ENFORCEMENT DECREE OF THE MEDICAL SERVICE ACT
Wholly Amended by Presidential Decree No. 20292, Sep. 28, 2007
Amended by Presidential Decree No. 20679, Feb. 29, 2008
Presidential Decree No. 21148, Dec. 3, 2008
Presidential Decree No. 21428, Apr. 20, 2009
Presidential Decree No. 22003, Jan. 27, 2010
Presidential Decree No. 22075, Mar. 15, 2010
Presidential Decree No. 22635, Jan. 24, 2011
Presidential Decree No. 22667, Feb. 14, 2011
Presidential Decree No. 23488, Jan. 6, 2012
Presidential Decree No. 23753, Apr. 27, 2012
Presidential Decree No. 23759, May 1, 2012
Presidential Decree No. 25050, Dec. 30, 2013
Presidential Decree No. 25840, Dec. 9, 2014
Presidential Decree No. 26526, Sep. 15, 2015
Presidential Decree No. 26742, Dec. 22, 2015
Presidential Decree No. 27241, jun. 21, 2016
Presidential Decree No. 27525, Sep. 29, 2016
Presidential Decree No. 27700, Dec. 27, 2016
Presidential Decree No. 27917, Feb. 28, 2017
Presidential Decree No. 27944, Mar. 20, 2017
Presidential Decree No. 28131, jun. 20, 2017
Presidential Decree No. 28695, Mar. 6, 2018
Presidential Decree No. 29195, Sep. 28, 2018
Presidential Decree No. 30106, Oct. 8, 2019
Presidential Decree No. 30480, Feb. 25, 2020
Presidential Decree No. 30990, Sep. 4, 2020
Presidential Decree No. 31013, Sep. 11, 2020
Presidential Decree No. 31398, Jan. 12, 2021
Presidential Decree No. 31774, jun. 15, 2021
The purpose of this Decree is to prescribe matters mandated by the Medical Service Act and matters necessary for enforcing said Act.
| Article 2 (Public Health Services of Nurses) |
"Health services prescribed by Presidential Decree" in Article 2 (2) 5 (c) of the Medical Service Act (hereinafter referred to as the "Act") means any of the following public health services: <Amended on Apr. 20, 2009; Feb. 14, 2011; Sep. 29, 2016; Dec. 27, 2016; Mar. 6, 2018> | 4. | Services determined by other statutes or regulations as health services of nurses. |
| Article 2-2 (Matters to Be Displayed on Name Tags) |
| (1) | Where persons who perform medical practices need to wear name tags by which they can be identified pursuant to the main clause of Article 4 (5) of the Act, it shall conform to the following classification: |
| 1. | Matters to be displayed on name tags: Matters classified as follows shall be indicated: |
| (a) | Medical personnel: Medical job titles and names: Provided, That in cases of medical specialists referred to in Article 77 (1) of the Act, specialist titles and names may be indicated; |
| 2. | Method of wearing a name tag: The name tag shall be marked on or attached to the clothing, or hanged on the neck, or worn in any other similar manner; |
| 3. | Method of manufacturing a name tag: The name tag shall be imprinted, engraved, affixed, stitched, or manufactured by similar methods; |
| 4. | Specifications and colors of a name tag: The contents of the name tag shall be visible with clear specifications and colors. |
| (2) | Detailed matters to be displayed on name tags; detailed methods of wearing and manufacturing name tags; detailed matters concerning specifications and colors of name tags, etc. under paragraph (1) shall be determined and publicly notified by the Minister of Health and Welfare. |
| (3) | "Cases prescribed by Presidential Decree" in the proviso of Article 4 (5) of the Act means cases where medical personnel are inside any of the following facilities: |
| 2. | An aseptic treatment room; |
| 3. | Any other facility similar to that prescribed in subparagraph 1 or 2, which is publicly notified by the Minister of Health and Welfare as deemed necessary to prevent hospital-acquired infection. |
[This Article Newly Inserted on Feb. 28, 2017]
| Article 3 (Scope of National Examination) |
| (1) | The national examination for medical doctors, dentists, oriental medical doctors, mid-wives or nurses referred to in Article 9 (1) of the Act (hereinafter "national examination") shall be conducted to test knowledge and skills in medicine, dental medicine, oriental medicine, midwifery, nursing, and public health and medicine-related laws and regulations. |
| (2) | The preliminary examination for doctors, dentists or oriental medical doctors under Article 9 (1) of the Act (hereinafter "preliminary examination") shall be given to test knowledge and skills necessary for a person having qualifications referred to in Article 5 (1) 3 of the Act to apply for the national examination under paragraph (1), and held divided into first and second examinations. <Amended on Apr. 20, 2009> |
| (3) | Persons who have passed a preliminary examination shall be exempted from a preliminary examination (including the first and second examinations), starting from the next national examination. |
| Article 4 (Administration and Public Announcement of National Examinations) |
| (1) | The Minister of Health and Welfare shall administer national examinations and preliminary examinations (hereinafter referred to as "national examination, etc.") at least once a year. <Amended on Feb. 29, 2008; Mar. 15, 2010> |
| (2) | The Minister of Health and Welfare shall order the Korea Health Personnel Licensing Examination Institute established under the Korea Health Personnel Licensing Examination Institute Act (hereinafter referred to as "management agency for national examinations, etc.") to administer the national examinations, etc. <Amended on Dec. 22, 2015> |
| (3) | When the head of the management agency for national examinations, etc. intends to administer the national examinations, etc., he or she shall obtain prior approval therefor from the Minister of Health and Welfare and give a public announcement of the date and place of the examinations, examination subjects, a period for the submission of an application for the examinations, and other matters necessary for the examinations by no later than 90 days before the examination date: Provided, That the place of examination may be publicly announced by no later than 30 days before the examination date after the number of applications for each region is determined. <Amended on Feb. 29, 2008; Mar. 15, 2010; May 1, 2012> |
| (4) | Notwithstanding paragraph (3), the head of the management agency for national examinations, etc. may shorten the period of public announcement referred to in paragraph (3) where the Minister of Health and Welfare deems it necessary to urgently staff up medical personnel for improving public health. <Newly Inserted on Jan. 12, 2021> |
| Article 5 (National Examination Subjects) |
The subjects and method of examinations, the selection method of successful applicants, and other necessary matters concerning national examinations shall be determined by Ordinance of the Ministry of Health and Welfare. <Amended on Feb. 29, 2008; Mar. 15, 2010>
| Article 6 (Examination Commissioners) |
The head of the management agency for national examinations, etc. shall commission examination commissioners, from among persons having professional knowledge in each subject of the examinations whenever he or she conducts national examinations, etc.
| Article 7 (Applications for and Announcement of Successful Applicant for National Examinations) |
| (1) | Any person who intends to apply for national examinations, etc. shall submit to the head of the management agency for national examinations, etc. the applications for examinations determined by such head. |
| (2) | The head of the management agency for national examinations, etc. shall determine and announce the successful applicants of the national examinations, etc. |
| Article 8 (Issuance of License Certificates) |
| (1) | Those who have passed the national examinations shall, accompanied by the documents determined by Ordinance of the Ministry of Health and Welfare, apply to the Minister of Health and Welfare for issuing a license certificates after the announcement of successful applicants. <Amended on Feb. 29, 2008; Mar. 15, 2010> |
| (2) | The license certificates shall be issued according to their classification, as prescribed by Ordinance of the Ministry of Health and Welfare, to those who have applied for the issuance of license certificates under paragraph (1). <Amended on Feb. 29, 2008; Mar. 15, 2010> |
| Article 9 (Request for Cooperation with Relevant Institutions) |
The head of the management agency for national examinations, etc. may, where it is deemed necessary to properly perform management duties for national examinations, etc., request the Government, local governments, or relevant institutions or associations to provide necessary cooperation, such as providing a place of examination and the supervision of examination.
