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Introduction: The disclosure of information that identifies deceased organ donors and/or organ transplant recipients by organ donation agencies and transplant centres is regulated in Australia by state and territory legislation, yet a significant number of donor family members and transplant recipients independently establish contact with each other. Aim: To describe and synthesize Australian laws and guidelines on the disclosure of identifying information. Method: Legislation and guidelines relevant to organ donation and transplantation were obtained following a search of government and DonateLife network websites. Information about the regulation of identity disclosure was extracted and synthesised using a process guided by Walt and Gilson's (1994) policy analysis framework. Findings: Nineteen documents were examined. Six guidelines refer to and were consistent with current legislation. Four documents did not address identity disclosure. All jurisdictions prohibit healthcare professionals from disclosing identifying information. In three states, the prohibition extends to all members of the public including donor family members and transplant recipients. Conclusion: Restrictions on identity disclosure have implications for public promotion of donation and transplantation where sharing of stories and images of organ donors and transplant recipients is common. Further research is required to understand the perspective of donor family members, transplant recipients, and healthcare professionals impacted by the current laws. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The evolution of Patient-Generated Health Data (PGHD) represents a major shift in healthcare, fueled by technological progress. The advent of PGHD, with technologies such as wearable devices and home monitoring systems, extends data collection beyond clinical environments, enabling continuous monitoring and patient engagement in their health management. Despite the growing prevalence of PGHD, there is a lack of clear understanding among stakeholders about its meaning, along with concerns about data security, privacy, and accuracy. This article aims to thoroughly review and clarify PGHD by examining its origins, types, technological foundations, and the challenges it faces, especially in terms of privacy and security regulations. The review emphasizes the role of PGHD in transforming healthcare through patient-centric approaches, their understanding, and personalized care, while also exploring emerging technologies and addressing data privacy and security issues, offering a comprehensive perspective on the current state and future directions of PGHD. The methodology employed for this review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and Rayyan, AI-Powered Tool for Systematic Literature Reviews. This approach ensures a systematic and comprehensive coverage of the available literature on PGHD, focusing on the various aspects outlined in the objective. The review encompassed 36 peer-reviewed articles from various esteemed publishers and databases, reflecting a diverse range of methodologies, including interviews, regular articles, review articles, and empirical studies to address three RQs exploratory, impact assessment, and solution-oriented questions related to PGHD. Additionally, to address the future-oriented fourth RQ for PGHD not covered in the above review, we have incorporated existing domain knowledge articles. This inclusion aims to provide answers encompassing both basic and advanced security measures for PGHD, thereby enhancing the depth and scope of our analysis. [ABSTRACT FROM AUTHOR]

The digitisation of healthcare systems has brought numerous benefits, including improved accessibility, enhanced efficiency and the potential for personalised medicine, ushering in a new era of medical advancements and streamlined patient care. However, alongside these advantages, it has also introduced a host of security and privacy challenges. The widespread adoption of digital technologies in healthcare raises concerns regarding security and privacy. This article explores critical issues surrounding the security and privacy of healthcare data in the digital age, aiming to highlight potential risks and vulnerabilities that arise with the adoption of technology in healthcare. Key security and privacy issues associated with digitisation efforts in healthcare are examined, and potential strategies to mitigate these concerns are discussed. The findings emphasise the importance of implementing robust security measures, ensuring patient privacy and fostering trust in digital healthcare systems. Furthermore, the article delves into the various challenges faced by healthcare organisations, policymakers and stakeholders in safeguarding sensitive medical information. These challenges encompass data breaches, unauthorised access, ransomware attacks and the potential misuse of patient data. Understanding these threats is essential for developing effective strategies to protect patient privacy and maintain data integrity. To address these challenges, the article presents a range of strategies and best practices, including implementing robust encryption measures, adopting multi-factor authentication, establishing secure communication channels and training healthcare professionals to be vigilant against cyber threats. Moreover, the significance of complying with regulatory frameworks, such as the Health Insurance Portability and Accountability Act and the General Data Protection Regulation, is explored to ensure the legal and ethical handling of patient data. By exploring these challenges and presenting practical strategies, this article aims to raise awareness among healthcare professionals and policymakers about the importance of prioritising security and privacy in the digitisation of healthcare systems. Acknowledging and proactively addressing these concerns will enable the healthcare industry to fully harness the potential of digitisation while ensuring the trust and confidence of patients and stakeholders. [ABSTRACT FROM AUTHOR]

