By Ramesh Sachdeva, MD, PhD, JD

This article is for educational purposes only. It is not legal advice. Please discuss any legal issues related to your situation with your attorney.

The clinical practice of sleep medicine intersects with the field of law in several areas. This educational article provides an overview of the breath and scope of legal issues that can confront the sleep practitioner. Specifically, this article attempts to demystify legal terms for better understanding of the clinician.

Civil issues

These can typically involve contract-related claims, which may be relevant to sleep practitioners who have employees or manage sleep labs. Claims will generally involve some form of breach or issues related to non-compete provisions.

Negligence claims related to provision of medical care resulting in injury will involve Tort Law and include medical malpractice. For example, failure to diagnose obstructive sleep apnea (OSA) resulting in an injury could be the basis of a medical malpractice claim. Such claims require the plaintiff (injured party) to prove four elements: duty, breach, cause, and harm. The timeframe during which such claims can be started is based upon the statute of limitations, which can vary across states and depend on whether the patient is an adult or minor.

Another legal issue is vicarious liability. This relates to the concept of “respondeat superior,” which results in liability of an employer for actions of their employee if such actions are performed within the scope of their expected duties. For example, a sleep lab owner may be vicariously liable for negligent actions of their employees. An important aspect of such claims surrounds the foreseeability of the event.

Criminal issues

Criminal liability typically requires proving “actus reus” (act) and “mens rea” (mindset). The sleep practitioner may be required to evaluate and testify in cases involving parasomnias. This is important as parasomnias may be considered as a defense for criminal actions of physical or sexual assaults and homicide.

False Claims Act

This is part of health care fraud and abuse, which can also include cases related to Stark Law (self-referral) and anti-kickback laws. False Claims Act violations can relate to submitting fraudulent claims for reimbursement to CMS. There is case law, which can take a broad view of the scope of a fraudulent claim. In one example, the lack of certified sleep technicians performing diagnostic services was within the scope of a false claim as these sleep technicians were not appropriately certified or licensed.

Drowsy driving

There can be criminal liability related to drowsy driving in some states in the U.S. For example, New Jersey enacted Maggie’s Law, making it a criminal offence for drivers who are sleep deprived for over 24 hours and cause a fatal accident. This law has been in place for several years, and although the law has increased awareness of the risks of drowsy driving, there has been limited successful convictions because of difficulties in establishing the required element of sleep deprivation.

Artificial Intelligence

With the rapid growth of the field of artificial intelligence (AI) and its potential impact on the practice of sleep medicine, there are several new legal issues that are emerging in this area. Each of the areas of legal liability discussed in this article can be impacted by AI. At present, there are more questions than answers, with emerging new regulations and case law. The recent European Union AI Act represents the first comprehensive AI regulation in the world. The major considerations in case law surrounding AI for medical use surrounds how liability is assessed in cases of patient harm when the clinician used AI. Specifically, this surrounds the legal issue whether the case is evaluated using medical malpractice or product liability standards, which can have different outcomes. There are other issues related to data privacy, security, consent, and concerns of algorithmic bias that can impact practitioners and health care entities.

Role of the sleep practitioner

The sleep practitioner has three important roles. The first is to stay aware of the new developments in the legal field that can impact their clinical practice. This will be particularly important as AI applications are adopted in clinical settings. Second, sleep practitioners can provide an invaluable role by serving as experts in sleep-related legal cases. Third, sleep practitioners can influence future policies and regulations, which impact law, by participating in advocacy forums and national policymaking organizations such as the American Academy of Sleep Medicine.

Dr. Ramesh Sachdeva is a practicing pediatric critical care and sleep physician. He is currently the Anne O’M Wilson Professor of Critical Care and chief of critical care medicine at the Children’s Hospital Los Angeles. He is a clinical professor of pediatrics at the Keck School of Medicine of the University of Southern California. Dr. Sachdeva obtained a JD cum laude from the Marquette University Law School.

This article appeared in volume 11, issue 1 of Montage magazine.