Open AccessClinical Integration of Next Generation Sequencing: A Policy Analysis
Author(s) -
Kaufman David,
Curnutte Margaret,
McGuire Amy L.
Publication year - 2014
Publication title -
the journal of law, medicine & ethics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.515
H-Index - 57
eISSN - 1748-720X
pISSN - 1073-1105
DOI - 10.1111/jlme.12158
Subject(s) - intellectual property , corporate governance , stakeholder , conversation , key (lock) , foundation (evidence) , quality (philosophy) , engineering ethics , political science , business , computer science , public relations , engineering , sociology , law , computer security , philosophy , communication , finance , epistemology
Clinical next generation sequencing (NGS) technologies are challenging existing regulatory paradigms. We advocate a coordinate policy approach, which first requires a comprehensive understanding of the existing regulatory and legal structures. This paper introduces four key policy domains — including quality assurance, insurance coverage, intellectual property management, and data sharing — that must be addressed to ensure high quality clinical NGS. In bringing these policy issues into conversation through this special issue for the Journal of Law, Medicine & Ethics , we hope to lay the foundation for further discussion by a range of stakeholder groups with diverse and strong interests in the governance of NGS.