The law and professional considerations of confidentiality.

In this month's Policy column, Iwan Dowie explores the laws of confidentiality, which forms part of the legal obligation of every community nurse.

The Costs of Anonymization: Case Study Using Clinical Data.

BACKGROUND: Sharing data from clinical studies can accelerate scientific progress, improve transparency, and increase the potential for innovation and collaboration. However, privacy concerns remain a barrier to data sharing. Certain concerns, such as reidentification risk, can be addressed through the application of anonymization algorithms, whereby data are altered so that it is no longer reasonably related to a person. Yet, such alterations have the potential to influence the data set's statistical properties, such that the privacy-utility trade-off must be considered. This has been studied in theory, but evidence based on real-world individual-level clinical data is rare, and anonymization has not broadly been adopted in clinical practice. OBJECTIVE: The goal of this study is to contribute to a better understanding of anonymization in the real world by comprehensively evaluating the privacy-utility trade-off of differently anonymized data using data and scientific results from the German Chronic Kidney Disease (GCKD) study. METHODS: The GCKD data set extracted for this study consists of 5217 records and 70 variables. A 2-step procedure was followed to determine which variables constituted reidentification risks. To capture a large portion of the risk-utility space, we decided on risk thresholds ranging from 0.02 to 1. The data were then transformed via generalization and suppression, and the anonymization process was varied using a generic and a use case-specific configuration. To assess the utility of the anonymized GCKD data, general-purpose metrics (ie, data granularity and entropy), as well as use case-specific metrics (ie, reproducibility), were applied. Reproducibility was assessed by measuring the overlap of the 95% CI lengths between anonymized and original results. RESULTS: Reproducibility measured by 95% CI overlap was higher than utility obtained from general-purpose metrics. For example, granularity varied between 68.2% and 87.6%, and entropy varied between 25.5% and 46.2%, whereas the average 95% CI overlap was above 90% for all risk thresholds applied. A nonoverlapping 95% CI was detected in 6 estimates across all analyses, but the overwhelming majority of estimates exhibited an overlap over 50%. The use case-specific configuration outperformed the generic one in terms of actual utility (ie, reproducibility) at the same level of privacy. CONCLUSIONS: Our results illustrate the challenges that anonymization faces when aiming to support multiple likely and possibly competing uses, while use case-specific anonymization can provide greater utility. This aspect should be taken into account when evaluating the associated costs of anonymized data and attempting to maintain sufficiently high levels of privacy for anonymized data. TRIAL REGISTRATION: German Clinical Trials Register DRKS00003971; https://drks.de/search/en/trial/DRKS00003971. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1093/ndt/gfr456.

Need for Nation-wide Regulatory Laws to Govern Privacy and Genomic Data in Healthcare.

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To Reveal or Not to Reveal, That Is the Wrong Question: Thoughts about Clinical Writing in Psychoanalysis.

This paper plays with the possibilities of writing about psychoanalytic work in different ways with different levels of disclosure about both patient and analyst. Various issues around anonymity, confidentiality, consent and identity are explored, highlighting the many questions that come up. These issues of how to write psychoanalytically are also addressed from the point of view of culture and the sociopolitical gestalt of our time.

What We Do, What We Say, What We Don't Say: Confidentiality In The Publication Of Clinical Writing.

Questions concerning analysts' publication of material from the analyses of their patients have troubled the field of psychoanalysis since its inception. Disguise inevitably distorts the clinical material and is often insufficient to protect the patient from recognition. Asking the patient's consent for publication intrudes upon and alters the analytic process. While analysts have largely reached a consensus about the need for anonymity in published material, there is still considerable debate about the necessity for obtaining patients' consent when using their material for publication. In this paper, I will trace the evolving meanings of disguise, and particularly of consent, in the analytic literature. I will place a particular emphasis upon the differing theoretical belief systems that underlie the analyst's decision to ask consent from her patient or not to do so, and I will argue that, although decisions on asking consent remain a complex matter, such coherent belief systems should play an important part in analysts' decisions regarding consent. I will illustrate my thought processes and some clinical situations with brief examples, and I will conclude with some practical recommendations, with the hope that these will stimulate further discussion in the analytic community.

