Real-world data is increasingly informing regulatory (and coverage decisions), but its value depends on whether it is fit for its intended purpose.In this article, I share key takeaways from the 2026 Duke-Margolis Convening on the State of Real-World Evidence Policy held on Monday, with a focus on FDA developments and the evaluation of RWD for regulatory use.

Digital health technologies and electronic health records are revolutionizing the healthcare sector and the future of healthcare is undeniably digital.

Challenges still exist, but work is being done to solve them. As technology continues to evolve and improve, we can expect even greater advancements in digital health tools, EHRs, and the use and analysis of the data collected from both technologies. Healthcare providers and patients must work together to ensure that accurate data is being collected and used in ways that facilitate its use in identifying optimal healthcare, both for the patient and for the wider US population.

FDA released their updated and final guidance on Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making on July 25, 2024. The guidance does not endorse specific data sources, study methodologies, or standards. Instead, it provides insight into the FDA’s concerns and considerations so sponsors can address these when conducting studies using data from EHRs and medical claims.