Quality and safety of healthcare should be dissected from macro-level, the healthcare system and management; meso-level, the special population group at risk; and mirco-level, individual patient care including compensation for damages for medical mishaps and the potential impact of application of advanced technology such as Artificial Intelligence (AI), SmartCare, Stem cell research. This issue includes articles addressing the different levels of the system. Robust system of clinical governance is needed to ensure quality and safety in healthcare delivery system. It is important to strike a balance having different levels of governance to avoid the accidents occurring with system weakness at different levels like holes in stacked cheese slices in “Swiss Cheese Model”, and not creating layers of bureaucracy hampering efficiency. Karamyshev et al describes how to improve multi-level governance by creation of a more flexible system of interaction between all levels of government facilitating the implementation of reforms and improve healthcare indicators in Ukraine in the context of European integration . The introduction of digital tools for monitoring and automating processes will reduce bureaucratic obstacles and increase the transparency of management decisions . Rigorousness of medical standard plays a crucial role to ensure the safety of the patient in the provision of quality health care services. Patients are vulnerable to complications of medical interventions and their safety should be accorded top priority. There is always a dynamic between clinical autonomy and patient-centred care and how best to regulate medical professionals. Pielak examines two models of care, the mandated self-regulation in England and Poland relying on different sources of law including the regulations of the Minister of Health . There is a shifting from consensus of medical authority figures towards the evidence-based medicine in England with National Institute for Health and Care Excellence (“NICE”) as “main provider of standards” . In Poland, there is no central entity accountable for the development of medical standards and the approach towards professional standards in the literature is still strongly influenced by the opinions of authority figures and the significant role of “the medical doctor’s knowledge resulting primarily from their professional practice, as well as their skills” . Polish law places greater trust in doctors and English law refers to objective medical guidelines. However, the author reveals that the position of judges in England is strengthened in terms of independent expert witness opinions, and Polish courts may only request explanations from experts or ask for new opinions . Dong and Wang examine the factors influencing the award and amount of pain and suffering damages in medical malpractice cases in China as success rate in medical malpractice claim by plaintiff in China is roughly 80%, while it is typically much lower in other countries, e.g., success rate in US in 2005 is 23% . Although a very large percentage of the winning plaintiffs receive pain and suffering damages, the amounts awarded are typically quite low. The economic level, percentage of liability, grade of disability and caps collectively determine the amount of pain and suffering damages and cap on the amount of pain and suffering damages substantially limits the amount to a controlled level. It is proposed to adjust the caps according to the inflation rather than abolishing the caps which would be an arbitrary reform measure and the judge will not have any baseline of the cap amount leading to uncontrolled amounts or significantly different amounts of similar cases hence avoiding excessive award for aggravated damages . Characteristics based on age, gender, physical and mental disability, ethnicity, under-privileged socio-economic group are usually defined as vulnerable groups with special protection offered. However, thus might put them at risk being stigmatised, marginalised or discriminated. Iyioha proposes an evidence-based concept of vulnerability as “Impact-based theory” . It explains women’s heightened experience of harms, especially women at various axes of inequality, and that supports the normative treatment of vulnerability under various legislation, including human rights law . Special measures to combat domestic violence should be means of ensuring public health and well-being and such measures have been demonstrated to constitute central elements of the system for preventing these offenses, complementing and balancing other state mechanisms in response to relevant challenges. Study by Bilovol et al assessed the effectiveness of applying special measures to combat domestic violence against the background of a steady trend toward the deterioration of population health and well-being at both national and global levels . A comprehensive development of the educational component, the involvement of healthcare professionals in identifying and studying what incites domestic violence, the deepening of various forms of cooperation with international and foreign partners, and focusing attention on the training of relevant National Police officers were proposed by authors to increase the effectiveness of the measures to combat domestic violence . Patients at final stage of illness might not always be accessible to quality of care for dying in dignity. Patients and families come from diverse ethnicity or religion different from healthcare providers so it is important to provide care that is respectful and appropriate within that particular faith or cultural tradition reflecting the wishes of the patients. Paper by Yang would illuminate the understanding of end of life care within traditional Chinese culture how one should focus on alleviating the suffering of the elderly and enhancing their quality of life rather than prolonging the end of life, such as death taboos and filial piety within traditional Chinese culture . With advancement of scientific technology, Artificial Intelligence (AI) has permeated into our daily living including healthcare delivery. Use of AI in healthcare has the potential to facilitate greater precision in diagnosis and treatment. However, there are ethical concerns in use of AI in patient care. Study Buruk and Ekemki has identified four themes related to addressing ethical issues in healthcare regarding AI for clinical practice and public health infrastructures: clinical safety duties, health data protection, medical device regulation, and meaningful human control on automated decision liability. More guidelines would be developed in addressing those areas to ensure safety and quality. Li and Iong has pointed out that the traditional medical regulation models to smart healthcare has revealed multiple drawbacks and the regulatory response to risks in smart healthcare should take inclusive and prudent regulation as its logical starting point, and risk grading and classification, regulatory sandboxes, and multi-actor collaborative regulation serving as the main regulatory tools. A cooperative regulatory model led by administrative agencies and involving multiple stakeholders can ensure the multidimensional implementation of risk regulation. Rapid advances in stem cell research are transforming modern science and medicine, while simultaneously revealing existing legal and ethical gaps. Mammadov* and Jafarova conducted a comparative analysis of legislation regulating stem cell research in the United Kingdom (UK), selected countries of the European Union (EU), the Commonwealth of Independent States (CIS), and some Asian countries . It reveals the differences in national approaches among countries and some fragmentation of legal frameworks within the organizations. Harmonization of regulations and the creation of a comprehensive regulatory framework, as well as increased interdisciplinary collaboration would reduce regulatory fragmentation and support ethically responsible research . Delivering quality healthcare with assurance to population requires multiple facets from boarder perspectives. Intersection between medicine and law is very much needed. This issue encompasses articles to zoom in and out different angles to protect health of the different population groups.
