The Food and Drug Administration intends to consolidate the numerous individual and labor-intensive systems it uses to collect safety reports about drugs and medical devices.

Currently, the various centers that make up the FDA report safety issues in both electronic and paper formats. The new Web-based system well accept the reports electronically, then automatically perform some preliminary analysis before rerouting the reports to the appropriate recipient. The FDA says the new system should be in place in about two years.

Just a couple of years ago the FDA expected that the adoption of radio-frequency identification technology for prescription drug tracking would take off. Although a few pharmaceutical companies have instituted electronic track-and-trace technology, including RFID, for securing drug supply chains, the pace is too slow for the FDA. Industry-wide adoption was anticipated by 2007. 

Now the FDA and state lawmakers are putting on the pressure. In Florida, come July 1, pharmaceuticals shipped within that state will need to be tracked. The Florida law doesn't mandate the use of RFID or bar codes, however. Starting January 1, California will require that prescription drugs distributed within the state to be accompanied by an electronic pedigree.

The FDA's preferred tracking tool is RFID, but in its latest report the agency concedes that in the short term, hybrid pedigree systems incorporating paper and technology, either RFID or bar codes, might be the way to go.

At a healthcare symposium yesterday, Senator Hillary Rodham Clinton told the audience that making all medical records paperless would be one way to fix the healthcare system by reducing inefficiency, redundancy and medical mistakes.

The Democratic senator from New York was the keynote speaker and the moderator of the symposium sponsored by HSBC Bank and held at a country club on Long Island, NY.
 
Clinton said that Long Islanders, with their higher cost of living, pay higher health care costs than the national average. The average Long Island individual pays 11 percent more in premiums than others nationally, and families pay about 6 percent more, said Clinton.

The senator's prescription called for taking advantage of information technology and putting all medical records on computer systems that protect privacy and, at the same time, can be accessed by healthcare providers.

Thanks to a measure passed in last week's House Appropriations bill for the Department of Health and Human Services, research funded by public tax dollars will soon be available to the public.

Scientists funded by the National Institutes of Health will soon be required to submit copies of their peer-reviewed journal manuscripts to NIH's online archive, PubMed Central. Those manuscripts would be available to the public for free on the Web site within a year of publication. The NIH already has a 'public access' policy in effect that asks NIH-funded scientists to submit their manuscripts on a voluntary basis.

Some people think that the one-year 'embargo' on the release of the manuscripts is too long, delaying citizens' access to important medical information; they are lobbying for a six-month timeframe.

The fiscal 2007 Labor, HHS, Education appropriations bill still has yet to be considered by the full House. The Senate is expected to vote on its Labor, HHS, Education and Related Agencies Appropriations bill later this summer.

As one of several health initiatives in Kentucky, the state has launched a statewide electronic health records (EHR) program by creating a database of newborn babies. Once the record is created, health professionals will be able to update it on an ongoing basis throughout the babies' lives.

Kentucky has also begun an e-prescribing program whose aim is to avoid duplicate and conflicting prescriptions and reduce drug interactions. Governor Ernie Fletcher, a physician, speaking at a health IT conference last week, said that the state's population has been using prescription drugs at two or three times the national rate.

Fletcher also said that he wants to foster regional partnerships that can acquire health IT systems less expensively than if healthcare providers and hospitals purchased them on an individual basis.

Under a new Department of Veterans Affairs program, veterans with chronic health conditions can receive telemedicine health care services at home.

Thanks to technology, and the free program called Care Coordination Home Telehealth, veterans with landline telephone service can have telemonitors installed in their homes and can send medical reading through a computer or phone line to care coordinators at a remote facility. For now, veterans with only cell-phone service are ineligible, but VA official say that they expect that to change in the near future.

The program boasts over 5,000 enrolees nationally.

Insurance giant American International Group (A.I.G.) announced yesterday that computer equipment was stolen last March from one of its Midwest offices. The computer contained personal information on 930,000 people.

The information was from employees of companies seeking corporate health insurance As far as A.I.G. knows, none of the information had been put to use in any way to date.

The data had been on a computer server and protected by a password. It consisted of names and Social Security numbers and, in some cases, fragments of medical information. Names and SS numbers were sometimes linked together. A.I.G. had received the information from 690 insurance brokers seeking quotes for coverage on health insurance for employees of companies across the country.

An A.I.G. spokesperson said the company had a copy of the stolen information and has been trying since the break-in to connect the names with addresses so it could notify people that their data had been taken. Letters to the 930,000 will go out in the next week. A.I.G. will also open a phone center to respond to questions.

The Veterans Affairs Department has ignored warnings, and has weak management and lax rules, when it comes to safeguarding personal information on military personnel. That is according to testimony given to Congress by the Government Accountability Office and the VA inspector general.

Both the GAO and the VA's inspector general reviewed VA information security following the theft of 26.5 million military personnel's private data last month. Reportedly, that information remains at risk because of weak security controls that have not yet been fixed.

Investigators found that the VA routinely failed to control and monitor employee access to private information, did not restrict users to "need-to-know" data and often waited too long to terminate accounts when an employee quit or was fired.

They also said the VA does not maintain a clear chain of command when it comes to enforcing security, and stressed that the agency will need stronger leadership under VA Secretary Jim Nicholson to force reform after five years of repeated warnings about security.