Determining the state of guidance on pediatric biobanking for researchers, HRECS, and families: Regulatory mapping of international guidance.

Biobanking-the storage of human biological samples, including tissue, blood, urine, and genetic data-raises many ethical, legal, and social issues, including confidentiality and privacy. Pediatric biobanking is more complicated, with difficulties arising because children lack capacity to consent and acquire this capacity upon maturity when the research is still ongoing. Yet given the limited availability of pediatric samples, the translational nature of biobanking presents a unique opportunity to share samples and produce clinically necessary information about pediatric development and diseases. Guidance on navigating these legal and ethical difficulties is needed for those involved in pediatric biobanking-including researchers, participants, and families, and those involved in biobank governance. This paper seeks to map the current regulatory framework governing pediatric biobanking to determine what guidance is currently offered. Regulatory mapping of current international and national guidelines on pediatric biobanking addressing the ethical, legal, and social nuances of pediatric biobanking was undertaken. This paper finds that international guidelines around biobanking are mostly for adults, and even when pediatric-specific, documents are non-binding, inconsistent, or only limited guidance is offered on a range of important issues specific to pediatric biobanks.   Conclusion: This paper shows a need for consistent, comprehensive, and clear regulation on pediatric biobanking so that research can more quickly, efficiently, and ethically be translated to useful information and treatment in pediatric care. What is Known: • Pediatric biobanking presents new opportunities to conduct valuable translational research to benefit pediatric populations. However, the storage of pediatric biological samples raises many ethical, legal and social issues-in part because child participants may be considered to lack capacity to consent but can acquire this capacity upon maturity when the research is still ongoing. Pediatric biobanks must grapple with issues of consent, confidentiality and privacy, and long-term participation regarding child participants. What is New: • Regulatory guidance on these ethical, legal, and social issues is needed for researchers, participants, and families and those involved in biobank governance. This paper identifies nationally specific and international guidance on biobanking and summarizes the guidance provided in relation to these pediatric specific issues. It finds that most guidance is non-binding and inconsistent between guidance documents and may offer only limited guidance to stakeholders. A need for consistent, comprehensive, and clear regulation on pediatric biobanking is needed at an international level to enable research.

Healthcare 5.0: A secure and distributed network for system informatics in medical surgery.

INTRODUCTION: Health records serve not only as a database of a patient's health history and treatment process but also as a crucial tool for doctors to diagnose and treat patients. However, the storage and sharing of these records are sensitive issues as they involve maintaining patient privacy and ensuring data transparency, security, and interoperability between different parties. Challenges to achieving these goals in the current surgical process can impact the allocation of medical resources and surgical outcomes. METHODS: This article proposes a healthcare 5.0 framework for medical surgery that deploys a secure and distributed network using Blockchain to demonstrate transactions between different parties in the orthopedic surgery process. The proposed network uses the Hyperledger Composer platform for deployment, and a patient-doctor-supplier orthopedic surgery network is designed and implemented to enable the safe sharing of medical records. RESULTS: A benchmarking tool was implemented for analyzing different scenarios of applying blockchain technology to orthopedic surgery. The application of blockchain technology to orthopedic surgery presents a promising solution for data sharing and supply chain management in the field. The integration of blockchain with cloud storage and hybrid encryption ensures secure and efficient storage of Electronic Health Record (EHR) and Personal Health Record (PHR) data. By leveraging the tamper-proof nature of blockchain and addressing concerns regarding centralized data storage, this scenario demonstrates enhanced security, improved access efficiency, and privacy protection in medical data sharing. CONCLUSIONS: The article demonstrates the feasibility of using an IoT-based blockchain network in orthopedic surgery, which can reduce medical errors and improve data interoperability among different parties. This unique application of blockchain enables secure sharing of medical records, ensuring transparency, security, and interoperability. The network design may also be applicable to other surgeries and medical applications in the future.