Social workers are bound to maintaining confidentiality of information provided by service users. The client provides information on the assumption that the social worker will maintain his privacy even in legal proceedings. However, sometimes social workers are forced to break the boundaries of confidentiality in accordance with legislation, such as in reporting harm or injury to a minor by his/her guardian, even if the latter is the social worker's client. This study examined the attitude of Israeli courts toward the limits of maintaining confidentiality in social work, using a quantitative-descriptive research of documents - judgments selected for this study. In the social work cases presented, the court outlined the boundaries of confidentiality and its perception of social workers' professional work. The findings revealed that social workers' clients rarely filed personal claims against them. The main legal issue raised in the judgments was the removal of confidentiality; most of the judgments found that the breach of confidentiality claim between social worker and client was unjustified. The study concludes by offering several courses of action to help educate social workers in dealing with the desire to maintain confidentiality in daily practice. [ABSTRACT FROM AUTHOR]

The use and disclosure of patient information is subject to multiple legal and ethical obligations. Within European human rights law the differences relating to consent are reflected in the separate requirements of data protection law, the common law, and professional ethics. The GDPR requires explicit consent. This contrasts with the ethical and common law availability of reliance on implied consent for the use of patient information for that patient's care and treatment. For any proposed use of patient information for healthcare purposes other than direct care, even where GDPR may be satisfied if the patient refuses to consent to disclosure, the information should not normally be disclosed. For any proposed use or disclosure outside healthcare the justification should normally be consent. However, consent is often not possible or appropriate and an overriding public interest can be relied upon to justify the use or disclosure, both legally and ethically. [ABSTRACT FROM AUTHOR]

This Viewpoint describes the newly finalized Reproductive Privacy Rule, a HIPAA regulatory update intended to prevent law enforcement in abortion-restrictive states from obtaining reproductive care medical records to prosecute patients and physicians. [ABSTRACT FROM AUTHOR]

The recently passed Privacy Legislation Amendment (Enforcement and Other Measures) Act 2022 (Cth) introduced important changes to the Australian Privacy Act 1988 (Cth) which increase penalties for serious and repeated interferences with privacy and strengthen the investigative and enforcement powers of the Information Commissioner. The amendments were made subsequent to a number of high profile data breaches and represent the first set of changes to the Privacy Act following the review of the Act commenced by the Attorney-General in October 2020. The submissions made to the review emphasized the need for more effective enforcement mechanisms to increase individuals' control over their personal information and as a form of deterrence. This article reviews the recent amendments to the Privacy Act and explains their effect. It comments upon the relevance of the amendments for health and medical data and other data collected in the context of healthcare, and refers to the Attorney-General's Department's review of the Privacy Act regarding other proposals relating to enforcement which have not as yet been put into effect in legislation. [ABSTRACT FROM AUTHOR]

Integrating personal health records (PHRs) and electronic health records (EHRs) facilitates the provision of novel services to individuals, researchers, and healthcare practitioners. Simultaneously, integrating healthcare data leads to complexities arising from the structural and semantic heterogeneity within the data. The subject of healthcare data evokes strong emotions due to concerns surrounding privacy breaches. Blockchain technology is employed to address the issue of patient data privacy in inter-organizational processes, as it facilitates patient data ownership and promotes transparency in its usage. At the same time, blockchain technology creates new challenges for e-healthcare systems, such as data privacy, observability, and online enforceability. This article proposes designing and formalizing automatic conflict resolution techniques in decentralized e-healthcare systems. The present study expounds upon our concepts by employing a running case study centered around preventive and personalized healthcare domains. [ABSTRACT FROM AUTHOR]

Recent developments in artificial intelligence technologies have come to a point where machine learning algorithms can infer mental status based on someone's photos and texts posted on social media. More than that, these algorithms are able to predict, with a reasonable degree of accuracy, future mental illness. They potentially represent an important advance in mental health care for preventive and early diagnosis initiatives, and for aiding professionals in the follow-up and prognosis of their patients. However, important issues call for major caution in the use of such technologies, namely, privacy and the stigma related to mental disorders. In this paper, we discuss the bioethical implications of using such technologies to diagnose and predict future mental illness, given the current scenario of swiftly growing technologies that analyze human language and the online availability of personal information given by social media. We also suggest future directions to be taken to minimize the misuse of such important technologies. [ABSTRACT FROM AUTHOR]

