Cybersecurity in Medical Devices

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 potential cybersecurity risks. Medical devices, like other computer systems, can be vulnerable to security breaches, potentially affecting the safety and effectiveness of the device. Threats and vulnerabilities cannot be eliminated, and reducing cybersecurity risks is especially challenging. The health care environment is complex, and manufacturers, hospitals, and facilities must work together to manage cybersecurity risks.

To assist our clients, RQMIS, Inc. and Twin Tech Labs announced a partnership to bring cybersecurity testing and monitoring to the ever-expanding market of software-based medical products and their associated networks and cloud-based platforms. FDA’s recent publications and guidance regarding premarket and post market requirements for cybersecurity testing and monitoring of medical devices have significantly expanded the regulatory threshold for a pathway to market. Twin Tech Labs brings to the table decades of experience in IoT, machine learning, and cybersecurity, including leveraging best-in-class open-source components and frameworks to secure digital assets.