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January 15, 2010

FDA furthers efforts on medical product safety tracking system
Continuing efforts to expand its medical product safety monitoring system, the Food and Drug Administration (FDA) has awarded a $72 million contract to Wellesley, MA-based Harvard Pilgrim Health Care Inc. (HPHC) to create a test version of the network. The pilot project will extend functionality of the FDA’s Sentinel System, allowing it to filter data into everyday, practice-level healthcare, according to FDA Commissioner Margaret A. Hamburg, M.D. Sentinel, in progress since 2008, is designed to provide FDA with the ability to analyze information collected during the course of routine healthcare, such as data from electronic health record systems, administrative and insurance claims databases, and medical registries. HPHC will build a scaled-down “mini-Sentinel” that identifies appropriate databases, develops a scientific framework for obtaining real-time data, and ensures data quality. http://www.fda.gov/NewsEvents/Newsroom/...

UCLA startup to begin wireless body monitoring system trials
Los Angeles-based MediSens Wireless, a startup company in UCLA’s California NanoSystems Institute, has obtained approval from the Food and Drug Administration to begin clinical trials on its wireless body-monitoring system. According to Dr. Jay Rindenau, M.D., chief medical officer at MediSens Wireless, the Clinical Movement Assessment System (CMAS) has a wide variety of medical applications, including rehabilitation, neurology, orthopedics, and physical therapy. It also has potential for in-home use to assess patient progress following neurotraumas and as a rehabilitative tool to expand the reach of telemedicine. MediSens plans to conduct a series of clinical trials to establish the viability of CMAS, involving community hospitals and public health facilities, as well as Ronald Reagan UCLA Medical Center. http://newsroom.ucla.edu/portal/ucla/...

Cerner gains early FDA approval for EHR data transfer tool
Kansas City, MO-based Cerner Corp. has received 510(k) premarket approval for its CareAware iBus connectivity software from the Food and Drug Administration, the company announced. According to Tom Herzog, Cerner’s vice president for information technology and healthcare devices, the clearance means the company can now market the product to connect medical devices to any electronic health record (EHR) systems for data transfer. Cerner created CareAware in response to an industry-wide problem in which medical devices are able to monitor patient vital signs, infuse medication, and perform other medical issues, but are usually not compatible with available EHR systems. CareAware allows bi-directional flow of information between the medical devices and EHRs, Herzog said. http://www.cerner.com/public/NewsReleases.asp?id=226&cid=10048

CTA offers grants for seniors’ remote patient monitoring programs
The Center for Technology and Aging (CTA) in Oakland, CA is offering up to six one-year grants, totaling $500,000, to organizations with remote health improvement programs for elderly adults. According to CTA Director David Lindeman, Ph.D., projects eligible for grants under the Remote Patient Monitoring Diffusion Grants Program must use already-proven technologies that are ready to be used more broadly. Grant applicants should have prior experience with remote patient monitoring technologies and must be able to demonstrate a positive and measurable impact in the near term. Letter of Intent deadline is March 12. Applicants will be notified by March 26 if selected to submit a full proposal. The anticipated start date for grant projects is July 1. Application information is available for download at www.techandaging.org/rpmgrant.pdf.  http://www.techandaging.org/grants_home.html

Teens regain hand function through virtual reality tele-rehab
Remotely monitored in-home virtual reality video games improved hand function and forearm bone health in teens with hemiplegic cerebral palsy, helping them perform activities of daily living such as eating, dressing, cooking, and other tasks for which two hands are needed, according to a study by researchers at Indiana University School of Medicine (IUSM) and Rutgers University Tele-Rehabilitation Institute. The findings suggest that such games could also benefit other persons with movement-hindering afflictions from strokes, arthritis, multiple sclerosis and orthopedic injuries, according to study lead author Dr. Meredith R. Golomb, associate professor of neurology at IUSM. Each participant was asked to exercise their affected hand 30 minutes per day, five days per week, using a specially fitted sensor glove linked to a remotely monitored video game console in their home. The study appears in the January issue of Archives of Physical Medicine and Rehabilitation. http://newsinfo.iu.edu/news/page/normal/13065.html

AMD Global launches updated telemedicine Web site
Telehealth technology supplier AMD Global Telemedicine Inc. in North Chelmsford, MA, has launched a new version of its corporate Web site. The updated site, at www.amdtelemedicine.com, includes full disclosure of AMD new product offerings, extended reach of all company programs and services, expanded content, improved graphic design and user interface, and overall increased visibility in the telemedicine industry, according to AMD President Steven Normandin. The new site “conveys AMD’s innovative, unique and knowledgeable position in the telemedicine market,” Normandin said. http://www.prweb.com/pdfdownload/3439914.pdf   http://www.amdtelemedicine.com/

