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The U.S. Food and Drug Administration (FDA) named University of Michigan Associate Professor Kevin Fu Acting Director of Medical Device Security in its Center for Devices and Radiological Health. This is a newly created 12-month post in which Fu will “work to bridge the gap between medicine and computer science and help manufacturers protect…

All companies in this day and age must devote some attention to cybersecurity risks. Regardless of industry, almost every entity maintains some form of personally identifiable information that requires protection (e.g., credit card information, Social Security numbers, bank account information, etc.). However, the medical device industry has additional concerns – it must make sure that…

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…

Demonstrating a continued focus on information security, the Food and Drug Administration (FDA) published draft guidance on Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.  As the title indicates, the draft guidance focuses on issues manufacturers should address in the development and design of medical devices prior to sale to consumers.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

Last week, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance, which details the agency’s recommendations for monitoring, identifying, and addressing cybersecurity vulnerabilities in medical devices after they have…

A study (registration required) by two data security firms, Norse in Silicon Valley and SANS, discussed in a recent L.A. Times article, confirms the concerns raised by the FDA and others about increased use of internet-connected medical devices by healthcare providers and the corresponding increase in the information systems of those providers being attacked,…