Presidential Decree No. 27214, jun. 8, 2016
| Article 1 (Purpose) |
| Article 2 (Composition of Commission) |
| (1) | Members of the National Patient Safety Commission (hereinafter referred to as the "Commission") under Article 8 (1) of the Patient Safety Act (hereinafter referred to as the "Act") shall be appointed or commissioned by the Minister of Health and Welfare according to the following category, taking their genders into consideration: |
| 1. | Persons falling under Article 8 (3) 1 of the Act: Five persons; |
| 2. | Persons falling under Article 8 (3) 2 of the Act: Five persons; |
| 3. | Persons falling under Article 8 (3) 3 of the Act: Three persons; |
| 4. | Persons falling under Article 8 (3) 4 of the Act: One person. |
| (2) | A term of office of members who fall under Article 8 (3) 1 through 3 shall be two years: |
| (3) | Where a member of the Commission falls under any of the following cases, the Minister of Health and Welfare may dismiss such member from his/her office: |
| 1. | Where he/she is incapable of carrying out his/her duties due to mental handicap; |
| 2. | Where he/she conducts any irregularity in connection with his/her duties; |
| 3. | Where he/she is deemed unsuitable for a member due to his/her delinquency of duties, injury to dignity, or any other reason; |
| 4. | Where he/she voluntarily confesses that it is difficult for him/her to perform his/her duties. |
| Article 3 (Operation of Commission) |
| (1) | The Chairperson of the Central Deliberative Committee shall represent the Central Deliberative Committee and exercise overall control of its affairs. |
| (2) | A meeting of the Commission shall be convoked at the request of not less than one third of all incumbent members or when the Chairperson of the Commission deems it necessary, and the Chairperson of the Commission shall preside over the meeting. |
| (3) | A majority of the members of the Commission shall constitute a quorum, and any decision thereof shall require the concurring vote of at least a majority of those present. |
| (4) | Where the Chairperson of the Commission is unable to perform his/her duties due to any extenuating circumstances, a member who has been designated in advance shall act on his/her behalf. |
| (5) | The Commission shall have one executive secretary to deal with its administrative affairs, who shall be appointed by the Minister of Health and Welfare from among public officials of the Ministry of Health and Welfare. |
| (6) | Commissioned members who have attended a meeting of the Commission may be reimbursed with allowances and travel expenses within budgetary limits. |
| Article 4 (Detailed Operation Rules) |
| Article 5 (Sub-commissions) |
| (1) | A sub-commission under Article 8 (5) of the Act (hereinafter referred to as "sub-commission") shall be comprised of not more than seven members including one Chairperson. |
| (2) | The Chairperson and members of a sub-commission shall be appointed by the Minister of Health and Welfare from among members of the Commission. |
| (3) | Except as provided for in paragraphs (1) and (2), detailed matters necessary for the composition, operation, etc. of subcommissions shall be determined by the Chairperson of the Commission following resolution of the Commission. |
| Article 6 (Standards for Patent Safety) |
| (1) | Matters to be included in the standards for patient safety referred to in Article 9 (1) of the Act (hereinafter refers to as "standards for patient safety") shall be classified as follows: |
| 1. | Following matters concerning the facilities and equipment of health and medical institutions defined in subparagraph 4 of Article 3 of the Framework Act on Health and Medical Services (hereinafter referred to as "health and medical institutions"): |
| (a) | Matters concerning the operation and management of facilities closely related with patent safety, such as patients' rooms, intensive care units, operating rooms, and emergency rooms; |
| (b) | Matters concerning the management and discarding of medical devices, etc. frequently used for the examination, diagnosis, medical care, treatment, etc. of patients; |
| 2. | Following matters concerning the management system of health and medical institutions: |
| (a) | Matters concerning the human resources and organizations in charge of patient safety activities; |
| (b) | Matters concerning the preparation and operation of manuals for systematic performance of patient safety activities; |
| (c) | Matters concerning a system to cope with any patient safety accident; |
| 3. | Matters to be observed concerning the following health and medical activities performed by health and medical services personnel defined in subparagraph 3 of Article 3 of the Framework Act on Health and Medical Services: |
