Cybersecurity, FDA - Medical Devices
All legally-marketed medical devices have benefits and risks. The FDA allows devices to be marketed when there is a reasonable assurance that the benefits to patients outweigh the risks. Medical devices are increasingly connected to the Internet, hospital networks, and other medical devices to provide features that improve health care and increase the ability of health care providers to treat patients. These same features also increase the risk of potential cybersecurity threats. Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. Threats and vulnerabilities cannot be eliminated, therefore, reducing cybersecurity risks is especially challenging. The heath care environment is complex, and manufacturers, hospitals, and facilities must work together to manage cybersecurity risks.