MRC Tells Congress – Do Not Pass Legislation, Wait for FDASIA Report

MRC Tells Congress – Do Not Pass Legislation, Wait for FDASIA Report

January 20th, 2014 // 1:37 pm @

Just as FDA has said, the mHealth Regulatory Coalition (MRC) has approved a new policy that urges the US Congress to not pass any legislation that regulates health information technology, which includes mHealth.

MRC states that lawmakers should instead wait for a required FDASIA report to come out that will detail risk based regulatory rules for health IT, which will include mobile medical apps. FDA, which is working with the FCC and the Office of the National Coordinator for Health IT is going to complete this year.

MRC stated that the time is not right for Congress to make legislative changes to federal regulations governing health IT. Congress should be waiting until the various federal agencies have a chance to publish their regulatory strategy that is required by FDASIA section 618. Also, the organization thinks that stakeholders have not had the time to think about all of the alternatives. Rushing legislation could have a negative impact on innovation and safety.

The SOFTWARE Act is the big issues, which is a bill that was introduced at the end of 2013 as an amendment to the FD and C Act and to act as a limit on FDA’s authority.

MRC’s counsel is a big critic of this Act, which has three classifications of software – clinical, health and medical. Clinical and health software will not have to be regulated under this proposal.He noted that many private stakeholders who support the legislation want to remove regulatory responsibility for those categories from the agency. They believe that Congress needs to come up with a new regulator and a regulatory scheme. He does not agree with this, and he thinks separating the software is going to have many problems and challenges.

The FDASIA report that is required by Congress in the first quarter of this year also is going to report on clinical decision support software. This was not even addressed by the FDA final guidance on mobile medical support apps. The general counsel for the Clinical Decision Support Coalition stated recently that it is working on a policy that will specifically define clinical decision support. He noted in a letter to Congress last year that it does not seem right for Congress to move ahead with legislation on CDS, when the FDASIA report is going to come out in early 2014.

 We have a unique FDASIA Webinar coming up on Jan. 29, please check it out.


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