| Article 9-2 (Restriction on Taking National Examinations) |
The criteria for restriction on taking the national examination, etc. under Article 10 (3) of the Act shall be as specified in attached Table 1. [This Article Newly Inserted on Jun. 20, 2017]
| Article 10 (Conditions of License) |
| (1) | "Specially designated areas" in Article 11 (1) of the Act means areas in need of public health and medical services, designated by the Minister of Health and Welfare, and "specially designated duties" means duties of national, public health and medical institutions, and duties of national, public, private health and medical research institutions in the basic medical science field. <Amended on Feb. 29, 2008; Mar. 15, 2010> |
| (2) | An allowance shall be paid, within budgetary limits, to medical personnel who are employed in specially designated areas or for specially designated duties under Article 11 (1) of the Act. |
| (3) | Matters necessary for the implementation method of license conditions and procedures for the order to serve as referred to in Article 11 (1) of the Act shall be determined by Ordinance of the Ministry of Health and Welfare. <Amended on Feb. 29, 2008; Mar. 15, 2010> |
| Article 10-2 (Scope of Vicarious Recipients) |
"Persons prescribed by Presidential Decree" in the provisions, with the exception of the subparagraphs, of Article 17-2 (2) of the Act means the following persons: | 1. | Lineal ascendants, descendants, and lineal ascendants' spouses of patients; |
| 2. | Spouse and spouse's lineal ascendants of patients; |
| 5. | Persons the Minister of Health and Welfare deems necessary for the continuous medical treatment of patients. |
[This Article Newly Inserted on Feb. 25, 2020]
[Previous Article 10-2 moved to Article 10-3 <Feb. 25, 2020>]
| Article 10-3 (Reading Records on Patients) |
[This Article Newly Inserted on Sep. 29, 2016]
[Moved from Article 10-2; previous Article 10-3 moved to Article 10-4 <Feb. 25, 2020>]
| Article 10-4 (Entrustment of Business to Establish and Operate Medical Record Transmission Support System) |
| (1) | Pursuant to the former part of Article 21-2 (4) of the Act, the Minister of Health and Welfare may entrust business concerning the establishment and operation of a medical record transmission support system prescribed in paragraph (3) of the same Article (hereinafter referred to as "medical record transmission support system") to the following specialized institutions: |
| 2. | A specialized institution the Minister of Health and Welfare determines and publicly notifies, taking into account organizations, workforce, expertise, etc. necessary to conduct the entrusted business. |
| (2) | Where the Minister of Health and Welfare intends to entrust business to establish and operate a medical record transmission support system pursuant to the former part of Article 21-2 (4) of the Act, the Minister shall publicly announce matters concerning the criteria, procedures, methods, etc. of entrustment in advance. |
| (3) | Where the Minister of Health and Welfare entrusts business to establish and operate a medical record transmission support system pursuant to the former part of Article 21-2 (4) of the Act, the Minister shall publicly notify matters concerning the details of entrustment, persons to which such business is entrusted, etc. in the Official Gazette and post such matters on the website of the Ministry of Health and Welfare. |
| (4) | A specialized institution to which business to establish and operate a medical record transmission support system is entrusted pursuant to the former part of Article 21-2 (4) of the Act shall report a project operation plan, current state of project implementation, fund management plan, fund implementation statement, etc. to the Minister of Health and Welfare. |
| (5) | The Minister of Health and Welfare shall determine and publicly notify detailed matters necessary for the public announcement of criteria for entrustment, etc., public notice of details of entrustment, etc., reporting on entrusted business, etc. under paragraphs (2) through (4). |
[This Article Newly Inserted on Jun. 20, 2017]
[Moved from Article 10-3; previous Article 10-4 moved to Article 10-5 <Feb. 25, 2020>]
| Article 10-5 (Measures to Ensure Safety of Information Retained in Medical Record Transmission Support System) |
| (1) | A specialized institution to which business to establish and operate a medical record transmission support system is entrusted pursuant to the former part of Article 21-2 (4) of the Act shall take the following measures to ensure the safety of the information retained in the medical record transmission support system pursuant to Article 21-2 (5) 1 of the Act: |
| 1. | Formulation and implementation of a management plan to ensure the safety of the information retained in the medical record transmission support system; |
| 2. | Access control and restriction on access authority to the information retained in the medical record transmission support system; |
| 3. | Establishment and operation of firewall, intrusion prevention system, and intrusion detection system to prevent unauthorized access to the medical record transmission support system; |
| 4. | Development and management of encryption technology, etc. which makes it possible to safely save and transmit the information retained in the medical record transmission support system; |
| 5. | Installation and update of security programs for the information retained in the medical record transmission support system; |
| 6. | Storage and management of access records to the medical record transmission support system; |
| 7. | Installation and update of anti-forgery and anti-counterfeiting programs for the information retained in the medical record transmission support system; |
| 8. | Development and implementation of safeguards for other information systems interconnected with the medical record transmission support system; |
| 9. | Other measures similar to those prescribed in subparagraphs 1 through 8, which the Minister of Health and Welfare deems particularly necessary to ensure the safety of the information retained in the medical record transmission support system. |
| (2) | The Minister of Health and Welfare shall determine and publicly notify detailed matters necessary to ensure the safety of the information retained in the medical record transmission support system prescribed in paragraph (1). |
[This Article Newly Inserted on Jun. 20, 2017]
[Moved from Article 10-4; previous Article 10-5 moved to Article 10-6 <Feb. 25, 2020>]
| Article 10-6 (Standardization of Electronic Medical Records) |
Matters subject to standardization, which the Minister of Health and Welfare determines and publicly notifies pursuant to Article 23-2 (1) of the Act shall be as follows: | 1. | Forms, terms, contents, etc. of electronic medical records prescribed in Article 23 (1) of the Act (hereinafter referred to as "electronic medical record"); |
| 2. | Facilities and equipment necessary for the safe management and preservation of electronic medical records under Article 23 (2) of the Act; |
| 3. | Structures, forms, functions, etc. of the electronic medical record system prescribed in Article 23-2 (1) of the Act (hereinafter referred to as "electronic medical record system"); |
| 4. | Other matters similar to those prescribed in subparagraphs 1 through 3, which the Minister of Health and Welfare deems particularly necessary for the efficient and unified management and use of electronic medical records. |
[This Article Newly Inserted on Jun. 20, 2017]
[Moved from Article 10-5; previous Article 10-6 moved to Article 10-7 <Feb. 25, 2020>]
| Article 10-7 (Certification of Electronic Medical Record System) |
| (1) | Criteria for certification of an electronic medical record system shall be as follows: |
| 1. | The standards the Minister of Health and Welfare determines and publicly notifies pursuant to Article 23-2 (1) of the Act shall be satisfied; |
| 2. | Compatibility necessary for electronic transmission between electronic medical record systems shall be secured; |
| 3. | Administrative, technical and physical information security shall be secured for the electronic medical record system; |
| 4. | Other criteria similar to those prescribed in subparagraphs 1 through 3, which the Minister of Health and Welfare deems particularly necessary, taking into consideration the functions, structures, forms, etc. of electronic medical record systems. |
| (2) | A person who intends to obtain certification of an electronic medical record system pursuant to Article 23-2 (2) of the Act shall submit an application for certification of the electronic medical record system (including applications in electronic form) to the Minister of Health and Welfare along with the following documents (including documents in electronic form): |
| 1. | Documents evidencing conformity with the criteria for certification prescribed in paragraph (1); |
| 2. | Design plan for the electronic medical record system; |
| 3. | The manual of the electronic medical record system and the performance test results; |
| 4. | Other documents similar to those prescribed in subparagraphs 1 through 3, which the Minister of Health and Welfare publicly notifies, deeming that they are particularly necessary for the certification of electronic medical record systems. |
| (3) | The Minister of Health and Welfare may, if necessary for the professional examination of an application for certification submitted pursuant to paragraph (2), request data or opinions from any institution, corporation, organization, expert, etc. related to healthcare or information and communication. |
| (4) | Where the Minister of Health and Welfare in receipt of an application for certification prescribed in paragraph (2) determines whether to grant certification, he or she shall notify the applicant of such determination in writing. |
| (5) | Where the Minister of Health and Welfare grants certification to an electronic medical record system pursuant to Article 23-2 (2) of the Act, he or she shall issue a certificate to the applicant, and post the details of the certification on the website of the Ministry of Health and Welfare, etc. |
| (6) | The Minister of Health and Welfare shall determine and publicly notify detailed matters necessary for certification criteria, certification procedures, certification methods, certification for modification, etc. of electronic medical record systems other than those prescribed in paragraphs (1) through (5). |
[This Article Newly Inserted on Jun. 20, 2017]
[Moved from Article 10-6; previous Article 10-7 moved to Article 10-8 <Feb. 25, 2020>]
| Article 10-8 (Labeling Certification of Electronic Medical Record Systems) |
| (1) | Where a person who has obtained certification of an electronic medical record system pursuant to Article 23-2 (2) of the Act intends to place a label including the matters certified pursuant to the former part of paragraph (3) of that Article, he or she shall place such label in compliance with the standards the Minister of Health and Welfare determines and publicly notifies for the details, size, color, design, etc. of such label. |
