欧洲通用数据保护条例（GDPR）对临床试验医学写作的影响综述

Q2 Health Professions

Medical Writing Pub Date : 2023-03-15 DOI:10.56012/ivhe5802

Tatiana Revenco, Gregory Collet

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引用次数: 0

摘要

欧洲通用数据保护条例2016/ 679 (GDPR)旨在确保欧盟(EU)个人的安全和隐私。位于欧盟内外的公司在处理欧盟公民的个人数据时必须遵守GDPR。医学写作包括与临床研究相关的文献的发展。为了编写这些文件，医学作者可以访问个人数据，包括被视为敏感数据的健康信息。因此，医学写作属于GDPR的范围，必须遵守其要求。本文概述了GDPR对医疗写作的影响，包括匿名化、假名化和数据最小化技术等安全措施。它还概述了在医学写作框架内为保证尊重数据主体的权利和自由而采取的技术和组织行动。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Overview of the European General Data Protection Regulation (GDPR) impact on medical writing for clinical trials

The European General Data Protection Regulation 2016/ 679 (GDPR) aims to ensure the security and privacy of individuals in the European Union (EU). Companies located within and outside of the EU must comply with GDPR when processing personal data of EU citizens. Medical writing includes the development of documents related to clinical research. To develop those documents, medical writers have access to personal data, including health information considered as sensitive data. Therefore, medical writing falls within the purview of GDPR and must comply with its requirements. This article is an overview of the impact of GDPR on medical writing including security measures such as anonymisation, pseudonymisation, and data minimisation techniques. It also provides an overview of the technical and organisational actions in the framework of medical writing to guarantee respect of data subjects’ rights and freedoms.

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来源期刊

Medical Writing Health Professions-Medical Terminology

CiteScore

0.40

自引率

0.00%

发文量

期刊介绍： Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.