More than five years ago, one of California's leading hospitals decided to leap into the future of medical care by digitizing its patients' health records. Despite a $50 million investment and countless hours trying to overcome persistent technical headaches, the system is still not fully up and running.
This summer, the University of California San Francisco Medical Center quietly wrote off more than a third of the money it has spent, terminated its contractor and prepared to start part of the project from scratch.
"We're disappointed. A lot of people put in a lot of hard work," said Ken Jones, the medical center's interim chief operating officer.
The costly setback pointedly illustrates the challenges health professionals face trying to meet a government mandate to bring American medicine into the computer age.
Federal officials expect to spend as much as $45 billion in economic stimulus funds over the next ten years to encourage doctors and hospitals to buy electronic records systems. The aim is to improve health care, tame spending and minimize medical mistakes.
Though it enjoys wide-reaching political support in Washington, the drive has generated less enthusiasm in the medical trenches. Many doctors and technology analysts warn that electronic records systems now on the market may constitute a risky investment for taxpayers. Early reports from some American and European hospitals, they say, suggest that some technology may prove unreliable and could even pose safety problems for patients.
"Our basic position is that the current products cannot meet our quality, safety or efficiency needs," said Kendall Rogers, an internist at the University of New Mexico. He chairs an information technology task force for the Society of Hospital Medicine, a doctors' group whose members work primarily in hospitals.
No government agency regulates digital health systems or tracks how well they work. There is no central repository for reporting problems, though a relatively small number of voluntary reports to the Food and Drug Administration hint at the range of breakdowns faced by some hospitals and doctors.
Some technology analysts also have criticized provisions in some sales contracts that may prohibit buyers of digital records software from publicly disclosing any flaws.
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U.S. Sen. Charles E. Grassley (R-Iowa), ranking member of the Senate Finance Committee, is looking into complaints from patients, doctors and engineers "regarding difficulties they have encountered" with the systems. In a letter sent last month, Grassley directed 10 manufacturers to report service problems since January 2007 to the committee.
Through a spokeswoman, the health information technology industry's trade association said it would have no comment on Grassley's probe or other quality issues. However, a spokeswoman for Cerner Corporation, an industry leader, said the company welcomed the senator's review and was cooperating with it.
"We are pulling the data and nearly ready to submit it," said Cerner spokeswoman Kelli Christman. "I think it's a great idea they are looking at it, particularly when (taxpayers) are investing billions of dollars."
In the case of the University of California San Francisco, the hospital ended its contract with General Electric "based on overall delay in getting an integrated system in place and fully functional," a spokeswoman said.
Despite the problems, many at the hospital remain committed to the idea of electronic records. Glitches are worrisome but the products are "getting better as more people use them," said Robert M. Wachter, a professor of medicine and an expert on patient safety issues.
"We have to jump in," Wachter said, "and accept the fact that there will be a learning curve and work our way through it."
Many health policy experts agree that phasing out paper medical charts could revolutionize health care. They often note that digital record-keeping will help foil medical mistakes stemming from sloppy doctor handwriting on prescription pads and save money from tests and X-rays that must be repeated when paper records can't be located.
Beyond simply storing written medical findings, the software is expected to link doctors with hospitals and federal health data banks. Doctors would be able to send and receive medical test results online and automatically remind patients when it's time for a check-up. Most systems have built-in alerts and alarms to warn doctors of dangerous drug interactions and boast other safety features to assist them in caring for patients.
And proponents predict that the ability to mine electronic data from millions of patients will yield clues about which medical treatments work the best, spot adverse drug reactions more quickly and speed up detection of infectious disease outbreaks.
David Blumenthal, a physician and the federal government's top health information technology official, said that as part of the stimulus program his office plans to spend $693 million to, among other things, "provide technical assistance, guidance and information on best practices" to doctors and hospitals.
As part of the stimulus bill, Congress directed Blumenthal's Office of National Coordinator within the Department of Health and Human Services to set standards for handing out the federal subsidies. Doctors who meet the standards can receive up to $44,000 in stimulus payments, starting in the fall of 2010. Hospitals are eligible for millions of these dollars.
The Obama administration wants to store every American's medical data online within the next five years, a goal first set by President George W. Bush. Even with the incentives, the magnitude of the task is enormous - downloading millions of existing records from some 600,000 doctors and about 5,000 hospitals and engineering dozens of software products to interact.
Blumenthal conceded in an April New England Journal of Medicine article that "huge challenges" lie ahead and that many systems weren't "user-friendly" or designed to improve quality and efficiency.
In a written response to questions this month, Blumenthal said his unit is learning from past problems with electronic health records, often referred to as EHRs. He said that in many cases the systems "have a tremendous record of success." Blumenthal wrote: "The overwhelming majority of physicians who use EHRs are satisfied and believe the new technology makes them better doctors. Of course, no one is perfect."
Critics say federal officials should pay more attention to the troubles that emerged in countries that were early adopters. For instance, Great Britain's electronic records system has been "beset by poor product quality, delays and repeated changes to delivery schedules," according to a British government evaluation in October 2005. Bugs still plague some parts of the system.
