The $2.5T healthcare industry is poised to fully embrace the benefits and efficiencies of mobile cellular communications, products, and services. Much of today’s care could be delivered with better quality and efficiency and less cost through the use of mobile technologes, all while improving the lives of patients through treatment in the comfort of their own homes and during their daily routines
Unfortunately, the current uncertainty around the scope and impact of FDA regulatory requirements is impeding progress and adoption of these new technologies. The mHealth Regulatory Coalition is forming to focus on that challenge.
The goal of the mHealth Regulatory Coalition is to work with FDA to write a guidance document that addresses what gets regulated and what does not. This coalition will be temporary, existing just long enough to accomplish the purpose of drafting the proposed guidance document. Estimated time for completing the process is one year.
5/17/12: This week, Senators Bennet and Hatch proposed an amendment to the Senate’s proposed Food and Drug Administration Safety and Innovation Act that effectively would establish an 18-month moratorium on the publication of FDA’s final guidance on mobile medical applications. In response, MRC has sent a letter to Senators Harkin and Enzi (the Chairman and ranking minority member of the Committee on Health, Education, Labor and Pensions, respectively) expressing the Coalition’s opposition to a moratorium and requesting that the Senators oppose any proposal that would delay publication of the guidance.
4/27/12: Because the 510(k) Program plays an important role in the regulation of mHealth technologies, the Coalition filed comments on the FDA’s draft guidance on April 26, 2012. Although the Agency’s draft guidance is a significant step toward clarifying the 510(k) Program, there are a number of areas that need clarification to produce a clear, predictable, and narrowly-tailored regulatory framework that promotes patient safety and innovation in mHealth.
4/3/12: The Coalition has submitted a letter to FDA again requesting that the agency re-propose the guidance on mobile medical applications. This joint letter is a follow-on to the January letter and is supported by a number of organizations that submitted comments on the original draft guidance.
1/23/12: On January 20, 2012, the MRC sent a letter to the FDA requesting that the Agency re-propose the draft guidance, allowing the public a reasonable opportunity to comment before the issuance of a final document.
10/20/11: The mHealth Regulatory Coalition is pleased to announce that, after more than a year’s worth of work, we submitted our proposed guidance document on October 19, 2011 as comments to the FDA’s draft guidance on mobile medical apps. The full comments on the Agency’s draft guidance can be found here.
9/30/11: After nearly nine months of development, the Coalition is releasing a pre-submission draft of its proposed guidance document. This draft combines the three documents released earlier this year and incorporates public comments from a variety of stakeholders. We encourage you to challenge our thinking and submit comments to Jason Brooke by Oct. 12, 2011.
6/27/11: The third and final portion of our proposed guidance document is now available for comment. We’ve focused this part on the complex issues associated with software in an mHealth ecosystem.
5/10/11: We’re moving along in our guidance development process. The second part of the proposed guidance document establishes a framework for addressing the regulation of accessories in an mHealth product.
4/25/11: The first of a three-part guidance document that the mHealth Regulatory Coalition plans to submit to FDA, this document is our initial attempt to develop a framework for determining what intended use claims would trigger regulation of an mHealth product by the agency.
3/1/11: List of mHealth Intended Use Examples
12/22/10: The mHealth Regulatory Coalition has developed a white paper entitled “A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth”. This 60-page paper focuses on a single question: What mHealth hardware and software will FDA regulate?
9/27/10: On September 27th the mHealth Coalition was featured in On-Line News as an important stakeholder in the mHealth space.
8/30/10: Published Article in August 2010 issue of BNA. Reproduced with permission from Health IT Law & Industry Report, 2 HITR 35 (August 30, 2010). Copyright 2010 by The Bureau of National Affairs, Inc. (800-372-1033)
8/16/10: Public Comments FDA Docket 2010-N-0291
7/23/10: Public Comments: Council on Medical Device Innovation Public Meeting
6/21/10: Mobile Health Coalition Forming to Draft Proposed Guidance for FDA Regulation of HIT. Reproduced with permission from Health IT Law & Industry Report, 2 HITR (June 21, 2010). Copyright 2010 by The Bureau of National Affairs, Inc. (800-372-1033)