Presidential Decree No. 27731, Dec. 30, 2016
| Article 1 (Purpose) |
| Article 2 (Composition of Rare Disease Management Committee) |
| (1) | The term of office of entrusted members of the rare disease management committee (hereinafter referred to as "committee") under Article 7 of the Rare Disease Management Act (hereinafter referred to as "Act") shall be three years, and they may be re-entrusted only one more time: |
| (2) | Where a committee member falls under any of the following, the Minister of Health and Welfare may dismiss him/her or terminate the entrustment agrement: |
| 1. | Where he/she is unable to perform duties due to mental disorder; |
| 2. | Where he/she has committed a violation with regard to duties; |
| 3. | Where he/she is deemed unfit for a member due to negligence, injury to dignity or other reasons; |
| 4. | Where he/she personally expresses his/her intent that fulfilling duties is difficult. |
| Article 3 (Operation of Rare Disease Management Committee) |
| (1) | The chairperson of the committee (hereafter referred to as "chairperson" in this Article) shall represent the committee and take charge of the business of the committee. |
| (2) | Where the chairperson is unable to perform duties due to unavoidable reasons, a member designated by the chairperson shall perform the duties in place of the chairperson. |
| (3) | A meeting of the committee shall be called by request of the Minister of Health and Welfare or not less than 1/3 of the members, or when the chairperson deems needs exist, and the chairperson shall chair the meeting. |
| (4) | The committee shall begin its session with the attendance of a majority of members on the register and a resolution is passed by a majority vote of the attending members. |
| (5) | The committee shall have an executive secretary to handle the duties of the committee, who shall be designated by the Minister of Health and Welfare from among public officials affiliated with the Ministry of Health and Welfare. |
| (6) | Entrusted members who attend a meeting of the committee may be paid allowances, traveling expenses and other necessary expenses within budgetary limit. |
| Article 4 (Specialized Committees) |
| (1) | In order to expertly deliberate on matters of deliberation, the committee may have specialized committees by field of expertise, if necessary. |
| (2) | A specialized committee by field of expertise shall consist of not more than ten members including a chairperson. |
| (3) | The chairpersons and members of specialized committees by field of expertise shall be appointed or entrusted by the Minister of Health and Welfare. |
| Article 5 (Detailed Operational Rules) |
| Article 6 (Projects for Statistics on Registration of Rare Diseaes) |
| (1) | For the efficient performance of projects for statistics on registration of rare diseases under the former part of Article 10 (1) of the Act (hereinafter referred to as "registration statistics project"), the Minister of Health and Welfare may construct and operate a comprehensive rare disease information management system as determined by the Minister of Health and Welfare. |
| (2) | Where the Minister of Health and Welfare handles sensitive information or personally identifiable information pursuant to Article 23 of the Personal Information Protection Act with regard to the implementation of registration statistics projects, he/she shall take measures necessary for assuring the safety of personal information as determined by the Minister of Health and Welfare. |
| (3) | Where the Minister of Health and Welfare deems needs exist for rare disease management, he/she may make public the outcomes of registration statistics projects as determined by the Minister of Health and Welfare. |
| Article 7 (Details, Methods, etc. of Fact-Finding Surveys) |
| (1) | The fact-finding surveys under Article 11 (1) of the Act (hereinafter referred to as "fact-finding surveys") shall be as listed hereunder: |
| 1. | Matters concerning distribution, etc. of rare disease patients by age, sex and region; |
| 2. | Matters concerning clinical signs, developments, etc. in rare disease patients; |
| 3. | Matters concerning treatment information, such as diagnosis, examination, prescription, etc. of rare disease patients; |
| 4. | Matters concerning personnel, facilities, equipment, etc. related to treatment of and research into rare disease patients; |
| 5. | Matters concerning inspection of books, data, etc. on rare disease patients; |
| 6. | Other matters the Minister of Health and Welfare deems specifically necessary for rare disease management. |
| (2) | The methods of fact-finding surveys shall be as follows: |
| 1. | Questionnaire surveys and specimen inspections of rare disease patients, household members, etc.; |
