The purpose of this Act is to contribute to the protection of patients and the improvement of medical service quality by prescribing matters necessary for the safety of patients.
The terms used in this Act are defined as follows: <Amended on Jan. 29, 2020>
| 1. | The term "patient safety incident" means an incident that has caused or is likely to cause any hazard prescribed by Ordinance of the Ministry of Health and Welfare to the safety of a patient in the course of providing any health and medical services to the patient by health and medical services personnel prescribed in subparagraph 3 of Article 3 of the Framework Act on Health and Medical Services (hereinafter referred to as "health and medical services personnel"); |
| 2. | The term "patient safety activities" means all activities conducted by the State, local governments, health and medical institutions prescribed in subparagraph 4 of Article 3 of the Framework Act on Health and Medical Services (hereinafter referred to as "health and medical institutions"), health and medical services personnel, patients, their guardians, and relevant institutions, corporations, and organizations to prevent patient safety incidents and the reoccurrence thereof. |
| Article 3 (Obligations of the State and Local Governments) |
| (1) | The State and local governments shall prepare and carry forward policies for patient safety and improvement of medical service quality. |
| (2) | The State and local governments shall prepare an institutional framework necessary for patient safety activities. |
| (3) | The State and local governments may provide administrative and financial support necessary for patient safety activities conducted by health and medical institutions, health and medical services personnel, and patients and their guardians. |
| (4) | The State and local governments shall endeavor to promote the participation of patients in patient safety activities. |
| Article 4 (Obligations of Heads of Health and Medical Institutions and Health and Medical Services Personnel) |
| (1) | In order to ensure patient safety and improvement of medical service quality, the heads of health and medical institutions and medical services personnel shall follow the policies of the State and local governments. |
| (2) | The heads of health and medical institutions and medical services personnel shall be equipped with facilities, equipment, and human resources to prevent occurrence of patient safety incidents, and shall fulfill their obligations required. |
| (3) | The heads of health and medical institutions and medical services personnel shall strive for patients and their guardians to participate in patient safety activities. |
| Article 5 (Rights and Obligations of Patients) |
| (2) | Patients and their guardians shall participate in patient safety activities. |
| Article 6 (Relationship to Other Statutes) |
| (1) | Matters concerning patient safety shall be governed by this Act, except as otherwise provided in other statutes. |
| (2) | Where any other statute related to patient safety is enacted or amended, it shall be ensured to conform to the purport of this Act. |
| Article 7 (Formulation of Comprehensive Plans for Patient Safety) |
| (1) | In order to ensure patient safety and improvement of medical service quality, the Minister of Health and Welfare shall formulate a comprehensive plan for patient safety (hereinafter referred to as "comprehensive plan" in this Article) every five years and implement it in consultation with heads of related central administrative agencies. |
| (2) | A comprehensive plan shall include the following matters: |
| 1. | Basic objectives, and direction for promotion, of patient safety activities; |
| 2. | Plan and methods of promoting patient safety activities; |
| 3. | Grasping of actual state of patient safety activities, and operation and management of reporting and learning system prescribed in Article 16; |
| 4. | Research and development of technologies for patient safety activities, and training of and support for specialized human resources; |
| 5. | Standards for patient safety referred to in Article 9; |
| 6. | Methods of participation of patients and their guardians in patient safety activities; |
| 7. | Other Matters necessary for the patient safety activities prescribed by Ordinance of the Ministry of Health and Welfare. |
| (3) | In order to formulate a comprehensive plan, the Minister of Health and Welfare may request the heads of institutions, corporations and organizations concerned to provide data necessary for the formulation of the comprehensive plan. In such cases, the heads of the relevant institutions, corporations and organizations shall comply with such request unless there is good cause. |
| (4) | Upon finalizing a comprehensive plan, the Minister of Health and Welfare shall report it to the National Assembly without delay. |
| (5) | The Minister of Health and Welfare shall publish a white paper on patient safety and announce it every five years. |
| Article 7-2 (Fact-Finding Surveys on Patient Safety Incidents) |
| (1) | The Minister of Health and Welfare may conduct a fact-finding survey on s (hereinafter referred to as "fact-finding survey") every five years and publish the findings so as to formulate and implement policies for patient safety and improving medical service quality. |
