Wearables and Malpractice Risk: When to Worry

Debra A. Shute

October 22, 2019

The best way to assess potential liability, therefore, is to examine prior technologies. For instance, consider similar questions produced by physician-patient email, Szabo suggests. When does it create a physician-patient relationship requiring a duty of care? How frequently must it be reviewed? When is a follow-up response required?

Established rules around imaging provide an additional perspective, says Poterack. "A lot of this is not necessarily settled and we don't know what's going to happen," he notes. "But in general, you can use the paradigm that if you get an x-ray or another imaging study of a patient, and there's a concerning finding and you don't recognize it or don't follow up, and it later develops into a malignancy, you're very clearly at some risk of being held responsible for failure to diagnose," he says.

Poterack cautions physicians that they should assume they have some responsibility to follow up on concerning data points received through wearables. "The difference here is that these devices potentially provide a tremendous volume of data to sift through," he adds.

Medical-Grade Wearable and Implanted Devices

Before giving up on incorporating wearables into physician practices, there are many more factors to take into account, and they differ depending on the particular device. While the list of devices is vast, a good starting point is to differentiate medical-grade devices with FDA approval from consumer wearables. It also matters whether the tracking was initiated by the patient or "prescribed" by the physician.

The medical/prescribed device path is better charted. Typically, dedicated patient-monitoring programs rely on approved devices that accurately measure specific values related to a particular chronic disease, such as diabetes, congestive heart failure, or chronic obstructive pulmonary disease, according to Denny Brennan, executive director of the Massachusetts Health Data Consortium.

"That technology is refined," he says. "They're going to be used with particular cohorts who are asked to—instead of going through the hassle of coming to the office and getting their readings done on a regular basis—do them at home from these devices."

When these devices are used as part of such care management, malpractice risk may be supported or undermined by documentation present in the EHR, according to Ronald B. Sterling, MBA, CPA, COO of MRG Medical, a company involved with full-service remote patient monitoring solutions.

"A physician's office may receive remote patient monitoring information any time on any day," says Sterling. "Typically, the incoming information is analyzed to determine whether the patient requires a response from the organization. For example, a patient-specific setting could trigger an alert to the on-call staff in the event that the patient's weight increased, or the pulse is outside of the patient's prescribed pulse range."

Make Sure Your Team Is Ready

Capturing and following up on such critical data requires the right technology and staff. To ensure secure and reliable transmission of data, organizations such as Partners HealthCare use vendor platforms to integrate data transmission and warning systems into existing workflows.

In some cases, such as the organization's congestive heart failure program, not only are patients' wireless scales and blood-pressure cuffs connected to the system, but those data are monitored around the clock.

"Heart failure is a very brittle illness," notes Kvedar. "So it makes sense to have a call center where nurses look at that data all the livelong day. We have people who are in charge of these data. These programs are designed to avoid high-cost events, so it makes sense to catch things early," he says.

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