title: Clinical integration of next generation sequencing: a policy analysis.
abstract: 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.
authors.affiliation: Director of Research at the Genetics and Public Policy Center at Johns Hopkins University in Washington, D.C.
authors.forename: David
authors.initials: D
authors.lastname: Kaufman
authors.forename: Margaret
authors.initials: M
authors.lastname: Curnutte
authors.forename: Amy L
authors.initials: AL
authors.lastname: McGuire
mesh_terms: D015894:Genome, Human; D006291:Health Policy; D059014:High-Throughput Nucleotide Sequencing; D006801:Humans; D017422:Sequence Analysis, DNA