| (2) | Where the Minister of Health and Welfare deems that it is necessary to supplement or improve the certified matters to be included in labels prescribed in the former part of Article 23-2 (3) of the Act, he or she may recommend matters necessary for such supplementation or improvement to the person who has obtained the certification of the electronic medical record system. |
[This Article Newly Inserted on Jun. 20, 2017]
[Moved from Article 10-7; previous Article 10-8 moved to Article 10-11 <Feb. 25, 2020>]
| Article 10-9 (Types of Medical Treatment Information Breach Incidents) |
"Incidents prescribed by Presidential Decree, such as the divulgence of medical treatment information or disruption in business of medical institutions" in Article 23-3 (1) of the Act means the following incidents: | 1. | Stealing and divulgence of medical treatment information; |
| 2. | Destruction, damage, concealment and loss of medical treatment information; |
| 3. | Disruption and paralysis of electronic medical record systems. |
[This Article Newly Inserted on Feb. 25, 2020]
| Article 10-10 (Measures for Preventing and Responding to Medical Treatment Information Breach Incidents) |
| 1. | Checking the weak points of the electronic medical record system of a medical institution; |
| 2. | Education and training for medical personnel or founders of medical institutions; |
| 3. | Matters necessary to ensure the safety and reliability of electronic medical record systems, which the Minister of Health and Welfare determines and publicly notifies. |
[This Article Newly Inserted on Feb. 25, 2020]
| Article 10-11 (Explanation about Medical Practices) |
| (1) | A written consent a patient (where a patient lacks a decision-making capacity, referring to his or her legal representative; hereafter in this Article the same shall apply) gives to a physician, dentist or oriental medical doctor pursuant to the main clause of Article 24-2 (1) of the Act, shall bear the signature, or the name and seal of the relevant patient. |
| (2) | Where a physician, dentist or oriental medical doctor informs a patient in writing of the grounds for changing the methods, details, etc. of the operation, blood transfusion or general anesthesia, and matters changed, pursuant to Article 24-2 (4) of the Act, he or she may, if necessary to protect the patient, provide the patient with oral explanations concurrently, as determined by the Minister of Health and Welfare. |
| (3) | A physician, dentist, or oriental medical doctor shall preserve and manage documents prescribed in the main clause of Article 24-2 (1) of the Act for two years from the date on which he or she obtains the consent of patients and documents prescribed in paragraph (4) of the same Article for two years from the date on which he or she informs patients. |
[This Article Newly Inserted on Jun. 20, 2017]
[Moved from Article 10-8 <Feb. 25, 2020>]
| (1) | Pursuant to Article 25 (1) of the Act, medical personnel shall report to the Minister of Health and Welfare their actual state, their current employment status, etc. by no later than December 31 of every third anniversary year from the date on which they obtain a license issued or reissued pursuant to Article 8 or 65 of the Act: Provided, That medical personnel who have reported in accordance with Article 2 (1) of the Addenda to the Medical Service Act (Act No. 10609) shall report by no later than December 31 of every third anniversary year from the date of report. |
| (2) | Pursuant to Article 25 (3) of the Act, the Minister of Health and Welfare shall entrust the receipt and acceptance of reports under paragraph (1) to the physicians' association, dentists' association, oriental medical doctors' association, midwives' association, and nurses' association under Article 28 of the Act (hereinafter referred to as “central associations”), respectively. |
| (3) | Matters necessary for the method, procedure, etc. for the reporting under paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
[This Article Wholly Amended on Apr. 27, 2012]
| Article 11-2 (Establishment of Ethics Committee) |
| (1) | Each ethics committee provided for in Article 28 (7) of the Act (hereinafter referred to as “ethics committee”) shall be comprised of 11 members, including one chairperson. |
| (2) | Each committee chairperson shall be commissioned by the head of each central association, from among committee members. |
| (3) | Committee members shall be commissioned by the head of each central association from among the following persons taking gender equality into consideration, and at least four committee members specified in subparagraph 2 shall be included therein: <Amended on Mar. 20, 2017> |
| 1. | Members of each central association, who have at least 10 years’ experience in the medical field; |
| 2. | Non-medical personnel who have abundant experience and knowledge in law, public health, media, the rights and interests of consumers, etc. |
| (4) | The term of office of each committee member shall be three years, renewable for only one further term. |
[This Article Newly Inserted on Apr. 27, 2012]
| Article 11-3 (Operation of Ethics Committee) |
| (1) | Each ethics committee shall deliberate, and pass a resolution, on the following: |
| 2. | Examinations of qualification for members of each central association and disciplinary actions against members; |
| 3. | Other matters stipulated by each central association's articles of incorporation as necessary for the establishment of ethics of members. |
| (2) | Each ethics committee shall meet at the call of the chairperson of the relevant ethics committee or upon request by the head of the relevant central association or by at least 1/3 of the registered ethics committee members. In such cases, the chairperson of the ethics committee shall notify each ethics committee member of the date, time, and place of the meeting and items on the agenda by no later than seven days before such meeting is held. |
| (3) | An ethics committee meeting shall commence with the attendance of at least 2/3 of the registered ethics committee members, and a resolution shall be adopted by concurrent votes of at least 2/3 of the ethics committee members present at the meeting: Provided, That a quorum for a meeting to pass a resolution on the matters specified in paragraph (1) 2 and 3 may be otherwise stipulated by each central association's articles of incorporation. |
| (4) | Where intending to deliberate, and pass a resolution, on any matter specified in paragraph (1) 1 or 2, the chairperson of an ethics committee shall grant the parties involved in the relevant case with an opportunity to make oral or written statements (including electronic documents). |
| (5) | An ethics committee may organize and operate a specialized advisory group for each field in accordance with the standards set by the Minister of Health and Welfare, if necessary for the professional review of the matters to be deliberated on and resolved under its jurisdiction. <Newly Inserted on Mar. 20, 2017> |
| (6) | Except as otherwise expressly provided for in paragraphs (1) through (5), matters necessary for operating an ethics committee or a specialized advisory group for each field shall be prescribed by each central association's articles of incorporation. <Amended on Mar. 20, 2017> |
[This Article Newly Inserted on Apr. 27, 2012]
| Article 11-4 (Exclusion of Members of Ethics Committee) |
| (1) | In any of the following circumstances, a member of the Ethics Committee shall be excluded from deliberation and resolution by the Ethics Committee: |
| 1. | If a committee member is a party to a case brought to the Ethics Committee for deliberation and resolution (hereafter referred to as “the case at issue” in this Article); |
| 2. | If a committee member is or was a relative of a party to the case at issue; |
| 3. | If a committee member works or worked for an institution to which a party to the case at issue has belonged within the last three years. |
| (2) | If a party to the case at issue has a ground to exclude a committee member under paragraph (1) or has any other ground to hardly expect impartiality from a committee member in deliberation and resolution, such party may file a petition for challenge against the committee member with the Ethics Committee, stating the reasons therefor in writing. |
| (3) | Upon receipt of a petition for challenge under paragraph (2), the Ethics Committee shall make a decision on whether to accept the challenge with the attendance of a majority of the registered committee members and by concurring votes of a majority of the committee members present at the meeting. In such cases, the committee member against whom the petition for challenge has been filed shall not participate in making such decision. |
| (4) | If a member of the Ethics Committee has any ground specified in paragraph (1) or (2), he or she may voluntarily recuse himself/herself from deliberation and resolution. |
[This Article Newly Inserted on Apr. 27, 2012]
| Article 12 (Applications for Permission to Establish Central Association) |
When a person intends to obtain permission to establish a central association under Article 29 (1) of the Act, he or she shall submit the following documents to the Minister of Health and Welfare: <Amended on Feb. 29, 2008; Mar. 15, 2010> | 1. | Articles of incorporation; |
| 4. | Establishment resolution; |
| 5. | Documents concerning the circumstances of election of founding representative; |
| 6. | Written consents of inauguration and resumes of executives. |
| Article 13 (Matters to Be Entered in Articles of Incorporation) |
Matters that shall be stated in articles of incorporation of a central association pursuant to Article 29 (2) of the Act shall be as follows: <Amended on Apr. 27, 2012> | 3. | Seats of the central association, branches, sub-branches; |
| 4. | Property or accounts and other matters concerning management and operation; |
| 5. | Matters concerning the designation of executive officers; |
| 6. | Matters concerning qualifications for and disciplinary actions against members; |
| 7. | Matters concerning modification of articles of incorporation; |
| 8. | Matters concerning the method of public announcement; |
| 9. | Matters concerning the operation of the Ethics Committee. |
| Article 14 (Applications for Permission to Modify Articles of Incorporation) |
Where any central association intends to obtain permission for modification of the articles of incorporation under Article 29 (3) of the Act, it shall submit the following documents to the Minister of Health and Welfare: <Amended on Feb. 29, 2008; Mar. 15, 2010> | 1. | Documents stating the details and reasons of the modification of the articles of incorporation; |
| 2. | Minutes of the meetings concerning the modification of the articles of incorporation; |
| 3. | A comparison chart for the new and old articles of incorporation, and other reference documents. |
| Article 15 (Branches of Central Association) |
Under Article 28 (5) of the Act, any central association shall establish branches each in a Special Metropolitan City, Metropolitan Cities, Dos and Special Self-Governing Provinces within three weeks from the date of the completion of the establishment registration: Provided, That branches of doctors' association in foreign countries shall be established within ten weeks from the date of obtaining permission for modifying the articles of incorporation thereof.
