[Background]
Following the amendment of the Medical Service Act (Act No. 21776, promulgated on June 9, 2026, taking effect on December 10, 2026) and pursuant to the delegation of the Enforcement Rule of the same Act to be amended accordingly, this amendment aims to securely manage and preserve Electronic Medical Records (EMR) and strengthen the protection of patients' personal information. It achieves this by expanding the scope of the obligation to retain access logs, requiring that logs be kept not only when medical personnel or the founder of a medical institution makes an additional entry or modification to an EMR, but also when they make an initial entry or view the record.
[Main Points]
A. Changing the purpose of the Notice from the existing "Standards on Facilities and Equipment" to "Matters concerning Standards on Facilities and Equipment and Access Logs" (Draft Article 1).
B. Deleting the existing term "log information" from the definitions and establishing a new definition for "access logs" in accordance with the Enforcement Rule of the Medical Service Act (Draft Article 2, Subparagraph 4).
C. Reorganizing provisions to enable the retention of access logs regarding viewing (reading) in accordance with the amendment of the Enforcement Rule of the Medical Service Act.
- Changing the title of Article 4 to "(Equipment, etc. for the History Management and Access Log Management of Electronic Medical Records)" (Draft Article 4).
- Specifying the functions of history management and the generation and retention of access logs as required equipment functions for EMR managers (Draft Article 4, Paragraph 1).
- Stipulating that the retention and management period of generated access logs shall be identical to the mandatory preservation period for medical records, etc., as determined in each subparagraph of Article 15, Paragraph 1 of the Enforcement Rule of the Medical Service Act (Draft Article 4, Paragraph 2).
D. Aligning the cited article numbers within the Notice according to the amendment and relocation of provisions in the Enforcement Decree of the Personal Information Protection Act (Draft Article 6, Subparagraphs 1 and 2).
E. Changing the base date for the reassessment period to January 1, 2027, to periodically review the validity of the Notice (Draft Article 9).
