IOM Report on Patient Safety, HIT Use Recommends Greater Public/Private Oversight

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By Genevieve Douglas

Greater oversight of health information technologies—including electronic health records, secure patient portals, and health information exchanges—by the public and private sectors is needed to protect patients from potential medical errors associated with the use of IT, according to a report released Nov. 8 by the Institute of Medicine.

According to the report, Patient Safety and Health IT: Building Safer Systems for Better Care, the Department of Health and Human Services should establish a mechanism for technology vendors and users to report health IT-related deaths, injuries, or unsafe conditions. Reporting of these events would be mandatory for vendors and voluntary, confidential, and non-punitive for care providers, the report said.

HHS also should publish an action and surveillance plan over the next 12 months that includes a schedule for working with the private sector to assess the impact of health IT on patient safety and minimizing the risk of its implementation and use, the report said.

Additionally, Congress should establish an independent federal entity to investigate patient deaths, injuries, or potential unsafe conditions associated with health IT, the report said. Based on those investigations, the entity could make nonbinding recommendations, allowing flexibility for HHS, health care organizations, vendors, and other experts to determine the best course forward.

The Office of the National Coordinator for Health Information Technology asked IOM to evaluate safety concerns and to identify actions that both government and the private sector can take to alleviate those concerns.

The IOM appointed a study committee, which recommended ways to make patient care safer using health IT so the nation will be in a better position to realize the technology's potential benefits.

Other recommendations from the report included:

• the creation of a Health IT Safety Council, funded by HHS, to evaluate criteria and develop methods for assessing and monitoring safety and measuring impacts of health IT on safety;

• annual publication of reports by HHS on the progress of health IT safety beginning in 2012; and

• cross-disciplinary research toward the use of health IT as part of a technical infrastructure that ensures the privacy and safety of health data while promoting “meaningful use” of health IT.

IOM plans to hold a news briefing Nov. 10 on the report.

Existing Patient Safety Evidence Inconclusive

Overall, the IOM committee found the literature on the impact of health IT on patient safety to be inconclusive. Some health IT applications were definitively successful at improving medication safety, the report said.

For example, the number of patients who receive the correct medication in hospitals increases when hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems.

However, the report also found that poorly designed health IT systems could create new hazards in the already complex delivery of care, and the ability to generalize the results across the health care system were limited.

Specifically, some studies on electronic health records found improvements in patient safety, while other studies found no effect, according to the report.

The IOM committee recommended that if improved patient safety through use of health IT is not realized, the Food and Drug Administration should regulate EHRs, health information exchanges, and personal health records.

Industry Support for Patient Safety Efforts

The report is another step in the health care industry's efforts to address issues surrounding patient safety and health IT use.

Rep. Tom Marino (R-Pa.) introduced legislation Oct. 21 that would create a system for reporting errors that occur when using EHRs or HIEs. The Safeguarding Access for Every (SAFE) Medicare Patient Act (H.R. 3239) seeks to provide legal safe harbors to Medicare and Medicaid providers using certified electronic health records or other health information technology (see previous article).

“Passing Congressman Tom Marino's SAFE Medicare Patient Act (H.R. 3239) would be an appropriate response in light of the IOM's report,” Joel White, executive director of the Health IT Now Coalition, told BNA Nov. 8.

“It is the right step forward in encouraging the utilization of cutting-edge health information technologies that will benefit patients and consumers nationwide,” White said.

According to White, EHRs can dramatically reduce medical errors, but there have been adoption problems. The IOM report stresses the need for continued focus on health IT safety initiatives, he added.

The report is available for post-publication purchase and pre-publication download at .