Under the AI Act, EU member states must provide a sandbox so that innovative AI systems can be safely tested for security and regulatory compliance in an isolated test environment.
The Spitzenverband Digitale Gesundheitsversorgung (SVDGV) has published a green paper proposing and outlining a regulatory sandbox specifically for healthcare.
It proposes enabling efficient testing by providing the following resources:
- Public goods: machine-readable medical guidelines, for example
- Company services: classification, study protocols or test data sets, for example
- Regulatory learning: working groups on general-purpose AI, dynamic AI systems and human oversight
The SVDGV published the press release, including the option to download the green paper, here: „AI Regulatory Sandbox“ in der Medizin (Green Paper)