Clinical Integration of Next Generation Sequencing: A Policy Analysis

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.