[Ethical and legal implications of digital mental health applications]. / Implicaciones éticas y legales de las aplicaciones digitales de salud mental.

The digitization of mental health enables significant shifts in clinical practice by harnessing vast amounts of data derived from the use of apps and wearables to enhance medical research, patient care, and health system efficiency. However, this process brings forth pertinent ethical and legal risks. Ethically, concerns primarily revolve around safeguarding the privacy and confidentiality of sensitive data, alongside the transformation of the doctor-patient relationship through technological interaction. Within the regulatory realm, issues encompass the classification of these tools as medical products, ensuring normative assurance of effective protection of mental health data, and addressing potential legal risks within this domain. This article aims to provide an overarching view of this landscape, serving as a catalyst for the technological, ethical, and legal discourse necessitated by digital mental health.

Legislation strengthening Maternal and Perinatal Death Surveillance and Response systems.

Historically, countries have primarily relied on policy rather than legislation to implement Maternal and Perinatal Death Surveillance and Response systems (MPDSR). However, evidence shows significant disparities in how MPDSR is implemented among different countries. In this article, we argue for the importance of establishing MPDSR systems mandated by law and aligned with the country's constitutional provisions, regional and international human rights obligations, and public health commitments. We highlight how a "no blame" approach can be regulated to provide a balance between confidentiality of the system and access to justice and remedies.

The Legal Status and Improvement Path of Human Genetic Data in Gene Therapy in China.

In the legal context of Chinese law, genetic data are an object of complex rights. At the level of private law, genetic data contain personal information, thus being protected by the Civil Code and the Personal Information Protection Law. At the level of public law, genetic data are important genetic resource that embody both public and national interests, which should also be regulated by public laws such as the Biosecurity Law and the Data Security Law. The recently issued Regulation on the Administration of Human Genetic Resources have refined the approval and record procedure, in order to promote the utilization of genetic data in China. At present, China still lacks sufficient protection for genetic data privacy, and the "informed consent" and "anonymization" system cannot work effectively. On the path of improvement, we should break constraints of individualism and start from the following three levels to strengthen genetic data privacy protection: formulating specialized legislation and leveraging the functions of group organizations and public interest litigation systems.

The Origins of "Confidential Commercial Information" at the FDA.

This Viewpoint reviews regulations regarding FDA's handing of confidential commercial information, explains how these regulations serve as a barrier to disclosure of information in the interest of public health, and suggests how information could be carefully shared to improve health outcomes and advance research.

Legal requirements for reporting clinical cases to the South African police or social services.

Medical confidentiality is the cornerstone for a trustful relationship between patients and the health professionals attending to them. However, when history or clinical findings suggest certain offenses, statutory laws (Children's Act, Older Persons Act, Mental Health Care Act, Sexual Offenses Act) establish a legal obligation for health professionals to report suspected instances of abuse to the police or alternatively, in some cases, to a designated social worker. Given the high rate of domestic violence and abuse in South Africa, health professionals are most likely to encounter such situations. Many clinicians are oblivious of the obligations, exposing themselves to possible liability and their patients to potential additional harm. This article aims to demonstrate the reporting requirements under the respective acts through case scenarios. Finally, the advantages and disadvantages of the existing legal setting are discussed briefly.

Unlocking Public Health Data: Navigating New Legal Guardrails and Emerging AI Challenges.

Here, we analyze the public health implications of recent legal developments - including privacy legislation, intergovernmental data exchange, and artificial intelligence governance - with a view toward the future of public health informatics and the potential of diverse data to inform public health actions and drive population health outcomes.

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.

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.

Towards regulatory generative AI in ophthalmology healthcare: a security and privacy perspective.

As the healthcare community increasingly harnesses the power of generative artificial intelligence (AI), critical issues of security, privacy and regulation take centre stage. In this paper, we explore the security and privacy risks of generative AI from model-level and data-level perspectives. Moreover, we elucidate the potential consequences and case studies within the domain of ophthalmology. Model-level risks include knowledge leakage from the model and model safety under AI-specific attacks, while data-level risks involve unauthorised data collection and data accuracy concerns. Within the healthcare context, these risks can bear severe consequences, encompassing potential breaches of sensitive information, violating privacy rights and threats to patient safety. This paper not only highlights these challenges but also elucidates governance-driven solutions that adhere to AI and healthcare regulations. We advocate for preparedness against potential threats, call for transparency enhancements and underscore the necessity of clinical validation before real-world implementation. The objective of security and privacy improvement in generative AI warrants emphasising the role of ophthalmologists and other healthcare providers, and the timely introduction of comprehensive regulations.

Medical Information Protection in Internet Hospital Apps in China: Scale Development and Content Analysis.

