By
Caitlin Fairchild
//
January 30, 2012
Six former employees filed suit with the U.S. District Court for the District of Columbia against the Food and Drug Administration alleging the agency monitored their personal emails warning Congress that risky medical devices had been approved, The Washington Post has reported.
The scientists and doctors claimed the information gathered on them contributed to harassment and wrongful termination by FDA, the Post reported Sunday.
All six former employees worked in the office of device evaluation and beginning in 2007 brought concerns about FDA approval of potentially ineffective medical devices to Congress, the White House, and the Health and Human Services Department's inspector general.
FDA monitored their correspondence and twice asked the HHS inspector general to launch an investigation, stating doctors and scientists had improperly disclosed confidential business information about the devices, according to documents obtained through a Freedom of Information Act request filed by the former agency workers.
"We have obtained new information confirming the existence of information disclosures that undermine the integrity and mission of the FDA and, we believe, may be prohibited by law," Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, wrote in a document in June 2010.
The HHS IG ...
By
Aliya Sternstein
//
January 27, 2012
This story has been updated.
The first-ever U.S. chief technology officer, Aneesh Chopra, is leaving the government in early February, White House officials announced Friday.
"As the federal government's first chief technology officer, Aneesh Chopra did groundbreaking work to bring our government into the 21st century," President Obama said in a statement.
Chopra served as the White House's ambassador to the commercial technology sector, working to stimulate entrepreneurialism in areas such as health information technology, green IT and nanotechnology. He also collaborated with first-ever federal chief information officer Vivek Kundra, who departed last summer, on IT initiatives aimed at transforming government operations through proven, private sector innovations -- like mobile apps and prize contests.
"Aneesh found countless ways to engage the American people using technology, from electronic health records for veterans, to expanding access to broadband for rural communities, to modernizing government records," Obama stated. "His legacy of leadership and innovation will benefit Americans for years to come, and I thank him for his outstanding service."
Chopra had Obama's ear in his dual capacity as an assistant to the president and a Senate-confirmed associate director at the Office of Science and Technology Policy. He had been serving ...
By
Bob Brewin
//
January 25, 2012
The Military Health System identified Symantec's Veritas Storage Foundation storage software as the cause of a shutdown of the AHLTA clinical data repository, which stores 9.7 million electronic records for active-duty and retired military personnel and their families.
The Defense Information Systems Agency also acknowledged it played a key role when the AHLTA -- or Armed Forces Health Longitudinal Technology Application -- CDR shut down last week.
DISA manages the Military Health System's AHLTA Information System Enterprise, including the repository, which is hosted in a Montgomery, Ala.-based DISA computing center that agency spokeswoman Laura Williams did not identify in email communication with Nextgov.
MHS said it took the CDR offline for most of the business day Tuesday, Jan. 17 to correct a problem with an upgrade to storage service software that was loaded over the three-day Martin Luther King Jr. weekend.
An MHS spokesman subsequently identified the software as Veritas Storage Foundation sold by Symantec. Williams said DISA needed to upgrade the software "to address a vendor operating system limitation that prohibits the operating system from accessing large file systems. This upgrade is necessary to the CDR as it is being prepared for increased data input and future ...
As U.K. report praises U.S. veterans' home health monitoring, it begs the question why telehealth hasn't gained traction across U.S. healthcare system.
Read more.
By
Maggie Fox
//
January 20, 2012
Scientists working on a controversial project to create new forms of H5N1 bird flu agreed on Friday to stop their work for 60 days while the debate plays out.
"We recognize that we and the rest of the scientific community need to clearly explain the benefits of this important research and the measures taken to minimize its possible risks," they wrote in a letter published jointly by the journals Science and Nature.
"We propose to do so in an international forum in which the scientific community comes together to discuss and debate these issues," added the letter, signed by 39 scientists including Ron Fouchier of Erasmus Medical Center in Rotterdam, Adolfo Garcia-Sastre of the Mount Sinai School of Medicine in New York and Yoshihiro Kawaoka of the University of Wisconsin.
"To provide time for these discussions, we have agreed on a voluntary pause of 60 days on any research involving highly pathogenic avian influenza H5N1 viruses leading to the generation of viruses that are more transmissible in mammals," the letter said. "In addition, no experiments with live H5N1 or H5 HA reassortant viruses already shown to be transmissible in ferrets will be conducted during this time."
Late last year the ...
By
Bob Brewin
//
January 20, 2012
The Veterans Affairs Department will start to move data center operations that support its Veterans Health Information Systems and Technology Architecture (VistA) electronic health records to data centers operated by the Defense Information Systems Agency in March. Officials expect to complete the transition in slightly more than a year, VA Chief Information Officer Roger Baker told Nextgov.