Abstract. The purpose of the study was to develop a model for managing the healthcare system in Ukraine based on the adaptation of European standards. The methodology included a detailed analysis of the European Union (EU) regulations, such as the Association Agreement between Ukraine and the European Union, concerning the implementation of European standards in the healthcare sector. The results of the study show that the harmonization of Ukrainian legislation with EU standards has a positive impact on the quality of healthcare services and the development of the overall healthcare system. Significant challenges have been identified, such as the difficulty of adapting European norms to the realities of the Ukrainian healthcare system, the lack of proper coordination between central and regional levels of government, and the low efficiency of monitoring the implemented reforms. Based on the results of the study, a model for improving multilevel governance was developed, which proposes the creation of a more flexible system of interaction between all levels of government, so facilitating the implementation of reforms and improve healthcare indicators in Ukraine in the context of European integration. In addition to the identified advantages and disadvantages, the study determined that the strategic development of the healthcare system in Ukraine in the context of European integration requires increased financial support and technical assistance from the EU. In particular, the introduction of digital tools for monitoring and automating processes will reduce bureaucratic obstacles and increase the transparency of management decisions. Keywords: healthcare industry, regulatory framework, EU directives, healthcare reform, public sector.
The objective of this study was to analyse legal discrepancies in the anti-human trafficking legislation of Central Asian countries and assess their impact on the efficacy of interstate cooperation and law enforcement in the region. The research employed a comprehensive methodology, encompassing a comparative legal analysis of national legislative frameworks in Tajikistan, Uzbekistan, Kazakhstan, and Kyrgyz Republic, an evaluation of their compliance with key international standards such as the UN Convention against Transnational Organized Crime, and an examination of secondary data from reports by international organisations and regional agreements. Despite legislative updates in Tajikistan, Uzbekistan, Kyrgyz Republic, and Kazakhstan aimed at implementing international norms, the study established that significant disparities persist in the definition and classification of various forms of exploitation. A notable gap was identified between formal legislative provisions and actual law enforcement practices. This was evidenced by inconsistent application of the non-punishment principle for victims, systemic barriers to victims’ access to justice and compensation, and insufficient investigative efficacy, particularly concerning labour exploitation, which, according to global data, remains one of the predominant forms (39% of detected cases in 2020). Additionally, an alarming increase in trafficking for forced criminal activity (up to 8% in 2022) was observed. While a marginal rise in the identification of male victims was recorded (up to 23% globally in 2020), women and girls continued to constitute the majority of victims (61% in 2022). The study demonstrated that the identified legal discrepancies directly hinder effective cross-border cooperation among Central Asian states, complicating information exchange, mutual legal assistance, and the prosecution of offenders. Based on the analysis, comprehensive recommendations were formulated to harmonise legislation, improve law enforcement practices and regional cooperation, and enhance victim protection in Central Asia. Keywords: Harmonisation of Norms; Victim Protection; Cross-border Crime; implementation of Standards; Regional Cooperation.
