HEALTH AND MEDICAL SERVICE TECHNOLOGY PROMOTION ACT
Wholly Amended by Act No. 9028, Mar. 28, 2008
Amended by Act No. 9932, Jan. 18, 2010
Act No. 10996, Aug. 4, 2011
Act No. 11713, Mar. 23, 2013
Act No. 11975, Jul. 30, 2013
Act No. 13105, Jan. 28, 2015
Act No. 14883, Sep. 19, 2017
Act No. 15344, Jan. 16, 2018
CHAPTER I GENERAL PROVISIONS
The purpose of this Act is to contribute to the sound development of the health and medical service industry and the promotion of the national health by establishing the master plan for the promotion of health and medical service technology; performing the research and development projects for health and medical service technology; prescribing matters concerning the certification of new excellent technology, health and medical service information, and similar matters; and establishing the National Evidence-based Healthcare Collaborating Agency performing the analysis on health and medical service technology and other relevant affairs.
| (1) | The terms used in this Act shall be defined as follows: <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11975, Jul. 30, 2013> |
| 1. | The term "health and medical service technology" means any technology falling under the following: |
| (a) | Technology related to medical science, dental surgery, oriental medicine, medical engineering and medical information science, etc.; |
| (b) | Technology related to developing and improving the efficiency of pharmaceuticals, medical device, foods, cosmetic and herb medicines, etc.; |
| (c) | Other technologies related to health and medical services related to the goods and services necessary for preservation and improvement of the health and life of the human body; |
| 7. | The term "new excellent technology" means any new technology in health and medical service certified by the Minster of Health and Welfare as a result of technology development firstly attained in the country or of improvement in the existing technology; |
| 8. | The term "research and development project of health and medical service technology" means any project supported by budget or fund for research and development of health and medical service technology (including research and development under the following Acts): |
| (2) | The specific fields of health and medical service technologies shall be prescribed by Presidential Decree. |
| Article 2-2 (Relationship to Other Acts) |
Except as otherwise provided in any other Act, the research into and development of health and medical service technology shall be governed by the provisions of this Act.
[This Article Newly Inserted by Act No. 11975, Jul. 30, 2013]
CHAPTER II PROMOTION POLICY OF HEALTH AND MEDICAL SERVICE TECHNOLOGY
| Article 3 (Protection and Fosterage of Technology Development) |
The Government shall establish and execute the policy for encouragement, protection and fosterage of the research and development activities for promotion of health and medical service technology and the new excellent technology, and may support the necessary expenses.
| Article 4 (Formulation of Master Plan for Fosterage of Health and Medical Service Technology) |
| (1) | In order to develop and promote health and medical service technology, the government shall formulate and implement a master plan for fosterage of health and medical service technology, every five years (hereinafter referred to as "master plan"). <Amended by Act No. 11975, Jul. 30, 2013> |
| (2) | The Minister of Health and Welfare shall prepare a master plan by putting together plans of related central administrative agencies and finalize it through deliberation of the Presidential Advisory Council on Science and Technology under the Presidential Advisory Council on Science and Technology Act (hereinafter referred to as the “Presidential Advisory Council on Science and Technology”). <Amended by Act No. 11975, Jul. 30, 2013; Act No. 15344, Jan. 16, 2018> |
| (3) | The following matters shall be included in the master plan: <Amended by Act No. 11975, Jul. 30, 2013> |
| 1. | Direction and goal of health and medical service technology; |
| 2. | Analysis of national and international environments of health and medical service technology; |
| 3. | Medium and long-term strategy for the important technology development; |
| 4. | Medium and long-term investment plan for promoting health and medical service technology; |
| 5. | Plan for supply of and demand for and fostering of human resources of health and medical service technology; |
| 6. | Other matters necessary for the development of health and medical service technology, prescribed by Presidential Decree. |
| (4) | The Minister of Health and Welfare shall establish an annual implementation plan based on the record of previous year and a plan for the next year of the relevant central administrative agency (hereinafter referred to as “implementation plan”) and report it to the Presidential Advisory Council on Science and Technology. <Newly Inserted by Act No. 11975, Jul. 30, 2013; Act No. 15344, Jan. 16, 2018> |