High-capacity data hiding for medical images based on the mask-RCNN model.

This study introduces a novel approach for integrating sensitive patient information within medical images with minimal impact on their diagnostic quality. Utilizing the mask region-based convolutional neural network for identifying regions of minimal medical significance, the method embeds information using discrete cosine transform-based steganography. The focus is on embedding within "insignificant areas", determined by deep learning models, to ensure image quality and confidentiality are maintained. The methodology comprises three main steps: neural network training for area identification, an embedding process for data concealment, and an extraction process for retrieving embedded information. Experimental evaluations on the CHAOS dataset demonstrate the method's effectiveness, with the model achieving an average intersection over union score of 0.9146, indicating accurate segmentation. Imperceptibility metrics, including peak signal-to-noise ratio, were employed to assess the quality of stego images, with results showing high capacity embedding with minimal distortion. Furthermore, the embedding capacity and payload analysis reveal the method's high capacity for data concealment. The proposed method outperforms existing techniques by offering superior image quality, as evidenced by higher peak signal-to-noise ratio values, and efficient concealment capacity, making it a promising solution for secure medical image handling.

A lightweight and secure protocol for teleworking environment.

The Internet has advanced so quickly that we can now access any service at any time, from any location. As a result of this capability, People around the world can benefit from the popularity and convenience of teleworking systems. Teleworking systems, however, are vulnerable to a range of attacks; as an unauthorized user enters the open communication line and compromises the whole system, that, in turn, creates a big hurdle for the teleworkers. Professional groups have presented numerous mechanisms for the security of teleworking systems to stop any harm, but there are still a lot of security issues like insider, stolen verifier, masquerade, replay, traceability and impersonation threats. In this paper, we propose that one of the security issues with teleworking systems is the lack of a secure authentication mechanism. In order to provide a secure teleworking environment, we have proposed a lightweight and secure protocol to authenticate all the participants and make the requisite services available in an efficient manner. The security analysis of the presented protocol has been investigated formally using the random oracle model (ROM) and ProVerif simulation and informally through illustration/attack discussions. Meanwhile, the performance metrics have been measured by considering computation and communication overheads. Upon comparing the proposed protocol with prior works, it has been demonstrated that our protocol is superior to its competitors. It is suitable for implementation because it achieved a 73% improvement in computation and 34% in communication costs.

Navigating Confidentiality Dilemmas in Student Support: An Institutional Ethnography Informed Study.

Introduction: School-level student support programmes provide students with pastoral care and support for academic, wellbeing and other issues often via a personal tutor (PT). PT work is a balancing act between respecting the confidential information divulged by students and doing what is expected in terms of accountability and duty of care. We aimed to explore how tutors manage this tension, with the aim of advancing understanding of student support programmes. Methods: This qualitative study was informed by an Institutional Ethnography approach. We conducted 11 semi-structured interviews with PTs from one medical school in Singapore. We considered how they worked in relation to relevant national and institutional-level policy documents and reporting guidelines. Data collection and analysis were iterative. Results: We crafted two composite accounts to illustrate the dilemmas faced by PTs. The first depicts a PT who supports student confidentiality in the same way as doctor-patient confidentiality. The second account is a PT who adopted a more mentoring approach. Both tutors faced confidentiality challenges, using different strategies to "work around" and balance tensions between accountability and maintaining trust. PTs were torn between school and student expectations. Discussion: Fostering trust in the tutor-student relationship is a priority for tutors but tensions between confidentiality, accountability and governance sometimes make it difficult for tutors to reconcile with doing what they think is best for the student. A more nuanced understanding of the concept of confidentiality may help support PTs and ultimately students.