“Vulnerability in 21st Century: Respect and Protect” is the theme of 2025 World Congress in Medical Law (WCML) held in Istanbul, Türkiye (Turkey) during the period 6 to 8 August 2025. The 2025 September issue (44:3) has published papers of plenary sessions on protection of vulnerable patients and patient safety. This issue will continue to publish presentations to address vulnerability from a wider medico-legal lens. Statue such as UK Mental Health Act preserves the common law presumption of capacity states a person assuming to have capacity unless it is established that the person lacking the capacity. However, people with moderate intellectual disability or functioning are at risk to be persuaded or manipulated into ill-advised course of action. On one hand, their rights to decision making should not be abrogated just because of some degree of intellectual disability. However, cautious should be exercise to prevent them being exploited. The plenary presentation by Munir during the 2025 World Congress for Medical Law addressed the issue of gullibility and vulnerability . The paper highlights Girona Declaration and Lancet Psychiatry consensus on borderline intellectual function and the rule of law’s legitimacy depending on how it safeguards those least equipped . Characteristics based on age, gender, physical and mental disability, ethnicity, under-privileged socio-economic group are usually defined as vulnerable groups and special protection should be offered. However, these groups being labelled vulnerable might put them at risk being stigmatised, marginalised or discriminated. The use of term “vulnerable” to describe women is contested by scholar in Iyioha’s plenary presentation proposing an evidence-based concept of vulnerability provisionally denoted as an Impact-based theory and it will be published in next issue . It explains women’s heightened experience of harms, especially women at various axes of inequality, and that supports the normative treatment of vulnerability under various legislation, including human rights law . The advancement of technology with powerful search engines are influencing medical management with patients holding preconceived opinions, to which doctors are expected to abide. Plenary presentation by Beran has highlighted the changing landscape for medical intervention from doctor centric to patient-centric putting doctors vulnerable to complaints, attacks in social media or even being sued by not satisfying expectation of patients . The paper has analysed cases that doctors are starting to defend against unwarranted defamations . Voluntary assisted dying is a contentious issue widely discussed and debated globally. People making the request need to be safeguarded of their decision making process as it is irreversible pathway. Saleme’s paper shares the Spanish law on eutanásia of the mandatory deliberative process with the attending physician rather than a mere bureaucratic formality with the dialogue designed to ensure that the patient fully understands their diagnosis, available treatments, palliative options, and the implications of choosing medical assistance in dying . This reinforces the informed consent process as a substantive, not just procedural, and the decision is within a therapeutic relationship rather than a transactional request. The paper highlights the Comisión de Garantía y Evaluación composing of medical, legal, and ethics experts appointed within each autonomous community to review documentation before the procedure taken place in cases where both medical reports are favorable or when a patient appeals a negative decision . This mechanism transforms the law from a purely medical protocol into a hybrid system of legal and ethical review, reflecting Spain’s decentralized governance and its commitment to multi-professional scrutiny., and physicians are also not obliged to participate and conscientious objection is explicitly recognised so professional freedom can be respected . Medical liability insurance is not just a financial product and more than indemnity coverage for healthcare professionals. It also plays an important to protect the public undergoing medical intervention. It provides a mechanism to compensate patients suffering damages as result of healthcare intervention due to negligence, error, or an unavoidable adverse outcome. It can serve as regulatory instrument to ensure patients safety. Dantas’ presentation compares Spanish and Brazilian approaches to medical liability insurance and analyse their plausible effects on patient safety, litigation patterns, and professional practice . The underwriting criteria by the Spain, insurers are promoting compliance with clinical guidelines and risk-reduction practice and Brazil could adopt regulatory incentives encouraging or requiring insurers to offer premium discounts to institutions and professionals demonstrating compliance with safety benchmarks such as accreditation, adverse-event reporting systems, or the use of surgical checklists . Certain professional mutual insurers in Spain, such as Agrupación Mutual Aseguradora (AMA) and SHAM España, have adopted risk-based underwriting models, offering premium adjustments or bonuses linked to compliance with patient safety standards and accreditation by national quality agencies (Instituto para la Calidad Sanitaria Española) . These programs, documented in the annual technical reports of the Dirección General de Seguros y Fondos de Pensiones(DGSFP) , illustrate how insurers can align economic incentives with safety performance. Medical liability insurance is therefore a structural determinant of how health systems handle patient harm, balance professional accountability with protection, and foster or hinder a culture of safety and transparency. The emergency legislation to curb transmission and safeguard public health responding to COVID-19 pandemic such as lockdowns, curfews, quarantines, and digital surveillance were by countries worldwide with varying degrees of necessity and proportionality. While these interventions mitigated disease spread, they would conflict with human rights norms by restricting freedoms of movement, assembly, privacy, and expression. Paper by Pooran prepated for oral presentation during WCML examines the legal tensions between pandemic management and international human rights law and analysing the principles of derogation and limitation under instruments such as the International Covenant on Civil and Political Rights and regional conventions, and evaluates how judicial and institutional oversight mediated between public health imperatives and civil liberties drawing on comparative jurisprudence and case studies The paper proposes normative principles to ensure that future pandemic legislation to remain effective yet rights-compliant, grounded in legality, necessity, proportionality, and accountability . Issues regarding access to medication by vulnerable population groups, vulnerability of lesbian couple achieving second parenthood and human trafficking putting women and girls as victims are also key issues of vulnerability. Universal and equitable access to essential medicine is essential component of achieving universal health coverage particularly for vulnerable and underprivileged population. Study by Zhanzhigitova et al has revealed findings of nearly half of the respondents experiencing difficulties in obtaining essential medications highlighting the importance of real time stock monitoring, improved communication channels and targeted interventions for at risk populations . The study provides insight to enhance the supply chain management targeting support for vulnerable population . The uncertainty of second parent of lesbian couples opting assisted reproductive methods expose the couples and children in vulnerable status. Paper by Liu examines the disputes of lesbian couples’ parenthood . Human trafficking is a global transnational crime that affects millions of individuals worldwide, making it an urgent issue for both law enforcement and international cooperation. Kamilova has conducted study to analyse legal discrepancies in the anti-human trafficking legislation of Central Asian countries and assess their impact on the efficacy of interstate cooperation and law enforcement in the region . The research findings led to the formulation of recommendations that are based on a comparative legal analysis of national legislations, international standards, and reports from authoritative organizations. Issues related to vulnerability requires intersection of legal, health, social, education and economic and cultural perspectives. The medico-legal issues on vulnerability need to develop a wider and boarder lens to uphold justice and equity. Papers in this issue provide good reference resources to uphold the doctrine of rule of law in safeguarding the rights of vulnerable groups.
