The Long and Winding Road of Regulating Laboratory Developed Tests w/ Catherine Sharkey

This episode is brought to you by Semafor Healthcare.Delivered weekly from David Lim, Semafor Healthcare connects the dots between decisions in government, business, and technology to reveal how they impact the future of healthcare. Each edition will provide the analysis you need to understand and stay ahead of a rapidly changing landscape. Subscribe for free.Health Affairs' Marianne Amoss interviews Catherine Sharkey from NYU School of Law to discuss regulations and patient safety regarding laboratory developed tests (LDT).View Health Affairs' current Request for Abstracts.Related Links:To Protect Patients And Spark Innovation, Codify The FDA’s Oversight Of Laboratory-Developed Tests (Health Affairs Forefront)F.D.A. Warns Patients About Some Prenatal Genetic Tests (New York Times)F.D.A. Wants to Regulate Prenatal Tests That Have Misled Parents (New York Times)Direct-to-Consumer Genetic Testing: The FDA's Dual Role as Safety and Health Information Regulator (DePaul Law Review)Regulatory and Medical Aspects of DTC Genetic Testing (Consumer Genetic Technologies: Ethical and Legal Considerations) Subscribe to Semafor Healthcare for free.