Electronic health record systems could give rise to increased liability for healthcare providers, according to professors from Case Western Reserve University.
“Risks to patient safety can arise from software bugs, computer shutdowns and user errors,” says Sharona Hoffman, professor of law and bioethics and co-director of Case Western Reserve's Law-Medicine Center, who along with her husband, Andy Podgurski, professor of computer science at the university's School of Engineering, wrote a comprehensive analysis of the liability risks associated with the use of EHRs. They recently published in the Berkeley Technology Law Journal.
“I don’t want to discourage providers from purchasing and using EHR systems,” says Hoffman. “Doctors make errors and face liability with paper records [as well]. The errors that arise from implementation of electronic records are just different, so providers need to be aware of them.”
"Whether or not there is a software bug, in the sense of a clear error that causes a wrong output, the usability of the system may be lacking, and that may lead a user to make mistakes that have safety implications," says Podgurski.
Medical mistakes that are associated with EHR system use can lead to litigation and liability, says Hoffman.
There is a mixed environment, at best, on the legal advise in how courts look at these cases, says Edward F. Shay, partner at Post and Schell, a health law and health information technology practice, in Philadelphia.
“Current case law tends to illustrate that in many instances, the standard of care does not require a physician to obtain or consult a patient’s prior medical records, whether in paper format or electronic,” Shay wrote in a 2005 paper on EHRs and liability.
The extent that EHRs will come up in malpractice litigation is going to be secondary, says Shay.
“They [EHRs] are not going to determine the standard of care. They might determine whether they adhered to the standard of care.”
Shay speculates that in nine cases out of 10 the cause of harm to the patient will be associated with something other than the technology.
“My general view is that in the law of medical malpractice the standard of care changes incrementally over a long period of time.”
“Ten years from now, I might say the standard of care in 15 states is that you have to use EHRs,” says Shay. But as for right now he says the evidence is not compelling enough for this to happen. “I can’t point to a single case now,” he says.
Hoffman and Podgurski’s article also draws attention to the issue that vendors are not required to disclose product flaws, with some contracts even prohibiting it.
At a minimum, federal regulations should require adverse event reporting when products have defects, Hoffman says.
“The unregulated free-for-all that has been the health IT marketplace, with dangerous and even outrageous practices I noted starting a decade ago, must come to an end as the market matures and as diffusion of this technology massively increases per the government mandates now in effect,” adds Scot Silverstein, MD, a senior Medical Informatics specialist at Drexel University, who blogs about failures in information technology.
“I would also hope that the government would have the power to require specific fixes if there is a serious problem and to impose fines or take other actions against vendors who engage in significant misconduct,” says Hoffman.