Privacidade e confidencialidade dos dados de pessoas idosas frente às tecnologias de monitoramento em saúde / Privacidad y confidencialidad de los datos de las personas mayores frente a las tecnologías de vigilancia de la salud / Privacitat i confidencialitat de les dades de las persones grans davant les tecnologies de vigilància de la salut / Privacy and data confidentiality of older people in the face of health monitoring technologies

O presente artigo discute os avanços e desafios das tecnologias de monitoramento em saúde de pessoas idosas e suas implicações na privacidade e confidencialidade dos dados coletados. Trata-se de estudo exploratório, fundamentado na literatura, com síntese narrativa. O texto contextualiza as demandas decorrentes do envelhecimento populacional e o uso de sensores e de outros dispositivos eletrônicos no monitoramento de atividades diárias de pessoas idosas em ambientes internos e externos. É importante ressaltar que os benefícios oferecidos pelas tecnologias não devem comprometer a privacidade e a confidencialidade dos dados. Para garantir isso, é necessário aprimorar os mecanismos regulatórios, estabelecendo padrões de segurança e princípios éticos para a proteção de dados pessoais, respeitando a privacidade e a confidencialidade dos dados.(AU)

L'article present discuteix els avenços i reptes de les tecnologies de monitoratge en salut de les persones majors i les seves implicacions en la privacitat i confidencialitat de les dades recopilades. Es tracta d'un estudi exploratori, fonamentat en la literatura, amb una síntesi narrativa. El text contextualitza les demandes derivades de l'envelliment de la població i l'ús de sensors i d'altres dispositius electrònics en el monitoratge de les activitats quotidianes de les persones majors en ambients interns i externs. És important destacar que els beneficis oferts per les tecnologies no han de comprometre la privacitat i la confidencialitat de les dades. Per garantir-ho, és necessari millorar els mecanismes reguladors, establint estàndards de seguretat i principis ètics pera la protecció de dades personals, respectant la privacitat i la confidencialitat de les dades.(AU)

El presente artículo discute los avances y desafíos de las tecnologías de monitorización en salud de personas mayores y sus implicaciones en la privacidad y confidencialidad de los datos recolectados. Se trata de un estudio exploratorio, fundamentado en la literatura, con síntesis narrativa. El texto contextualiza las demandas derivadas del envejecimiento poblacional y el uso de sensores y otros dispositivos electrónicos en la monitorización de actividades diarias de personas mayores en ambientes internos y externos. Es importante resaltar que los beneficios ofrecidos por las tecnologías no deben comprometer la privacidad y confidencialidad de los datos. Para garantizar esto, es necesario mejorar los mecanismos reguladores, estableciendo estándares de seguridad y principios éticos para la protección de datos personales, respetando la privacidad y confidencialidad de los dato.(AU)

This article discusses the advances and challenges of health monitoring technologies for elderly individuals and their implications on the privacy and confidentiality of collected data. It is an exploratory study grounded in the literature, with a narrative synthesis. The text contextualizes the demands arising from the aging population and the use of sensors and other electronic devices in monitoring daily activities of elderly people in both indoor and outdoor environments. It is important to emphasize that the benefits offered by these technologies should not compromise the privacy and confidentiality of the data. To ensure this, it is necessary to enhance regulatory mechanisms by establishing security standards and ethical principles for the protection of personal data, while respecting privacy and data confidentiality.(AU)

Best practice for embryology staffing in HFEA licensed assisted conception centres-guidance from Association of Reproductive & Clinical Scientists.

