Bradley Merrill Thompson Quoted in Article, “Industry Advocates Call for FDA to Update, Clarify Health IT Regulations”


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 "Industry Advocates Call for FDA to Update, Clarify Health IT Regulations."

Following is an excerpt:

The Food and Drug Administration should update and clarify its existing regulatory policies for health information technologies—also known as e-health—rather than create new ones, health care industry associations and advocates said in letters to federal regulators Aug. 28. ?...

"We believe that updating the current FDA regulatory system to address the unique characteristics of e-health is necessary," attorneys from the Washington-based health care law firm Epstein Becker & Green P.C. wrote in a white paper attached to their letter to ONC. "Such modernization will encourage the innovation needed to advance health care and ensure that patients will receive the benefits of some incredible breakthroughs in a timely way." ?...

The Epstein Becker & Green letter was authored by attorney Bradley Merrill Thompson. ?...

The Epstein Becker letter and white paper argued that health IT needs to be protected from over-regulation and unclear regulations. ?...

In particular, the paper said, FDA should outline how its medical device classification rules are applied to health IT tools. Currently, many health IT developers are unsure whether FDA will regulate health IT tools, particularly mobile medical applications, the same way the agency regulates medical devices.

In 2011 FDA published draft guidance on how it intended to oversee mobile medical applications, describing how it could regulate a limited number of apps as medical devices and treat others as too low-risk to subject them to medical device oversight requirements (5 MELR 476, 7/27/11).

FDA "needs to act in a way that is clear and predictable," the paper said.

"Written FDA rules that the agency ignores destroy that predictability," the paper said. "The agency's words and deeds must match."

The paper also called for a "holistic approach to regulation," in which the three agencies would coordinate their efforts to oversee health IT issues.

"Having multiple agencies overseeing a particular industry creates a substantial risk of throwing sand in the gears of innovation through duplicative and disjointed regulation," the paper said. "It can be very hard to serve two masters, let alone three."