Insights
Healthcare software architecture, European health-data regulation and patient-facing services.
US Core 9.0.0 is the FHIR profile layer for USCDI v6. TEFCA remains document exchange plus Facilitated FHIR — 11 QHINs, 71,000+ sites and 464 million documents by end of 2025.
What the development team should map before code: medical destination, MDCG 2019-11 rev.1, branches of rule 11, IEC 62304 and SOUP inventory — separate from the English-speaking MDR guide.
NIS2 operational evidence pack for a health IT team: Art. 21 and 23 of Directive (EU) 2022/2555, 24/72/one-month clocks, ANSSI and CERT-FR, and the dual-channel GDPR.
What the platform should exchange around video: ANS repository v1.5.1, INS, CDA, DMP, MSSanté, FHIR Appointment/Encounter, and why WebRTC is not EHDS.
A scope-led engineering guide to GDPR, NIS2, MDR/IVDR and phased EHDS requirements, with primary sources and practical evidence for health IT teams.
How GDPR patient rights — access, rectification, erasure, portability, and restriction — create real technical requirements for healthcare integration pipelines, and the engineering patterns to implement them without disrupting clinical workflows.
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