Heath code apps, along with robust testing, isolation, and the care of cases, are a vital strategy for containing the spread of the COVID-19 outbreak in China. They have remained stable and consistent, allowing China to extensively restore its social and economic development. However, the ethical and legal boundaries of deploying health code apps for disease surveillance and control purposes are unclear, and a rapidly evolving debate has emerged around the promises and risks of their fast promotion. The article outlines the legal challenges by applying the core values of the Personal Information Protection Law (PIPL), the fundamental law for personal information protection in China, into the context of the nationwide use of health code apps. It elaborates on the balance between the demands for upholding individuals' rights to the security of their personal information and those for public access to such information to prevent the spread of infectious diseases. It identifies the current gaps in addressing personal information harms during the use of the apps, particularly with regard to user consent, transparency, necessity, storage duration, and security safeguards. [ABSTRACT FROM AUTHOR]

Respecting the consent and confidentiality of a patient is an underlying element in establishing the patient's trust in the physician and, implicitly, obtaining the patient's compliance. In particular, cases of inmate patients require increased attention in order to fulfill this goal against a background of institutional interferences, which, in certain situations, may endanger the autonomy of the physician and their respect for the inmate's dignity. The purpose of this article is to depict the characteristics of consent and confidentiality in a prison environment, in special cases, such as hunger strikes, violent acts, HIV testing, COVID-19 measures, and drug use, bringing into focus the physician and the inmate in the context of the particular situation where the target is disciplining someone in order for them to conform to social and juridical norms. Respecting the dignity of the inmate patient requires an adequate approach of informed consent and confidentiality, depending on each case, considering the potential unspoken aspects of the inmate's account, which can be key elements in obtaining their compliance and avoiding malpractice claims. [ABSTRACT FROM AUTHOR]

This Viewpoint summarizes a recent lawsuit alleging that a hospital violated patients' privacy by sharing electronic health record (EHR) data with Google for development of medical artificial intelligence (AI) and discusses how the federal court's decision in the case provides key insights for hospitals planning to share EHR data with for-profit companies developing medical AI. [ABSTRACT FROM AUTHOR]

The article focuses on a recent final rule by the U.S. Department of Health and Human Services (HHS) that enhances privacy protections for individuals seeking legal reproductive care, including abortions, and for clinicians providing these treatments.

Background and Objective: Maintaining privacy and ensuring confidentiality with patients is paramount to developing an effective patient-provider relationship. This is often challenging in over-crowded Emergency Departments (EDs). This survey was designed to explore patients’ perceptions on maintenance of privacy and confidentiality and their subsequent interactions with providers in a busy tertiary care hospital in Karachi. Methods: Trained nursing staff conducted structured interviews with 571 patients who presented to The Indus Hospital (TIH) ED from January to December 2020. All patients were 14 years of age or older, could speak and understand Urdu, and provide informed consent. Patients were asked about their perceptions of privacy and confidentiality in the ED and whether this affected their interactions with providers. Results: Respondents were primarily men (64%) under the age of 45 (62%) presenting for the first time (49%). The majority of patients felt that privacy and confidentiality were maintained, however 10% of patients reported that they had rejected examination due to privacy concerns and 15% of patients reported that they had changed or omitted information provided to a provider due to confidentiality concerns. There was correlation between privacy and confidentiality concerns and patient-provider interactions (p<0.0001). Conclusions: Despite the often over-crowded and busy environment of the ED, patients generally felt that privacy and confidentiality were maintained. Given the correlation between perception and behavior and the importance of an effective patient-provider relationship, particularly in the acute setting when morbidity and mortality is high, initiatives that focus on maintaining privacy and confidentiality should be pursued. [ABSTRACT FROM AUTHOR]

