LifeTime and improving European healthcare through cell-based interceptive medicine.

Here we describe the LifeTime Initiative, which aims to track, understand and target human cells during the onset and progression of complex diseases, and to analyse their response to therapy at single-cell resolution. This mission will be implemented through the development, integration and application of single-cell multi-omics and imaging, artificial intelligence and patient-derived experimental disease models during the progression from health to disease. The analysis of large molecular and clinical datasets will identify molecular mechanisms, create predictive computational models of disease progression, and reveal new drug targets and therapies. The timely detection and interception of disease embedded in an ethical and patient-centred vision will be achieved through interactions across academia, hospitals, patient associations, health data management systems and industry. The application of this strategy to key medical challenges in cancer, neurological and neuropsychiatric disorders, and infectious, chronic inflammatory and cardiovascular diseases at the single-cell level will usher in cell-based interceptive medicine in Europe over the next decade.

LEGAL NATURE OF MEDICAL SERVICES: SPECIFICS OF UKRAINIAN DOCTRINE.

The purpose of the article is to analyze the specifics of the Ukrainian doctrine regarding the legal nature of medical services and areas for improving legal regulation. The research is based on the analysis and comparison of Ukrainian and EU law, content analysis of the terminology of legal sources, legal positions of the Constitutional Court of Ukraine, scientific researches, description and generalization of existing achievements and issues in the field of legal regulation of healthcare services. Research methods are monographic analysis, systematic and structural analysis, comparative and legal analysis, linguistic analysis, content analysis, method of generalization. The need to unify the special categorical apparatus of Ukrainian legislation has been substantiated. It has been proved that due to the improvement of domestic legislation through the implementation of the norms of European private law, the doctrine and practice of legal regulation will correspond to the nature of the regulated relations. The content, structure, and specific features of legal relations for the provision of medical services in the Ukrainian legal system have been determined. The authors have made a conclusion about the private legal nature of medical services in the domestic legal doctrine. Recommendations have been made for the legislation of Ukraine, which regulates civil relations for the provision of medical services, regarding the introduction of special norms related to the personal non-property rights of the relations' participants, contractual representation of a patient, legal terms for the provision of medical services without obtaining the consent.

Looking Beyond GINA: Policy Approaches to Address Genetic Discrimination.

Concerns about genetic discrimination (GD) often surface when discussing research and innovation in genetics. Over recent decades, countries around the world have attempted to address GD using various policy measures. In this article, we survey these approaches and provide a critical commentary on their advantages and disadvantages. Our examination begins with regions featuring extensive policy-making activities (North America and Europe), followed by regions with moderate policy-making activities (Australia, Asia, and South America) and regions with minimal policy-making activities (the Middle East and Africa). Our analysis then turns to emerging issues regarding genetic testing and GD, including the expansion of multiomics sciences and direct-to-consumer genetic tests outside the health context. We additionally survey the shortcomings of current normative approaches addressing GD. Finally, we conclude by highlighting the evolving nature of GD and the need for more innovative policy-making in this area.

Investigating Investigation Powers under the Health Practitioner Regulation National Law.

Investigators and inspectors appointed under the Australia Health Practitioner Regulation National Law play important roles by gathering and assessing evidence used in disciplinary proceedings and/or criminal prosecutions. In performing these roles, investigators and inspectors exercise "police-like" powers including coercive questioning and entry onto private property with or without a search warrant. The investigation process can add additional stress and anxiety for health practitioners who are subject to disciplinary proceedings. It is difficult for an aggrieved party to challenge the lawfulness of the exercise of an investigation power in a tribunal as tribunals lack jurisdiction to rule on the legality of an investigation power or the admissibility of evidence. This article explores the range of powers possessed by investigators and inspectors under the National Law and a number of issues relating to the exercise of those powers.

Regulatory Investigations: Regulators, Regulatees and the Public Interest.

