The European Genome-phenome Archive in 2021.

The European Genome-phenome Archive (EGA - https://ega-archive.org/) is a resource for long term secure archiving of all types of potentially identifiable genetic, phenotypic, and clinical data resulting from biomedical research projects. Its mission is to foster hosted data reuse, enable reproducibility, and accelerate biomedical and translational research in line with the FAIR principles. Launched in 2008, the EGA has grown quickly, currently archiving over 4,500 studies from nearly one thousand institutions. The EGA operates a distributed data access model in which requests are made to the data controller, not to the EGA, therefore, the submitter keeps control on who has access to the data and under which conditions. Given the size and value of data hosted, the EGA is constantly improving its value chain, that is, how the EGA can contribute to enhancing the value of human health data by facilitating its submission, discovery, access, and distribution, as well as leading the design and implementation of standards and methods necessary to deliver the value chain. The EGA has become a key GA4GH Driver Project, leading multiple development efforts and implementing new standards and tools, and has been appointed as an ELIXIR Core Data Resource.

[Legal aspects in digital cardiology]. / Rechtliche Aspekte in der digitalen Kardiologie.

Digital assistants have become an indispensable tool in modern cardiology. The associated technological progress offers a significant potential to increase the efficiency of medical processes, enable more precise diagnoses in a shorter time, and thus improve patient care. However, the integration of digital assistants into clinical cardiology also raises new challenges and questions, particularly regarding the handling of legal issues. This review article aims to raise awareness of individual legal issues resulting from the use of digital technologies in cardiology. The focus is on how to deal with various legal challenges that cardiologists face, including issues related to treatment freedom, professional confidentiality and data protection. The integration of digital assistants in cardiology leads to a noticeable improvement in efficiency and quality of patient care, but at the same time, it involves a variety of legal challenges that need to be carefully addressed.

When Parents Request Nondisclosure: Rights of Adolescents to Access Their Health Information and Implications of the 21st Century Cures Act Final Rule.

AbstractDespite broad ethical consensus supporting developmentally appropriate disclosure of health information to older children and adolescents, cases in which parents and caregivers request nondisclosure continue to pose moral dilemmas for clinicians. State laws vary considerably regarding adolescents' rights to autonomy, privacy, and confidentiality, with many states not specifically addressing adolescents' right to their own healthcare information. The requirements of the 21st Century Cures Act have raised important ethical concerns for pediatricians and adolescent healthcare professionals regarding the protection of adolescent privacy and confidentiality, given requirements that chart notes and results be made readily available to patients via electronic portals. Less addressed have been the implications of the act for adolescents' access to their health information, since many healthcare systems' electronic portals are available to patients beginning at age 12, sometimes requiring that the patients themselves authorize their parents' access to the same information. In this article, we present a challenging case of protracted disagreement about an adolescent's right to honest information regarding his devastating prognosis. We then review the legal framework governing adolescents' rights to their own healthcare information, the limitations of ethics consultation to resolve such disputes, and the potential for the Cures Act's impact on electronic medical record systems to provide one form of resolution. We conclude that although parents in cases like the one presented here have the legal right to consent to medical treatment on their children's behalf, they do not have a corresponding right to direct the withholding of medical information from the patient.

ChatGPT in private practice: The opportunities and pitfalls of novel technology.

OBJECTIVE: This article explores the transformative impact of OpenAI and ChatGPT on Australian medical practitioners, particularly psychiatrists in the private practice setting. It delves into the extensive benefits and limitations associated with integrating ChatGPT into medical practice, summarising current policies and scrutinising medicolegal implications. CONCLUSION: A careful assessment is imperative to determine whether the benefits of AI integration outweigh the associated risks. Practitioners are urged to review AI-generated content to ensure its accuracy, recognising that liability likely resides with them rather than with AI platforms, despite the lack of case law specific to negligence and AI in the Australian context at present. It is important to employ measures that ensure patient confidentiality is not breached and practitioners are encouraged to seek counsel from their professional indemnity insurer. There is considerable potential for future development of specialised AI software tailored specifically for the medical profession, making the use of AI more suitable for the medical field in the Australian legal landscape. Moving forward, it is essential to embrace technology and actively address its challenges rather than dismissing AI integration into medical practice. It is becoming increasingly essential that both the psychiatric community, medical community at large and policy makers develop comprehensive guidelines to fill existing policy gaps and adapt to the evolving landscape of AI technologies in healthcare.

