Experts: Safety oversight needed as patient records go digital

Introduction

Though electronic health records may greatly improve medical care in the future, the technology poses a host of safety concerns that demand attention to protect patients from harm, witnesses told a government panel meeting in Washington on Thursday.

Safety issues are surfacing as the government tees up a plan to spend billions of dollars in stimulus money to help doctors and hospitals adopt the systems. Digitizing medicine is a high priority in the Obama administration’s campaign to reform health care.

Earlier this week, the U.S. Food and Drug Administration disclosed that potential safety risks from health information technology—including reports of six patient deaths and several dozen injuries in the past two years—have prompted it to lay out proposals for regulating the devices for the first time.

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, suggested that the agency is leaning against requiring government approval before a health information technology product goes on the market. The agency prefers a “lighter touch,” he said.

Under the stimulus law, doctors can receive up to $44,000 in extra Medicare payments if they purchase digital systems and take a number of steps to make “meaningful use” of them. Hospitals can receive millions of dollars from the same program. Draft regulations for dispensing the money were released in late December and payments could begin going to hospitals late this year.

David Blumenthal, the administration’s top health information technology official, said at Thursday’s hearing that ensuring the safety of the systems is “critical for our activities.”

Several witnesses, however, were skeptical that the government is paying enough attention so far. Ross Koppel, a sociology professor at the University of Pennsylvania and an expert on the safety of digital medical devices, said that he worried that the rush to collect stimulus money will lead many doctors and hospitals to purchase equipment with serious flaws—and be stuck with it.

“If a hospital buys a $70 million- to $100 million-system, and then spends five times that implementing it, they are wed to it for many years,” Koppel said. He said that the technology companies have little incentive to fix defects promptly once the sale is made.

Koppel said his research has found about 80 specific patient safety risks, from abnormal lab reports that appear normal to orders written by doctors for a patient that are “strangely transformed.” He blamed the technology industry for failing to quickly fix reported software bugs and advise doctors of them.

Electronic health records, or EHRs, can be widely adopted in the next ten years “if we are willing to apply systemic analysis of patient safety defects,” Koppel said. “Faith-based EHRs won’t get us into heaven.”

The goal to create a digital medical record for every American by 2014 was first set under President George W. Bush. But the Obama administration raised the stakes by pressing for billions of dollars in stimulus funding to accomplish that goal.

David Classen, a physician affiliated with the University of Utah, said that several studies suggested that benefits from health information technology “are not being achieved as expected and that it may take several years to achieve these benefits.” Safety is a concern, he said, citing one study that found “adverse drug events in more than 25 percent of patients in a hospital with a fully implemented” digital records system.

Dave deBronkart, a cancer survivor and patient advocate known as “e-PatientDave,” said that doctors and other users of the systems need to publish problems with the devices into a system that would “help us identify the best opportunities to improve safety.”

Shuren, the FDA official, offered three possible options for federal oversight. He said the agency could require makers of the devices to register them with the government and to submit reports on safety issues and correct problems that surface. The agency also could compel manufacturers to report safety concerns and set minimum guidelines to assure the quality of products. The most stringent option would be to subject them to broader regulatory oversight before the products are ever sold.

At the hearing, Shuren said that the agency has “concerns” about doing pre-market reviews of health information technology because these devices are often tailored at each facility in ways that could affect their safety.

With all the differences, “how do you assess that before it goes to market?” he said in an interview. “To try to figure it out in advance is probably not doable.” But Shuren said the agency wanted to hear the panel’s recommendations before making any formal decisions on regulation.

The manufacturers of the systems generally have opposed regulation by the FDA, arguing in part that imposing strict controls would slow down the government’s campaign to spur widespread adoption of the technology.

While manufacturers were represented on the panel, no single person spoke for the industry. But Carl Dvorak, executive vice president of Epic Systems Corporation, a Wisconsin-based company that builds the systems mainly for hospitals and large medical practices, wrote in prepared testimony that regulation will not necessarily create a “safer” electronic medical record “and might actually limit innovation and responsiveness when it is needed most.”

U.S. Sen. Charles E. Grassley of Iowa, the ranking Republican on the Senate Finance Committee, also has raised concerns about the safety of digital medical systems. He has asked a number of prestigious hospitals to report safety problems to him and criticized the lack of a national system for reporting “product errors or failure and adverse events associated with the use of such products.”

In a Feb. 24 letter to Department of Health and Human Services Secretary Kathleen Sebelius, Grassley added that he had been “surprised by the lack of discussion about patient safety concerns” when the devices are “not functioning properly, or when they are being used incorrectly.”

The letter asks Sebelius to respond to a series of questions, including whether the FDA has “sufficient authority” to regulate these products and who should be responsible for making sure manufacturers meet quality standards.