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Emerged in the early 2000s, direct-to-consumer (DTC) genetic testing has helped consumers access and understand their genetic information without the involvement of a healthcare provider. Unlike traditional clinical-based testing, in which a healthcare provider is responsible for ordering, testing, interpreting, and communicating the results, DTC testing provides valuable insights directly to individuals about their genetic information. It empowers consumers and their families to be proactive about their health and lifestyle. The online testing format has become increasingly popular due to its accessibility and affordability. However, it raises concerns about the accuracy and reliability of the results, data security and how to ensure privacy for consumers and regulators. A hybrid model combining elements from both DTC and clinical-based genetic testing has surfaced in the market recently. In the US, current health-related DTC genetic tests are not recognized for diagnostic purposes; instead, these tests are intended to provide genetic information that is associated with certain conditions, which may encourage consumers to take the opportunity to discuss the results and their implications with a healthcare provider. This DTC genetic testing review focuses on the fundamental concepts, applications, benefits, limitations, risks, and consumer concerns, as well as the state of the DTC framework compared with the clinical-based and hybrid models. Additionally, the regulatory oversight, data protection, and healthcare professional perspective on DTC genetic testing in the US will be discussed, including current policies and regulations. [ABSTRACT FROM AUTHOR]

Genetic information is intimate and telling data warranting privacy in public and private realms. The privacy protections offered in the United States and Canada vastly differ when it comes to genetic privacy. Search and seizure law mirrors the privacy gap in the countries, as well as their treatment of DNA database information. [ABSTRACT FROM AUTHOR]

The domain of accessible information about celebrities, political leaders, and other public figures is expanding as technology evolves, placing new stresses on already uneasy legal boundaries around their privacy. The availability of cheap, fast, and informative genetic sequencing technologies, combined with growing public interest in genetic information, makes it likely that we will soon witness paparazzi carrying swabs and sterile tubes in search for genetic materials connected in some way to the public figures they pursue. In a world in which genetic paparazzi are not only a possibility, but a probability, courts will inevitably be asked to determine the legal status of genetic materials and information obtained from public figures without consent. The genetics of public figures serves as a useful test case of the legal framework governing genetics and privacy, because public figures are at the same time beneficiaries of more rights than most of us--in the form of rights of publicity--and fewer rights--in the form of diminished expectations of privacy. When disputes involving genetic paparazzi ultimately reach the courtroom, judges will have to confront scenarios that touch on fundamental questions regarding the nature of genetics and its relationship to concepts of personhood and identity, property, health and disease, intellectual property, and reproductive rights. While the question of what courts will decide is intriguing, this Article moves beyond such predictions to focus on how resulting court decisions in seemingly narrow cases may have broad and potentially harmful impact. Despite the complexity of the legal issues that such suits will implicate, the constraints of existing law make it likely that courts will address such disputes largely through the lens of traditional privacy and publicity rights. In this Article we argue that pursuing genetic paparazzi cases through the narrow lens of existing privacy and publicity law would ignore the multidimensional nature of genetic materials and information, leading to unintended and problematic consequences for how the law approaches genetics. We go on to highlight additional aspects of genetic materials and information that policymakers, courts, and lawyers ought to consider when responding to media excursions into the genetics of public figures so as not to impede other genetic interests that might be implicated. [ABSTRACT FROM AUTHOR]