| Article 16 (Permission to Modify Articles of Incorporation to Establish Medical Corporations) |
| (1) | A medical corporation referred to in Article 33 (2) 3 of the Act (hereinafter referred to as "medical corporation") or a nonprofit corporation referred to in subparagraph 4 of the same paragraph that intends to obtain permission for establishing a corporation or modifying its articles of incorporation pursuant to the former part of paragraph (9) of the same Article, shall submit the documents classified as follows to the competent administrative agency: |
| 1. | Where it intends to obtain permission for establishing a corporation: The following documents: |
| (a) | A draft of the articles of incorporation which reflects the fact that the establishment and operation of a medical institution coincide with the its purpose business and the seat of the medical institution; |
| (b) | A project plan and a fund-raising plan to establish and operate a medical institution; |
| (c) | A plan to secure facilities, equipment, human resources, etc. of a medical institution; |
| (d) | Documents required under related statutes or regulations when a nonprofit corporation referred to in Article 33 (2) 4 of the Act intends to obtain permission for the establishment of a corporation (applicable only to nonprofit corporations); |
| (f) | Other documents publicly notified by the Minister of Health and Welfare as deemed necessary in connection with the establishment and operation of a medical institution; |
| 2. | Where it is intended to obtain permission for modifying its articles of incorporation: The following documents: |
| (a) | A draft of the articles of incorporation which reflects the fact that the establishment and operation of a medical institution coincide with the its purpose business and the seat of the medical institution; |
| (b) | Documents set forth in subparagraph 1 (b) and (c); |
| (c) | Documents required under related statutes or regulations when a nonprofit corporation referred to in Article 33 (2) 4 of the Act intends to obtain permission for modifying its articles of incorporation (applicable only to nonprofit corporations); |
| (d) | Documents necessary to obtain permission for modifying the articles of incorporation pursuant to Article 48 (3) of the Act; |
| (e) | Other documents publicly notified by the Minister of Health and Welfare as deemed necessary in connection with the establishment and operation of a medical institution. |
| (2) | Matters concerning the standards for, methods of preparation and detailed contents of the documents set forth in paragraph (1) (excluding subparagraph 1 (d) and (e) and 2 (c) and (d)), and other relevant matters shall be determined and publicly notified by the Minister of Health and Welfare. |
[This Article Newly Inserted on Sep. 29, 2016]
| Article 17 Deleted. <Apr. 27, 2012> |
| Article 17-2 (Measures to Be Taken upon Closure or Suspension of Business) |
Upon receipt of a report on the closure or suspension of business of a medical institution pursuant to Article 40 (1) of the Act, the head of a Si/Gun/Gu (referring to the head of an autonomous Gu; hereinafter the same shall apply) shall take measures to verify the following matters pursuant to paragraph (5) of that Article: <Amended on Feb. 25, 2020> | 2. | Whether medical records, etc. (including electronic medical records: hereinafter referred to as "medical records, etc.") referred to in Article 22 (1) of the Act are appropriately transferred to other medical institutions or are retained in the medical institution in accordance with Article 40 (2) of the Act; |
| 4. | Other measures similar to those prescribed in subparagraphs 1 through 3, which are deemed particularly necessary by the Minister of Health and Welfare to properly manage the closure or suspension of business of the medical institution. |
[This Article Newly Inserted on Jun. 20, 2017]
| Article 18 (Entrustment of Establishment and Operation of Medical Care-Related Infection Surveillance System) |
| (1) | Pursuant to Article 47 (6) of the Act, the Commissioner of the Korea Centers for Disease Control and Prevention may entrust any of the following institutions with the establishment and operation of a medical care-related infection surveillance system referred to in paragraph (4) of that Article (hereinafter referred to as "medical care-related infection surveillance system"): <Amended on Sep. 11, 2020> |
| 3. | Nonprofit corporations incorporated pursuant to Article 32 of the Civil Act or any other statute to conduct businesses regarding the prevention and control of medical care-related infection; |
| 4. | Other institutions deemed by the Commissioner of the Korea Centers for Disease Control and Prevention to have expertise in the prevention and control of medical care-related infection. |
| (2) | Where the Commissioner of the Korea Centers for Disease Control and Prevention intends to entrust the establishment and operation of the medical care-related infection surveillance system under Article 47 (6) of the Act, the Commissioner shall publicly announce matters regarding the guidelines, procedures, methods, etc. for such entrustment beforehand. <Amended on Sep. 11, 2020> |
| (3) | Once the establishment and operation of the medical care-related infection surveillance system is entrusted under Article 47 (6) of the Act, the Commissioner of the Korea Centers for Disease Control and Prevention shall give public notice of the details of entrustment and information on a person entrusted therewith in the Official Gazette and shall post them on the website of the Korea Centers for Disease Control and Prevention. <Amended on Sep. 11, 2020> |
| (4) | Details necessary for making public announcement of entrustment standards and giving public notice of entrustment under paragraphs (2) and (3) shall be determined and publicly notified by the Commissioner of the Korea Centers for Disease Control and Prevention. <Amended on Sep. 11, 2020> |
[This Article Newly Inserted on Sep. 4, 2020]
| Article 19 (Application for Permission to Establish Medical Corporations) |
A person who intends to establish a medical corporation under Article 48 (1) of the Act shall submit an application for permission to establish a medical corporation and related documents determined by Ordinance of the Ministry of Health and Welfare to the Special Metropolitan City Mayor, a Metropolitan City Mayor, a Special Self-Governing City Mayor, a Do Governor, or a Special Self-Governing Province Governor (hereinafter referred to as "Mayor/Do Governor") having jurisdiction over the area in which the principal office of such corporation is located. <Amended on Feb. 29, 2008; Mar. 15, 2010; Sep. 28, 2018; Sep. 4, 2020>
| Article 20 (Mission of Medical Corporations) |
Medical corporations, as well as non-profit corporations that have established medical institutions under Article 33 (2) 4 of the Act, shall contribute to public hygiene and shall not seek profit, in conducting business of medical treatment (including incidental business that medical corporations conduct under Article 49 of the Act).