| (5) | Where the Minister of Health and Welfare formulates the master plan and implementation plan, he/she may report them to the policy deliberative committee for health and medical service technology pursuant to Article 6 and listen to its opinion. <Newly Inserted by Act No. 11975, Jul. 30, 2013> |
| (6) | In order to establish the master plan and implementation plan, the Minister of Health and Welfare may request data from the head of related central agency as prescribed by Presidential Decree. <Newly Inserted by Act No. 11975, Jul. 30, 2013> |
| Article 5 (Promotion of Research and Development Projects of Health and Medical Service Technology) |
| (1) | The government shall perform the research and development projects of health and medical service technology (hereinafter referred to as "research and development projects") in order to carry forward the master plan efficiently. <Amended by Act No. 11975, Jul. 30, 2013> |
| (2) | The Minister of Health and Welfare may select the research tasks classified by year and by field as research and development projects and conclude an agreement with the following institutions or organizations, to have them conduct research. In such cases, where an institution from among the institutions prescribed in subparagraph 4 is not a corporation, the agreement may be concluded with the representative of the corporation to which such institution belongs: <Amended by Act No. 9932, Jan. 18, 2010> |
| 1. | National and public research institutions; |
| 4. | Research institutes affiliated with enterprises falling under the standard prescribed by Presidential Decree; |
| 5. | Research institutions that are corporations incorporated under the Civil Act or other Acts; |
| 6. | Other research institutions or organizations in the field of health and medical service technology, prescribed by Presidential Decree. |
| (3) | Contributions from the government or a person other than the government or other technology development funds of enterprises shall be appropriated for expenses necessary for the researches under paragraph (2). |
| (4) | The Minister of Health and Welfare may provide contributions to an institution or an organization performing research under paragraph (2) in order to carry out the research and development project. <Amended by Act No. 9932, Jan. 18, 2010> |
| (5) | When selecting the research tasks and concluding an agreement under paragraph (2) and providing the contributions under paragraphs (3) and (4), the Minister of Health and Welfare shall endeavor not to lay disproportionate emphasis on the specific institution or organization, etc. <Amended by Act No. 9932, Jan. 18, 2010> |
| (6) | Matters necessary for the method of selection of research tasks and conclusion of agreement under paragraph (2) and the provision, use and management of the contributions under paragraphs (3) and (4) shall be prescribed by Presidential Decree. |
| Article 6 (Policy Deliberative Committee for Health and Medical Service Technology) |
| (1) | The policy deliberative committee for health and medical service technology (hereinafter referred to as the "Committee") shall be established under the jurisdiction of the Minister of Health and Welfare in order to deliberate on the important matters concerning health and medical service technology including formulation of the policy to develop health and medical service technology, etc. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11975, Jul. 30, 2013> |
| (2) | The Committee shall deliberate on matters in the following subparagraphs: <Amended by Act No. 11975, Jul. 30, 2013> |
| 1. | Matters related to major policy formulation and coordination for promotion of health and medical service technology; |
| 2. | Formulation of the medium and long-term development strategy for the health and medical service technology; |
| 3. | Determination on the order of priority of research and development tasks of health and medical service technology; |
| 4. | Distribution of support funds for research and development projects; |
| 5. | Management and computerization of information and statistics in the field of health and medical service; |
| 6. | Matters concerning the joint researches in health and medical service technology among academic circles, research institutions, and industrial circles; |
| 7. | Matters related to evaluation of research and development activities of health and medical service technology; |
| 8. | Other matters necessary for the promotion of health and medical service technology as prescribed by Presidential Decree. |
| (3) | If necessary to deliberate on the matters as referred to in the subparagraphs of paragraph (2), the Committee may conduct investigations and researches or listen to the opinions of the relevant persons. |
| (4) | The Committee may organize and operate specialized committee classified by field for the efficient operation. |
| (5) | Except matters as prescribed by this Act, other matters necessary for the structure and operation of the committee and specialized committee shall be prescribed by Presidential Decree. |
| Article 7 (Designation of Specialized Institution for Research and Development Activities) |
