Information technology that supports health management functions, such as medication management and clinical results, is exempt from FDA regulations, according to the agency's recent framework. (Thomas Brown/Staff)
In the tightly regulated world of healthcare delivery, those who toil in the fields of information technology had been facing a quandary. Is health IT medicine? If so, it would be subject to government regulation. If it is technology, however, it would be exempt from the rigors of oversight.
The Food and Drug Administration resolved the question with the April publication of a framework declaring that the products of health IT are not the same as medical devices and thus not subject to healthcare regulations. Now companies are sorting through what the decision means for their products and systems.
“The new FDA framework on health IT goes further than previous documents from the FDA and will lead to less confusion and aversion of healthcare for developers,” said Travis Good, CEO of health software company Catalyze.
The FDA declaration goes even further, noting that even IT products that straddle the line still will be exempt. “For most health IT products that may be considered devices, FDA does not intend to focus its oversight on them,” said Bakul Patel, senior policy advisor for the FDA’s Center for Devices and Radiological Health.
Practitioners whose work encompasses IT research and direct medical delivery say the new information could clear the way for greater innovation among IT leaders who up until now have been nervous about the FDA’s position on medical technology.
“The FDA is a large government bureaucracy with a large regulatory framework for companies to jump through. There are all these steps that have to be accomplished and signed off on, and it just dramatically lengthens the time to approval,” said Dr. Christopher Longhurst, chief medical information officer and a practitioner at Stanford Children’s Health.
Longhurst acknowledges that IT research may come with risks, but he reads the FDA statement as saying that those risks are by and large acceptable. Take for instance electronic health care records. “If implemented poorly you can really screw things up, patients really can be hurt by poorly documented software,” he said. “What the FDA has said is that the benefits of health IT dramatically outweigh the risk.”
To give its all-clear to health IT developers, the FDA may have decided to rethink its approach to what constitutes a device, said Divan Dave, CEO of electronic health records software developer OmniMD.
Rather than look at what it is, he said, that guidelines look at what it does. “The report’s proposed strategy and recommendations are based on the premise that risk and corresponding controls should focus on health IT functionality – not the specific platform on which such functionality resides, or the product name or description of which it is a part,” he said.
In doing so, the FDA shifts the focus away from regulation and onto other metrics of quality assurance, calling for a culture of safety and quality, Dave said. It urges IT developers to leverage best practices, employ industry-led testing and certification, and selectively use tools such as voluntary reporting and training.
FDA issued the new framework in conjunction with other regulatory bodies, include the Office of the National Coordinator for Heath IT (ONC) and the Federal Communications Commission.
The FCC is tasked with ensuring the growing body of wireless healthcare technologies stays on the safe side by minimizing the potential for causing harmful interference to radio services, according to the FDA.
The ONC meanwhile will lead the creation of a public-private Health IT Safety Center, which will serve as a forum for developing health IT best practices and will help industry continue to innovate.
Experts say these efforts should help the health IT community to continue its rapid pace of development, without the burden of weighty government oversight.
“The concern has been that any regulation would not be thoughtful, that there would not be a common sense approach. For every change a developer makes, they could have required huge amounts of paperwork and it would have prevented vendors from responding to marketplace needs,” said Robert Oscar, CEO of mobile health company RxEOB.
“This means the marketplace will continue to grow, we’ll see more use of data to drive intelligent decision-making,” he said.