Legal aspects regarding the use and integration of electronic medical records for epidemiological purposes with focus on the Italian situation

Q3 Nursing

Epidemiology Biostatistics and Public Health Pub Date : 2022-07-06 DOI:10.2427/8971

A. Stendardo, F. Preite, R. Gesuita, S. Villani, A. Zambon

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引用次数: 1

Abstract

The "Observational Studies" working group of the Italian Association of Medical Statistics and Clinical Epidemiology (SISMEC) has undertaken to study the impact of recent healthcare sector regulations on the legal and organisational aspects of managing all EMR databases with emphasis on Legislative Decree No. 196/2003 (the Italian Personal Data Protection Law). This paper examines six issues relating to theirs legal implications. The first section, “Confidentiality”, provides definitions and the regulatory context for the terms "confidentiality" and "personal data". In the second, “Nature of data held in electronic medical record archives”, we discuss the problem of sensitive data and procedures to make the identification code anonymous. In “Data ownership” we highlight the difference between the data controller and the database controller. The fourth section, “Conditions for processing”, discusses problems associated with using research data from one study in other investigations. In the fifth, “Patient consent”, we address the problems related to patient consent. Finally in “Penalties” we outline the main civil and criminal liability issues applied in case of non-compliance with the provisions of the Personal Data Protection Code. Where possible, we provide suggestions on how to comply with the legal requirements of managing medical record archives in order to make it easier for researchers to remain in compliance with the relevant provisions.

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关于为流行病学目的使用和整合电子病历的法律问题，重点是意大利的情况

意大利医学统计和临床流行病学协会(SISMEC)的"观察研究"工作组已着手研究最近的医疗保健部门条例对管理所有电子病历数据库的法律和组织方面的影响，重点研究第196/2003号法令(意大利个人数据保护法)。本文探讨了与它们的法律含义有关的六个问题。第一部分“保密”提供了术语“保密”和“个人资料”的定义和监管背景。第二章“电子病历档案中保存的数据的性质”，讨论了敏感数据的问题和使识别码匿名的程序。在“数据所有权”中，我们强调了数据控制器和数据库控制器之间的区别。第四部分，“处理条件”，讨论了在其他调查中使用一项研究的研究数据的相关问题。在第五部分“患者同意”中，我们讨论了与患者同意相关的问题。最后，在“处罚”中，我们概述了在不遵守《个人资料保护法》规定的情况下适用的主要民事和刑事责任问题。在可能的情况下，我们就如何遵守医疗档案管理的法律要求提供建议，以使研究人员更容易遵守相关规定。

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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来源期刊

Epidemiology Biostatistics and Public Health PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-

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期刊介绍： Epidemiology, Biostatistics, and Public Health (EBPH) is a multidisciplinary journal that has two broad aims: -To support the international public health community with publications on health service research, health care management, health policy, and health economics. -To strengthen the evidences on effective preventive interventions. -To advance public health methods, including biostatistics and epidemiology. EBPH welcomes submissions on all public health issues (including topics like eHealth, big data, personalized prevention, epidemiology and risk factors of chronic and infectious diseases); on basic and applied research in epidemiology; and in biostatistics methodology. Primary studies, systematic reviews, and meta-analyses are all welcome, as are research protocols for observational and experimental studies. EBPH aims to be a cross-discipline, international forum for scientific integration and evidence-based policymaking, combining the methodological aspects of epidemiology, biostatistics, and public health research with their practical applications.