Investigative genetic genealogy (IGG) is a new technique for identifying criminal suspects and unidentified deceased and living persons that has sparked controversy. In a criminal case, the technique involves uploading genetic information left by a putative perpetrator at the crime scene to one or more direct-to-consumer genetic genealogy databases with the intention of identifying the perpetrator's genetic relatives and, eventually, locating the perpetrator on the family tree. In 2018, IGG helped to identify the Golden State Killer, and it has since been used in hundreds of investigations in the United States. Here, we report findings from in-depth interviews with 24 U.S.-based individuals involved in IGG that are relevant to the technique's current practice and predicted future. Key findings include: an emphasis on restricting IGG as a conceptual and technical matter to lead generation; the rapid growth of a private and largely self-regulating industry to support IGG; general recognition of three categories of cases associated with distinct practical, ethical, and policy questions, as well as varying degrees of controversy; and the significant influence of perceived public opinion on IGG practice. The experiences and perspectives of individuals in the IGG trenches related to these and other issues are potentially useful inputs to ongoing efforts to regulate the technique., Competing Interests: Declaration of Competing Interests C.J.G. and S.M.F. are members of the Investigative Genetic Genealogy Working Group of the Scientific Working Group on DNA Analysis Methods. A.L.M. is a former member of the FamilyTreeDNA Citizen’s Panel. C.J.G. is a member of the Policy and Practice Subcommittee of the National Technology Validation and Implementation Collaborative Forensic Investigative Genetic Genealogy Technical Validation Working Group. She is also a member of the Advisory Board of the Investigative Genetic Genealogy Accreditation Board., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

The article offers information on Predictive Health Information and Employment Discrimination under the Americans with Disabilities Act and Genetic Information Nondiscrimination Act (GINA). It mentions completion of a draft sequence of the human genome facilitated the study of genomic variation, including research using single nucleotide variants, genome-wide association studies (GWAS), genotype-phenotype associations, and other methods.

The landscape of genetic testing for breast cancer susceptibility has transformed dramatically over the last decade and a half. Traditionally, the process of genetic testing resided fully within a medical infrastructure, from identification of appropriate testing candidates to gene selection to risk mitigation recommendations. More recently, decreasing costs, advancing technology, and a growing understanding of therapeutic implications of certain genetic test results have led to more widespread uptake of testing that increasingly involves broad multigene panels. Germline genetic testing for breast cancer susceptibility can now be obtained through one of three approaches: through clinical care; a direct‐to‐consumer (DTC) approach that is entirely consumer‐driven; or a hybrid, patient‐initiated, provider‐mediated model. Increased access to testing has led to extensive dialogue about the best way to conduct testing and act on results. Points of discussion include: selection of appropriate candidates for genetic testing; optimal composition of genes on panels; informed consent; safe return of results; privacy; and legal protections for those found to have relevant pathogenic or likely pathogenic variants. As more individuals undergo genetic testing, a growing population of individuals with inherited breast cancer predisposition informs optimal management of cancer risk and also highlights unanswered questions. This article aims to review the current state of genetic testing for inherited breast cancer susceptibility including testing approaches, the legal, ethical and social landscape, and selected contemporary management issues. [ABSTRACT FROM AUTHOR]

Making data broadly accessible is essential to creating a medical information commons (MIC). Transparency about data-sharing practices can cultivate trust among prospective and existing MIC participants. We present an analysis of 34 initiatives sharing DNA-derived data based on public information. We describe data-sharing practices captured, including practices related to consent, privacy and security, data access, oversight, and participant engagement. Our results reveal that data-sharing initiatives have some distance to go in achieving transparency. [ABSTRACT FROM AUTHOR]

The author explores the issues surrounding informed consent for genetic testing in autopsy. Topics covered include the importance of reviewing autopsies performed under authority of a state's law governing medical examiners or coroners (ME/C), the highlights of the position paper of the National Association of Medical Examiners (NAME) on genetic testing and details of some of the legal cases in the U.S. about informed consent.

The Genetic Information Nondiscrimination Act of 2008 (GINA) provides federal safeguards to prohibit employer or insurance discrimination based on personal or familial genetic information or conditions. Awareness of the implications of genetic testing in individuals and families and of state and federal legislation in place for their protection is an essential component of oncology nursing practice. This article discusses the critical role of the oncology nurse in interacting with and providing information about GINA to patients in a cancer care setting engaged in genetic assessment. [ABSTRACT FROM AUTHOR]

