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  • Amendment to the Enforcement Decree of the Medical Service Act
    • Competent Ministry : Ministry of Health and Welfare
    • Advance Publication of Legislation : 2018-05-30
    • Opinion Submission Deadline : 2018-07-09

(1) Reasons for Proposal

The Amendment adds social media providing social networking services (SNS) to the scope of media subject to self-review of medical service advertisements; prescribes requirements for consumer organizations that may organize and deliberate on the self-reviews of medical service advertisements; allows public announcements and corrective advertising in the event of a violation of medical service advertisement-related regulations; and otherwise prescribes matters delegated by the amended Medical Service Act, thereby closing the loopholes arising from the operation of the current system.

(2) Major Provisions

A. Standards for prohibiting medical service advertisements (Article 23)

Specify that in Article 56 (2) 14 (d) of the Act, the advertisements specified by Presidential Decree shall be advertisements indicating accreditation by a national accreditation body certified by the International Society for Quality in Health Care (ISQua)

B. Targets subject to medical service advertisement reviews and outsourcing of review operations (Article 24)

○ Specify that in Article 57 (1) 5 of the amended Medical Service Act, the advertising media specified by the Presidential Decree shall be social media providing a social networking service (SNS) with not less than 100,000 users per day on average during the 3 months right before the end of the previous year

○ Require any organization for self-reviews of medical service advertisements to be equipped with computer equipment, an office, a dedicated department, and at least three full-time staff members (including persons with extensive experience and knowledge relevant to medical services or advertising); and any consumer organization that intends to carry out operations involved in medical service advertisement reviews to be a consumer organization that has filed a registration with the Fair Trade Commission and to include provisions relevant to medical services or advertising in its founding purpose or scope of duties

C. Public announcement of violations and corrective advertising (Article 31-7)

Prescribe the content, frequency, size, media, etc., of public announcements or corrective advertising according to the content, extent, duration, frequency, etc., of violations; provided that such matters may be determined through discussions with a review committee operated by a private self-review organization for medical service advertisements

(3) Amendment Details
Partial Amendment to the Enforcement Decree of the Medical Service Act

Partially amend the Enforcement Decree of the Medical Service Act as follows.
In Article 19, change “an application, accompanied by documents determined by Ordinance of the Ministry of Health and Welfare” to “an application specified by the Ordinance of the Ministry of Health and Welfare, accompanied by the relevant documents.”
In the main sentence of Article 21, change “the application, accompanied by documents determined by Ordinance of the Ministry of Health and Welfare” to “the application specified by the Ordinance of the Ministry of Health and Welfare, accompanied by the relevant documents.”
In Article 23 (1) excluding the subparagraphs, change “Article 56 (5) of the Act” to “Article 56 (4) of the Act”; delete subparagraph 7; re-number subparagraphs 3 through 6, 8, 9, and 10 to subparagraphs 4 through 7, 10, 11, and 13, respectively; and newly insert subparagraphs 3, 8, 9, and 12 as follows.
  3. Advertising any information concerning a medical person, medical institution, medical service, or various medical-service related matters that has not been objectively acknowledged, lacks objective evidence, or is false;
  8. Advertising that exaggerates objective facts concerning a medical person, medical institution, medical service, or various medical-service related matters;
  9. Advertising that claims to support a qualification or name with no legal basis;
  12. Advertising domestically to attract foreign patients under Article 27 (3) of the Act;
In Article 23, change paragraph 2 to paragraph 3, and newly insert paragraph 2 as follows.
  ② In Article 56 (2) 14 (d) of the Act, advertisements specified by Presidential Decree shall be advertisements indicating accreditation by the national accreditation body accredited by the International Society for Quality in Health Care (ISQua).
In Article 24 (1) excluding the subparagraphs, change “Internet media specified by Presidential Decree” to “Internet media specified by Presidential Decree” and “advertising media specified by Presidential Decree” under subparagraph 5,” and newly insert subparagraph 5 under the same paragraph as follows.
  5. Social media providing a social networking service (SNS) with not less than 100,000 users per day on average during the 3 months immediately preceding the end of the previous year.
Change Article 24 (2), excluding the subparagraphs, as follows.
  An organization for self-reviews under Article 57 (2) of the Act shall meet the following requirements:
Change Article 24 (2) 1 and 2 as follows.
  1. Computer equipment and an office to handle operations concerning reviews of medical service advertisements, etc., under Article 57 and Article 57-3 of the Act;
  2. At least one dedicated department and at least three full-time staff (including persons with extensive experience and knowledge relevant to medical services or advertising) able to handle operations concerning reviews of medical service advertisements, etc., under Article 57 and Article 57-3 of the Act.
Delete Article 24 (2) 3 and change paragraph 3 of the same Article as follows.
  ③ A consumer organization able to conduct reviews of medical service advertisements in accordance with Article 57 (2) 2 of the Act shall meet all of the following requirements.
  1. Be a consumer organization registered with the Fair Trade Commission in accordance with Article 29 of the Framework Act on Consumers;
  2. Include provisions relevant to medical services or advertising in its founding purpose or scope of operation;
  3. Be otherwise free of issues that may affect the fair and transparent review of advertisements
Newly insert Article 24 (4) as follows.
  ④ Matters that are not subject to a medical service advertisement review under Article 57 (3) 4 of the Act shall be as follows.
  1. Founder of a medical institution;
  2. Website address of a medical institution;
  3. Opening days and hours of a medical institution.
Delete Articles 25 through 27, Article 27-2, Article 28, an Article 28-2.
Change Article 29, paragraph 1, subparagraphs 1 through 7 to subparagraphs 2 through 8, and newly insert subparagraph 1 as follows.
  1. Development of standards for accreditation in accordance with Article 38-3 (1) of the Act;
In Article 29 (1) 2 (formerly subparagraph 1), change “Examination” to “examination and follow-up.”
In Article 30, subparagraph 3, change “public health and medical services” to “public health and medical services or facility safety diagnosis.”
Newly insert Article 31-7 as follows.
Article 31-7 (Public Announcement of Violations and Corrective Advertising) ① Where the Minister of Health and Welfare or a head of Si/Gun/Gu issues an order for a public announcement or corrective advertising to address a violation committed by the founder of a medical institution, the head of a medical institution, or a medical person, or issues an order for corrective advertising, he or she shall specify the content, frequency, size, media, etc., of the public announcement or corrective advertising by considering the following factors.
  1. Content and extent of the violation;
  2. Duration and frequency of the violation.
  ② When issuing an order for a public announcement or corrective advertising to address a violation in accordance with paragraph 1, the Minister of Health and Welfare or head of Si/Gun/Gu may determine the content, frequency, size, media, etc., of the public announcement or corrective advertising through discussions with a review committee pursuant to Article 57-2 of the Act.
Change Article 42, paragraphs 3 through 5 to paragraphs 4 through 6, respectively, and newly insert paragraph 3 as follows.
  ③ The Minister of Health and Welfare may entrust a public institution associated with the health industry to carry out affairs concerning the operation of accounting standards for medical institutions pursuant to Article 62 (1) of the Act.
In Article 42, paragraph 6 (formerly paragraph 5), change “(4)” to “(5).”

Addenda

This Decree shall enter into force on 9/28/2018.



Regulatory effect assessment
  • 의료법 시행령 규제영향분석서.hwp [download]
Legislative proposal (draft)
  • 의료법 시행령 일부개정령안.hwp [download]