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PATIENT SAFETY ACT

Act No. 13113, Jan. 28, 2015

 Article 1 (Purpose)
The purpose of this Act is to contribute to the protection of patients and the improvement of medical service quality by prescribing necessary matters for the safety of patients.
 Article 2 (Definitions)
The definitions of the terms used in this Act shall be as follows:
1. The term "patient safety accident" means an accident 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, and patients and their protectors to prevent patient safety accidents 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 protectors.
(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 accidents, and shall fulfill their obligations required.
(3) The heads of health and medical institutions and medical services personnel shall strive for patients and their protectors to participate in patient safety activities.
 Article 5 (Rights and Obligations of Patients)
(1) Any patient shall have the right to receive safe health and medical services (referring to health and medical services prescribed in the subparagraph 1 of Article 3 of the Framework Act on Health and Medical Services; hereinafter the same shall apply).
(2) Patients and their protectors shall participate in patient safety activities.
 Article 6 (Relationship with other Acts)
(1) Matters concerning patient safety shall be governed by this Act, except as otherwise expressly provided for in other Acts.
(2) Where any other Act related to patient safety is enacted or amended, it shall be ensured to conform to the purport of this Act.
 Article 7 (Formulation, etc. 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 protectors in patient safety activities;
7. Other necessary matters concerning 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 any special ground exists.
(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.
(6) A comprehensive plan shall be connected to the plans on the development of health and medical services referred to in Article 15 of the Framework Act on Health and Medical Services.
 Article 8 (National Patient Safety Commission)
(1) In order to deliberate on the following matters concerning patient safety, the National Patient Safety Commission (hereinafter referred to as the "Commission" in this Article) shall be established in the Ministry of Health and Welfare:
1. Major policies for patient safety and improvement of medical service quality;
2. Project plans for prevention of safety accidents and the reoccurrence thereof;
3. Utilization and disclosure of the results of analysis of the contents of reports on patient safety accidents filed under Article 14 (1);
4. Other important matters concerning patient safety that the Chairperson deems necessary for a deliberation.
(2) The Commission shall consist of not more than 15 members including one chairperson.
(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:
1. Persons recommended by the medical doctors' association, dentists' association, oriental medical doctors' association, midwives' association, and nurses' association prescribed in Article 28 of the Medical Service Act and the association of medical institutions prescribed in Article 52 of the same Act;
2. Persons recommended by the labor circle, non-profit, non-governmental organizations defined in Article 2 of the Assistance for Non-Profit, Non-Governmental Organizations Act, and consumer organizations under Article 29 of the Framework Act on Consumers;
3. Persons that have extensive knowledge on and experience in patient safety;
4. 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.
(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 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 Index)
(1) The Minister of Health and Welfare shall develop and disseminate an index that proposes 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) Necessary matters concerning the development and dissemination of a patient safety index shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 11 (Patient Safety Commission)
(1) Any hospital-level medical institution that is equivalent to or larger than 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 commission shall deliberate on the following affairs:
1. Formulation and implementation of plans for prevention of patient safety accidents and the reoccurrence thereof;
2. Appointment and placement of exclusive personnel for patient safety 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 reporter who has filed a report under Article 14 (1) and the matters reported;
5. Formulation and implementation of plans for patients and their protectors to participate in patient safety activities;
6. Other necessary matters concerning patient safety activities, which are prescribed by Ordinance of the Ministry of Health and Welfare.
(3) Matters concerning the organization and operation of the commission and other necessary matters shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 12 (Exclusive Personnel)
(1) Any hospital-level medical institution that is equivalent to or larger than the size prescribed by Ordinance of the Ministry of Health and Welfare shall have exclusive personnel who exclusively perform the affairs related to patient safety and improvement of medical service quality (hereinafter referred to as "exclusive personnel").