| (1) | The Minister of Health and Welfare may designate the Korea Health Industry Development Institute under the Korea Health Industry Development Institute Act or an institution and an organization in the field of health and medical service as a specialized institution for research and development projects and have it perform the following affairs: <Amended by Act No. 9932, Jan. 18, 2010; Act No. 10996, Aug. 4, 2011> |
| 1. | Support for research and technology development for health and medical service enterprises; |
| 2. | Investigation, planning, evaluation and management of research and development projects; |
| 3. | Agreement on research tasks under Article 5 (2); |
| 4. | Management and circulation of the health and medical service information under the provisions of subparagraphs 2 through 4 of Article 10; |
| 5. | Other affairs as prescribed by Ordinance of the Ministry of Health and Welfare for the promotion of health and medical service technology. |
| (2) | The Minister of Health and Welfare may subsidize the expenses to be incurred in performing the affairs referred to in the subparagraphs of paragraph (1) to any specialized institution for research and development projects under paragraph (1). <Amended by Act No. 9932, Jan. 18, 2010; Act No. 10996, Aug. 4, 2011> |
| Article 7-2 (Preparation of System for Classification of Health and Medical Service Technology) |
| (1) | In order to effectively manage information, human resources, research and development projects related to health and medical service technology, the Minister of Health and Welfare shall prepare a classification system of health and medical service technology and continuously complement and develop it. |
| (2) | Matters necessary for the preparation, etc. of the system for classification of health and medical service technology pursuant to paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
[This Article Newly Inserted by Act No. 11975, Jul. 30, 2013]
| Article 7-3 (Establishment and Operation of System for Integrated Information of Health and Medical Service Technology) |
The Minister of Health and Welfare may establish and operate an integrated information system of health and medical service technology for the effective advancement and integrated management of research and development projects of health and medical service technology.
[This Article Newly Inserted by Act No. 11975, Jul. 30, 2013]
| Article 8 (Certification of New Excellent Technology) |
| (1) | The Minister of Health and Welfare may certify superior technology in health and medical services as new excellent technology in order to promote development of new technology and to widely disseminate the achievement. <Amended by Act No. 9932, Jan. 18, 2010> |
| (2) | A person that intends to obtain new excellent technology certification shall file an application therefor with the Minster of Health and Welfare, as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 9932, Jan. 18, 2010> |
| (3) | The Minister of Health and Welfare shall examine and evaluate the technology applied for certification under paragraph (2), and if he/she certifies it as new excellent technology, he/she shall notify it to the public and issue a certificate certifying it as a new excellent technology. <Amended by Act No. 9932, Jan. 18, 2010> |
| (4) | The Government shall formulate supporting measures, including financial support, in order to promote the commercialization of the new excellent technology. |
| (5) | The Minister of Health and Welfare may require a person that applies for certification of new excellent technology to bear the expenses incurred in examining and evaluating the technology applied for certification under paragraph (2), as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 9932, Jan. 18, 2010> |
| (6) | Matters necessary for new excellent technology subject to certification, standard therefor, examination thereof, support therefor, etc. under paragraphs (3) and (4) shall be prescribed by Presidential Decree. |
| (7) | The Minister of Health and Welfare may entrust the Korea Health Industry Development Institute provided for in the Korea Health Industry Development Institute Act with affairs of certification of new excellent technology under paragraphs (1) through (6), as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11975, Jul. 30, 2013> |
| Article 8-2 (Use of New Excellent Technology Certification Mark, and Relevant Matters) |
| (1) | A person who has obtained new excellent technology certification pursuant to Article 8 (1), may put a new excellent technology certification mark (hereinafter referred to as “certification mark”) on each product manufactured by making use of the relevant new excellent technology, or on its package, container, publicity materials, etc. |
| (2) | No person, other than persons who have obtained new excellent technology certification pursuant to Article 8 (1), may use such certification mark or similar. |
| (3) | A person who uses a certification mark, shall annually report (including reporting in the form of electronic document) on details of the use of such certification mark, outcomes from such use, etc. to the Minister of Health and Welfare. In such cases, the procedures, etc. for reporting on the certification mark shall be prescribed by Ordinance of the Minister of Health and Welfare. |
