The frontiers of medical negligence and diagnosis: an interview-based analysis.

While errors in medical diagnosis are common and often litigated, the different dimensions of diagnosis-formation, communication, recording-have received much less legal attention. When the process of diagnosis is differentiated in this way, new and contentious legal questions emerge that challenge the appropriateness of the Bolam/Bolitho standard. To explore these challenges, we interviewed 31 solicitors and barristers and asked them: (i) whether Montgomery should apply to information about alternative diagnoses; and (ii) whether the Bolam/Bolitho standard should be rejected in 'pure diagnosis' cases. Our qualitative analysis of the interviews sheds light not only on the two questions posed, but also on three cross-cutting themes. First, Bolam/Bolitho is criticised on two grounds that are often conflated: its paternalism for patients and its deference to medical professionals. Second, adopting different standards for different aspects of treatment and diagnosis may be justified in principle, but it can sometimes be difficult or not make sense in practice. Third, new conceptions of patients, doctors, and courts are being articulated in terms of rights or responsibilities over risks. In mapping these issues at the frontiers of medical negligence, this empirical study identifies potential pressure points for future legal developments.

Guiding organisational decision-making about COVID-19 asymptomatic testing in workplaces: mixed-method study to inform an ethical framework.

BACKGROUND: Workplace programmes to test staff for asymptomatic COVID-19 infection have become common, but raise a number of ethical challenges. In this article, we report the findings of a consultation that informed the development of an ethical framework for organisational decision-making about such programmes. METHODS: We conducted a mixed-method consultation - a survey and semi-structured interviews during November-December 2020 in a UK case study organisation that had introduced asymptomatic testing for all staff working on-site in its buildings. Analysis of closed-ended survey data was conducted descriptively. An analysis approach based on the Framework Method was used for the open-ended survey responses and interview data. The analyses were then integrated to facilitate systematic analysis across themes. Inferences were based on the integrated findings and combined with other inputs (literature review, ethical analysis, legal and public health guidance, expert discussions) to develop an ethical framework. RESULTS: The consultation involved 61 staff members from the case study organisation (50 survey respondents and 11 interview participants). There was strong support for the asymptomatic testing programme: 90% of the survey respondents viewed it as helpful or very helpful. Open-ended survey responses and interviews gave insight into participants' concerns, including those relating to goal drift, risk of false negatives, and potential negative impacts for household members and people whose roles lacked contractual and financial stability. Integration of the consultation findings and the other inputs identified the importance of a whole-system approach with appropriate support for the key control measure of isolation following positive tests. The need to build trust in the testing programme, for example through effective communication from leaders, was also emphasised. CONCLUSIONS: The consultation, together with other inputs, informed an ethical framework intended to support employers. The framework may support organisational decision-making in areas ranging from design and operation of the programme through to choices about participation. The framework is likely to benefit from further consultation and refinement in new settings.

Differentiating Negligent Standards of Care in Diagnosis.

Diagnosis lies at the heart of the medical encounter, yet it has received much less attention than treatment. It is widely assumed that negligent diagnosis claims should be governed by the Bolam test, but we demonstrate that this is not always the case. First, we disaggregate the diagnostic process into three different acts: forming the diagnosis, communicating it to the patient, and recording it. Second, we consider alternatives to Bolam for defining negligence, including less deferential profession-led standards, patient-led standards, and even a reasonable person standard. Third, bringing together these distinctions-within the diagnostic process, and between standards of care-we reveal the unappreciated complexity of negligent diagnosis. Analysing the standard of care that might apply to the three different acts in the diagnostic process, we identify reasons to think that Montgomery should apply to the communication of a diagnosis. We also argue that even in areas where the law is well-established, such as the application of Bolam to the formation of a diagnosis, challenging questions arise that require further attention. Throughout, the framework and analysis that we develop have significant implications for a set of negligence cases, as well as for medical education, clinical guidelines, and patient care.

