How Wearable Medical Devices Raise Issues for Healthcare Professionals

Providers need to familiarize themselves with all applicable laws and make sure their practices conform to applicable requirements.

Fremont, CA: Most Americans are fighting chronic diseases such as high blood pressure, diabetes, and heart disease, but advanced technologies are emerging to improve the treatment of these conditions. Now healthcare professionals suggest that patients wear a medical device to monitor their condition.

Such devices and the advanced apps that support them have proved to improve care by offering constant monitoring that could potentially save lives. Using these wearables may also decrease healthcare costs by eliminating the requirement for office visits that would otherwise be essential to monitor a patient’s progress. Wearable medical devices may give data that can help healthcare professionals better understand how a single patient’s multiple chronic conditions interact as well as support research efforts through anonymized data.

Wearable Technology and Cybersecurity

The collection of electronic health data from wearable technology requires compliance with federal and state privacy laws associated with notice and consent and also raises a risk that an internet-connected device can be vulnerable to cyberattacks.

The US Food and Drug Administration (FDA) is completely focused on this risk and has issued guidance for pre-market as well as post-market management of cybersecurity in medical devices. Device manufacturers are responsible for offering security updates to their software in order to address vulnerabilities, and when these updates do not affect device functionality or their intended use, the updates do not need FDA review. But where a cybersecurity vulnerability presents a risk of patient harm, the product can be recalled.

Wearable Technology and Data Privacy

Data privacy concerns are only increasing with time. A disparate assortment of federal and state laws inflicts requirements on the disclosure of, as well as the occasional use of, health information. Providers need to familiarize themselves with all applicable laws and make sure their practices conform to applicable requirements.

Privacy compliance obligations often require that physicians limit access to the streaming patient data to physician assistants, nurse practitioners, or other clinicians who are also providing care. Providers should also ensure that timely and accurate documentation is added to the patient’s electronic health record (EHR). Providers must explain to their patients what data are being collected and how they will be utilized before securing the patients’ informed consent.