GDPR

GDPR
  • 文章类型: Systematic Review
    GDPR的实施旨在为整个欧盟/欧洲经济区的个人数据保护建立一个总体框架。直接从队列参与者收集的数据的联系,可能作为健康研究的重要工具,必须遵守数据保护规则和隐私权。我们的目标是调查将未成年人的队列数据与常规收集的教育和健康数据相比较的法律可能性。方法:对EUR-Lex和葡萄牙GDPR实施的国家法律数据库中公开发布的法律法规进行了法律比较分析和范围审查,芬兰,挪威,以及荷兰及其相关的国家法规,旨在为2021年4月30日之前实施的健康研究建立记录链接。结果:GDPR不能确保成员国之间数据保护立法的完全统一,从而为国家立法提供灵活性。处理个人数据的例外情况,例如,公共利益和科学研究,必须在欧盟/欧洲经济区或国家法律中规定。国家解释的差异在跨国研究和记录链接方面造成了障碍:葡萄牙需要书面同意和道德批准;芬兰允许链接大多未经国家社会和卫生数据许可证管理局的同意;挪威基于区域伦理委员会的批准和适当的信息技术保密;荷兰主要基于选择退出系统和数据保护影响评估。结论:尽管GDPR是最重要的法律框架,将队列数据与常规收集的健康和教育数据联系起来时,国家立法执行最重要。由于国家的解释各不相同,健康研究迫切需要法律干预,以平衡个人的信息自决权和公共利益。在欧盟/欧洲经济区进行更多的协调可能会有所帮助,但对于那些未经明确同意已经为注册和研究公共利益开辟了余地的成员国来说,不应该有害。
    Background: The GDPR was implemented to build an overarching framework for personal data protection across the EU/EEA. Linkage of data directly collected from cohort participants, potentially serving as a prominent tool for health research, must respect data protection rules and privacy rights. Our objective was to investigate law possibilities of linking cohort data of minors with routinely collected education and health data comparing EU/EEA member states. Methods: A legal comparative analysis and scoping review was conducted of openly accessible published laws and regulations in EUR-Lex and national law databases on GDPR\'s implementation in Portugal, Finland, Norway, and the Netherlands and its connected national regulations purposing record linkage for health research that have been implemented up until April 30, 2021. Results: The GDPR does not ensure total uniformity in data protection legislation across member states offering flexibility for national legislation. Exceptions to process personal data, e.g., public interest and scientific research, must be laid down in EU/EEA or national law. Differences in national interpretation caused obstacles in cross-national research and record linkage: Portugal requires written consent and ethical approval; Finland allows linkage mostly without consent through the national Social and Health Data Permit Authority; Norway when based on regional ethics committee\'s approval and adequate information technology safeguarding confidentiality; the Netherlands mainly bases linkage on the opt-out system and Data Protection Impact Assessment. Conclusions: Though the GDPR is the most important legal framework, national legislation execution matters most when linking cohort data with routinely collected health and education data. As national interpretation varies, legal intervention balancing individual right to informational self-determination and public good is gravely needed for health research. More harmonization across EU/EEA could be helpful but should not be detrimental in those member states which already opened a leeway for registries and research for the public good without explicit consent.