| (4) | Where a person who has obtained new excellent technology certification pursuant to Article 8 (1) violates methods for using a certification mark or uses it by improper means, including using it after the expiration of the relevant certification period, the Minister of Health and Welfare may recommend or order the person to take corrective measures. In such cases, matters necessary for the methods for using the certification mark, recommendation or order for correction, etc. shall be prescribed by Presidential Decree. |
[This Article Newly Inserted by Act No. 13105, Jan. 28, 2015]
| Article 9 (Revocation of Certification of New Excellent Technology) |
| (1) | The Minister of Health and Welfare may revoke new excellent technology certification under Article 8 (1) if it falls under any of the following: Provided, That where it falls under subparagraph 1, he/she shall revoke the new excellent technology certification: <Amended by Act No. 9932, Jan. 18, 2010> |
| 1. | Where the new excellent technology certification has been obtained by fraud or other improper means; |
| 2. | Where products manufactured by making use of the new excellent technology certification have serious defect in quality control or performance (limited to cases where the new excellent technology itself has serious defect); |
| 3. | Where another person’s rights, including industrial property right, have been infringed. |
| (2) | Matters necessary for the procedure, method, etc., for revocation under paragraph (1) shall be prescribed by Presidential Decree. |
| Article 10 (Promotion of Health and Medical Service Information) |
The Minister of Health and Welfare shall promote the projects under the following subparagraphs for the production, circulation, and utilization of health and medical service information: <Amended by Act No. 9932, Jan. 18, 2010>
| 1. | Fosterage of specialized research institutions for the management of health and medical service information; |
| 2. | Research, development and management concerning the standards of affairs for the promotion of computerization in the field of health and medical service and welfare; |
| 3. | Invigoration of common use of health and medical service information; |
| 4. | Other important projects for the development of health and medical service information as prescribed by Ordinance of the Ministry of Health and Welfare. |
| Article 11 (Promotion of Cooperative Research) |
The Minister of Health and Welfare shall promote the cooperative research among academic circles, research institutions and industrial circles for the efficient development and fosterage of health and medical service technology, and may support preferentially the cooperative research and development under the Cooperative Research and Development Promotion Act. <Amended by Act No. 9932, Jan. 18, 2010>
| Article 12 (Special Case of Use of Industrial Property Right etc.) |
| (1) | Notwithstanding the State Property Act, the Minister of Health and Welfare may, in consultation with the Minister of Strategy and Finance, transfer gratuitously the industrial property right deemed especially necessary for the industrial development, out of industrial property right which have reverted to the State as a result of the research tasks performed under Article 5 (2), to a person who has performed the research tasks or who has jointly invested with the government to perform the research tasks. <Amended by Act No. 9932, Jan. 18, 2010> |
| (2) | Notwithstanding the Commodity Management Act, the Minister of Health and Welfare may, in consultation with the Administrator of the Public Procurement Service, transfer gratuitously the research apparatus, equipment and trial products used in the performance of the research tasks and which have reverted to the State, if deemed especially necessary, to a person who has performed the research tasks under Article 5 (2) or who has jointly invested with the government for said research and development. <Amended by Act No. 9932, Jan. 18, 2010> |
| Article 13 (Reports, etc.) |
| (1) | The Minister of Health and Welfare may, if necessary for achieving the purpose of this Act, have a person who has received the support under Articles 3 and 5 (4) report the management status of the related affairs, as prescribed by Presidential Decree or have a public official under his/her control conduct investigation or inquire of the related person. <Amended by Act No. 9932, Jan. 18, 2010> |
| (2) | A public official who carries out investigation or inquiries under paragraph (1) shall bear the voucher indicating such authority and produce it to the parties concerned. |
| Article 14 (Collection and Use of Royalties) |
| (1) | The Minister of Health and Welfare may collect a royalty from a person who intends to use, transfer, lease or export research outcomes pursuant to Article 5 (2), as prescribed by Presidential Decree. <Amended by Act No. 9932, Jan. 18, 2010> |
| (2) | The Minister of Health and Welfare may use royalties collected under paragraph (1) for the following projects. In such cases, he/she shall undergo consultation with the Minister of Strategy and Finance pursuant to Article 53 (5) of the National Finance Act: <Amended by Act No. 9932, Jan. 18, 2010> |
