# Korea's AI Framework Act places the use of AI medical devices inside high-impact AI, obliging the user to keep it under human management and supervision and to be able to explain its output

Page: https://flyvolo.ai/en/changes/ev-20260721-radiologist-3
Date: 2026-07-21 · Stage: Constraint
Can this record move a task judgement? yes
Occupation: https://flyvolo.ai/en/careers/radiologist

## Scope

South Korea. The word that matters in Article 2(4)(ra) is use: the high-impact category covers the development and the use of medical devices and digital medical devices, so a hospital running a cleared AI reading tool is an AI-using operator under this Act and not merely a customer of one. Article 34(1) then attaches duties to that operator — a risk-management plan, an ability to explain the output and the main criteria behind it, documentation, and item 4, human management and supervision. Article 31(1) separately requires telling the user in advance that the service runs on AI. Two limits: the detail is left to a Presidential Decree not contained in this text, and the fundamental-rights impact assessment in Article 35 is only a best-efforts duty. This says nothing about how many radiologists a hospital employs, and nothing about accuracy — it fixes who has to be able to answer for the output.

## Source

- 국가법령정보센터 (Korea Ministry of Government Legislation) — 인공지능 발전과 신뢰 기반 조성 등에 관한 기본법, 법률 제21311호 — https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%9D%B8%EA%B3%B5%EC%A7%80%EB%8A%A5%EB%B0%9C%EC%A0%84%EA%B3%BC%EC%8B%A0%EB%A2%B0%EA%B8%B0%EB%B0%98%EC%A1%B0%EC%84%B1%EB%93%B1%EC%97%90%EA%B4%80%ED%95%9C%EA%B8%B0%EB%B3%B8%EB%B2%95 (primary source)

## What this means

The duty follows the tool into the hospital. Korea's Act covers not just building an AI medical device but using one, so a department that switches on a cleared reading tool takes on its own obligations: keep it under human supervision, be able to explain the output and the criteria behind it, and tell the patient the service runs on AI. The emerging task on this page — being the named person on a report a machine helped write — is now a legal position in at least one country, not a prediction.

## What it does not show yet

It does not say a single Korean hospital has switched such a tool on, and it does not touch accuracy or turnaround. Nor does it settle how heavy the duty is: the Presidential Decree that defines what supervision and explanation actually require is not in this text, and until it exists the burden could land anywhere between a policy document and a second read of every study.

## How to verify it yourself

If you read in Korea, ask what your department has written down about who signs a report the tool touched, and whether the patient is told. Both are now legal questions with a named answer, and a department that cannot produce one has not started.


More: https://flyvolo.ai/llms.txt