Examining the Challenges for a Wearables Revolution in Healthcare

Wearable technology has the capacity to unlock broad, far-reaching possibilities in the healthcare industry. Wearables can help continuously collect invaluable, individualized real-world data to support innovation in care delivery and clinical research. Leveraging wearables to gather comprehensive physical and behavioral user metrics can help identify those at risk of disease, improve adherence to treatment regimens, and enhance the overall patient experience. Digital data can also be used to measure patient-centered endpoints in clinical trials and observational studies to determine the factors driving patient outcomes, enabling a true “digital transformation” in healthcare. Patient confidentiality can be a major concern when it comes to protecting the data of those using wearable devices. Collecting patient information that is not required by a provider or pharmaceutical company can have serious ethical implications. Industries need to prioritize implementing strong cybersecurity protections around their devices’ data, in compliance with HIPAA regulations, to protect users and the integrity of the information collected. Companies must also ensure that their wearable technologies have regulatory grade hardware. A recent article detailing regulatory aspects of smart devices for cardiac monitoring highlighted the safety and regulatory assessments conducted by entities like the U.S. Food and Drug Administration and the European CE Mark. The strict guidelines that wearable devices must meet to be disseminated in the market are important for the pharmaceutical industry to consider as they invest in durable, reliable hardware for their wearables. Leading organizations will have to expand their scope to include the latest innovations of smart wearables and their medical uses that meet the highest standards for safety and performance.