The Association of Reproductive and Clinical Scientists (ARCS) has long promoted the importance of externally accredited training and assessment of scientific staff within assisted conception centres to ensure professional registration and relevant training at all levels. This not only gives scientific staff the opportunity to empower themselves but also acts to ensure assisted conception centres maintain the highest standards of care and quality for patients whilst meeting HFEA requirements for staffing and training. It also provides assurance to patients that treatment is being delivered by highly trained and competent staff. Clinical embryology practice requires intense concentration, with increasingly complex treatment plans and options coupled with the ever-present consequences of clinical error at the forefront of practitioners' minds, exhaustion and burn out are very real risks. Overloading embryology teams is likely to lead to increased error rates and serious incidents. This guideline aims to bring the sector in line with other Clinical Science specialities to optimise patient care, increase safety, reduce risk (including the risk of legal action against centres and individuals), ensure the use of recognised job titles with appropriate levels of remuneration, and provide centres with a template to work towards for appropriate levels of scientific staffing.

Disclosure of genetic risk to family members: A qualitative study on healthcare professionals' perceived roles and responsibilities.

This paper presents the perspectives of healthcare professionals regarding their roles and responsibilities in supporting patients with the disclosure of genetic risk to their families. The study involved eight focus groups and two individual interviews with 34 healthcare professionals working in medical genetics services across Portugal. The data were analyzed thematically, resulting in three primary themes: i) informing patients about the risk to relatives; ii) ensuring patient confidentiality; and iii) encouraging family communication. Participants believed it is their responsibility to inform patients about the genetic risk to their relatives, with patients bearing a moral responsibility to convey this information. They explained that the principles of medical confidentiality of the patient take precedence over any direct responsibility to patients' relatives. Treating personal and familial genetic information separately was perceived as challenging to implement and potentially problematic. While most participants reported encouraging patients to inform their relatives, the extent to which they facilitate this communication varies and is also constrained by lack of resources and concerns about complying with legal requirements. Some participants called for clearer national guidelines. These results contribute for ongoing discussions regarding the scope of practice and the roles and responsibilities of healthcare professionals in appropriately cascading pertinent information to at-risk relatives.

An assessment of ten popular pregnancy applications (Apps) available for women in Australia.

OBJECTIVE: Given the growing popularity of health Apps, this study aimed to evaluate popular pregnancy Apps among Australian women. DESIGN: Ten popular pregnancy mobile device Apps accessible within Australia were assessed using the Deakin Health E-technologies Assessment Lab (HEAL) framework, the Australian Privacy Principles (APP) and other context-specific criteria. RESULTS: Most Apps were robust in use and user-friendly in terms of design. Based on the HEAL assessment, all the Apps scored between 70 and 89 out of 120. Only two of the ten Apps were locally hosted and operated. Only one App could search local health services using Victorian postcodes. All ten Apps were aligned with various privacy policy guidelines, but only one was reported to be fully aligned with the APP as it is locally hosted and operated. None of the Apps had accessibility features such as for visual or hearing difficulties. Only one App could be assessed as able to interface with the electronic medical record system in Australia due to a lack of publicly available information on this capability. CONCLUSIONS: Due to privacy concerns, pregnancy Apps accessible in Australia should be used with caution unless care is taken to select an App that fully complies with local requirements or international equivalents. All Apps were subjectively rated as moderate in quality, and more attention to accessibility and privacy features by App developers is recommended, along with the focus on integration with Australian digital health services.

From posts to protection: Ethical considerations regarding forensic psychiatrists and a duty to warn based on social media.

Increasing use of social media in forensic mental health evaluations will lead to new challenges that must be resolved by forensic practitioners and the legal system. One such dilemma is the discovery of information that would typically trigger a legal duty and professional ethics obligation for mental health professionals to breach doctor-patient confidentiality to promote public safety and prevent harm to vulnerable third parties. Although the law and professional organizations offer clear guidance for practitioners in the treatment role, there is currently no clarity from the law or instruction from professional organizations on what mental health professionals should do if they discover such information during a confidential forensic evaluation. For example, a forensic evaluator may find evidence on social media of an evaluee's threats to seriously harm others, abuse of children and the elderly, or severely impaired driving. There are no clear guidelines for how a forensic psychiatrist should respond in these complicated situations. We review the legal concepts and historical evolution of confidentiality, privilege, and mandated reporter duties that forensic practitioners should consider in these legally ambiguous situations. Finally, we discuss ethics frameworks practitioners can implement to determine their most ethical course of action when faced with such dilemmas.