| 2. | Inspection of data on the medical charts, etc; |
| 3. | Sample questionnaire surveys and specimen inspections of the public; |
| 4. | Other methods that the Minister of Health and Welfare determines to be specifically necessary for fact-finding surveys. |
| (3) | Where the Minister of Health and Welfare deems needs exist for the efficient promotion of a fact-finding survey, he/she may request related research institutes, organizations or specialists to conduct a fact-finding survey. |
| (4) | In addition to those prescribed in paragraphs (1) through (3), matters necessary for fact-finding surveys shall be determined by the Minister of Health and Welfare. |
| Article 8 (Medical Expense Support Projects) |
| (1) | The medical expense support projects under Article 12 of the Act (hereinafter referred to as "medical expense support project") shall be as listed hereunder: |
| 1. | Inspection of data on the property and income of persons to be given medical expense support; |
| 2. | Selection of persons to be given medical expense support and notification thereto; |
| 3. | Payment of medical expenses to persons to be given medical expense support; |
| 4. | Publicity relating to medical expense support; |
| 5. | Development and management of an information system for medical expense support. |
| (2) | Persons whose income, property, etc. are below the standard determined and publicly notified each year by the Minister of Health and Welfare from among those under the following shall be eligible for medical expense support under Article 12 (1) of the Act: |
| 1. | Rare disease patients among the health insurance policyholders or dependents under Article 5 of the National Health Insurance Act; |
| 2. | Rare disease patients among the eligible recipients under Article 3 of the Medical Care Assistance Act. |
| (3) | A person who intends to be given medical expense support pursuant to Article 12 (1) of the Act shall file an application for support with the head of a jurisdictional public health center as prescribed by Ordinance of the Ministry of Health and Welfare. |
| (4) | The head of a jurisdictional public health center in receipt of an application for medical expense support pursuant to paragraph (2) may request related central administrative agencies, local governments or public institutions under the Act on the Management of Public Institutions to submit data, to verify information, etc. where needs arise for the inspection or verification of personal information, family relations, income, property, etc. of the applicant. |
| (5) | When the head of a jurisdictional public health center requests the submission of data, verification of information, etc. to others pursuant to paragraph (4), he/she may make a request through a social security information system under Article 37 of the Framework Act on Social Security (hereinafter referred to as "social security information system"). |
| (6) | In addition to those prescribed in paragraphs (1) through (5), detailed matters necessary for the scope of medical expense support projects, for medical expense support, etc. shall be determined and publicly notified by the Minister of Health and Welfare. |
| Article 9 (Scope of Financial Information, etc.) |
| (1) | "Other data or information prescribed by Presidential Decree" referred to in Article 13 (1) 1 of the Act shall mean the following data or information: |
| 1. | Demand deposit, such as ordinary deposit, savings deposit, free savings deposit, etc.: Average balance during the less than three month period in the most recent past; |
| 2. | Savings deposit, such as time deposit, time installment savings, time savings, etc.: Balance or total payments; |
| 3. | Stocks, beneficiary certificates, investments and investment shares: Final market value. In such case, to the evaluation of unlisted stocks, Article 54 (1) of the Enforcement Decree of the Inheritance Tax and Gift Tax Act shall apply |
| 4. | Bonds, notes, checks, debt certificates and preemptive right certificates: Face value; |
| 5. | Annuity savings: Amounts paid regularly or final balance; |
| 6. | Interests, dividends or discounts occurring from the financial property under subparagraphs 1 through 5. |
| (2) | "Other data or information prescribed by Presidential Decree" referred to in Article 13 (1) 2 of the Act shall mean the following data or information: |
| 1. | Current state of loans and details of unpaid debts; |
| 2. | Amount of unpaid credit card debts. |
| (3) | "Other data or information prescribed by Presidential Decree" referred to in Article 13 (1) 3 of the Act shall mean the following data or information: |
| 1. | Insurance policy: Refund to be received if an insurance policy is cancelled or the amount of premiums paid during the less than one year period in the most recent past; |
