Review on current state of regional regulations around medical device cyber security

• Main Author: Yang, Yang
• Other Authors: Song Juha
• Format: Final Year Project
• Language: English
• Published: Nanyang Technological University 2023
• Subjects: Engineering::Bioengineering
• Online Access: https://hdl.handle.net/10356/166809
• Institution: Nanyang Technological University

The landscape of the cyberspace is always evolving and new cyberthreats continue to emerge constantly. Cybersecurity in the medical device industry is an increasing concern and regulatory authorities are tackling it each in their own way. In comparison of the cybersecurity landscape between four different regions, it was found that the TGA of Australia have the most comprehensive and strict regulations regarding medical device cybersecurity and software in and as a medical device. The U.S. FDA is not far behind in terms of implemented regulations, followed by the European Union and finally, Singapore. However, Singapore has proposed legislations regarding medical device cybersecurity and once enforced, may put Singapore on par with Australia in terms of medical device cybersecurity regulatory requirement comprehensiveness and strictness.