Archive for the ‘News’ Category

Institute of Medicine report says FDA not fit to regulate HIT

Monday, November 14th, 2011

Health information technology has been touted as crucial to better healthcare, but a new report says an entirely new regulatory agency is needed to oversee this largely unregulated sector, which can also injure or kill patients if it’s not operating properly.

In pushing for a new oversight body, the respected Institute of Medicine, an independent research and advisory organization, is explicitly advising that the Food and Drug Administration (FDA) not be tasked with the job – a recommendation that is bound to be controversial.  [Read More]

Michigan HIE Puts Sustainability Into Play

Tuesday, November 8th, 2011

South East Michigan Health Information Exchange joins Nationwide Health Information Network Exchange, also helps Social Security Administration improve eligibility processes. Read More

TRICARE directs SAIC to offer credit monitoring for data theft patients

Tuesday, November 8th, 2011

The TRICARE Management Activity  directed Science Applications International Corp. to provide credit monitoring services for up to 4.9 million beneficiaries whose health information was stored on backup computer tapes stolen from an SAIC employee’s car in San Antonio. Read More

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.

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

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.
 

Docs Averse to Sharing Patient Data, Even for Public Health

Monday, July 11th, 2011

FALLS CHURCH – Leading medical and recall news headlines from Noblis Health Innovation for Monday, July 11. Click on the underlined item for the actual link to the story:

When it comes to disclosing identifiable patient information, family doctors are reluctant to do so – even for public health purposes such as tracking influenza, according to a recent study.

Joint Commission Safety Goals Should Be Part of EHR Certification

Monday, July 11th, 2011

FALLS CHURCH – Leading medical and recall news headlines from Noblis Health Innovation for Monday, July 11. Click on the underlined item for the actual link to the story:

The Joint Commission’s 2011 National Patient Safety Goals (NPSG) for hospitals should be included in electronic health record certification and criteria for meaningful use.

Defibtech Lifeline and ReviveR AEDs Recalled

Wednesday, May 18th, 2011

FALLS CHURCH – Leading medical and recall news headlines from Noblis Health Innovation for Monday, March 21. Click on the underlined item for the actual link to the story:

  •  Medwatch alert: Defibtech will provide customers with a free software upgrade. Because the conditions that may lead to a canceled shock occur rarely, it is recommended that customers keep their AEDs in service during the software upgrade process. Full instructions and recommendations are being mailed to affected customers.

GS1 is the emerging data standard for medical products

Wednesday, May 18th, 2011

FALLS CHURCH – Leading medical and recall news headlines from Noblis Health Innovation for Monday, March 21. Click on the underlined item for the actual link to the story:

  • Learn more about GS1: For over 35 years, GS1 global supply chain standards have delivered proven results in many industries including the groundbreaking U.P.C. in retail. Now the U.S. healthcare industry is working together to leverage the value of GS1 Standards to improve patient safety and supply chain efficiency.