The Clinical Decision Support (CDS) Coalition charges that a bipartisan bill introduced in October 2013 to amend the Federal Food, Drug, and Cosmetic Act “goes too far” in deregulating CDS software that requires regulation to ensure the health and safety of patients. Read more on the Coalition’s legislative proposal here: http://www.fiercemobilehealthcare.com/story/cds-coalition-software-act-goes-too-far/2014-01-31?utm_medium=nl&utm_source=internal.
Statement by Bradley Merrill Thompson, General Counsel, mHealth Regulatory Coalition, on the Food and Drug Administration’s Final Guidance for Mobile Medical Application Developers
Mr. Thompson is a well-known and respected expert on issues related to FDA regulation of medical technologies. He is available for comment on the FDA final guidance on mobile medical technologies and other developing FDA issues.
We applaud the U.S. Food and Drug Administration for issuing guidance that will illuminate a pathway for developers of mobile health applications. This final guidance brings greater clarity to one of the most vibrant sectors of health care innovation and will serve as a catalyst for more rapid development of apps that are redefining American medicine.
There are two aspects of the FDA’s final guidance that are particularly praiseworthy. First, the agency has drawn a clear line of separation between mobile applications that pose minimal, if any, risk to consumers and those that are integral to health care diagnosis and delivery by medical professionals. By essentially deregulating many of the health-related apps that can transform smartphones into wellness devices, the FDA has performed a tremendous service for patients and consumers.
Also, the FDA has recognized the fast-moving nature of the mobile application industry and has created a guiding mechanism that is not static, but that allows adaptability to innovation. It is significant that the agency is creating a dynamic webpage to see real-time comments and questions about the regulatory approach to mobile applications. It is encouraging, to say the least, that a federal agency sees the importance of flexibility in working with a technological sector that is in a state of constant evolution.
There are still questions, of course, as to how the FDA will oversee mobile applications that have, in its determinations, the potential for greater risk. For now, though, this guidance shows a genuine desire on the part of regulators to be advocates for innovation and health care transformation.
The Supplement to the Citizens Petition Docket ID: FDA-2012-P-0617 Filed by the Combination Products Coalition outlines additional ways FDA can give guidance to industry. The Supplement is available here: http://cdscoalition.org/wp-content/uploads/2013/09/EBG-FDA-Suppl-Citizens-Petition.pdf
This white paper outlines some factors related to innovation that the agencies, and in particular FDA, should consider as they put together the government’s strategy. More specifically, it identifies outdated aspects of the existing FDA regulatory framework and suggests significant changes to address the unique aspects of health IT. It also advocates for a holistic approach among FDA, FCC and ONC to avoid confusion, duplication and regulatory conflict.
CDS is a critical and growing part of healthcare. It includes a broad range of products with varying degrees of risks, from body mass index calculators to complex radiation dosage. The CDS Coalition believes that all CDS cannot be treated the same way from a regulatory perspective – and many low risk CDS products should not be actively regulated at all.
In 2011, FDA announced it is developing guidance on the regulation of clinical decision support software. For the past year and a half, the CDS Coalition has been working on a proposed regulatory framework that takes into account the unique aspects of CDS and helps ensure that CDS software will not become over-regulated. On July 17th the Coalition held a webinar to gather additional input on their framework so that the Coalition can provide FDA a comprehensive proposal that reflects the views of patients, provider and others in the industry.
Slides from the webinar are available here: http://cdscoalition.org/wp-content/uploads/2013/07/CDS-Webinar-Slides.pdf. If you have feedback on the framework please direct them to Kim Tyrrell-Knott at firstname.lastname@example.org.