As techniques such as next generation sequencing, which determines the precise order of the nucleotides that make up DNA, are used in patient diagnosis and treatment, three critical policy areas remain ill-defined:
- Regulation by the U.S. Food and Drug Administration and Center for Medicare and Medicaid Services.
- Reimbursement policies for clinical utility and payment.
- Intellectual property protections including the patenting of human genes and proprietary.
A comprehensive analysis of these three key policy areas is on its way and the initial findings appear in a special issue for the Journal of Law, Medicine & Ethics, with the aim of developing a coordinated policy approach.
Dr. Maggie Curnutte, postdoctoral associate in the Center for Medical Ethics and Health Policy at the Baylor College of Medicine, is one of the authors of the special issue and reports on this on the Baylor College of Medicine blog.
You can also download free of charge the policy analysis on Clinical Integration of Next Generation Sequencing here.