| (2) | Where necessary for conducting fact-finding surveys, the Minister of Health and Welfare may request the heads of related central administrative agencies, the heads of local governments, the heads of public institutions defined under Article 4 of the Act on the Management of Public Institutions, the heads of health and medical institutions, and the heads of other related institutions, corporations, or organizations to submit necessary data. In such cases, the heads of related central administrative agencies, etc., shall comply with such request, unless there is good cause. |
| (3) | Matters necessary for methods and contents of a fact-finding survey shall be prescribed by Presidential Decree. |
[This Article Newly Inserted on Jan. 29, 2020]
| Article 8 (National Patient Safety Commission) |
| (1) | In order to deliberate on the following matters concerning patient safety, the National Patient Safety Commission (hereafter referred to as the "Commission" in this Article) shall be established in the Ministry of Health and Welfare: <Amended on Jan. 29, 2020> |
| 1. | Major policies for patient safety and improvement of medical service quality; |
| 2. | Project plans for prevention of patient safety incidents and the reoccurrence thereof; |
| 3. | Utilization and disclosure of the results of analysis of the contents of reports on patient safety incidents filed under Article 14 (1) and (2); |
| 4. | Other important matters concerning patient safety that the Chairperson deems necessary for a deliberation. |
| (2) | The Commission shall consist of up to 17 members including one chairperson. <Amended on Jan. 29, 2020> |
| (3) | The Vice Minister of Health and Welfare shall be the Chairperson of the Commission, and the members of the Commission shall be appointed or commissioned from among the following persons: <Amended on Jan. 29, 2020> |
| 4. | Persons with extensive knowledge of and experience in patient safety; |
| 5. | Public officials of Grade III or higher who belong to the Ministry of Health and Welfare, or public officials who belong to the senior civil service thereof; |
| 6. | Other public officials in general service belonging to the Senior Executive Service of the related central administrative agencies (including public officials in special service or in extraordinary civil service equivalent thereto). |
| (4) | Meetings of the Commission shall be held at least once each year. |
| (5) | Subcommissions may be established for the efficient operation of the Commission. |
| (6) | Matters concerning the organization and operation of the Commission and subcommissions and other necessary matters shall be prescribed by Presidential Decree. |
| Article 8-2 (Central Patient Safety Centers) |
| (1) | In order to effectively implement policies of the relevant central administrative agencies for protecting patients and improving medical service quality, the Minister of Health and Welfare may designate a non-profit corporation prescribed by Presidential Decree as a central patient safety center whose purposes are patient safety activities. |
| (2) | A central patient safety center shall perform the following tasks: |
| 1. | Implementation of the comprehensive plan for patient safety; |
| 2. | Support for the development and dissemination of the standards for patient safety referred to in Article 9 and the patient safety indicators referred to in Article 10; |
| 3. | Support for the operation of a patient safety commission referred to in Article 11; |
| 4. | Support for the management of dedicated patient safety personnel under Article 12; |
| 5. | Receipt, verification, and analysis of patient safety incidents; |
| 6. | Research on patient safety activities; |
| 7. | Other matters necessary for protecting patients and improving the medical service quality. |
| (3) | The Minister of Health and Welfare may bear all or some of expenses incurred in the performance of tasks under the subparagraphs of paragraph (2) to support central patient safety centers designated pursuant to paragraph (1) within the budget. |
| (4) | Matters necessary for the designation and operation of central patient safety centers referred to in paragraphs (1) through (3) shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
[This Article Newly Inserted on Jan. 29, 2020]
| Article 8-3 (Regional Patient Safety Centers) |
| (1) | The Minister of Health and Welfare may designate a hospital-level medical institution, relevant association, or organization, etc. of at least the size prescribed by Ordinance of the Ministry of Health and Welfare as a regional patient safety center in order to implement regional policies for protecting patients and improving medical service quality and to effectively support the policies of the relevant central administrative agency. |
| (2) | A regional patient safety center may perform the following programs: |
| 1. | Education programs related to patient safety incidents; |
| 2. | Prevention of patient safety incidents and public relations activities therefor; |
| 3. | Support for reporting patient safety incidents; |
| 4. | Other programs entrusted by the Minister of Health and Welfare. |
| (3) | The Minister of Health and Welfare may bear all or some of expenses incurred in the performance of programs under the subparagraphs of paragraph (2) to support regional patient safety centers designated pursuant to paragraph (1) within the budget. |
| (4) | Where a regional patient safety center designated pursuant to paragraph (1) falls under any of the following, the Minister of Health and Welfare may revoke the designation thereof or order it to make corrections: |