| (a) | Diagnosis and examination; |
| (b) | Medical procedures, operations, and anesthesia; |
| (c) | Prescription for, and preparation, administration and management of, medicines medical supplies; |
| (d) | Prevention and management of infectious diseases; |
| 4. | Other Matters similar to those prescribed in subparagraphs 1 through 3, which the Minister of Health and Welfare deems particularly necessary for preventing and managing patient safety accidents. |
| (2) | In determining the standards for patient safety, the Minister of Health and Welfare may request relevant institutions, organizations, experts, etc. to provide their opinions and data. |
| (3) | The Minister of Health and Welfare shall finalize the standards for patient safety following deliberation of the Commission and post the finalized standard for patient safety on the Internet home page of the Ministry of Health and Welfare. |
| (4) | Paragraphs (2) and (3) shall apply |
| (5) | Except as provided for in paragraphs (1) through (4), detailed matters concerning the establishment, modification, operation, etc. of the standards for patient safety shall be determined by the Minister of Health and Welfare. |
| Article 7 (Institutions to be Requested to Provide Data for Development of Patient Safety Index) |
| 1. | Accrediting institutions under Article 58 (2) of the Medical Services Act; |
| 2. | The National Evidence-based Healthcare Collaborating Agency under Article 19 of the Health and Medical Service Technology Promotion Act; |
| 3. | The Korea Institute for Health and Social Affairs under Article 8 (1) of the Act on the Establishment, Operation and Fostering of Government-Funded Research Institutes, Etc.; |
| 4. | The Korea Health Industry Development Institute under the Korea Health Industry Development Institute Act; |
| 5. | Other institutions determined and publicly notified by the Minister of Health and Welfare among institutions closely related with health and medical services. |
| Article 8 (Entrustment, etc. of Operation of System for Reporting and Learning of Patient Safety Accidents) |
| (1) | The Minister of Health and Welfare may, pursuant to Article 16 (5) of the Act, entrust the operation of the reporting and learning system referred to in paragraph (1) of the same Article (hereinafter referred to as "reporting and learning system") to any of the following specialized institutions: |
| 1. | An accrediting institution under Article 58 (2) of the Medical Services Act; |
| 2. | The Health Insurance and Assessment Service under Article 62 of the National Health Insurance Act; |
| 3. | The Korea Medical Dispute Mediation and Arbitration Agency under Article 6 of the Act on Remedies for Injuries from Medical Malpractice and Mediation of Medical Dispute. |
| (2) | Where the Minister of Health and Welfare entrusts the operation of the reporting and learning system under paragraph (1), he/she shall publicly notify such information as the name and location of the relevant institution, name of its representative, details of entrusted affairs, etc. |
| Article 9 (Subsidization of Expenses for Reporting and Learning System) |
| 1. | Operating expenses required for the operation of the reporting and learning system, including personnel expenses and rent; |
| 2. | Expenses for the installation and maintenance of facilities, equipment, programs, etc. necessary for the reporting and learning system; |
| 3. | Expenses required for the improvement, maintenance and repair of the reporting and learning system. |
| Article 10 (Management of Sensitive Information and Personally Identifiable Information) |
| 1. | Affairs related to the grasping of actual state of patient safety activities referred to in Article 7 (2) 3 of the Act; |
| 2. | Affairs related to the confirmation of qualifications of exclusive personnel for patient safety referred to in Article 12 (1) of the Act; |
| 3. | Affairs related to the education on patient safety activities under Article 13 of the Act; |
| 4. | Affairs related to the autonomous reporting of a patient safety accident under Article 14 of the Act; |
| 5. | Affairs related to the development of patient safety index under Article 15 (1) of the Act; |
| 6. | Affairs related to the operation of the reporting and learning system under Article 16 (1) of the Act (applicable only to cases where information and data are managed by the relevant system); |
| 7. | Affairs related to the verification of information on a patient safety accident on which an autonomous report has been filed and the data have been collected under Article 17 (2) of the Act. |