Buyer pain-language selected: EU AI Act healthtech high-risk reviewAI classification decision logGDPR DPIA AI evidencehuman oversight owner handoffmedical AI procurement questionnaireclinical workflow AI trust evidence
Why this bottleneck matters
Healthtech AI deals can stall when product, clinical, privacy, security and finance teams answer AI-risk questions from different evidence sources. This template gives buyers a clean view of what is approved, what needs adviser review and which compliance, safety, savings or customer claims must be blocked.
Public source anchors used
Regulation (EU) 2024/1689 is the EU Artificial Intelligence Act. The GDPR is Regulation (EU) 2016/679. This template uses those public regulatory references only as source anchors for internal evidence routing; it does not interpret obligations or decide legal status.
Decision-log template
All rows are synthetic examples only. They are not production data, patient data, personal data, health data, customer data or buyer approval evidence.
| Decision area | Buyer question | Evidence to collect | Accountable owner | Adviser question | Unsafe claim to block |
|---|---|---|---|---|---|
| Use-case inventory | Which patient, clinician, billing or operational workflow uses AI? | AI use-case register, workflow diagram, user role list, intended-use note. | Product owner + clinical/business owner | Which use cases require formal legal/regulatory/clinical classification review? | “Not regulated AI” without owner-approved classification evidence. |
| High-risk classification screen | Could the workflow affect access, triage, diagnosis, treatment, safety or essential services? | Classification screening note, risk register, rationale, decision date, reviewer names. | Legal/compliance + accountable executive | Does qualified counsel/regulatory owner agree with the classification and next steps? | “Low risk” or “high-risk ready” without documented adviser review. |
| GDPR and DPIA linkage | How does AI classification connect to data protection, special-category data and DPIA decisions? | Data-flow map, lawful-basis note, DPIA screening, retention/deletion note, DPO comments. | DPO/privacy + product owner | Is a DPIA, DPO review or processor/subprocessor wording update needed? | “GDPR compliant” or “no DPIA needed” without accountable approval. |
| Human oversight | Who reviews AI outputs before clinical, patient access, billing or safety action? | Human-review trigger list, escalation matrix, override log, training record. | Clinical/business owner + operations | Are oversight controls adequate for the specific workflow and user group? | “Fully automated clinical decisions” without explicit review evidence. |
| Model change and monitoring | How are prompts, model versions, retrieval sources and regressions approved? | Change log, regression test pack, rollback owner, release decision record. | AI engineering + QA owner | Which changes require reclassification, DPIA refresh or buyer notice? | “No accuracy drift” without monitoring and retest evidence. |
| Vendor and subprocessor evidence | Which AI vendors, subprocessors and data locations are involved? | Vendor inventory, DPA/subprocessor list, data residency note, training-use evidence. | Security + procurement + privacy | What can be shared externally and what must stay under NDA or adviser review? | “EU hosted” or “no training use” without source evidence. |
| Cost and scaling exposure | What happens if AI usage, tokens, images, inference or support tickets scale? | Usage dashboard, unit-cost assumptions, budget owner, alert and approval thresholds. | Finance/FinOps + engineering owner | Which spend thresholds require approval before production expansion? | “Guaranteed savings” or “fixed AI cost” without approved assumptions. |
| External claims | What can sales, website, investor or procurement materials safely claim? | Claim approval log, source links, owner sign-off, expiry/review date. | Marketing + legal/compliance + product | Which compliance, accuracy, safety, customer, ranking or ROI claims must be removed? | “EU AI Act compliant”, “clinically validated”, “customer-proven” or “ROI proven” without evidence. |
Recommended buyer packet
- Download the synthetic CSV and mirror the columns internally.
- Attach the GDPR/DPIA/security questionnaire source map.
- Link relevant rows to the Europe healthtech evidence room.
- Use the diagnostic package if owners, gaps and claim boundaries need a fixed-scope review.
Explicit claim boundary
This is a buyer-education and synthetic template asset only. It is not a real European healthtech case study, not production data, not patient data, not personal data, not health data, not customer data, not a testimonial, not a certification, not EU AI Act compliance proof, not high-risk AI classification advice, not medical-device classification advice, not conformity-assessment evidence, not GDPR compliance proof, not DPIA approval, not NHS proof, not ISO 27001 proof, not SOC 2 proof, not legal advice, not privacy advice, not DPO advice, not security advice, not audit advice, not procurement advice, not clinical advice, not medical advice, not billing advice, not cloud-provider partnership evidence, not vendor ranking evidence, not savings evidence, not ROI evidence, not lead evidence, not customer evidence and not revenue evidence. No outreach was sent.
FAQ
- Who should own this log?
- A named accountable owner should coordinate product, clinical/business, privacy/DPO, security, procurement, finance/FinOps and legal/regulatory reviewers.
- What should be blocked before sending?
- Any EU AI Act, GDPR, DPIA, medical-device, clinical-safety, ISO, SOC 2, accuracy, savings, ROI, customer or ranking claim without approved evidence and owner review.
- Does AICS need credentials to start?
- No. The first pass should use redacted exports, approved screenshots, synthetic templates, owner notes and questionnaire rows only.