Data Standards and Platform Interoperability

This chapter examines the role of health data and interoperability standards, their harmonization and role within data platforms (in particular federated networks) internationally as we see more utilization of platforms to interact with Real-World Data (RWD) for Real-World Evidence (RWE) generation, from a regulatory science and Health Technology Assessment (HTA) perspective. An overview of the current fragmented and challenged environment is described as the foundation for proposing a vision of achieving large-scale interoperability in supporting technical, methodological and evidence generation, in particular based on emerging trends. The need for Findable, Accessible, Interoperable, and Reusable (FAIR) data, and the role data standards, in particular those emerging as leading with regards to regulatory decision, and emerging platforms for network, at-scale evidence generation, are summarized as a foundation to exploring unified visions for standards and platforms. Based on current knowledge, emerging trends, and the opportunity to create not only local but also regional and international platform initiatives, key considerations in architectures, technologies, fitness for purpose, and methods, to support key decisions in addressing at-scale use of RWD for RWE generation and data standards/platforms, and with considerations in ensuring interoperability of evidence generation, are explored. The chapter closes by citing recently published calls to action to accelerate the adoption of interoperability standards.