Medical and Healthcare
We handle a wide range of legal issues in the medical and healthcare fields. We provide practical and specialized legal services tailored to the specific characteristics of each client, including medical institutions, nursing care providers, pharmaceutical companies, medical device manufacturers, and healthcare-related companies.
(1) Legal services for medical institutions
We provide a wide range of support services to medical and welfare service providers such as hospitals, clinics, dental clinics, nursing care facilities, and social welfare corporations, from day-to-day legal support to crisis management. We offer prompt support for initial responses to medical accidents and internal disputes, explanations and responses to patients, establishment of medical safety systems, investigation and reporting support in the event of incidents, and various administrative responses. In the event of accidents or disputes at hospitals or facilities, initial response is critical. By entering into an advisory agreement, we can respond promptly.
Additionally, we offer specialized labor management services tailored to the medical field (such as managing physicians’ work arrangements and working hours), as well as various training programs and seminars for medical staff, managers, and administrative staff.
(2) Healthcare business and the Pharmaceutical and Medical Device Act compliance
We provide support for legal risk management and regulatory compliance in each phase, from research and development to manufacturing, advertising and promotion, distribution, and post-sales support (adverse reaction reporting, recalls, etc.) for healthcare products such as pharmaceuticals, medical devices, cosmetics, health foods, and regenerative medicine products. We offer practical advice based on our expertise in relevant laws and regulations such as the Pharmaceutical and Medical Device Act and the Act against Unjustifiable Premiums and Misleading Representations.
(3) Security and information management for medical institutions
We provide legal support for the protection of patient information in medical institutions, the safe management of electronic medical records and medical information systems, and measures against information leaks and cyber-attacks. Based on the Act on the Protection of Personal Information and the Medical Information System Security Management Guideline, we assist in the establishment of information management regulations, log management systems, and subcontractor management systems, respond to security incidents, support reporting to administrative agencies, and provide legal advice on the provision of information to third parties. In addition, we also provide support for internal audits, in-house education, and the development of business continuity plans (BCPs).
(4) Digital and IT healthcare
We also provide legal support in new digital healthcare fields such as online medical consultations, telemedicine, health management apps, AI diagnosis, wearable devices, and PHR (Personal Health Record). We offer legal advice based on the Act on the Protection of Personal Information, appropriate management of medical information, privacy protection, cross-border transfer regulations, and other relevant laws and regulations.
(5) Research and development / Industry-academia collaboration
We also provide support for contract administration during the research and development phase, including joint research and development in the medical and healthcare fields, industry-academia collaboration agreements, technology transfer and licensing agreements, and more. We can also provide legal advice regarding ethics review board (IRB) compliance.