Patient orgs urge balanced oversight of health IT

Fifteen patient groups are calling on federal officials to allow Food and Drug Administration Safety Innovation Act (FDASIA) Workgroup ample time to develop proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health IT to promote innovation, protect patient safety and avoid regulatory duplication.

“To that end, we urge the administration to allow ample time for the FDASIA Workgroup to complete its work and to take into consideration the administration’s final recommendations on a risk-based regulatory framework pertaining to health IT in any future agency guidance or policy to be released associated with the regulation or oversight of health IT,” according to the July 29 letter. The letter was addressed to leadership at the Center for Medicare & Medicaid Services, the Office of the National Coordinator for Health IT and the FDA and copied to congressional health committees.  

While the groups reiterated their support for health IT and its role in improving health and healthcare, they said that health IT oversight “must be implemented in a balanced way that also fosters innovation and encourages adoption of these technologies.”

The groups further called on agencies to work with Congress on a new risk-based regulatory framework and the development of appropriate oversight mechanisms for health IT, including mobile applications.

“We believe that, by working collaboratively, Congress and the administration can produce a statutory framework for regulation of health IT based on risk while supporting innovation and patient safety,” according to the letter.