Health data hubs: an analysis of existing data governance features for research

Abstract

Background Digital transformation in healthcare and the growth of health data generation and collection are important challenges for the secondary use of healthcare records in the health research field. Likewise, due to the ethical and legal constraints for using sensitive data, understanding how health data are managed by dedicated infrastructures called data hubs is essential to facilitating data sharing and reuse. Methods To capture the different data governance behind health data hubs across Europe, a survey focused on analysing the feasibility of linking individual-level data between data collections and the generation of health data governance patterns was carried out. The target audience of this study was national, European, and global data hubs. In total, the designed survey was sent to a representative list of 99 health data hubs in January 2022. Results In total, 41 survey responses received until June 2022 were analysed. Stratification methods were performed to cover the different levels of granularity identified in some data hubs’ characteristics. Firstly, a general pattern of data governance for data hubs was defined. Afterward, specific profiles were defined, generating specific data governance patterns through the stratifications in terms of the kind of organization (centralized versus decentralized) and role (data controller or data processor) of the health data hub respondents. Conclusions The analysis of the responses from health data hub respondents across Europe provided a list of the most frequent aspects, which concluded with a set of specific best practices on data management and governance, taking into account the constraints of sensitive data. In summary, a data hub should work in a centralized way, providing a Data Processing Agreement and a formal procedure to identify data providers, as well as data quality control, data integrity and anonymization methods.

Sharing sensitive data in life sciences: an overview of centralized and federated approaches

“…As a matter of fact, researchers need to take into consideration different regulations, policies and recommendations, including the GDPR that superseded the Data Protection Directive 95/46/EC [ 67 ] in Europe, the Artificial Intelligence Act (AI Act) [ 68 ], the Health Insurance Portability and Accountability Act (HIPAA) [ 69 ] in the United States, the World Medical Association’s Declaration of Helsinki on ‘Ethical Principles for Medical Research Involving Human Subjects’ [ 70 ] and the Council of Europe ‘Convention on Human Rights and Biomedicine’ (Oviedo Convention) [ 71 ] to name but a few. In addition, and despite harmonization efforts such as the EHDEN project [ 72 ] or GA4GH [ 73 , 74 ], national data hubs, healthcare centres and research institutions often use customized system architectures, data formats, data standards and cybersecurity protocols, which makes technical interoperability between data infrastructures in Europe and beyond challenging [ 75 ].…”

Data Governance in Multimodal Behavioral Research

“…The increasing availability of diverse data sources, such as electronic health records, social media, and wearable devices, has opened up new avenues for research and innovation [3]. In this context, multimodal behavioral research has emerged as a promising field that leverages the power of big data analytics to gain insights into human behavior and health [4,5].…”

Regulação da inteligência artificial na saúde

“…A estruturação de centros de dados (data hubs) que agregam dados de saúde é um dos principais desses mecanismos. Um centro de dados de saúde é uma infraestrutura técnica digital com a missão principal de permitir a partilha de dados de saúde, assegurando acessibilidade em conformidade com a regulação de governança de dados (ALVAREZ- ROMERO et al, 2023). Um bom exemplo é o Espaço Europeu de Dados de Saúde (European Health Data Space -EHDS), apresentado como uma proposta regulatória pela Comissão Europeia em maio de 2022 (EUROPEAN COMMISSION, 2022d).…”