欧洲健康数据空间--拟议的认证系统能否有效防范网络威胁?

IF 1.8 Q1 LAW European Journal of Risk Regulation Pub Date : 2024-04-18 DOI:10.1017/err.2024.25
Federica Casarosa
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引用次数: 0

摘要

欧洲健康数据空间提案旨在创建一个共同空间,让个人可以通过可信和安全的方式控制自己的健康数据。其目的不仅在于改善医疗服务,还在于增加将健康数据用于研究和创新的机会。为了取得这些成果,该提案为欧洲健康记录系统以及健康设备和应用程序实施了一项强制性自我认证计划,设定了与互操作性和安全性相关的基本要求。虽然这是首次制定对所有成员国都具有强制性的横向框架,但立法提案中包含的安全要求还不够详细和全面。鉴于网络威胁日益增加,影响健康数据的安全事件可能会对患者的生命造成潜在影响,因此必须以最有效的方式采取和实施网络安全措施。本文将对欧洲健康数据空间提案进行分析,指出可能出现的未决问题和疑虑,并将其与拟议的《网络复原力法》进行比较,找出通过这一横向法规可能解决的问题和仍未解决的问题。
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European Health Data Space – Is the Proposed Certification System Effective against Cyber Threats?

The proposal for a European Health Data Space aims at creating a common space where individuals may control their health data in a trusted and secure way. The objective is not only improving healthcare delivery, but also enhancing the opportunities to use health data for research and innovation. To achieve these results, the proposal implements a mandatory self-certification scheme for European health records systems as well as for wellness devices and applications, setting up essential requirements related to interoperability and security. Although this is the first intervention that sets a horizontal framework that is mandatory for all Member States, the security requirements that are included in the legislative proposal are not sufficiently detailed and comprehensive. Given that cyberthreats are increasing and security incidents affecting health data may potentially have an impact on the lives of patients, it is important that cybersecurity measures are adopted and implemented in the most effective way. The paper will analyse the European Health Data Space proposal pointing to the open issues and doubts that may be emerging and it will compare them with the proposed Cyber Resilience Act, identifying the issues that may be solved thanks to this horizontal regulation and the ones that instead remain open.

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来源期刊
CiteScore
6.10
自引率
0.00%
发文量
34
期刊介绍: European Journal of Risk Regulation is an interdisciplinary forum bringing together legal practitioners, academics, risk analysts and policymakers in a dialogue on how risks to individuals’ health, safety and the environment are regulated across policy domains globally. The journal’s wide scope encourages exploration of public health, safety and environmental aspects of pharmaceuticals, food and other consumer products alongside a wider interpretation of risk, which includes financial regulation, technology-related risks, natural disasters and terrorism.
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