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  • 文章类型: Journal Article
    在本文中,我们确定和审查关键挑战,以弥合中小企业之间的知识差距,公司,组织,企业,政府机构和公众在采用,推广和利用区块链技术。在这种情况下,所指出的挑战是网络安全和数据隐私。其他挑战由文献支持,在研究数据安全管理系统和法律框架以确定有效加密的类型和种类时,数据采集,ISO27001和通用数据保护条例下的政策和结果。区块链,一种革命性的存储和不变性方法,提供了强大的存储策略,再加上智能合约,给用户建立伙伴关系的能力,通过在安全的数字域中进行商业交易的基于法律的系统共享信息和同意。全球范围内,道德和法律挑战显著不同;公共和私营部门在部署此类防御性数据管理战略时的同意和信任,与实现确定性和正义的问责制和透明度制度直接相关。因此,这些领域的投资和研究对于在国家之间建立包括卫生在内的对话至关重要,应涵盖社会各阶层的金融和市场战略。提出了一个包含大数据元素的框架,机器学习和可视化方法和技术。通过文献,我们确定了进行实验以检测所需的系统,捕获,处理和存储数据。这包括隔离数据包数据,以告知网络安全和隐私相关活动的级别,并确保以安全的方式展示透明度,聪明和有效的方式。
    In this paper, we identify and review key challenges to bridge the knowledge-gap between SME\'s, companies, organisations, businesses, government institutions and the general public in adopting, promoting and utilising Blockchain technology. The challenges indicated are Cybersecurity and Data privacy in this instance. Additional challenges are set out supported by literature, in researching data security management systems and legal frameworks to ascertaining the types and varieties of valid encryption, data acquisition, policy and outcomes under ISO 27001 and the General Data Protection Regulations. Blockchain, a revolutionary method of storage and immutability, provides a robust storage strategy, and when coupled with a Smart Contract, gives users the ability to form partnerships, share information and consent via a legally-based system of carrying out business transactions in a secure digital domain. Globally, ethical and legal challenges significantly differ; consent and trust in the public and private sectors in deploying such defensive data management strategies, is directly related to the accountability and transparency systems in place to deliver certainty and justice. Therefore, investment and research in these areas is crucial to establishing a dialogue between nations to include health, finance and market strategies that should encompass all levels of society. A framework is proposed with elements to include Big Data, Machine Learning and Visualisation methods and techniques. Through the literature we identify a system necessary in carrying out experiments to detect, capture, process and store data. This includes isolating packet data to inform levels of Cybersecurity and privacy-related activities, and ensuring transparency demonstrated in a secure, smart and effective manner.
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  • 文章类型: Journal Article
    OBJECTIVE: This study aimed to determine the prevalence of epilepsy in four European countries (Austria, Denmark, Ireland, and Romania) employing a standard methodology. The study was conducted under the auspices of ESBACE (European Study on the Burden and Care of Epilepsy).
    METHODS: All hospitals and general practitioners serving a region of at least 50 000 persons in each country were asked to identify patients living in the region who had a diagnosis of epilepsy or experienced a single unprovoked seizure. Medical records were accessed, where available, to complete a standardized case report form. Data were sought on seizure frequency, seizure type, investigations, etiology, comorbidities, and use of antiseizure medication. Cases were validated in each country, and the degree of certainty was graded as definite, probable, or suspect cases.
    RESULTS: From a total population of 237 757 in the four countries, 1988 (.8%) patients were identified as potential cases of epilepsy. Due to legal and ethical issues in the individual countries, medical records were available for only 1208 patients, and among these, 113 had insufficient clinical information. The remaining 1095 cases were classified as either definite (n = 706, 64.5%), probable (n = 191, 17.4%), suspect (n = 153, 14.0%), or not epilepsy (n = 45, 4.1%).
    CONCLUSIONS: Although a precise prevalence estimate could not be generated from these data, the study found a high validity of epilepsy classification among evaluated cases (95.9%). More generally, this study highlights the significant challenges facing epidemiological research methodologies that are reliant on patient consent and retrospective chart review, largely due to the introduction of data protection legislation during the study period. Documentation of the epilepsy diagnosis was, in some cases, relatively low, indicating a need for improved guidelines for assessment, follow-up, and documentation. This study highlights the need to address the concerns and requirements of recruitment sites to engage in epidemiological research.
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  • 文章类型: Journal Article
    This article reviews the clinical photography and video data processing and storage arrangements of the Medical Illustration Department (MID) at the Queen Elizabeth Hospital Birmingham National Health Service (NHS) Foundation Trust (QEHB), part of the University Hospitals Birmingham (UHB) NHS Foundation Trust umbrella group. This review suggests that the department\'s current workflow and technical processing solution satisfies the requirements of the general data protection regulation (GDPR). At the time of writing, there were no additional financial costs or technical skills required for implementing GDPR regulations but this could change in future data processing systems. There are significant potential costs for non-compliance with GDPR. Brexit is unlikely to have any effect on complying with GDPR requirements. The GDPR gives the public the right to access information and be informed of how and why it is processed. It is recommended that improved administrative processing capability to accommodate this requirement should be included in future data processing designs. At the QEHB informed consent for use of photographs and videos is currently adequate to satisfy the common law of confidence.
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