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.
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 white paper submitted in August by Epstein Becker & Green urges the various agencies involved to work together.
"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."
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."
On Sept. 4, the workgroup created by the FDA Safety Innovation Act of 2012 (FDASIA) legislation submitted its long-awaited final recommendations to the ONC Health IT Policy Committee. HHS is now slated to work with the ONC, FDA and FCC to draft a report made from the recommendations to inform Congress on proposed strategies for regulating HIT, including mobile technology.
In a Sept. 6 blog, Robert Jarrin senior director of government affairs for Qualcomm, Inc., said Qualcomm hopes FDA will publish final mobile medical applications guidance as soon as possible. "The FDASIA Workgroup has independently delivered its final recommendations recognizing the importance of expediting guidance on HIT software, mobile medical apps and related matters" and "I could not agree more," Jarrin said.
Janet M. Marchibroda, director of Health Innovation for the Bipartisan Policy Center notes the workgroup's first draft of recommendations issued earlier this summer indicated that substantial additional regulation of health IT beyond what is currently in place is not warranted, with the exception of medical device data system, medical device accessories, certain forms of high-risk clinical decision support, and higher-risk software use cases.
"The draft report appropriately does not specifically define which agencies or organizations should carry out various aspects of the new framework," Marchibroda said.
The Sept. 4 recommendations from the FDASIA workgroup, along with public comments that were received by Aug. 31, in response to an HHS formal FDASIA Request for Comments on the Development of a Risk-Based Regulatory Framework and Strategy for Health IT, are expected to help HHS write its report for Congress, expected by January 2014, Marchibroda said.