Digital health is transforming nearly every aspect of our health care system, improving efficiency, expanding access to treatments and technologies, and ushering in increased development of personalized medicine. The transformation of health care during the COVID-19 pandemic has shed light on how these advancements are changing drug development, how care is delivered, and is allowing patients to be involved in managing and developing their care.

The application of digital health tools to biopharmaceutical research and development and the U.S. Food and Drug Administration-regulated lifecycle of a product, which we refer to as digital health R&D, is beginning  to positively disrupt biopharmaceutical development. Thanks to advancements in science and technology, the biopharmaceutical industry is leveraging digital R&D to improve drug development and deliver value to patients.

One of the foundational elements of a modern digital R&D regulatory framework is a common lexicon and understanding of key terms to orient stakeholders and facilitate conversations related to R&D tools and technologies. PhRMA emphasizes that defining these terms is intended only to facilitate engagement and conversations related to policy. In developing this lexicon, attention was paid to reviewing and incorporating existing terms, definitions, and lexicons where appropriate.

It does not suggest any divergent regulatory standard for digital health technology tools as compared to non-digital tools. This resource provides a list of key terms identified by the biopharmaceutical industry and suggested definitions.