Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Tri-Agency Health IT Report Emphasizes Risk-Based Scheme, But Lacks Some Detail, Observers Say."
Following is an excerpt:
A joint draft report on health IT regulation from FDA, the Federal Communications Commission and the HHS Office of the National Coordinator for Health Information Technology includes many signals industry watchers were looking out for, laying out a risk-based approach that focuses on function rather than platform. But it leaves some details undefined.
After some missed deadlines, the three agencies issued the long-awaited, congressionally mandated report to map out a regulatory framework for health IT April 3. It was released in draft form, and the agencies plan to accept public comments for the next 90 days. ...
Bradley Thompson, who was a member of the FDA Safety and Innovation Act-mandated workgroup that drew up recommendations for the agencies, agreed that the BPC framework proved an inspiration for the final agency product. "I think it shows that people in industry, on Capitol Hill, and in the agencies are largely in agreement. Indeed, it seems that all three sectors are saying about 90 percent the same things," he wrote in an email to "The Gray Sheet." ...
Thompson, from the mHealth Regulatory Coaltion, which represents some in industry and has been supportive of an FDA oversight role, had one specific critique of the report: it lacked specific detail, he said. The report covers its topics at a "high level," he said. ...
The report does not provide a general set of criteria for determining when a particular type of clinical decision support software would fall into the lower-risk health management or the higher-risk medical device categories. Instead, it lists examples of high-risk uses, such as computer aided diagnosis or detection; remote display or notification of real-time alarms from bedside monitors; radiation treatment planning; and electrocardiographic analytical software.
Thompson said he was disappointed by a lack of clarity on this subject. The examples provide in the report, he said, are largely already known. ...
Thompson said the report also lacked clarity on other topics, including the distinction between wellness and disease; medical device accessories; and software modules. "The report explicitly mentions all of those areas and says that they will be the subject of further clarity," he said.
Thompson said he expected more details in the report, particularly given the amount of time the agencies took to put it together. "Industry has been waiting a very long time," Thompson said.