New government drug repurposing programs: Opportunities and uncertainties.

Drug repurposing can be cheaper and faster than developing new compounds. Yet, it remains underused, partially because of regulatory and intellectual property challenges. Policy-makers in the United States and Europe have created seven drug development programs that aim to overcome these challenges using a variety of different strategies.

Human embryo models: the importance of national policy and governance review.

Integrated and non-integrated stem cell-based embryo models are becoming widely adopted tools in biomedical research with distinct advantages over animal models for studying human development. Although SCB-EMs have tremendous benefits for research, they raise a number of social, ethical and legal questions that affect future research and widespread adoption in industry and clinical settings. The 2021 International Society for Stem Cell Research Guidelines for Stem Cell Research and Clinical Translation provide helpful guidance on many of these issues but do not have force in domestic law. Careful appraisal and development of national legal and ethical frameworks is crucial. Paving the way to better regulation provides an ethical and social foundation to continue using human embryo models and to fully realise their potential benefits for reproductive medicine.

Montgomery's legal and practical impact: A systematic review at 6 years.

RATIONALE, AIMS AND OBJECTIVES: Six years ago, the Supreme Court judgement in Montgomery v Lanarkshire changed medical law. It introduced a new patient-based standard of care for the communication of treatment risks and alternatives, rejecting the doctor-based standard that had long governed all aspects of medical negligence. This is the first systematic review to analyse the literature on Montgomery. Our aim is to appraise and synthesize the literature on Montgomery's impact on medicine and the law and to identify areas for further academic enquiry and implications for professional guidance and training. METHODS: Searches were run in Medline, Embase, PsycINFO, Web of Science, Scopus, Westlaw UK, HeinOnline, and LexisNexis. Two reviewers screened papers. Extracted data was analysed and discussed by an interdisciplinary team. PRISMA guidelines were followed. RESULTS: Of the 1134 papers identified, 100 met the inclusion criteria. These papers revealed significant disagreement on four core sets of issues, focusing on Montgomery's impact on: (1) legal and professional duties; (2) medical practice; (3) the patient experience; and (4) litigation. The first set addresses whether the case actually changed doctors' legal and professional duties, the relationship between GMC guidance and medical law, and the boundaries of Montgomery. The second explores whether the decision has incentivized defensive medicine, its resource implications, and doctors' knowledge of it. The third concerns whether and how the decision has promoted patient autonomy and involvement in their own care. The fourth focuses on whether the case has caused an increase in litigation. CONCLUSIONS: Despite the abundance of legal and medical literature on Montgomery, many issues remain unresolved. Empirical research is required for many of the questions. Doctrinal analysis informed by medical knowledge is also required to assess whether Montgomery may have unrecognized ramifications-for example, whether it will require the disclosure of risks associated with diagnostic uncertainty, where doctors advise patients without performing procedures.

Standard contractual clauses for cross-border transfers of health data after Schrems II.

Standard contractual clauses (SCCs) have long been considered the most accessible method to transfer personal data legally across borders. In July 2020, the Court of Justice of the European Union (CJEU) in Data Protection Commissioner v Facebook Ireland Limited, Maximillian Schrems (Schrems II) placed heavy conditions on their use. The Schrems II Court found that SCCs were valid as 'appropriate safeguards' for data transfers from EU entities to others outside the EU/EEA as long as unspecified 'supplementary measures' were in place to compensate for the lack of data protection in the third country. Data protection officers are under intense pressure to explain these measures and allow routine transfers to continue. Some authorities interpret the decision as preventing the use of SCCs to transfer personal data outside of the EU because private contracts cannot comprehensively redress gaps in national law. This article argues that these authorities are mistaken and that notwithstanding Schrems II SCCs can still be useful instruments for cross-border transfers. This is especially true in highly regulated contexts such as medical research. This paper traces the history of SCCs under the General Data Protection Regulation (GDPR) and shows how the CJEU in Schrems II misunderstood the purpose of SCCs and other Article 46 GDPR 'appropriate safeguards'. The CJEU mistakenly approached Article 46 safeguards such as SCCs as being similar to country-specific adequacy rulings under Article 45 GDPR. But unlike Article 45 adequacy rulings, SCCs were not intended to provide a stand-alone mechanism for transfer reliant on the law of the importing country. Rather SCCs provide an alternative, multi-layered standard for data protection that encompasses law, technology and organizational commitments. Their purpose is to be used in situations where legislation alone is insufficient to protect data subject rights. The European Commission's new draft SCCs support this analysis.

