Promising for patients or deeply disturbing? The ethical and legal aspects of deepfake therapy.

Deepfakes are hyper-realistic but fabricated videos created with the use of artificial intelligence. In the context of psychotherapy, the first studies on using deepfake technology are emerging, with potential applications including grief counselling and treatment for sexual violence-related trauma. This paper explores these applications from the perspective of medical ethics and health law. First, we question whether deepfake therapy can truly constitute good care. Important risks are dangerous situations or 'triggers' to the patient during data collection for the creation of a deepfake, and when deepfake therapy is started, there are risks of overattachment and blurring of reality, which can complicate the grieving process or alter perceptions of perpetrators. Therapists must mitigate these risks, but more research is needed to evaluate deepfake therapy's efficacy before it can be used at all. Second, we address the implications for the person depicted in the deepfake. We describe how privacy and portrait law apply and argue that the legitimate interests of those receiving therapy should outweigh the interests of the depicted, as long as the therapy is an effective and 'last resort' treatment option, overseen by a therapist and the deepfakes are handled carefully. We suggest specific preventative measures that can be taken to protect the depicted person's privacy. Finally, we call for qualitative research with patients and therapists to explore dependencies and other unintended consequences. In conclusion, while deepfake therapy holds promise, the competing interests and ethicolegal complexities demand careful consideration and further investigation alongside the development and implementation of this technology.

Towards a less voluntary vaccination policy in the Netherlands? Findings from an expert interview study.

BACKGROUND: The Netherlands traditionally favours a voluntary approach to vaccination. However, during the COVID-19 pandemic multiple European countries drastically altered their vaccination policies, which fuelled societal and political debate about the need to make the Dutch vaccination policy less voluntary, particularly by utilising pressure or coercion. AIM: To provide insight in expert's views on main normative issues concerning a less voluntary vaccination policy (for adults). Our study adds to the existing debate by addressing this topic from a multidisciplinary viewpoint. METHODS: We conducted 16 semi-structured interviews with legal, medical and ethical experts on the Dutch vaccination policy, between November 2021 and January 2022. We analysed interview transcripts through inductive coding. RESULTS: Most experts believe a less voluntary vaccination policy is of added value under certain circumstances, as exemplified by the outbreak of COVID-19. For such a policy, a legislative approach might be most effective. However, different views exist on the desirability of a less voluntary approach. Main arguments in favour are based on epidemiological circumstances and a duty towards the collective health interest, whilst arguments against are based on the questionable necessity and adverse effectiveness of such policy. CONCLUSIONS: If implemented, a less voluntary vaccination policy should be context-specific and take into account proportionality and subsidiarity. It is recommendable for governments to embed such policy (a priori) in flexible legislation.

[Broadening NIPT needs more care]. / Zoeken naar 'nevenbevindingen'?

In a research setting (TRIDENT-2), Dutch pregnant women undergoing prenatal screening for trisomies 21, 18 and 13 with the Non-Invasive Prenatal Test (NIPT), are offered the choice to also receive information about incidental findings. In a recent report, the Health Council of the Netherlands has recommended to retain this option, but to only report those incidental findings that very probably will lead to serious health outcomes for the child. A working group has been appointed to draw up a guideline for this. In this article we argue that actively searching for desired 'incidental findings' in fact amounts to broadening the scope of the screening and that a justification of this choice is still lacking. A core issue is whether the benefits of such broader screening outweigh the drawback of inevitably also generating findings that do not fit in with the aim of the screening: providing meaningful reproductive choices.

[Case reports of deceased patients]. / Casuïstiek van overleden patiënten.

Publishing a patient history or case report fulfills an important role in education and scientific research. However, this requires proper privacy protection. The main rule is that it must be nearly impossible to identify a patient in the presented case. If complete anonymity is not a possible, or if this is doubtful, publication is only possible after the patient's informed consent. But what if such authorization cannot be obtained, e.g. after a patient's death, or due to unknown whereabouts? In such a situation it should be possible to publish these cases, but only after careful consideration of all interests by authors and editorial board, possibly including opinions of the next of kin.

Experts reflecting on the duty to recontact patients and research participants; why professionals should take the lead in developing guidelines.

