A Washington D.C. law firm known for its work with mHealth companies is asking the U.S. Food and Drug Administration to "adopt significant fundamental changes to keep pace with medicine and technology."

 

The request is part of a 12-page white paper submitted to the Office of the National Coordinator for Health Information Technology by Bradley Merrill Thompson, an attorney with Epstein Becker Green and the legal counsel for the mHealth Regulatory Coalition. The ONC is seeking public comments as it prepares to develop a health information technology regulatory framework with the FDA and Federal Communications Commission.

 

[See also: Who should oversee mHealth regs?.]

 

The paper, titled "Enhancing Innovation in e-Health through a Systems Approach to Regulation: A Blueprint for FDA Modernization," calls for the FDA to "modernize its regulatory approach to embrace the fact that we are witnessing a transformation of the medical technology landscape from one shaped by individual, discrete products to a new era of complex, connected diagnostic and therapeutic systems that deliver holistic care."

 

The FDA has been in the middle of a battle over regulation of mobile medical apps, one of the fastest growing segments of the healthcare landscape. Roughly two years ago, the FDA issued preliminary guidance outlining what apps it would regulate, and asked for public comment. mHealth advocates have been awaiting the FDA's final guidance since then, with the mHealth Regulatory Coalition calling for a document as soon as possible to help end confusion and spur investment in the field.

 

Complicating matters, however, is a broad-based coalition of HIT stakeholders who feel the FDA shouldn't release that final document until after the ONC, FDA and FCC have come up with an HIT regulatory framework, as mandated by the FDA Safety Innovation Act of 2012 (FDASIA). Some have even argued that the FDA isn't the right agency to oversee mHealth regulation.

 

The white paper submitted this month by Epstein Becker & Green urges the various agencies involved to work together.

 

[See also: Sparks fly over mHealth regs.]

 

"Having multiple agencies overseeing a particular industry creates a substantial risk of throwing sand in the gears of innovation through duplicative and disjointed regulation. It can be very hard to serve two masters, let alone three," the paper stated. "In the case of e-health, the government didn’t set out to have multiple agencies regulating product development, but through the convergence of the technology, FDA, ONC and FCC can all now find themselves regulating the same products."

 

The paper goes on to say that "coordination among the three agencies is essential."

 

"This coordination needs to embrace the fact that the market is moving toward integrated systems of drugs, medical devices and health IT, and that proper regulatory oversight needs to reflect that reality," the paper noted. "Disjointed policymaking among the three agencies will not facilitate innovation, and will also not do an effective job at ensuring the safety and effectiveness of these health technology systems. We need a new approach."

 

In the case of the FDA, the white paper argues that the agency "needs to provide clarity and predictability with regard to the types of health IT the agency regulates, and for any software that is regulated, the classification."

 

"This needs to extend to both FDA guidance, and FDA enforcement action," the paper continued. "(The) FDA needs to act in a way that is clear and predictable. Written FDA rules that the agency ignores destroy that predictability. The agency’s words and deeds must match."

 

The paper outlines a number of areas where its writers feel the FDA must either modernize its rules or be more specific in enforcement. For example, the paper urged the agency to allow more collaboration among vendors, clinicians and scientists on the development of new technologies.

 

"Presently we are working on a proposal for a very different approach to the oversight of collaboration in the healthcare industry," the paper noted, "Before presenting it to the federal government, we are distributing copies among many stakeholders in order to improve the proposal."

 

In its conclusion, the paper indicates that there is "very good alignment among regulators, patients and industry when it comes to our ultimate objectives."

 

"We believe that updating the current FDA regulatory system to addresses the unique characteristics of e-health is necessary," the paper concluded. "Such modernization will encourage the innovation needed to advance healthcare and ensure that patients will receive the benefits of some incredible breakthroughs in a timely way."

 

The workgroup created by the FDASIA legislation is expected to submit its findings to Health and Human Services Secretary Kathleen Sebelius soon, after which the HHS will work with the ONC, FDA and FCC to draft a report to Congress that outlines a proposed strategy for regulating HIT, including mobile technology. To date, there is no word on whether the FDA is delaying its final document until after the workgroup finishes its research.