(2) Exclusive personnel shall perform the following affairs:
1. Collection, analysis, management and sharing of information on patient safety accidents;
2. Education of health and medical services personnel to prevent patient safety accidents and the reoccurrence thereof;
3. Education of patients and their protectors for their patient safety activities;
4. Other patient safety activities prescribed by Ordinance of the Ministry of Health and Welfare.
(3) The Minister of Health and Welfare may subsidize expenses required by health and medical institutions having exclusive personnel for their operation.
(4) Qualifications, standards for placement of exclusive personnel, and other relevant matters 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 exclusive 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) Necessary matters concerning 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 (Autonomous Reporting, etc. of Patient Safety Accidents)
(1) A person prescribed by Ordinance of the Ministry of Health and Welfare who has caused or become aware of the occurrence of a patient safety accident, such as health and medical services personnel and a patient, (hereinafter referred to as "reporter") may report such fact to the Minister of Health and Welfare.
(2) Where a report under paragraph (1) (hereinafter referred to as "autonomous report") has been filed by a person who had caused a patient safety accident, the relevant administrative dispositions under the Medical Service Act and other Acts or subordinate statutes related to health and medical services may be mitigated or exempted.
(3) Matters to be included in an autonomous report and the methods, procedures, etc. for filing a report shall be prescribed by Ordinance of the Ministry of Health and Welfare.
 Article 15 (Request for Data for Development of Patient Safety Index)
(1) To develop a patient safety index, 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:
1. The National Health Insurance Corporation under the National Health Insurance Act;
2. The Health Insurance Review and Assessment Service under the National Health Insurance Act;
3. The Korea Medical Dispute Mediation and Arbitration Agency under the Act on Remedies for Injuries from Medical Malpractice and Mediation of Medical Disputes;
4. The Korea Consumer Agency under the Framework Act on Consumers;
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 any justifiable ground exists.
 Article 16 (System for Reporting and Learning of Patient Safety Accidents)
(1) To secure patient safety, the Minister of Health and Welfare shall establish and operate a system for reporting and learning of patient safety accidents (hereinafter referred to as "reporting and learning system" in this Article) necessary for the examination, research and sharing of data related to patient safety accidents reported autonomously or collected under Article 15.
(2) Where any cause prescribed by Ordinance of the Ministry of Health and Welfare occurs, such as cases where a patient safety accident turns out to be a new type of accident or where it is likely to occur a serious hazard to safety of patients, the Minister of Health and Welfare shall release an alert to health and medical institutions.
(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 who are not the reporters of autonomous reports:
1. Any person who manufactures, imports or sells drugs 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 the establisher of a health and medical institution.
(4) A person who is requested to submit data or state his/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) Necessary matters concerning 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, etc. of Autonomous Reports)
(1) The Minister of Health and Welfare shall not disclose any information on the reporter of an autonomous report against his/her will and, in case of a health and medical institution which has autonomously reported a patient safety accident that had occurred in the same institution, the Minister shall not disclose any information on the relevant health and medical institution against the will of the head thereof.
(2) After conducting verification prescribed by Ordinance of the Minister of Health and Welfare of information concerning a patient safety accident on which an autonomous report has been filed and the data has been collected under Article 15, it shall be made sure to delete the parts of such information and data which make it possible to distinguish any personal identification.
(3) No person who engages in or has engaged in affairs related to the collection and analysis of information on patient safety accidents, release of alert, etc. shall disclose to other persons any confidential information that he/she has learned in the course of carrying out his/her duties, or use it for the purpose other than performing his/her duties.
(4) No head of a health and medical institution shall dismiss or transfer a reporter of an autonomous report which pertains to the relevant health and medical institution or take any other measures disadvantageous to him/her in regard to his/her status or treatment of him/her, for reason of such report.
 Article 18 (Penal Provisions)
(1) A person who discloses confidential information or use it for the purpose other than performing his/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.
ADDENDUM
This Act shall enter into force one year and six months after the date of its promulgation.