Wearables and Malpractice Risk: When to Worry

Debra A. Shute

October 22, 2019

But when it comes to less serious scenarios, such as at-home blood pressure or glucose monitoring, the objective isn't to catch an acute event, notes Poterack. "It's about maximizing and streamlining medication adherence and medication regimens," he says.

Patients and Doctors Need to Know What to Expect

In either situation, it's crucial to clearly communicate expectations with patients. "This is a nascent area, so I wouldn't want to imply that we've got all that [risk management] figured out," Kvedar says. "We feel like we're on solid footing when we enroll patients in our programs and make it very clear to them that these data are not to be viewed as going directly in front of the eyeballs of their doctor—and that if they feel sick, they should seek urgent care."

Kvedar acknowledges the fear that a patient will argue that it's the practice's responsibility to intervene when numbers are out of range. "There's always some risk that someone's going to feel that the practice didn't catch or act on a blood pressure reading of 180 systolic, and hold them accountable for that," he says. "I hasten to add that there is no case law showing that. It's purely a fear that is not backed up by lots of examples in the real world."

It can be very important to document that the risk has been explained to the patient and they have understood it and made an informed choice to go forward.

As an attorney, Szabo recommends that an agreement outlining expectations, roles, and responsibilities regarding wearables be placed in the patient's chart. "It can be very important to document that the risk has been explained to the patient and they have understood it and made an informed choice to go forward."

With plenty of experience writing terms of use for patient portals, Szabo notes that the first provision is that if someone thinks he or she is having a medical emergency, they should dial 911.

Consumer-Grade Wearables

On the other hand, consumer-grade wearables and devices are outside of a healthcare organization's control, notes Poterack. "We don't do quality checks on them or see how they're working. We don't maintain them," he says. "In many cases, we may not easily be able to know what the algorithm is behind it or what exactly the data mean."

These unknowns don't necessarily mean that data from such devices can't be useful to informing care, but again, expectations should be made explicit, Poterack says.

For now, it may be wise for physicians to encourage patients to use their device as a motivational tool or for better discussions with their doctor, but refrain from collecting the data, Poterack says.

Brennan agrees, noting that the technology is further along than the healthcare system. "The business isn't ready, the regulators aren't ready, and the underlying business model for the companies involved is not prepared to switch from a consumer retail-based approach to one that's more industrial, where they have to sign off," he says. "I'm sure someone will try early, and they'll [probably] get sued. There are so many risks that need to be nailed down," Brennan says.

He also warns of indirect malpractice risks from compounding physicians' workload. "Doctors are having a terrible time," Brennan says, adding that many physicians already spend an extraordinary amount of time outside of clinical care updating the EHR. "The idea of opening the EHR to capture a whole new flood of data—even if you are covered legally—creates more work than it's worth, as far as the physicians see it."

Embrace Cautious Optimism

Physicians shouldn't let the potential for problems hold them back too much, according to Szabo. "Unfortunately, the practice of medicine is a risk-rich environment. There are all kinds of things done for very good reasons that have a certain amount of risk you're not going to get away from," he says.

For example, there's plenty of evidence to show that a diagnostic colonoscopy can save a person's life, but there remains a risk that a person who undergoes the procedure could suffer a perforated colon. "That doesn't mean you'd say we'll never do another colonoscopy. The answer is that we're going to be really careful when we do," Szabo says.

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