Digital technologies and analytic methods have the potential to transform healthcare and every aspect of the biomedical enterprise. However, effectively doing so requires reimagining approaches to data collection/ingestion, data flow, analysis and pragmatic execution. This meeting will address some of the fundamental challenges in applying these powerful tools to discovery, translation, innovation and care. The program will focus on the following challenges: (1) rigorous data collection and ingestion in biomedicine; (2) assessment, positioning and regulation of novel devices in the healthcare ecosystem; (3) creating the integrative infrastructure and convergent ecosystem necessary for the digital transformation of healthcare. This meeting will bring together individuals from diverse sectors of the biomedical enterprise and healthcare ecosystem, to collaboratively confront these challenges and derive workable and integrative solutions. These conversations will include perspectives from traditional healthcare providers, biomedical researchers, data scientists, device development (including wearables and domestic devices) companies, regulatory science representatives, payers, as well as those from retail, tech and other non-traditional industries. These multi-disciplinary discussions and approach will also be fostered by the joint meeting format with the “Drug Development in the Digital Age” meeting, featuring joint sessions such as “AI in Drug Discovery.” Ultimately, the goal of the meeting is to outline the intellectual, infrastructural and cultural underpinnings required to ensure a rigorous scientific basis for the successful implementation of digital paths to improve human health.