Background In the era of socially distanced clinical and medical research practices, the use of electronic communication has flourished. The Australian Information Commissioner recently ordered a Victorian general practice to pay $16,400 in compensation following a breach of privacy. This is the largest award of compensation made by the Commissioner in the context of a medical or healthcare privacy matter. The practice had inadvertently sent an email containing sensitive information to an incorrect email address. The email included information concerning the human immunodeficiency virus status of the complainants. Objective The aim of this article is to provide an overview of this important case in Australian information and privacy law, which relates to the operation of an Australian general practice and research activity undertaken within the practice context. Discussion In an era marked by a great increase in the use of electronic communication in the medical setting, it is essential that practices both manage electronic communication well and respond appropriately when an error arises. [ABSTRACT FROM AUTHOR]

Objectives: Critical care medicine is a natural environment for machine learning approaches to improve outcomes for critically ill patients as admissions to ICUs generate vast amounts of data. However, technical, legal, ethical, and privacy concerns have so far limited the critical care medicine community from making these data readily available. The Society of Critical Care Medicine and the European Society of Intensive Care Medicine have identified ICU patient data sharing as one of the priorities under their Joint Data Science Collaboration. To encourage ICUs worldwide to share their patient data responsibly, we now describe the development and release of Amsterdam University Medical Centers Database (AmsterdamUMCdb), the first freely available critical care database in full compliance with privacy laws from both the United States and Europe, as an example of the feasibility of sharing complex critical care data.Setting: University hospital ICU.Subjects: Data from ICU patients admitted between 2003 and 2016.Interventions: We used a risk-based deidentification strategy to maintain data utility while preserving privacy. In addition, we implemented contractual and governance processes, and a communication strategy. Patient organizations, supporting hospitals, and experts on ethics and privacy audited these processes and the database.Measurements and Main Results: AmsterdamUMCdb contains approximately 1 billion clinical data points from 23,106 admissions of 20,109 patients. The privacy audit concluded that reidentification is not reasonably likely, and AmsterdamUMCdb can therefore be considered as anonymous information, both in the context of the U.S. Health Insurance Portability and Accountability Act and the European General Data Protection Regulation. The ethics audit concluded that responsible data sharing imposes minimal burden, whereas the potential benefit is tremendous.Conclusions: Technical, legal, ethical, and privacy challenges related to responsible data sharing can be addressed using a multidisciplinary approach. A risk-based deidentification strategy, that complies with both U.S. and European privacy regulations, should be the preferred approach to releasing ICU patient data. This supports the shared Society of Critical Care Medicine and European Society of Intensive Care Medicine vision to improve critical care outcomes through scientific inquiry of vast and combined ICU datasets. [ABSTRACT FROM AUTHOR]

Hannah Ellis and Peter Ellis discuss the legal precedent relating to confidentiality [ABSTRACT FROM AUTHOR]

In recent years, phylogenetic analysis of HIV sequence data has been used in research studies to investigate transmission patterns between individuals and groups, including analysis of data from HIV prevention clinical trials, in molecular epidemiology, and in public health surveillance programs. Phylogenetic analysis can provide valuable information to inform HIV prevention efforts, but it also has risks, including stigma and marginalization of groups, or potential identification of HIV transmission between individuals. In response to these concerns, an interdisciplinary working group was assembled to address ethical challenges in US-based HIV phylogenetic research. The working group developed recommendations regarding (1) study design; (2) data security, access, and sharing; (3) legal issues; (4) community engagement; and (5) communication and dissemination. The working group also identified areas for future research and scholarship to promote ethical conduct of HIV phylogenetic research. [ABSTRACT FROM AUTHOR]

The lack of paediatric medicines, including innovative and advanced ones, is a long-lasting and well-known problem at European and international levels. Despite the existing legal frameworks and incentives, children remain deprived of many kinds of therapy because of challenges faced in appropriately study and tailoring medicinal and other products for them. In this context, the necessity to foster paediatric research addressing unsolved and uncovered issues within a 'translational approach' has appeared. This article, after having clarified the concept of translational research in the perspective of the establishment of a European paediatric research infrastructure (RI), will identify and point out ethical, legal and regulatory issues particularly relevant in a children's rights perspective. It concludes asking for the setting up of an adequate model of governance within a future RI, including adequate and independent ethical oversight and a pluridisciplinary common service dealing with ethical, legal and societal issues relevant for children. [ABSTRACT FROM AUTHOR]

The authors emphasize the need to respect the rights of patient and study participants to privacy in journal publication. They cite the impact of rapid growth in the volume of electronic health records on privacy protections for personal health information. They also urge authors and editors to eliminate nonessential identifying data from a manuscript to protect a patient's right to privacy.

