EU AI Act compliance for Healthtech

What applies

Articles + provisions of Regulation (EU) 2024/1689 — Artificial Intelligence Act most directly engaged by Healthtech deployments:

• Art. 6(1)
• Annex I (MDR)
• Annex III §5(d)

What this looks like in Healthtech

AI-incorporating medical devices are high-risk via Art. 6(1) + Annex I (MDR). Emergency-triage / patient-prioritisation AI separately under Annex III §5(d). Full Chapter II obligations.

Flagship exampleNotified-body conformity assessment for Class IIa CDS: how do you prove post-market surveillance + human oversight without a verifiable chain?

Where Promethean's evidence layer fits

The substrate emits specific evidence kinds that map to EU AI Act obligations. Most directly relevant for Healthtech:

• l12-receipt-chain

• reviewer-gate-log

• spec-hash-commitment

For the full sector view including LLM-feature catalogue, tier recommendation, and reviewer-gate examples, see the Healthtech sector page.