'Do No Harm' Applies to Medical Software, Says IOM

November 11, 2011

November 11, 2011 — In 1999, the Institute of Medicine (IOM) raised healthcare's consciousness about medical mistakes and patient safety with its landmark study titled "To Err Is Human."

Twelve years later, the IOM is putting out another message: All-too-human clinicians are committing medical errors with the help of computer software, a serious problem that could warrant regulation by the US Food and Drug Administration (FDA) if matters do not improve. In a new report issued yesterday and sponsored by the Department of Health and Human Services (HHS), the IOM urged both government and the private sector to exercise greater oversight over health information technology that has the capacity not only to save lives but also to endanger them.

And high-tech hazards invariably have a human context, according to the IOM. A hard-to-use electronic form for ordering medications can lead to mistakes, and to overdosing. Incessant warnings about possible drug interactions can induce "alert fatigue" in prescribers, who then ignore important as well as inconsequential ones. Hospital nurses may scan bar codes for medications and patient identification without using their own eyeballs to confirm that the patient is taking the right pill.

The IOM is not the first to sound such alarms. A study published in the Journal of the American Medical Informatics Association this past summer, for example, reported that the error rate for electronic prescriptions matches that for paper scripts — about 1 in 10.

The IOM is not recommending, at least for now, that the FDA regulate medical software, noting that the agency's approach toward drugs and medical devices might not translate well in terms of vetting software apps. Nevertheless, HHS should put the FDA in charge of this realm in case other efforts do not bring about enough progress in terms of safety and reliability, according to the IOM. And the agency should create the needed regulatory framework ahead of time.

Physicians Discouraged From Sharing Software Problems

How much of a safety risk is posed by health information technology remains a mystery, the IOM report states. Hard evidence is lacking, partly because software vendors "discourage the free exchange of safety-related information in their contracts with healthcare providers." Nondisclosure clauses can make a physician think twice about sharing a screen shot of an error-prone electronic health record (EHR) template with a colleague who uses a different system. Hold-harmless clauses that make customers (and not the vendor) liable for any adverse events associated with use of the software have a similar chilling effect, according to the IOM.

"They may fear that disclosing unsafe features may unfairly increase their risk of liability," write the report authors.

The IOM urges HHS to lean on vendors to lift the lid of secrecy. HHS, for example, could publish a list of firms proffering contracts that explicitly allow the free exchange of patient-safety information and those firms that do not. Physicians, hospitals, and other providers in the market for the technology could choose accordingly.

Vendors also should be required to report all adverse events related to their products, the IOM recommends. A different standard would apply to product users. Any reporting of safety issues on their part should be voluntary, confidential, and nonpunitive. And it should be easy, too. The IOM suggests that EHR systems come with an embedded screen button that would permit a 1-click report of "harms and hazards" associated with health information technology.

The IOM said that the network of regional Patient Safety Organizations authorized under federal law is probably the best candidate for collecting both mandatory and voluntary reports of safety issues. The job of aggregating, analyzing, and investigating these reports, however, would fall to a new, independent federal agency. This entity would lack enforcement powers, such as the ability to pull an EHR product off the market, according to the IOM. However, it could provide feedback to vendors, share its findings with the public, and recommend corrective action to HHS.

The IOM ruled out existing federal agencies such as the FDA for this job. It noted that giving the FDA investigative responsibilities "would be at odds with its oversight function." Plus, the agency lacks the necessary funding and expertise to fill this role adequately, the IOM said.

"We Should Not Be Complacent"

The IOM report drew qualified praise from the Healthcare Information and Management Systems Society (HIMSS), the nation's largest trade organization for professionals and vendors in that field.

"HIMSS...agrees with the IOM that we should not be complacent; there are ways to make health information technology even safer and better for healthcare providers and the patients they serve," said HIMSS president and CEO H. Stephen Lieber in a press release. Lieber noted that his group has proposed a number of remedies that line up with IOM recommendations. One example is funding research into EHR usability.

"Intuitive and easy-to-use systems," he said, "increase the likelihood of the right decisions being made at the right time for the right patient."

However, Lieber also drew attention to the IOM's longstanding warnings about the risks of old-fashioned paper charts. "The paper-based health system kills," he said.

An unvarnished view of the industry's response to the IOM safety recommendations comes from healthcare IT consultant and HIMSS member Mark Anderson.

"None of the vendors like any of this," said Anderson, president of AC Group in Montgomery, Texas, in an interview with Medscape Medical News. In particular, medical software companies dislike the idea of removing hold-harmless clauses from contracts and becoming exposed to lawsuits about software-related mishaps.

Anderson is the coauthor of a recent study warning that EHRs could increase the odds of their physician-users being sued for malpractice. The report blames some of the problem on faulty design — lab results get recorded in an EHR, yet the system does not automatically alert physicians to them when they prescribe a medication that might be contraindicated by an abnormal value. Likewise, too much data on an EHR screen can make it hard to find what is actionable, according to Anderson.

Like the IOM, Anderson recommends that government, healthcare providers, and software vendors work harder to prevent tech-related errors.

"It could be a big problem if plaintiffs' attorneys find out about this stuff," he said.

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