| Article 21 (Application for Permission to Dispose of Property or Modify Articles of Incorporation) |
Where any medical corporation intends to obtain permission to dispose of property or modify the articles of incorporation under Article 48 (3) of the Act, it shall submit an application for permission and related documents determined by Ordinance of the Ministry of Health and Welfare to a Mayor/Do Governor having jurisdiction over the area in which the principal office of such corporation is located: Provided, That a medical corporation falling under Article 11 of the Addenda to the Medical Service Act (No. 4732), which has been assisted with public loans from the State, shall submit such application and documents to the Minister of Health and Welfare via a Mayor/Do Governor. <Amended on Feb. 29, 2008; Mar. 15, 2010; Sep. 28, 2018>
| Article 22 (Medical Information System Projects) |
"Project prescribed by Presidential Decree" in Article 49 (1) 6 of the Act means any of the following projects: <Amended on Jun. 20, 2017> | 1. | System development and operation projects to prepare and manage electronic medical records; |
| 2. | System development and operation projects to prepare and manage electronic medical prescriptions; |
| 3. | System development and operation projects to save and transmit video records. |
| Article 22-2 (Operation of National Academy of Medicine of Korea) |
| (1) | The business year of the National Academy of Medicine of Korea established under Article 52-2 (1) of the Act (hereinafter referred to as the "National Academy") shall coincide with the fiscal year of the Government. |
| (2) | The National Academy shall report matters concerning the plan for and current status of providing its services, funds management plan, disbursement breakdown of funds, etc. to the Minister of Health and Welfare, as determined by the Minister of Health and Welfare. |
| (3) | The National Academy shall develop and implement measures necessary for medical personnel, related experts, etc. in various fields to participate in the operation of its organization, provision of its services, and other relevant matters in equilibrium. |
[This Article Newly Inserted on Sep. 29, 2016]
| Article 23 (Standards for Prohibition of Medical Service Advertisement) |
| (1) | Specific standards for prohibiting medical service advertisement under Article 56 (2) of the Act shall be as follows: <Amended on Dec. 3, 2008; Jan. 27, 2010; Apr. 27, 2012; Feb. 28, 2017; Sep. 28, 2018> |
| 1. | Advertising any new medical technology that has not gone through the assessment of the new medical technology pursuant to Article 53 of the Act; |
| 2. | Advertising with a clear expression that the medical treatment skills or methods of specific medical institutions or specific medical personnel are effective without failure in the treatment of diseases, or advertising the treatment stories of patients or the clinical experiences of not more than six months; |
| 3. | Falsely advertising, such as advertising matters different from objective facts with respect to medical personnel, medical institutions, medical services, and others related to medical treatment; |
| 4. | Advertising that medical treatment skills or methods performed or advertised by the founder of a specific medical institution, the head of a medical institution, or medical personnel (hereinafter referred to as “medical personnel, etc.”) are far superior and more effective than those of other medical personnel, etc.; |
| 5. | Advertising unfavorable matters on medical treatment skills or methods performed or advertised by other medical personnel, etc. for the purpose of slandering the relevant medical personnel, etc.; |
| 6. | Advertising by posting videos or photographs which the general public feel disgusted at such as those showing the scenes of operations of patients performed by medical personnel, or the affected parts, etc. of patients; |
| 7. | Advertising any medical service or therapy provided by medical personnel, etc., which lacks essential information, such as foreseeable side effects likely to cause serious harm to the safety of patients, or which provides such essential information in an inconspicuous manner, such as a hardly readable, small font; |
| 8. | Advertising by exaggerating objective facts with respect to medical personnel, medical institutions, medical services, and various matters related to medical treatment; |
| 9. | Advertising content that contains qualifications or names with no legal basis; |
| 11. | Advertising medical services subject to review under Article 57 (1) of the Act without review or differently from the reviewed contents; |
| 12. | Advertising domestically to perform the acts referred to in Article 27 (3) of the Act for the purpose of attracting foreign patients; |
| 13. | Advertising that contains false or vague contents, information, etc. as to the discount, and amount of exemption, of non-covered medical expenses, and the items eligible for, or the period or scope of non-covered medical expenses referred to in Article 45 of the Act, or the non-covered medical expenses before applying discount or exemption; |
| 14. | Advertising by using various certificates of merit, letters of appreciation, etc. or advertising by using an expression that certification, guarantee, or recommendation is given or by any other similar expression: Provided, That cases falling under any item of Article 56 (2) 14 of the Act shall be excluded. |
| (2) | "Advertisement prescribed by Presidential Decree, such as an advertisement indicating certification obtained from an international evaluation organization that has signed an agreement for collaboration with the World Health Organization" in Article 56 (2) 14 (d) of the Act means any of the following: <Newly Inserted on Sep. 28, 2018> |
| 1. | An advertisement indicating certification obtained from an international evaluation organization that has signed an agreement for collaboration with the World Health Organization; |
| 2. | An advertisement indicating certification from an accreditation agency of each country recognized by the International Society for Quality in Health Care. |
| (3) | Where medical personnel, etc. advertise their medical services on their websites, the Minister of Health and Welfare may determine and publicly notify detailed standards for prohibiting medical advertisement pursuant to paragraph (1). <Amended on Feb. 29, 2008; Mar. 15, 2010; Sep. 28, 2018> |
| Article 24 (Deliberation on Medical Services Advertisement) |
| (1) | “Internet media prescribed by Presidential Decree” in Article 57 (1) 4 of the Act means the following media: <Amended on Apr. 27, 2012> |
| 3. | Internet media that mainly provides broadcast programs of a broadcasting business operator prescribed in subparagraph 3 of Article 2 of the Broadcasting Act online under a name or title, such as ‘broadcasting’, ‘TV’, or ‘radio’; |
| (2) | "Advertising media prescribed by Presidential Decree" in Article 57 (1) 5 of the Act means any advertising medium providing social network services that has at least 100,000 daily users on average for the last three months as at the end of the preceding year. <Amended on Sep. 28, 2018> |
| (3) | An institution or organization referred to in the subparagraphs of Article 57 (2) of the Act shall have all of the following to conduct voluntary deliberation: <Amended on Sep. 28, 2018> |
| 1. | At least one department and three full-time workers (persons with abundant knowledge and experience in the field of medical services or advertisement shall be included) that are exclusively responsible for affairs regarding deliberation on and monitoring of medical service advertisements under Articles 57 and 57-3 of the Act; |
| 2. | Computerized equipment and an office to be used to perform affairs regarding deliberation on and monitoring of medical service advertisements under Articles 57 and 57-3 of the Act. |
| (4) | "Organization that meets the requirements prescribed by Presidential Decree" in Article 57 (2) 2 of the Act means an organization satisfying all of the following requirements: <Newly Inserted on Sep. 28, 2018> |
| 2. | The details related to medical services and advertisements shall be included in the purpose of establishing an organization and the scope of its affairs. |
| (5) | An institution or organization that intends to report under Article 57 (2) of the Act shall submit a written report and related documents determined by Ordinance of the Ministry of Health and Welfare to the Minister of Health and Welfare. <Newly Inserted on Sep. 28, 2018> |
| (6) | The Minister of Health and Welfare shall disclose the current status of reports that he or she has received under paragraph (5) on the website of the Ministry of Health and Welfare. <Newly Inserted on Sep. 28, 2018> |
| 1. | The founder of a medical institution and the year of its foundation; |
| 2. | The website address of a medical institution; |
| 3. | The dates and time of diagnosis and treatment by a medical institution; |
| 6. | The fact that the founder or medical personnel of a medical institution is recognized for their qualifications as a medical specialist under Article 77 (1) of the Act and their specialized areas. |
[Title Amended on Sep. 28, 2018]
| Article 25 Deleted. <Sep. 28, 2018> |
| Article 26 Deleted. <Sep. 28, 2018> |
| Article 27 Deleted. <Sep. 28, 2018> |
| Article 27-2 Deleted. <Sep. 28, 2018> |
