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.

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.