Medical Device Daily Washington Editor

The Bipartisan Policy Center, a think tank of sorts populated by former members of Congress, issued a paper recently dealing with oversight of healthcare information technology (HIT), arguing that FDA should not be involved in such oversight. The problem with that view is that FDA has already inserted itself into the discussion, but the Office of the National Coordinator for Healthcare Information Technology (ONC) has hinted it may be willing to take on the task. Others, however, are asking whether formal regulatory requirements are even needed.

ONC published a Dec. 21, 2012, document detailing its own HIT patient safety surveillance proposal, but the paper comes up short of naming itself as a replacement for FDA in regulatory terms. The ONC document notes that the FDA Safety and Innovation Safety Act of 2012 (FDASIA) calls on FDA, "with the collaboration of ONC and the Federal Communications Commission," to "release a report proposing a strategy and recommendations for an appropriate, risk-based regulatory framework for health IT which promotes safety and innovation."

Perhaps a more telling passage in the document states that ONC will "fund health IT safety interventions in hospitals and physician practices to evaluate risk management implementation processes and interventions related to the safety of health IT."

FDA rolled out a proposed guidance for medical device data systems roughly two years ago, but indicated it would continue to exercise enforcement discretion where hospital HIT systems are concerned. FDA's John Murray told the audience at a meeting of the Association for the Advancement of Medical Instrumentation (AAMI; Arlington, Virginia) that hospitals using unmodified off-the-shelf software had no reason to worry about oversight or FDA inspections, but entities that customized off-the-shelf software or purchased custom-written software should expect to at the very least register their systems with the agency (Medical Device Daily, March 25, 2011).

The Bipartisan Policy Center (BPC) paper asserts that clinical software "should be subject to a new oversight framework rather than traditional regulatory approaches applied to medical devices," a notion the authors support by remarking on a purportedly lower risk profile for such software. The paper adds that FDA's "current regulatory approach for medical devices is generally not well suited for health IT" because of the degree of customization involved in HIT, one of the subjects addressed by FDAers at the AAMI gathering.

Tom Leary, VP for government relations at the Healthcare Information Management Systems Society (HIMSS; Chicago) told Medical Device Daily that ONC has come to no formal decision – at least none it has announced – about taking the lead on regulation of HIT, or whether there will be formal regulations. "When I talked to them, they [indicated they] are interested in figuring out what something like this would look like, but they're still in the exploratory stage," he said.

Leary said ONC will maintain a primary focus on patient safety, but is concerned about anything that would suppress innovation. He said ONC is asking, "is there a need for some sort of regulation?"

"I think everyone recognizes that once you're in the FDA regulatory environment, the time to market might be longer," Leary observed, so ONC is exploring the question of "are there ways short of FDA regulations that could be implemented?" The approach could either be a certification processes for electronic health records and other healthcare data systems, or a code of conduct among vendors "that agree to meet certain requirements," he said.

When asked whether FDA has indicated a willingness to let ONC handle HIT, Leary said, "we've talked to them, and that's part of the collaboration" required by FDASIA. Leary noted that the collaboration involves the Agency for Healthcare Research and Quality as well as ONC and FDA, adding, "I don't know that they've worked out one [agency] versus the other."

On the question of whether 21 CFR Part 11 and the quality systems regulations might serve as a blueprint for a voluntary standard or an ONC regulatory framework, Leary said "I'm not aware that the discussion has gone that far, but it's a great question for us to investigate as well."

Leary said the take-away from these developments is that "everyone is seeking a balance between patient safety and innovation." Still, he cautioned, "we are in the early stage of figuring out . . . how this will all work out."

FDA to meet over devices in extreme weather

Even as the snow was still melting on the ground in Arizona, FDA published a statement in the Feb. 21 edition of the Federal Register announcing an advisory meeting to discuss several weather-related issues, such as "the potential effects of extreme weather and natural disasters on medical device manufacturing chain processes and marketed medical device safety and quality."

FDA reported the same day that it is seeking feedback on the issues that will be addressed during the course of the meeting, which will include a discussion of "how to optimize the use of FDA's current regulatory framework to address" the aforementioned risks.

Among the scenarios FDA expressed interest in is how a power outage would affect the operation of devices such as infusion pumps and ventilators in both clinical and home sites of service. Another topic is that of how a power outage and any associated flooding or fire would affect operations at a device manufacturing plant, including the impact on clean rooms "and other controlled environments."

The meeting will take place April 11 at the Hilton Washington DC North Hotel (Gaithersburg, Maryland). Those interested in commenting for the government record should register their comments at regulations.gov under docket number FDA-2013-N-0118.

Aetna updates PCR indications list

Aetna (Hartford, Connecticut) has updated the list of indications for which it will cover polymerase chain-reaction diagnostics, adding two to the list of covered indications and deeming another three still experimental.

The insurer stated in a Feb. 15 update that PCR testing is covered for diagnosis of hepatitis C and for diagnosis of pertussis "in persons with cough." However, PCR is not yet covered for detection of Enterococcus faecalis and Staphylococcus aureus, as is the case for diagnosis of influenza.

Mark McCarty, 703-361-2519