| Article 28 (Eligibility for Accreditation of Medical Institutions) |
"Medical institutions prescribed by Presidential Decree" in Article 58 (1) of the Act means any of the following medical institutions: [This Article Newly Inserted on Sep. 4, 2020]
| Article 28-2 Deleted. <Sep. 28, 2018> |
| Article 29 (Entrustment of Accreditation of Medical Institutions) |
| (1) | Pursuant to Article 58 (2) of the Act, the Minister of Health and Welfare shall entrust the following business affairs to the Korea Institute for Healthcare Accreditation referred to in Article 58-11 of the Act (hereafter in this Article referred to as the “KOIHA”): <Amended on Sep. 28, 2018; Sep. 4, 2020> |
| 3. | Receipt of applications for accreditation under Article 58-4 (1) through (3); |
| 4. | Evaluation of whether a medical institution is in compliance with the accreditation standards under the former part of Article 58-4 (4) of the Act; |
| 8. | Publication of the standards for accreditation of medical institutions accredited under Article 58-7 (1) of the Act, the term of validity of accreditation, the results of evaluation conducted pursuant to Article 58-4 (4) of the Act, etc. through Internet websites, etc.; |
| (2) | The head of the KOIHA shall report the details of affairs entrusted to and handled by the agency to the Minister of Health and Welfare, as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended on Sep. 4, 2020> |
[This Article Wholly Amended on Jan. 24, 2011]
| Article 30 (Composition of Medical Institution Accreditation Commission) |
Members of the Medical Institution Accreditation Commission under Article 58-2 (1) of the Act (hereinafter referred to as the “Accreditation Commission”) shall be appointed or commissioned by the Minister of Health and Welfare as follows: <Amended on Sep. 28, 2018> | 3. | Three persons with abundant knowledge and experience in the field of public health and medical services or safety diagnosis of medical institution facilities; |
| 4. | One Grade-III or higher-ranking public official or one public official who is a member of the Senior Executive Service, from among public officials of the Ministry of Health and Welfare. |
[This Article Wholly Amended on Jan. 24, 2011]
| Article 31 (Term of Office of Commission Members) |
| (1) | The term of office of each commission member under subparagraphs 1 through 3 of Article 30 shall be two years. |
| (2) | The term of office of a commission member commissioned to replace a commission member resigning from office shall coincide with the remaining term of office of his or her predecessor. |
[This Article Wholly Amended on Jan. 24, 2011]
| Article 31-2 (Dismissal from Office of Members of Accreditation Commission) |
The Minister of Health and Welfare may dismiss a member of the accreditation Commission from office if he or she falls under any of the following cases:
| 1. | Where he or she member becomes incapable of performing his or her duties due to any mental disorder; |
| 2. | Where he or she engages in misconduct in connection with his or her duties; |
| 3. | Where he or she is deemed unsuitable as a member due to neglect of duties, injury to dignity, or any other ground; |
| 4. | Where he or she voluntarily admits that it is impracticable for him or her to perform his or her duties. |
[This Article Newly Inserted on Sep. 29, 2016]
[Previous Article 31-2 moved to Article 31-3 <Sep. 29, 2016>]
| Article 31-3 (Operation of Accreditation Commission) |
| (1) | The chairperson shall represent the Accreditation Commission and shall exercise overall control over the affairs of the Accreditation Commission. |
| (2) | The Accreditation Commission shall hold a meeting at the call of the chairperson or at least one-third of the registered commission members, and the commission chairperson shall preside over the meeting. |
| (3) | A meeting of the Accreditation Commission shall be duly formed with the attendance of a majority of the registered members, and a resolution shall be adopted by concurrent votes of a majority of the commission members present at the meeting. |
| (4) | If the commission chairperson is unable to perform his or her duty due to extenuating circumstances, a commission member appointed by the commission chairperson in advance shall act on behalf of the commission chairperson. |
| (5) | Except as otherwise expressly provided for in paragraphs (1) through (4), matters necessary for the operation, etc. of the Accreditation Commission shall be determined by the commission chairperson, subject to prior resolution thereon by the Accreditation Commission. |
[This Article Newly Inserted on Jan. 24, 2011]
[Moved from Article 31-2; previous Article 31-3 moved to Article 31-4 <Sep. 29, 2016>]
| Article 31-4 (Administrative Secretary) |
| (1) | The Accreditation Commission shall appoint one administrative secretary, who shall perform administrative affairs of the Accreditation Commission. |
| (2) | The administrative secretary shall be appointed by the Minister of Health and Welfare, from among public officials of the Ministry of Health and Welfare. |
[This Article Newly Inserted on Jan. 24, 2011]
[Moved from Article 31-3; previous Article 31-4 moved to Article 31-5 <Sep. 29, 2016>]
| Article 31-5 (Allowances) |
Commission members who attend a meeting of the Accreditation Commission, except for public officials, shall be reimbursed for allowances and travel expenses within budgetary limits.
[This Article Newly Inserted on Jan. 24, 2011]
[Moved from Article 31-4 <Sep. 29, 2016>]
| Article 31-6 (Entrustment of Operation of Vocational Training Centers for Nursing Workforce) |
| (1) | Pursuant to Article 60-3 (2) of the Act, the Minister of Health and Welfare may entrust the affairs related to the operation of a vocational training center for nursing workforce referred to in paragraph (1) of the same Article (hereinafter referred to as "vocational training center for nursing workforce") to any of the following specialized institutions or organizations: |
| 3. | Any other specialized institution or organization publicly notified by the Minister of Health and Welfare, taking into account the organizational structure, workforce, expertise, etc. necessary for the performance of entrusted services. |
| (2) | Where the Minister of Health and Welfare intends to entrust the operation of a vocational training center for nursing workforce pursuant to Article 60-3 (2) of the Act, he or she shall publicly announce matters related to the criteria and procedures for, and the methods, etc. of the entrustment in advance. |
| (3) | When the Minister of Health and Welfare entrusts the operation of a vocational training center for nursing workforce pursuant to Article 60-3 (2) of the Act, he or she shall publicly notify matters related to the details of the entrustment, entrustee, etc. in the Official Gazette and post them on the website of the Ministry of Health and Welfare. |
| (4) | A specialized institution or organization entrusted with the operation of a vocational training center for nursing workforce pursuant to Article 60-3 (2) of the Act, shall report matters related to the plan for and current status of providing its services, funds management plan, disbursement breakdown of funds, etc. to the Minister of Health and Welfare, as determined by the Minister of Health and Welfare. |
| (5) | Detailed matters necessary for the public announcement of criteria for entrustment, public notice of details, etc. of entrustment, reporting on entrusted affairs, and other relevant matters prescribed in paragraphs (2) through (4) shall be determined and publicly notified by the Minister of Health and Welfare. |
[This Article Newly Inserted on Sep. 29, 2016]
| Article 31-7 (Publication of Offense and Corrective Advertisement) |
| (1) | When the Minister of Health and Welfare or the head of a Si/Gun/Gu orders medical personnel, etc. to publish an offense or run a corrective advertisement under Article 63 (2) 2 or 3 of the Act, he or she shall determine the details, frequency, size, or medium of such publication or corrective advertisement, considering the following: |
| 1. | The details and degree of an offense; |
| 2. | The duration and frequency of an offense. |
| (2) | When the Minister of Health and Welfare or the head of a Si/Gun/Gu orders medical personnel, etc. to publish an offense or run a corrective advertisement under paragraph (1), he or she may determine the details, frequency, size, or medium of such publication or corrective advertisement in consultation with the deliberation committees established under Article 57-2 (2) of the Act. |
[This Article Newly Inserted on Sep. 28, 2018]
| Article 32 (Scope of Acts of Degrading Medical Personnel's Dignity) |
| (1) | The scope of acts of degrading the dignity of medical personnel referred to in Article 66 (2) of the Act shall be as follows: <Amended on Sep. 15, 2015; Jun. 15, 2021> |
| 1. | Conducting medical treatment not recognized academically (including midwifery services and nursing services; hereinafter the same shall apply); |
| 2. | Conducting unethical medical treatment; |
| 3. | Running false or exaggerated advertisements; |
| (e) | Health and medical information on cosmetics, functional cosmetics or organic cosmetics defined in subparagraphs 1 through 3 of Article 2 of the Cosmetics Act; |
| 4. | Conducting excessive medical treatment, such as unnecessary tests, medication or surgery, or requesting unjustly excessive medical treatment fees; |
