Push for safety oversight of electronic medical records is moving at a crawl

Introduction

Nearly two years after the Obama administration announced plans to spend $40 billion to help doctors and hospitals adopt electronic medical records, government officials are still grappling with how best to regulate these systems to assure patient safety. And a meeting this week made it clear firm rules are still many months away.

Although federal officials have acknowledged that electronic medical record systems can create new safety concerns, the administration appears content to let the Institute of Medicine (IOM), which it has contracted to study the topic, chart a path through the bureaucratic confusion “on what the federal agencies should do to maximize the safety of health information technology.” The nonprofit institute is part of the National Academies and conducts research on health topics.

The directive came Tuesday from the government’s top e-health czar, David Blumenthal, during the first public meeting of an IOM committee tasked by Blumenthal’s office to come up with recommendations on how to improve the safety of electronic health records.

Blumenthal asked members to issue their report by next September so that his office could use the material in drafting detailed rules for how and when the federal government will pay doctors and hospitals for using digital health systems to improve patient care.

The payments were pledged as part of the massive economic stimulus legislation passed a month after President Obama took office. The bill allocated approximately $40 billion — to be paid out over several years — to health care providers who convert to digital record systems and meet government benchmarks for demonstrating that the technology is improving patient care.

“We wouldn’t be proceeding if we didn’t think the electronic world was safer than the paper world,” said Blumenthal, who heads the Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology. “But we still have to be wary and attentive to our responsibilities that the implementation of this change is as safe as it could possibly be.”

During a daylong meeting earlier this week at Washington D.C. hotel, committee members — who range from doctors to patient safety specialists to information technology researchers — heard from a variety of experts both on how digital systems improve patient care, and what new safety problems can emerge from the new technology.

The digital transformation effort will “cut waste, eliminate red tape, and reduce the need to repeat expensive medical tests,” Obama said in announcing the initiative two years ago. “It just won’t save billions of dollars and thousands of jobs — it will save lives by reducing the deadly but preventable medical errors that pervade our health care system.”

Not everyone agreed. For instance, the Congressional Budget Office estimated in a May 2008 report that the government could end up spending more money investing in digital health records that it would ultimately save.

It was the Institute of Medicine that first pushed the idea of using electronic health records 10 years ago in its landmark study, To Err is Human, which highlighted these systems as a way to cut down on the tens of thousands of errors that unintentionally kill people each year in hospitals.

But saving dollars and lives won’t be easy, experts say, and many are divided on how best to oversee the process. Though some critics have raised questions about the privacy of electronic health systems, the IOM committee will only be looking at the potential safety benefits and drawbacks.

“We are right now balancing in the federal government the need to push rapidly forward with a new technology that the Institute of Medicine and other authorities have highlighted as critical to many, many healthcare purposes…against the need to be vigilant with their limitations and vigilant with the safety of particular technologies,” Blumenthal said. “Finding that balance is something very much on our mind.”

Supporters of greater oversight point out that most of the data demonstrating how electronic medical records can improve patient care have come from just a few large, sophisticated health care institutions, and even then, the gains in patient safety have sometimes been relatively modest, experts said at the meeting.

Industry officials say that more doctors and hospitals have begun purchasing systems since the stimulus legislation. But there’s a long way to go. A December report by the President’s Council of Advisors on Science and Technology found that “almost 80 percent of physicians — the majority in small, independent practices — lack even rudimentary digital records.”

Many who spoke at the IOM committee meeting urged the government to create standards, certification and testing requirements to ensure that the design of these systems focuses on patient safety. And, they asserted that better data on the problems of electronic health records is needed.

“There is a need for the basic science of safety of H.I.T. [health information technology],” said Peter Pronovost, medical director of the Center for Innovations in Quality Patient Care at Johns Hopkins University School of Medicine. “There is still a lot of basic knowledge we don’t have.”

But those efforts face opposition from industry officials. A representative of one of the biggest manufacturers, Sumit Rana of Epic Systems, told the panel not to create binding rules on system design “for fear of stifling innovation.”

Right now, the safety of electronic health record systems is not regulated and, no single source collects data on problems associated with their use, the Huffington Post reported in an earlier investigation. The probe documented pitfalls from these systems, such as a failure to alert hospital workers to a critically ill patient who had been moved to in their ward. The result: the patient suffered seizures for hours. In another example, hospital workers misread the computer screen and dispensed 10 times the prescribed dose of medication, causing the patient to suffer a heart attack.

The government requires that all systems eligible for reimbursement be certified by private groups of experts that are federally sanctioned, but those certifications do not address the safety of the systems.

The FDA, which considers electronic health records medical devices, has held off any regulation of the systems, despite nearly two decades of warnings about potential safety problems, according to an earlier probe by the Huffington Post Investigative Fund. And the FDA’s recent proposals for greater oversight have faced opposition from Blumenthal’s office.

Instead, a patchwork of organizations gathers mostly voluntary information, but much of it is not public. The largest collection the public can access comes from the FDA, which has received 370 reports of adverse events involving health information technology since January 2008, Jeffery Shuren, head of the agency’s Center for Devices and Radiological Health, told the committee.

A new patient safety organization backed by medical malpractice insurers, EHRevent system, recently launched to collect voluntary reports.

And the Department of Health and Human Services’ Agency for Healthcare Quality and Research is developing tests doctors can run on their systems to uncover design flaws.

But even if the data is collected, part of the challenge in identifying problems, said William Munier, director of the Center for Quality Improvement and Patient Safety at the Agency for Healthcare Quality and Research, is that the technology is often one of the factors, but not the only one that leads to a medical error.

Yet, some experts said, without more information it may be difficult for the government to demonstrate some of the health care improvements it is promising.

“The prevalence of these basic slips is very wide,” said Ben Shneiderman, who runs the Human-Computer Interaction Laboratory at the University of Maryland. “Until we have a more public data collection, we will not have quality.”