| 2. | Annuity insurance: Refund to be received if an insurance policy is cancelled or the amount to be received on a regular basis. |
| Article 10 (Request for Financial Information, etc. and Provision thereof) |
| (1) | Where the head of a public health center receives a written consent from persons seeking medical expense support pursuant to Article 13 (1) of the Act, he/she shall submit it to the Minister of Health and Welfare through a social security information system. |
| (2) | Where, pursuant to Article 13 (2) of the Act, the Minister of Health and Welfare, who is in receipt of a written consent under paragraph (1), requests the heads of financial companies, etc. under subparagraph 1 of Article 2 of the Act on Real Name Financial Transactions and Confidentiality or the heads of credit information collection agencies under Article 25 of the Credit Information Use and Protection Act (hereinafter referred to as "financial institutions, etc.") to provide financial information, credit information and insurance information (hereinafter referred to as "financial information, etc."), he/she shall make a request in writing (including electronic format) containing the following: |
| 1. | Names and resident registration numbers of persons seeking medical expense support; |
| 2. | Scope of financial information, etc., base date for inquiry and inquiry period. |
| (3) | Where the heads of financial institutions, etc. who are requested to provide financial information, etc. pursuant to paragraph (2) provide relevant financial information, etc. to the Minister of Health and Welfare, they shall provide the financial information, etc. in writing (including electronic format) containing the following: |
| 1. | Names and resident registration numbers of persons seeking medical expense support; |
| 2. | Names of financial institutions, etc. providing financial information, etc.; |
| 3. | Names and account numbers of financial products to be provided; |
| 4. | Details of financial information, etc. |
| (4) | The Minister of Health and Welfare may request the heads of financial institutions, etc. to provide financial information, etc. through an information and communications network of an association, federation, national federation with which the financial institutions, etc. are affiliated. |
| (5) | Where the Minister of Health and Welfare is provided with financial information, etc. pursuant to paragraph (3) or (4), he/she shall notify the financial information, etc. to the head of jurisdictional public health center through a social security information system. |
| (6) | In addition to those prescribed in paragraphs (1) through (5), detailed matters necessary for making a request for the provision of financial information, etc. and for providing financial information, etc. shall be determined and publicly notified by the Minister of Health and Welfare. |
| Article 11 (Requirements for Designation as Specialized Rare Disease Institutes) |
| (1) | "Requirements prescribed by Presidential Decree, such as facilities, personnel, etc." referred to in Article 14 (1) of the Act shall mean the following requirements: |
| 1. | A medical institution under Article 3 (2) 1 (a) of the Medical Service Act: Following requirements: |
| (a) | That it shall have at least one medical specialist for treating and researching a rare disease; |
| (b) | That it shall have an office for the treatment of and research into a rare disease; |
| (c) | That is shall have a track record of treatment of a rare disease for at least one year; |
| (d) | That it shall have an online business processing system necessary for performing the duties under the subparagraphs of Article 14 (1) of the Act; |
| 2. | A medical institution under Article 3 (2) 3 (a) and (e) of the Medical Service Act: Following requirements: |
| (a) | That it shall have at least three staff members including at least one medical specialist for treating and researching a rare disease; |
| (b) | That it shall have an office for the treatment of and research into a rare disease, and facilities determined and publicly notified by the Minister of Health and Welfare; |
| (c) | That it shall have a department in charge of the duties under the subparagraphs of Article 14 (1) of the Act; |
| (d) | That it shall meet the requirements under subparagraph 1 (c) and (d). |
| (2) | Detailed standards for requirements for designation under paragraph (1) shall be determined and publicly notified by the Minister of Health and Welfare. |
| Article 12 (Entrustment of Evaluation of Specialized Rare Disease Institutes) |
