PUBLISHED BY healthadvances.com
HEALTH ADVANCES – DIGITAL THERAPEUTIC ALLIANCE
GUIDANCE TO INDUSTRY:
Classification of Digital Health Technologies
PREFACE: PROJECT CONTEXT, OVERVIEW, AND METHODOLOGY
The digital transformation of healthcare is in full swing. With this rapid pace of innovation comes a complicated and overlapping array of digital technologies that is difficult for patients, clinicians, payers, and policymakers to differentiate, evaluate, and ultimately benefit from. As the leading international organization on digital therapeutic thought leadership and education, the Digital Therapeutics Alliance (DTA) has partnered with Health Advances, a life sciences strategy consulting firm, to assist in defining and classifying the full spectrum of digital health technologies (DHTs). By offering robust categorizations and precise definitions, this guidance aims to foster a unified and consistent understanding of the digital landscape for all stakeholders interacting with and hoping to benefit from digital products.
We performed comprehensive external benchmarking of how DHTs are currently defined and classified.
Our research was informed by the latest publications from regulatory bodies (e.g., the United States Food and Drug Administration (FDA), the United Kingdom’s National Institute for Consumer Education (NICE)), trade organizations (e.g., DTA, Digital Medicine Society (DiME)), analysts and investors (e.g., Rock Health), as well as the global landscape of innovative digital health companies crafting their own definitions and messaging (Figure A). By identifying key points of differentiation across DHTs, we revised the DTA’s classification framework to better reflect the landscape of DHTs today and one that better services where the industry is headed. We then pressure tested the revised classifications with US physicians, US commercial and government payers, and DTA member companies to arrive at this guidance for industry (Figure B).
Given the rapid development of digital products and pioneering companies in this space, we aim to consistently revisit and update this guidance to consider novel technologies and incorporate feedback from the broader healthcare industry.