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Data Security Implications in Digital Health:
Published in Connie White Delaney, Charlotte A. Weaver, Joyce Sensmeier, Lisiane Pruinelli, Patrick Weber, Nursing and Informatics for the 21st Century – Embracing a Digital World, 3rd Edition, Book 4, 2022
Elaine Zacharakis Loumbas, Marisol Peters
There are several federal and state laws protecting sensitive health information. Two of the most significant federal privacy laws related to sensitive health conditions are GINA and 42 CFR Part 2 (CMS, 2010). GINA stands for the Genetic Information Nondisclosure Act (Gregory, 2018). It is a federal law that protects genetic information. CFR means “Code of Federal Regulations”. The HITECH Act promulgated the HIPAA omnibus rules which incorporate provisions of GINA into the HIPAA privacy scheme. Forty-two CFR Part 2 establishes privacy protections for alcohol and substance abuse information (HHS, 1996a). Additionally, there are both federal and state laws regarding AIDS. All 50 states have specific laws regarding mental health information as well as other sensitive health conditions. Many states have genetic privacy laws that have more protections than GINA. There are also state laws related to sexually transmitted diseases and other sensitive health conditions.
Clinical Cancer Genetics
Published in Pat Price, Karol Sikora, Treatment of Cancer, 2020
Rosalind A. Eeles, Lisa J. Walker
There is ongoing work to ensure adequate genetic privacy is maintained for patients, given the potential of the new technologies described above. There have been statements by the US Government’s Department of BioEthics regarding this, and it is hoped that sufficient regulation can be brought into force to protect patients’ privacy while allowing them and their doctors to access such data as are necessary and useful to them.
Genetic testing and risk perception in the context of personalized medicine
Published in Ulrik Kihlbom, Mats G. Hansson, Silke Schicktanz, Ethical, Social and Psychological Impacts of Genomic Risk Communication, 2020
Sabine Wöhlke, Marie Falahee, Katharina Beier
Given these ambivalences, a person’s right to autonomy plays a crucial role in the handling of genetic information. While in principle, autonomy is a guiding principle for all kinds of health-related information, there is special emphasis on this in the genetic context. Many legislations and ethical frameworks grant individuals a ‘right to know’ or ‘right not to know’ and stress the importance of genetic privacy (Gilbar et al. 2016; Etchegary and Fowler 2008; Andorno 2004). In this context, genetic information is typically presented as being specific to the individual – a unique individual ‘fingerprint’ that distinguishes it from others. However, this perception neglects the supra-individual dimension of genetic risk information. In fact, knowing about an individual’s genetic disposition may also reveal something about potential health risks for family members (Gaff et al. 2005). This is even more the case with genome-based testing as this may ‘have far greater implications for family relations than does directed, conventional genetic testing’ (Mendes et al. 2017: 3). For this reason, debates about disclosing or not disclosing genetic information to family members (or testing or not testing on behalf of family members) do not sufficiently reflect the implications for family dynamics. In fact, framing these questions in terms of individual autonomy ignores the fact that any decision taken will impact familial relationships and dynamics (Gilbar 2007; Schicktanz 2018; Wöhlke and Perry 2019).
Privacy and the Genetic Community
Published in The American Journal of Bioethics, 2022
Marisa A. Leib-Neri, Anya E. R. Prince
At the federal level, the U.S. currently regulates genetic privacy by protecting certain sensitive information in certain sectors. Notably, the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule prohibits disclosure of personal health information, which includes identifiable genetic information, by covered entities, such as health care providers, hospitals, and insurance companies. In employment and health insurance, GINA prohibits covered entities from collecting genetic information or using such information to discriminate. Outside of HIPAA and GINA, the general U.S. privacy regime is built on a foundation of individual notice and consent. That is, consumers are provided information in user agreements about what personal data a company may collect and how companies may share this data. By continuing to use the product and engage in the activity, the individual is consenting to the collection and future sharing of their data. The notice and consent framework is ostensibly meant to give individuals control over what data they allow others to gain access to and share.
Is Genetic Exceptionalism Past Its Sell-By Date? On Genomic Diaries, Context, and Content
Published in The American Journal of Bioethics, 2019
Our recommendations strove to put genetic information in context. For example, the very first recommendation of our report read: “Information about past, present or future health status, including genetic information, should not be used to deny health care coverage or services to anyone” (ELSI Insurance Task Force 1993, 2, emphasis added). We had come to see genetic information as a subset of all health-related information. It had its particular qualities that deserved to be understood and accommodated, but the similarities were even more important. We concluded that it was wiser not to regard genetic information as wholly distinctive in kind. I thought I detected some uncertainty even among the advocates for treating genetic information as different. In the article describing their commendable effort to draft a Genetic Privacy Act, Annas and colleagues included this very important conditional: “To the extent that we accord special status to our genes and what they reveal, genetic information is uniquely powerful and uniquely personal, and thus merits unique privacy protection” (Annas et al. 1995).
Privacy and ethical challenges in next-generation sequencing
Published in Expert Review of Precision Medicine and Drug Development, 2019
Nicole Martinez-Martin, David Magnus
Privacy and confidentiality have long been core tenets for ethical medical practice. Physicians need patients to disclose sensitive and personal information in order to provide appropriate medical care for them. In turn, patients need to be able to trust that these disclosures will not lead to harm[17]. ‘Confidentiality’ refers to the obligations of professionals, such as physicians, not to disclose information entrusted to them unless authorized to do so[18]. Privacy generally refers to the rights of individuals to make decisions over what personal information is shared and how. Privacy remains a concept that is notoriously difficult to define, particularly as it encompasses a tangle of associated rights and obligations that are dependent upon context[19]. In medical settings, and particularly when it comes to genetic privacy, the type of privacy at stake has been described as informational privacy[20]. Information privacy is ‘defined by how much personal information is available from sources other than the individual to whom it pertains.’ [9] Informational privacy involves decisions about the communication of personal information and the use of that data, as well as how information is stored, maintained, disclosed and protected[21]. NGS generates a substantial amount of genetic information, including almost all adverse protein-coding alleles in the genome for each participant[22]. The probabilistic nature of genetic information and evolving understandings of genetic data also pose challenges for stakeholders making decisions regarding how to approach and address privacy. While confidentiality obligations apply to NGS results, patients need to be adequately informed of how practices such as data sharing and electronic health records may impact their data and pose risks to privacy.