The COVID-19 pandemic compelled governments worldwide to adopt emergency legislation to curb transmission and safeguard public health. Measures such as lockdowns, curfews, quarantines, and digital surveillance were implemented with varying degrees of necessity and proportionality. While these interventions mitigated disease spread, they frequently conflicted with human rights norms by restricting freedoms of movement, assembly, privacy, and expression. This paper examines the legal tensions between pandemic management and international human rights law, analysing the principles of derogation and limitation under instruments such as the International Covenant on Civil and Political Rights and regional conventions. Drawing on comparative jurisprudence and case studies, it evaluates how judicial and institutional oversight mediated between public health imperatives and civil liberties. The paper concludes by proposing normative principles to ensure that future pandemic legislation remains effective yet rights-compliant, grounded in legality, necessity, proportionality, and accountability. Keywords: pandemic; emergency powers; human rights; public health; proportionality; surveillance; accountability; data protection; non-derogable rights; judicial oversight; legislative review; global health governance
People with mild Intellectual Developmental Disorder (IDD), Borderline Intellectual Functioning (BIF), and many autistic individuals share social-cognitive vulnerabilities that manifest as gullibility, persuadability, credulity, and acquiescence under authority. These traits, rooted in executive function, Theory-of-Mind, and pragmatic language differences, are disproportionately exploited in adversarial settings: accusatorial interrogation (e.g., Reid technique), Miranda waivers, plea bargaining, and immigration detention. We situate gullibility in Stephen Greenspan’s foundational framework; examine U.S. criminal cases (Atkins, Briseño/Moore, Hall, Brendan Dassey) and the civil immigration system’s parallel risks (including immigration practices affecting disabled detainees); and trace historical continuities from institutionalization and sterilization (Buck v Bell) to modern nativism. We highlight the Girona Declaration (Catalonia) and Lancet Psychiatry consensus on BIF as policy models, and propose safeguards—universal vulnerability screening, adapted rights advisement, mandatory “appropriate adult”/counsel, and limits on deceptive tactics—consistent with Article 13 of the United Nations Committee on the Rights of Persons with Disabilities (UN CRPD). The goal is a rights-protective, clinically informed jurisprudence. Keywords: Gullibility; Intellectual Developmental Disorder; Borderline Intellectual Functioning; Autism; Theory of Mind; False Confession; Miranda; Death Penalty; Immigration Detention; UN CRPD.
This paper introduces the biological and legal challenges facing lesbian couples aiming for parenthood in the UK. Biologically, they rely on Assisted Reproductive Technologies (hereafter ARTs) if they wish for children with genetic links. UK law introduces further uncertainties regarding who is recognised as the second parent. These biological and legal uncertainties contribute to the difficulty of identifying legal parenthood in lesbian couples. The paper examines disputes regarding lesbian couples’ legal parenthood, to demonstrate that although the current law protects the gestational mother as the legal mother, it fails to clearly identify the second legal parent. This poses potential risks to other interested parties including the genetic mother and the resulting children and it is therefore argued that UK law should be revised to reduce potential risks to lesbian couples using ARTs and their resulting children. Keywords: Lesbian Shared Parenthood; Lesbian shared in vitro Fertilisation; Donor Insemination; Legal Parenthood; Same-sex Couple
Abstract: Introduction: Legal medicine has become ‘patient-centric’ with search engines provoking self-diagnoses and challenges. This paper examines potential to create physician vulnerability and need to protect reputations. Doctor Vulnerability: Not satisfying patient expectation may generate complaints and social media to attack doctors forcing them to seek legal remedies. Courts hold patients accountable for dishonest, online comments, yet the internet encourages patients to litigate against health professionals with whom (s)he is dissatisfied. Can a Physician Be Sued for Negligence by a Patient He Never Met?: Recent cases confirm that a doctor can be sued, even if the relevant clinician never met the patient, if his/her action (or inaction) establishes a doctor-patient relationship. Response to Doctor Vulnerability: A plastic surgeon was awarded damages following defamation, despite his refusal to treat the patient. Justice Rothman held a patient accountable for posting dishonest, online comments about a surgeon’s professional conduct and also awarded damages to an orthopaedic surgeon experiencing similar vitriolic sentiment online. The USA case, Carlotti v. Petta, successfully sued a former patient – receiving a jury verdict of $12 million in December 2011. On 2 May 2025, a large Sydney conference of medical practitioners addressed perceived bias by the Australian Health Practitioner Regulation Agency (AHPRA), in Australia. Conclusions: Medical intervention has changed from doctor – centric to patient-centric. Search engines are influencing medical management with patients holding preconceived opinions, to which doctors are expected to abide and failure to do so providing potential for vexatious complaints. Doctors are starting to fight back.