EHR usage by office-based physicians doubles from 2001 to 2009
Almost 44 percent of office-based physicians used electronic health record (EHR) systems in 2009, more than double the total from eight years earlier, according to a survey by the Centers for Disease Control’s National Center for Health Statistics. Preliminary findings in the latest National Ambulatory Medical Care Survey note that 1 in 5 of those physicians with EHRs have systems with basic features such as clinical notes, laboratory results and prescription orders, while another 6 percent of users have fully functional EHR systems. Those models include features such as digital reminders, drug interaction alerts, and electronic order transmissions. The increased use of EHRs over the second half of the decade bodes well for the government’s attempt to have all Americans with an EHR by 2014, according to the survey.   http://www.cdc.gov/nchs/data/hestat/emr_ehr/emr_ehr.pdf

Scotland nears completion of national EHR program
The NHS national electronic health record (EHR) project is having its problems, but Scotland’s efforts are coming along steadily, according to the country’s Emergency Care Summary (ECS) board. ECS Chairperson Libby Morris said almost all of Scotland’s 5.2 million residents now have ECS records – the equivalent of an EHR – largely because of the extra care devoted to patient privacy. In contrast, England’s National Health Service (NHS) launched its National Programme for IT in 2002 but has struggled with budgetary and deadline issues. Critics are calling for the $20.5 billion [USD] project to be scrapped, but the government is instead scaling back the program by almost $1 billion and continuing the program. To date, only 1 million people in England, out of 51 million, have an EHR that can be accessed nationally. http://www.guardian.co.uk/society/2010/...

Biomedical research funding took drastic drop late in decade
With the exception of the American Recovery and Reinvestment Act (ARRA), funding for biomedical and related research in the United States slowed down from 2003 to 2008, according to a study by researchers at the University of Rochester, University Hospitals Case Medical Center in Cleveland, University of Buffalo, Johns Hopkins University, and Alerion Institute in North Garden, VA. The report notes that compared to substantial increases in research funding from 1994-2003, financial support dried up from 2003 to 2007, and appears to have decreased by 2 percent in 2008. “The 2007-2009 severe global recession has renewed focus on public spending and has caused companies and foundations to reexamine their priorities,” the study notes. “Researchers and sponsors are increasingly aware that financing is necessary, but not sufficient, to sustain progress.” The study was published in the Jan. 13 issue of The Journal of the American Medical Association. http://jama.ama-assn.org/cgi/content/full/303/2/137?home

CMS, ONC accepting public comment on ‘meaningful use’ matters
The public comment period is underway for the federal government’s newly proposed “meaningful use” regulations. In December, the Centers for Medicare and Medicaid Services released a long-awaited notice of proposed rulemaking on how healthcare providers can demonstrate meaningful use and quality for federal incentive payments. The Office of the National Coordinator for Health Information Technology has also published an interim final rule on EHR technology certification standards in the Federal Register. Public comment on both items will be accepted until March 15, with revised regulations and final rules issued during spring 2010. Comments may be submitted electronically at http://www.regulations.gov, in person, or by regular, express or overnight mail. http://edocket.access.gpo.gov/2010/pdf/E9-31217.pdf   http://edocket.access.gpo.gov/2010/pdf/E9-31216.pdf

U.S. may take cue from Denmark in national EHR creation
The United States is studying Denmark’s healthcare system to see whether its successes in electronic health record (EHR) deployment can be duplicated, according to a report in The New York Times. Considered to be the most efficient healthcare model in the world, Denmark is well ahead of the U.S. when it comes to implementation of a national EHR. Nearly all primary care physicians and half of all the small country’s hospitals use EHRs, compared to 17 percent of doctors and 10 percent of hospitals in the U.S. Part of the Danes’ success is attributed to the nation’s small size, homogenous population, and regulated healthcare system. Healthcare in Denmark is financed by taxes, and most services are free, according to national health information agency director Otto Larsen. In contrast, the United States must contend with 50 different state governments and various privacy laws, according to Harvard Medical School Chief Information Officer Dr. John D. Halamka. http://www.nytimes.com/2010/01/12/health/12denmark.html

Consumer hesitation puts brakes on health IT adoption
Failure of consumers to embrace health information technology and digital medical solutions is slowing the medical industry’s switch to electronic patient records, according to a report on MSNBC. David Cerino, general manager of the Consumer Health Solutions Group for Microsoft Corp., said consumers fear lapses of security in recordkeeping and too much concentration of personal information in too few hands. But too little consumer demand keeps manufacturers and administrators from justifying the cost of digitizing patient records, according to Deepak Ayyagari, director of technology programs at Sharp Laboratories of America. Still, nearly all clinicians and administrators agree that the industry needs to get digitized “first and foremost,” Qualcomm Inc. Senior Director of Market Development Clint McClellan said.  http://www.msnbc.msn.com/id/34646119/ns/...

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