Industry Advocates Call for FDA To Update, Clarify Health IT Regulations

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By Alex Ruoff  

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FDA's current regulatory framework is outdated and many health IT developers are uncertain about how their products will be regulated in the future, advocates wrote to the Office of the National Coordinator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.”

Similarly, representatives from the Pharmaceutical Research and Manufacturers of America (PhRMA), an industry association for pharmaceutical research and biotechnology companies, wrote ONC in June asking the agency to align the activities and regulatory efforts of FDA, ONC, and the Federal Communications Commission.

The 11-page white paper, titled Enhancing Innovation in e-Health Through a Systems Approach to Regulation: A Blueprint to FDA Modernization, includes recommendations for “modernizing” FDA regulations to support health IT developers.

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

ONC oversees the Food and Drug Safety and Innovation Act (FDASIA) workgroup, part of a congressionally mandated partnership between the Department of Health and Human Services, FCC, and FDA. The three agencies are charged with issuing a report on possible regulation of health IT tools, including mobile medical applications.

Modernization Recommended

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.

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.”

PhRMA Requests

In a letter to ONC, Sarah Spurgeon, assistant general counsel for PhRMA, and Michelle Drozd, the organization's senior director for policy and research, asked that any health IT regulations created be mindful of the needs of developers and avoid duplicitous regulation.

To that end, ONC should minimize redundancy both between and within the federal agencies that oversee health IT, namely FDA, FCC, and HHS, the letter said.

“This will be more straightforward if the current missions of these agencies are preserved without expansion of scope,” PhRMA said.

Specially, PhRMA officials suggested FDA “focus upon [health IT] aspects that are directly related to protecting the public health by assuring the safety, efficacy and security of medical products for human use,” while ONC focuses on privacy and security issues facing health IT.


Both letters were sent in response to a request for comments from ONC published in the May 30 Federal Register (78 Fed. Reg. 32,390).

The FDASIA workgroup is set to wrap up recommendations in September for a report to Congress with proposals for a risk-based regulatory framework for health IT that includes policies for regulating mobile medical applications (see related item).

In July, the workgroup announced it would not seek to subject health IT tools to FDA premarket oversight; rather the workgroup would focus on post-market surveillance and certification programs (7 MELR 507, 8/7/13).


To contact the reporter on this story: Alex Ruoff at

To contact the editor responsible for this story: Kendra Casey Plank at

The Epstein Becker Green letter to ONC is at

The white paper is at

The PhRMA letter is at