A risk-based regulatory framework for health IT: recommendations of the FDASIA working group.
The Secretary of Health and Human Services (HHS) acting through the Food and Drug Administration (FDA), and in collaboration with the Federal Communications Commission (FCC) and Office of the National Coordinator for Health IT (ONC) was tasked with delivering a report on an appropriate, risk-based regulatory framework for health information technology (IT). An expert stakeholder group was established under the auspices of the Health IT Policy Committee to help provide [...]
Author(s): Slight, Sarah P, Bates, David W
DOI: 10.1136/amiajnl-2014-002638