| 1. | Research and development projects; |
| 2. | Other projects prescribed by Presidential Decree for the promotion of the health and medical industry. |
| (3) | The Minister of Health and Welfare may entrust any specialized institution for a research and development project with affairs concerning the collection, management and use of royalties under paragraphs (1) and (2). <Newly Inserted by Act No. 10996, Aug. 4, 2011> |
| (4) | Matters necessary for the collection, management and use of royalties under paragraphs (1) and (2) and other related matters shall be prescribed by Presidential Decree. |
CHAPTER III FOSTERING OF RESEARCH-ORIENTED HOSPITALS
| Article 15 (Designation, etc. of Research-Oriented Hospitals) |
| (1) | The Minister of Health and Welfare may designate a hospital with outstanding research capability as a research-oriented hospital, among dental hospitals and oriental medical hospitals pursuant to Article 3 of the Medical Service Act and general hospitals, superior general hospitals and specialized hospitals pursuant to Articles 3-3 through 3-5 of the same Act, in order to establish a system for close cooperation of basic studying and clinical studying and to maximize the productivity of research and development. |
| (2) | Any research-oriented hospital under paragraph (1) shall meet the following requirements: |
| 1. | Research infrastructure, etc. such as research organization, research personnel, research facility and equipment, etc. of the hospital shall meet the standard prescribed by Ordinance of the Ministry of Health and Welfare; |
| 2. | Research outcomes, etc of the hospital for the recent three years shall meet the standard prescribed by Ordinance of the Ministry of Health and Welfare. |
| (3) | When the Minister of Health and Welfare designates the research-oriented hospital pursuant to paragraph (1), he/she shall perform the evaluation on each subparagraph of paragraph (2) every three years. <Amended by Act No. 11975, Jul. 30, 2013> |
| (4) | The Minister of Health and Welfare may perform the evaluation pursuant to paragraph (3) of medical institutions designated as research-oriented hospitals pursuant to paragraph (1) every three years and re-designate them or cancel the designation thereof based on the evaluation result. <Amended by Act No. 11975, Jul. 30, 2013> |
| (5) | The Minister of Health and Welfare may outsource the evaluation pursuant to paragraphs (3) and (4) to the relevant specialized institutions or organizations. |
| (6) | Matters necessary for the standard and procedure for designation and re-designation of research-oriented hospitals, procedure for outsourcing evaluation designated hospitals and other relevant affairs shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
[This Article Newly Inserted by Act No. 10996, Aug. 4, 2011]
| Article 15-2 (Cancelling Designation of Research-oriented Hospitals) |
| (1) | Where the medical institution that is designated or re-designated as research-oriented hospital pursuant to Article 15 falls under any of the followings, the Minister of Health and Welfare shall cancel the designation thereof: |
| 1. | Cases of being designated by fraud or other improper means; |
| 2. | Cases of failure to meet the designation requirements; |
| 3. | Cases of hoping the cancellation of designation of research-oriented hospital. |
| (2) | Matters necessary for the procedure, etc. of cancelling designation of research-oriented hospitals shall be prescribed by Ordinance of Ministry of Health and Welfare. |
[This Article Newly Inserted by Act No. 11975, Jul. 30, 2013]
Where the Minister of Health and Welfare intends to cancel the designation of research-oriented hospital in cases falling under Article 15-2 (1) 1, he/she shall execute a hearing thereof. [This Article Newly Inserted by Act No. 11975, Jul. 30, 2013]
| Article 16 (Duty of Research-oriented Hospitals) |
The head of a medical institution that is designated as a research-oriented hospital pursuant to Article 15 (1), shall perform the following duties: | 1. | To develop and foster health and medical service technology, he/she shall establish and implement a plan for a research and development project of the relevant medical institution every three years; |
| 2. | He/she shall actively support the affiliated research personnels, etc. of the relevant medical institutions so that there is no inconvenience in performing the research. |
[This Article Newly Inserted by Act No. 10996, Aug. 4, 2011]
| Article 17 (Supporting Research-oriented Hospitals) |
The Government may support the medical institutions designated as research-oriented hospitals pursuant to Article 15 (1) in human resources, budget, etc. necessary to develop and foster health and medical service technology. [This Article Newly Inserted by Act No. 10996, Aug. 4, 2011]
| Article 18 (Prohibition on Use of Similar Name) |
The name of a research-oriented hospital or the name similar thereto shall not be used by hospitals other than the research-oriented hospitals prescribed in this Act.
