COVID-19 is a highly contagious infection with no proven treatment. Approximately 2.5% of patients need mechanical ventilation while their body fights the infection.1 Once COVID-19 patients reach the point of critical illness where ventilation is necessary, they tend to deteriorate quickly. During the pandemic, patients with other conditions may also present at the hospital needing emergency ventilation. But ventilation of a COVID-19 patient can last for 2–3 weeks. Accordingly, if all ventilators are in use, there will not be time for (...) patients to ‘queue up’ to wait for those who arrived earlier to recover. Those who need a ventilator will die if they do not receive access to one quickly. Many nations now face the prospect that they failed to prepare appropriately for this foreseen risk of pandemic (another issue worthy of legal analysis) and that their populations will need far more ventilators than the health service can supply. For many weeks, the UK has been anticipating a surge of COVID-19 infections that could leave patients queuing in hospitals for ICU care. Luckily, social distancing has ‘flattened the curve’ and this problem might not arise. There is still a degree of risk, however, and other countries will not be so lucky. At some point, during this pandemic or the next, all countries will need to answer hard questions about whether and when scarce ICU resources (such as ventilators, beds and staff) should be either withheld or withdrawn from certain groups of patients solely for the purpose of providing them to others. Attempts to answer these questions can be found in a wide range of ICU triage protocols and ethical guidance documents, many of which embrace the foundational principle of ‘save the most lives’. Unfortunately, this worthwhile goal has generated many suggestions that could violate the law. This article identifies …. (shrink)

Data sharing – broadly defined as the exchange of health-related data among multiple controllers and processors – has gained increased relevance in the health sciences over recent years as the need and demand for collaboration has increased. This includes data obtained through healthcare provisions, clinical trials, observational studies, public health surveillance programs, and other data collection methods. The practice of data sharing presents several notable challenges, however. Compliance with a complex and dynamic regulatory framework is essential, with the General Data (...) Protection Regulation being a prominent example in a European context. Recent regulatory developments related to clinical trial transparency, trade secrecy, data access, AI training data, and health data spaces further contribute to the difficulties. Simultaneously, government initiatives often encourage scientists to embrace principles of “open data” and “open innovation.” The variety of regulations in this domain has the potential to impede widespread data sharing and hinder innovation. This edited volume, therefore, compiles comparative case studies authored by leading scholars from diverse disciplines and jurisdictions. The book aims to outline the legal complexities of data sharing. By examining real-world scenarios from diverse disciplines and a global perspective, it explores the normative, policy, and ethical dilemmas that surround data sharing in the health sciences today. Chapter Patient Perspectives on Data Sharing, Chapter Supplementary Measures and Appropriate Safeguards for International Transfers of Health Data after Schrems II are available open access under a Creative Commons Attribution 4.0 International License via link.springer.com. (shrink)

The regulation of stem cell research is an issue that has drawn much comment, criticism and even judicial arbitration in recent years. An emerging issue, addressed in this article, is how the fruits of that research-stem cell medicine-are likely to be regulated en route from lab to market. Taking account of the ethical, legal, social and safety issues raised by stem cell medicine and the goals of governance, the article explains the relevant regulatory instruments (e.g. the draft UK Stem Cell (...) Bank Code, the EU Directive on Human Tissue, the EU Directives on medical products and devices, and the Human Tissue Act 2004) and critically examines the framework they provide. (shrink)