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 [...]
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By Robert Hudock, on March 1st, 2010
 Print This PostMarch 1st, 2010 | Tags: 510k, avaliability, confidentiality, Dynamic Testing, Electronic Health Records, FDA, HIT, integrity, MDDS, ONC, Policy Committee, requirements specificastion, Shuren, Validation | Category: Center for Devices and Radiological, FDA, Health Information Technology, MDDS, Medical Device Data System |
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Content of the Notice to the Secretary of HHS for a Reportable Security Breach
Under the HITECH breach notification requirements, covered entities must notify HHS of all reportable breaches. HHS recently released a list of breaches, including the covered entity, the business associate, number of individuals affected, and the location of the information lost. More than 35 HIPAA covered entities have reported breaches involving more than 500 individuals’ PHI since September 2009. The theft/loss of laptops, desktop and portable media by far represent the majority of the security breaches reported thus far. A summary of breaches reported thus far appears [...]