[This Article Newly Inserted by Act No. 10996, Aug. 4, 2011]
CHAPTER IV NATIONAL EVIDENCE-BASED HEALTHCARE COLLABORATING AGENCY
| Article 19 (Establishment of the National Evidence-based Healthcare Collaborating Agency) |
| (1) | The National Evidence-based Healthcare Collaborating Agency shall be established to perform the analysis and evaluation on the health and medical service technology and the products manufactured by making use of such technology (excluding technology concerning foods and cosmetics and products therefrom; hereinafter the same shall apply). <Amended by Act No. 11975, Jul. 30, 2013> |
| (2) | The National Evidence-based Healthcare Collaborating Agency shall be a corporation. |
| (3) | The National Evidence-based Healthcare Collaborating Agency shall be established by registration of incorporation in the seat of its main office. |
| (4) | Matters necessary for the registration of incorporation under paragraph (3) and other registration shall be prescribed by Presidential Decree. |
| Article 20 (Articles of Association) |
| (1) | The following matters shall be included in the articles of association of the National Evidence-based Healthcare Collaborating Agency: |
| 3. | Seat of the main office; |
| 4. | Matters concerning affairs and execution; |
| 5. | Matters concerning property and accounting; |
| 6. | Matters concerning executive officers and employees; |
| 7. | Matters concerning the board of directors; |
| 8. | Matters concerning modification of the articles of association; |
| 9. | Matters concerning method of public notification; |
| 10. | Matters concerning establishment, amendment and abrogation of internal regulations. |
| (2) | The National Evidence-Based Healthcare Collaborating Agency shall be authorized by the Minister of Health and Welfare to modify the articles of association. <Amended by Act No. 9932, Jan. 18, 2010> |
The National Evidence-based Healthcare Collaborating Agency shall perform the affairs under the following subparagraphs concerning the health and medical service technology and the products manufactured by making use of Said technology: <Amended by Act No. 11975, Jul. 30, 2013>
| 1. | Gathering, analysis, evaluation of information and economical analysis of safety and effectiveness of health and medical service technology as well as evaluation of new medical service technology and other affairs; |
| 2. | Support for the research to develop evidences at the national level for health and medical service technology; |
| 3. | Analysis of improvements in health of the people and analysis of demand for research and development; |
| 4. | Analysis of evidences for health and medical service technology and dissemination and diffusion of the evaluation result; |
| 5. | Support for the development and dissemination of evidence-based clinical practice guidelines; |
| 6. | Exchange and cooperation with domestics and overseas institutions related to health and medical treatment, and gathering and management of statistics and information on health and medical treatment; |
| 7. | Other affairs concerning the establishment of evidence-based national health and medical treatment system, prescribed by Presidential Decree. |
| Article 22 (Board of Directors) |
| (1) | The National Evidence-based Healthcare Collaborating Agency shall have the board of directors for the deliberation and resolution on important matters concerning the affairs. |
| (2) | The board of directors shall consist of a president and directors. |
| (3) | The president shall call the board of directors and become the Chairperson of the board of directors. |
| (4) | The auditor may attend and speak at the board of directors. |
| (5) | Other matters necessary for the board of directors shall be prescribed by the articles of association. |
| Article 23 (Executive Officers) |
| (1) | The National Evidence-based Healthcare Collaborating Agency shall have executive officers consisting of within 15 members of directors, including one president, and one auditor. |
| (2) | The term of the president shall be three years and the term of directors, other than the president, and the auditor shall be two years. |
| (3) | The full-time executive officers among executive officers prescribed in paragraph (1) shall be not more than two persons. |
| (4) | The appointment of the executive officers and the auditor, other than the president, shall be prescribed by the articles of incorporation. |
| (5) | The auditor shall audit the operation and accounting of the National Evidence-based Healthcare Collaborating Agency. |
| (1) | The president shall represent the National Evidence-based Healthcare Collaborating Agency, have the overall control of the operation, and command and supervise the employees under his/her control. |
