Mining the human genome after Association for Molecular Pathology v. Myriad Genetics

• Published in: Genetics in medicine Vol. 16; no. 7; pp. 504 - 509
• Main Author: Evans, Barbara J
• Format: Journal Article
• Language: English
• Published: New York Nature Publishing Group US 01-07-2014; Elsevier Limited; Nature Publishing Group
• Subjects: 631/114/129/2043; 631/208/1516; Biomedical and Life Sciences; Biomedicine; Confidentiality - legislation & jurisprudence; Data Mining - legislation & jurisprudence; Genetics; Genome, Human; Genomes; Health Insurance Portability and Accountability Act; Human Genetics; Humans; Information Dissemination - legislation & jurisprudence; Information sharing; Laboratory Medicine; Neoplasms - genetics; Neoplasms - pathology; Pathology, Molecular - ethics; Pathology, Molecular - legislation & jurisprudence; Privacy; Privacy - legislation & jurisprudence; Special; special-article; Supreme Court Decisions; United States; United States; genetic databases; gene patents; CLIA; data sharing; Association for Molecular Pathology v. Myriad Genetics; HIPAA; innovation policy
• ISSN: 1098-3600; 1530-0366
• DOI: 10.1038/gim.2013.186

The Supreme Court’s recent decision in
Association for Molecular Pathology v. Myriad Genetics
portrays the human genome as a product of nature. This frames medical genetics as an extractive industry that mines a natural resource to produce valuable goods and services. Natural resource law offers insights into problems medical geneticists can expect after this decision and suggests possible solutions. Increased competition among clinical laboratories offers various benefits but threatens to increase fragmentation of genetic data resources, potentially causing waste in the form of lost opportunities to discover the clinical significance of particular gene variants. The solution lies in addressing legal barriers to appropriate data sharing. Sustainable discovery in the field of medical genetics can best be achieved through voluntary data sharing rather than command-and-control tactics, but voluntary mechanisms must be conceived broadly to include market-based approaches as well as donative and publicly funded data commons. The recently revised Health Insurance Portability and Accountability Act Privacy Rule offers an improved—but still imperfect—framework for market-oriented data sharing. This article explores strategies for addressing the Privacy Rule’s remaining defects. America is close to having a legal framework that can reward innovators, protect privacy, and promote needed data sharing to advance medical genetics.
Genet Med
16
7, 504–509.