The knowledge and reuse practices of researchers utilising government health information assets, Victoria, Australia, 2008-2020.

BACKGROUND: Using government health datasets for secondary purposes is widespread; however, little is known on researchers' knowledge and reuse practices within Australia. OBJECTIVES: To explore researchers' knowledge and experience of governance processes, and their data reuse practices, when using Victorian government health datasets for research between 2008-2020. METHOD: A cross-sectional quantitative survey was conducted with authors who utilised selected Victorian, Australia, government health datasets for peer-reviewed research published between 2008-2020. Information was collected on researchers': data reuse practices; knowledge of government health information assets; perceptions of data trustworthiness for reuse; and demographic characteristics. RESULTS: When researchers used government health datasets, 45% linked their data, 45% found the data access process easy and 27% found it difficult. Government-curated datasets were significantly more difficult to access compared to other-agency curated datasets (p = 0.009). Many respondents received their data in less than six months (58%), in aggregated or de-identified form (76%). Most reported performing their own data validation checks (70%). To assist in data reuse, almost 71% of researchers utilised (or created) contextual documentation, 69% a data dictionary, and 62% limitations documentation. Almost 20% of respondents were not aware if data quality information existed for the dataset they had accessed. Researchers reported data was managed by custodians with rigorous confidentiality/privacy processes (94%) and good data quality processes (76%), yet half lacked knowledge of what these processes entailed. Many respondents (78%) were unaware if dataset owners had obtained consent from the dataset subjects for research applications of the data. CONCLUSION: Confidentiality/privacy processes and quality control activities undertaken by data custodians were well-regarded. Many respondents included data linkage to additional government datasets in their research. Ease of data access was variable. Some documentation types were well provided and used, but improvement is required for the provision of data quality statements and limitations documentation. Provision of information on participants' informed consent in a dataset is required.

Physicians' attitudes towards secondary use of clinical data for biomedical research purposes in Germany. Results of a quantitative survey.

BACKGROUND: For biomedical data-driven research purposes, secondary use of clinical data carries great but largely untapped potential. Physicians' attitudes and their needs towards secondary data use are essential to inform its practical and ethically sound implementation but are currently understudied. OBJECTIVE: Therefore, the objectives of the study are to assess physicians' (i) general attitudes and concerns, (ii) willingness to adapt workflows and to make data available for secondary use, (iii) group-specific conditions toward implementation of secondary use and associated concerns of physician-scientists and purely clinical physicians. METHODS: We developed an online survey based on a literature review and an expert interview study. Physicians in private practice and at two large German university hospitals were surveyed from May 2021 until January 2022. RESULTS: In total, 446 physicians participated in the survey. 96% [380/397] of all physicians reported a positive attitude towards secondary use; 87% [31/397] are in-principle willing to support secondary use of clinical data along with a small proportion of physicians with fundamental reservations. Secondly, the most important conditions for adapting workflows were funding of additional time and effort for research-adequate documentation (71% [286/390]) and the most important condition for providing patients' clinical data was reliable protection of patients' privacy (67% [254/382]). Thirdly, physician-scientists were more likely than purely clinical physicians to request additional funding for research-adequate documentation as a precondition for support (83% vs 69%, P = .002) and the privilege to conduct research with their own patients' clinical data before other researchers are allowed to (43% vs 11%, P < .001); while purely clinical physicians more frequently require reliable protection of patient privacy (76% vs 62%, P = .007) and monetary compensation (45% vs 25%, P < .001). CONCLUSION: Since this study presents high in-principle willingness of physicians to support secondary use along with little general concerns, it seems essential to address physicians' group-specific conditions toward secondary use in order to gain their support.