Pilarska Anna, Zimmermann Agnieszka, Piątkowska Kamila, Jabłoński Tomasz
Department of Medical and Pharmacy Law, Medical University of Gdańsk, Tuwima 15, 80-210 Gdańsk, Poland.
Legal Department, European Medicines Agency, 1083 HS Amsterdam, The Netherlands.
Healthcare (Basel). 2020 Oct 19;8(4):410. doi: 10.3390/healthcare8040410.
Patient safety means a condition in which a patient does not suffer any unnecessary actual harm, nor is exposed to any potential harm related to healthcare. The World Health Organization's recognition of patient safety, as one of the most important factors in determining high quality healthcare, initiated the systematic introduction of changes in the approach to this issue, both globally and on the level of individual healthcare service providers. In order to enhance the quality and ensure the safety of healthcare services provided, national, European Union, and worldwide institutions focus on the introduction of a so-called patient safety culture. The creation of this safety culture would not be possible without the establishment of its legal framework. The purpose of this article is to shed light on the legislative achievements of the European Union within patient safety, taking into consideration acts that summarize the level of implementation of individual recommendations. This study can be useful both for those who focus their scientific interests on the subject of patient safety and those who need concise information on the legislative measures of the Community in this respect, as well as for medical personnel who want to become acquainted with this issue without reading comprehensive legal acts.
患者安全是指患者不会遭受任何不必要的实际伤害,也不会面临与医疗保健相关的任何潜在伤害的一种状态。世界卫生组织将患者安全视为决定高质量医疗保健的最重要因素之一,这在全球范围内以及在各个医疗服务提供者层面上,引发了对该问题处理方式的系统性变革。为了提高所提供医疗服务的质量并确保其安全性,国家、欧盟及全球机构都致力于引入所谓的患者安全文化。如果没有建立其法律框架,这种安全文化的创建将是不可能的。本文的目的是阐明欧盟在患者安全方面的立法成就,同时考虑到总结各项建议实施水平的法案。这项研究对于那些将科学兴趣集中在患者安全主题上的人、那些需要关于共同体在这方面立法措施的简明信息的人以及那些想要在不阅读全面法律法案的情况下了解该问题的医务人员来说都可能是有用的。