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介绍在开发创新药物的视角下获取个人数据以用于科学研究的关键要素。

Introducing Key Elements Regarding Access to Personal Data for Scientific Research in the Perspective of Developing Innovative Medicines.

机构信息

CRIDS (Research Centre on Information, Law & Society), Faculty of Law, University of Namur Namur Belgium Bar of Brussels.

Lawyer, responsible for International Relations, Espace Éthique Méditerranéen/PACA-Corse, Assistance Publique Hôpitaux de Marseille/Aix-Marseille Université Marseille France.

出版信息

Eur J Health Law. 2020 May 18;27(3):195-212. doi: 10.1163/15718093-BJA10011.

Abstract

This article aims at opening discussions and promoting future research about key elements that should be taken into account when considering new ways to organise access to personal data for scientific research in the perspective of developing innovative medicines. It provides an overview of these key elements: the different ways of accessing data, the theory of the essential facilities, the Regulation on the Free Flow of Non-personal Data, the Directive on Open Data and the re-use of public sector information, and the General Data Protection Regulation (GDPR) rules on accessing personal data for scientific research. In the perspective of fostering research, promoting innovative medicines, and having all the raw data centralised in big databases localised in Europe, we suggest to further investigate the possibility to find acceptable and balanced solutions with complete respect of fundamental rights, as well as for private life and data protection.

摘要

本文旨在就开发创新药物的视角下,探讨和推动新的途径以组织获取个人数据用于科研时应考虑的关键要素的相关研究。本文概述了这些关键要素:获取数据的不同方式、必需设施理论、非个人数据自由流通条例、开放数据和公共部门信息再利用指令,以及《通用数据保护条例》(GDPR)中关于获取个人数据用于科研的规则。为了促进研究、推动创新药物发展,并将所有原始数据集中在欧洲本地化的大型数据库中,我们建议进一步研究是否有可能找到完全尊重基本权利、私人生活和数据保护的可接受和平衡的解决方案。

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