Disclosure of medical data to relatives after the patient's death: recent legal developments with respect to relatives' entitlements in the Netherlands

In the Netherlands the physician is still bound to professional confidentiality after the patient's death. However, in the legal doctrine and in case law some exceptions have been recognized, especially for circumstances where the relatives have a legitimate interest in the inspection of medical records of the deceased. Today developments as regards the Dutch proposal to new legislation on patients' rights, notably the proposed insertion of a provision stipulating the conditions under which the relatives have a right of access to medical records of the deceased, give cause for renewed consideration of this issue related to legal protection after death. This article explores whether the proposed provision corresponds to the prevailing principles regarding disclosure of medical data after death. It is concluded that there is a need to reconsider the provision's wording or to adhere to self-regulation of the Royal Dutch Medical Association in order to strike an appropriate balance between the various interests concerned.     

The genetics of secrecy in adoption, artificial insemination, and in vitro fertilization

In light of the significant role that heredity plays in many disease processes, statutes requiring strict secrecy with regard to medical records in cases of adoption, artificial insemination and in vitro fertilization should be reassessed. In adoption cases, attitudes concerning the adoptee's ancestry have progressed over the century, but adoptees still are unable to access their records. The problem of inaccessibility is also apparent in medical genetics clinics where valuable genetic information, necessary for an accurate diagnosis, is unavailable to the clinic, the adoptive parents, and the birth parents. A uniform law which responds to these interests and problems should be promulgated. This Note discusses the need for better access to and availability of medical records. The Note proposes a Uniform Act and suggests that, at a minimum, it include a scheme for regulating the donation of genetic material, strong record-keeping requirements with respect to family histories and pedigrees, and finally, an open access provision for certain information for both children and parents.     

Electronic health record: Wiring Europe’s healthcare

The European Commission wants to boost the digital economy by enabling all Europeans to have access to online medical records anywhere in Europe by 2020. With the newly enacted Directive 2011/24/EU on patients’ rights in cross-border healthcare due for implementation by 2013, it is inevitable that a centralised European health record system will become a reality even before 2020. However, the concept of a centralised supranational central server raises concern about storing electronic medical records in a central location. The privacy threat posed by a supranational network is a key concern. Cross-border and Interoperable electronic health record systems make confidential data more easily and rapidly accessible to a wider audience and increase the risk that personal data concerning health could be accidentally exposed or easily distributed to unauthorised parties by enabling greater access to a compilation of the personal data concerning health, from different sources, and throughout a lifetime.     

Missing persons-missing data: the need to collect antemortem dental records of missing persons

The subject of missing persons is of great concern to the community with numerous associated emotional, financial, and health costs. This paper examines the forensic medical issues raised by the delayed identification of individuals classified as "missing" and highlights the importance of including dental data in the investigation of missing persons. Focusing on Australia, the current approaches employed in missing persons investigations are outlined. Of particular significance is the fact that each of the eight Australian states and territories has its own Missing Persons Unit that operates within distinct state and territory legislation. Consequently, there is a lack of uniformity within Australia about the legal and procedural framework within which investigations of missing persons are conducted, and the interaction of that framework with coronial law procedures. One of the main investigative problems in missing persons investigations is the lack of forensic medical, particularly, odontological input. Forensic odontology has been employed in numerous cases in Australia where identity is unknown or uncertain because of remains being skeletonized, incinerated, or partly burnt. The routine employment of the forensic odontologist to assist in missing person inquiries, has however, been ignored. The failure to routinely employ forensic odontology in missing persons inquiries has resulted in numerous delays in identification. Three Australian cases are presented where the investigation of individuals whose identity was uncertain or unknown was prolonged due to the failure to utilize the appropriate (and available) dental resources. In light of the outcomes of these cases, we suggest that a national missing persons dental records database be established for future missing persons investigations. Such a database could be easily managed between a coronial system and a forensic medical institute. In Australia, a national missing persons dental records database could be incorporated into the National Coroners Information System (NCIS) managed, on behalf of Australia's Coroners, by the Victorian Institute of Forensic Medicine. The existence of the NCIS would ensure operational collaboration in the implementation of the system and cost savings to Australian policing agencies involved in missing person inquiries. The implementation of such a database would facilitate timely and efficient reconciliation of clinical and postmortem dental records and have subsequent social and financial benefits.     

