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Exploring access to genomic risk information and the contours of the HIPAA public health exception.

ABSTRACT: Considerable resources have been invested in research to identify pathogenic and likely pathogenic variants that cause morbidity and mortality and also in returning these results to patients. The public health impact and cost-effectiveness of these efforts are maximized when probands' relatives are informed of their risk and offered testing. However, such 'Traceback' cascade testing programs face multiple obstacles, including perceived or actual legal and regulatory hurdles. Here, using genetic cancer syndromes as a test case, we explore the contours of the Public Health Exception to the HIPAA Privacy Rule to assess whether it is a viable pathway for implementing a Traceback program. After examining the Privacy Rule as well as state laws and regulations for reportable conditions and genetic privacy, we conclude that this is not currently a viable approach for Traceback programs. We conclude by reflecting on ethical considerations of leveraging HIPAA's public health exception to disclose PHI directly to at-risk relatives and offering insights for how legal hurdles to such a Traceback program could be overcome, if desired.

SUBMITTER: Wagner JK

PROVIDER: S-EPMC9740515 | biostudies-literature | 2022 Jul-Dec

REPOSITORIES: biostudies-literature

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Exploring access to genomic risk information and the contours of the HIPAA public health exception.

Wagner Jennifer K JK Tanniru Juhi K JK Chane Courtney A CA Meyer Michelle N MN

Journal of law and the biosciences 20220701 2

Considerable resources have been invested in research to identify pathogenic and likely pathogenic variants that cause morbidity and mortality and also in returning these results to patients. The public health impact and cost-effectiveness of these efforts are maximized when probands' relatives are informed of their risk and offered testing. However, such 'Traceback' cascade testing programs face multiple obstacles, including perceived or actual legal and regulatory hurdles. Here, using genetic ...[more]

PMID: 36518815

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Project description:BackgroundMaking high-quality health and care information available to members of the general public is crucial to support populations with self-care and improve health outcomes. While attention has been paid to how the public accesses and uses health information generally (including personal records, commercial product information or reviews on healthcare practitioners and organisations) and how practitioners and policy-makers access health research evidence, no overview exists of the way that the public accesses and uses high quality health and care information.PurposeThis scoping review aimed to map research evidence on how the public accesses and uses a specific type of health information, namely health research and information that does not include personal, product and organisational information.MethodsElectronic database searches [CINAHL Plus, MEDLINE, PsycInfo, Social Sciences Full Text, Web of Science and SCOPUS] for English language studies of any research design published between 2010-2022 on the public's access and use of health research or information (as defined above). Data extraction and analysis was informed by the Joanna Briggs Institute protocol for scoping reviews, and reported in accordance with the PRISMA extension for scoping reviews.ResultsThe search identified 4410 records. Following screening of 234 full text studies, 130 studies were included. One-hundred-and-twenty-nine studies reported on the public's sources of health-research or information; 56 reported the reasons for accessing health research or information and 14 reported on the use of this research and information. The scoping exercise identified a substantial literature on the broader concept of 'health information' but a lack of reporting of the general public's access to and use of health research. It found that 'traditional' sources of information are still relevant alongside newer sources; knowledge of barriers to accessing information focused on personal barriers and on independent searching, while less attention had been paid to barriers to access through other people and settings, people's lived experiences, and the cultural knowledge required.ConclusionsThe review identified areas where future primary and secondary research would enhance current understanding of how the public accesses and utilises health research or information, and contribute to emerging areas of research.

Project description:BackgroundMovement towards evidence-based practices in many fields suggests that public health (PH) challenges may be better addressed if credible information about health risks and effective PH practices is readily available. However, research has shown that many PH information needs are unmet. In addition to reviewing relevant literature, this study performed a comprehensive review of existing information resources and collected data from two representative PH groups, focusing on identifying current practices, expressed information needs, and ideal systems for information access.MethodsNineteen individual interviews were conducted among employees of two domains in a state health department--communicable disease control and community health promotion. Subsequent focus groups gathered additional data on preferences for methods of information access and delivery as well as information format and content. Qualitative methods were used to identify themes in the interview and focus group transcripts.ResultsInformants expressed similar needs for improved information access including single portal access with a good search engine; automatic notification regarding newly available information; access to best practice information in many areas of interest that extend beyond biomedical subject matter; improved access to grey literature as well as to more systematic reviews, summaries, and full-text articles; better methods for indexing, filtering, and searching for information; and effective ways to archive information accessed. Informants expressed a preference for improving systems with which they were already familiar such as PubMed and listservs rather than introducing new systems of information organization and delivery. A hypothetical ideal model for information organization and delivery was developed based on informants' stated information needs and preferred means of delivery. Features of the model were endorsed by the subjects who reviewed it.ConclusionMany critical information needs of PH practitioners are not being met efficiently or at all. We propose a dual strategy of: 1) promoting incremental improvements in existing information delivery systems based on the expressed preferences of the PH users of the systems and 2) the concurrent development and rigorous evaluation of new models of information organization and delivery that draw on successful resources already operating to deliver information to clinical medical practitioners.

Project description:BackgroundThe role of consent for research use of health information is contentious. Most discussion has focused on when project-specific consent may be waived but, recently, a broader range of consent options has been entertained, including broad opt-in for multiple studies with restrictions and notification with opt-out. We sought to elicit public values in this matter and to work toward an agreement about a common approach to consent for use of personal information for health research through deliberative public dialogues.MethodsWe conducted seven day-long public dialogues, involving 98 participants across Canada. Immediately before and after each dialogue, participants completed a fixed-response questionnaire rating individuals' support for 3 approaches to consent in the abstract and their consent choices for 5 health research scenarios using personal information. They also rated how confident different safeguards made them feel that their information was being used responsibly.ResultsBroad opt-in consent for use of personal information garnered the greatest support in the abstract. When presented with specific research scenarios, no one approach to consent predominated. When profit was introduced into the scenarios, consent choices shifted toward greater control over use. Despite lively and constructive dialogues, and considerable shifting in opinion at the individual level, at the end of the day, there was no substantive aggregate movement in opinion. Personal controls were among the most commonly cited approaches to improving people's confidence in the responsible use of their information for research.ConclusionBecause no one approach to consent satisfied even a simple majority of dialogue participants and the importance placed on personal controls, a mechanism should be developed for documenting consent choice for different types of research, including ways for individuals to check who has accessed their medical record for purposes other than clinical care. This could be done, for example, through a web-based patient portal to their electronic health record. Researchers and policy makers should continue to engage the public to promote greater public understanding of the research process and to look for feasible alternatives to existing approaches to project-specific consent for observational research.

Dataset Information

Exploring access to genomic risk information and the contours of the HIPAA public health exception.

Publications

Exploring access to genomic risk information and the contours of the HIPAA public health exception.

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