| 1. | Where it is designated by fraud or other improper means; |
| 2. | Where it fails to perform the programs referred to in the subparagraphs of paragraph (2) for at least six months without good cause; |
| 3. | Where the industrial education center is deemed to significantly fall short of the capabilities to perform duties. |
| (5) | Matters necessary for procedures for the designation and operation, and revocation of designation, of a regional patient safety center and corrective orders paragraphs (1) through (4) shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
[This Article Newly Inserted on Jan. 29, 2020]
| Article 9 (Standards for Patient Safety) |
| (1) | The Minister of Health and Welfare shall prescribe the standards for patient safety, such as facilities, equipment, management system of health and medical institutions and matters to be observed by health and medical services personnel for patient safety (hereinafter referred to as "standards for patient safety" in this Article), as prescribed by Presidential Decree. |
| (2) | The heads of health and medical institutions and health and medical services personnel shall observe the standards for patient safety when they conduct patient safety activities. |
| Article 10 (Patient Safety Indicators) |
| (1) | The Minister of Health and Welfare shall develop and disseminate indicators that propose standards for evaluation, etc. which make it possible to measure and check performance degree in respect of patient safety and improvement of medical service quality (hereinafter referred to as "patient safety indicators"). |
| (2) | Matters necessary for the development and dissemination of patient safety indicators shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
| Article 11 (Patient Safety Commission) |
| (1) | Any hospital-level medical institution of at least the size prescribed by Ordinance of the Ministry of Health and Welfare shall establish and operate a patient safety commission (hereinafter referred to as "commission" in this Article) for patient safety and improvement of medical service quality. |
| (2) | The head of a medical institution that has installed a commission shall file an annual report with the Minister of Health and Welfare with respect to whether a commission has been established and the composition and operation of the commission: <Newly Inserted on Jan. 29, 2020> |
| (3) | The commission shall deliberate on the following affairs: <Amended on Jan. 29, 2020> |
| 1. | Formulation and implementation of plans for prevention of patient safety incidents and the reoccurrence thereof; |
| 2. | Appointment and placement of dedicated patient safety personnel prescribed in Article 12; |
| 3. | Activities for improvement of medical service quality and establishment and operation of patient safety system of the health and medical institution; |
| 4. | Protection of a person who has filed a report under Article 14 (1) and (2) and the matters reported; |
| 5. | Formulation and implementation of plans for patients and their guardians to participate in patient safety activities; |
| 6. | Other matters necessary for the patient safety activities prescribed by Ordinance of the Ministry of Health and Welfare. |
| (4) | Matters concerning the organization and operation of a commission, methods of and procedures for reporting, and other necessary matters shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended on Jan. 29, 2020> |
| Article 11-2 (Relationship between Patient Safety Commission and Other Commissions) |
A medical institution establishing and operating a patient safety commission under Article 11 may, if necessary, operate the patient safety commission after integrating it with another commission established and operated under other statutes, which are prescribed by Ordinance of the Ministry of Health and Welfare. [This Article Newly Inserted on Jan. 29, 2020]
| Article 12 (Dedicated Patient Safety Personnel) |
| (1) | Any hospital-level medical institution of at least the size prescribed by Ordinance of the Ministry of Health and Welfare shall have personnel dedicated to the performance of affairs related to patient safety and improvement of medical service quality (hereinafter referred to as "dedicated patient safety personnel") consisting of either of the following persons: <Amended on Jan. 29, 2020> |
| 1. | A person who has served in a health and medical institution for at least the period prescribed by Ordinance of the Ministry of Health and Welfare after obtaining a license of a medical doctor, dentist, oriental medical doctor, pharmacist, or nurse; |
| (2) | The head of a medical institution that has dedicated patient safety personnel shall report the status of assignment of such personnel to the Minister of Health and Welfare every year. <Newly Inserted on Jan. 29, 2020> |
| (3) | Dedicated patient safety personnel shall perform the following duties: <Amended on Jan. 29, 2020> |
| 1. | Collection, analysis, management, and sharing of information on patient safety incidents; |
| 2. | Education of health and medical services personnel to prevent patient safety incidents and the reoccurrence thereof; |
| 3. | Education on patient safety activities among patients and their guardians; |
| 4. | Other patient safety activities prescribed by Ordinance of the Ministry of Health and Welfare. |
