What is the idea behind NFDI4Health?
Epidemiological and clinical trial data have the advantage of being highly structured. Data collections in this field entail detailed phenotypes of study subjects and are generated according to a defined protocol. These data are most appropriate to investigate (1) the prognosis, aetiology and burden of diseases on individual and population level, (2) the influence of risk factors incl. nutritional factors and (3) the efficacy of preventive, diagnostic and therapeutic interventions.
Although individual studies are highly standardised and well-documented, they seldom fulfil FAIR data principles: (1) Findability is often hampered. For public health data, so far, international attempts are limited to support standards for publication and to establish study/protocol registries. Clinical trials are registered in the WHO approved German Clinical Trials Registry hosted by DIMDI, but the collected data are not described in standard formats. (2) Modalities of data access are typically not reported in sufficient detail. (3) Different epidemiological databases are usually not interoperable. For instance, there is vast methodological heterogeneity in approaches to assess dietary intake and to investigate associations with health outcomes. (4) Data protection requirements restrict reuse of data because these highly sensitive data often cannot be anonymised and reuse is limited by the informed consent of study participants.
“New opportunities for data analysis in the interest of improving population health”
Based on these limitations, the key objectives of NFDI4Health are to create new opportunities for data analysis in the interest of improving population health, in particular: (1) to enable findability of and access to structured health data from registries, administrative health databases, clinical trials, epidemiological studies and public health surveillance, (2) to implement a health data framework for centralised searching and accessing existing decentralised epidemiological/ clinical data infrastructures, (3) to enhance data sharing, record linkage, harmonised data quality assessments, federated analyses of personal health data in compliance with privacy regulations and ethics principles, (4) to enable the development and deployment of new, machine processable consent mechanisms and innovative data access services by operationalising the FAIR data principles, (5) to foster data sharing and cooperation between clinical research, epidemiological and public health communities, (6) to foster interoperability of currently fragmented IT solutions related to metadata repositories, cohort browsing, data quality and harmonisation, (7) to develop business models to secure sustainability of structures and services.
The overarching aim of NFDI4Health is to create an infrastructure based on standards which thus enables harmonisation, is expandable and facilitates the retrieval and use of public health data, (dietary) exposure data as well as clinical trial data, facilitating structured combination and interoperability.