Study on legal policy to handle medical big data including genome data

2019 Fiscal Year Final Research Report

• Project/Area Number: 17K17798
• Research Category: Grant-in-Aid for Young Scientists (B)
• Allocation Type: Multi-year Fund
• Research Field: New fields of law; Medical and hospital managemen
• Research Institution: Keio University (2018-2019); National Center for Global Health and Medicine (2017)
• Principal Investigator: FUJITA Takanori 慶應義塾大学, 医学部(信濃町), 特任講師 (80627646)
• Project Period (FY): 2017-04-01 – 2020-03-31
• Keywords: プライバシー / 個人情報保護 / 医療情報 / ゲノム情報 / 医療ビッグデータ / 医療等ID / 同意 / 公益

Outline of Final Research Achievements

Medical big data, especially genomic information, is unique in comparison to other information and requires careful handling, including consent at the time of acquisition.
The purpose of this study is to examine the legal system in Japan from an interdisciplinary and cross-disciplinary point of view, taking into account such particularities. For this reason, we discussed the Japanese policies for the revision of the Personal Information Protection Law in Japan in 2020, the Next Generation Medical Infrastructure Law, and Medical ID, etc., by comparing the situation in Europe, the United States, and Asia, especially with the efforts of GA4GH (Global Alliance for Genomics and Health) regarding the handling of genomic information, and compiled policy recommendations for the future.

Free Research Field

医事法学

Academic Significance and Societal Importance of the Research Achievements

本研究の結果、特に、（必ずしも同意によらない）公益目的での利用に関する法整備、データ運用のためのシステム基盤構築、データベース利用に関する立法措置、認知機能が低下した高齢者等同意能力が不十分な場合の取り扱いの設定等の重要性が示唆された。個人情報保護法制において、本人の同意が（半ば過剰に）重視されて来た中、2019年末以来のCOVID-19を始めとする感染症への対応においても、こうした視点での個人に紐付いた医療に関するデータの取扱いの学術的・社会的な重要性は増している。