Medicine · Korea AI Framework Act
Korea AI Framework Act for clinical AI workflows
Korea AI Framework Act in clinical AI workflows: what compliance requires, who asks for evidence, and the records to keep.
01 / The rule
What Korea AI Framework Act requires
AI business operators that develop AI or provide products and services using AI, including foreign operators whose conduct affects the Korean market or users.
- 01Notify users in advance when a product or service uses high-impact or generative AI (Art. 31(1)).
- 02Label generative AI output; if using a machine-readable mark, also indicate it at least once by text, voice or similar (Art. 31(2)).
- 03Clearly notify or label virtual sound, images or video that are hard to tell from reality (Art. 31(3)).
- 04High-impact AI operators: implement the Article 34(1) measures and keep supporting documents for five years.
- 05Foreign operators above revenue or user thresholds: appoint a domestic representative (Art. 36).
02 / In this sector
In a clinical AI workflow
Written for AI systems generally, with specific duties for generative AI output and for high-impact AI used in ten listed domains. Separate safety duties attach to models trained with at least 10^26 operations that meet further frontier criteria.
Clinical committees and health system AI governance.
HHS §1557 · HIPAA · FDA PCCP.
03 / Records
Records to keep
- 01Advance AI-use notices by surface and version
- 02Output labelling and watermark specifications
- 03High-impact classification decision and Article 34(1) measure records kept five years
- 04Domestic representative appointment, where thresholds are met
Optional evidence · where Planisphere fits
Keep a record anyone can check
When your team meets a duty, Planisphere can seal the event it reports as a receipt.
A disclosure shown, a review signed, a model change approved: the event your system reports.
The event becomes a sealed receipt, dated and attributed to whoever is signed in.
Paste the receipt into Verify. No account or key.
A record supports your compliance evidence process. It is not a legal finding or a certification. Systems that call Planisphere's gate API can also hold or refuse an action before it runs.
SOURCES
Go back to the source
Korea Ministry of Government Legislation (law.go.kr)
Korea Ministry of Government Legislation (law.go.kr)
US International Trade Administration
Future of Privacy Forum
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