| (4) | The Minister of Health and Welfare may subsidize expenses required by health and medical institutions having dedicated patient safety personnel for their operation. <Amended on Jan. 29, 2020> |
| (5) | Standards for placement of dedicated patient safety personnel under paragraph (1) and methods of and procedures for reporting under paragraph (2) shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
| Article 13 (Education on Patient Safety Activities) |
| (1) | Exclusive personnel shall regularly receive education on patient safety activities. |
| (2) | Where it is deemed necessary for the patient safety, the Minister of Health and Welfare may order dedicated patient safety personnel or health and medical services personnel to receive education on patient safety activities in addition to regular education conducted under paragraph (1). |
| (3) | The Minister of Health and Welfare may conduct the education referred to in paragraphs (1) and (2) by entrusting it to relevant specialized institutions, etc. |
| (4) | Matters necessary for the methods, time, content, entrustment, etc. of the education referred to in paragraphs (1) through (3) shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
| Article 14 (Reporting on Patient Safety Incidents) |
| (1) | Health and medical services personnel, patients, and any other persons prescribed by Ordinance of the Ministry of Health and Welfare who have caused, become aware of, or expect the occurrence of a patient safety incident, may report such fact to the Minister of Health and Welfare. <Amended on Jan. 29, 2020> |
| (2) | Where any of the following patient safety incidents occurs in a hospital-level medical institution of at least the size prescribed by Ordinance of the Ministry of Health and Welfare, the head of the relevant medical institution shall report such fact to the Minister of Health and Welfare without delay: <Newly Inserted on Jan. 29, 2020> |
| 1. | Where there occurs a patient safety incident involving the death of, or serious physical or mental harm to, a patient caused by an operation, blood transfusion, general anesthesia of details different from those for which an informed consent is obtained pursuant to Article 24-2 (1) of the Medical Service Act; |
| 2. | Where there occurs a patient safety incident involving the death of, or serious physical or mental harm to, a patient caused by medication different from that documented in the patient's medical records or medication administered by routes or doses different from the medical records; |
| 3. | Where a patient safety incident occurs due to an operation on the wrong patient or body part; |
| 4. | Where a patient dies or suffers serious physical or mental damage due to physical violence in a medical institution. |
| (3) | Where a report under paragraph (1) (hereinafter referred to as "autonomous report") has been filed by a person who had caused a patient safety incident, the relevant administrative dispositions under the Medical Service Act and other statutes or regulations related to health and medical services may be mitigated or exempted. <Amended on Jan. 29, 2020> |
| (4) | Matters to be included in an autonomous report and a report under paragraph (2) (hereinafter referred to as "mandatory report") and the methods of and procedures for reporting, etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended on Jan. 29, 2020> |
[Title Amended on Jan. 29, 2020]
| Article 15 (Request for Data for Development of Patient Safety Indicators) |
| (1) | To develop patient safety indicators, the Minister of Health and Welfare may request the heads of the following institutions to provide data prescribed by Ordinance of the Ministry of Health and Welfare: |
| 5. | Other institutions prescribed by Presidential Decree which keep data related to patient safety. |
| (2) | The head of an institution in receipt of a request prescribed in paragraph (1) shall render cooperation unless there is good cause. |
| Article 15-2 (Request for Submission of Data Related to Patient Safety Incidents) |
| (1) | The Minister of Health and Welfare may request the heads of the following institutions to provide data related to a patient safety incident prescribed by Ordinance of the Ministry of Health and Welfare in order to share information related to a patient safety incident: |
| 5. | Other institutions prescribed by Presidential Decree which retain data related to patient safety incidents. |
| (2) | The head of an agency in receipt of a request prescribed in paragraph (1) shall render cooperation unless there is good cause. In such cases, data containing sensitive information referred to in Article 23 of the Personal Information Protection Act and personally identifiable information (including resident registration numbers) referred to in Article 24 of the same Act shall be provided after deleting such personally identifiable information. |
[This Article Newly Inserted on Jan. 29, 2020]
| Article 16 (System for Reporting and Learning of Patient Safety Incidents) |
| (1) | To secure patient safety, the Minister of Health and Welfare shall establish and operate a system for reporting and learning of patient safety incidents (hereinafter referred to as "reporting and learning system" in this Article) necessary for the examination, research, and sharing of data related to information on patient safety incidents reported under Article 14 or data collected under Articles 15 and 15-2. <Amended on Jan. 29, 2020> |
