Webinar Scheduled for Friday, April 17: "Current Status of Medical AI and Data Policy in the U.S."

The Tokyo Foundation (Minato-ku, Tokyo; President: Mieko Nakabayashi) will hold a webinar titled "Current Status of Medical AI and Data Policy in the U.S." starting at 2:00 p.m. on Friday, April 17, 2026. "Non-SaMD (Non-Software as a Medical Device: AI tools and healthcare IT that do not fall under medical devices)" is a general term for smartphone health management apps and AI-based diet and sleep advice functions. Although they are not legally treated as medical devices, they currently form a huge digital health market. Furthermore, as tools that support peripheral clinical tasks and communication with patients, Non-SaMD is essential for implementing medical DX in the field, drawing attention to its system design and policy trends. Particularly in the U.S., under the second Trump administration, the policy direction has shifted from a regulatory focus to promoting the utilization of medical AI, including Non-SaMD, strengthening movements that support related infrastructure and private investment. These changes also affect international rule-making and are directly linked to discussions on medical DX and AI utilization in Japan. Therefore, in this webinar, Dr. Takanori Fujita, Chief Researcher of the Foundation, who has been conducting research under the theme of "Realizing a Society Utilizing AI Data," will welcome Mr. Eiji Sasahara (Representative Director of the Japan Cloud Security Alliance). Based on the latest Review "Digital Health Reform and Data Protection under the Second Trump Administration" published on April 6, they will focus on Non-SaMD, which has not yet been sufficiently discussed in Japan, and decipher the latest U.S. trends surrounding medical AI, healthcare IT, and medical DX. - U.S. Policy Trends Regarding Non-SaMD in the Second Trump Administration For Non-SaMD, where institutional development is still underway in Japan, we will organize the latest U.S. trends shifting from regulatory focus to deregulation and innovation promotion, and explain the flow of rule unification by state and related infrastructure investments. - Impact and Implications of U.S. Medical AI and Data Policies on Japan We will decipher what implications U.S. medical AI and data policies, which have a significant influence on international standard formation, provide for Japan's medical DX and AI utilization. - Latest Commentary by Experts Mr. Eiji Sasahara, who is well-versed in GRC (Governance, Risk, and Compliance) in the cloud sector, will provide an easy-to-understand explanation of the current status and future direction surrounding Non-SaMD based on the latest review. ■ Event Outline Date and Time: Friday, April 17, 2026, 14:00-15:30 Format: Zoom Webinar * Please register via the application form by accessing the URL below or scanning the QR code on the right.