We're familiar with the multitude of laws that dictate when and how to adopt and use electronic health records. There are 2,000 statutes and regulations related to electronic health information, according to Tara Ramanathan, a public health analyst with the Centers for Disease Control and Prevention, who spoke on a May 26 webinar sponsored by the American Bar Association Health Law Section.
But now we've begun to focus more on EHRs in the other legal venue: the courtroom.
The move was inevitable.
For years, people have been lamenting the "unintended consequences" of EHRs having an adverse effect on patient safety. So it makes sense that the patients suffering these consequences would start filing medical malpractice lawsuits against the providers using the EHR. The number of EHR-related malpractice problems has hit "critical mass," according to HL7's Reed Gelzer.
Unfortunately, both humans and computers are to blame for errors. There's not only sloppy copy-and-paste, failure to review automatic fill-ins and default templates, data entry errors and lack of training; there's also technology or system failures, design flaws and lack of relevant alerts.
But EHRs are having an impact in the courtroom beyond bearing witness or party to error. Evidently, electronic medical records are viewed differently from paper records, which has far reaching consequences in a lawsuit.
"Unlike paper records, where incomplete or illegible records are expected, with EHRs they're expected to be complete and immediately accessible and portable," explained attorney Rene Quashie, with Epstein Becker Green in the District of Columbia, who also spoke on the webinar.
Perhaps more significantly, EHRs are changing the nature of malpractice litigation. For instance, EHRs hold much more data than paper records. While that seems better, it creates more complexity and increases liability because it's easier to miss a small detail buried in the data; more access to clinical information could create new legal duties to act, such as to search patient information generated by others and available via a health information exchange, Quashie said.
EHRs may even change the "standard of care" required of providers. For instance, a physician who overrides an alert could be accused of deviating from the standard of care, even if the physician is acting appropriately and/or no harm occurred. Clinical decision support guidelines, despite being input into EHRs by computer programmers--not clinicians--could "solidify" the standard of care which otherwise might be subject to debate, Quashie warned.
"Failure to use an EHR may itself constitute a deviation from the standard of care," he said.
EHRs are great tools, and have already shown potential to improve patient health and safety. But they're new tools, and not unlike any new innovation, they take some getting used to and create some road bumps along the way.
EHRs not only are transforming how healthcare is performed, they're also on the cusp of reshaping the law surrounding that care. Are they the right changes? Or do we need to take a step back and reassess them?
For example, those in the weeds of the EHR-world know that EHRs can be manipulated so that the patient's records themselves are wrong. They may not even be sufficiently reliable to be used in court. So should they influence the standard of care?
The law is ever-evolving, albeit slowly, one statute and one court decision at a time. It also lags behind innovation, as Quashie pointed out. But there' a difference between lagging behind and changing direction. If that's the case, let's hope jurisprudence is choosing wisely. - Marla (@MarlaHirsch and @FierceHealthIT)