The potential for adverse consequences of investigations by a regulatory authority into complaints made against a person whom it regulates raises important questions about how regulators or similar bodies are, or should be, held accountable for their actions. This article examines the legal duties or other obligations that a regulator of health practitioners owes to people it regulates as well as to those who make complaints or submit notifications and to the public at large. It raises the general question of what duties or obligations any regulator or similar body with investigatory or coercive powers owes to persons arising out of its investigations. It finds that although they do not have a legal duty of care to a regulatee to protect them from harm, there may be other reasons why a regulator may want to consider the welfare of those whom it regulates as well as other affected parties.

Throwing a Cat among the Pridgeon(s): The New South Wales Court of Appeal and the Public Interest Test under the Health Practitioner Regulation National Law.

This section examines the 2022 decision of Pridgeon v Medical Council of New South Wales in the New South Wales Court of Appeal that has taken a fundamentally different view of the public interest test employed in immediate action hearings under the Health Practitioner Regulation National Law. The section starts by examining the case and then looks at the approach taken by subsequent decisions. It will argue that the decision is substantially at odds with earlier authorities from all around Australia and fails to understand properly the meaning and purpose of the test.

Acting Immediately - A Review of Recent Court and Tribunal Decisions Reviewing the Use of the Immediate Action Power under the National Law.

The power of National Boards to take immediate action under the Health Practitioner Regulation National Law Act to restrict the ability of health practitioners to practise is an important aspect of the regulator's drive to protect the public. This article examines the development of the law in respect of the use of the power, primarily by reference to court and tribunal decisions across the various jurisdictions in Australia. Some of the key principles from the decisions are identified as well as certain areas in which the law is still developing and may be a little uncertain.

FDA Regulation and Approval of Medical Devices: 1976-2020.

Importance: US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks. The US Food and Drug Administration (FDA) attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation. Objective: To review the development of laws and standards affecting the evaluation and oversight of medical devices by the US regulatory system and the outcomes of this system from 1976 to 2020. Evidence Review: Laws enacted by US Congress and regulations promulgated by the FDA through 2020; databases maintained by the FDA of device authorizations from 1976 to 2020; and annual reports of user fees paid to the FDA by industry. Findings: Since Congress and the FDA initiated premarket review of medical devices in 1976, some fundamental innovations in the device regulation system have included special pathways to accelerate availability of investigational devices, more flexible evidence and review requirements, and increased funding to the FDA through industry-paid user fees. From 1987 to 2020, the annual number of novel devices granted premarket approval (which excludes supplements) ranged from 8 to 56 (median, 32), and the number of clearances for 510(k) devices (those that are "substantially equivalent" to marketed devices) ranged from 2804 to 5762 (median, 3404). User fee funding for devices was established in 2002 and annual fees collected increased from $30 million in 2003 (in 2019 dollars) to more than $208 million in 2019; this represented 43% of FDA funding related to the review of medical devices. Although many new devices have led to considerable patient benefit, such as hypodermic needles and magnetic resonance imaging machines, important adverse events caused by some devices, such as an implanted device for birth control and a surgical mesh implant for pelvic organ prolapse, have led to calls to reexamine the regulatory system for such products. Conclusions and Relevance: Over the last 45 years, medical device regulation has become more complex, with more regulatory pathways and greater variations in the evidence and controls required for authorization. Increased FDA support from industry and concern about flexible authorization requirements reflect the tension between efficient access and the need for assurances that products will safely benefit patients.

The ongoing discussion on termination of life on request. A review from a German/European perspective.

BACKGROUND: Interest in the topic of termination of life has been growing for 2 decades. After legalisation of active euthanasia and assisted suicide (EAS) in the Netherlands in 2002, movements to implement similar laws started in other European countries. However, many people objected to legalisation on the basis of the experiences in the Netherlands and as a matter of principal. METHODS: This selected and focussed review presents the theoretical discussions about EAS and describes the respective parliamentary discussions in Germany and the data and experiences in the Netherlands. It also considers people with mental disorders in the context of termination-of-life services. RESULTS: So far, only a few European countries have introduced legislation on EAS. Legalisation of EAS in the Netherlands resulted in an unexpectedly large increase in cases. The number of people with mental disorders who terminate their lives on request remains low. CONCLUSIONS: Experience from the Netherlands shows that widening criteria for EAS has problematic consequences.KEY POINTSTermination of life on request, which a subgroup of people support, is a matter of ongoing debate.Because of several problematic aspects, including ethical considerations, only a few countries in the world allow active euthanasia or assisted suicide.Even if euthanasia is well regulated, legalising it can have problematic consequences that are difficult to control, such as an unwanted excessive increase in euthanasia cases.The well-documented experiences with the euthanasia law in the Netherlands serve as an example of what is to be expected when euthanasia is legalised.We need to pay close attention to the relationship between suicide and suicide prevention on the one hand and euthanasia acts and promotion of euthanasia on the other.Further ethical, psychological and legal research is needed. In particular, the role of palliative medicine in societies' approach to end-of-life care must be explored in much more detail.