This article examines how different regulatory approaches to medical liability insurance (MLI) in Spain and Brazil influence patient safety, compensation pathways, and professional practice. Spain mandates MLI or equivalent financial guarantees for private-sector health care providers and channels public-sector liability through the State, creating predictable compensation mechanisms and insurer-driven safety incentives. Brazil, by contrast, operates under an optional model where insurance uptake depends on individual or institutional choice, resulting in heterogeneous risk management practices and heavier reliance on judicial processes to secure redress. Drawing on doctrinal and policy analysis, the study explores the structural consequences of these frameworks for patient protection, legal certainty, professional wellbeing, and institutional learning. It argues that carefully calibrated mandates or hybrid schemes—combining minimum financial security standards with access safeguards, earlyresolution mechanisms, and data-driven safety programs—offer a promising path to stronger patient safety, greater professional security, and fairer, faster compensation when care fails. Objective To compare Spanish and Brazilian approaches to MLI and analyze their plausible effects on patient safety, litigation patterns, and professional practice. Methods Doctrinal and policy analysis of governing Spanish law—particularly Article 46 of Law 44/2003 (Regulation of Health Professions), Article 36 of Law 40/2015 (Public Sector Legal Regime), and Article 106(2) of the Spanish Constitution—and of Brazilian federal law as to the absence of a general mandate for MLI. The analysis is complemented by a structured comparison of expected system behaviors (risk management, compensation pathways, institutional culture), without reporting unverifiable statistics. Keywords: Medical liability insurance; patient safety; comparative health law; Spain; Brazil; administrative liability; risk management; judicialization; professional regulation.
Abstract This article offers a critical and interdisciplinary analysis of Spain’s Organic Law 3/2021 on euthanasia. Drawing on official statistics from 2021 to 2023 and on a paradigmatic case study, it examines how the legal right to medical assistance in dying is being implemented and the ethical challenges it has raised. The discussion analyzes the Spanish experience within a global context, explores tensions between patient autonomy and vulnerability, and highlights the need for procedural safeguards and systemic improvements to transform formal rights into effective access. Keywords: Euthanasia; Organic Law 3/2021; Ethics of care; Vulnerability; Patient Autonomy; Medical Law.
Digital technology and Artificial Intelligence (AI) pose major challenges for the 21st century deployed in almost all areas of daily activities, and particularly in medical practice. Thanks to the digitization of multiple test results, medical letters, and operation reports, they can now be grouped together in a digital file. At the same time, the use of digital tools and algorithms is leading to a new use of medicine to support decision-making, improved prevention, predictive medicine and precision medicine. Computer-assisted surgery and surgical robots are improving patient care. AI and Deep Learning can be used to analyse medical images, providing major diagnostic support. The digitization of healthcare delivery is of direct benefit to the patient, e.g., the digitised medical record (DMR) and telemedicine can enable patients to consult a doctor and be treated remotely by healthcare professionals. These activities generate digitised health data, which are kept and stored in large databases that collectively, represent an important source of information for health knowledge. A twofold question arises: should we respect the patient's interest by protecting data confidentiality? Or can we share these data in the interest of society, to advance science? It cannot be said that one of these interests prevails over the other, so why deprive society of the benefits of secondary use of individual data? In France, these two interests can coexist in a balanced way. The patient’s interest is protected by the health care system, which provides social protection for all citizens on the basis of equality and solidarity, so that the entire population has access to this social protection system. All administrative data relating to the health of all citizens are collected by the health insurance system, which finances all medical care. Personal medical data (diagnosis, treatment) are isolated in an independent exclusive medical system that respects professional secrecy. These data are not linked to administrative data. This specificity has been implemented in the general framework of the French tradition of personal data protection (confidentiality) since Data Protection Act of 1978 . The French health insurance system has created “mon espace santé”, a digital platform where patients can store and manage access to their personal health data in a fully protected and secure manner. In the public interest, health insurance data, combined with hospital medical data, are centralised in a single national data warehouse: the Système National des Données de Santé (SNDS), and access is organised to share data for public health purposes. This system is unique in that it contains all the medical data of the French population (70 million of citizens), where digitised data are stored under a pseudonym. To support our argument, individual benefit will be presented first, followed by the collective interest. Then the original French system, SNDS, the centralised public database containing data on the entire population. And finally, the secondary use of data will show how public and private interests can exist together, without one taking precedence over the other. Keywords: digital health; health data , SNDS (Centralised French Health database) artificial intelligence; GDPR; public good; European Health Data Space.
