Navigating the EU AI Act: A Checklist for Mental-Health Apps

The European Union’s AI Act—formally adopted in February 2025—reclassifies any system that offers psychological advice or therapy as “high-risk AI.” That means mental-health developers must clear a higher bar for data governance, transparency, and human oversight before launching in the EU market. This post breaks down the legal text into a practitioner-friendly checklist so teams like ours at Atlas Mind can ship compliant products without drowning in policy jargon.

1. Understand Your Risk Category—It’s Probably “High Risk”

Article 6 lists “AI systems intended to be used for emotional state recognition, or for providing mental-health assistance” as high-risk. Translation: if your product delivers coping strategies, mood tracking, or CBT exercises, you’re in scope—and subject to Articles 8–15 compliance obligations.

2. Data Governance & Documentation

• Data Provenance: Prove every data source is lawfully obtained and relevant to user well-being.
• Bias Management Plan: Document how you test for demographic bias in training data and model outputs.
• Data Minimization: Store only what you need for therapeutic benefit—no surplus metadata.

3. Human Oversight Requirements

The Act mandates a “human-in-the-loop” or “human-on-the-loop” approach for high-risk tools. At Atlas Mind we interpret this as:

1. Real-time escalation: Clinicians can intervene when the bot detects crisis language.
2. Periodic audit: Monthly transcript reviews by licensed professionals to ensure tone and safety.

4. Transparency & User Rights

• Plain-Language Disclosure: Inform users they are interacting with AI, not a human therapist.
• Explainability on Demand: Provide a short rationale describing how the AI generated a recommendation if a user asks.
• Easy Opt-Out: Allow users to delete their data or request human-only support.

5. Security & Robustness Testing

Article 15 requires documented “reasonably foreseeable misuse” tests. Implement red-team prompts—self-harm, hate speech, medical mis-direction—and demonstrate mitigations in your technical file.

6. Conformity Assessment & CE Marking

Before entering the EU market you’ll need:

• Technical File: Complete with risk management, test results, data lineage.
• EU Declaration of Conformity: Signed by a responsible legal entity.
• CE Mark: Affixed to your digital product, signaling compliance.

7. Implementation Timeline

The Act grants a 24-month grace period (until Feb 2027) for high-risk categories. If you’re launching sooner, build compliance work into your 2025 roadmap so you’re not scrambling in 2026.