Cascade screening is the process of contacting relatives of people who have been diagnosed with certain hereditary conditions. Its purpose is to identify, inform, and manage those who are also at risk. We conducted a scoping review to obtain a broad overview of cascade screening interventions, facilitators and barriers to their use, relevant policy considerations, and future research needs. We searched for relevant peer-reviewed literature in the period 1990-2017 and reviewed 122 studies. Finally, we described 45 statutes and regulations related to the use and release of genetic information across the fifty states. We sought standardized best practices for optimizing cascade screening across various geographic and policy contexts, but we found none. Studies in which trained providers contacted relatives directly, rather than through probands (index patients), showed greater cascade screening uptake; however, policies in some states might limit this approach. Major barriers to cascade screening delivery include suboptimal communication between the proband and family and geographic barriers to obtaining genetic services. Few US studies examined interventions for cascade screening or used rigorous study designs such as randomized controlled trials. Moving forward, there remains an urgent need to conduct rigorous intervention studies on cascade screening in diverse US populations, while accounting for state policy considerations. [ABSTRACT FROM AUTHOR]

Objective: Multiple surveys show that patients want medical privacy; however, there are costs to maintaining privacy. There are also risks if information is not shared. A review of previous surveys found that most surveys asked questions about patient's privacy concerns and willingness to share their medical information. We found only one study that asked about sharing medical information for better care and no survey that asked patients about the risk, cost or comparison between medical privacy and privacy in other areas. To fill this gap, we designed a survey to: (1) compare medical privacy preferences to privacy preferences in other areas; (2) measure willingness to pay the cost of additional privacy measures; and (3) measure willingness to accept the risks of not sharing information.Methods: A total of 834 patients attending physician offices at 14 sites completed all or part of an anonymous questionnaire.Results: Over 95% of patients were willing to share all their medical information with their treating physicians. There was no difference in willingness to share between primary care and specialty sites including psychiatry and an HIV clinic. In our survey, there was no difference in sharing preference between standard medical information and information with additional legal protections including genetic testing, drug/alcohol treatment and HIV results. Medical privacy was ranked lower than sharing social security and credit card numbers, but was deemed more private than other information including tax returns and handgun purchases. There was no statistical difference for any questions by site except for HIV/AIDS clinic patients ranking privacy of the medical record more important than reducing high medical costs and risk of medical errors (p < .05). Most patients were willing to spend a modest amount of additional time for privacy, but few were willing to pay more for additional medical privacy. Most patients were unwilling to take on additional risks to keep medical information hidden.Conclusions: Patients were very willing to share medical information with their providers. They were able to see the importance of sharing medical information to provide the best possible care. They were unwilling to hide information from providers if there was increased medical risk. Patients were willing to spend additional time for privacy, but most were unwilling to spend extra money. Sixty-eight percent of patients favored reducing medical costs over privacy. [ABSTRACT FROM AUTHOR]

The article discusses several developments involving the legal aspects of compelled disclosures of health records, a right to privacy, and access to health information in America as of 2017. The U.S. Genetic Information Nondiscrimination Act of 2008 is addressed, along with America's Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the nation's Health Information Technology for Economic and Clinical Health (HITECH) Act.

Objective: To highlight the possibility of genetic discrimination in the United States with respect to carrier screening under limitations of the Genetic Information Nondiscrimination Act (GINA) and to encourage providers to educate patients about this possibility during pretest counseling., Methods: Review of current professional guidelines and practice resources regarding the necessary components of pretest counseling for carrier screening in the context of GINA's limitations and the potential impact of carrier screening results on life, long-term care and disability insurance., Results: Current practice resources advise that patients in the United States should be informed that their employer or health insurance company generally cannot use their genetic information during the underwriting process. However, these resources do not elaborate on GINA's limitations or explain why there may be adverse consequences to patients regarding these limitations. Studies have demonstrated significant gaps in provider knowledge of GINA, especially for those without formal genetic training., Conclusion: Enhanced education and provision of GINA educational resources for providers and patients will help ensure that patients have the opportunity to prioritize their insurance needs prior to undergoing carrier screening., (© 2023 John Wiley & Sons Ltd.)