| (2) | Where any cause prescribed by Ordinance of the Ministry of Health and Welfare arises, such as cases where a patient safety incident turns out to be a new type of incident or where it is likely to pose a serious harm to patient safety, the Minister of Health and Welfare shall release an alert to a health and medical institution and, if necessary, may recommend improvements or corrections to the institution. <Amended on Jan. 29, 2020> |
| (3) | For the release of an alert under paragraph (2), the Minister of Health and Welfare may request necessary cooperation, such as the submission of data or statement of opinion, from the following persons, other than those who filed a report on a patient safety incident under Article 14: <Amended on Jan. 29, 2020> |
| 1. | Any person who manufactures, imports, or sells medications or medical devices; |
| 2. | Any installer or manager of facilities or equipment of a health and medical institution; |
| 3. | Health and medical services personnel or a founder of a health and medical institution. |
| (4) | A person who is requested to submit data or state his or her opinion under paragraph (3) shall comply with such request. |
| (5) | The Minister of Health and Welfare may entrust the operation of the reporting and learning system to a specialized institution as prescribed by Presidential Decree. |
| (6) | The Minister of Health and Welfare may subsidize all or any part of the expenses required by a specialized institution entrusted with the operation of the reporting and learning system for its operation, as prescribed by Presidential Decree. |
| (7) | Matters necessary for the establishment, operation, entrustment of the reporting and learning system, subsidization of expenses, etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
| Article 17 (Keeping Confidentiality of Reporting on Patient Safety Incidents) |
| (1) | The Minister of Health and Welfare shall not disclose any information on the person who filed a report on a patient safety incident under Article 14 against the will of such person and, in case of a health and medical institution where the occurrence of a patient safety incident has been reported, the Minister shall not disclose any information on the relevant health and medical institution against the will of the head thereof. <Amended on Jan. 29, 2020> |
| (2) | Information on a patient safety incident voluntarily reported and data collected pursuant to Articles 15 and 15-2 shall be cleared of all personally identifiable information after the verification prescribed by Ordinance of the Ministry of Health and Welfare is conducted: Provided, That if a person who has filed an autonomous report (limited to persons who have caused the patient safety incident) consents thereto, personally identifiable information of such person need not be deleted. <Amended on Jan. 29, 2020> |
| (3) | No person who engages in or has engaged in affairs related to the collection and analysis of information on patient safety incidents, release of alert, etc. shall disclose to other persons any confidential information that he or she has learned in the course of carrying out his or her duties, or use it for the purpose other than performing his or her duties. |
| (4) | No head of a health and medical institution shall dismiss or transfer a person affiliated with the institution, who filed a report on a patient safety incident under Article 14, or take any other measures disadvantageous to him or her in regard to his or her status or treatment of him or her, for reason of such report. <Amended on Jan. 29, 2020> |
[Title Amended on Jan. 29, 2020]
| Article 18 (Penalty Provisions) |
| (1) | A person who discloses confidential information or use it for the purpose other than performing his or her duties in violation of Article 17 (3) shall be punished by imprisonment for not more than three years or by a fine not exceeding 30 million won. |
| (2) | A person who has taken any measures disadvantageous to a reporter of an autonomous report in violation of Article 17 (4) shall be punished by imprisonment for not more than two years or by a fine not exceeding 20 million won. |
| Article 19 (Administrative Fines) |
| (1) | The following persons shall be subject to an administrative fine not exceeding three million won: |
| 1. | The head of a medical institution who fails to submit data or submits false data, in violation of Article 14 (2); |
| 2. | A person who interferes with mandatory reporting under Article 14 (2). |
| (2) | Any person who falls under any of the following subparagraphs shall be subject to an administrative fine not exceeding one million won: |
| 1. | A person who fails to report or who files a false report, in violation of Article 11 (2); |
| 2. | A person who fails to report or who files a false report, in violation of Article 12 (2); |
| (3) | The Minister of Health and Welfare shall impose and collect administrative fines under paragraphs (1) and (2), as prescribed by Presidential Decree. |
[This Article Newly Inserted on Jan. 29, 2020]
ADDENDUM <Act No. 13113, Jan. 28, 2015>
This Act shall enter into force one year and six months after the date of its promulgation.
ADDENDUM <Act No. 16893, Jan. 29, 2020>
This Act shall enter into force three months after the date of its promulgation: Provided, That the amended provisions of Articles 8 (1) 3, 11 (3) 4, 14 (2) through (4), and 19 shall enter into force one year after the date of its promulgation.