Tag Archives: FDA

Health Apps: Convenience vs. Security Risks

The pace of innovation in healthcare today has produced an amazing increase in the number of available mobile apps for health-related information. More than 300,000 healthcare apps are available online. These apps are developed and designed to fit within the “connected health model” which attempts to provide flexible and efficient healthcare services by using connected … Continue Reading

FDA Issues Draft Guidance for Connected Medical Devices

Demonstrating a continued focus on information security, the Food and Drug Administration (FDA) published draft guidance on Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.  As the title indicates, the draft guidance focuses on issues manufacturers should address in the development and design of medical devices prior to sale to consumers.  This draft guidance … Continue Reading

FDA Issues Draft Cybersecurity Guidance for Device Manufacturers

Last week, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance, which details the agency’s recommendations for monitoring, identifying, and addressing cybersecurity vulnerabilities in medical devices after they have … Continue Reading

Social Media Guidance Issued For Pharmaceutical Entities

The U.S. Department of Health and Human Services, Food and Drug Administration (FDA) recently issued draft guidance entitled “Guidance for Industry-Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media For Prescription Human and Animal Drugs and Biologics.” The draft guidance is intended to describe the FDA’s current thinking about how manufacturers, packers, and distributors (firms) … Continue Reading
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