Resources

Clinical care has become more reliant on the internet of things. The interconnectivities has dramatically increased the devices flexibility and efficiency. Unfortunately ,this interconnectivity also poses a risk  to patient safety and privacy.In response,the medical device industry has adopted more secure development practices, including a wide variety of guidelines, standards and best practices to ensure that an adequate cybersecurity posture is maintained throughout the medical device life cycle. One of the main challenges for the manufacturer and other stakeholders within the healthcare industry is the lack of a clear understanding and awareness of existing standards and best practices. And so, significant security risks persist.

To tackle this challenge the CMDC has compiled a list of resources to help medical device manufacturers with the development and maintenance of medical devices throughout the device lifecycle. 

Overview of cybersecurity in the medical device lifecycle 

Elements of a product security program

Pre-market security activities

Post-market security activities

End of Support and Management of Legacy Technologies

• Technological Leadership Institute - M.S. in Medical Device Innovation
• Earl E. Bakken Medical Devices Center
• College of Continuing and Professional Studies  - Cybersecurity Bootcamp

• FDA Digital Health Center of Excellence - Cybersecurity
• FDA Fact Sheet: The FDA's Role in Medical Devices Cybersecurity: Dispelling Myths and Understanding
• Cyber Security and Infrastructure Security Agency - Stop, Think, Connect Campaign
• National Cybersecurity Alliance
• Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook - Oct 2018 (.pdf)