An Introduction to Medical Device Security

This whitepaper provides an overview of the cyber security risks that are challenging the medical device manufacturing community. It was inevitable that medical devices would become an attractive target for exploitation and criminal activity.  Regulators and legislators are acting to ensure that data protection laws and device testing standards reflect this new risk, but they fall behind the hackers in a fast-moving race. As devices contain ever more complex software, the need to write secure code often becomes challenging and exposes devices to attacks that can be conducted locally or even from outside the clinical setting.  For device manufacturers wishing to launch products in Europe recent changes to data protection requirements have forced many to rethink how they process personal data which is challenging the previously held notions of patient consent. The good news is that with proper product testing, device manufacturers can get ahead of the curve and build vibrant, secure devices that embrace modern, internet based technologies.