An HIT Moment with ... is a quick interview with someone we find interesting. Sharona Hoffman is professor of law and bioethics and co-director of the Law-Medicine Center at Case Western Reserve University School of Law in Cleveland, OH. She recently published an article, E-Health Hazards: Provider Liability and Electronic Health Record Systems in Berkeley Technology Law Journal with co-author Andy Podgurski, a CWRU professor of computer science who also contributed to the information below.
The article suggests that a hospital may expose itself to liability for physician acts, from which it is currently protected, by forcing doctors to follow its EHR-enforced practice guidelines. Should this be a significant concern?
This is a complicated legal question and I don’t think it should be of primary concern for hospitals. Whether a hospital is vicariously liable for the acts of physicians will depend upon the degree of control it has over them. Often, a hospital can prove that the physician is an independent contractor. In some circumstances, however, doctors are found to be employees and not independent contractors. The issuance of an EHR practice guideline alone, however, probably will not undercut the independent contractor defense.
Provider errors due to software usability issues have made headlines recently. The article suggests an option of requiring all EHRs to use a standard user interface. Given the competitive and proprietary nature of the EHR industry, is that likely or even advisable? Is there a precedent in other industries?
Major software platforms like Microsoft Windows and the Mac have user interface standards or guidelines that application vendors follow. An EHR interface standard should define an essential level of consistency between the UIs of different system. It shouldn’t require them to be identical.
How much liability do software vendors and hospitals have for programming errors and setup mistakes, respectively? Do you think those cases are coming up but being settled out of court such that the problem is understated?
Vendors would have primary responsibility in such cases. Vendors both design the software and help hospitals implement the systems and train employees. Hospitals would have liability if they tried to customize the system inappropriately on their own or did not engage experts to provide responsible training. They could also be held liable for mistakes that employees, rather than independent contractors, made with the system that caused patient harm.
The vast majority of cases that are filed in court do not produce a reported decision and many of these are settled, so you are right that it is difficult to know how many EHR cases have arisen.
In fact, regardless of litigation, a major problem is that there is no adverse event reporting requirement. If an EHR system has a problem, the vendor or user doesn’t have to report it to any regulatory agency. Nobody is keeping track of what kinds of problems are arising and how frequently. Therefore, EHR system purchasers can’t obtain information they need to make educated decisions.
The article concludes that the federal government should oversee and monitor EHRs in some way that goes beyond simple certification. Explain why that’s the case and who in the industry should advocate for government involvement.
EHR systems are much more than just record-keeping systems. They manage patient care in a lot of ways, and therefore, they are safety-critical. They provide doctors with prompts and alerts concerning patient allergies, other drugs patients are taking, and the patient’s medical history. They provide a mechanism by which doctors order diagnostic tests, medications, and other treatments. They will create the patient record and could be the way by which a physician communicates with other departments or with the patient herself.
If anything goes wrong with any of these functions because of software bugs, computer shutdowns, or user errors due to poor system design, this could be catastrophic for medical outcomes.
The FDA regulates drugs and devices. A responsible doctor would never think of implanting a pacemaker that is not FDA-approved, because a flawed device could kill the patient. We believe that EHR systems will be just as critical for patient welfare and therefore, they require an equal degree of government oversight.
Anyone who really cares about patients and medical outcomes should be advocating for government involvement.
As you looked at the EHR industry and EHR adoption by providers, what aspects concern you the most, both as an attorney and a patient?
EHR systems have the potential to improve patient care significantly. They can increase efficiency, provide doctors with essential information about the patient, and help doctors make optimal medical decisions. Most other industries are computerized, so it is certainly time for the medical profession to catch up. However, in implementing EHR systems, we must proceed cautiously and responsibly.
It is extremely important that the government establish appropriate approval and monitoring processes for EHR systems. These must include an adverse event reporting requirement.
We have heard from a lot of health care providers that the systems they have are difficult to navigate, reduce efficiency because they require too much time and data, and disrupt the relationship with the patient. Some doctors feel that they are overwhelmed by irrelevant or trivial electronic alerts and that they don’t have time to listen to and examine patients because they are too busy attending to the demands of the computer.
Therefore, we need regulatory standards and criteria that ensure that vendors minimize these problems. Once a practice purchases a system for millions of dollars and trains its staff, it will not be able switch to a different system that is better. It is only with appropriate oversight and quality-control that we can maximize the potential of this technology.