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Compliance and regulatory positioning

Positioned honestly, on an equal footing across regions

Veriomics is Decision Support Software for research. We’re clear about what we hold today, what’s on the roadmap, and which regulations we operate under, and the decision-support boundary is a structural property, not a disclaimer.

The boundary

A structural boundary, not advisory text.

The decision-support boundary is built into the system itself, not laid on as advisory text. The platform does not auto-execute any clinical, policy, or institutional action, and offers no “apply automatically” for consequential decisions. The decision authority always remains with the user.

intended_use.py
class IntendedUse(str, Enum):
    RESEARCH_ONLY = "research_only"

# Enforced at the data layer on every analytical,
# predictive, or evidentiary output.

No region privileged

Ten regulatory regions, equal footing.

Veriomics is classified as Decision Support Software, and no single market is privileged in framing, pricing, or data residency.

  • Australia

    TGA, Therapeutic Goods Administration

  • Canada

    Health Canada

  • European Union

    EMA, European Medicines Agency

  • India

    CDSCO, Central Drugs Standard Control Organisation

  • Japan

    PMDA, Pharmaceuticals and Medical Devices Agency

  • Nordic countries

    National medicines agencies

  • Pakistan

    DRAP, Drug Regulatory Authority of Pakistan

  • Singapore

    HSA, Health Sciences Authority

  • United Kingdom

    MHRA, Medicines and Healthcare products Regulatory Agency

  • United States

    FDA, Food and Drug Administration, Decision Support Software classification

Stated honestly

Current support and roadmap items.

We do not claim certifications we do not hold. The following are marked as current or as roadmap items, plainly.

Compliance standards with current or roadmap status.
StandardStatusNote
GDPRCurrentData protection aligned with the EU General Data Protection Regulation.
21 CFR Part 11CurrentElectronic records and signatures support for regulated-research workflows.
NHS DSPTRoadmapNHS Data Security and Protection Toolkit, planned, not yet attained.
ISO 27001RoadmapInformation security management certification, roadmap item.
ISO 27701RoadmapPrivacy information management extension, roadmap item.
SOC 2 Type IIRoadmapService organisation controls report, roadmap item.
NHS DTACRoadmapNHS Digital Technology Assessment Criteria, roadmap item.
HITRUSTRoadmapHITRUST CSF certification, roadmap item.

Questions about regional deployment or the boundary?