HL7 Vulcan

The wait is over! 🎉 The recorded sessions from the Health Data Policy to Practice event are now available on our YouTube channel! Check out the recordings here: https://lnkd.in/e6GYDnhR If you missed a session, we've got your back. You can find the TedTalk style discussions on some of our biggest projects, like the Real World Data, UDP, and EPI projects led by Gustav V., Hugh Glover, and João Almeida. There's also the VIB panel discussion led by Sandy Vance and the EU projects panel led by Catherine E Chronaki, FHL7, FIAHSI, MBA. Which one did you find the most valuable? #interoperability #clinicalresearch #realworlddata #FHIR #dataprotocol

Big things happened in the European Health Data Space (EHDS) last week! In collaboration with TEHDAS2 joint action, Vulcan members gathered in Copenhagen, Denmark to meet with officials in the EHDS. We shared two productive days of panels and Tedtalks on Vulcan projects, sharing the progress and success of these initiatives. Perhaps the most fruitful part of the program was the Vulcan-hosted workshop and breakouts, where individuals from governments, academia, and industry worked together to articulate solutions in the EHDS. We'd like to extend a hearty thank you to our organizers and moderators: James McDermott, Sandy Vance, and Catherine E Chronaki, FHL7, FIAHSI, MBA, Jesper Kjær, and Lisa Collins. And thank you, THANK YOU to our speakers who traveled from distances both small and great to share the wealth of their knowledge and experience with the EHDS. Gustav V. Hugh Glover João Almeida Davera Gabriel, RN FHL7 FAMIA Dan Hydes Steve Heard Beverly Buckta, Sc.D. Peter Casteleyn Yoanni Th. Matsakis Jannik Wheler Nersey Rastan 🚠 Panagiotis Telonis Luc Nicolas Rebecca Baker Recordings of the sessions are coming soon, so be sure to keep your eyes on this LinkedIn channel to hear more about interoperability in clinical research.

🚀 HL7 Vulcan is proud to announce the launch of six new implementation guides as part of our Vulcan Interoperability Bridge (VIB) program — a significant milestone in bringing the power of FHIR standards to clinical research. With support from the ASTP and the FDA, 23 industry leaders collaborated on these 6 new guides, providing fully baked, ready-to-implement concepts that will bring tangible value to the world of clinical research. Focused on the areas of improved research site operations and the utilization of real-world data, these proofs of concept deliver faster reporting and reduced study costs. “This is only the beginning,” says Vulcan Founder Amy Cramer MMCi, BSN,CPHQ Cramer. “Clinical research needs to catch up with the technological infrastructure found in healthcare, and the VIB program is designed to illuminate these possibilities.” Through the VIB program, Vulcan is proving that interoperability can transform clinical research — for patients, providers, and the future of medicine. Big shout out to Sandy Vance for organizing and operating the VIB cohort, Amy Cramer MMCi, BSN,CPHQ and James McDermott for their leadership, and Stephen Konya and Mitra Rocca for their support of the project. Huge congratulations to all the VIB champions, who came up with each concept, wrote the guides, and rallied all the supporting participants who made each proof of concept possible: Debi Willis, Cal Collins, Qi Li, Richard Yeatman, Michael Buckley and Kimberly Tableman. 🥂 🔗Read the full press release here: https://lnkd.in/e8aUtGqV #HL7 #VulcanFHIR #ClinicalResearch #Interoperability #FHIR

📣 Deadline Extension! 📣 Project Vulcan is co-hosting the “Health Data Policy to Practice” event with TEHDAS, the organization moving “Towards the European Health Data Space” – and Vulcan membership is invited! This intimate, exclusive event, primarily comprised of EU government officials, academics, and a handful of industry leaders, promises to be like no other. Expect an agenda heavily focused on thought leadership, data-sharing with FHIR success stories, and breakout sessions designed to foster real insights in solving the “how” to build the next iterations of connectivity for clinical research. Registration is closing on September 17th, but there are a few spaces left for the Vulcan sessions. Register here: https://lnkd.in/eXMQFXY5 Will we see you in Copenhagen? Tell us in the comments!

Project Vulcan is co-hosting the “Health Data Policy to Practice” event with TEHDAS, the organization moving “Towards the European Health Data Space” – and we’re able to extend invites to our membership! This intimate, exclusive event, primarily comprised of EU government officials, academics, and a handful of industry leaders, promises to be like no other. Expect an agenda heavily focused on thought leadership, data-sharing with FHIR success stories, and breakout sessions designed to foster real insights in solving the “how” to build the next iterations of connectivity for clinical research. Registration is closing on September 17th, but there are a few spaces left for the Vulcan sessions. Hope to see you in Copenhagen! Register here: https://tehdas.eu/