Purpose: This review identifies the prominent topics in the literature pertaining to the ethical, legal, and social issues (ELSI) raised by research investigating personalized genomic medicine (PGM). Methods: The abstracts of 953 articles extracted from scholarly databases and published during a 5-year period (2008-2012) were reviewed. A total of 299 articles met our research criteria and were organized thematically to assess the representation of ELSI issues for stakeholders, health specialties, journals, and empirical studies. Results: ELSI analyses were published in both scientific and ethics journals. Investigational research comprised 45% of the literature reviewed (135 articles) and the remaining 55% (164 articles) comprised normative analyses. Traditional ELSI concerns dominated the discourse including discussions about disclosure of research results. In fact, there was a dramatic increase in the number of articles focused on the disclosure of research results and incidental findings to research participants. Few papers focused on particular disorders, the use of racial categories in research, international communities, or special populations (e.g., adolescents, elderly patients, or ethnic groups). Conclusion: Considering that strategies in personalized medicine increasingly target individuals' unique health conditions, environments, and ancestries, further analysis is needed on how ELSI scholarship can better serve the increasingly global, interdisciplinary, and diverse PGM research community. [ABSTRACT FROM AUTHOR]

The article discusses bioethics and the potential impact that genetics could have on real property rights in America, and it mentions intellectual property law and the question of whether the use of genetic information in housing transactions is lawful under U.S. federal and state laws. Human genetic research is addressed in relation to adult-onset and late-onset disorders such as cardiovascular disease. Alzheimer’s disease and health information disclosure laws are assessed.

The article discusses the legal aspects of biobanking, privacy rights, and the regulation of biomedical research in the U.S. as of 2016, and it mentions the guidelines for sharing biological samples and health information in America. Technological innovations are addressed in relation to the creation and storage of personal- and health-related data. The internal governance of biobanks is examined, along with informed consent and confidentiality and human subjects protections.

The article discusses the legal and privacy issues associated with genetic testing in the U.S.

Context.--Next-generation sequencing performed in a clinical environment must meet clinical standards, which requires reproducibility of all aspects of the testing. Clinical-grade genomic databases (CGGDs) are required to classify a variant and to assist in the professional interpretation of clinical next-generation sequencing. Applying quality laboratory standards to the reference databases used for sequence-variant interpretation presents a new challenge for validation and curation. Objectives.--To define CGGD and the categories of information contained in CGGDs and to frame recommendations for the structure and use of these databases in clinical patient care. Design.--Members of the College of American Pathologists Personalized Health Care Committee reviewed the literature and existing state of genomic databases and developed a framework for guiding CGGD development in the future. Results.--Clinical-grade genomic databases may provide different types of information. This work group defined 3 layers of information in CGGDs: clinical genomic variant repositories, genomic medical data repositories, and genomic medicine evidence databases. The layers are differentiated by the types of genomic and medical information contained and the utility in assisting with clinical interpretation of genomic variants. Clinical-grade genomic databases must meet specific standards regarding submission, curation, and retrieval of data, as well as the maintenance of privacy and security. Conclusion.--These organizing principles for CGGDs should serve as a foundation for future development of specific standards that support the use of such databases for patient care. [ABSTRACT FROM AUTHOR]

The Genetic Information Nondiscrimination Act (GINA) is a federal law that became fully effective in 2009 and is intended to prevent employers and health insurers from discriminating against individuals based on their genetic or family history. The article discusses the sections of GINA, what information constitutes genetic information, who enforces GINA, and scenarios in which GINA does not apply. Also discussed are the instances in which an employer may request genetic information from employees, including wellness or genetic monitoring programs. Finally, the article offers a look at how GINA affects nurses who are administering wellness or genetic monitoring programs on behalf of employers. [ABSTRACT FROM AUTHOR]

