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SeoHyung LEE  Lawyer

SeoHyung LEE Chief Attorney

SeoHyung LEE

 Chief Attorney

Advisory Attorney, Ministry of Food and Drug Safety

T. 070-7510-2016Email

SeoHyung LEE

Chief Attorney

Advisory Attorney, Ministry of Food and Drug Safety

T. 070-7510-2016Email

"A healthcare legal partner with expertise in regulation and risk management"

Attorney SeoHyung LEE, a member of the AI & Intelligence Group and the Medical Bio Healthcare Group, multidimensionally analyzes regulatory, compliance, and dispute issues arising across diverse industries, providing strategic advisory considering the intersection of technology and law. In particular, she is a regulatory specialist attorney who has presented practice-oriented solutions in areas centered on healthcare, bio, digital healthcare, and advanced technology industries, where data utilization and regulatory response are simultaneously required. In technology-based industries such as pharmaceuticals, medical devices, digital healthcare, and advanced bio-pharmaceuticals, she has analyzed regulatory risks across the entire process from research and development through licensing, clinical trials, market launch, advertising, and data utilization, and has designed compliance systems suited to AI and data utilization structures. In addition to being an attorney, she holds qualifications as a pharmacist, patent attorney, and Doctor of Laws, and has accumulated regulatory practice and advisory experience at various institutions and industry sites by serving as Senior Researcher at the Seoul National University Law Research Institute and Research Professor at the Ewha Womans University Bio-Medical Law Research Institute. She focuses on providing practical interpretation and strategy-centered advisory frameworks to achieve clients' business objectives within the regulatory environment.

Experience

  • (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

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