The strong expansion of new applications of digital technologies in healthcare – including, for example, artificial intelligence and machine learning algorithms, virtual and augmented reality solutions, digital therapies, remote patient monitoring systems, etc. – has prompted the US Food and Drug Administration (FDA) to set up a new Advisory Committee entirely dedicated to the topic of digital health. The Digital Health Advisory Committee, which is expected to become fully operational as of 2024, will be tasked with advising the agency on all aspects of digital technologies in healthcare in order to better understand the risks, benefits, and potential clinical outcomes from them.

The committee will be composed of people from different disciplines and backgrounds with the necessary technical and scientific expertise. The voting core of the committee will consist of nine members, who will be joined by temporary members selected for particular meetings depending on the topics discussed. Among the areas that could be touched by the activities of the newly formed Digital Health Advosory Committee are decentralised clinical trials, patient-generated health data and cybersecurity.