BACKGROUND: Hospital apps are increasingly being adopted in many countries, especially since the start of the COVID-19 pandemic. Web-based hospitals can provide valuable medical services and enhanced accessibility. However, increasing concerns about personal information (PI) and strict legal compliance requirements necessitate privacy assessments for these platforms. Guided by the theory of contextual integrity, this study investigates the regulatory compliance of privacy policies for internet hospital apps in the mainland of China. OBJECTIVE: In this paper, we aim to evaluate the regulatory compliance of privacy policies of internet hospital apps in the mainland of China and offer recommendations for improvement. METHODS: We obtained 59 internet hospital apps on November 7, 2023, and reviewed 52 privacy policies available between November 8 and 23, 2023. We developed a 3-level indicator scale based on the information processing activities, as stipulated in relevant regulations. The scale comprised 7 level-1 indicators, 26 level-2 indicators, and 70 level-3 indicators. RESULTS: The mean compliance score of the 52 assessed apps was 73/100 (SD 22.4%), revealing a varied spectrum of compliance. Sensitive PI protection compliance (mean 73.9%, SD 24.2%) lagged behind general PI protection (mean 90.4%, SD 14.7%), with only 12 apps requiring separate consent for processing sensitive PI (mean 73.9%, SD 24.2%). Although most apps (n=41, 79%) committed to supervising subcontractors, only a quarter (n=13, 25%) required users' explicit consent for subcontracting activities. Concerning PI storage security (mean 71.2%, SD 29.3%) and incident management (mean 71.8%, SD 36.6%), half of the assessed apps (n=27, 52%) committed to bear corresponding legal responsibility, whereas fewer than half (n=24, 46%) specified the security level obtained. Most privacy policies stated the PI retention period (n=40, 77%) and instances of PI deletion or anonymization (n=41, 79%), but fewer (n=20, 38.5%) committed to prompt third-party PI deletion. Most apps delineated various individual rights, but only a fraction addressed the rights to obtain copies (n=22, 42%) or to refuse advertisement based on automated decision-making (n=13, 25%). Significant deficiencies remained in regular compliance audits (mean 11.5%, SD 37.8%), impact assessments (mean 13.5%, SD 15.2%), and PI officer disclosure (mean 48.1%, SD 49.3%). CONCLUSIONS: Our analysis revealed both strengths and significant shortcomings in the compliance of internet hospital apps' privacy policies with relevant regulations. As China continues to implement internet hospital apps, it should ensure the informed consent of users for PI processing activities, enhance compliance levels of relevant privacy policies, and fortify PI protection enforcement across the information processing stages.

Secrets Clutched in a Dead Hand: Rethinking Posthumous Psychotherapist-Patient Privilege in the Light of Reason and Experience with Other Evidentiary Privileges.

Attorney-client privilege was held by the Supreme Court to extend beyond death in 1996, albeit only ratifying centuries of accepted practice in the lower courts and England before them. But with the lawyer's client dead, the natural outcome of such a rule is that privilege--the legal enforcement of secrecy--will persist forever, for only the dead client could ever have waived and thus end it. Perpetuity is not traditionally favored by the law for good reason, and yet a long and broad line of precedent endorses its application to privilege. The recent emergence of a novel species of privilege for psychotherapy, however, affords an opportunity to take a fresh look at the long-tolerated enigma of eternity and the imprudence of thoughtlessly importing it to the newest addition to the family of privileges. Frankly, humanity has always deserved better than legalisms arrogating to the inscrutability of the infinite.

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.

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.

Certificates of Confidentiality and Mandatory Reporting.

This Viewpoint discusses the importance of obtaining federal certificates of confidentiality to free researchers to perform important research into child sexual abuse.

A review on legal issues of medical robots.

This paper examines the legal challenges associated with medical robots, including their legal status, liability in cases of malpractice, and concerns over patient data privacy and security. And this paper scrutinizes China's nuanced response to these dilemmas. An analysis of Chinese judicial practices and legislative actions reveals that current denial of legal personality to AI at this stage is commendable. To effectively control the financial risks associated with medical robots, there is an urgent need for clear guidelines on responsibility allocation for medical accidents involving medical robots, the implementation of strict data protection laws, and the strengthening of industry standards and regulations.

COMMENTARY: Protecting healthcare privacy: Analysis of data protection developments in India.

Patient privacy is essential and so is ensuring confidentiality in the doctor-patient relationship. However, today's reality is that patient information is increasingly accessible to third parties outside this relationship. This article discusses India's data protection framework and assesses data protection developments in India including the Digital Personal Data Protection Act, 2023.

Protecting Privacy of Pregnant and LGBTQ+ Research Participants.

This Viewpoint summarizes existing federal regulations aimed at protecting research data, describes the challenges of enforcing these regulations, and discusses how evolving privacy technologies could be used to reduce health disparities and advance health equity among pregnant and LGBTQ+ research participants.