EHDEN Ethical Advisory Board (EAB), and colleagues, publish new conceptual, socio-technical framework supporting research via federated data networks: Concentric Circles View

5th October 2022, Brussels, Belgium: Working with real word data is not just about the data itself, nor only technical, methodological, or platform aspects, but also governance, ethical and legal compliance. Ensuring citizen or patient protection, privacy and meeting legal requirements are critical elements, requiring trust, trustworthiness and reliance on appropriate systems and appropriate involvement of patients and the public.

EHDEN takes this very seriously and is grateful to work with experts in the field, and importantly, representatives of the patient community, in addressing the need to fulfill socio and technical requirements via our Ethics Advisory Board. Our EAB, with clinical colleagues, sister IMI project PIONEER, legal experts from Industry trade associations, European Patients’ Forum and EHDEN project lead Partner, Janssen, recently published a paper outlining a conceptual framework in this domain.

The paper, in Frontiers in Big Data, “A concentric circles view of health data relations facilitates understanding of sociotechnical challenges for learning health systems and the role of federated data networks”, by Richard Milne, Mark Sheehan, et al., outlines a framework for understanding the challenges associated with using RWD, and the potential of a federated data network.

The authors’ aim is “to enable a consistent understanding of the fit between the local relationships within which data are produced and the extended socio-technical systems that enable their use.” The paper suggests a model for understanding these relationships, called the Concentric Circles View, that they propose may help understand and tackle challenges associated with the use of real world data in the health setting. They use the model to understand why federated networks may be well placed to address emerging issues and adapt to the evolving needs of health research for patient benefit. They conclude that the CCV may provide a useful way of understanding and tackling the major challenges associated with using real world data.

Lead author, Dr Richard Milne, Wellcome Connecting Centre, Cambridge, UK, stated, “The paper is a multidisciplinary effort to understand some of the diverse challenges faced in collecting, sharing and using health data”, while co-author, Nigel Hughes, Scientific Director, Janssen, and EHDEN Project Lead, commented, ”It’s vitally important we have a transparent position regarding the use of patient data for research purposes, and while certainly a federated data network inherently incorporates privacy preserving components, we need a socio-legal framework to support all stakeholders in being compliant. We are delighted to see this publication, and the ensuing work that will follow.”

FIGURE 1. The Concentric Circles View of a possible arrangement of data relationships for a single individual. In the proposed model, the initial circle (A) is the most intimate to the individual, and here involves the direct sharing of information within an individual's social network. Data related to this individual are also shared between health providers (B), stored on hospital data systems (C) and in research studies in which they participate (D) and used, in anonymised form by other researchers and the pharmaceutical industry, for example in drug discovery research (E). Each of these contexts involves a distinct social, legal, ethical, and technical configuration.¹

Explored further in the publication, aspects from consent through to public and patient involvement, with an emphasis on local, people-centred data relationships, the CCV is proposed as a way that all those involved in a health data system can visualise these relationships.

The extended EAB, authors of this paper, will be exploring further evaluation of the CCV framework within the context of federated data networks, such as IMI EHDEN and IMI PIONEER, and other data collaboration models for subsequent publications. A lay version of the paper will also be developed.

To support dissemination, and to articulate some of the key issues involved in this domain, a new sister series of podcasts will accompany the Voice of EHDEN podcast through the remainder of this year, and into 2023. An announcement will follow in due course.