AI Medical SW Doctor Answer Regulatory Support Meeting
Dr. Answer Capable of Predicting and Diagnosing 8 Major Diseases
Clinical trials are underway at 37 medical institutions in Korea.


The emergence of AI doctors in Korea that treat patients based on medical big data is expected to accelerate.

On the 31st, the Ministry of Science and ICT held a meeting at Seoul Asan Medical Center to discuss cooperation measures to support the medical device licensing of 'Doctor Answer,' an AI medical software developed with domestic technology.

The meeting was attended by Vice Minister Jang Seok-young of the Ministry of Science and ICT and Deputy Minister Yang Jin-young of the Ministry of Food and Drug Safety, as well as officials from medical institutions and companies participating in the development of Doctor Answer.

Attendees listened to explanations regarding the development and clinical trial status of Dr. Answer, as well as demonstrations and applications for specific diseases, and discussed ways to expedite medical device approval for Dr. Answer.

Doctor Answer is AI medical software being developed with the participation of a total of 1,962 people, including 26 domestic medical institutions and 22 ICT companies, centered around Asan Medical Center. The Ministry of Science and ICT and the project team invested a total of 48.8 billion won (36.4 billion won from government, 12.4 billion won from private sector) in the development of Dr. Answer over the past three years (2018–2020).

Doctor Answer consists of 21 AI software programs capable of supporting the prediction and diagnosis of diseases in clinical settings for eight major diseases (breast cancer, colorectal cancer, prostate cancer, cardiovascular and cerebrovascular diseases, heart disease, dementia, epilepsy, and rare genetic diseases in children), and is currently conducting clinical trials at 37 medical institutions in Korea.

Among the 21 software products, 11 were classified as medical devices by the Ministry of Food and Drug Safety. Of these, 4 types, including cerebral hemorrhage diagnosis (cerebral hemorrhage diagnosis, coronary artery calcification score diagnosis, colon polyp analysis based on endoscopic image analysis, and automatic numerical segmentation of brain images), have already received medical device approval from the Ministry. Seven types, including early dementia diagnosis, are currently undergoing approval review, 5 are classified as non-medical devices, and prototypes of the remaining 5 are under development.

In addition, to lay the foundation for Dr. Answer's entry into the global market, cross-validation for local application is being pursued at six hospitals under the Saudi Arabian Ministry of Defense Health and Human Health (MNG-HA).

Yang Jin-young, Deputy Minister of Food and Drug Safety, stated, “In 2017, the Ministry of Food and Drug Safety established the world’s first guidelines for the review of medical devices incorporating AI technology,” adding, “We will support Dr. Answer so that it can quickly obtain medical device approval.”

Jang Seok-young, the Second Vice Minister of Science and ICT, stated, “Dr. Answer plays a key role in the Digital New Deal project,” adding, “We will support Dr. Answer so that it can provide high-quality medical services both domestically and internationally.”