Law Blog 2.0

On February 25, 2009, at a Health Information Technology Policy Committee Adoption/Certification Workgroup meeting, Dr. Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological highlighted concerns with the current state of regulation around Health Information Systems which are not currently actively regulated by FDA. Dr. Shuren’s testimony highlighted three areas of concern: (1) the FDA’s legal and regulatory authorities over medical devices and the approach we have taken with respect to HIT to date; (2) a Review of various safety issues that have been reported to the FDA and other unique challenges presented by HIT; and (3) Possible approaches the FDA could take in the future to help address these [...]