| (2) | The president shall be appointed by the Minister of Health and Welfare from among persons that have abundant clinical knowledge and experiences. <Amended by Act No. 9932, Jan. 18, 2010> |
| Article 25 (Revenue Source) |
| (1) | The National Evidence-based Healthcare Collaborating Agency shall be operated with the government contributions, donations and other proceeds. |
| (2) | The Government shall provide the contributions necessary for appropriation of the operational expenses of the National Evidence-based Healthcare Collaborating Agency, within budgetary limits. <Amended by Act No. 10996, Aug. 4, 2011> |
| (3) | Matters necessary for the provision and use of the government contributions under paragraph 1 shall be prescribed by Presidential Decree. |
| Article 26 (Provision of Data) |
| (1) | The National Evidence-based Healthcare Collaborating Agency may request a national institution and a public institution prescribed by Presidential Decree to submit data to collect information necessary for research. In such cases, the requested institution shall comply with the request unless there are special reasons. |
| (2) | Where the National Evidence-based Healthcare Collaborating Agency requests data pursuant to paragraph (1), it may request a submission of data including personal information, such as sensitive information under Article 23 of the Personal Information Protection Act and unique identifying information under Article 24 of the same Act. In such cases, the relevant national institution or public institution shall submit the data after deleting the parts making personal identification possible. <Amended by Act No. 11975, Jul. 30, 2013> |
| (3) | Notwithstanding paragraph (2), where the National Evidence-based Healthcare Collaborating Agency needs to collect data possessed by more than two national institutions and public institutions and analyze it for research, it may collect the data after receiving the data including the part of which personal identification is possible from national institutions and public institutions. In such cases, the part making personal identification possible shall be deleted without fail. <Newly Inserted by Act No. 11975, Jul. 30, 2013> |
| (4) | No data provided pursuant to paragraphs (1) through (3) shall be used for the purpose other than research. <Newly Inserted by Act No. 11975, Jul. 30, 2013> |
| Article 27 (Application Mutatis Mutandis of the Civil Act) |
Except as otherwise provided for in this Act, the provisions of the Civil Act governing incorporated foundations shall apply mutatis mutandis to matters concerning the National Evidence-based Healthcare Collaborating Agency.
| Article 28 (Duty to Maintain Confidentiality) |
No executive officer or employee of the National Evidence-based Healthcare Collaborating Agency or a person who was once an executive officer or an employee thereof shall divulge or misappropriate confidential information that he/she has become aware of in the course of performing his/her duties.
CHAPTER V PENALTY PROVISIONS
| Article 29 (Penalty Provisions) |
A person who violates Article 28 shall be punished by imprisonment with labor for not more than two years or by a fine not exceeding twenty million won. <Amended by Act No. 10996, Aug. 4, 2011; Act No. 14883, Sep. 19, 2017>
| Article 30 (Administrative Fines) |
| (1) | A person who uses the name of a research-oriented hospital or similar, in violation of Article 18, shall be subject to an administrative fine not exceeding three million won. |
| (2) | Any of the following persons shall be subject to an administrative fine not exceeding two million won: <Newly Inserted by Act No. 13105, Jan. 28, 2015> |
| 1. | A person who has obtained new excellent technology certification under Article 8 (1) by fraud or other improper means; |
| 2. | A person who has used a certification mark or similar, in violation of Article 8-2 (2); |
| 3. | A person who fails to report on details of the use of a certification mark, outcomes from such use, and other relevant matters under Article 8-2 (3); |
| 4. | A person fails to comply with a corrective order under Article 8-2 (4). |
| (3) | Administrative fines prescribed in paragraphs (1) and (2) shall be imposed and collected by the Minister of Health and Welfare or the Special Metropolitan City Mayor, a Metropolitan City Mayor, a Do Governor, or a Special Self-Governing Province Governor. <Amended by Act No. 13105, Jan. 28, 2015> |
[This Article Newly Inserted by Act No. 10996, Aug. 4, 2011]
ADDENDA
Article 1 (Enforcement Date)
This Act shall enter into force on six months after the date of its promulgation: Provided, That Article 2 of the Addenda shall enter into force on the date of its promulgation.
