France · healthcare
Healthcare
Patient information, consent, timing, human review and evidentiary record for covered care journeys.
Regulatory Packs
A Regulatory Pack is neither a blanket compliance promise nor a library of legal text. It defines the rules, versions, reviews and artefacts NELSE may use for a bounded use case. Every pack exposes its actual maturity.
The target architecture separates an EU core from the national rules required for the selected use case. A country extension is never presented as automatic: it requires sources, scope, reference cases, review and an identified version.
France · healthcare
Patient information, consent, timing, human review and evidentiary record for covered care journeys.
France · research
Project qualification, research regimes, evidence, owners, timelines, reviews and proof within a defined perimeter.
EU · AI use
Governance of AI uses and systems, internal policy, human oversight, runtime events and evidence for defined flows.
France / EU · insurance
Advice duties, recommendation rationale, delivered documents, longitudinal review and context reconstruction.
EU · MDR / IVDR
Classification, change, vigilance and impacted dossiers. Public coverage remains limited to modules actually validated.
EU · credit
Repeat decisions, pre-contractual duties and customer-journey controls. No production perimeter is claimed yet.
EU · AML
Qualification, human review, events and evidence. This pack is not presented as currently available.
EU · incidents
Focused use case: event qualification, regulatory clocks, owners, notifications and evidence. Not a general-purpose GRC suite.
What a pack contains
Sources, jurisdictions, versions, exclusions and assumptions explicitly identified.
Rules and states usable by NELSE capabilities for the covered use case.
Tests, reviews, versions, human decisions and evidence aligned with the level actually claimed.
These statuses describe public commercial maturity, not blanket legal certification. Results depend on the facts, the perimeter actually covered, the version loaded and the human reviews required.
Build with NELSE
Software vendors and regulated organisations can keep their own product experience and integrate a regulatory perimeter through NELSE API. Scope, usage, responsibilities and service commitments are defined in writing.
Bring us your case
Describe the operating problem. We prepare the relevant product, deployment programme and integration path around your actual scope.