Archive for September, 2011

HHS Unveils Personal Health Record Privacy Notice

Friday, September 23rd, 2011

The Department of Health and Human Services (HHS) has unveiled an easy-to-read, standardized template to help consumers learn more about the privacy and security policies and data practices of personal health record (PHR) products. Read more.

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Health IT Lobbies for Patient ID

Friday, September 23rd, 2011

The Health Information Management Systems Society is asking its members to lobby Congress for a “nationwide patient identity solution” to improve accuracy of patient medical records and reduce errors traced to misidentification.  Read more

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GAO: FDA Should Enhance Its Oversight of Recalls

Friday, September 23rd, 2011
 For many high-risk recalls, firms faced challenges, such as locating specific devices or device users, and thus could not correct or remove all devices.  From 2005 through 2009, firms initiated 3,510 medical device recalls, an average of just over 700 per year. FDA classified the vast majority—nearly 83 percent—as class II, meaning use of these recalled devices carried a moderate health risk, or that the probability of serious adverse health consequences was remote. Just over 40 percent of the recalls involved cardiovascular, radiological, or orthopedic devices. FDA has used recall data to monitor individual recalls and target firms for inspections. However, it has not routinely analyzed recall data to determine whether there are systemic problems underlying trends in device recalls. Thus, FDA is missing an opportunity to use recall data to proactively identify and address the risks presented by unsafe devices.  Read the entire report at the GOA website.
 

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