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Personal Information Protection Commission Moves to Rationalize Health and Medical Regulations... "Improving Difficulties in Data Utilization"

Roundtable Held on Rationalizing Regulations for the Use of Health and Medical Data

The Personal Information Protection Commission said on the 9th that it held an on-site roundtable with the Ministry of Health and Welfare to rationalize personal information regulations in the health and medical sector.


The roundtable, held on this day, was conducted as a follow-up measure to the discussion on "Rationalizing Core Regulations for K-Bio" at the 2nd Strategy Meeting on Rationalizing Core Regulations held in October last year. It was organized to hear about on-site regulatory and institutional difficulties that arise in the process of utilizing health and medical data and to discuss improvement measures.


Personal Information Protection Commission Moves to Rationalize Health and Medical Regulations... "Improving Difficulties in Data Utilization" The Personal Information Protection Commission said on the 9th that it held an on-site meeting with the Ministry of Health and Welfare to rationalize personal data regulations in the healthcare sector. Song Kyunghee, chairperson of the Personal Information Protection Commission, speaks at the meeting. Photo provided by the Personal Information Protection Commission.

According to the Personal Information Protection Commission, the government has continued its efforts to rationalize regulations since the previous strategy meeting. It has prepared detailed criteria for the research use of deceased persons' medical data and specified them in guidelines, while also issuing a non-action opinion on pseudonymous information regarding the "use of pseudonymized medical data of deceased patients for research and educational purposes." A non-action opinion is a system in which the Personal Information Protection Commission receives detailed information on the processing of pseudonymous information, reviews whether it violates laws and regulations, and, if it determines that there is no illegality, notifies that the case is not subject to administrative action.


At the roundtable, researchers from Kakao Healthcare and Seoul National University Hospital presented cases of developing artificial intelligence (AI) based on medical data and research trends in the use of health and medical data. In doing so, they explained both the importance of expanding data sharing that they have experienced firsthand and the difficulties faced by on-site researchers.


Next, the Personal Information Protection Commission introduced the main policy directions of the "Innovation Plan for the Pseudonymous Information System and Its Operation" announced in September last year, and presented newly introduced systems for the safe use of data, such as the one-stop pseudonymization support service and the non-action opinion on pseudonymous information.


In the discussion that followed the presentations, participants including researchers from university hospitals and companies developing medical AI and medical devices offered suggestions for expanding the sharing and use of medical data. A variety of opinions were presented, including on the following issues raised at the previous Strategy Meeting on Rationalizing Core Regulations: plans for utilizing medical data of deceased persons; difficulties in determining the appropriateness of pseudonymization; and ways to enhance the utilization of the Personal Information Innovation Zone.


Chairperson Song Kyunghee said, "For the development of new bio industries such as medical AI and digital health, the safe use of health and medical data, based on the trust of all stakeholders, must be ensured," adding, "Going forward, we will work closely with related ministries such as the Ministry of Health and Welfare to proactively resolve the difficulties in data utilization that are being felt in the field."


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