Standards of Care for Smart Devices


by, Lexicon Legal

In recent years, smartwatches and wearable bio trackers have greatly expanded the information available to medical providers. These expanding technologies provide many exciting possibilities for clinicians – especially as healthcare is provided remotely more often in the era of COVID-19. The latest iteration of the Apple Watch, announced in late 2020, is largely focused on these particular issues. It features oxygen monitoring and tracks other health data in response to the specific medical problems that the coronavirus creates. While clinicians should embrace the possibilities of digital healthcare technologies, they must do so with caution. There are medical malpractice implications for clinicians who rely too heavily on unproven technologies. The Journal of the American Medical Association recently published an important opinion piece on this issue in which doctors and a lawyer raised important issues about medical malpractice and digital health technologies.



Digital technologies have created incredible opportunities for clinicians to gather more information than ever before. By wearing monitors that can wirelessly transmit data to a central location, patients are able to send their doctors biometric information at all times of the day and night. They are also able to provide information over long periods of time. This freedom gives providers far more information than they are able to gather in a single office visit. Some of these devices are even able to regulate medical treatment on their own without the intervention of a medical provider. “Smart pumps” are a combination monitoring and delivery device that greatly assists diabetic patients. The pump monitors the patient’s blood glucose, then administers insulin as needed based upon the results of its own testing. This allows for much better control of the diabetic condition, and in turn, results in better outcomes for the patient’s long-term health. The possibilities are vast – and they could make a great improvement to the quality of life for patients managing chronic health conditions. But the news is not all good for medical providers.



Unfortunately, these new digital technologies are not held to the same rigorous testing standards that the medical profession uses before adopting other technologies for widespread use. Wearable bio trackers and health apps do not require FDA approval. They are not subjected to peer-reviewed publication, and there is not even a significant body of clinical research about the accuracy of these programs. This means that clinicians must be careful about relying too heavily on this data. Digital health technologies have been known to create many false positives: for example, a recent development in the Apple Watch allows it to monitor for atrial fibrillation, but some healthy, asymptomatic wearers have received notices about arrhythmias and been warned to see a doctor about the health of their heart. This causes unnecessary stress and expense but generally does no long-term harm to the patient. However, bigger issues arise if a medical professional makes decisions that could endanger a patient’s life based on possibly inaccurate information.


During the coronavirus pandemic, many healthcare providers have relied on a patient’s own reports of oxygen saturation levels. This data might come from a portable oxygen monitor that was purchased from a reputable source. It could also come from the latest Apple Watch, which is also capable of monitoring a wearer’s blood oxygen saturation levels. This is a very new development that has been subjected to little – if any – validity testing. It is concerning to realize that this was the source of information for many clinicians making life-and-death decisions about hospitalization and respiratory support measures during a deadly global pandemic. There is little doubt that medical malpractice claims could arise from circumstances in which a medical provider places too much trust in information from an untested digital health device.



Whenever a new technology arises, it takes time for legal claims involving that technology to arrive in court. Wearable health devices and digital monitors are still quite new. Because of this, there is not yet a body of case law or clear answers involving the standard of care for clinicians who use these technologies. Legal practitioners who take on cases involving these issues must constantly monitor both the legal and medical journals for developments in this area. In the meantime, medical practitioners must use their common sense in using these technologies. The “reasonably prudent healthcare provider” standard still applies. While the reasonably prudent healthcare provider might rely on a portable oxygen monitor from a company that has manufactured the product for fifty years, it is less prudent to rely on information from a new app that was only released six months ago. It is even less prudent to make critical decisions – such as whether to hospitalize a coronavirus patient – based solely on this new, unproven technology. Consider the prudence of those decisions when relying on new digital health technologies. Would the healthcare provider be able to justify the clinical decisions to a panel of their colleagues? How would they support the decision at a morbidity and mortality conference? Could they stand their ground against an expert witness in court? These are just some of the considerations that can help them make healthcare decisions that are both reasonable and prudent.


Medical malpractice litigators face a wide variety of challenges on many fronts. They must stay up to date on developments in both medicine and law – and now technology, as well – in order to know about new clinical studies and new case law that could affect their case.


Guidepoint provides a wide array of services that can support your medical understanding of legal arguments with reliable data. Guidepoint can connect you with the right experts, data, and research that will help you make better arguments on behalf of your clients. Contact us today to learn about how our services support your practice.


Please note: This article contains the sole views and opinions of Lexicon Legal Content and does not reflect the views or opinions of Guidepoint Global, LLC (“Guidepoint”). Guidepoint is not a registered investment adviser and cannot transact business as an investment adviser or give investment advice. The information provided in this article is not intended to constitute investment advice, nor is it intended as an offer or solicitation of an offer or a recommendation to buy, hold or sell any security. Any use of this article without the express written consent of Guidepoint and Lexicon Legal Content is prohibited.


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