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[Seminar] Regulatory Framework Surrounding Medical Device Programs and Healthcare Apps

Points that related businesses should be aware of - Personal Information Protection Law, insurance coverage, transactions with medical institutions, research and development, etc.

Our company will hold a business seminar. With the arrival of a super-aged society and the increasing public interest in healthcare and medical issues due to the COVID-19 pandemic, various healthcare-related applications and software products have been developed and released in recent years thanks to advancements in IT technology. Among these program products, those aimed at the diagnosis and treatment of diseases are subject to regulation under the Pharmaceuticals and Medical Devices Act (PMDA) as medical device programs, just like tangible medical devices and hardware. Whether or not a program falls under the PMDA regulations significantly affects the effort and costs for businesses in obtaining licenses and complying with regulations, while determining whether a program qualifies as a medical device program is not straightforward. This seminar will provide a detailed explanation of the points that relevant businesses should pay attention to, including the applicability of medical device programs, the Personal Information Protection Act, and other related considerations. [Seminar Details] ■ Date and Time: November 21 (Thursday) 16:30-18:30 (Doors open at 16:00) ■ Speaker: Yasutaka Tokuda, Partner, Lawyer at Mori Hamada & Matsumoto *For more details, please refer to the PDF document or feel free to contact us.

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