Practical AI governance for hospitals, biotech, health tech, and pharma: audit-ready evidence you can defend, not just a framework on a shelf.
From a first readiness check to a certified AI Management System, Primas-One meets your organization wherever it is today, and stays with you as your AI use grows.
The regulatory environment around AI in healthcare has moved from guidance to enforceable obligation. These are the dates and numbers a board is being asked about.
This is what you actually buy from Primas-One. Each one stands on its own; run in sequence, they take you from "we don't know our AI exposure" to a certifiable AI Management System.
Where every engagement starts: a clear map, not a sales pitch.
A structured diagnostic of every AI system you run, build, or buy, mapped against the frameworks that actually apply to you (EU AI Act, FDA, HIPAA, GxP, or the WHO principles, depending on your sector) and scored against ISO/IEC 42001.
IncludesOutcome. A written readiness report and roadmap you can act on immediately, whether or not you engage us further.
Start with this engagementSystem by system, not one blanket judgment call.
A deep-dive risk and bias assessment of each individual algorithm or model: the level of specificity regulators and auditors expect, and the level a generic "AI audit" rarely delivers.
IncludesOutcome. A defensible, documented risk position for every AI system you run: the evidence regulators and auditors ask for first.
Start with this engagementGovernance that keeps working after the report is filed.
The operational layer that turns a one-time assessment into a living program: ownership, controls, and monitoring that catch problems while they are still small.
IncludesOutcome. A living risk-management program, not a binder that goes stale the week after it is delivered.
Start with this engagementThe credential that turns "we take this seriously" into something you can prove.
Full design and build-out of a certifiable AI Management System (AIMS), the same standard that is becoming a procurement gate in enterprise and health-system RFPs, the way ISO 27001 did for security.
IncludesOutcome. A certification-ready AI Management System, and for organizations that pursue it, a globally recognized ISO/IEC 42001 certificate.
Start with this engagementMost clients run all four in sequence over one continuous engagement. Every one is also available on its own: start wherever your organization actually is today.
Not a separate product line: the specialized work that plugs into a Readiness Assessment, Risk Assessment, Risk Management program, or ISO/IEC 42001 implementation once your sector or situation calls for it.
Structured, recurring assessments that go beyond a one-time review.
The living documentation and regulatory mapping auditors and regulators expect.
The people and processes that keep a program running once it is built.
Governance work that reaches beyond your own walls, to vendors, investors, and partners.
Every engagement is scoped against your actual AI footprint before you commit, and you can stop after any stage.
Inventory every AI system in use, classify risk, and map current-state gaps against ISO/IEC 42001, the EU AI Act, FDA, HIPAA, and WHO expectations relevant to you.
Design the governance structure, policies, and documentation set your organization needs, sized to your team, not a generic template.
Stand up the AI Management System: risk registers, model cards, technical files, incident-response plans, and training.
Prepare for ISO/IEC 42001 certification audit or the equivalent regulatory review: evidence organized, gaps closed, team rehearsed.
Ongoing post-market surveillance, incident-response readiness, and board reporting, so governance stays current as your AI use grows.
Every line on the left is drawn from enforcement actions, litigation, and breach-cost data already on the record in 2025–2026.
The same logic (high-risk AI classification, non-delegable deployer duties, board-level AI literacy, and audit-ready documentation) applies wherever AI touches regulated decisions about people. Financial services, insurance, and critical-infrastructure and public-sector organizations face the same EU AI Act deployer obligations and the same reasonable-care standard under frameworks like the NIST AI RMF.
Our methodology was built in one of the most tightly regulated, highest-stakes environments there is. Healthcare remains where we go deepest, and where our team's clinical and public-health background gives us an edge a generalist firm can't match.
A vendor's compliance claim covers the vendor's obligations, not yours. Under the EU AI Act and emerging U.S. state law, the organization that deploys an AI system carries its own, non-transferable duties: risk analysis, human oversight, incident reporting, and record-keeping. Our work builds the evidence that those duties are being met on your side.
A security audit asks whether your systems are protected. AI governance asks whether the decisions an AI system influences are safe, fair, documented, and accountable, and whether you can demonstrate that to a regulator, an auditor, or a court. The two overlap on controls, but the frameworks, evidence, and reviewers are different.
It depends on how many AI systems you run and how much governance already exists. A readiness assessment is measured in weeks; a full AI Management System build to certification readiness is typically a few months. We scope it against your actual footprint before you commit, and you can stop after any engagement.
Yes. Our methodology was built for multi-jurisdiction health and global-health programs, and ISO/IEC 42001 is an international standard by design. Where a program spans many countries with uneven local law, we build one governance framework that travels and note the local requirements it has to satisfy.
No one can. What a governance program does is put the evidence regulators and courts ask for first: a documented risk analysis, clear ownership, human oversight, and an incident process, on the record before you need it. That is the difference between demonstrating reasonable care and improvising it.
No. Every engagement is scoped to the team you have. For smaller organizations we right-size the readiness assessment and the risk work so it runs without pulling people off their day jobs, and we build documentation that a lean team can actually keep current.
Whether you are preparing for AI regulation, assessing an existing AI system, implementing ISO/IEC 42001, strengthening cybersecurity, or building an enterprise AI governance program, Primas-One can help you take the next step with confidence.
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