Identifying Gaps and Establishing a Development Plan for Consensus Real-World Data Standards

PURPOSE: Standards provide technical specifications which are voluntarily used to demonstrate that products, services, or processes meet a certain level of quality, safety, and/or reliability. While international standards organizations exist (e.g., European Committee for Standardization, US National Institute of Standards and Technology), standards are often developed by stakeholders who need to utilize them.Within HEOR, studies using real-world data (RWD) such as healthcare claims, electronic health records (EHR), registries, device-derived data, or other patient-generated data may be subject to healthcare interoperability standards, regulatory or payer study data submissions standards, as well as standards for data semantics, syntax, transport, security, and services. Development of validated algorithms in claims/EHR, performance measures using wearables, and prediction using artificial intelligence/machine learning (AI/ML) provide examples with nuanced considerations. While the needs may change based on the overarching purpose of the study, a basic set of consensus standards for all RWD used for HEOR is imperative to establish the viability, credibility, and acceptance of these data for increased use in healthcare research and decision making. DESCRIPTION: This panel will introduce types of data standards used across fields and highlight those already available for RWD. The discussion leaders will introduce known gaps in the data standards for RWD and solicit additional information about gaps from the audience. Through polling, participants will identify and prioritize the most pressing needs for developing consensus data standards for RWD. Three examples (claims/EHR, wearables, AI/ML) will be used to illustrate key nuances to consider for standards development. Group brainstorming of potential tactics, stakeholders to engage, and decision-makers to consider will be followed by solicitation of interest in participating in RWD standards development.