FDA Does Not Regulate Telemedicine or Intends to
(Thursday, October 29, 2020]
As telemedicine and virtual care increasingly become the norm for most patient-doctor interactions, FDA does not have any rules or standards for it. FDA treats telemedicine as similar to videoconferencing or teleconferencing interactions between patients and their providers, and as such does not intend to regulate the tools used for telemedicine. On the positive side, this has led to an explosion of options to the consumers and healthcare providers whereby most common medical information can be generated and shared, and routine patient-doctor interactions can be done via video or audio links creating unprecedented convenience and efficiency. At the same time, due to lack of standards, the telemedicine and virtual care tools available to consumer-patients significant vary. The variability of tools limits telemedicine to mostly just being a videoconference facility. Telemedicine can be integrated with digital medicine tools to do a lot more such as providing diagnostic and even therapeutic applications. The same hands-off policy for communication tools used in healthcare extrapolates to mobile apps, connected devices, and health monitoring devices. Digital health tools have the ability to expedite affordable universal healthcare fueled by early detection and intervention for many common diseases, management of chronic diseases, and increasing general health monitoring. So far FDA has mostly focused on encouraging common sense protections for privacy and security such as cybersecurity measures that must be in place for any digital health tool. FDA has been increasing its profile in digital health over the years and now has a dedicated Digital Health Center for Excellence to consolidate resources but it needs to get directly involved with patient group to understand patient perspective and expectations from digital health and telemedicine. The developers too need to interact with FDA starting early in the development and continuing through validation and implementation of digital health products, even those that may not be explicated regulated but may help create a collaborative digital health ecosystem.