An empirical study of large, human biobanks: intellectual property policies and financial conditions for access.

Biobanks are repositories that collect, store and distribute large quantities of biological samples and associated data (collectively called biobank `material'). Although biobanks have different modes of operation, all face a variety of similar challenges. Some of these challenges, such as donor consent and privacy, have been rigorously debated, but comparatively less attention has been paid to biobanks' intellectual property (IP) practices. IP rights (particularly patents) are integral to the translation of research into clinically relevant outcomes and, therefore, are key features in the business models of many biobanks. As a foundation for such research, commentators have identified five IP clauses of interest: (i) non-obstruction clauses; (ii) march-in clauses; (iii) grant-back clauses; (iv) return-of-results clauses and (v) reach-through clauses (also commonly called `reach-through rights'). In the limited literature that discusses the five clauses, commentators have largely debated their advantages and disadvantages in the abstract. The IP terms that biobanks actually use have not been empirically examined, apart from some small case studies. In particular, no industry-wide evidence exists on three points of biobanks' IP practice: (i) if and how biobanks implement these five types of IP clauses, (ii) whether any norms or standards have emerged, and (iii) whether the norms and standards align with commentators' recommendations for using the five IP clauses. To address these three gaps, the authors conducted a systematic, global survey of the IP clauses used by large, human biobanks. The results indicate that biobanks draft bespoke policies to meet their own needs, and probably do so without knowledge of the gamut of IP terms available. This study also revealed that, in general, biobanks are using IP terms differently from the advice of the commentators. On reviewing the differences, we encourage the use of march-in and grant-back clauses, discourage biobanks from using redundant non-obstruction clauses, and call for more research on return-of-results clauses. We also encourage the use of reach-through clauses to claim royalties (not IP), but only in limited circumstances; for example, where user access fees do not cover a biobanks' operational costs.

Patient data ownership: who owns your health?

This article answers two questions from the perspective of United Kingdom law and policy: (i) is health information property? and (ii) should it be? We argue that special features of health information make it unsuitable for conferral of property rights without an extensive system of data-specific rules, like those that govern intellectual property. Additionally, we argue that even if an extensive set of rules were developed, the advantages of a property framework to govern health information would be slight: propertization is unlikely to enhance patient self-determination, increase market efficiency, provide patients a foothold in the data economy, clarify legal uses of information, or encourage data-driven innovation. The better approach is to rely less, not more, on property. We recommend a regulatory model with four signature features: (i) substantial protection for personal health data similar to the GDPR with transparent limits on how, when, and by whom patient data can be accessed, used, and transmitted; (ii) input from relevant stakeholders; (iii) interoperability; and (iv) greater research into a health-data service, rather than goods, model.

Ethical principles and a practical approach to support policy making through the next phases of the COVID-19 pandemic and beyond.

There is an urgent need for an ethical framework to help us address the local and national challenges that we face as clinicians during the COVID-19 pandemic. We propose four key commitments from which a practical and consistent ethical approach can be derived. These commitments are to articulate the needs, rights and interests of the different stakeholders affected by any policy; to be accountable and transparent, recognising that people are autonomous individuals with values and concerns of their own; to consider the impact of our actions on the sustainability of the NHS, infrastructure, service demands and staff welfare; and to treat everybody equitably, with all deserving of consideration and care. Implementing these commitments will require a number of specific actions. We must put in place frameworks enabling clear advocacy for each competing objective; communicate policy and practice effectively to the public; promote integration of decision-making among social, primary, secondary and tertiary care and reduce or stop unnecessary or inefficient interventions; minimise health inequalities; and build spare capacity into the system.In this article, we expand on these actions, and note the legal context in which this would be delivered.

