"Many in industry have been waiting for years to find out more specifically the distinction between wellness and disease, exactly what constitutes medical device accessories, exactly what constitutes clinical decision support software that FDA would regulate, and parsing medical device software modules for regulation," Thompson told Health Data Management.

"The report explicitly mentions all of those areas and says that they will be the subject of further clarity, and outside of the report obviously the agenda for 2014 for FDA includes those items," he said. "But I would like to have seen more in the report about where the agency plans to go with regard to those items."


Thompson says one important part of the report is that it proposes taking steps to facilitate the interoperability of medical devices and health IT, an important part that's been left out of other HIT policy initiatives.

Category 3: Products with medical device health IT functions
This is the most high-risk group, that could pose great risks to patients. According to the report, the FDA would continue to regulate items such as software for bedside monitoring, radiation treatment and computer-aided detection.

"This proposed strategy will facilitate innovation, protect patients and support FDA's focused oversight on higher-risk technology, similar to medical devices that are currently regulated," said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.

Creating a Health IT Safety Center
The report calls for ONC to form a Health IT Safety Center in partnership with the FDA, the FCC, HHS' Agency for Healthcare Research and Quality (AHRQ), and other organizations. The Health IT Safety Center would work on best practices and provide a forum for the exchange of ideas and information focused on patient safety.

"The draft report reflects FCC's narrow but important role in encouraging new and innovative wireless medical technologies and ensuring that developers and users of these technologies are minimizing the potential for causing potentially harmful interference to radio services," said Matt Quinn, the FCC's director of health care initiatives.

Report stirs different viewpoints
"The bottom line is that HHS, and the three agencies, are proposing a very light touch to overseeing innovation in health IT, and that has to be good news for HIT developers," Thompson said in a written analysis.

"My primary criticism of the plan is that it doesn't move very aggressively to define exactly the dividing line between the software that FDA does in fact regulate and that which it doesn't," he told DOTmed News.

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