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.

Ep 148 [11 September 2024]: Derk Arts MD PhD, Founder & CEO at Castor (https://www.castoredc.com/) – We discussed technology considerations and the support necessary to launch and sustain a successful RWE study. 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 147 [04 September 2024]: This was a special episode of Real-World Wednesdays (RWW) as part of the RWEsearch Annual Summit 2024: https://healtharkinsights.com/event/rwesearch-virtual-annual-summit-2024/ C. K. Wang MD, Chief Medical Officer at COTA – We discussed the RWD Trifecta: Data Quality, Fit-for-Use, and AI -- Leveraging "quality" RWD to develop and validate AI for current RWE use cases - examples & experiences. 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 146 [31 July 2024]: Craig Parzynski, Executive Director and Head of Biostatistics & Analytics at Genesis Research Group – We discussed major considerations in the use of RWD in RWE and for clinical trials. This was a conceptual conversation at the business leader level, with no expectation of biostatistical experience or expertise. 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 145 [24 July 2024]: Aaron Mann, CEO of the Clinical Research Data Sharing Alliance (CRDSA, https://crdsalliance.org/) – We discussed the Clinical Research Data Sharing Alliance (CRDSA) and strategies to reuse prior clinical trial data when paired with RWD to optimize the creation of external or supplemental controls as well as the underlying regulatory considerations and challenges with access to the appropriate RWD needed by the research team. 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 144 [17 July 2024]: Myla Maloney MBA, Chief Growth Officer at PINC AI Applied Sciences – We discussed the importance of having an embedded relationships within healthcare systems in order to optimize clinical care alignment across care settings & specialties that support technological transformation and advancement faciliting access to RWD that help bridge gaps between life sciences, clinical research and health care. 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.