Isolating residents including wandering residents in care and group homes: Medical ethics and English law in the context of Covid-19.

This article investigates the lawfulness of isolating residents of care and group homes during the COVID-19 pandemic. Many residents are mobile, and their freedom to move is a central ethical tenet and human right. It is not however an absolute right and trade-offs between autonomy, liberty and health need to be made since COVID-19 is highly infectious and poses serious risks of critical illness and death. People living in care and group homes may be particularly vulnerable because recommended hygiene practices are difficult for them and many residents are elderly, and/or have co-morbidities. In some circumstances, the trade-offs can be made easily with the agreement of the resident and for short periods of time. However challenging cases arise, in particular for residents and occupants with dementia who 'wander', meaning they have a strong need to walk, sometimes due to agitation, as may also be the case for some people with developmental disability (e.g. autism), or as a consequence of mental illness. This article addresses three central questions: (1) in what circumstances is it lawful to isolate residents of social care homes to prevent transmission of COVID-19, in particular where the resident has a strong compulsion to walk and will not, or cannot, remain still and isolated? (2) what types of strategies are lawful to curtail walking and achieve isolation and social distancing? (3) is law reform required to ensure any action to restrict freedoms is lawful and not excessive? These questions emerged during the first wave of the COVID-19 pandemic and are still relevant. Although focussed on COVID-19, the results are also relevant to other future outbreaks of infectious diseases in care and group homes. Likewise, while we concentrate on the law in England and Wales, the analysis and implications have international significance.

International transfers of health data between the EU and USA: a sector-specific approach for the USA to ensure an 'adequate' level of protection.

International health research increasingly depends on collaboration and combination using medical data to advance treatment and drug discovery. The European Union (EU), through its General Data Protection Regulation, has tightened the rules for sharing data across borders to protect individual privacy. These new rules threaten cooperation between the EU and the USA, the two largest public funders of biomedical research. This article analyzes the primary pathway for sharing research data with the USA, the US-EU Privacy Shield, and argues that the Shield is ill-suited to support complex health studies. Its legitimacy is in question under both EU and US law, and its terms are too restrictive for the variety of exchanges underlying research, treatment, and care. As an alternative, we propose that the USA seek an additional sector-based adequacy determination based on the existing US health privacy law, the Health Insurance Portability and Accountability Act. A sector-specific approach to adequacy for health would avoid many of the most contentious issues that divide the USA and EU on data protection. It could also serve as a model for other third-party jurisdictions and facilitate international harmonization of health research practices.

COVID-19 contact tracing apps: a stress test for privacy, the GDPR, and data protection regimes.

Digital surveillance has played a key role in containing the COVID-19 outbreak in China, Singapore, Israel, and South Korea. Google and Apple recently announced the intention to build interfaces to allow Bluetooth contact tracking using Android and iPhone devices. In this article, we look at the compatibility of the proposed Apple/Google Bluetooth exposure notification system with Western privacy and data protection regimes and principles, including the General Data Protection Regulation (GDPR). Somewhat counter-intuitively, the GDPR's expansive scope is not a hindrance, but rather an advantage in conditions of uncertainty such as a pandemic. Its principle-based approach offers a functional blueprint for system design that is compatible with fundamental rights. By contrast, narrower, sector-specific rules such as the US Health Insurance Portability and Accountability Act (HIPAA), and even the new California Consumer Privacy Act (CCPA), leave gaps that may prove difficult to bridge in the middle of an emergency.