📣 News! 📣 Join us for the HL7 Connectathon in Pittsburgh to engage with the core development team and fellow stakeholders! Attendees will participate in testing and demonstrations, including a “Bring you own protocol" opportunity to apply the UDP FHIR specifications to your sample ICH M11-formatted protocol - guided by experts.   Leading the Connectathon are experts from HL7 Vulcan, ICH M11/M2, CDISC and TransCelerate BioPharma Inc. all of whom are working toward a digital form of clinical protocols. They'll additionally be showcasing the Vulcan UDP project will integrate the ICH M11 template, technical specification, models, and terminology & the CDISC/TransCelerate Unified Study Definition Model (USDM) to enable FHIR exchange of clinical protocols, bringing clinical research and clinical care closer together. We invite clinical trial sponsors, system vendors, and stakeholders involved in clinical operations, trial feasibility, regulatory submissions, and other business processes that may be involved in exchange of protocols or utilization of structured protocol data. Technical and non-technical SMEs are welcome. Want to learn more? Attend our Connectathon Kick-Off call on August 18th – with plenty of time remaining to register!    Aug 18, 2025 - 10:00 ET Join Zoom Meeting: https://lnkd.in/g6hMbm5C Meeting ID: 940 2197 2038 Passcode: 831004        #FHIR #FHIRConnectathon #ICHM11 #cesharp #protocoldigitization #digitalprotocol #clinicalresearch #clinicalprotocol #clinicaltrials

Please join us for the webinar Igniting Innovation: Project Vulcan Meets BYOT Webinar where the DTRA Bring Your Own Tech Team and HL7 Vulcan are coming together for a webinar to explore their overlapping works in interoperability. When: Thursday 14th August 2025 - 11.00 - 12.00 ET Who: HL7 Vulcan members Amy Cramer MMCi, BSN,CPHQ, (Johnson & Johnson), Brian Alper (Computable Publishing LLC) and Sandy Vance (Counterpoint Solutions, LLC) and the Decentralized Trials & Research Alliance (DTRA) members Joe Dustin (Dauntless eClinical Strategies), Rick Greenfield (RealTime eClinical Solutions), and Brandon Maggio (GSK) Where: https://lnkd.in/gkZMtDZC More details on the following post: https://lnkd.in/dQMGziES

📢 Vulcan Connectathon: 2 tracks 📢 FHIR to OMOP and Schedule of Activities Wednesday, June 25, 2025 9:00 AM Kick Off Join Here  Thursday, June 26, 2025 4:00 PM Track Highlights Join Here 📅 Event Date: Wednesday, 25 June 2025 and Thursday, 26 June 2025 📅 Event Time: 09.00 a.m to 4.00 p.m EST 📅 Registration: Free to join 🎯 The Vulcan Accelerator invites members and non-members, developers, programmers, technology experts, analysts, and other community members to learn about and test Fast Healthcare Interoperability Resources (FHIR) Application Programming Interfaces (APIs) and support FHIR Implementation Guides (IGs) during this two-day testing event. More information about the tracks agenda and how to join can be found on this page: https://lnkd.in/e37xMbRz #HL7Vulcan, #FHIR, #interoperability

📢 Vulcan Webinar series: Utilizing the Digital Protocol 📢 📅 Event Date: Wednesday, 25 June 2025 📅 Event Time: 9:00 to 10:15 a.m. EST 📅 Registration: QR code on picture or follow the link (https://lnkd.in/e6hfNJSj) Building on the success of our previous webinars, we’re excited to announce the next webinar in the series! Join us as we explore Vulcan’s UDP (Utilizing the Digital Protocol)—a project accelerating ICH M11 and end-user value. Our panellists: Hugh Glover, Technical Director, Vulcan   Mary Lynn Mercado, Global Head Protocol Delivery & US Site Head, Regulatory Writing & Submissions, Novartis Stacy Tegan, Program director, TransCelerate Biopharma They will: * Provide a brief overview of the UDP project, including how it complements ICH M11 and TransCelerate/CDISC USDM (Unified Study Definition Model) * Highlight the progress towards Vulcan’s publication of an implementation guide (IG), including: - Timelines, current status and planned content – what can you expect in the IG - Read-out from the May 2025 connectathon and how this supports the IG - A look inside the HL7 process and how you can participate  * Discuss practical steps to prepare for implementation   If you are new to Vulcan UDP: Check out this overview video (https://lnkd.in/e7Et_r-2) for a comprehensive background to the Vulcan UDP project and a summary of our progress.   Ideal Attendees:  Anyone interested in clinical data interoperability Solution providers that utilize clinical protocol information, such as study builders and authoring platforms, structured content management tools  Sponsors and CROs involved in processes that consume protocol information, such as protocol and development authoring, clinical trial digital and technology support  Regulatory operations, submissions & document management  Data managers, innovation managers, infrastructure managers, programmers in clinical development Health Authorities, such as clinical trial regulators, regulatory submission review (i.e., FDA and EMA)   #HL7Vulcan, #FHIR, #interoperability, #TransCelerate, #CDISC

A heartfelt thank you to HL7 Europe and all the contributors to the Vulcan UDP track at the HL7 Connectathon. Your collaboration and support among organizations are invaluable. Looking forward to the first issue of the FHIR Implementation Guide! #HL7Vulcan James McDermott TransCelerate BioPharma Inc. CDISC