- This dedicated issue focuses on the medical, legal, and ethical concerns related to the continued use of electronic fetal monitoring (EFM) in childbirth [often referred to as continuous electronic fetal heart rate monitoring (FHR monitoring) and cardiotocography (CTG) in various countries and various publications]. - EFM’s half century old theory says that EFM patterns correctly interpreted will predict hypoxic ischemic encephalopathy, thereby allowing just-in-time cesarean sections [C section] that prevent cerebral palsy [CP] or other long-term neurologic disorders. - But despite EFM being a fifty year worldwide standard of care, despite tens of millions of babies delivered by C section, the rate of CP remains essentially the same today - Five decades of research has proven EFM does not predict or prevent CP or any other permanent adverse neurologic condition. In fact, research proves that most CP is caused by prenatal factors such as inflammatory conditions, infections, and genetic anomalies. - EFM has a proven 99% false positive rate. As a result, EFM has contributed to a C section rate today of 30%-40% and more, leading to a cornucopia of complications for mothers and babies of that major abdominal operation - CP lawsuits are now prevalent in all industrialized countries and are among the most expensive adding unnecessary billions to healthcare costs much of which is consumed by trial lawyers and their EFM “experts” and very little by CP children and their families. - Although for decades medicine has held the key to stopping this lawsuit onslaught which convicts innocent physicians, nurses, and midwives of causing CP, medicine has done nothing to help their innocent colleagues. - Currently, there is considerable effort by EFM manufacturers and others to expand EFM to developing nations, especially Africa. But if EFM does more harm than good in industrialized nations how much more harm will it do in regions with limited money, healthcare resources, and infrastructure? - Would today be soon enough?
If one puts forward a question what medical law is all about, the common answer will be medical mishaps as result of clinical negligence leading to lawsuit and/or inquires of disciplinary bodies or death inquest (Coroner cases). Sometimes it would involve elements of crime, e.g., illegal prescription of drugs particularly controlled drugs, clinical intervention not allowed by law (procedures without consent or prohibited by law), frauds such as misrepresentation of medical bills/certificates. One view on medical law is that it is essentially concerned with relationship between patients and healthcare professional . Medical law will come in when something has gone wrong during the clinical encounter. This perspective is too narrow and also dark side of thinking. Medical law is made up from wide range of disciplines of law not only tort law and criminal law and also including human right law, public law including public health regulations, evidence law, contract law, corporation law, commercial law, family law, administrative law, employment law and so on. Medical law should also cover how injustice and inequity of health services towards vulnerable population that would have impact on individual and public health. In describing medical law, Herring has cited from one commentor suggesting medical lawyer needs to be a ‘Jacqui of all trades’, meaning someone has broad knowledge and skills across many disciplines, though they may not be a master in any one of them. This would explain why medical law is not regarded as distinct discipline of law. However, the complexity involving competencies across wide range of subjects provides opportunities for specialisation of medical law. Medical law should encompass legal related issues in healthcare delivery system covering different stages of clinical journey. Medical law should also address the legal determinants of health as the aim of the Lancet Commission is to enhance the global health community's understanding of law, regulation, and the rule of law as effective tools to advance population health and equity . Well-designed laws can help build strong health systems, ensure safe and nutritious foods, evaluate and approve safe and effective drugs and vaccines, create healthier and safer workplaces, and improve the built and natural environments; and conversely, poorly designed laws or poorly implemented or enforced can harm marginalised populations and entrench stigma and discrimination . Articulation of legal determinants of health must strongly emphasise the role of law in improving fairness in social arrangements and the distribution of resources conducive to health . Therefore, the subject of medical law will require expertise from diverse disciplines extending beyond knowledge in medicine and law. The articles in this issue demonstrate the complexity and special skills of medical law. Medical law needs an international platform to pool experts from diverse fields to address the boarder perspectives of medical law. The journal will continue to play the key role in providing the platform to advance knowledge and skills in medical law globally.
Parental decisions in biomedicine shape every aspect of children’s lives, from birth to death, from illness to health. This article examines three distinct fields of parental decision: reproduction, genetics and the end of life. With the development of new reproductive technologies, the range of parental choices has significantly widened: healthy gametes may be used from donors, or embryos may be screened and selected before the implantation. The growing availability of various genetic technologies, such as genetic testing and screening, prenatal and preimplantation diagnostics, also create opportunities for parents to make decisions with important and lasting consequences on their child’s life. When parents are confronted with an incurable disease in their child, they are forced to make end-of-life decisions and may seek extraordinary remedies. Any new technology that offers hope in such a desperate situation may be regarded as lifesaving or at least capable of prolonging life or making unavoidable death more dignified. In all three biomedical cases parents literally make life and death decisions which are informed by their visions of a good life for their children. The author argues for the assessment of the best interest of the child in the light of the new technologies, and to provide assistance to parents in this hard decision making.
