FDA won't regulate medical device data systems

Draft guidance published Friday by the U.S. Food and Drug Administration seemingly paves the way for smoother medical device interoperability by lowering the burden on developers of medical device data systems (MDDS) to comply with agency requirements.

The guidance notes that "additional experience" with MDDS since down-classifying such tools from Class III devices, which are considered high-risk, to Class I (low-risk) in February 2011 prompted FDA's decision to "not enforce compliance with ... regulatory controls." Such tools, the guidance notes, are not intended to control or "alter the functions ... of any connected medical devices," but rather:

  • Enable electronic transfer or exchange of medical device data: The guidance gives the example of software that collects output from a ventilator on a patient's CO2 level, transmitting that data to a central repository
  • Store and retrieve medical device data, such as historical blood pressure information that can be reviewed by a physician
  • Convert medical device data from one format to another: For instance, converting digital data generated by a pulse oximeter into a digital format to be printed
  • Display medical device data: For instance software that displays a previously stored electrocardiogram for a patient

The guidance, according to Bakul Patel, senior policy adviser to the director of the Center for Devices and Radiological Health at FDA, allows MDDS developers to focus on improving interoperability with other medical devices. He added that the guidance is consistent with the health IT risk-based framework issued in April in conjunction with the Office of the National Coordinator for Health IT and the Federal Communications Commission as mandated by the Food and Drug Administration Safety and Innovation Act.

"These systems are the foundation for intercommunication and interoperability among devices and between medical devices and other health IT," Patel said in a blog post. "FDA believes that this will encourage greater innovation in the development and maturation of these systems."

Attorney Brad Thompson, of Epstein Becker Green, who serves as general counsel for both the mHealth Regulatory Coalition and the CDS Coalition, called the guidance consistent with the notion that the FDA is getting out of the broad health IT management sphere, passing those duties off to the ONC. He added that it's a big change from when the FDA originally crafted MDDS, which he said was done fairly narrowly.

"I think they decided that the risk simply isn't there for FDA-style controls, and that ONC voluntary standards are more consistent with the risk level," Thompson said in an email to FierceHealthIT.

Thompson said that while he appreciated the desire for speed, he was bothered by the fact that the FDA chose to issue a guidance document rather than publish an official rulemaking.

"That's a sloppy way to regulate," he said. "There is a regulation on the books that needs to be changed. I'm tired of FDA avoiding the proper legal channels to do this sort of thing."

Joseph Smith, chief medical and science officer for the West Health Institute, however, applauded the process.

"In rapidly moving innovative spaces, I'm not sure that we're all best served by hard-and-fast rules as much as we are by iterative and responsive policy decisions," Smith told FierceHealthIT. "We have to make sure that regulation moves at the pace of innovation, because innovation moving at the pace of regulation is unacceptable."

The guidance, Smith said, gives more latitude to health IT developers such as Apple and Samsung, both of which recently launched high-profile health IT efforts.

"As commercial, consumer-looking enterprises get into healthcare, they tend to have a bumper around their activity," Smith said. "They put up a barrier and talk about how they're in 'health and wellness' but not really in healthcare. They kind of run up to the issue but they don't get deeply involved in the meat of healthcare. I think this gives them more freedom to do that."

Smith added that the guidance plays directly into issues that will be discussed at a House Energy and Commerce Committee meeting next Tuesday, which will focus on improving the digital healthcare landscape. The committee published a whitepaper earlier this week asking for comments on accelerating and embracing technology development.

"This notion of de-regulating and democratizing innovation with digital technology to re-engineer healthcare is part of that discussion," Smith said.

To learn more:
- here's the guidance (.pdf)
- check out Patel's blog post
- read about the upcoming House Energy and Commerce Committee meeting