Baker also said VA already has shifted data center operations that support the Veterans Benefits Management System and the post-9/11 GI Bill to commercial data centers operated by Terremark Worldwide, a subsidiary of Verizon Communications.
Baker said the transfer will not cause a cut in any VA jobs. Data center operation is not a core VA mission, he said.
Moving the VistA electronic health records to DISA data centers will help support development of a joint electronic health record for both departments, which will make it the largest in the world, serving 9.7 million active-duty personnel, retirees and their families, and 6 million veterans.
VA Secretary Eric Shinseki and then-Defense Secretary Robert Gates agreed in March 2011 to develop the joint health record.
Baker said each of VA's 152 hospitals will have one to six servers, depending on the size ...
By
Bob Brewin
//
January 19, 2012
Tom Grill/Getty Images
The Military Health System shut down the AHLTA clinical data repository -- which stores 9.7 million electronic records for active-duty and retired military personnel and their families -- after experiencing problems with a commercial software package that manages data storage, a top MHS official told Nextgov.
This shutdown, in turn, forced military clinicians to use the AHLTA -- or Armed Forces Health Longitudinal Technology Application -- electronic health record system in "local mode," without access to the main record database.
The AHLTA repository was taken offline at 8:26 a.m. EST on Tuesday and was restored at 6 p.m. the same day, according to Mary Ann Rockey, MHS program executive officer for Joint Medical Information Systems.
Rockey said the CDR was taken offline "in order to correct a problem with a version upgrade to storage services that was loaded over the weekend," which included Monday, the Martin Luther King federal holiday. She did not identify the commercial software package.
In her emailed statement, Rockey said the commercial storage software package was "part of a series of upgrades that will enhance AHLTA data storage speed and capacity of the CDR. Several software and hardware components have already been ...
By
Bob Brewin
//
January 6, 2012
Notable Solutions/Newscom
TRICARE contractor Science Applications International Corp. was hit with a second class action lawsuit filed in a California state court seeking unspecified monetary damages related to the theft of computer tapes containing the records of 4.9 million health care beneficiaries.
The latest suit seeks certification as a class action for all TRICARE beneficiaries in California whose personal identity and health care information were compromised by the theft of the tapes, which occurred in September 2011 in San Antonio. The suit was filed in December on behalf of retired Marine Col. Mark Losack in the Superior Court of California in San Diego by the law firms of Robbins Umeda LLP and Blood Hurst, & O'Reardon LLP.
The complaint says that while it is difficult to estimate the number of TRICARE beneficiaries in California whose personal information was stored on the stolen tapes, "the proposed class contains hundreds of thousands of members."
SAIC originally was sued over the data theft in a Texas state court last October in a class action suit, which sought $4.9 billion in damages on the behalf of one plaintiff. Richard Coffman, the Beaumont, Texas, attorney who filed that suit said he amended ...
By
Aliya Sternstein
//
January 5, 2012
Martina Kalaba/Newscom
This story has been updated.
The Food and Drug Administration is building a surveillance app for clinicians and regulators to monitor patients having bad reactions to experimental drugs administered during public health crises, agency officials said.
The so-called Real-Time Application for Portable Interactive Devices, or RAPID, will collect videos and images of patient reactions, such as skin lesions, as well as sound recordings of medical histories. And the app will be able to display geographic trends in effects by tracking the Global Positioning System locations of users. The system first will be tested on a small number of smartphone users and later tried out on tablet computers, including iPads, according to a notice posted Wednesday on the government buying website FedBizOpps.
FDA plans to contract with a software developer that can produce a fully operational prototype within one year and a strategy for fielding the app nationwide, the solicitation stated. The tool must be compatible with iPhones, Android-based phones and BlackBerry devices -- in that order of priority, according to the announcement.
There is not yet a timetable for hiring a company or for nationwide rollout. "It is still very early in the acquisition process," FDA spokeswoman Patricia ...
By
Joseph Marks
//
January 3, 2012
Around the time he took office as the nation's 28th president in 1913, Woodrow Wilson wrote that "government ought to be all outside and no inside."
That simple binary made sense 99 years ago. At the time, the results of government studies, executive orders and meeting notes were either available to the public or they weren't. The so-called outside, where government information met the public, was limited to a few key places such as the Government Printing Office and the National Archives.
With the birth of the Internet, the "outside" became effectively limitless, which has resulted in a new set of challenges. While the government is publishing more information than ever through about 18,000 websites, it's become increasingly difficult for agency information to reach the public.
Older federal sites weren't designed to work optimally with Google and other search engines, so Web searches today often list government data well below less authoritative, outdated or recycled sources. That doesn't mean that data is outside the public view, but it's not exactly catching the average citizen's eye, either.
The Energy Department, for instance, collects and publishes troves of information about fuel prices, alternative energy ...
