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Genetic Information and the Law
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Health Insurance Portability and Accountability Act (HIPAA)
A federal law that provides data privacy and security provisions for safeguarding medical information, including genetic information.
BRCA1 and BRCA2
Genes that produce tumor suppressor proteins. Legal debates have arisen over the patentability of human genes following the Supreme Court's decision in Association for Molecular Pathology v. Myriad Genetics.
Human Genome Project
An international scientific research project with the goal of determining the sequence of human DNA and identifying genes. Created legal challenges in intellectual property and privacy.
Genetic Counseling
A process to evaluate and understand a family's risk of an inherited medical condition. There are confidentiality and ethical standards set to protect the information shared during genetic counseling sessions.
DNA Fingerprinting
The analysis of DNA from samples of body tissues or fluids to identify individuals. Used in criminal law to provide evidence in criminal investigations.
Forensic Genetics
The branch of genetics that deals with the application of genetic knowledge to legal problems and legal proceedings. Used primarily for identifying criminal suspects and victims.
Preimplantation Genetic Diagnosis (PGD)
A procedure used to detect genetic defects within embryos created through in vitro fertilization (IVF) before pregnancy. Legal issues include the ethics of selecting embryos based on genetic characteristics.
Genetic Privacy
The right to keep one's genetic information confidential. GINA and the HIPAA Privacy Rule provide protections for genetic information.
Genetic Information Nondiscrimination Act (GINA)
A federal law that prohibits genetic discrimination in health insurance and employment, with some exceptions like military members.
Biobanking
The process of collecting, storing, and managing biological samples like DNA for research. Legal issues include consent, privacy, and ownership of genetic material.
Family Medical History
Information about diseases and health conditions that run in a person's family. GINA protects against discrimination based on family medical history.
Pharmacogenomics
The study of how genes affect a person's response to drugs. This emerging field can lead to legal issues concerning drug approval and patent law.
Gene Therapy
A technique that uses genes to treat or prevent disease. Entails legal and regulatory considerations, particularly with respect to safety, efficacy, and ethical concerns.
Genetic Discrimination
The act of treating individuals differently because of their actual or perceived genetic differences. Protected under the Genetic Information Nondiscrimination Act (GINA) of 2008.
Direct-to-Consumer Genetic Testing
Genetic tests that are marketed directly to consumers. The FDA regulates these tests and there are privacy concerns under the law about personal genetic information.
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