“Inspiration, Not Blueprint”
- lealedwon
- September 10, 2025
- DATA2VALUE INITIATIVE
- expertview
- 0 Comments
Health data interoperability is rising on the political agenda on both sides of the Atlantic. In the U.S., the new CMS Interoperability Framework reflects Washington’s push to modernize patient data flows. Prof. Dr. Sylvia Thun emphasizes that while there are notable impulses, the EU’s path is defined by the European Health Data Space (EHDS) – including binding rules, governance, and GDPR-grade safeguards.
The CMS Digital Health Tech Ecosystem Interoperability Framework is voluntary. Networks self-attest to compliance as “CMS-Aligned,” while providers, payers, and apps are encouraged to join. The framework draws on United States Core Data for Interoperability version 3 (USCDI v3), mandates FHIR APIs for structured and unstructured data, and expands into areas like appointment and encounter notifications, a record-locator function, and a national provider directory. Patient-facing apps are central: they must verify identity, integrate with Medicare, and deliver tangible use cases such as “Kill the Clipboard” or conversational AI assistants.
“The CMS Interoperability Framework shows the Trump Administration’s interest and commitment to improving the flow of health data throughout the American healthcare system. Many of the initiatives within the framework reaffirm and build on work the US Department of Health and Human Services has undergone since the 21st Century Cures Act was passed by Congress in 2016 .”
Andrew Tomlinson is the Senior Director, Regulatory and International Affairs for the American Health Informatics Association.
Inspiration, Not Equivalence
The U.S. approach is notable for its user-centered workflows and the central role given to apps. From FHIR-based encounter notifications to record-locator functions, these are practical flows that could ease clinicians’ workload and improve the patient experience. Europe should advance similar details without delay. But there is a decisive difference. The CMS model is voluntary. The EHDS is binding law, with deadlines, governance, and enforceable conformity. In Europe, the benchmark must remain EHRxF/FHIR conformance, shared data catalogues, and GDPR-grade safeguards.
Germany on the EHDS Track
Germany’s current reforms already align with the EHDS. The DigiG and GDNG laws are scaling the electronic patient record (ePA), advancing the e-prescription, and enabling data use for research under strict privacy protections. These steps are designed to integrate with MyHealth@EU and the broader EHDS framework. U.S.-style features like provider directories and record-locator services are attractive, but they must be implemented in ways that are EHDS- and GDPR-conform, not imported wholesale.
What Europe Should Borrow
- User-centric flows: clipboard-free intake should become standard.
- Operational FHIR: routine use of appointments and encounter notifications across systems.
- Findability: federated, privacy-preserving record-locator services.
- Governed app ecosystems: clear criteria, secure identity, and trusted discovery channels.
Where Europe Must Hold the Line
- Legal enforceability: interoperability cannot remain optional.
- Privacy by design: GDPR standards must govern apps and AI assistants.
- Cross-border consistency: national innovations must plug into EHDS to avoid fragmentation.
Bottom Line: EHDS remains Europe’s Benchmark
The CMS framework provides inspiration for patient-centered flows and app ecosystems. But Europe’s task is different: to implement EHDS capabilities at scale, grounded in binding law, strong governance, and privacy by design. The U.S. can inspire. But Europe’s benchmark remains the EHDS.
Prof. Dr. Sylvia Thun is Director of the BIH Center for Digital Health at Charité and a leading voice for interoperable, patient-centered digital healthcare in Europe. You can meet her at the Data2Value Executive Dialogue on October 14, in Berlin.