Sequencing technology is increasing the scale of information that could benefit patients who have been tested in the past. This raises the question whether professionals have a duty to recontact such patients or their families. There is currently no clear basis for a legal duty to recontact, and professional guidelines are limited. We conducted interviews with 14 senior professionals from the Netherlands and UK to obtain a range of opinions on what obligations are estimated to be possible or desirable. There was (near) consensus that a lack of resources currently inhibits recontacting in clinical practice, that recontacting is less desirable in research, that information on recontacting should be part of informed consent, and that a legal duty should follow professional standards. There was a diversity of opinions on the desirability of a more systematic approach, potential obligations in hybrid clinical-research projects, and who should bear responsibility for seeking updates. Based on the literature, legal framework and these interviews, we conclude that a general duty to recontact is unlikely, but that in specific circumstances a limited duty may apply if the benefit to the individual is significant and the burden on professionals not too extensive. The variation in opinion demonstrates that further deliberations are desirable. The development of guidelines-a process the European Society of Human Genetics has begun-is important to ensure that the courts, in deciding a recontacting case, can take into account what professionals consider responsible standards in this field.

Legal challenges for the implementation of advanced clinical digital decision support systems in Europe.

Systems based on artificial intelligence and machine learning that facilitate decision making in health care are promising new tools in the era of 'personalized' or 'precision' medicine. As the volume of patient data and scientific evidence grows, these computerised decision support systems (DSS) have great potential to help healthcare professionals improve diagnosis and care for individual patients. However, the implementation of these tools in clinical care raises some foreseeable legal challenges for healthcare providers and DSS-suppliers in Europe: How does the use of complex and novel DSS relate to professional standards to provide a reasonable standard of care? What should be done in terms of testing before DSS can be used in regular practice? What are the potential liabilities of health care providers and DSS companies if a DSS fails to function well? How do legal requirements for the protection of patient data and general privacy rights apply to likely DSS scenarios? In this article, we provide an overview of the current law and its general implications for the use of DSS, from a European perspective. We conclude that healthcare providers and DSS-suppliers will have the best chance of meeting legal challenges if: they are first tested in translational research with the patients' explicit, informed consent; DSS-suppliers and healthcare providers are able to clarify and agree on their individual legal responsibilities, and; patients are properly informed about privacy risks and able to decide themselves whether their data can be used for other purposes, or are stored and processed outside the EU. DSS developers and healthcare providers will need to work together closely to ensure compliance with national and European regulations and standards required for reasonable and safe patient care. RELEVANCE FOR PATIENTS: Advanced digital decision support systems have the potential to improve patient diagnosis and care. In this article we discuss key legal issues to support translational research using DSS and ensure that they meet the high standards for protection of patient safety and privacy in Europe.

Exploring the potential duty of care in clinical genomics under UK law.

Genome-wide sequencing technologies are beginning to be used in projects that have both clinical diagnostic and research components. The clinical application of this technology, which generates a huge amount of information of varying diagnostic certainty, involves addressing a number of challenges to establish appropriate standards. In this article, we explore the way that UK law may respond to three of these key challenges and could establish new legal duties in relation to feedback of findings that are unrelated to the presenting condition (secondary, additional or incidental findings); duties towards genetic relatives as well as the patient and duties on the part of researchers and professionals who do not have direct contact with patients. When considering these issues, the courts will take account of European and international comparisons, developing guidance and relevant ethical, social and policy factors. The UK courts will also be strongly influenced by precedent set in case law.

Next-generation sequencing-based genome diagnostics across clinical genetics centers: implementation choices and their effects.

