Posts tagged “high-risk”
EU AI Act for Insurers: Which Insurance AI Is High-Risk?
Life and health underwriting and pricing AI is high-risk under Annex III point 5(c). Motor and home pricing, claims triage and fraud detection mostly aren't. What insurers and insurtechs owe, with dates as of November 2026, a table and a checklist.
Biometric AI under the EU AI Act: Verification vs Identification
Face login, selfie ID checks, age estimation, emotion detection: which biometric AI is banned, which is high-risk and which falls outside Annex III? The verification exemption explained, with dates as of November 2026, a table and a checklist.
Importers and Distributors under the EU AI Act (Articles 23–24)
Reselling or importing someone else's high-risk AI? Articles 23 and 24 make you check CE marking, the declaration of conformity and instructions before it ships. Who counts as importer or distributor, when you become the provider, dates as of November 2026, and a checklist.
Article 6(3) Exemption: What the Commission's Draft High-Risk Guidelines Allow
The Commission's draft Article 6 guidelines show which Annex III AI features can escape high-risk status under Article 6(3), and which can't. Worked examples, the profiling test, the split-architecture trap and the four-part memo, ahead of final guidelines due by the end of 2026.
EU AI Act for EdTech: Proctoring, Grading and the Emotion-Recognition Ban
Admissions, grading, placement and proctoring AI is high-risk under Annex III point 3 from 2 December 2027. Emotion recognition in schools has been banned since February 2025. A feature-by-feature map for EdTech teams.
EU AI Act Article 10 Data Governance Requirements, After the Omnibus
Article 10 tells high-risk AI providers how to govern training, validation and test data. The Digital Omnibus deleted Article 10(5) and moved the bias-data rule into a new Article 4a. Here is what the data file needs now.
EN 18286: The First AI Act Harmonised Standard, Explained
On 14 October 2026 the EU cited EN 18286 in the Official Journal. It gives high-risk AI providers a presumption of conformity for Article 17 QMS duties, and nothing else. Here is what that means.
EU AI Act Digital Omnibus: New Deadlines 2026–2028
Regulation (EU) 2026/1744, in force 27 July 2026, moved Annex III high-risk rules to 2 Dec 2027 and Annex I to 2 Aug 2028. What did not move.
EU AI Act Article 26: Deployer Obligations
You bought the model. You still have duties. Article 26 covers instructions, human oversight, logs, worker notice, and when you must switch the system off.
EU AI Act Article 16: Provider Obligations List
Article 16 is the index of high-risk provider duties. Here is each item in plain English, when it applies after the Omnibus, and what to collect first.
EU AI Act Article 17: Quality Management System
Article 17 is a QMS for high-risk AI, not ISO theatre. What must be in it, who needs it, and why copying your ISO 9001 manual will not pass.
EU AI Act Article 13: Instructions for Use
Article 13 is the manual your deployers will be judged against. What it must say, who writes it, and why a help-centre article is not enough.
EU AI Act Article 15: Accuracy, Robustness, Cyber
Article 15 is the performance rule for high-risk AI. What accuracy you must declare, what robustness means, and the AI-specific attacks you have to plan for.
How to Classify an AI System under the EU AI Act
A seven-step classification you can finish in an afternoon: prohibited, Annex I, Annex III, the Article 6(3) exit, and what to file if you claim you are not high-risk.
Buying High-Risk AI: an EU Procurement Checklist
The vendor's CE mark does not finish your job. Ten questions to ask before you sign, and the Article 26 duties that stay with you after go-live.
EU AI Act Credit Scoring: Annex III for Fintech
Creditworthiness AI is high-risk. Fraud detection is not. How Annex III point 5(b) and 5(c) treat scoring, BNPL, and life or health insurance pricing.
EU AI Act and MDR: Medical Device Overlap
Most medical AI is high-risk twice: once under the MDR or IVDR, once under Article 6(1). What doubles, what can share a notified body, and the 2028 date.
Are AI Agents Regulated under the EU AI Act?
There is no 'agent' chapter. An agent is an AI system classified by intended purpose. When a tool-using loop becomes high-risk, GPAI, or just Article 50.
What Actually Counts as a 'High-Risk' AI System Under the EU AI Act?
High-risk isn't about how advanced your model is — it's about what decision it touches. Here's the full Annex III list, the Article 6 classification logic, and the one exemption that can take you back out of high-risk.
What Does 'Human Oversight' Actually Require? (Article 14)
Article 14 says high-risk AI must be built so a human can effectively oversee it — but 'a human in the loop' isn't enough on its own. Here's what real oversight means, the automation-bias trap, and the four-eyes rule for biometrics.
The EU Database: Registering Your High-Risk AI System (Article 49)
Before a high-risk AI system goes on the market, it usually has to be registered in a public EU database. Here's what Article 49 requires, what becomes public, who registers, and why it's the step founders forget until launch day.
Do You Need CE Marking and a Conformity Assessment for Your AI?
If your AI system is high-risk, yes — you must run a conformity assessment, draw up an EU declaration of conformity, and affix the CE marking before you can sell it. Here's which assessment route applies to software AI, and why most can self-assess.
How to Report a Serious AI Incident Under the EU AI Act (Article 73)
If your high-risk AI system causes serious harm, you have as little as two days to report it. Here's what counts as a 'serious incident', the exact deadlines, who you report to, and how this differs from post-market monitoring.
EU AI Act Timeline: Every Deadline From 2025 to 2027
The EU AI Act doesn't switch on all at once — it phases in across four key dates from February 2025 to August 2027. Here's exactly what applies when, so you know which deadline is actually yours.
What Does EU AI Act Compliance Actually Cost?
The scary five- and six-figure estimates floating around assume you're high-risk. Most companies aren't. Here's an honest breakdown of what compliance costs by risk tier — and why classification is the single biggest cost lever.
Is Your HR AI Actually High-Risk? The Annex III Category 4 Test, Decoded
Annex III category 4 covers AI in employment and recruitment — but the trigger is 'appreciable impact on career prospects,' not 'makes the final hiring decision.' Here's how to apply the test.
When Your General-Purpose AI Becomes a High-Risk AI System (And Who's Responsible)
Article 6(2) of the EU AI Act makes a deployer's intended use case the trigger for high-risk classification of GPAI systems. Here's where liability sits and what model providers must do.