Principles for Enhancing Patient and Provider Access to Digital Health Technologies

We are in the midst of one of the greatest technological advances in history, with rapid, widespread adoption of digital technologies, including the use of Artificial Intelligence and Machine Learning (AI/ML), across industries. Continued advancements in the healthcare sector will depend on comprehensive reimbursement policy that supports adoption of innovative Food and Drug Administration (FDA)-regulated digital health technologies, which the FDA describes as technologies and devices using computing platforms, connectivity, software, and sensors for healthcare and related uses. Digital health technologies may include technologies intended for use as a medical device or product (e.g., Software as a Medicare Device), in a medical product, as companion diagnostics, or as an adjunct to other medical products.