February attempting to head off FDA regulation of HIT.

That panel recommended HHS give the healthcare industry time to craft a regulatory framework outside the FDA, which currently regulates medical devices and has already begun regulating certain mobile medical applications that perform functions similar to hard-wired medical devices.

A 2011 report from the Institute of Medicine Health IT and Patient Safety: Building Safer Systems for Better Care (PDF) “forms the basis of what's going to happen with FDA regulation,” Classen said. The report found that there was a dearth of data to objectively assess the safety of health information technology systems. Classen served on the IOM's Committee on Patient Safety and Health Information Technology, which produced the report. But the IOM committee didn't call for the FDA to step in and regulate.

U.S. Rep. Renee Ellmers (R-N.C.), a former nurse, has been pressing HHS, not precisely for regulation, but to come up with a plan to address the issues raised by the report.

In March, Christy Foreman, director of the Office of Device Evaluation with the Center for Devices and Radiological Health at the FDA, testified before a House Energy and Commerce subcommittee (PDF) saying the FDA received 130 responses to its 2011 draft guidance announcing the FDA was going to exercise its authority to regulate most mobile devices, but intended only a “narrowly tailored” approach to regulate a small subset of mobile medical apps that meet the FDA definition of a device.

Foreman said the FDA has reviewed about 100 mobile medical apps and the limited regulatory role outlined in the guidance was “overwhelmingly” supported in the 130 comments the FDA has received since. Foreman spoke only briefly about recommendations on broader health IT regulation required under the 2012 law, noting it would be a “risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety and avoids regulatory duplication.”

At the same hearing, Dr. Farzad Mostashari, national coordinator for health information technology, testified (PDF) that health IT “will only fulfill its enormous potential to improve patient safety if the risks associated with its use are identified, if there is a coordinated effort to mitigate those risks.” HHS' Office of the National Coordinator issued a draft patient safety and surveillance plan in December 2012 that stopped short of FDA regulations. A final version of the plan is expected soon.

One issue with possible FDA regulation, Classen said, is that healthcare IT developers have a much more rapid development cycle than devicemakers. Another, he said, is the FDA's current process for regulation of medical devices is “flawed.”

Classen conceded that, given the FDA's existing presence in medical device regulation, it would seem to be “the natural group to regulate this, but if you look at their record, it is awful, it is beyond awful.”

Classen pointed to an FDA decision in the 1990s to begin regulating software used in the nation's blood banks in the wake of some patient safety incidents that resulted in patient deaths. That, he said, brought an end to rapid development cycles by blood bank software developers. “There hasn't been a lot of innovation in HIT for blood banks as a result,” he said.

In April, the federally chartered Health Information Technology Policy Committee added a new workgroup to advise the ONC at HHS, the Federal Communications Commission and the FDA on “key considerations to improve patient safety and promote innovation in health information technology (Health IT), including mobile medical applications.”

The panel will provide input through the ONC to the FDA, which is required by the FDA and Innovation Act of 2012 to issue a report on a regulatory scheme for health IT by January 2014, Classen said.

The direction of those deliberations indicate a likelihood that the FDA will seek a similar framework for HIT regulation that it uses for medical devices, Classen said.

During the question-and-answer period, Dr. Joseph Schneider, chief medical information officer and medical director of clinical information at Baylor Health Care System and chairman of the Texas Medical Association's ad hoc health IT committee, expressed a preference for reporting of adverse patient safety events linked to health IT systems to a single, national reporting entity, similar to what the transportation industry has in the National Transportation Safety Board.

But Classen said the current federal direction appears to have providers reporting IT safety events to existing patient safety organizations.

“The hope is all (patient safety organizations) will use common formats for reporting so all of their data can be rolled up,” Classen said.

In an interview after his presentation, Classen said FDA regulation has little backing in the clinical community. “I can't think of too many physicians that support more healthcare regulation,” he said.

The support, he said, seems to be coming from the government itself, particularly the FDA and ONC, which have a pair of health IT patient safety initiatives ongoing.

At least one AMDIS member, Dr. Rod Tarrago, CMIO of Children's Hospitals and Clinics, Roseville, Minn., wanted to shift the discussion from possible FDA regulation to patients, who, according to multiple studies, have suffered harm by the healthcare system.

“Put (an electronic health record) in front of a new resident with (only) an hour's training, and he's dangerous,” Tarrago said.

Follow Joseph Conn on Twitter: @MHJConn