In this position article, we synthesize various knowledge gaps in information privacy scholarship and propose a research agenda that promotes greater cross‐disciplinary collaboration within the iSchool community and beyond. We start by critically examining Westin's conceptualization of information privacy and argue for a contextual approach that holds promise for overcoming some of Westin's weaknesses. We then highlight three contextual considerations for studying privacy—digital networks, marginalized populations, and the global context—and close by discussing how these considerations advance privacy theorization and technology design. [ABSTRACT FROM AUTHOR]

Based on the theory of communication privacy management, we explored: (a) undocumented immigrant youth's privacy rules for managing their undocumented status disclosures to nonfamily members, and (b) responses to disclosures by recipients and undocumented youth. Semi-structured interviews were conducted with 30 undocumented youth (10th–12th grades) who immigrated to the U.S. from Mexico. Youth managed their undocumented status with nonfamily members using criteria related to support activation, protection, acceptance, and a sense of empowerment. When disclosed, most recipients responded by providing emotional support and advice. Youth felt positively toward recipient reactions that were nonjudgmental. Lastly, most participating youth felt better after revealing their undocumented status because the youth learned that the recipient was in a similar situation or because the youth experienced catharsis. Our results show the extent to which preexisting privacy management research applies to an understudied, marginalized group and provides new insights on privacy management. [ABSTRACT FROM AUTHOR]

Facial photography presents a unique ethical dilemma, as faces are difficult to deidentify for publication. We performed a review of the literature to examine current guidelines for the publication of facial photographs. We also reviewed societies' websites, journal requirements, and ethical and legal aspects of confidentiality. Most articles emphasized the importance of consent for photography and publication. Masking is not appropriate, but some journals continue to allow masking. Most legislation allows patients to restrict the uses of photographs. In the end, it is imperative to protect patient privacy by obtaining consent for photograph publication after full disclosure of risks, and specific recommendations are provided regarding a comprehensive consent process. [ABSTRACT FROM AUTHOR]

Abstract Insights into the incidence and survival of cancer, the influence of lifestyle and environmental factors and the interaction of treatment regimens with outcomes are hugely dependent on observational research, patient data derived from the healthcare system and from volunteers participating in cohort studies, often non-selective. Since 25th May 2018, the European General Data Protection Regulation (GDPR) applies to such data. The GDPR focusses on more individual control for data subjects of 'their' data. Yet, the GDPR was preceded by a long debate. The research community participated actively in that debate, and as a result, the GDPR has research exemptions as well. Some of those apply directly; other exemptions need to be implemented into national law. Those exemptions will be discussed together with a general outline of the GDPR. I propose a substantive definition of research—absent in the GDPR—which can warrant its special status in the GDPR. The debate is not over yet. Most legal texts exhibit ambiguity and are interpreted against a background of values. In this case, those could be subsumed under informational self-determination versus solidarity and the deeper meaning of autonomy. Values will also guide national implementation and their interpretation. The value of individual control or informational self-determination should be balanced by nuanced visions about our mutual dependency in healthcare, as an ever-learning system, especially in the European solidarity-based healthcare systems. Good research governance might be a way forward to escape the consent or anonymise dichotomy. Highlights • Provides an in-depth overview of the GDPR, relevant for researchers. • Shows how healthcare and research is not equated with social media. • Provides a substantive definition of research in the context of the GDPR. • Discusses the underlying values in the debate. • Mentions the principles by which researchers should govern projects. [ABSTRACT FROM AUTHOR]