Article 2 (Preparation of Establishment)
| (1) | The Minister for Health, Welfare and Family Affairs shall commission the Establishment Committee members not more than seven within 60 days from the date of promulgation of this Act in order to perform the affairs related to establishment of the National Evidence-based Healthcare Collaborating Agency. |
| (2) | The Establishment Committee members shall prepare the articles of incorporation and obtain authorization therefor from the Minister for Health, Welfare and Family Affairs by affixing name and seal, or signature. |
| (3) | When the Establishment Committee members have obtained authorization under paragraph 2, they shall file for registration for establishment of the National Evidence-based Healthcare Collaborating Agency by joint signature without delay. |
| (4) | When the President of the National Evidence-based Healthcare Collaborating Agency is appointed, the Establishment Committee members shall transfer the affairs to the President without delay. |
| (5) | The Establishment Committee members shall be deemed dismissed when the transfer of affairs has been completed. |
Article 3 (Transitional Measures concerning Management Institution for Research and Development Projects)
The health and medical service technology support institution designated under the previous provisions as of January 12, 2000, on which the Health and Medical service Technology Promotion Act (Act No. 6161) was in force, shall be deemed designated as the management institution for research and development projects under the amended provisions of Article 7. Article 4 (Transitional Measures concerning New Excellent Technology Certification)
The technology certified as new excellent technology by the Korea Health Industry Development Institute prior to April 28, 2007, on which the Health and Medical Service Technology Promotion Act (Act No. 8065) was in force, shall be deemed the new excellent technology certified by the Minister for Health, Welfare and Family Affairs under the amended provisions of Article 8. Article 5 Omitted.
Article 6 (Relationship to Other Acts)
Where the provisions of the previous Health and Medical Service Technology Promotion Act are cited by other Acts, as at the time this Act enters into force, and if this Act includes the provisions corresponding thereto, the corresponding provisions of this Act shall be deemed cited in lieu thereof.
ADDENDA <Act No. 9932, Jan. 18, 2010>
Article 1 (Enforcement Date)
This Act shall enter into force two months after the date of its promulgation. (Proviso Omitted.)
Articles 2 through 5 Omitted.
ADDENDUM <Act No. 10996, Aug. 4, 2011>
This Act shall enter into force on the date of its promulgation: Provided That, the amended provisions of Articles 15 through 18 and 30 shall enter into force six months after the date of its promulgation.
ADDENDA <Act No. 11713, Mar. 23, 2013>
Article 1 (Enforcement Date)
This Act shall enter into force on the date of its promulgation.
Articles 2 through 6 Omitted.
ADDENDUM <Act No. 11975, Jul. 30, 2013>
This Act shall enter into force on the date of its promulgation: Provided, That the amended provisions of Articles 4 and 7-2 shall enter into force six months after the date of its promulgation.
ADDENDUM <Act No. 13105, Jan. 28, 2015>
This Act shall enter into force six months after the date of its promulgation.
ADDENDUM <Act No. 14883, Sep. 19, 2017>
This Act shall enter into force on the date of its promulgation.
ADDENDA <Act No. 15344, Jan. 16, 2018>
Article 1 (Enforcement Date)
This Act shall enter into force three months after the date of its promulgation.
Articles 2 through 4 Omitted.