Article 50 requires providers to design AI systems that interact with natural persons so that those persons are informed they are interacting with an AI, and that synthetic audio, image, video, or text output is marked as artificially generated or manipulated in a machine-readable format. Deployers of emotion-recognition or biometric-categorisation systems must inform exposed persons.

Why it matters

Digital therapeutics and clinical chat interfaces should surface an explicit AI disclosure and, where they generate synthetic content (for example patient education videos), meet the labelling requirement. This applies even when the device is not high-risk.

Common pitfalls

•Failing to implement clear, user-facing disclosures that explicitly state interaction with an AI system is occurring. This can lead to user confusion and non-compliance, even if the AI is not deemed high-risk.
•Not adequately labeling synthetic content in a machine-readable and easily understandable format. Simply adding a small, obscure disclaimer may not meet the intent of informing users about artificially generated material.
•Assuming that transparency obligations only apply to high-risk AI systems. Many transparency requirements, like informing users of AI interaction and labeling synthetic content, apply more broadly regardless of risk classification.
•Overlooking the specific requirements for deployers of emotion-recognition or biometric-categorisation systems to inform exposed persons. This is a distinct obligation beyond general AI interaction disclosures.

Sources

Regulation (EU) 2024/1689, Article 50 · EUR-Lex
FDA - Medical Devices · FDA
European Commission - Medical Devices · European Commission

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