Innovation in healthcare is highly supply-driven, leading to underinvestment in less profitable health areas, unmet needs and inefficient use of public resources. This study proposes a framework to structure the identification of health-related patient and societal needs across different health conditions, supporting the evolution towards needs-driven healthcare policy and innovation. The Needs Examination, Evaluation and Dissemination (NEED) assessment framework was based on the results of two systematic literature reviews and stakeholder and expert consultation. The first review concerned patient needs criteria and the second concerned societal needs criteria. Relevant publications in Ovid Medline® or Embase®, in English, French or Dutch were included. The NEED framework addresses patient, societal, and future needs across health, healthcare, and social domains. Patient-level needs encompass five criteria in the health domain (e.g., impact on quality of life), four in the healthcare domain (e.g., burden of treatment) and four in the social domain (e.g., impact on social life). Societal needs encompass four health needs criteria (e.g., transmissibility), two healthcare needs criteria (e.g., value for money) and two social needs criteria (e.g., productivity losses). Future needs criteria (2) consider future burden of disease and economic burden. Equity is recognised as a transverse dimension, requiring unmet needs data disaggregated by population sub-groups. Each criterion is associated with one or more measurable indicators. This framework represents an important first step towards a more needs-driven healthcare policy and innovation landscape.