Healthcare Information Security

mHealth and the FDA

HSCC Releases Joint Medical Device Security Lifecycle Guidance

January 29, 2019 - The Healthcare and Public Health Sector Coordinating Council (HSCC) released its medical device guidance on Monday, to help vendors, providers, and other stakeholders secure these devices throughout the product lifecycle. HCSS is a private-public workgroup with members from the Food and Drug Administration, Cerner, the Mayo Clinic, Department of Homeland Security, and security...

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FDA Implementing Risk-Based Medical Device Regulation

by Elizabeth Snell

The FDA will soon launch a new Digital Health Innovation Plan, which will include a focus on implementing a risk-based approach to medical device regulation, according to FDA Commissioner Scott Gottlieb, MD. Gottlieb explained in a...


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