Examining legal and ethical challenges in HIV/AIDS disclosure obligations and medical practices: a case study from China.

In accordance with China's regulations on the prevention and control of HIV/AIDS, individuals diagnosed with HIV are required to disclose their medical condition when soliciting medical care in Mainland China. Empirical field investigations, however, indicate that people living with HIV (PLHIV) predominantly comply with this mandate only under conditions of absolute necessity. The ensuing conundrum, juxtaposing the imperative of privacy against the duty of disclosure, has materialised into a recurrent vicious cycle in its practical application, intensifying the intrinsic trust disparities characterising doctor-patient interactions. A meticulous scrutiny of pertinent legal precedents, coupled with in-depth field studies, reveals that the genesis of these complications can be traced back to an unforeseen metamorphosis in the legislative intent underpinning HIV/AIDS prevention and therapeutic strategies. While the initial objective was risk mitigation, the effect of enactment in real-world scenarios has significantly decreased. Owing to factors including extensive media reporting as well as prevailing public discourse, PLHIV, rather than being perceived as rights-bearing entities in legal frameworks, are increasingly relegated to the restrictive and dehumanising labels of 'HIV/AIDS'. As these individuals navigate their rights through alternative non-regulatory channels, circumventing formal legal obligations, their efficacy in actualising these rights is concurrently undermined.

Moving Genomics into the Clinic: Platforms for Implementing Clinical Genomic Data-Sharing in Ways That Address Ethical, Legal and Social Implications.

This section explores the challenges involved in translating genomic research into genomic medicine. A number of priorities have been identified in the Australian National Health Genomics Framework for addressing these challenges. Responsible collection, storage, use and management of genomic data is one of these priorities, and is the primary theme of this section. The recent release of Genomical, an Australian data-sharing platform, is used as a case study to illustrate the type of assistance that can be provided to the health care sector in addressing this priority. The section first describes the National Framework and other drivers involved in the move towards genomic medicine. The section then examines key ethical, legal and social factors at play in genomics, with particular focus on privacy and consent. Finally, the section examines how Genomical is being used to help ensure that the move towards genomic medicine is ethically, legally and socially sound and that it optimises advances in both genomic and information technology.

European Health Data Space, Use of Data and Data Subjects' Control over Their Own Health Data: Can an Opt-Out Restore the Balance?

The creation of the European Health Data Space is a milestone. It establishes something new and makes it possible to have faster and more efficient health treatment, but also to untap the potential of unused data for policy-making and development of new technologies. However, for the EHDS to be functional, it is imperative that a balance it struck between the aim of having useful data to achieve important public objectives on one side and the goal of enabling patients to have control over their health data. The original Draft Report of the European Parliament came closest to achieving these objectives and should have represented the blueprint for the final compromise. Having a harmonised opt-out for secondary use is crucial for striking the right balance between the mentioned objectives. The end result is far from perfect regarding primary use, but represents a good balance in the area of secondary use concerning the opt-out.

Anonymous Gamete Donation: a Case for Balancing Under Article 8 ECHR.

Anonymous gamete donation creates a specific conflict between human rights and public interests under Article 8 of the ECHR. This was first assessed in the ECtHR's landmark decision in Gauvin-Fournis and Silliau v. France of 7 September 2023. This article critically analyses this judgment, taking into account the European legal framework for anonymous gamete donation, the recommendations of the competent authorities and the previous case law of the ECtHR on the right to know one's biological origin as an integral part of one's identity that is protected under the right to private and family life.

PROTECTION OF CONFIDENTIAL MEDICAL INFORMATION IN UKRAINE: PROBLEMS OF LEGAL REGULATION.

