Hello, this is lawyer Lee Young-Kyung from Cheongchul Law Firm.

Article 56, Paragraph 2, Item 1 of the Medical Service Act prohibits advertisements concerning new medical technologies that have not undergone evaluation as per Article 53 of the Medical Service Act. Let’s take a look at what 'new medical technology' is and what actual violations there are.

[Question]

What are the unassessed new medical technology advertisements prohibited by the Medical Service Act?

[Answer]

1. Relevant Legal Provisions

As mentioned earlier, Article 56, Paragraph 2, Item 1 of the Medical Service Act and Article 23, Paragraph 1, Item 1 of the Enforcement Decree of the Medical Service Act prohibit advertisements concerning unassessed new medical technologies. Article 53 of the Medical Service Act stipulates the evaluation of new medical technologies, which refers to 'newly developed medical technologies' that the Minister of Health and Welfare recognizes as needing evaluation for safety and efficacy.

2. Violation Cases

If new medical technology has not been evaluated or if the evaluation result is pending, advertising the medical practice in that state is prohibited. Previous problematic cases include advertisements for 'autologous blood (PRF) implants' or advertisements using the phrase 'promotion of bone growth using autologous blood.' More direct violations include advertisements that stated 'the Ministry of Health and Welfare has certified the evaluation of new medical technology' for unassessed new medical technologies.

Such advertisements may also correspond to false or exaggerated advertisements under the Advertising Act, in addition to provisions of the Medical Service Act.

3. How to Confirm Evaluation Results of New Medical Technologies

If you are advertising new medical technologies, it is crucial to check in advance whether the technology is subject to new medical technology evaluation and its evaluation results. This can be confirmed through the application for checking whether it is included in the non-coverage criteria as per Article 9-2 of the Rules on Standards for Health Insurance Benefits or Article 3 of the Rules on New Medical Technology Evaluation (Korean Health Insurance Review and Assessment Service). Additionally, evaluation results and the status of ongoing evaluations can also be confirmed through announcements by the Ministry of Health and Welfare and the 'New Medical Technology Evaluation Headquarters website.'

Cheongchul Law Firm provides advice related to the Medical Service Act and medical advertising to numerous healthcare companies and medical institutions based on expertise and experience accumulated through large domestic law firms and in-house lawyers from major corporations such as Kimjang Law Office, Taepyeongyang, Gwangjang, Sejong, and Yulchon.

If you are grappling with issues related to the Medical Service Act and medical advertising, please do not hesitate to contact Cheongchul Law Firm.