MOHW announced the amended "Guidelines on Utilizing Medical Health Data"
작성자 관리자날짜 2023-03-01 10:10:28조회수 184
The Ministry of Health and Welfare ("MOHW") of Korea recently announced the amended "Guidelines on Utilizing Medical Health Data" on December 28, 2022. The Personal Information Protection Act ("PIPA") of Korea was amended in August 2020 to permit anonymization of personal information for the use of collecting statistics, public welfare, scientific research and other beneficiary purposes without the express consent of the person/individual. Thereafter the MOHW announced its amended Guidelines on Utilizing Medical Health Data that permitted anonymization of medical data to be used for medical purposes. This recent amendment is the second amendment to the guideline.
The definition of Medical Data encompasses a vast array of data including medical images, biometrics, DNA, healthcare provider notes, diagnostic data test records etc. and the Guideline has provided methods of anonymizing Medical Data to be compliant with local laws and regulations. Since the initial introduction of the Guideline, medical institutions have provided feedback on items that were not clear with regard to anonymization requirements for various Medical Data to the MOHW and thus the MOHW announced its recent amendments to the Guideline after receiving feedback. For example, for medical images, the MOHW have determined that images that have deleted/mosaiced items that can identify any particular individual would be deemed as anonymized Medical Data that can be used for various public purposes. In addition, for DICOM images, the old Guidelines required that DICOM Head be deleted, but the amendment now only requires the information that can identify an individual in the HEAD to be deleted instead of the entire DICOM Head. In addition, the Data Review Board requirement at medical institutions have been relaxed to only require two outside board members (from more than half previously), and thus respecting the decision making of the medical institution.
Collecting and utilizing Medical Data is critical for AI development and SaMD product development. And although these amendments are a welcomed change to the existing Guideline, the current Medical Device Act of Korea requires IDE and IRB approval for initial feasibility studies of medical devices that utilizes Medical Data, which can hinder such efforts. Although such changes had been proposed to relax the regulations previously, these amendments were unfortunately ultimately dropped by the National Assembly of Korea. Despite this hiccup, we believe that medical device and especially digital health regulatory amendments are taking a step in the right direction and are optimistic that such amendments will continue to be implemented to permit greater freedom and advancements in the medical device field going forward.
Please let us know if you have any questions regarding the above or any other medical device related matters in Korea at pro@mdrex.co.kr