Implementation of next-generation DNA sequencing (NGS) technology into routine diagnostic genome care requires strategic choices. Instead of theoretical discussions on the consequences of such choices, we compared NGS-based diagnostic practices in eight clinical genetic centers in the Netherlands, based on genetic testing of nine pre-selected patients with cardiomyopathy. We highlight critical implementation choices, including the specific contributions of laboratory and medical specialists, bioinformaticians and researchers to diagnostic genome care, and how these affect interpretation and reporting of variants. Reported pathogenic mutations were consistent for all but one patient. Of the two centers that were inconsistent in their diagnosis, one reported to have found 'no causal variant', thereby underdiagnosing this patient. The other provided an alternative diagnosis, identifying another variant as causal than the other centers. Ethical and legal analysis showed that informed consent procedures in all centers were generally adequate for diagnostic NGS applications that target a limited set of genes, but not for exome- and genome-based diagnosis. We propose changes to further improve and align these procedures, taking into account the blurring boundary between diagnostics and research, and specific counseling options for exome- and genome-based diagnostics. We conclude that alternative diagnoses may infer a certain level of 'greediness' to come to a positive diagnosis in interpreting sequencing results. Moreover, there is an increasing interdependence of clinic, diagnostics and research departments for comprehensive diagnostic genome care. Therefore, we invite clinical geneticists, physicians, researchers, bioinformatics experts and patients to reconsider their role and position in future diagnostic genome care.

Handling unsolicited findings in clinical care: a legal perspective.

In this article, the phenomenon of unsolicited findings will be explored in the context of European and Dutch legal standards. It focuses on the responsibilities of care providers, and the rights of patients' when unsolicited findings are discovered during regular diagnostics. On the basis of the latter, I will suggest some guidelines for the handling of unsolicited findings in clinical care; in doing so, some attention will be paid to the research context.

[Sex tourism and AIDS: doctors between duty and powerlessness]. / Sekstoerisme en AIDS: de arts tussen missie en machteloosheid.

What can a doctor do if he knows that an HIV-positive patient who is refusing antiretroviral therapy is going on a sex tourism holiday to Thailand, for example? A doctor in a moral dilemma could break professional confidentiality in order to protect any sexual partners, but in this case these partners are not known. In practice, the only thing the doctor can do is to talk to the patient about his responsibility to prevent infection of others and to point out the risks of unsafe sex for the patient himself.

[Introduction of next-generation sequencing in health care: what are the implications for physicians and patients?]. / Invoering van 'next-generation sequencing' in de zorg: wat betekent dat voor artsen en patiënten?

Next-generation sequencing (NGS) involves the laying down of the sequence of the entire genome or exome at one time. This technique is expected to become one of the approaches in diagnostic testing. The genetically determined vulnerability of individuals to disorder and their response to treatment can be determined at one go. However, this gives rise to ethical and legal questions, particularly in the area of the protection of patient privacy. These questions include provision of information to the patient about the DNA investigation and the chance of incidental findings, feedback to the patient concerning incidental findings and the storage and reuse of the genetic information. It is important to begin discussion of the legal and ethical consequences of NGS investigations at an early stage. This article may be the stimulus for this discussion.

Introduction of a national electronic patient record in The Netherlands: some legal issues.

The electronic patient record (EPR) is a major technological development within the healthcare sector. Many hospitals across Europe already use institution-based electronic patient records, which allow not only for electronic exchange of patient data within the hospital, but potentially also for sharing medical data with external healthcare providers, involved in the patient's care, such as general practitioners or pharmacists. In this article, we discuss the attempt made by the Dutch government to introduce a nationwide electronic patient record (n-EPR). Describing and analyzing the new legislation that is currently being developed to establish the infrastructure for the n-EPR and the related legal issues, we conclude that the introduction of a n-EPR give rise to some substantial concerns. These vary from technical and quality issues such as the reliability of patient data and sufficient standardization and interoperability of the systems used, to issues in the field of data security and confidentiality. For a successful introduction of the n-EPR within the healthcare sector, a condicio sine qua non is that the related legislation provides sufficient safeguards and clarity with respect to the responsibilities and liabilities of its main users: the healthcare professionals.

Regulating tissue research: do we need additional rules to protect research participants?

This article explores whether additional rules are needed for the regulation of tissue research in Europe. A human rights-based approach (referring to international documents and illustrative examples from national legislation) is taken to address the question: what is so special about tissue, in particular when compared to personal data? The existing regimes in Europe on data protection and clinical trials are presented and examined for their suitability to govern tissue research, taking into account the differences between data and tissue. Six recommendations are outlined, highlighting important points future legislation on tissue research must take into account.