On moving targets and magic bullets: Can the UK lead the way with responsible data linkage for health research?

Abstract

HighlightsWe explore key elements of good governance in health linkage.Adaptive reflexive governance models are essential.Two examples illustrate how we can achieve standardisation of practice.Distinct elements of governance compiled in a composite fashion tend to challenges.

Patient focused registries can improve health, care, and science

“…Data security for registries will be critical, as will models of consent that are sufficiently agile to respect patients' preferences and to cope with evolution of systems and changes in the purposes for which data may be used and in who may access and use which data over time. 34 Although many problems will need to Decision support "dashboards"-Graphs of patient level data over time enable patients and clinicians to detect relations between symptoms and interventions…”

Medical Data Donation, Consent and the Public Interest After Death: A Gateway to Posthumous Data Use

“…• The scheme is intended to be user friendly and widespread, to encourage and enable those individuals who wish to participate to easily donate their data posthumously; • This model of PMDD is designed to facilitate sharing of a comprehensive medical dataset, as included in participants' personal medical records (PMRs); • Such a scheme should be voluntary and participatory -OII explicitly reject the argument that informed consent is not required for PMDD, though acknowledge the merit in further consideration of how informed consent operates where data is repurposed in ways that cannot be anticipated at the point of data collection. (Krutzinna et al 2018) This chapter responds to this call for scrutiny of what good governance looks like in circumstances where consent does not, as I will argue, provide a 'single magic bullet' (Laurie et al 2015). The central argument advanced -that consent in PMDD should be understood as merely one aspect of a holistic governance regime -is wholly consistent with the OII's position that PMDD should enable willing participants to consent to volunteer their data.…”

“…Having proposed that consent in PMDD is more properly understood as merely one aspect of a holistic governance regime, Part III suggests that authorisation has a role to play. This is where certain uses of data may be permitted by an access committee, in the absence of consent, and is illustrated by the work of the Confidentiality Advisory Group and the Public Benefit and Privacy Panel, as described further below (Laurie et al 2015). Consideration of the operationalisation of this re-orientation, in the context of PMDD, brings to the fore the potential role of the public interest in navigating the various interests engaged.…”

Business analysis for a sustainable, multi-stakeholder ecosystem for leveraging the Electronic Health Records for Clinical Research (EHR4CR) platform in Europe

“…However, considerable hurdles must be overcome [47], including privacy and security issues [48], and other practical, technological, economic, political, professional and societal barriers which impede the exploitation of EHR [45,47]. In particular, patients expect safe and high-quality care, privacy protection, rights of access and correction, and the opportunity to give consent for research uses of their health information [45,48].…”