Genes, cells, and biobanks: Yes, there's still a consent problem.

From a research perspective, the interest in biobanking continues to intensify. Governments and industry have invested heavily in biobanks, as exemplified by initiatives like the United Kingdom Biobank and United States' Precision Medicine Initiative. But despite this enthusiasm, many profound legal and ethical challenges remain unresolved. Indeed, there continues to be disagreements about how best to obtain consent and the degree and nature of control that research participants retain over donated samples and health information. Emerging social trends-including concerns about commercialization and perceived rights of continuing control ("biorights")-seem likely to intensify these issues.

Ethical and legal considerations related to disorders of consciousness.

PURPOSE OF REVIEW: The purpose of this review is to describe ethical and legal issues that arise in the management of patients with disorders of consciousness ranging from the minimally conscious state to the coma state, as well as brain death. RECENT FINDINGS: The recent literature highlights dilemmas created by diagnostic and prognostic uncertainties in patients with disorders of consciousness. The discussion also reveals the challenges experienced by the disability community, which includes individuals with severe brain injury who are classified as having a disorder of consciousness. We review current guidelines for management of patients with disorders of consciousness including discussions around diagnosis, prognosis, consideration of neuropalliation, and decisions around life sustaining medical treatment. SUMMARY: In the setting of uncertainty, this review describes the utility of applying a disability rights perspective and shared decision-making process to approach medical decision-making for patients with disorders of consciousness. We outline approaches to identifying surrogate decision makers, standards for decision-making and decision-making processes, specifically addressing the concept of futility as a less useful framework for making decisions. We also highlight special considerations for research, innovative and controversial care, brain death, organ donation, and child abuse and neglect.

Medico-Legal Aspects of Concussion.

Concussion and the sequelae have been controversial medico-legal issues for over 150 years. The following topics which are also important in clinical practice are discussed: definitions of concussion, neuroimaging, onset and prognosis of headaches, cognitive impairment, cognitive rehabilitation, post-traumatic stress disorder, and risk of later development of dementia.

Considering medical assistance in dying for minors: the complexities of children's voices.

Medical assistance in dying (MAID) legislation in Canada followed much deliberation after the Supreme Court of Canada's ruling in Carter v. Canada Included in this deliberation was the Special Joint Committee on Physician Assisted Dying's recommendation to extend MAID legislation beyond the inclusion of adults to mature minors. Children's agency is a construct advanced within childhood studies literature which entails eliciting children's voices in order to recognise children as active participants in constructing their own childhoods. Using this framework, we consider the possible extension of MAID legislation to most minors. We highlight important questions regarding how insights from children's voices could be mobilised in the life or death context of MAID. We conclude that children's voices have the potential to help determine their eligibility for MAID; however, incorporating children's voices in the context of MAID requires careful consideration due to the complexity of voice.

Ethical framework for adult social care in COVID-19.

In March 2020, the Government produced a document entitled "Responding to COVID-19: The Ethical Framework for Adult Social Care" ('The Ethical Framework'). In this article, we summarise the key features of the proposed ethical framework and subject it to critical analysis. We highlight three primary issues. First, the emphasis placed on autonomy as the primary ethical principle. We argue if ever there was a context in which autonomy should dominate the ethical analysis, this is not it. Second, we examine the interface between ethics and law which is largely overlooked in the document. Finally, we explore the surprising lack of attention paid to the concept of responsibility and communal obligations within the framework.