- The theme of 2025 World Congress in Medical Law (WCML) held in Istanbul, Türkiye (Turkey) during the period 6 to 8 August is “Vulnerability in 21st Century: Respect and Protect”. - Plenary paper by Özsunay has described how Child’s Rights Convention and Oviedo Convention are integral parts of the current Turkish law with some national laws laying down protective measures for vulnerable people . - The well-established terms of “vulnerability” and “vulnerable persons in international law and national laws can help to clarify some sensitive issues related to medical law so “vulnerable persons” should be understood and defined in its widest content and not be limited only to “minors” and “vulnerable adults”, and can include others such as disabled people, elderly people, pregnant women, single parents with minor children, victims of trafficking in human beings, persons with serious illnesses, persons with mental disorders, persons who have been subjected to torture, rape or other forms of psychological, physical or sexual violence - Echoing the themes of 2025 WCML, this issue also include articles to address vulnerable population from wider perspectives. Victims of sexual violence or rape are vulnerable group. - Article by Bhaskar and Desikan has highlighted that sexual offenders share numerous similarities, particularly in their thought processes and behavioural patterns . - The article analyse the interplay of psychology and the law, based on the literature reporting the effectiveness of various therapies and strategies for relapse prevention, aiming to identify the effective approach for the administration and management of sexual offences and the handling of offenders to avoid sexual recidivism. - This is in line with the doctrine of public health emphasising on preventive care better than curative treatment. - People living in wartime are also vulnerable requiring protection by legislative measures. - Legislative change during wartime should do more than responding to challenges of medical care during wartime such as evacuation of patients, supporting medical care in military operations, protection of medical workers in the conflict zone, and provision of medical care to displaced persons and military veterans, and it should also pay special attention to protect the rights of patients, especially vulnerable categories such as children, the elderly, people with disabilities and displaced persons and rehabilitation of those affected by the war, including military veterans, displaced civilians, and healthcare workers as stated in the article by Turchina et al describing the wartime changes in medical law Ukraine . - The psychological trauma of war is often difficult of recovery so legislative framework should be developed to ensure integration of mental health services into the primary health care system for early intervention and continuous support. The recommendations by the article can enable Ukraine also other countries facing war conflicts to rebuild healthcare system that is more resilient and responsive to future emergencies. - Medical interventions are not without risk and patients should be safeguarded for the safety. Article by Beran (plenary presentation of 2025 WCML) calls for patient involvement in decision making upholding the ethical principles of beneficence and autonomy, and informed decisions necessitate being adequately informed including disclosure of “material risks” and right of refusal . - There are many regulations made in Turkish Medical Law regarding patient safety with Heath Professions Board vested with important duties to ensure patient safety as stated in the article by Hakeri (plenary presentation of 2025 WCML) . Sanctions of criminal law and compensation law will also be applied to healthcare professionals if the patient is harmed by negligent act of healthcare professionals under Turkish law . - Vulnerability should also cover issue such as rights to decide medical treatment being overridden by public interest such as mandatory vaccination. Mandatory vaccination for COVID-19 vaccination during pandemic has raised the delicate issue of balancing public and private interests. - Article by Roncati and Roncati raises the principle of legality and reasonableness should be constantly evaluated with the changing scientific by health policy makers so their decisions would depend on the current state of scientific evidence rather than prospective outcomes . - Surrogacy is a complex reproductive arrangement posing legal and ethical challenges in balancing the rights of intended parents’ parental rights and the reproductive autonomy of surrogate mothers particularly when the consent of surrogate mother is withdrawn during pregnancy. Both surrogate mother and intended mother can both be regarded as vulnerable persons as they are affected by pregnancy. - Article by Gosmasta et al has examined case studies, legal frameworks and ethical issues to provide a balanced strategy to protect the legitimate expectations of intended parents and also respecting the autonomy of surrogate . - The article suggests to use mediation as primary tool to resolve the disputes with a balanced approach for the surrogate, intending parents and medical practitioners enforcing the surrogacy contracts. - Emerging Artificial Intelligence (AI) technology in healthcare brings great advancement in patient care. However, one cannot under-estimate the complexity and challenges posed in patient safety. - Article by Johnson and Nevin has raised the issue that AI development is moving faster than regulators can keep pace and a holistic approach is needed with collaboration between different stakeholders to regulate, govern and oversee the ethical and safe use of AI in clinical care . - Medical technology has advanced rapidly bringing tremendous benefits to mankind. However, patients can also expose to greater risks with medical interventions unless patient safety is accorded higher priority. The concept of vulnerability should be defined in boarder and wider perspectives with changing socio-demographic and economic-political changes. - The presentations of the Conference ranged from more foundational areas to more specialized and contemporary topics and was able to see directly the application of various theories and methods to an area that will be always relevant to medical law .
