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FDA Sends Draft of Health IT Regulations to Congress

healthcare systemThe Food and Drug Administration Safety Innovation Act working group has released a draft document that proposes recommendations about how mobile healthcare technology should be regulated, Government Health IT reported Thursday.

The FDA, HHS‘ Office of the National Coordinator for Health IT and the Federal Communications Commision jointly developed the risk-based regulatory framework, according to the article by Diana Manos and Eric Wicklund.

Manos and Wicklund write the report includes policy language resulting from a collaborative effort led by the Bipartisan Policy Center.

ACT, a grassroots organization of information technology firms, expressed support to the workgroup’s proposal to create a health IT center.

“Convening stakeholders to identify sustainable, innovative health IT systems is critical, and ACT will provide significant input through this open and transparent process,” said Morgan Reed, ACT executive director, according to Manos and Wicklund’s article.

“We look forward to bringing our expertise in mobile app privacy, security, COPPA, and other regulatory frameworks to this discussion,” Reed added.

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