1. The White House, Office of the Press Secretary, Fact Sheet: President Obama’s Precision Medicine Initiative (January 30, 2015), www.whitehouse.gov/precision-medicine
2. US Dep’t of HHS/FDA, Public Workshop – Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests (November 12, 2015b), www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm459449.htm.
3. US Dep’t of HHS/FDA, Sentinel Program Interim Assessment (FY 15) (September 24, 2015a), www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM464043.pdf, at 4.
4. US Dep’t of HHA/FDA, Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests – Preliminary Discussion Paper (December 29, 2014c.), www.fda.gov/downloads/medicaldevices/newsevents/workshopsconferences/ucm427869.pdf
5. Individuals’ Right under HIPAA to Access Their Health Information;CFR § 164.524,2016