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

被引:12
作者
Evans, Barbara J. [1 ]
机构
[1] Univ Houston, Ctr Law, Ctr Biotechnol & Law, Houston, TX 77004 USA
基金
美国国家卫生研究院;
关键词
Association for Molecular PathOlogy v. Myriad; Genetics; CLIA; data aharing; genetic; -databaSes; gene patents; HIPAA; innovation policy; LAW;
D O I
10.1038/gim.2013.186
中图分类号
Q3 [遗传学];
学科分类号
071007 ; 090102 ;
摘要
The Supreme Courts recent decision in Association for Moiecu, lar Pathology v. Myriad Genetics portrays the- human genome as " a product of nature. This frames medical genetics aS an eXtrac. tive 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,clini..cal 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. They recently revised Health Insurance Portabil:ity 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, proteet,privacy, and-promote needed data sharing to advance medical genetics.
引用
收藏
页码:504 / 509
页数:6
相关论文
共 28 条
[1]  
[Anonymous], 2013, Federal register, V78, P5566
[2]  
[Anonymous], MYRIAD GENE PATENT R
[3]  
[Anonymous], WHAT IS EITI
[4]  
[Anonymous], 2005, AM HER SCI DICT
[5]  
[Anonymous], HLTH SAF DRINK WAT B
[6]  
Bastida AE, 2013, INT MINING OIL GAS L
[7]  
Chen J, 2004, NORTHWEST U LAW REV, V98, P1617
[8]   The next controversy in genetic testing: clinical data as trade secrets? [J].
Cook-Deegan, Robert ;
Conley, John M. ;
Evans, James P. ;
Vorhaus, Daniel .
EUROPEAN JOURNAL OF HUMAN GENETICS, 2013, 21 (06) :585-588
[9]  
Evans BJ., 2011, Harv. JL & Tech., V25, P69
[10]  
Gomez-lbafiez JA., 2003, REGULATING INFRASTRU