The FDA's goal of introducing widespread use of tiny radio transmitters on prescription drug bottles to track shipments and thwart counterfeiters will not meet the anticipated 2007 target date.
 
Initially, when officials announced the plan in 2004, it was thought that widespread adoption was feasible by 2007. The agency has encouraged drug makers, wholesalers and distributors to implement electronic tracking systems with RFID technology, but has not made it a requirement.

FDA officials said they could not say when the technology would be prevalent across the prescription drug supply chain, but said they were taking steps to speed the adoption of RFID or other ways of tracing prescription drugs from drug manufacturer to wholesalers and pharmacies. By the end of the year, the agency will require wholesalers to provide a "pedigree" showing a record of the drug's movements along the supply chain.

Prescription drug counterfeits are rare, but seem to be growing in frequency and sophistication, according to the FDA. Fake versions of Viagra, Lipitor, and Procrit and other widely used medications have been uncovered in recent years.

Investment in innovative new treatments and IT systems is the prescription for treating the country's soaring health care costs. That is according to Senator Edward Kennedy who gave the keynote address at the Healthcare Information Management Systems Society (HIMSS) Summit last week in Washington D.C. The Summit was held in conjunction with National Health IT Week. 

Investment in IT will also help to increase efficiency and reduce medical errors, said Kennedy. The Democratic senator from Massachusetts stressed the importance of bipartisan legislation. While the Senate did pass the "Wired for Health Care Quality Act" six months ago, it is up to both sides to cooperate and work together find solutions. Areas cited by Kennedy as being particularly important to address in legislation are grant programs, establishing RHIOs and federal/state partnerships, providing for low interest loans, and developing best practice centers to help healthcare providers keep up-to-date.

Results of a new study show that when health care providers and healthcare insurance companies collaborate, rates of follow-up for women with breast cancer increase.

Researchers in Buffalo, New York have linked electronic medical records (EMR) between providers and insurers and have been able to identify nearly every woman who does not receive appropriate follow-up treatment. Additionally, they have set up a notification system to facilitate the follow up.

The EMRs of 17,329 women with Univera Healthcare were analyzed. Among the 1,206 women eligible for follow-up care, 16 percent did not receive the recommended biopsies or repeat diagnostic imaging within a recommended time frame.

The study findings were presented at the annual meeting of the American Society of Clinical Oncology in Atlanta.

The Department of Health and Human Services has allotted $1.2 billion to help states, U.S. territories and metropolitan areas to improve their ability to respond to bioterrorism attacks and other public health emergencies.

The money will be used to enhance infectious disease surveillance and investigation; expand public health labs and improve their electronic communications with hospitals and government health departments; and augment the preparedness of hospitals and the delivery systems to deal with large numbers of casualties.

The department has earmarked $5.4 million of the total funding to develop the Early Warning Infectious Disease Surveillance program for U.S. states bordering Canada and Mexico.

As a result of the recent theft of personal data on 26.5 million veterans, the Department of Veterans Affairs is now facing two class-action lawsuits.
 
The Vietnam Veterans of America (VVA) and four other veterans groups have filed a class-action lawsuit seeking $1,000 in damages for each veteran who can show that he or she has been harmed by the data theft. The National Gulf War Resource Center, Radiated Veterans of America, Citizen Soldier, and Veterans for Peace have joined VVA in this lawsuit.

Additionally, two other servicemen filed a class-action lawsuit U.S. District Court for the Eastern District of Kentucky. That suit also seeks $1,000 in damages for any veteran damaged by the data theft.

The VVA suit is asking the court to prevent the VA from altering any of its data storage systems until a court-appointed panel of experts determines how to prevent future security breaches.

According to a recently released report from The Center for Studying Health System Change, the proportion of doctors with access to information technology is up somewhat.

The center surveyed physicians about the use of IT in their practice for five specific clinical activities, each of which has been shown to improve patient care:

· Obtaining information about treatment alternatives or recommended guidelines
· Exchanging clinical data and images with other physicians
· Accessing patient notes, medication lists or problem lists
· Generating preventive treatment reminders for the physician's use
· Writing prescriptions

 Almost 21 percent of doctors interviewed in 2004-2005 said they had access to technology for the above-mentioned tasks, up from 11.4 percent in 2000-2001. However, nearly 17 percent didn't have any access to clinical information technology for any of the five activities, 20 percent only had it for one activity.

It has been shown that when physicians computerize tasks and adopt electronic medical records, they also cut down on errors and save money and time. But the same obstacles loom large: technology is expensive, no national standard has been established and altering office procedures takes time-and more money.

Computer data containing the personal information of about 17,000 beneficiaries enrolled in health care plans with Humana Inc. is not secure. That is according to Mark McClellan, administrator of the federal Centers for Medicare and Medicaid.

Citing a finding by the U.S. Health and Human Services (HHS) inspector general, CMS said that a computer file containing the data was not maintained in secure way. In a separate incident, applications containing personal information from about 250 people applying for Humana plans were stolen from an insurance agent's car in Minnesota last month.

McClellan said that steps were being taken to protect those older and disabled patients in the Humana incidents. Additionally, according to McClellan, Humana must contact  the affected beneficiaries and give them free access to credit monitoring services for one year, and also must submit a plan to make sure similar violations do not reoccur.