Posted: April 29th, 2018

Genetic Privacy Laws and the Future of Precision Medicine

Genetic Privacy Laws and the Future of Precision Medicine

Precision medicine is an emerging field that aims to tailor medical interventions based on individual genetic variations. By using genomic data, precision medicine can potentially improve diagnosis, prevention, and treatment of various diseases. However, precision medicine also poses significant challenges for the privacy and security of genetic information, which may have implications for personal, familial, and social well-being. This paper examines the current legal frameworks that protect genetic privacy in different jurisdictions, and discusses some of the ethical issues that arise from the use and disclosure of genetic information in the context of precision medicine.

Legal Frameworks for Genetic Privacy

Genetic privacy is the right to control access to and use of one’s genetic information, which may reveal sensitive information about one’s health, ancestry, identity, and relationships. Genetic privacy is not explicitly recognized as a human right in international law, but it may be derived from other rights, such as privacy, autonomy, dignity, and non-discrimination. Different jurisdictions have adopted different approaches to protect genetic privacy, ranging from comprehensive legislation to sector-specific regulation to self-regulation by industry or professional bodies.

In the United States, the federal Health Insurance Portability and Accountability Act (HIPAA) protects the privacy of medical information in general, including genetic information generated for clinical purposes. However, HIPAA does not apply to direct-to-consumer genetic testing (DTC-GT), which is a popular service that allows individuals to access their genetic information without involving a health care provider. The federal Genetic Information Nondiscrimination Act of 2008 (GINA) prohibits discrimination based on genetic information in employment and health insurance coverage, but it does not cover life, disability, or long-term care insurance or any other insurance product. Some states have enacted additional laws that provide more protection for genetic privacy, such as requiring informed consent for genetic testing or restricting the use of genetic information by law enforcement or third parties.

In the European Union, the General Data Protection Regulation (GDPR) provides a comprehensive framework for the protection of personal data, including genetic data. The GDPR defines genetic data as personal data relating to the inherited or acquired genetic characteristics of a natural person that give unique information about their physiology or health. The GDPR requires that genetic data be processed lawfully, fairly, and transparently, and that data subjects have rights to access, rectify, erase, restrict, object to, and port their data. The GDPR also imposes strict conditions for obtaining consent for processing genetic data, such as ensuring that it is freely given, specific, informed, and unambiguous. Moreover, the GDPR prohibits processing genetic data for discriminatory purposes or for purposes incompatible with the original purpose of collection.

In other parts of the world, such as Australia, Canada, China, India, Japan, and South Africa, there are varying degrees of legal protection for genetic privacy. Some countries have specific laws or guidelines that regulate genetic testing or research, while others rely on general data protection laws or ethical principles to safeguard genetic information. Some countries also recognize indigenous rights or community interests in relation to genetic resources or traditional knowledge.

Ethical Issues in Genetic Privacy

The use and disclosure of genetic information in precision medicine raises several ethical issues that need to be addressed by law and policy makers, health care providers, researchers, and individuals. Some of these issues are:

– The right to know versus the right not to know one’s genetic information: Individuals may have different preferences or expectations about accessing their own genetic information or sharing it with others. Some may want to know their genetic risks or carrier status for certain diseases or traits, while others may prefer not to know or to defer knowing until they are ready. Some may want to share their genetic information with their relatives or health care providers for medical or personal reasons, while others may want to keep it private or anonymous. How should these conflicting rights be balanced and respected?
– The duty to warn versus the duty to protect confidentiality: Health care providers and researchers may face a dilemma when they discover genetic information that has implications for the health or well-being of their patients’ relatives or other third parties. Should they disclose this information without consent to prevent harm or respect confidentiality to protect privacy? How should they determine who is at risk and who should be informed? What are the potential benefits and harms of disclosure or non-disclosure?
– The consent versus the public interest: Individuals may consent to provide their genetic information for a specific purpose, such as diagnosis or treatment. However, their genetic information may also have value for other purposes, such as research or public health. Should their consent be required for secondary use of their genetic information or should it be waived in the public interest? How should they be informed about the potential uses and users of their genetic information? How should they be able to withdraw their consent or opt out of further participation?
– The ownership versus the stewardship: Individuals may claim ownership or control over their genetic information, as it is derived from their biological samples and reflects their personal identity. However, their genetic information may also be seen as a common good or a social resource, as it is shared with their relatives and contributes to scientific knowledge and social welfare. Who should own or control the access to and use of genetic information? How should the benefits and burdens of generating and using genetic information be distributed among individuals, communities, and society?

Conclusion

Precision medicine promises to revolutionize health care by providing more personalized and effective interventions based on individual genetic variations. However, precision medicine also poses significant challenges for the privacy and security of genetic information, which may have implications for personal, familial, and social well-being. This paper examined the current legal frameworks that protect genetic privacy in different jurisdictions, and discussed some of the ethical issues that arise from the use and disclosure of genetic information in the context of precision medicine. It is important to address these issues in a way that respects the rights and interests of individuals, while also promoting the advancement and application of precision medicine for the benefit of society.

References

– Southwood D. In Genes We Trust: Genetic Privacy in the Age of Precision Medicine. In: Southwood D, editor. Personhood in the Age of Biolegality. Cham: Springer; 2020. p. 189-212.
– Stiles D, Appelbaum PS. Cases in Precision Medicine: Concerns About Privacy and Discrimination After Genomic Sequencing. Ann Intern Med. 2019;170(9):S65-S69.
– Sweeney L, Abu A, Winn J. Privacy and Security in the World of Precision Medicine. GPSolo. 2021;38(4):36-41.
– Rothstein MA, Knoppers BM. The Genetic Information Privacy Act. JAMA. 2020;324(23):2379-2380.

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