The legal system has been preparing for an explosion of epigenetic issues in public health, environmental regulation and litigation. So far, this explosion has been muted, and for now epigenetic data protection merely seems to be "enjoying" the same technological and legal challenges experienced by other clinical and research data. However, three areas of development suggest where epigenetic data protection may prove problematic. This article examines these three issues, noting the rapid expansion of research based on EMR-sourced clinical data, the large number of data protection models that can apply to genetic data (including point-of-use prohibitions on discrimination and confidentiality), and the increasing and controversial dangers of deidentified information being reidentified. [ABSTRACT FROM AUTHOR]

Returning genetic research results to relatives raises complex issues. In order to inform the U.S. debate, this paper analyzes international law and policies governing the sharing of genetic research results with relatives and identifies key themes and lessons. The laws and policies from other countries demonstrate a range of approaches to balancing individual privacy and autonomy with family access for health benefit, offering important lessons for further development of approaches in the United States. [ABSTRACT FROM AUTHOR]

Research biobanks are heterogeneous and exist to manage diverse biosample types with the goal of facilitating and serving biomedical discovery. The perspectives of biobank managers are reviewed, and the perspectives of two biobank directors, one with experience in institutional biobanks and the other with national cooperative group banks, are presented. Most research biobanks are not designed, nor do they have the resources, to return research results and incidental findings to participants or their families. [ABSTRACT FROM AUTHOR]

A person cannot consider information that she does not have. Unlawful discrimination, therefore, frequently requires discriminators to have knowledge about protected status. This Article exploits that simple reality, arguing that protecting privacy can prevent discrimination by restricting access to the very information discriminators use to discriminate. Although information related to many antidiscrimination categories, like race and sex, may be immediately apparent upon meeting a person, privacy law can still do significant work to prevent discrimination on the basis of less visible traits such as genetic information, age, national origin, ethnicity, and religion, as well as in cases of racial or gender ambiguity. To that end, this Article explores the advantages and disadvantages of enacting privacy protections to thwart discrimination. It concludes that the weaknesses endemic to privacy law might be addressed by adopting an explicit antidiscrimination purpose. Hence, just as privacy law may further antidiscrimination, so may antidiscrimination enhance privacy law. [ABSTRACT FROM AUTHOR]

The retention and secondary use of residual newborn screening dried blood samples without parental consent have generated controversy and resulted in lawsuits against health departments in Texas, Minnesota and Indiana. This manuscript summarizes the legal issues raised in the litigation and highlights additional parental concerns. [ABSTRACT FROM AUTHOR]

The article focuses on issues about laws related to genetic information and employee wellness programs in the U.S. It discusses the impact of a bill called the Preserving Employee Wellness Programs Act on the protection of Americans' privacy as well as on the prevention of misuse of their medical information.

The article discusses the article "Protecting Posted Genes: Social Networking and the Limits of GINA," by Sandra Lee and Emily Borgelt, published in the November 2014 issue of "American Journal of Bioethics." Topics discussed include Genetic Information Nondiscrimination Act (GINA) only prohibiting intentional acquisition of genetic information, shortcomings of GINA in relation to employment at will, and interpretation of GINA by some courts to cover only health-related information.

The combination of decreased genotyping costs and prolific social media use is fueling a personal genetic testing industry in which consumers purchase and interact with genetic risk information online. Consumers and their genetic risk profiles are protected in some respects by the 2008 federal Genetic Information Nondiscrimination Act (GINA), which forbids the discriminatory use of genetic information by employers and health insurers; however, practical and technical limitations undermine its enforceability, given the everyday practices of online social networking and its impact on the workplace. In the Web 2.0 era, employers in most states can legally search about job candidates and employees online, probing social networking sites for personal information that might bear on hiring and employment decisions. We examine GINA's protections for online sharing of genetic information as well as its limitations, and propose policy recommendations to address current gaps that leave employees’ genetic information vulnerable in a Web-based world. [ABSTRACT FROM PUBLISHER]