| 5. | Giving and receiving money and other valuables in connection with work, such as selection of specialized doctors; |
| 6. | Enticing or causing enticement of patients who are about to use other medical institutions into going to medical institutions at which they are employed or which they have established, for profits; |
| 7. | Enticing patients who get prescriptions from them into visiting a particular drugstore in collusion with the opener of such drugstore or a person employed at such drugstore, for profit. |
| (2) | Deleted. <Apr. 27, 2012> |
| Article 33 (Request of Central Association for Suspension of Qualification) |
A request for the suspension of qualification under Article 66-2 of the Act shall be made by submitting a document which states the date, time, and place of the meeting of the Ethics Committee and the reasons and grounds for the request for suspension of qualification, to the Minister of Health and Welfare. [This Article Wholly Amended on Apr. 27, 2012]
| Article 34 Deleted. <Apr. 27, 2012> |
| Article 35 Deleted. <Apr. 27, 2012> |
| Article 36 Deleted. <Apr. 27, 2012> |
| Article 37 Deleted. <Apr. 27, 2012> |
| Article 38 Deleted. <Apr. 27, 2012> |
| Article 39 Deleted. <Apr. 27, 2012> |
| Article 40 (Entrustment of Affairs Related to Evaluation for Designation of Education and Training Centers for Assistant Nurses) |
| (1) | Pursuant to the latter part of Article 80 (2) of the Act, the Minister of Health and Welfare may entrust affairs related to the designation of an education and training center for assistant nurses to any of the following institutions: |
| 2. | Any other institution publicly notified by the Minister of Health and Welfare as a specialized institution with the organizational structure, workforce, expertise, etc. necessary to perform the entrusted affairs. |
| (2) | Where the Minister of Health and Welfare entrusts affairs related to the evaluation for designation of an education and training center for assistant nurses pursuant to the latter part of Article 80 (2) of the Act, Article 31-6 (2) through (5) shall apply mutatis mutandis to the public announcement of criteria for entrustment, public notice of details of the entrustment, reporting on the entrusted affairs, etc. |
[This Article Newly Inserted on Dec. 27, 2016]
| Article 41 (Grounds for Revocation of Designation of Education and Training Center for Assistant Nurses) |
"Grounds prescribed by Presidential Decree, such as obtaining the designation by fraudulent or illegal means" in Article 80 (3) of the Act, means any of the following grounds: | 1. | Where an education and training center for assistant nurses is designated by fraud or other improper means; |
| 2. | Where an education and training center for assistant nurses fails to meet the criteria for designation of an education and training center for assistant nurses; |
| 3. | Where an education and training center for assistant nurses refuses to perform affairs of education and training or provides no education or training for at least three months; |
| 4. | Where an education and training center for assistant nurses issues a diploma of education and training or a certificate of completion of the course by fraudulent or other illegal means; |
| 5. | Where the curricula or contents of education are in contravention of statutes or regulations, or where it is deemed impracticable to attain the purpose of designation of an education and training center. |
[This Article Newly Inserted on Dec. 27, 2016]
| Article 42 (Entrustment of Business) |
| (1) | The Minister of Health and Welfare may entrust business for preparing standards for medical terms, and forms and details of medical records, etc. prescribed in Article 22 (4) of the Act to the following institutions pursuant to Article 86 (2) of the Act: <Newly Inserted on Feb. 25, 2020> |
| 2. | A specialized institutions equipped with organizations, human resources, expertise, etc. necessary to conduct the business entrusted, which the Minister of Health and Welfare determines and publicly notifies. |
| (2) | The Minister of Health and Welfare may entrust business concerning the receipt of applications for the certification of electronic medical record systems, notification of results of certification, and issuance of certificates prescribed in Article 23-2 (2), and business concerning the promotion of development of technology and use of electronic medical record systems prescribed in paragraph (5) of the same Article to the following institutions pursuant to Article 86 (2) of the Act: <Newly Inserted on Jun. 20, 2017; Feb. 25, 2020> |
| 2. | An institution the Minister of Health and Welfare determines and publicly notifies, taking into account the organizational structure, workforce, expertise, etc. necessary to conduct the business entrusted. |
| (3) | Pursuant to Article 86 (2) of the Act, the Minister of Health and Welfare may entrust the following specialized institutions with such business affairs as the receipt of reports on non-covered medical expenses under Article 45-2 (1) of the Act and investigation and analysis of the current status of non-covered medical expenses under Article 45-2 (2) of the Act, as well as the disclosure of the results thereof: <Amended on Jun. 20, 2017; Feb. 25, 2020; Jun. 15, 2021> |
| 1. | A physicians' association, dentists' association or oriental medical doctors' association prescribed in Article 28 of the Act; |
| 3. | Other institutions the Minister of Health and Welfare publicly notifies, taking into account the organizational structure, workforce, expertise, etc. necessary to conduct the business entrusted. |
| (4) | The Minister of Health and Welfare may entrust business concerning the operation of accounting standards for medical institutions prescribed in Article 62 (2) of the Act to the following institutions pursuant to Article 86 (2) of the Act: <Newly Inserted on Sep. 28, 2018; Feb. 25, 2020> |
| 2. | A specialized institution equipped with organizations, workforce, expertise, etc. necessary to conduct the business entrusted, which is an institution the Minister of Health and Welfare determines and publicly notifies. |
| (5) | The Minister of Health and Welfare may entrust business concerning the receipt of applications to obtain designation as assistant nurse education and training institutions prescribed in Article 80 (2) of the Act and the issuance of certificates of designation to the following institutions pursuant to Article 86 (2) of the Act: <Newly Inserted on Dec. 27, 2016; Jun. 20, 2017; Sep. 28, 2016; Feb. 25, 2020> |
| 2. | A specialized institution equipped with organizations, workforce, expertise, etc. necessary to conduct the business entrusted, which the Minister of Health and Welfare determines and publicly notifies. |
| (6) | The Minister of Health and Welfare may entrust business concerning reporting on the actual state, employment, etc. of assistant nurses prescribed in Article 80 (4) of the Act and refresher training for assistant nurses prescribed in Article 80 (5) of the Act to the following institutions pursuant to Article 86 (2) of the Act: <Newly Inserted on Dec. 27, 2016; Jun. 20, 2017; Sep. 28, 2018; Feb. 25, 2020> |
| 2. | An institution established with assistant nurses as its members and having a nationwide organization; |
| 3. | A specialized institution equipped with organizations, workforce, expertise, etc. necessary to conduct the business entrusted, which the Minister of Health and Welfare determines and publicly notifies (limited to refresher training for assistant nurses prescribed in Article 80 (5) of the Act). |
| (7) | Where the Minister of Health and Welfare entrusts business prescribed in paragraphs (1) through (6) pursuant to Article 86 (2) of the Act, Article 31-6 (2) through (5) shall apply mutatis mutandis to the public announcement of criteria for entrustment, public notice of details of entrustment, etc., and reports on entrusted business, etc. <Amended on Dec. 27, 2016; Jun. 20, 2017; Sep. 28, 2018; Feb. 25, 2020> |
[This Article Newly Inserted on Sep. 29, 2016]
| Article 42-2 (Management of Sensitive Information and Personally Identifiable Information) |
The Minister of Health and Welfare (including persons entrusted with affairs of the Minister of Health and Welfare pursuant to Articles 10-4 (1), 11 (2), 31-6 (1), and 42 (1) through (5)); the Commissioner of the Korea Disease Control and Prevention Agency; a Mayor/Do Governor; the head of a Si/Gun/Gu (including persons with authority delegated or entrusted, where a Mayor/Do Governor or the head of a Si/Gun/Gu delegates or entrusts his or her authority for relevant affairs); medical personnel; the head of a medical institution; a person working for a medical institution; the founder or manager of a medical institution prescribed in Article 37 of the Act; or an agency responsible for the management of national examinations, may manage information about health prescribed in Article 23 of the Personal Information Protection Act; criminal records prescribed in subparagraph 2 of Article 18 of the Enforcement Decree of the aforesaid Act; and materials in which a resident registration number or alien registration number prescribed in subparagraph 1 or 4 of Article 19 of the aforesaid Decree is included, if essential to perform any of the following affairs: <Amended on Apr. 27, 2012; Sep. 29, 2016; Dec. 27, 2016; Feb. 28, 2017; Jun. 20, 2017; Feb. 25, 2020; Sep. 11, 2020; Jun. 15, 2021> | 3-2. | Preparing, issuing or transmitting (limited to online prescriptions) medical certificates, post mortem examination reports, certificates or prescriptions under Article 17 or 18 of the Act; |