What the publisher can teach the patient: intellectual property and privacy in an era of trusted privication

This article begins with a premise that intellectual property and privacy have something significant and yet understated in common: both are about balancing a creator's desire to control a particular set of data with consumers' desires to access and redistribute that data. Both law and technology influence such balancing, making it more or less palatable to use data for particular purposes--whether one is an individual making a copy of a popular song for a friend, or a hospital selling a list of maternity ward patients to a day care service. In the shadow of the Internet's rapid development and concomitant easing of barriers to data sharing, holders of intellectual property are pairing increased legal protection with the technologies of "trusted systems." I describe how these technologies might allow more thorough mass distribution of data, while allowing publishers to retain unprecedented control over their wares. For instance, an e-Book seller might charge one price for a read-only copy that could not be printed or forwarded and charge an additional fee for each copy or printout made. Taking up the case of medical privacy, I then suggest that those who worry about the confidentiality of medical records, particularly as they are digitized by recent congressional mandate, might seek to augment comparatively paltry legal protections with trusted systems technologies. For instance, a trusted system could allow a patient to specify how and by whom her records could be used; within limits, she could allow full access to her primary care physician, while allowing only time-limited access to emergency care providers, non-personally identifiable access to medical researchers, and no access at all for marketing purposes. These technologies could allow for new kinds of privacy protection, without sacrificing the legitimate interests of the consumers of medical records.     

Arresting Developments? Restricting the Enforcement of the UK's Universal Jurisdiction Provisions

Recently introduced legislative amendments limit the issue of arrest warrants on the application of a private prosecutor where jurisdiction is based on universal jurisdiction. The amendments addressed a ‘loophole’ in English law whereby a private prosecutor could seek and be granted an arrest warrant, generally in respect of an individual on a short term visit to the UK, even though the consent of the Attorney General would be required for the prosecution to continue. This article argues that these amendments addressed legitimate evidentiary and diplomatic relations concerns, are consistent with the UK's international obligations, and are in line with the UK's policy on the exercise of universal jurisdiction and with international trends. However, given the limited category of persons who were subject to such arrest warrants under the previous law and the practice of the UK concerning special missions, the amendments may be of limited practical significance.     

Postmortem genetic testing in sudden unexplained death: A public health laboratory experience

Sudden unexplained death in the young poses a diagnostically challenging situation for practicing autopsy pathologists, especially in the absence of anatomic and toxicological findings. Postmortem genetic testing may identify pathogenic variants in the deceased of such cases, including those associated with arrhythmogenic channelopathies and cardiomyopathies. The Wisconsin State Laboratory of Hygiene (WSLH) is a state-run public health laboratory which performs postmortem genetic testing at no cost to Wisconsin medical examiners and coroners. The current study examines sequencing data from 18 deceased patients (ages 2 months to 49 years, 5 females) submitted to WSLH, from 2016 to 2021. Panel-based analysis was performed on 10 cases, and whole exome sequencing was performed on the most recent 8 cases. Genetic variants were identified in 14 of 18 decedents (77.8%), including 7 with pathogenic or likely pathogenic variants (38.9%). Whole exome sequencing was more likely to yield a positive result, more variants per decedent, and a larger number of variants of uncertain significance. While panel-based testing may offer definitive pathogenic variants in some cases, less frequent variants may be excluded. Whole exome testing may identify rare variants missed by panels, but increased yield of variants of uncertain significance may be difficult to interpret. Postmortem genetic testing in young decedents of sudden unexplained death can provide invaluable information to autopsy pathologists to establish accurate cause and manner of death and to decedent's relatives to allow appropriate management. A public health laboratory model may be a financially advisable alternative to commercial laboratories for medical examiner's/coroner's offices.     

Patient termination of a life-sustaining medical device: Suicide or natural death?

Medical technology has made tremendous strides in extending the lives of patients who have suffered organ failure. Machines can now replace the function of the kidneys, the heart, and other vital organs. Much has been written about a patient's right to refuse or direct the withdrawal of medical treatment, especially at the end of life, under the guise of “death with dignity.” However, little attention has been paid to the situation where a patient elects to deactivate their life-sustaining medical device without a physician's involvement. This raises the challenging question of whether the patient's manner of death should be classified as suicide or natural. Surprisingly, common law, statutes, medical ethics, and public health practice are not in alignment on the answer. This article will explore the ramifications and far-reaching impact that such divergence has on the survivors and the medical community, as well as recommend corrective actions and practical approaches for the medical and legal practitioner.     