In Big Data health research, concerns have risen about privacy and data protection. While the ethical and legal discussion about these issues is ongoing, so is research practice. The aim of this qualitative case study is to gain more insight into how these concerns are currently dealt with in practice. For this multiple-case study, the YOUth cohort, a longitudinal cohort focusing on psychosocial development, and Big Data Psychiatry, a pilot study in Big Data analytics on psychiatric health data, were selected. A broad range of relevant documents were collected and semi-structured interviews with stakeholders were conducted. Data were coded, studied and divided into themes during an iterative analytical process. Three themes emerged: abandoning anonymisation, reconfiguring participant control, and the search for guidance and expertise. Overall, the findings show that it takes considerable effort to take privacy and data protection norms into account in a Big Data health research initiative, especially when individual participant level data need to be linked or enriched. By embracing the complexity of the law in an early phase, setbacks could be prevented, the existing flexibility within the law could be utilised, and systems or organisations could be designed and constructed to take relevant rules into account. Our paper illustrates that a close collaboration of experts with different backgrounds within the initiative may be necessary to be able to successfully navigate this process. [ABSTRACT FROM AUTHOR]

Purpose Expanding networks of data portals and repositories linked to electronic patient record systems, along with advances in information technology, have created both new opportunities in improving public health and new challenges in protecting patient privacy. The purpose of this paper is to review stakeholder perspectives and provide a framework for promoting implementation of current privacy protection improvement recommendations.Design/methodology/approach This paper summarizes a workshop session discussion stemming from the 2017 Information Technology and Communication in Health (ITCH) biennial international conference in Victoria, British Columbia, Canada. The perspectives within health service research, journalism, informatics and privacy protection were represented.Findings Problems underlying gaps in privacy protection in the USA and Canada, along with then-current changes recommended by public health leaders as well as Information and Privacy Commissioners, were identified in a session of the 2015 ITCH conference. During the 2017 conference, a workshop outlined the current situation, identifying ongoing challenges and a lack of significant progress. This paper summarizes that 2017 discussion identifying political climate as the major impediment to progress on this issue. It concludes with a framework to guide the path forward.Originality/value This paper provides an international perspective to problems, resources and solution pathways with links useful to readers in all countries. [ABSTRACT FROM AUTHOR]

Professionals, including social workers, in the child protection context are frequently required to make decisions on whether to share sensitive personal information about children, their families, and others with colleagues and across institutional and jurisdictional boundaries. Sharing information across agencies and organisations is essential to allow joined-up service provision and to effectively protect and support children and their families. A legal framework that supports this decision making is a necessary, although not sufficient, condition for effective information sharing. This article examines the complex legal framework that governs information sharing across the Australian states and territories. It identifies a number of structural and regulatory elements that unnecessarily limit information sharing or have a tendency to create a culture that is risk averse, rather than proactive, in sharing information. The article suggests structural and regulatory reforms that would improve the legal framework for sharing information, while at the same time giving due recognition to the human rights that come into tension in this policy context: the right to privacy and the rights of the child. [ABSTRACT FROM AUTHOR]

Background: Apps targeted at health and wellbeing sit in a rapidly growing industry associated with widespread optimism about their potential to deliver accessible and cost-effective healthcare. App developers might not be aware of all the regulatory requirements and best practice principles are emergent. Health apps are regulated in order to minimise their potential for harm due to, for example, loss of personal health privacy, financial costs, and health harms from delayed or unnecessary diagnosis, monitoring and treatment. We aimed to produce a comprehensive guide to assist app developers in producing health apps that are legally compliant and in keeping with high professional standards of user protection.Methods: We conducted a case study analysis of the Australian and related international policy environment for mental health apps to identify relevant sectors, policy actors, and policy solutions.Results: We identified 29 policies produced by governments and non-government organisations that provide oversight of health apps. In consultation with stakeholders, we developed an interactive tool targeted at app developers, summarising key features of the policy environment and highlighting legislative, industry and professional standards around seven relevant domains: privacy, security, content, promotion and advertising, consumer finances, medical device efficacy and safety, and professional ethics. We annotated this developer guidance tool with information about: the relevance of each domain; existing legislative and non-legislative guidance; critiques of existing policy; recommendations for developers; and suggestions for other key stakeholders.Conclusions: We anticipate that mental health apps developed in accordance with this tool will be more likely to conform to regulatory requirements, protect consumer privacy, protect consumer finances, and deliver health benefit; and less likely to attract regulatory penalties, offend consumers and communities, mislead consumers, or deliver health harms. We encourage government, industry and consumer organisations to use and publicise the tool. [ABSTRACT FROM AUTHOR]

