李瑞亨 Chief Attorney
李瑞亨
李瑞亨
“在监管和风险管理方面具有专业知识的医疗保健法律合作伙伴”
Seohyung Lee是人工智能/智能组和医疗生物保健组的律师，对各行业中出现的监管、合规和争议问题进行三维分析，并提供考虑技术和法律交叉点的战略建议。 他是一名监管律师，在需要数据利用和监管响应的领域提出了以实践为导向的解决方案，特别是在医疗保健、生物、数字医疗保健和高科技行业。 在医药、医疗器械、数字医疗、先进生物制药等科技型行业，我们分析了从研发阶段到许可、临床试验、营销、广告、数据使用等全流程的监管风险，设计了适合人工智能和数据利用架构的合规体系。 除了律师身份外，他还拥有药剂师、专利律师和法学博士资格。他还曾担任首尔大学法学研究所高级研究员和梨花女子大学生物医学法研究所研究教授，积累了在各机构和行业现场的监管实践和咨询经验。 我们专注于提供实用的解释和以战略为导向的咨询系统，以在监管环境下实现客户的业务目标。
medical treatmentExperience
- (Former) Practical training at Yoon & Yang Law Firm, Inc.
- (Former) LK Partners Law Firm
- (Former) Senior Researcher, Law Research Institute, Seoul National University Law School
- (Former) Research Professor, Biomedical Law Research Institute, Ewha Womans University Law School
- (Former) Seung Law Firm
- (Current) Daeryun Law Firm (Limited)
Key Activities
- Advisor to the Ministry of Food and Drug Safety
- Member of the Ministry of Food and Drug Safety Administrative Disposition Review Committee
- Legislative Director, Academic Committee Member, Korean Medical Information Society
- Samsung Seoul Hospital Data Review Board (DRB) member
- Member of Institutional Bioethics Committee (IRB) at Seoul National University Bundang Hospital
- Hanyang University Guri Hospital Institutional Bioethics Committee (IRB) member, advisory member
- Advisory member of the Future Medical Research Foundation under the Ministry of Science and ICT
- Advisory member of the Korean Association of Medical Social Workers
- Legal advice to members of the Korean Neuropsychiatric Association
- Member of Korean Medical Law Society
- Member of the Korean Society of Bioethics
- Member of Korean Legal Philosophy Society
- Ministry of Health and Welfare, Ministry of Food and Drug Safety and affiliated public institutions, and related academic societies and associations invited to lecture at symposiums and academic conferences
- Contributions, books, and university lectures in the biomedical field
Key Achievements
- Advice on research, development and marketing, including clinical trials (IRB and clinical trial plan approval, etc.) of drugs and medical devices, GMP, product approval, health insurance listing and drug price determination, adverse reaction reporting, labeling and advertising, etc.
- Advising on research and development of new medical technology products such as digital healthcare and advanced biopharmaceuticals, application for new medical technology evaluation, and marketing.
- Advised on practical work related to certification of innovative pharmaceutical companies and Ministry of Health and Welfare and Korea Health Industry Development Institute
- Litigation regarding administrative measures such as license suspension and business suspension of medical personnel and medical institutions
- Compliance advice on advertising regulations for medical institutions, pharmaceuticals, medical devices, etc.
- Litigation related to medical disputes between medical institutions and patients
- Compliance advisory and litigation related to rebates
- Advising on the establishment of medical corporations and overseas expansion of medical institutions
- Participating in revising laws on bioethics and safety, enacting the Advanced Regenerative Bio Act, and revising the “Health and Medical Data Utilization Guidelines”
- Legislative consulting on laws, notices, and guidelines such as the Pharmaceutical Affairs Act, Medical Services Act, Medical Device Act, Bioethics and Safety Act, Fair Trade Act, Advanced Regenerative Bio Act, Personal Information Protection Act, Cosmetics Act, and Food Sanitation Act.
- Advisory and litigation related to contracts with hospital management support companies (MSO)
- Evidence investigation and evidence preservation application case for compensation for urological medical accident damages
- Health Insurance Review and Assessment Service, lawsuit against Ministry of Health and Welfare's administrative disposition related to nursing care benefits
- Advice on data processing and privacy protection regulations
- Advised a large construction company on product liability.
- Advice on intellectual property rights, including technology licensing, patents, and trademark infringement
- Advisory and litigation regarding regulatory sandbox application by the Ministry of Science and ICT
Education
- Graduated from Ewha Womans University College of Pharmacy, Department of Pharmaceutical Sciences (Bachelor of Pharmacy)
- Graduated from Ewha Womans University Law School (Master of Laws)
- Graduated from Ewha Womans University, Department of Law (Doctor of Laws)
Publications and Papers
- 『Law and Life of Koreans (Completely Revised Edition)』 (Ministry of Justice/Korean Legal Education Center, 2021)
- 『Law and Philosophy in the Corona Era』 (Parkyoungsa, 2021)
- 『Biomedical Ethics (Completely Revised 4th Edition)』 (Dongnyok, 2023)
- 『Health and Medical Informatics』 (Gunja Publishing, 2024)
- 『Criminal) Correctional Precedents』 (Parkyoungsa, 2024)
- “Duty of outpatient prescription medical institutions to return pharmaceutical expenses in relation to the comprehensive fee system - Focusing on the Supreme Court decision 2009du8786 pronounced on November 26, 2009 - ”, 「Bioethics Policy Research」 Vol. 5, No. 1 (2011).
- “Contemplation of the construction of domestic health care big data legislation - Focusing on the guarantee of the right to know -”, 「Medical Jurisprudence」 Vol. 19, No. 3 (2018).
- “Study on measures to improve anonymization under bioethics law”, Bioethics Vol. 20, No. 2 (2019).
- “Review of personal information protection legislation and direction of revision from the perspective of privacy protection - Focusing on the dichotomy between public and private sectors -”, 「Bioethics Policy Research」 Vol. 13, No. 2 (2020), etc.
Certifications
- Attorney
- Pharmacist
- Patent Attorney
medical treatment
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