Laboratory Developed Tests and Their Regulation -
Laboratory developed tests (LDTs) are in vitro diagnostic tests (IVDs) that are designed, developed, manufactured, and performed within a single laboratory. Although the...more
Navigating the U.S. Healthcare Regulatory Landscape for Wearable Devices -
Complex Environment Includes Key Federal Agencies FDA, FTC, OCR, CPSC, CMS, and OIG -
The wearable device market is emerging as a key player...more
6/19/2019
/ Biotechnology ,
California Consumer Privacy Act (CCPA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Consumer Product Safety Commission (CPSC) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Technology-Assisted Review ,
Telemedicine ,
Value-Added Services
Recently, the Centers for Medicare & Medicaid Services (CMS) decided to provide nationwide reimbursement for certain in vitro, companion diagnostic tests that employ Next Generation Sequencing (NGS) for patients with advanced...more
In this issue:
- Best Patent Practices Under the America Invents Act
- CMS Issues Final Rule for Implementing Sunshine Act
- New IP Litigation Team a Boon for Firm's Life Sciences and Technology...more