The aim of the article is to analyze the legal aspects and mechanisms of confidential medical information protection about an individual in the health care sphere in Ukraine. During the scientific research, various methods of cognition of legal phenomena were used. Among the general scientific approaches, the dialectical method was primarily used, which allowed to identify trends in the development of patient information rights and formulate proposals for improving legislation in the field of medical data protection. The formal-legal method was used to provide a comprehensive characterization of the EU (European Union) and Ukrainian legislation in the sphere of confidential medical information protection. Additionally, general scientific logical methods (analysis and synthesis, comparison and analogy, abstraction, and modeling) were used in order to study the problems of information relations in the medical field and establish legal liability for violation of the confidentiality of such information. The definitions of medical data, medical information, confidential medical data, and medical confidentiality have been researched and compared. The article identified the legitimate grounds for disclosing confidential medical information about an individual in the healthcare sector. Authors revealed the gaps in Ukrainian legislation regarding the confidential medical data protection by healthcare professionals and electronic medical systems regulators. The necessity of expanding the list of subjects responsible for preserving confidential medical information has been substantiated. The study explored the case law of the European Court of Human Rights in the field of the medical data confidentiality violation. It has been outlined the potential judicial remedies and liability for violating the right to personal medical information confidentiality of an individual in the healthcare sector. The legal grounds and cases of possible lawful disclosure of confidential medical information have been analyzed. Attention has been drawn to the insufficient regulation of access to medical confidentiality during martial law. It has been emphasized that the mechanism for protecting the violated right to confidentiality of medical information involves appealing to the Ukrainian Parliament Commissioner for Human Rights or to the court. The increasing role of international legal acts in ensuring the protection of medical data in the European Union and Ukraine has been highlighted.

Data protection during the coronavirus crisis.

Smartphone apps to track SARS-CoV 2 infections need to fulfill certain minimal requirements to guarantee privacy and justify their use under data protection laws.

Legal and ethical considerations of artificial intelligence in skin cancer diagnosis.

Artificial intelligence (AI) technology is becoming increasingly accurate and prevalent for the diagnosis of skin cancers. Commercially available AI diagnostic software is entering markets across the world posing new legal and ethical challenges for both clinicians and software companies. Australia has the highest rates of skin cancer in the world and is poised to be a significant benefactor and pioneer of the technology. This review describes the legal and ethical considerations raised by the emergence of artificial intelligence in skin cancer diagnosis and proposes recommendations for best practice.

Sharing ICU Patient Data Responsibly Under the Society of Critical Care Medicine/European Society of Intensive Care Medicine Joint Data Science Collaboration: The Amsterdam University Medical Centers Database (AmsterdamUMCdb) Example.

OBJECTIVES: Critical care medicine is a natural environment for machine learning approaches to improve outcomes for critically ill patients as admissions to ICUs generate vast amounts of data. However, technical, legal, ethical, and privacy concerns have so far limited the critical care medicine community from making these data readily available. The Society of Critical Care Medicine and the European Society of Intensive Care Medicine have identified ICU patient data sharing as one of the priorities under their Joint Data Science Collaboration. To encourage ICUs worldwide to share their patient data responsibly, we now describe the development and release of Amsterdam University Medical Centers Database (AmsterdamUMCdb), the first freely available critical care database in full compliance with privacy laws from both the United States and Europe, as an example of the feasibility of sharing complex critical care data. SETTING: University hospital ICU. SUBJECTS: Data from ICU patients admitted between 2003 and 2016. INTERVENTIONS: We used a risk-based deidentification strategy to maintain data utility while preserving privacy. In addition, we implemented contractual and governance processes, and a communication strategy. Patient organizations, supporting hospitals, and experts on ethics and privacy audited these processes and the database. MEASUREMENTS AND MAIN RESULTS: AmsterdamUMCdb contains approximately 1 billion clinical data points from 23,106 admissions of 20,109 patients. The privacy audit concluded that reidentification is not reasonably likely, and AmsterdamUMCdb can therefore be considered as anonymous information, both in the context of the U.S. Health Insurance Portability and Accountability Act and the European General Data Protection Regulation. The ethics audit concluded that responsible data sharing imposes minimal burden, whereas the potential benefit is tremendous. CONCLUSIONS: Technical, legal, ethical, and privacy challenges related to responsible data sharing can be addressed using a multidisciplinary approach. A risk-based deidentification strategy, that complies with both U.S. and European privacy regulations, should be the preferred approach to releasing ICU patient data. This supports the shared Society of Critical Care Medicine and European Society of Intensive Care Medicine vision to improve critical care outcomes through scientific inquiry of vast and combined ICU datasets.

