In South Florida and across the country, a growing number of physicians are using wearable medical devices to monitor chronic conditions. Today’s monitoring devices, along with their sophisticated applications, have a multitude of benefits, including providing constant care and reducing the cost and need for office visits. They can potentially save lives and assist with ensuring the delivery of cost-effective patient care. However, there are important legal considerations that physicians should understand when deploying this rapidly evolving technology.
One of the most important issues is data privacy. Various state and federal laws impose requirements on the disclosure and, occasionally, use of health information. Physicians should understand the applicable laws and address them. For example, they should adopt privacy policies and practices that protect the stream of data from a patient’s monitoring device and regularly ensure the safety of his or her network. That might also mean limiting access to the data to nurse practitioners, physician assistants or other clinicians and ensuring correct documentation is added to the patient’s electronic health record (EHR). Physicians should also explain to their patients what data is being collected and how it will be used, so patients can give informed consents.
Another area that physicians need to be cognizant of is state licensing regulations. For example, they may come into play if a physician is treating a patient in a state in which he or she is not located. In Florida, we see a lot of individuals who only reside in the state on a seasonal basis.
From the legal standpoint, one area we should see developing in the coming years is how devices will be used in medical malpractice cases. Areas that will be fleshed out include when a physician-patient relationship requiring a duty of care is created and what constitutes a breach of care when a physician decides to use or, conversely, not to use wearable medical devices.
Questions that will likely be addressed include whether the data was timely and accurately reviewed, was it timely addressed and who is responsible during each of these steps. The device itself may also be investigated. For example, one issue may be whether the device’s design or its software application is the reason why it recorded inaccurate data. Similarly, patients’ actions will need to be evaluated including, did the patient properly use the device or alert physicians to changes they were noticing. All of these issues may need to be sorted out in a court of law.
Physicians also need to stay apprised of product developments, including potential recalls or software updates. If a new version of a monitoring application is released, a procedure should be in place to update the patient’s device, either remotely or in the next office visit.
Likewise, if there is a recall of the device itself, physicians should immediately remove any equipment still in inventory and promptly notify their patients who are actively using the technology. While a manufacturer traditionally has a duty to warn consumers about a recall, it is the physician who has the strongest ongoing contact with affected patients.
In any case, physicians and other providers should have effective procedures in place to notify patients about any issues regarding their monitoring devices and applications. In the event of a problem, they should document the steps they have taken and be sure their recordkeeping will stand up in a court of law.
Although outside the scope of this article, two additional considerations are worth mentioning. First, providers should consider fraud and abuse laws as they enter into agreements regarding devices or referrals of patients for health care items or services, particularly if they are reimbursed by federal programs like Medicare or Medicaid.
Second, providers should be cognizant of consumer protection laws that prohibit deceptive and unfair business practices when explaining the devices and benefits to consumers.
Monitoring devices and applications are changing the practice of medicine and will continue to do so in the future. Therefore, it is essential for providers to understand the legal and regulatory issues associated with the deployment of this powerful technology.
Attorney Stephanie L. Carman assists healthcare and life science clients in transactional and litigation matters at Hogan Lovells LLP in Miami.