Healthcare — Evidence for Clinical & Healthtech AI
When AI assists triage, imaging, documentation, or care pathways, later reviewers need more than a hospital SIEM export. Sigigo witnesses the decision boundary as checkable evidence — without requiring you to ship raw PHI to us.
Who this is for
Health systems, digital health vendors, imaging and documentation AI providers, and payer organizations deploying models that influence coverage or care recommendations.
- Clinical decision support and triage assistants
- Imaging / radiology AI and report copilots
- Ambient documentation and prior-auth automation
- Payer medical review or utilization AI
How the EU AI Act affects this industry
For clinical, payer, and healthtech AI, the Act is mostly about whether your system is high-risk, who is the provider vs deployer, and whether Article 12 automatic logging (plus deployer retention under Article 26) applies. Classification is a legal question — start with counsel or the FLI Compliance Checker.
High-risk classification is product- and use-specific. Medical devices and Annex III essential-services paths can bring Article 12 automatic logging and deployer retention (Article 26). Documentation copilots and chatbots often trigger Article 50 transparency even when Annex III does not apply. Pair AI Act analysis with MDR/FDA pathways via legal and regulatory affairs — Sigigo is not a notified body.
| Situation | If high-risk rules apply | How Sigigo helps |
|---|---|---|
| Clinical decision support / triage | May be high-risk → Art. 12 logging + oversight evidence | Session chain: input refs, model version, clinician override, action |
| Imaging / diagnostic AI | Often high-risk or device-regulated — classify carefully | Witness inference + human verify steps; Private Commitment Mode for studies |
| Ambient documentation copilots | Art. 50 disclosure common; Art. 12 only if high-risk use | Transparency events + optional inference commitments |
| Payer prior-auth / utilization AI | May touch essential-services high-risk rules | Prove score, reviewer decision, and coverage action linkage |
Standalone Annex III high-risk systems face a primary deadline of December 2027. Starting automatic logging earlier builds a lifetime trail — catch-up later cannot recreate history. Full field map: Article 12 guide.
Article 12 requires automatic lifetime logging for high-risk systems — not cryptographic integrity by itself. Sigigo adds signed, exportable evidence so that trail holds up when challenged. See the Article 12 FAQ.
Why this industry needs proof first
Care and coverage disputes, safety reviews, and regulators ask whether the trail reflects what the system actually did — not what an admin could edit afterward. Privacy rules also punish shipping more PHI than necessary to yet another vendor.
| Common stack | What goes wrong under scrutiny |
|---|---|
| EHR / PACS activity logs | Mutable; incomplete model/session linkage |
| Model SaaS audit UI | Care site must trust the vendor’s dashboard |
| Research notebook exports | Not automatic production recording |
| Policy PDF + sample cases | Process intent ≠ per-inference trail |
Decision boundary → events
Prefer input_hash / input_ref for clinical payloads. Link clinician overrides to the same session_id.
| Workflow step | What to prove | Sigigo action |
|---|---|---|
| Order / study / note intake | Inputs received | ai_act.input_received |
| Model inference | Model version + output | ai_act.inference_started → output_generated |
| Guideline / chart retrieval | Context used | ai_act.context_retrieved |
| Clinician accepts / edits / rejects | Human oversight | ai_act.human_review_completed / human_override |
| Downstream order or report | Action taken | ai_act.action_executed |
| Safety / incident event | Escalation trail | ai_act.serious_incident_reported |
Privacy-first defaults
Use Private Commitment Mode so Sigigo witnesses commitments without holding notes, images, or identifiers by default. Pair with region-pinned deployment — see data sovereignty.
Other frameworks that often apply
| Framework | How Sigigo helps |
|---|---|
| HIPAA accountability / audit expectations | Tamper-evident access and decision evidence without turning Sigigo into your EHR |
| FDA / 21 CFR Part 11 patterns (where relevant) | Signed trails for software actions, approvals, and validation-relevant events |
FAQ
- Is Sigigo a medical device or clinical system of record?
- No. Sigigo is evidence infrastructure alongside your EHR, PACS, and model stack. We witness decision-boundary events; we do not replace clinical systems or perform conformity assessment.
- Do we have to send PHI to Sigigo?
- No. Private Commitment Mode is designed so sensitive payloads stay in your environment while you still get checkable proofs.
- Does Article 12 apply to every clinical AI tool?
- No — only where EU high-risk rules apply. Use legal classification first, then instrument automatic logging where required. Sigigo makes that trail checkable.
Map a clinical or documentation AI flow — including AI Act scope — with our team: contact us.
This guide supports qualification and architecture planning — it is not legal advice. Work with your legal and compliance teams on classification, DPAs, and deployment approvals. See also our Regulatory & Compliance page.