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.
FDA’s current regulatory framework is outdated and many health IT developers are uncertain about how their products will be regulated in the future, advocates wrote to the Office of the National Coordinator for Health IT.
“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.
The paper said FDA should:
- provide clarity and predictability with regard to the types of health IT the agency regulates;
- engage in more outreach, both in the creation of useful guidance and face-to-face educational programs for developers;
- coordinate with FCC and ONC to ensure a “unified regulatory approach”;
- modernize its rules for off-label promotion to allow for closer collaboration among vendors and clinicians;
- define any premarket requirements for health IT; and
- modernize its registration and listing requirements to “reflect the fact that much software is developed virtually.”
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.