Social workers are held to many ethical obligations regarding patients including maintaining patient confidentiality and staying up to date on confidentiality laws, statutes, and regulations. As the landscape of health care continues to change, including the increased use of technology to maintain patient records, highlights this need. The changes in the regulations on confidentiality of those who are receiving substance use treatment, 42 CFR Part 2, are presented. The other regulations and laws covered include HIPAA, HITECH, and the ACA. This includes the changes that have taken place, how to be compliant, and which to follow when. [ABSTRACT FROM AUTHOR]

Viewpoint describes the limitations of patient privacy under HIPPA regarding abortion services and miscarriages and discusses important considerations for patients, clinicians, and health care centers. [ABSTRACT FROM AUTHOR]

Background: With the goal of realizing genome-based personalized healthcare, we have developed a biobank that integrates personal health, genome, and omics data along with biospecimens donated by volunteers of 150,000. Such a large-scale of data integration involves obvious risks of privacy violation. The research use of personal genome and health information is a topic of global discussion with regard to the protection of privacy while promoting scientific advancement. The present paper reports on our plans, current attempts, and accomplishments in addressing security problems involved in data sharing to ensure donor privacy while promoting scientific advancement.Methods: Biospecimens and data have been collected in prospective cohort studies with the comprehensive agreement. The sample size of 150,000 participants was required for multiple researches including genome-wide screening of gene by environment interactions, haplotype phasing, and parametric linkage analysis.Results: We established the T ohoku M edical M egabank (TMM) data sharing policy: a privacy protection rule that requires physical, personnel, and technological safeguards against privacy violation regarding the use and sharing of data. The proposed policy refers to that of NCBI and that of the Sanger Institute. The proposed policy classifies shared data according to the strength of re-identification risks. Local committees organized by TMM evaluate re-identification risk and assign a security category to a dataset. Every dataset is stored in an assigned segment of a supercomputer in accordance with its security category. A security manager should be designated to handle all security problems at individual data use locations. The proposed policy requires closed networks and IP-VPN remote connections.Conclusion: The mission of the biobank is to distribute biological resources most productively. This mission motivated us to collect biospecimens and health data and simultaneously analyze genome/omics data in-house. The biobank also has the mission of improving the quality and quantity of the contents of the biobank. This motivated us to request users to share the results of their research as feedback to the biobank. The TMM data sharing policy has tackled every security problem originating with the missions. We believe our current implementation to be the best way to protect privacy in data sharing. [ABSTRACT FROM AUTHOR]

Background: Engaging patients across the research trajectory supports research that is generalizable, high quality, timely and actionable. However, this approach comes with challenges and opportunities as investigators and engaged patient stakeholders encounter institutional policies around patient engagement, privacy and research participant protection.Objective: To describe the resolution and impact of quandaries arising when patient stakeholders' values and preferences conflicted with institutional policies.Methods: Case study from a Patient-Centered Outcomes Research Institute-funded trial.Results: The first example focuses on the tension between the health care organization's requirements for background checks for all patient advisors and the funders' requirement to engage hard-to-reach populations. To create an environment of mutual trust and respect with patient stakeholders, the research team decided against imposing background checks. All 53 patient and parent advisors have served continuously for 2 years and meeting attendance exceeds 95%. The second example describes parent stakeholders' role in revising a letter informing patients about a privacy violation. Among 49 families affected by and informed about this violation, 35 (71%) agreed to participate. The third example focuses on how patient stakeholder preferences about study reminders conflict with the 1996 Health Insurance Portability and Accountability Act rules. While patient stakeholders strongly endorsed text message reminders, regulations and technology do not permit reminders with enough detail to ensure clarity. Although retention rates exceeded 90%, attendance at study appointments was below 75% and below 60% for minority and low socio-economic status families.Conclusion: Patient engagement positively impacts research. Resolving conflicts between patient-engaged research and existing institutional policies and regulations would allow this impact to become fully realized. [ABSTRACT FROM AUTHOR]