As exome and genome sequencing move into clinical application, questions surround how to elicit consent and handle potential return of individual genomic results. This study analyzes nine consent forms used in NIH-funded sequencing studies. Content analysis reveals considerable heterogeneity, including in defining results that may be returned, identifying potential benefits and risks of return, protecting privacy, addressing placement of results in the medical record, and data-sharing. In response to lack of consensus, we offer recommendations. [ABSTRACT FROM AUTHOR]

Numerous state laws and the federal Genetic Information Nondiscrimination Act (GINA) have been enacted to prevent or redress genetic discrimination in employment and health insurance, but laws protecting against genetic discrimination in life insurance have been less common and weak. Consequently, some individuals with a genetic risk of a serious illness have declined presymptomatic genetic testing, thereby decreasing their prevention and treatment options and increasing their mortality risk. In 2020, Florida became the first state to prohibit life insurance companies from using the results of presymptomatic genetic tests in underwriting. Although the law was "only" intended to prevent genetic discrimination, a possible or even likely consequence of the law will be to encourage timely genetic testing by at‐rick individuals and thereby save lives. [ABSTRACT FROM AUTHOR]

The article discusses a right to privacy in relation to Canadian paediatric biobanks, and it mentions the legal efforts to control access to and the use of personal information. Privacy legislation and policies are addressed, along with legislative reform and the Supreme Court of Canada's definition of information privacy. Public trust and the legal aspects of third parties are examined, along with the use and transfer of a child's data and the Canadian Charter of Rights and Freedoms.

This paper discusses the privacy challenges associated with cell therapy research and related innovations. A review of privacy issues identified in the academic literature reveals both theoretical and practical challenges. The author considers the governance of privacy issues in this context by Canadian legislative, jurisprudential and ethical privacy frameworks, paying particular attention to the application of data protection legislation to tissue research. The author briefly examines relevant international instruments and the approaches by the United Kingdom and the United States. The current Canadian regulatory framework, as applied to cell therapy research, fails to provide robust, comprehensive privacy protection. [ABSTRACT FROM AUTHOR]

With the advent of the Human Genome Project and widespread fears over human cloning and medical privacy, a number of states have moved to protect genetic privacy. Oregon''s unique Genetic Privacy Act of 1995, which declared that an individual had property rights to their DNA, has provoked national and international interest and controversy. This paper critically reviews the literature on genetic privacy and gene patenting from law, philosophy, science and anthropology. The debate in Oregon, from 1995 to 2001, illustrates many of the key issues in this emerging area. Both sides of the debate invoke the property metaphor, reinforcing deterministic assumptions and avoiding more fundamental questions about the integrity of the body and self-identity. The anthropological critique of the commodification of the body, and the concept of ‘embodiment’ are useful in analyzing the debate over DNA as property. [Copyright &y& Elsevier]

The recent controversy at Virginia Commonwealth University involving research ethics raises important and complex issues in survey and pedigree research. The primary questions are whether family members of survey respondents themselves become subjects of the project and if they are subjects whether informed consent must be obtained for investigators to retain private information on these individuals. This article provides an analysis of the ethical issues and regulatory standards involved in this debate for consideration by investigators and institutional review boards. The analysis suggests that strong protections for the rights and welfare of subjects and their family members can be incorporated into survey and pedigree research protocols without hindering projects with extensive consent requirements. [ABSTRACT FROM AUTHOR]

Explains autonomy, respect and genetic information policy. Kantian concept of autonomy; Difference between respect for autonomy and autonomy; Need to consider the prima facie duties in the context of the full scope of an individual's genetic responsibilities.

The awesome predictive power of genetic medicine promises great advancements in not only the treatment of identifiable conditions but the prevention of their pathological manifestations. At the same time, the release and dissemination of this genetic or medical information poses a distinct risk of loss of privacy and stigmatization to carriers of genetic disorders. In order to safeguard the individual right of autonomy, privacy, confidentiality and informed consent—yet accommodate the legitimate interests of employers and insurers to obtain medical information relevant to their professional needs and economic responsibilities—a balance must be struck legislatively at the federal and state levels of government. [ABSTRACT FROM AUTHOR]

The article discusses the article "Protecting Posted Genes: Social Networking and the Limits of GINA," by Sandra Lee and Emily Borgelt, published in November 2014 issue of "American Journal of Bioethics." Topics discussed include protected genetic information (PGI) discovery by medical certifications and examinations, employee's physician to ensure no PGI in certification form, and no enforcement mechanism in Genetic Information Nondiscrimination Act (GINA) against health care professionals.

