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Researchers must collaborate globally to rapidly respond to the COVID-19 pandemic. In Europe, the General Data Protection Regulation (GDPR) regulates the processing of personal data, including health data of value to researchers. Even during a pandemic, research still requires a legal basis for the processing of sensitive data, additional justification for its processing, and a basis for any transfer of data outside Europe. The GDPR does provide legal grounds and derogations that can support research addressing a pandemic, if the data processing activities are proportionate to the aim pursued and accompanied by suitable safeguards. During a pandemic, a public interest basis may be more promising for research than a consent basis, given the high standards set out in the GDPR. However, the GDPR leaves many aspects of the public interest basis to be determined by individual Member States, which have not fully or uniformly made use of all options. The consequence is an inconsistent legal patchwork that displays insufficient clarity and impedes joint approaches. The COVID-19 experience provides lessons for national legislatures. Responsiveness to pandemics requires clear and harmonized laws that consider the related practical challenges and support collaborative global research in the public interest.

Background: People with dementia and other forms of cognitive impairment form a substantial proportion of patients admitted to hospitals, but problems in their care are persistent. One widely proposed improvement approach involves the use of systems using visual identifiers to help staff quickly recognise people with suspected dementia, with the goal of supporting more personalised care. The aim of this paper is to identify the identifier systems in use and staff perceptions of their strengths and weaknesses. Methods: We undertook an online survey of staff providing care for people with dementia in acute and mental health hospitals across the United Kingdom. The questionnaire covered different types of visual identifier systems for dementia. It used categorical and open‐response questions to access staff views of their use in practice. Responses were analysed using descriptive statistics, and the Framework approach for free‐text answers. Results: 162 responses were received from staff in at least 48 hospitals. Of these, 128 had direct experience of using visual identifier systems. They reported that multiple identifier systems are in use, including schemes with national scope and locally developed approaches. Most respondents reported that more than one system is in use in their hospital. Different types of identifier were seen to have different strengths and weaknesses. Respondents had a broadly positive view of identifiers, but highlighted risks including lack of reliable and consistent use (linked to competing pressures on staff time), lack of staff training, uncertainty about patient and family views, and unclear consent processes. Conclusions: Our study suggests that a wide range of identifier systems is in use in UK hospitals, with many hospitals using more than one. Further consideration should be given to ensuring that multiple perspectives—including those of patients and carers—are drawn on in optimising their design, resolving ethical issues and supporting implementation. [ABSTRACT FROM AUTHOR]

Introduction: To understand when knowledge objects in a computable biomedical knowledge library are likely to be subject to regulation as a medical device in the United Kingdom., Methods: A briefing paper was circulated to a multi-disciplinary group of 25 including regulators, lawyers and others with insights into device regulation. A 1-day workshop was convened to discuss questions relating to our aim. A discussion paper was drafted by lead authors and circulated to other authors for their comments and contributions., Results: This article reports on those deliberations and describes how UK device regulators are likely to treat the different kinds of knowledge objects that may be stored in computable biomedical knowledge libraries. While our focus is the likely approach of UK regulators, our analogies and analysis will also be relevant to the approaches taken by regulators elsewhere. We include a table examining the implications for each of the four knowledge levels described by Boxwala in 2011 and propose an additional level., Conclusions: If a knowledge object is described as directly executable for a medical purpose to provide decision support, it will generally be in scope of UK regulation as "software as a medical device." However, if the knowledge object consists of an algorithm, a ruleset, pseudocode or some other representation that is not directly executable and whose developers make no claim that it can be used for a medical purpose, it is not likely to be subject to regulation. We expect similar reasoning to be applied by regulators in other countries., Competing Interests: Jeremy Wyatt and Philip Scott co‐chair the joint UK British Computer Society‐Faculty of Clinical Informatics special interest group on Mobilising Computable Biomedical Knowledge. Matthew South is a founder and shareholder of Deontics Ltd. The authors declare no other commercial or other competing interests that may have affected their views or interfered with their impartiality in carrying out this work., (© 2023 The Authors. Learning Health Systems published by Wiley Periodicals LLC on behalf of University of Michigan.)