The 29th International World Congress for Medical Law took place in İstanbul, Türkiye on 5-8 August, 2025. It had more than 250 attendants from 55 countries all over the world. Students need directions somewhat, since they are at the beginning of their learning journey. We need to see the basics of many areas so we can draw a path for ourselves. As a student from outside law, this congress allowed me to be introduced to the lay of the land for medical law with its diversity in its presentations and attendants. The primary thing that made the congress great in this regard was the fact that its presentations ranged from more foundational areas to more specialized and contemporary topics......................................................................... I was able to see directly the application of various theories and methods to an area that will be always relevant to medical law. It was both timeless and down-to-earth........................................Overall, this congress was an invaluable experience for a student like me, as it allowed the opportunities to participate in its organization and presentations, and to meet more experienced people in the field to get an idea and directive for our future paths.
YOU CAN ONLY WALK A HUNDRED YEARS WITH A SMILE: Interview with Dr. Richard Wilbur Reported by Milda KUIZINAITĖ
Introduction: Patient safety is a fundamental concern for all health workers and requires trustworthy health care delivery. Patients must be involved in their care and decision-making. Informed consent is imperative with the recipient retaining the right to fully understand proposed treatment and its consequences, underwriting “Patient Autonomy”. Principles: Basic principles include “Autonomy” and Beneficence”, the patient’s right to decide treatment designed in their “best interests”. The sanctity of life is less relevant than autonomy. Informed Consent: Cardozo J stated that everyone of sound mind could decide what happens to his /her body. Informed Consent v Consent: Rogers v Whitaker defined “material risk” for informed consent and questioned the Bolam Principle regarding advice to the prospective patient. Capacity: Capacity is a legal concept relating to a person’s ability to make their own decisions. An individual’s ability to make certain decisions may be compromised and they may require a substitute decision-maker. Consent in Clinical Trials: Clinical trials require Human Research Ethics Committee approval and recognise lack of equipoise, between researcher and subject. Consent must avoid coercion and acknowledge alternative treatments. Advanced Care Directives: There must be respect for Advanced Care Directives, prepared by the patient when (s)he was competent, even if same results in negative outcomes, contrary to the sanctity of life. The directive can contain all the patient’s needs, values and preferences for future care and nominate a substitute decision-maker. An Advance Care Directive is a formal title for a Living Will Conclusions: Patients should be involved in decision-making with adequate information, recognising that informed decisions necessitate being adequately advised of “Material Risks”, and respects Autonomy and Beneficence.
As a complicated reproductive arrangement, surrogacy has special ethical and legal difficulties, especially when it involves striking a balance between the intended parents' parental rights and the surrogate mother's reproductive autonomy. Legal tensions arise following disagreements over child custody, the enforceability of surrogacy agreements, and the autonomy of the surrogate mother, particularly when her consent may be withdrawn or changed during pregnancy, and are critically examined in this research study. The rights and responsibilities of each party, surrogate mother, intending parents, and medical professionals remain less studied in the Indian legal setting, where the Surrogacy (Regulation) Act, 2021, has recently gone into effect. The study also looks into the growing involvement of medical professionals in such conflicts, when they may be called upon to defend surrogacy agreements or to present arguments related to ethical transgressions or confidentiality violations. These threeway conflicts show how urgently needed are systems able to handle the complicated legal, emotional, and medical issues at play. The study suggests using Alternative Dispute Resolution (ADR) procedures including mediation, negotiation, conciliation and arbitration in this order to settle disputes pertaining to surrogacy. These provide a quicker, less confrontational, and more private settlement process, which may be especially helpful in sensitive cases such as surrogacy. This research aims to provide a balanced strategy that protects the legitimate expectations of intended parents whilst respecting the surrogate's physical autonomy by examining case studies, legal frameworks, and ethical issues. The paper will focus on mediation as a primary tool to resolve disputes within the tripartite relationship. In summary it promotes a rights based yet unified legal system that can use mediation to settle surrogacy conflicts quickly and humanely.
This study explores the significant changes in medical law in Ukraine since the onset of Russian aggression in 2014, and focusses on how the ongoing conflict has reshaped the legal framework governing healthcare. The paper examines the key legal reforms introduced in response to the challenges of war, such as the establishment of military hospitals, the mobilization of medical resources, the protection of medical personnel in conflict zones, and the integration of telemedicine into the healthcare system. The 2022 full-scale invasion intensified the need for immediate legal adaptations to ensure the continuity of healthcare services for both civilians and military personnel. The study highlights the critical role of international support in reinforcing Ukraine's medical system during wartime and identifies the lessons learned from these legal changes. The paper concludes by proposing recommendations for strengthening the healthcare legal framework to better prepare Ukraine for future crises and to guarantee access to medical care for all segments of the population.
