Six Things You Need to Know About Medical Devices and Cybersecurity

Concern over cybersecurity touches our lives in new ways almost daily. Today, there is growing concern over millions of people who use connected medical devices that use off-the-shelf software.

Here are six things the FDA’s Center for Devices and Radiological Health wants you to know about the safety of networked medical devices:

1. Hacking of commercially-available software can give attackers unauthorized access to networks and medical devices, compromising device effectiveness and patient safety. This concern prompted the agency guidance that covers major responsibilities for makers of devices using this software.

2. What’s affected? Examples include systems that obtain, archive, and communicate pictures on networks at healthcare facilities (such as computed tomography, magnetic resonance, ultrasound, and nuclear medicine), systems that monitor patient activity (such as ECG systems), and those that communicate with clinical labs.

3. FDA guidance explaining agency rules for makers of devices that use off-the-shelf software and connect to networks also may be useful to others responsible for keeping networked devices safe, such as suppliers of network software and hardware (e.g., computers, routers, and operating systems) and healthcare organizations and administrators who set up and maintain networks of connected devices.

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