Business Venturing in Regulated Markets-Taxonomy and Archetypes of Digital Health Business Models in the European Union: Mixed Methods Descriptive and Exploratory Study.

Background: Digital health technology (DHT) has the potential to revolutionize the health care industry by reducing costs and improving the quality of care in a sector that faces significant challenges. However, the health care industry is complex, involving numerous stakeholders, and subject to extensive regulation. Within the European Union, medical device regulations impose stringent requirements on various ventures.