Events

February 18, 2014

8 types of medical apps a Senate bill asks FDA to stop regulating

Bradley Merrill Thompson’s, one of the general counsels for the CDS Regulatory Coalition, examples of the types of apps that the PROTECT Act would instruct the FDA to stop regulating were featured in a mobihealthnews article here: http://mobihealthnews.com/29895/8-types-of-medical-apps-a-senate-bill-asks-fda-to-stop-regulating/. The examples were also featured in a Fierce Mobile Healthcare article available here: http://www.fiercemobilehealthcare.com/story/protect-act-would-deregulate-high-risk-cds-mobile-medical-apps/2014-02-13.

January 31, 2014

CDS Coalition: SOFTWARE Act goes too far

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.

January 17, 2014

ATA 2014: 19th Annual Meeting & Trade Show

ATA 2014: 19th Annual Meeting & Trade Show
May 18 – 20, 2014
Baltimore, MD

January 17, 2014

HiMSS14 Annual Conference & Exhibition

HiMSS14 Annual Conference & Exhibition
February 23-27, 2014
Orlando, FL

September 24, 2013

Statement by Bradley Merrill Thompson, General Counsel, mHealth Regulatory Coalition, on the Food and Drug Administration’s Final Guidance for Mobile Medical Application Developers

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.

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