On October 18, 2018, the FDA published Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. This guidance outlined recommendations for cybersecurity device design and labeling as well as important documents that should be included in premarket approval submissions. This guidance comes at a critical time as the healthcare industry is a prime target for hackers. On January 22, 2019, the U.S. Department of Homeland Security Industrial Control System Cyber Emergency Team (US-CERT) issued another advisory regarding medical device ...
Blog Editors
Recent Updates
- Medicaid Behavioral Health Investigations and Payment Suspensions in D.C. Are Increasing – How Providers Can Limit Risk
- ‘Emilie’ Is Not a Psychiatrist: Pennsylvania Board of Medicine Alleges Unlawful Practice of Medicine by an AI Chatbot
- DOJ’s West Coast Strike Force to Target Health Care Fraud in Arizona, Nevada, and Northern California
- DOJ FOCUS Initiative Prioritizes “High Quality” Data Miner Actions by FCA Whistleblowers
- FDA Proposal Would Leave Semaglutide, Tirzepatide, and Liraglutide Off 503B Bulks List