Consent to Treatment for Transgender Youth: The Next Chapter – Bell & Anor v The Tavistock and Portman NHS Foundation Trust & Ors

In September 2021, the Court of Appeal reversed the controversial decision of Quincy Bell v Tavistock and Portman NHS Trust in a victory for transgender rights. At first instance, the Divisional Court had set a high legal threshold for transgender children to attain Gillick competence to consent to treatment with puberty blockers – effectively restricting access to treatment for many. On appeal, the Court of Appeal held that children are capable in law of giving valid consent to treatment for gender dysphoria, and court authorisation would not be routinely required before children could access such treatment. This note considers the implications of the Court of Appeal decision for the law on minors and consent to medical treatment in the transgender health context.     

Medical data breaches: Notification delayed is notification denied

The EU and the United States have implemented data breach notification rules that cover the health sectors. Nevertheless, data breach incidents involving medical data continue to rise, especially in the US and the UK. The HITECH Act, Pub. L. 111-5 Title XIII is the first federal health breach notification law in the US to be characterized by less government intrusions, while the revised EU Privacy Directive, 2009/136/EC calls for tougher privacy protection for data held by electronic communication providers. While the EU law sets a global de facto standard, the law remains toothless without strong enforcement mechanisms.     

Dead ringers? Legal persons and the deceased in European data protection law

Notwithstanding suggestions that the concrete treatment of legal and deceased person data during European data protection's development has been broadly comparable, this article finds that stark divergences are in fact apparent. Justification for the inclusion of both categories has rested on a claimed linkage to living natural person interests. However, despite early fusion, legal persons have been increasingly seen to have qualitatively different information entitlements compared to natural persons, thereby leaving European data protection with a very limited and indirect role here. In contrast, living natural persons and the deceased have not been conceived as normatively dichotomous and since the 1990s there has been growing interest both in establishing sui generis direct protection for deceased person data and also indirect inclusion through a link with living natural persons. Whilst the case for some indirect inclusion is overwhelming, a broad approach to the inter-relational nature of data risks further destabilizing the personal data concept even in relation to living persons alone. Given that jurisdictions representing almost half of the EEA's population now provide some direct protection and the challenges of managing digital data on death continue to grow, the time may be ripe for a ‘soft’ recommendation on direct protection in this area. Drawing on existing law and scholarship, such a recommendation could seek to specify the role of both specific control rights and diffuse confidentiality obligations, the criteria for time-limits in each case and the need for a balance with other rights and interests which recognises the significantly decreasing interest in protection over time.     

From electronic health records to personal health records: emerging legal issues in the Italian regulation of e-health

In 2012, the Italian Legislator has provided an appropriate legal framework for the realisation of the national Electronic Health Records (EHR) system, in which the patient plays a pivotal role: with the implementation of the Fascicolo sanitario elettronico (FSE), patients will have access to their EHRs through the online platform, and decide which data to share and with whom. In this perspective, one of the most interesting innovations is the so-called ‘taccuino’, a digital space of patients’ FSE in which they can autonomously record data and information relating to their health. Patients’ ability to access their own health data and EHR at any time and to enter information by themselves in a personal area is a unique form of power at a European level, but their legal consequences are still vague. The aim of this contribution is to offer a first review of the Italian e-health reform, showing the most critical aspects.     

State secrets: access to information under the Human Reproductive Technology Act 1991 (WA)

Many Australian children have a biological father who gave his sperm so that the child's mother could conceive and raise them. Many of these children, and their parent(s), do not know who that biological father is. However, some want to know. The article examines the Western Australian law on access to information about the identity of parties in these arrangements. It is argued that there is an implied right to access identifying information where all parties consent to the exchange of information; that this right has been ignored in official and medical practice and opportunities for good record-keeping missed; and that the current law allows a parent to give consent to the exchange of identifying information on behalf of their child at any time after the child is conceived.     

Privacy and research involving humans

Human research ethics committees in Australia are required to consider compliance with privacy law as an element of the ethics of research. Recent legislation has introduced federal private sector privacy protection, as well as privacy protection at State and Territory levels. In Victoria, which is used as an example in this article, State privacy legislation covers public sector information and health records. This article considers the implications for research involving human participants and for ethics committees of the new privacy regimes. Although privacy law is a potential barrier to research about humans, the need for exceptions has been dealt with effectively in the context of medical or health research. However, privacy law and its chilling effect could potentially be a serious impediment to some forms of non-health-related research, such as social and socio-legal research.     

