ENFORCEMENT DECREE OF THE PATIENT SAFETY ACT
Presidential Decree No. 27214, jun. 8, 2016
Amended by Presidential Decree No. 30872, Jul. 28, 2020
Presidential Decree No. 31414, Jan. 26, 2021
The purpose of this Decree is to prescribe matters mandated by the Patient Safety Act and matters necessary for the enforcement of said Act.
| Article 1-2 (Details and Methods of Fact-finding Surveys of Patient Safety Accidents) |
| 1. | The scale of the patient safety accident occurred; |
| 2. | Matters concerning the characteristics of the patient safety accident, such as the type of the accident, the place where the accident occurred, the degree of harm, and the possibility of prevention; |
| 3. | Other matters on which the Minister of Health and Welfare deems it necessary to conduct fact-finding surveys for patient safety and improvement of medical service quality. |
| (2) | The Minister of Health and Welfare may conduct a fact-finding survey by entrusting such fact-finding survey to a specialized research institute or organization, or related expert. |
| (3) | The Minister of Minister of Health and Welfare may supplement a fact-finding survey by conducting a temporary survey if an additional survey is necessary due to change, etc. in the social environment related to patient safety. |
[This Article Newly Inserted on Jul. 28, 2020]
| Article 2 (Composition of the Commission) |
| (1) | Members of the National Patient Safety Commission (hereinafter referred to as the "Commission") under Article 8 (1) of the Act shall be appointed or commissioned by the Minister of Health and Welfare according to the following category, taking gender equality into consideration: <Amended on Jul. 28, 2020> |
| (2) | A term of office of members who fall under Article 8 (3) 1 through 4 shall be two years: Provided, That the term of office of a member newly commissioned due to dismissal of an existing member shall be the remainder of his or her predecessor's term of office. <Amended on Jul. 28, 2020> |
| (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 or her office: |
| 1. | Where he or she is incapable of carrying out his or her duties due to mental or physical disorder; |
| 2. | Where he or she conducts any irregularity in connection with his or her duties; |
| 3. | Where he or she is deemed unsuitable for a member due to his or her delinquency of duties, injury to dignity, or any other reason; |
| 4. | Where he or she voluntarily confesses that it is difficult for him or her to perform his or 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 or her duties due to any extenuating circumstances, a member who has been designated in advance shall act on his or 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) |
Except as provided in this Decree, necessary matters concerning the composition and operation of the Commission shall be determined by the Chairperson of the Commission following resolution of the Commission.
| 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 5-2 (Designation of Central Patient Safety Center) |
[This Article Newly Inserted on Jul. 28, 2020]
| 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: |
| (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; |
| (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 mutatis mutandis to the procedures for the modification of the standards for patient safety: Provided, That deliberation by the Commission may be omitted if the Minister of Health and Welfare deems it unnecessary to submit the relevant modification to the Commission for deliberation because the modified matter is trifle or insignificant. |
| (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 6-2 (Administrative Data Matching) |
| 1. | Licenses of relevant physicians, dentists, Korean medicine doctors, pharmacists, and nurses; |
| 2. | Licenses of specialized medical doctors; |
| 3. | National pension subscriber certificates; |
| 4. | Health Insurance entitlement status certificates. |
| (2) | Where the Minister of Health and Welfare fails to obtain prior consent under the latter part of paragraph (1), he or she may request the relevant data subject as defined in subparagraph 3 of Article 2 of the Personal Information Protection Act to submit the relevant data. |
[This Article Newly Inserted on Jul. 28, 2020]
| Article 7 (Institutions to Be Requested to Provide Data for Development of Patient Safety Index) |
"Institutions prescribed by Presidential Decree" in Article 15 (1) 5 of the Act means the following agencies, institutes, and institutions: | 1. | The Korea Institute for Healthcare Accreditation established under Article 58-11 of the Medical Services 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 7-2 (Institutions to Be Requested to Provide Data Related to Patient Safety Accidents) |
| (1) | "Institutions prescribed by Presidential Decree" in Article 15-2 (1) 5 of the Act means the following agencies, institutes, institutions, and services: |
| 4. | The Korea Institute for Healthcare Accreditation under Article 58 -11 of the Medical Services Act; |
| 7. | Other institutions determined and publicly notified by the Minister of Health and Welfare among those that hold data related to patient safety accidents. |
[This Article Newly Inserted on Jul. 28, 2020]
| Article 8 (Entrustment of Operation of System for Reporting and Learning of Patient Safety Accidents) |
The Minister of Health and Welfare shall, pursuant to Article 16 (5) of the Act, entrust the operation of the reporting and learning system under paragraph (1) of the same Article (hereinafter referred to as "reporting and learning system") to the Central Patient Safety Center designated under Article 8-2 (1) of the Act (hereinafter referred to as the "Central Patient Safety Center"). [This Article Wholly Amended on Jul. 28, 2020]
| Article 9 (Subsidization of Expenses for Reporting and Learning System) |
The Minister of Health and Welfare may, pursuant to Article 16 (6) of the Act, subsidize the following expenses required by a specialized institution entrusted with the operation of the reporting and learning system within budgetary limits: | 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) |
| 2. | Affairs related to the confirmation of qualifications of exclusive personnel for patient safety referred to in Article 12 (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. |
| Article 11 (Criteria for Imposition of Administrative Fines) |
[This Article Newly Inserted on Jan. 26, 2010]
ADDENDUM <Presidential Decree No. 27214, Jun. 8, 2016>
This Decree shall enter into force on July 29, 2016.
ADDENDA <Presidential Decree No. 30872, Jul. 28, 2020>
Article 1 (Enforcement Date)
This Decree shall enter into force on July 30, 2020: Provided, That the amended provisions of subparagraph 1 of Article 7 shall enter into force on September 5, 2020. Article 2 (Transitional Measures concerning Institute to Be Designated as Central Patient Safety Center)
"Korea Institute for Healthcare Accreditation under Article 58-11 of the Medical Service Act" in the amended provisions of Article 5-2 and those of subparagraph 4 of Article 7-2 shall be construed as "accrediting institution under Article 58 (2) of the Medical Service Act" until September 4, 2020.
ADDENDUM <Presidential Decree No. 31414, Jan. 26, 2021>
This Decree shall enter into force on January 30, 2021.