Background: Domestic violence and abuse (DVA) and child safeguarding are interlinked problems, impacting on all family members. Documenting in electronic patient records (EPRs) is an important part of managing these families. Current evidence and guidance, however, treats DVA and child safeguarding separately. This does not reflect the complexity clinicians face when documenting both issues in one family.Aim: To explore how and why general practice clinicians document DVA in families with children.Design and Setting: A qualitative interview study using vignettes with GPs and practice nurses (PNs) in England.Method: Semi-structured telephone interviews with 54 clinicians (42 GPs and 12 PNs) were conducted across six sites in England. Data were analysed thematically using a coding frame incorporating concepts from the literature and emerging themes.Results: Most clinicians recognised DVA and its impact on child safeguarding, but struggled to work out the best way to document it. They described tensions among the different roles of the EPR: a legal document; providing continuity of care; information sharing to improve safety; and a patient-owned record. This led to strategies to hide information, so that it was only available to other clinicians.Conclusion: Managing DVA in families with children is complex and challenging for general practice clinicians. National integrated guidance is urgently needed regarding how clinicians should manage the competing roles of the EPR, while maintaining safety of the whole family, especially in the context of online EPRs and patient access. [ABSTRACT FROM AUTHOR]

In 1999-2003, SIIM (then SCAR) sponsored the creation of several special topic Primers, one of which was concerned with computer security. About the same time, a multi-society collaboration authored an ACR Guideline with a similar plot; the latter has recently been updated. The motivation for these efforts was the launch of Health Information Portability and Accountability Act (HIPAA). That legislation directed care providers to enable the portability of patient medical records across authorized medical centers, while simultaneously protecting patient confidentiality among unauthorized agents. These policy requirements resulted in the creation of numerous technical solutions which the above documents described. While the mathematical concepts and algorithms in those papers are as valid today as they were then, recent increases in the complexity of computer criminal applications (and defensive countermeasures) and the pervasiveness of Internet connected devices have raised the bar. This work examines how a medical center can adapt to these evolving threats. [ABSTRACT FROM AUTHOR]

The significant co-occurrence between men’s violence against female partners and child abuse and neglect is well documented. It is less clear how child safety should be managed in family violence research with their mothers. This issue is salient toisafe, a New Zealand–based Internet intervention study testing improvement in safety decisions and mental health outcomes for women experiencing intimate partner violence. This article discusses the legislative, professional, and ethical considerations that contribute to the development of the child safety protocols and discusses the development of theisafeprotocol. Hypothetical scenarios of the application of theisafeprotocol are used to illuminate the issues and provide a basis for future discussion. [ABSTRACT FROM PUBLISHER]

Large sets of data and human specimens, such as blood, tumour tissue and DNA, are deposited in biobanks for research purposes, preferably for long periods of time and with broadly defined research aims. Our research focuses on the retention of data and biological materials obtained from children. However important such paediatric biobanks may be, the privacy interests of the children involved and the related risks may not be ignored. The privacy issues arising from paediatric biobanks are the central focus of this article. We first review the international regulations that apply to biobanks and then summarise viewpoints expressed by experts in a round-table discussion. We confine ourselves here to two normative questions: (1) How much control should children's parents or legal representatives, and later the children themselves, have over the stored materials and data? (2) What should be done if research findings emerge that have serious implications for a child's health?Conclusion: On the basis of international legal standards and the views of experts, involved in paediatric biobanking, we argue that biological material of children may only be stored in a biobank for scientific purposes if parents provide their explicit consent, the child is re-contacted at 16 or 18 years of age to reconsider storage and use of its material, and the biobank maintains a limited policy in disclosure of individual research findings to the child's parents. What is Known: • Increasingly, biological material of children is stored in biobanks for research purposes. • Clear standards on the conditions under which children's cells or tissues may be stored and used are lacking. What is New: • According to experts, storage and use of children's materials should only be allowed if performed in accordance with appropriate consent procedures and feedback policies. [ABSTRACT FROM AUTHOR]

Accurate data on the prevalence and psychological effects of human trafficking as well as treatment outcomes for survivors are essential for measuring the impact of interventions and generating better understanding of this phenomenon. However, such data are difficult to obtain. A legal mandate for health care professionals to report trafficking opens opportunities for advancing our work in the field of human trafficking but also poses risks to survivors seeking services. In this article, we provide an analysis of some critical ethical considerations for the development and implementation of a mandatory reporting policy and offer recommendations for the ethical implementation of such a policy. [ABSTRACT FROM AUTHOR]