| 3-4. | Verifying details of medical records, or sending or transmitting copies of medical records, clinical opinions on the progress of medical treatment of patients, etc. under Article 21-2 (1) of the Act; |
| 4. | Reporting the actual status of medical personnel, his or her current employment status, etc. prescribed in Article 25 of the Act; |
| 5. | Controlling exposure of radiation to workers involved in radiation from radiation generators for diagnosis prescribed in Article 37 of the Act; |
| 5-3. | Supporting the survey of the current securement of nursing workforce, and vocational education of nursing workforce and their career development prescribed in Article 60-3 (1) 1 through 5 of the Act; |
| 11. | Reporting the actual status of assistant nurses and their current employment status prescribed in Article 80 (4) of the Act. |
[This Article Newly Inserted on Jan. 6, 2012]
| Article 43 (Calculation Basis of Penalty Surcharges) |
The amount of penalty surcharges referred to in Article 67 of the Act shall be assessed by applying criteria of attached Table 1-2, based on the criteria for medical service suspension disposition determined by Ordinance of the Ministry of Health and Welfare, with kinds and degree of offenses taken into consideration. <Amended on Feb. 29, 2008; Apr. 20, 2009; Mar. 15, 2010; Jun. 20, 2017>
| Article 44 (Procedure for Imposition and Collection of Penalty Surcharges) |
| (1) | When intending to impose penalty surcharges under Article 67 of the Act, the Minister of Health and Welfare, a Mayor/Do Governor or head of a Si/Gus/Gu shall clearly state the kinds of the relevant offenses and the amount of penalty surcharges in writing and issue a notice for payment. <Amended on Feb. 29, 2008; Mar. 15, 2010> |
| (2) | Procedures for the collection of penalty surcharges shall be determined by Ordinance of the Ministry of Health and Welfare. <Amended on Feb. 29, 2008; Mar. 15, 2010> |
| Article 44-2 (Re-Examination of Regulation) |
| (1) | The Minister of Health and Welfare shall examine the appropriateness of the following matters every three years, counting from each base date specified in the following (referring to the period that ends on the day before the base date of every third year) and shall take measures, such as making improvements: <Amended on Dec. 9, 2014; Sep. 15, 2015; Jun. 20, 2017> |
| 1. | Base date for the calculation of penalty surcharges referred to in Article 43 and Table 1-2: January 1, 2014; |
| 2. | Base date for the imposition of administrative fines referred to in Article 45 and Table 2: January 1, 2014. |
| (2) | The Minister of Health and Welfare shall examine the appropriateness of the standards for prohibiting medical advertisement prescribed in Article 23 every two years, counting from January 1, 2015 (referring to the period that ends on the day before January 1 of every second year) and shall take measures, such as making improvements. <Newly Inserted on Dec. 9, 2014> |
[This Article Newly Inserted on Dec. 30, 2013]
| Article 45 (Criteria for Imposition of Administrative Fines) |
[This Article Wholly Amended on Sep. 15, 2015]
ADDENDA <Presidential Decree No. 20292, Sep. 28, 2007>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Article 2 (Relationship to Other Statutes or Regulations)
Where the provisions of the former Enforcement Decree of the Medical Service Act have been cited in other statutes or regulations at the time when this Decree enters into force, it shall be deemed that the relevant provisions of this Decree have been cited in place of the former provisions if there are provisions corresponding thereto in this Decree.
ADDENDA <Presidential Decree No. 20679, Feb. 29, 2008>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 9 Omitted.
ADDENDA <Presidential Decree No. 21148, Dec. 3, 2008>
Article 1 (Enforcement Date)
This Decree shall enter into force on December 6, 2008.
Articles 2 and 3 Omitted.
ADDENDUM <Presidential Decree No. 21428, Apr. 20, 2009>
This Decree shall enter into force on May 1, 2009: Provided, That the amended provisions of subparagraph 2 of Article 2 enters into force on July 8, 2009.
ADDENDA <Presidential Decree No. 22003, Jan. 27, 2010>
Article 1 (Enforcement Date)
This Decree shall enter into force on February 1, 2010.
Articles 2 through 5 Omitted.
ADDENDA <Presidential Decree No. 22075, Mar. 15, 2010>
Article 1 (Enforcement Date)
This Decree shall enter into force on March 19, 2010. (Proviso Omitted.)
Articles 2 and 3 Omitted.
ADDENDA <Presidential Decree No. 22635, Jan. 24, 2011>
Article 1 (Enforcement Date)
This Decree shall enter into force on January 24, 2011.
Article 2 Omitted.
ADDENDA <Presidential Decree No. 22667, Feb. 14, 2011>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Article 2 Omitted.
ADDENDA <Presidential Decree No. 23488, Jan. 6, 2012>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Article 2 Omitted.
ADDENDUM <Presidential Decree No. 23753, Apr. 27, 2012>
This Decree shall enter into force on April 29, 2012: Provided, That the amended provisions of Articles 23 and 24 shall enter into force on August 5, 2012.
ADDENDA <Presidential Decree No. 23759, May 1, 2012>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Article 2 (Applicability to Pubic Announcement of Examinations)
The provisions that amend a deadline for the public announcement of examinations, etc. in this Decree shall apply to examinations conducted on or after January 1, 2013.
ADDENDUM <Presidential Decree No. 25050, Dec. 30, 2013>
This Decree shall enter into force on January 1, 2014. (Proviso Omitted.)
ADDENDA <Presidential Decree No. 25840, Dec. 9, 2014>
Article 1 (Enforcement Date)
This Decree shall enter into force on January 1, 2015.
Articles 2 through 16 Omitted.
ADDENDA <Presidential Decree No. 26526, Sep. 15, 2015>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Article 2 (Applicability to Scope of Acts of Degrading Medical Personnel's Dignity)
The amended provisions of Article 32 (1) 3-2 shall apply, beginning with a medical personnel's act of providing false or exaggerated health and medical information after this Decree enters into force. Article 3 (Transitional Measures concerning Composition of Members of Deliberative Committee)
The deliberative body which has been established and is operated as at the time this Decree enters into force under the former provisions shall organize members of the deliberative committee in accordance with the amended provisions of Article 28 (2) and (4) within three months after this Decree enters into force. Article 4 (Transitional Measures concerning Imposition of Administrative Fines)
| (1) | The application of the criteria for the imposition of an administrative fine against an act committed before this Decree enters into force shall be governed by the former provisions, notwithstanding the amended provisions of attached Table 2. |
| (2) | The disposition for imposing administrative fines due to violations committed before this Decree enters into force shall be excluded from the calculation of the number of times of the violations prescribed in the amended provisions of attached Table 2. |
ADDENDA <Presidential Decree No. 26742, Dec. 22, 2015>
Article 1 (Enforcement Date)
This Decree shall enter into force on December 23, 2015.
Article 2 Omitted.
ADDENDA <Presidential Decree No. 27241, Jun. 21, 2016>
Article 1 (Enforcement Date)
This Decree shall enter into force on June 23, 2016.
Articles 2 and 3 Omitted.
ADDENDUM <Presidential Decree No. 27525, Sep. 29, 2016>
This Decree shall enter into force on September 30, 2016.
ADDENDUM <Presidential Decree No. 27700, Dec. 27, 2016>
This Decree shall enter into force on January 1, 2017.
ADDENDUM <Presidential Decree No. 27917, Feb. 28, 2017>
This Decree shall enter into force on March 1, 2017.
ADDENDUM <Presidential Decree No. 27944, Mar. 20, 2017>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 28131, Jun. 20, 2017>
This Decree shall enter into force on June 21, 2017.
ADDENDA <Presidential Decree No. 28695, Mar. 6, 2018>
Article 1 (Enforcement Date)
This Decree shall enter into force on March 13, 2018. (Proviso Omitted.)
Article 2 Omitted.
ADDENDUM <Presidential Decree No. 29195, Sep. 28, 2018>
This Decree shall enter into force on September 28, 2018.
ADDENDA <Presidential Decree No. 30106, Oct. 8, 2019>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 5 Omitted.
ADDENDA <Presidential Decree No. 30480, Feb. 25, 2020>
Article 1 (Enforcement Date)
This Decree shall enter into force on February 28, 2020.
Articles 2 (Transitional Measures for Standards for Calculating Penalty Surcharges)
Notwithstanding the amended provisions of attached Table 1-2, the application of standards for calculating penalty surcharges to offenses committed before this Decree enters into force shall be governed by the former provisions.
ADDENDUM <Presidential Decree No. 30990, Sep. 4, 2020>
This Decree shall enter into force on September 5, 2020.
ADDENDA <Presidential Decree No. 31013, Sep. 11, 2020>
Article 1 (Enforcement Date)
This Decree shall enter into force on September 12, 2020.
Articles 2 and 3 Omitted.
ADDENDUM <Presidential Decree No. 31398, Jan. 12, 2021>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 31774, Jun. 15, 2021>
This Decree shall enter into force on June 30, 2021.