AI compliance monitoring
Continuous monitoring of regulatory changes, internal policy adherence and audit readiness — so your compliance team leads strategy instead of chasing paperw…
Intelligent care starts with earlier insight. From diagnosis to treatment design, the shift to data-driven precision is reshaping how health systems think and act.
In healthcare and life sciences, AI pays off first where the work is documentation and knowledge: clinical and regulatory documents, patient and admin queries, research synthesis and quality records. Clinical decision support and AI in medical devices come later, with stricter evidence and conformity requirements. The common rule is answers grounded in approved sources, a named human accountable for every sensitive decision and an audit trail from day one.
Continuous monitoring of regulatory changes, internal policy adherence and audit readiness — so your compliance team leads strategy instead of chasing paperw…
Extract obligations, flag risks and track key dates across your entire contract portfolio — without your legal team reading every line.
Deploy an AI layer that resolves the majority of customer queries instantly — across every channel, around the clock — so your human agents focus on the conversations that actually need them.
Extract, classify and act on information from contracts, reports, invoices and forms — at the speed and scale no human team can match.
Build the controls, audit trails and risk framework that turn AI deployments from a liability into a governed, defensible part of your operations.
Handle employee queries, automate routine HR processes and free your HR team to focus on the work that actually requires human judgement.
An AI assistant designed for regulated environments — healthcare, public services and financial services — that handles sensitive queries with the accuracy, compliance and empathy they require.
AI-powered quality monitoring that inspects, classifies and flags issues across production, service delivery and customer interactions — at a scale no manual…
An AI research layer that searches, synthesises and structures information from internal and external sources — so your teams spend time on judgement, not on…
Independent AI strategy: opportunity inventory, value sizing, build/buy decisions, governance design and a 90-day plan your board and teams can defend.
Lineage, quality SLAs, PII handling, and consent tracking on the pipelines AI consumes—so models pass audit and analysts trust the data.
Connect your documents, systems and expertise into a governed knowledge layer that anyone in your organisation can query — and trust.
Continuous regulatory monitoring on Synapse with jurisdiction-aware feeds, control mapping, and audit-ready evidence—built for compliance ownership.
Inferred skills inventory, gap analysis, and supply/demand forecasts—so workforce planning becomes a decision instead of a guess.
Under the EU AI Act (Regulation (EU) 2024/1689), most high-risk healthcare AI comes through Annex I: software that is, or is a safety component of, a medical device or in vitro diagnostic under the MDR or IVDR and needs a notified-body assessment. Those obligations apply later; check the consolidated text for the date. Annex III adds uses such as emergency patient triage, eligibility for public healthcare services and risk pricing in life and health insurance, whose obligations apply from December 2027 after the Digital Omnibus on AI entered into force on 27 July 2026. AI literacy (Article 4) and Article 50 transparency already apply. Check the consolidated text on EUR-Lex or the AI Act Service Desk.
Not every assistant is high-risk. An assistant that answers administrative questions or searches internal SOPs usually carries transparency duties: people must know they are talking to AI. What changes the classification is the intended purpose. If the same tool starts suggesting diagnoses or prioritising patients, it needs to be reassessed, and if you fine-tune or white-label a model you may take on provider duties.
The AI Act sits on top of rules that already weigh heavily in the sector. Health data is a special category under the GDPR, which usually means a data protection impact assessment and strict limits on purpose and access. The European Health Data Space (EHDS) regulation, adopted in 2025 and applied in phases, will shape access to and secondary use of health data. NIS2 lists healthcare among the sectors with cybersecurity and incident-reporting obligations. This is practical guidance, not legal advice.
No. Classification depends on the intended purpose. AI that is part of a medical device under the MDR or IVDR, emergency patient triage or decisions on access to public healthcare services are high-risk. A tool that drafts administrative replies or searches internal procedures usually is not, though it still has transparency duties and must comply with the GDPR.
Yes, with conditions. Health data is a special category under the GDPR, so you need a legal basis, a clear purpose, minimisation and usually an impact assessment. In practice that means controlling where the model runs and what it can see, pseudonymising where possible and logging access. For many teams, running models in their own infrastructure or a sovereign cloud is the deciding factor.
By grounding it in approved sources and making it cite them, by letting it say “I don’t know” and hand over to a person, and by testing it on realistic cases rather than exam-style questions. Benchmarks that only test knowledge recall say little about how a model behaves with incomplete, multimodal patient records.
Usually with documentation: regulatory dossiers, technical files for raw materials, quality records and SOPs. It is high-volume work where errors are costly and the value of finding the right document fast is easy to see. Thinkia worked on exactly this kind of documentation layer and expert assistant with a science-led pharma and consumer health group.
A named person who reviews before any irreversible or clinical action, clear thresholds for when the system escalates, a review interface that shows the sources and the reasoning, and feedback from those reviews that improves the system. Oversight is a workflow you design, not a checkbox.
No. The AI Act’s prohibitions and AI literacy duties already apply, and the GDPR applies today. Starting with lower-risk use cases and documenting as you go is the sensible route: when the high-risk obligations kick in, you will already have the governance in place.
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