| (1) | Pursuant to Article 15 (3) of the Act, the Minister of Health and Welfare may entrust following institutions or organizations with the duties of evaluation of specialized rare disease institutes under Article 14 (1) of the Act (hereinafter referred to as "specialized rare disease institutes"): |
| 1. | Public institutions established with an establishment objective related to health and medical services from among the public institutions under Article 4 of the Act on the Management of Public Institutions; |
| 2. | Institutions or organizations determined and publicly notified by the Minister of Health and Welfare, which have structure, personnel, expertise, etc. necessary for performing entrusted duties. |
| (2) | Where the Minister of Health and Welfare intends to entrust the duties of evaluating specialized rare disease institutes pursuant to Article 15 (3) of the Act to an institution or organization, he/she shall, beforehand, publicly announce matters concerning standards for entrustment, procedures therefor, methods thereof, etc. |
| (3) | Where the Minister of Health and Welfare intends to entrust the duties of evaluating specialized rare disease institutes pursuant to Article 15 (3) of the Act to an institution or organization, he/she shall publicly notify matters concerning the details of entrustment, trustees, etc. in the official gazette, and post them on the website of the Ministry of Health and Welfare. |
| (4) | The institution or organization entrusted with the duties of evaluating specialized rare disease institutes pursuant to Article 15 (3) of the Act shall report the Minister of Health and Welfare on the project operational plan, current state of implementation of the project, fund operational plan, details of disbursed funds, etc. |
| (5) | Detailed matters necessary for the public announcement of standards for entrustment, etc., public notification of details of entrustment, report on entrusted duties, etc. shall be determined and publicly notified by the Minister of Health and Welfare. |
| Article 13 (Delegation of Authority) |
| 1. | Implementation and management of registration statistics projects under Article 10 of the Act; |
| 2. | Implementation and management of fact-finding surveys under Article 11 of the Act; |
| 3. | Designation and cancellation of designation as specialized rare disease institutes under Article 14 of the Act; |
| 4. | Development and dissemination of methods, etc. of preventing and treating rare diseases under Article 16 (1) of the Act; |
| 5. | Education to cultivate specialists under Article 17 (2) of the Act. |
| Article 14 (Handling of Sensitive Information and Personally Identifiable Information) |
| (1) | Where an unavoidable situation arises when the following duties are performed, the Minister of Health and Welfare and the heads of local governments (including persons entrusted with the duties of the Minister of Health and Welfare pursuant to Article 15 (3) of the Act and persons delegated with the authority of the Minister of Health and Welfare pursuant to Article 22 (1) of the Act) may handle information on health under Article 23 of the Personal Information Protection Act (limited to cases in which duties under subparagraphs 1 through 3 are performed) or data containing resident registration numbers, driver's license numbers or foreigner registration numbers under subparagraph 1 or 4 of Article 19 of the Enforcement Decree of the same Act: |
| 1. | Duties concerning rare disease research and development projects under Article 9; |
| 2. | Duties concerning registration statistics projects under Article 10; |
| 3. | Duties concerning fact-finding surveys under Article 11; |
| 4. | Duties concerning designation and cancellation and designation as specialized rare disease institutes under Article 14; |
| 5. | Duties concerning evaluation of specialized rare disease institutes under Article 15. |
| (2) | Where an unavoidable situation arises when performing the duties of medical expense support for rare disease patients under Article 12 of the Act or Article 8 of this Decree, the head of a jurisdictional public health center may handle data containing information on health under Article 23 of the Personal Information Protection Act and data containing resident registration numbers or foreigner registration numbers under subparagraph 1 or 4 of Article 19 of the Enforcement Decree of the same Act. |
| (3) | Where an unavoidable situation arises when implementing the projects under the subparagraphs of Article 8 (2) of the Act, the heads of rare disease support centers may handle data containing information on health under Article 23 of the Personal Information Protection Act and data containing resident registration numbers or foreigner registration numbers under subparagraph 1 or 4 of Article 19 of the Enforcement Decree of the same Act. |