Ep 151 [02 October 2024]: Doug Fridsma MD PhD, Chief Medical Informatics Officer (CMIO) at Health Universe – Former CMIO at Datavant, Former President and CEO at the American Medical Informatics Association (AMIA), and Former Chief Science Officer at the Office of the National Coordinator for Health IT (ONC/HHS) – We discussed regulatory changes in the EHR decision support arena. He provided an overview policy changes and delve into the relevance of these changes for the RWD/RWE market, specifically focusing on the new ONC, 45 CFR § 170.315(b)(11) Decision Support Interventions (DSI) Criterion, a set of updated rules for health IT systems that go into effect by January 1, 2025. These changes aim to make health IT systems more interactive and data-driven, ultimately helping healthcare providers and researchers alike. https://www.healthit.gov/test-method/decision-support-interventions ONC/HHS (b)(11) primer: https://www.healthit.gov/sites/default/files/2024-07/DSI_Explainer_9_Key_Functionalities_DSI_Criterion_508.pdf Please check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.club Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 150 [25 September 2024]: Christopher Blanchette PhD MBA, Vice President, Clinical Data Science & Evidence, NNI, Novo Nordisk – Our 150th Real-World Wednesdays (RWW): we discussed the importance of meaningful RWE at product launch ("Evidence at Launch") and how trial tokenization as well as other methods support these efforts. In addition, a great perspective on the real-world evidence and epidemiology career path. Please check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.club Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 149 [18 September 2024]: AI entrepreneur, Aaron Leibtag, CEO of Pentavere.ai – We discussed the current state of RWD and acceptance to support research use cases. Please check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.club Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.