U.S. regulators work to agree on a patient safety plan to address concerns about potential EHR errors hurting patient care.
As the Obama administration attempts to modernize the healthcare sector by incentivizing a shift to electronic health records, some medical executives, physicians and researchers have been uneasy about distributing and sharing digital medical information.
While electronic health records (EHR) are expected to improve care by enabling doctors to easily access and share a patient’s history, they can also raise the risk of misdiagnosis or other errors that may threaten patient safety and expose physicians to liabilities, according to U.S. health experts.
There are few published statistics on EHR risks, as noted in a 2011 Institute of Medicine Report, but a report on patient safety published by the ECRI Institute found incomplete patient data, malfunctioning health IT systems, and incorrect information being entered in patient files are among the top problems that can lead to a series of medical errors, such as prescribing the wrong medication.
Recognizing that the understanding of EHR benefits and risks is largely anecdotal, the Office of the National Coordinator for Health Information Technology (ONC) in December proposed the Health IT Patient Safety Action & Surveillance Plan, which comprises a set of guidelines and actions for medical and health IT professionals. The plan is designed to eliminate medical errors, improve quality of care, protect patients and facilitate efficiency in the health care system. The ONC, part of the U.S. Department of Health and Human Services (HHS), called on U.S. experts to submit public comments on the plan in February.
In his comments on the plan, Dr. James Madara, chief executive and executive vice president and of the American Medical Association, sounded the alarm about digital records in outpatient health offices.
“Physicians are concerned about potential liabilities from EHR system design and software flaws as well as lack of interoperability among EHR systems that could result in incomplete or missing information, which may lead to errors in patient diagnosis and treatment (e.g. patient matching),” he said in the letter, calling on regulators to conduct additional research.
Madara’s comments echoed concerns expressed by the ONC in its plan about “new potentials for harm.” It cited as an example the risk that “poor user interface design or unclear information displays can contribute to clinicians ordering medications not appropriate for their patients’ condition.”
Before drafting the safety plan, the ONC asked the Institute of Medicine in 2011 to evaluate health IT safety concerns and create a list of actions to guide a blueprint of the plan. The institute made several sweeping recommendations, including the creation of a federal watchdog that would be charged with protecting U.S. patients from safety violations.
Instead, the safety plan proposes to hand regulator responsibilities to “existing federal authorities,” such as the ONC and the Agency for Healthcare Research and Quality (AHRQ), a unit of HHS that spearheads improving medication management via health IT.
The American Hospital Association, commenting on the plan, cautioned the ONC against stepping on AHRQ’s toes, thus duplicating safety efforts. “We encourage ONC to assume a coordinating role in this endeavor,” the association’s letter said.
Dr. Joseph Schneider, chair of the Texas Medical Association’s ad hoc committee on health IT, found it unsettling that the ONC used terms such as “should” or “can require” in the safety plan. Schneider said in a letter to the ONC it would be more appropriate to use authoritative language, such as “will,” when addressing standards and requirements.
“Significant patient safety risks exist now and new ones will emerge in the next one to two years as many EHR and other HIT vendors merge or go out of business,” Schneider wrote in the letter. “Therefore, it is imperative to set mandatory deadlines and have a robust reporting and leasing system in place now, not later.”
For the plan to be successful, Schneider recommended the appointment of a “highly-visible `HIT Safety Czar’ to oversee, coordinate and market health IT patient safety across multiple organizations, programs, developers and end-users.”
Despite medical experts raising several flags across ONC’s safety plan, holistically speaking, they welcomed the agency’s first crack at developing an approach to address patient safety in health IT.
ONC spokesman Peter Ashkenaz told HealthBiz Decoded the agency appreciates “the interest and input from everyone who responded. We expect the final safety plan will be issued very soon.”
If done right, digital records stand to improve medical care for U.S. consumers, but there are some obstacles to overcome first.