Health IT Now Reacts to FDA Draft Guidance for General Wellness, Medical Device Accessories

Washington, D.C. – Joel White, executive director of the Health IT Now Coalition made the following statement on FDA’s draft guidance for general wellness and medical device accessories.

“Health IT Now is disappointed to see the release of FDA guidance attempting to define the regulatory parameters for health IT, not because we disagree with the policy, but because it continues FDA’s reach into new technologies at the same time Congress is working on changes to the FDA’s authority in this area.

“More specifically, the draft guidance comes at a crossroads for the FDA, as the agency is facing bipartisan legislation moving through both houses of Congress that would clarify the role of the agency with regard to regulating health IT. The guidance comes on the heels of the Office of the National Coordinator working group on FDASIA report, which states that regulation of health IT must be fixed in legislation not regulation because it is ‘broken at the written law level.’

“We urge the FDA and the ONC to work with legislators in Congress to develop a new regulatory framework that encourages innovation and protects the safety of patients. The Health IT Now Coalition looks forward to continuing to work with Congress and the Administration on the new framework and providing a higher quality of care to patients.”

 

About the Health IT Now Coalition:  Health IT Now (HITN) is a broad based coalition of patient groups, provider organizations, employers and payers that supports incentives to deploy health information technology to improve care, provider performance, patient outcomes, and to lower costs. Learn more at www.healthitnow.org.

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