日本次世代醫療基盤法之簡介【本期企劃】 試閱
The General Guide to the“Next Generation Medical Infrastructure Act”
日本近年來不遺餘力地想將大數據運算援用於醫療資料庫之第二次利用上,而以新制定之法律「次世代醫療基盤法」,突破現行有關蒐集資料之利用目的及提供第三人之限制。本文即以日本去年完成之法制為對象,簡介其立法之背景、理念及法制度中,有關提供醫療資料之醫療機關等應遵守之義務、對醫療資訊進行匿名加工之受認定匿名加工業者被規範之義務等,讓臺灣對日本為活用醫療資料庫所新訂之法制有基礎之認識。
The content of this article is intended to provide a general guide to the “Next Generation Medical Infrastructure Act,” the Act came into force on May 11, 2018 in Japan. It establishes a system which including two important legal proceedings, according to the provision of the act, one that certifies business operators can properly and reliably as certified medical data anonymization agencies, in order to promote advanced R&D and create new industries relating to health and medical care through secure and proper use of anonymized medical data. The other the medical institutions, it will become possible to provide medical data to certified agencies if the medical institutions provide a opt-out mechanism for their patients in advance.
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