Posts tagged College of Health Information Management Executives.
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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 ...
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Recent Updates
- The DOJ’s Bulk Sensitive Data Rule and Your Obligation to “Know Your Data”
- Eliminating the GRAS Pathway: An Update
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- FDA Proposal Would Extend Food Traceability Rule’s Compliance Deadline to July 2028
- NYDFS Cybersecurity Crackdown: New Requirements Now in Force, and "Covered Entities" Include HMOs, CCRCs—Are You Compliant?