Moving from paper to electronic data is expected to have widespread patient safety benefits, but could the use of electronic health records actually heighten the liability risks clinicians and hospitals face? And does the existence of the technology change what is legally expected of physicians?
At least in the initial phase of implementation, the answer to both questions may be yes, according to Michelle Mello, JD, PhD, a professor of law and public health in the Harvard School of Public Health.
Mello is the author of more than 100 articles and book chapters on the medical malpractice system, medical errors and patient safety, research ethics, clinical ethics, and other topics. Speaking at the World Congress 3rd Annual Leadership Summit on Mobile Health in Cambridge, Mass., on July 28, she noted that as systems mature, there will be clear opportunities to avoid errors, but providers should recognize the potential for new kinds of errors to develop.
“There’s the potential for the failure of clinicians to use the technology consistently,” she said. “There may be bugs, defective applications and system crashes.” In the transition to an all-electronic environment, there can be documentation gaps in the interface between paper and electronic records.
Before courts have weighed in on new legal standards of care, newer modes of treatment may be problematic. For example, she said, the use of e-mail has the potential to improve communication between providers and patients and improve patient satisfaction. But the use of e-mail with patients may allow for arguments that clinicians are being less thorough. “Not seeing a patient in person might be considered negligent in some circumstances,” Mello said. Also, patients may develop expectations about what defines a reasonable response time to e-mail correspondence.
Clinical decision support (CDS) can transform and improve care and can catch errors before they harm patients. But Mello said a significant change in malpractice law could involve CDS features. Widespread use of CDS may establish new standards of care. The existence of EHR systems means there is more documentation of clinical decisions and activity and more discoverable evidence, including metadata such as time stamps. Departures from CDS guidelines could bolster a plaintiff’s case, she added.
“Systems document when providers choose to deviate from the algorithms in CDS, and the onus will be on clinicians to legally justify why they did,” Mello said. Several chief medical information officers in the audience expressed their concerns about this topic, and said they have struggled to determine which alerts have the most value in their system and which are just having an “information overload” effect on clinicians.
They noted that many organizations find the current generation of drug-drug interaction alerts excessive and unhelpful and end up turning them off. Could that open them up to liability concerns, they wondered.
Mello also noted that the law is as yet unclear in proportioning whether problems with EHRs arise from medical malpractice or product liability. “So when system vendors present you with contracts that immunize them from product liability, don’t sign them,” she said. “Let the facts of the case dictate who has liability.”
The larger question is: Does the existence of this technology change what is expected of physicians? Access to information may create legal duties to act on it, Mellow said. In the future, the failure to adopt EHR technologies may itself constitute a deviation from the standard of care. “You cannot live in an electronic dark age when access to this technology improves care,” she said. The technology may raise the bar on reasonable response time to a patient’s clinical developments.
The technology will no doubt have long-term impacts on the legal standards of care, Mello noted, and it should. “We want the law to respond to changes in clinical care and nudge providers along,” she said. The question is: Will the courts get it right?”