The article discusses the article "Protecting Posted Genes: Social Networking and the Limits of GINA," by Sandra Lee and Emily Borgelt, published in the November 2014 issue of "American Journal of Bioethics," and Genetic Information Nondiscrimination Act (GINA). Topics discussed include relationship between health insurance and employment in the U.S. and limitations of GINA, shared and posted genetic data protection under GINA, and fear of employment genetic discrimination (GD) online.

The article discusses the article "Protecting Posted Genes: Social Networking and the Limits of GINA," by Sandra Lee and Emily Borgelt, published in the November 2014 issue of "American Journal of Bioethics." Topics discussed include three policy recommendations to address the limits of Genetic Information Nondiscrimination Act (GINA), low chances of strategies eliminating availability of third-party access to genetic information, and possibility of legislative expansion of GINA framework.

Purpose: Cell-free fetal DNA (cfDNA) analyzes maternal and fetoplacental DNA, generating highly personal genetic information for both mother and fetus. This study aimed to determine how laboratories retain, use, and share genetic information from cfDNA. Other outcomes included laboratories' adherence to American Society of Human Genetics (ASHG) privacy principles, and the readability of privacy policies., Methods: Laboratories offering cfDNA aneuploidy screening were identified from online searches, curated databases, and a genomics news website. Of 124 laboratories identified, 13 were commercial laboratories offering cfDNA aneuploidy screening in the United States, and were included. Genetic privacy policies from eligible laboratories were identified by reviewing requisition and consent forms, which were obtained online or by direct contact., Results: Most laboratories use prenatal genetic information for research (n = 10, 77%), and more than half (n = 7, 54%) shared genetic information with others. Overall, laboratories inadequately disclosed privacy risks. In a readability analysis, 9 of 11 (82%) laboratories' genetic privacy policies were written at or above a 12th grade reading level., Conclusion: Most laboratories allowed for prolonged use and sharing of cfDNA data, demonstrated incomplete adherence to ASHG privacy recommendations, and provided consents written in college-level language. Laboratories should revise their consent forms, and providers should help patients understand these forms., (© 2021. The Author(s), under exclusive licence to the American College of Medical Genetics and Genomics.)

Background: Privacy-related concerns can prevent equitable participation in health research by US Indigenous communities. However, studies focused on these communities' views regarding health data privacy, including systematic reviews, are lacking., Methods: We conducted a systematic literature review analyzing empirical, US-based studies involving American Indian/Alaska Native (AI/AN) and Native Hawaiian or other Pacific Islander (NHPI) perspectives on health data privacy, which we define as the practice of maintaining the security and confidentiality of an individual's personal health records and/or biological samples (including data derived from biological specimens, such as personal genetic information), as well as the secure and approved use of those data., Results: Twenty-one studies involving 3234 AI/AN and NHPI participants were eligible for review. The results of this review suggest that concerns about the privacy of health data are both prevalent and complex in AI/AN and NHPI communities. Many respondents raised concerns about the potential for misuse of their health data, including discrimination or stigma, confidentiality breaches, and undesirable or unknown uses of biological specimens., Conclusions: Participants cited a variety of individual and community-level concerns about the privacy of their health data, and indicated that these deter their willingness to participate in health research. Future investigations should explore in more depth which health data privacy concerns are most salient to specific AI/AN and NHPI communities, and identify the practices that will make the collection and use of health data more trustworthy and transparent for participants., (© The Author(s) 2020. Published by Oxford University Press on behalf of the American Medical Informatics Association.)