First prosecution of a Dutch doctor since the Euthanasia Act of 2002: what does the verdict mean?

On 11 September 2019, the verdict was read in the first prosecution of a doctor for euthanasia since the Termination of Life on Request and Assisted Suicide (Review Procedures) Act of 2002 was installed in the Netherlands. The case concerned euthanasia on the basis of an advance euthanasia directive (AED) for a patient with severe dementia. In this paper we describe the review process for euthanasia cases in the Netherlands. Then we describe the case in detail, the judgement of the Regional Review Committees for Termination of Life on Request and Euthanasia (RTE) and the judgement of the medical disciplinary court. Both the review committees and the disciplinary court came to the conclusion there were concerns with this case, which mainly hinged on the wording of the AED. They also addressed the lack of communication with the patient, the absence of oral confirmation of the wish to die and the fact that the euthanasia was performed without the patient being aware of this. However, the doctor was acquitted by the criminal court as the court found she had in fact met all due care criteria laid down in the act. We then describe what this judgement means for euthanasia in the Netherlands. It clarifies the power and reach of AEDs, it allows taking conversations with physicians and the testimony of the family into account when interpreting the AED. However, as a practical consequence the prosecution of this physician has led to fear among doctors about prosecution after euthanasia.

An operational approach to the execution of MR examinations in patients with CIED.

In the context of the increasing spread of cardiac active implantable heart devices (CIEDs) in the population and of the wide diagnostic/therapeutic utility of magnetic resonance (MRI) examinations, the goal of this paper is to provide the experience of the Santa Maria Nuova Hospital of the USL Tuscany Center in Florence and to report an organizational proposal to perform, in the hospital settings, MRI examinations on patients carrying CIED. This report is intended to show the operational choices of a Radiology Department which organizes this activity in accordance with the new Italian regulatory framework in the field of safety of MR sites (Ministero della Salute in Decreto Ministeriale 10 agosto 2018 Determinazione degli standard di sicurezza e impiego per le apparecchiature a risonanza magnetica, 2018).

How to Legalize Medically Assisted Death in a Free and Democratic Society.

In 2015, the Supreme Court of Canada struck down the criminal law prohibiting physician assisted death in Canada. In 2016, Parliament passed legislation to allow what it called 'medical assistance in dying (MAID).' The authors first describe the arguments the Court used to strike down the law, and then argue that MAID as legalized in Bill C-14 is based on principles that are incompatible with a free and democratic society, prohibits assistance in dying that should be permitted, and makes access to medically-assisted death unnecessarily difficult. They then propose a version of MAID legislation ('Ideal MAID') that gives proponents and opponents of MAID everything they can legitimately want, contend that it is the only way to legalize MAID that is compatible with a free and democratic society, and conclude that it is the way to legalize MAID in Canada and other similarly free and democratic societies.

National survey and analysis of barriers to the utilisation of the 2005 mental capacity act by people with bipolar disorder in England and Wales.

Background: The Mental Capacity Act (2005) (MCA) provides a legal framework for advance planning for both health and welfare in England and Wales for people if they lose mental capacity, for example, through mania or severe depression.Aims: To determine the proportion of people with bipolar disorder (BD) who utilise advance planning, their experience of using it and barriers to its implementation.Methods: National survey of people with clinical diagnosis of BD of their knowledge, use and experience of the MCA. Thematically analysed qualitative interviews with maximum variance sample of people with BD.Results: A total of 544 respondents with BD participated in the survey; 18 in the qualitative study. 403 (74.1%) believed making plans about their personal welfare if they lost capacity to be very important. A total of 199 (36.6%) participants knew about the MCA. A total 54 (10%), 62 (11%) and 21 (4%) participants made advanced decisions to refuse treatment, advance statements and lasting power of attorney, respectively. Barriers included not understanding its different forms, unrealistic expectations and advance plans ignored by services.Conclusion: In BD, the demand for advance plans about welfare with loss of capacity was high, but utilisation of the MCA was low with barriers at service user, clinician and organisation levels.