Feds Release FDASIA Workgroup Report On Health IT Governance

A widely anticipated report from the U.S. Food and Drug Administration and other agencies may finally clear the air on how healthcare IT – and mHealth in particular – will be regulated.

The Department of Health and Human Services' Office of the National Coordinator for Health IT and the Federal Communications Commission joined the FDA in drafting the report, which was mandated under the Food and Drug Administration Safety Innovation Act (FDASIA) of 2012. The report now goes on to Congress.

Dan Haley, vice president of government and regulatory affairs and assistant general counsel at athenahealth, said he sees “a lot of good language,” in the report. That language was taken from an industry collaboration of 100 or more experts, including athenahealth, led by the Bipartisan Policy Center (BPC).