非婚同居中女性健康权保护的法律困境及对策

规范非婚同居已经成为我国婚姻法学界的共识,但同居中女性的健康权问题却被忽略了。在司法实践中,许多法官往往用侵权法规则来解决相关的法律纠纷,在现行的法律框架下,这只是一种权宜之计。女性在非婚同居中的健康权不仅仅是女性健康不受侵犯的一种私法上的消极权利,也是一种积极的权利,国家有义务通过相关法律制度来保障女性健康权,这一点需要通过尽快制定非婚同居的法律来实现。     

医疗纠纷病历资料保全存在问题与对策

《侵权责任法》第六十一条第二款规定，患者要求查阅、复制病历资料的，医疗机构应当提供。第五十八条规定，医疗机构隐匿或者拒绝提供与纠纷有关的病历资料的，人民法院推定医疗机构有过错。病历资料作为医疗损害案件诉讼的核心证据，对病历资料保全自然就成为医患双方诉前关注的焦点问题。由于现行法律法规对病历资料规定的不一致，导致医患双方对病历资料的范围、保全的方式方法、封存病历资料期限、保全病历资料主体等诸多问题认识极不一致，争议颇多。造成医患双方在发生医疗纠纷的基础上进而引发次生纠纷，导致医患矛盾进一步加深，不利于纠纷的及时解决。笔者不揣简陋，试对病历资料保全环节中存在的问题及对相关问题提出规制建议，希望同仁不吝赐教。     

Rules of agency practice and procedure concerning OSHA access to employee medical records. The Occupational Safety and Health Administration of the United States Department of Labor (OSHA). Final rule

These rules of agency practice and procedure, promulgated today as a new 29 CFR 1913.10, govern OSHA access to personally identifiable employee medical information contained in medical records. The rules are structured to protect the substantial personal privacy interests inherent in identifiable medical records, while also permit OSHA to make beneficial use of these records for proper occupational safety and health purposes. The rules regulate the manner in which OSHA will seek access to employee medical records, and how the medical information will be protected once in the agency's possession.     

关于病历所有权的探讨

本文从病历的内容、形成等来区分病历所有权的归属,笔者将病历分为三部分:客观部分、主观分析部分、治疗部分,分别归属于患者、医方所有、治疗部分归患医方共用的观点,并对病历的使用进行了探讨。     

‘First Among Equals’: Breaking the Deadlock in Parental and Sibling Funeral Disputes

Family disputes over a loved one’s funeral arrangements are increasingly frequent, with courts intervening if consensus cannot be reached. In many common law jurisdictions, the law favours the executor where the deceased made a will and the highest ranking next-of-kin where the deceased died intestate. But what if two or more people fall within the same kinship tier and have equal rights to determine the deceased’s fate—who has the final say? Adopting a uniquely comparative approach which draws the authorities together for the first time, this article analyses the factors devised by judges in Australia and England, and contrasts them with the discrete statutory tests adopted in parts of Canada and the United States. Having evaluated the various approaches, the article proposes its own hybrid legal solution for breaking the deadlock in so-called ‘equal kinship disputes’.     

Prevention for those who can pay: insurance reimbursement of genetic-based preventive interventions in the liminal state between health and disease

Clinical use of genetic testing to predict adult onset conditions allows individuals to minimize or circumvent disease when preventive medical interventions are available. Recent policy recommendations and changes expand patient access to information about asymptomatic genetic conditions and create mechanisms for expanded insurance coverage for genetic tests. The American College of Medical Genetics and Genomics (ACMG) recommends that laboratories provide incidental findings of medically actionable genetic variants after whole genome sequencing. The Patient Protection and Affordable Care Act (ACA) established mechanisms to mandate coverage for genetic tests, such as BRCA. The ACA and ACMG, however, do not address insurance coverage for preventive interventions. These policies equate access to testing as access to prevention, without exploring the accessibility and affordability of interventions. In reality, insurance coverage for preventive interventions in asymptomatic adults is variable given the US health insurance system''s focus on treatment. Health disparities will be exacerbated if only privileged segments of society can access preventive interventions, such as prophylactic surgeries, screenings, or medication. To ensure equitable access to interventions, federal or state legislatures should mandate insurance coverage for both predictive genetic testing and recommended follow-up interventions included in a list established by an expert panel or regulatory body.