British officials have singled out Cerner, a major subcontractor on parts of the National Health Service project, for criticism. A House of Commons report in January of this year found that the project was four years behind schedule and that progress to fix things had been "very disappointing." The report cited "considerable problems with the Cerner product."
Trustees of a 327-bed hospital in the seaside resort community of Weston-super-Mare in southwest England found "continuing problems" with Cerner's digital system in a September 2008 audit, calling it "difficult and overly complicated to use." The audit added that "training needs to be improved and users have little confidence in the information generated."
Cerner officials declined to comment about the British project for this article.
In Sweden, a country widely hailed for its progress in computerizing health records, a government panel last May issued a report linking computer malfunctions to "severe incidents" and even deaths. The panel favored stricter regulation of digital health systems.
Manufacturers in the United States have staved off formal regulation, telling the Food and Drug Administration in May 2008 that their products should be excluded from review partly as a means to speed up their adoption.
The industry went on to say that no deaths or injuries could be attributed to a software failure. But there is no way to know for sure, because unlike makers of medical devices, companies manufacturing health information technology systems are under no obligation to report injuries resulting from software malfunctions to the government--and only Cerner Corporation appears to be doing so voluntarily.
Among about four dozen voluntary filings about software malfunctions involving Cerner products is one sketchy report of a death said to be linked to the company's digital prescription software. Such reports are logged by the FDA's online reporting system and can be entered anonymously and with no identifying information. The record indicates that the report came in January from an unnamed physician. Cerner said the FDA has taken no action as a result.
The other reports, agency records show, range from mixing up patients or posting data to the wrong chart to confusing medication doses. The FDA reports indicate that a few of the malfunctions resulted in injuries, while the company said others that posed a significant risk were discovered before anyone was hurt.
• In December 2008, Cerner reported to the FDA that two patients had received too much medicine from pharmacies because the system failed to update changes in doses doctors had ordered. In one case, an elderly patient received too much of a blood thinner for six weeks. No injury resulted, according to the report.
• In June 2008, a pharmacist reported that three children's hospitals had identified similar problems with medication orders that rounded off small numbers, causing an error in dosage. The pharmacist said the hospital nearly gave a patient ten times the correct dose of insulin because of the defect.
• In June 2007, Cerner reported that messages stored to a patient's file would wipe out earlier ones. "Patient care could be adversely affected as clinical decisions could be based on incorrect information," the company stated. Cerner said it was working on a software update to correct the problem.
• In August 2007, Cerner reported its radiology system was mixing up patients, which the company stated "could potentially cause the radiologist to interpret images from one pt. and generate dictation on a different pt." The company said three reports were mixed up, but doctors caught the errors and no injury resulted.
• April 2006: A three-week-old lab system dropped the word "no" from herpes simplex virus test results. As a result two of five patients were told they had the virus when they did not. At least one person started taking antiviral crème treatment because of the error.
Cerner regulatory affairs director Shelley Looby said reports of injuries or defects are "extremely rare." She said the company voluntarily files about six or seven reports with the FDA each year.
"I think that our software is safe and effective. When we do find an issue we are upfront about it," Looby said, adding: "We want to make sure we do the right thing."
Sharona Hoffman, a Case Western Reserve University law professor and expert on legal risks posed by digital record storage, said rigorous pre-market testing and inspections are needed to wipe out many software bugs. In her view, manufacturers should be required to report any flaws to the government.
Computerizing health records "is a very significant development that could lead to a new era in medicine, if we do it right," Hoffman said.
University of Pennsylvania sociologist Koppel, a prominent researcher on the topic, agrees. He is critical of "non-disclosure" clauses inserted in sales contracts by some health technology firms, which oblige buyers to keep quiet about any problems that crop up. The companies also benefit from "hold harmless" clauses that may shift liability for errors caused by their systems to the doctors and hospitals that use them.
"That's critical," said Koppel. "It takes the onus away from the vendor. Even if there are thousands of complaints, the vendor is not responsible for repairing it."
Trying to Adapt
For the government, the hardest group to persuade may well be the doctors themselves. Their early experience with digitizing records has drawn mixed reviews. In late May, a health care analyst reported that one in five physicians in the Phoenix area who went digital ditched their systems after they turned out to cost more than expected, slowed them down, or were too tough to master and keep running.
The "simple act of writing a prescription can take five times as long on a computer as it does with pen and paper," wrote Chris Clancy, an analyst with the consulting firm HealthLeaders InterStudy.
Others argue that most doctors who have taken the plunge would never go back to pen and paper and that those who are reluctant will come around. Brad Tritle, who directs a group in Arizona that promotes electronic records, expects the tech industry to adapt smartly and quickly by upgrading its offerings. "There are some fantastic systems," Tritle said.
Yet the existing concerns are echoed in dozens of mostly negative postings to a blog recently set up by federal health officials to solicit comments about the digital records plan. Blumenthal said in his written response to questions that officials are "glad the blog is generating good feedback, that's what it was supposed to do." He also wrote: "We want to hear from doctors, hospital leaders, patients and anyone who has thoughts about this important program."
For his part, Koppel, the University of Pennsylvania sociologist, said he believes the stimulus spending is misplaced if it helps subsidize the purchase of systems that rely on years-old technology.
"I think that the money the administration has allocated should be used to figure out how to make more usable and more responsive software," he said.