Your Patient's Smartwatch Could Be a Legal Time Bomb

Medscape

3 days ago

A few years ago, a patient in her 30s saw Nicholas Dragolea, MBBS, a general practitioner when her Apple Watch showed an irregular heart rhythm. She had no family history of heart disease or any related symptoms, such as breathlessness, palpitations, lightheadedness, heart racing, or chest pain, Dragolea said. He ordered a Holter monitor and confirmed that the patient had paroxysmal atrial fibrillation. He started her on weight control treatment and anticoagulants. 'It's important because if you don't diagnose and treat it [PAF] early, it increases the risk of stroke, and the patient can become more symptomatic later on,' he told Medscape Medical News.
As patients buy and use more wearable devices, doctors are increasingly being presented with data from their patients asking for medical opinions. It's an extension of Dr Google, when patients come to their physicians after having read about a medical condition online. How doctors react (or not) to their patient's wearable data and their legal liability in doing so has implications for both doctor and patient.
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Medscape continually surveys physicians and other medical professionals about key practice challenges and current issues, creating high-impact analyses. For example, a Physicians and Malpractice Report 2024 found that Two out of three physicians worry about malpractice exposure occasionally.
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Growing Use of Wearables
A December 2024 survey from The Ohio State University Wexner Medical Center, Columbus, Ohio, found that about two thirds of Americans regularly use wearable devices to monitor their heart, including smartwatches, portable blood pressure machines, fitness apps, and wearable movement/fitness trackers. The study found that only one quarter of these users, however, currently share their data with their physician.
For physicians without protocols for handling the data, this may be a relief. A 2024 ZS Future of Health Report showed that 71% of US physicians surveyed were overwhelmed by the amount of data available to them, a potential barrier to adopting connected health systems. The same percentage said they don't know what to do with the onslaught of that data.
How to Assess Patients' Wearables Data
When a patient shares concerning wearables data, the physician should prioritize the history and examination, said Dragolea, also following any national guidelines. Sharing guidelines can help calm a patient's nerves as well, if the doctor does conduct follow-up testing.
Dragolea would ask patients about their family history, symptoms, how they felt when the wearables data were recorded, what the patient's concern is, and any expectations they have in handling it. 'Nowadays, they will likely have done research about what it means,' he said. He doesn't recommend overinvestigating an issue that's less concerning. But if doing nothing will make the patient anxious, that's not good either — because they'll likely just make an appointment with another doctor.
It's also important to assess the data source. Someone with a wearable that showed low oxygen readings may just need education that the devices can give erroneous readings if moved the wrong way or if the patient was sweaty when the reading occurred.
Dragolea sometimes explains to patients that the devices are mostly for wellness and are not approved medical devices. 'The data is not always accurate, and it is not always data we can act on to instruct us in any particular problem or diagnosis,' Dragolea said.
Some devices have FDA medical clearance, and others do not. Dragolea takes heart data from an Apple Watch more seriously than devices without this regulatory approval, he said.
If a doctor has not heard of the patient's device, they can quickly search online to see if it has FDA clearance or if there are clinical studies citing methodology backing up the outcomes, said Bethany Corbin, a healthcare innovation attorney at Corbin Legal. 'It can take 1 or 2 minutes to type in the device name plus 'clinical trial' to see if it's vetted from a clinical perspective,' she said. If it's not, that doesn't mean it's inaccurate, but doctors should take the readings with a different grain of salt, she added.
William Haas, MD, who specializes in wellness and integrative medicine, uses wearable data more frequently than many practices. 'From the lens of the average practitioner, a lot has to do with the alerts alongside the symptoms,' he said. 'Then I decide if I need to pursue proper medical testing to evaluate it further.'
When talking to patients about wearables, Haas tells them, 'They're not diagnostics, but they're excellent early warning signs.' If a device shows low oxygen saturation at night, it could be sleep apnea. He then asks the patient if their partner says they snore or if the partner notices the patient having periods during sleep when they're not breathing. He asks if they wake up tired in the morning. For cardiac issues, 'we try to match up data like an elevated heart rate, lightheadedness, and dizziness — targeted symptoms to match up to data points.'
Haas gives less credence to devices' proprietary health indices. 'They may come up with a recovery index based on heart rate variability, but I'd be more apt to look at actual heart rate variation,' he said.
In addition to smartwatches and rings, there are wearables like glucose and blood pressure monitors. And there's overlap with patient-submitted data, which can also be instructive. Corbin shared the story of a woman who brought her phone-based period tracking app data to her provider. The data showed cycle irregularity including breakthrough bleeding. The provider performed a physical exam and said the patient was fine, suggesting stress as a cause. The woman went to a different provider who followed the patient for a few months, ordering a Pap smear, which was positive for cervical cancer.
Proactive Tracking
A lot of doctors are hesitant to recommend wearable technologies, as they haven't vetted them and don't know what's most accurate, said Corbin. 'Patients and consumers know more about devices than doctors do,' she added. There can be practice liability if it's not set up to collect and track wearables data in the electronic health record, if they're not consistently monitoring incoming data, and there's no feedback loop. 'I don't see doctors embracing digital health tools,' she said. 'There's more liability in not monitoring versus not using them.'
Haas does incorporate wearables in his practice, which focuses on wellness. 'In my practice I almost never make a recommendation to my patients that I don't use myself,' he said, as he wants to know how the device works and what potentially can be tracked.
He also uses a platform [Headsuphealth] to aggregate smart data, lab testing, and self-reported questionnaires. It shares trends over time for individual patients and groups of patients. 'It gives me more context on how to interpret some smart device data to match up to lab testing and to look for correlations.'
Legal Liability
Haas noted that 'you're not legally required to act on every bit of data,' but there are legal risks if a doctor ignores a patient's symptoms alongside wearable alerts without proper documentation.
It's an issue worth following, as more patients will report wearables data to doctors in the future, said Dragolea. 'I believe the numbers will increase as more people get wearables, rings, watches, and earrings as well.' This will require a lot more conversations with patients about the data quality and maybe more help from regulators on what to do in these cases, he said.