Insights
Healthcare software architecture, European health-data regulation and patient-facing services.
Who needs HDS certification, what the v2 referential and the 24 March 2026 decree changed, how to split the six hosting activities between IaaS and vendor, and the architecture checklist to settle before the audit.
A practical engineering view of IEC 62304:2006+A1:2015: how software safety classification works with risk controls, which clauses apply to Class A, B and C, how to handle SOUP, and how pull requests, CI reports, tags and SBOMs become audit evidence.
What a software editor or hospital IT team needs to integrate France's secure health messaging: trust-space actors, the API LPS, Pro Santé Connect authentication, IHE XDM attachments, patient messaging and the timeline.
A practical guide to connecting software to Pro Santé Connect: Datapass and sandbox onboarding, the authorization code flow, scopes and claims, token lifetimes, logout, mTLS and the Espace de Confiance.
Which USCDI version certified health IT must support in 2026, which US Core release goes with it, what HTI-1 changed for (g)(10), decision support and information blocking, and what the HTI-5 proposal would change.
CMS-0057-F points impacted payers at Da Vinci CRD, DTR and PAS. Operational prior-auth rules generally 2026; FHIR APIs generally 1 January 2027. Pin live STU versions. Not a payer certification.
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