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A risk-based regulatory framework for health IT: recommendations of the FDASIA working group.

Lookup NU author(s): Professor Sarah SlightORCiD


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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 input into the development of this framework, including how healthcare IT systems could be stratified in terms of risk and recommendations about how the regulatory requirements currently in place should be adapted. In this paper, we summarize the public deliberations and final public report of the expert stakeholder group, and conclude with key suggestions intended to address the charge to recommend the features of a risk-based regulatory framework that promote innovation, protect patient safety, and avoid regulatory duplication. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to

Publication metadata

Author(s): Slight SP, Bates DW

Publication type: Article

Publication status: Published

Journal: Journal of the American Medical Informatics Association : JAMIA

Year: 2014

Volume: 21

Issue: e2

Pages: e181–e184,

Print publication date: 01/10/2014

Online publication date: 24/04/2014

Acceptance date: 08/04/2014

ISSN (print): 1067-5027

ISSN (electronic): 1527-974X

Publisher: BMJ Publishing Group Limited


DOI: 10.1136/amiajnl-2014-002638

PubMed id: 24763676


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