{"id":1650,"date":"2026-08-31T05:58:00","date_gmt":"2026-08-30T20:58:00","guid":{"rendered":"https:\/\/onepress.co.kr\/index.php\/briefing\/2026-08-31-china-ai-medical-imaging-ethics-en\/"},"modified":"2026-08-31T05:58:00","modified_gmt":"2026-08-30T20:58:00","slug":"2026-08-31-china-ai-medical-imaging-ethics-en","status":"publish","type":"briefing","link":"https:\/\/onepress.co.kr\/index.php\/briefing\/2026-08-31-china-ai-medical-imaging-ethics-en\/","title":{"rendered":"China issues ethics guidelines requiring human review, right of withdrawal and data security for AI medical imaging research"},"content":{"rendered":"

2026-08-31 05:58 KST<\/strong><\/p>\n

China’s Ministry of Science and Technology released ethical guidelines for artificial intelligence medical imaging research on August 27, ensuring human supervision, fairness, privacy protection, safety and transparency from algorithm development to clinical verification and translational research. The guidelines also include the principle that patients should be aware of the use of AI and be able to choose to consent.<\/p>\n

This does not mean that new AI diagnostic devices have been approved or that AI has been allowed to replace doctors’ judgment. This document is an ethical reference standard for research institutions and researchers, and medical device approval and clinical application by hospital must follow separate laws and reviews.<\/p>\n

What type of research is being targeted?<\/h2>\n

It covers a wide range of basic algorithm research, technology development, clinical verification, and actual conversion research for analyzing medical images such as X-rays, CT, MRI, ultrasound, and pathology images with AI. This is not an executive order that blanketly imposes new approval conditions on all medical devices already sold. This guideline outlines questions to be asked by ethics committees and developers during the research phase.<\/p>\n

What are the six principles<\/h2>\n

The guidelines present as core principles the promotion of human well-being, fairness, respect for human autonomy, personal information and data security, safety and controllability, and strengthening transparency. High accuracy alone is not enough; it means looking at what group of data was learned from, who is more likely to make errors, and whether people can overturn or stop the results.<\/p>\n

\"China
This AI-generated image explains the topic; it is not a photograph of the actual event, observation, or experiment.<\/figcaption><\/figure>\n

What do patients and research participants need to know?<\/h2>\n

Researchers must communicate in understandable terms the fact that AI is being used in medical image processing, the expected benefits and risks, and the scope of data use. Participants must be able to refuse consent or withdraw it subject to conditions. However, whether exceptions apply to consent methods, such as reuse of existing anonymized data, must be examined in conjunction with China’s existing research ethics regulations and institutional deliberation.<\/p>\n

How do we deal with bias and personal information?<\/h2>\n

A model created with data from only one hospital or one population may underperform across different equipment, regions, and ages. The guidelines call for representative data, performance checks by group, and minimal data collection and access control. Since anonymization does not eliminate all risks of re-identification, security at the storage, transmission, and sharing stages must be managed separately.<\/p>\n

What hasn’t been confirmed yet?<\/h2>\n

Although the guidelines set out six principles, they are not a new law establishing administrative measures in case of violation and product approval procedures. It remains to be seen what kind of checklist and public reporting each institution’s ethics review will actually require. You must check the original text from the Ministry of Science and Technology and the approval data from the national medical device regulatory agency.<\/p>\n

Primary sources and independent checks<\/h2>\n

China Ministry of Science and Technology official release<\/a><\/p>\n

Official guideline PDF<\/a><\/p>\n

Xinhua independent summary<\/a><\/p>\n

WHO ethics and governance benchmark<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China’s Ministry of Science and Technology has released ethics guidelines for AI medical imaging research. This is a reference guide for researchers and does not constitute approval or clinical performance certification for a specific diagnostic AI.<\/p>\n","protected":false},"featured_media":0,"template":"","meta":[],"class_list":["post-1650","briefing","type-briefing","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/onepress.co.kr\/index.php\/wp-json\/wp\/v2\/briefing\/1650","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/onepress.co.kr\/index.php\/wp-json\/wp\/v2\/briefing"}],"about":[{"href":"https:\/\/onepress.co.kr\/index.php\/wp-json\/wp\/v2\/types\/briefing"}],"wp:attachment":[{"href":"https:\/\/onepress.co.kr\/index.php\/wp-json\/wp\/v2\/media?parent=1650"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}