Addressing Ethical Challenges in US-Based HIV Phylogenetic Research.

In recent years, phylogenetic analysis of HIV sequence data has been used in research studies to investigate transmission patterns between individuals and groups, including analysis of data from HIV prevention clinical trials, in molecular epidemiology, and in public health surveillance programs. Phylogenetic analysis can provide valuable information to inform HIV prevention efforts, but it also has risks, including stigma and marginalization of groups, or potential identification of HIV transmission between individuals. In response to these concerns, an interdisciplinary working group was assembled to address ethical challenges in US-based HIV phylogenetic research. The working group developed recommendations regarding (1) study design; (2) data security, access, and sharing; (3) legal issues; (4) community engagement; and (5) communication and dissemination. The working group also identified areas for future research and scholarship to promote ethical conduct of HIV phylogenetic research.

Informed consent: its importance for retrolective research and medical science progress.

In retrolective research, the information necessary to answer the research question is directly generated from medical records and other clinical-documentary sources. This article analyzes the waiver of informed consent and privacy notice when research is retrolective, from which two lines of argument emerge: one is the physician's duty to protect patient dignity, integrity, right to self-determination and privacy, as well as the confidentiality of the information obtained from him; the other is retrolective research contribution to the control of diseases and society's health improvement. Waiver of informed consent or privacy notice documented in the medical record is important for retrolective research, but it has ethical implications for researchers who do not comply with the rationality and personal responsibility they have before society.

En la investigación retrolectiva, la información necesaria para responder la pregunta de investigación se genera directamente de expedientes clínicos y de otras fuentes clínico-documentales. Este artículo analiza la dispensa del consentimiento informado y el aviso de privacidad cuando la investigación es retrolectiva, de lo cual emergen dos líneas de argumentación: una es el deber del médico de proteger la dignidad, la integridad, el derecho a la autodeterminación, la intimidad del enfermo y la confidencialidad de la información obtenida de él; la otra es la contribución de las investigaciones retrolectivas al control de las enfermedades y a la mejora de la salud de la sociedad. La dispensa del consentimiento o el aviso de privacidad en el expediente clínico es importante para la investigación retrolectiva, pero tiene implicaciones éticas para los investigadores que no cumplan con la racionalidad y responsabilidad personal que tienen ante la sociedad.

Signalling Standards for Progress: Bridging the Divide Between a Valid Consent to Use Patient Data Under Data Protection Law and the Common Law Duty of Confidentiality.

In this article, we analyse the legal components of disclosing confidential patient information under the UK's common law duty of confidentiality (CLDoC) and processing personal (health) data under the UK's General Data Protection Regulation (GDPR) and Data Protection Act 2018. We describe the ostensible divide between the CLDoC and data protection law when it comes to the requirements of a valid signal of consent by a patient to use and disclose patient information, obtained by a health professional in the context of direct care, for health care and health research purposes. Ultimately, our analysis suggests that we are saddled, at least in the medium term, with two regimes operating with different standards of a valid consent-while putatively protecting similar interests. There is, however, opportunity for progress. It is possible to improve professional guidance on the interaction between the regimes and to achieve significant normative alignment without aligning the signalling standard for consent; this would promote consistent protection of reasonable expectations of patients across both regimes. Further coherence would require aligning not only the standard, but also the role played by consent under each regime. Here we argue that, in relation to direct care, any such shift should be away from consent as the normal justification. In relation to health research, on the contrary, it should be toward consent as the normal justification for use and disclosure of patient information under both the CLDoC and data protection law.

A Normative Framework for the Reconciliation of EU Data Protection Law and Medical Research Ethics.

EU data protection law and medical research ethics overlap in scope and content in numerous instances in which personal data are processed in medical research. It is not always the case, however, that the conditions outlined by the two rule-sets precisely coincide. In the past few years, this lack of confluence has led to confusion as to how the two rule-sets should best relate to one another. This confusion has led to different approaches to the relationship being taken, on occasion leading to counter-intuitive conclusions. Unfortunately, there has hitherto been little effort to provide clarity to this confusion. In this regard, this article attempts to provide a general normative framework aimed at facilitating optimally cogent and just reconciliations of EU data protection law and medical research ethics.