Medical devices are becoming more and more connected to the internet, hospital networks, and other medical devices. While this provides convenient features that help improve the diagnosis, prevention, monitoring and treatments in healthcare, it also increases the risk of hacking and cybersecurity issues.
One recent study found that connected devices outnumber people in healthcare settings by as many as 3 to 1, but many of those devices lack sufficient security to prevent attacks.
As medical devices become more advanced and the Software as a Medical Device (SaMD) industry increases, it is crucial that these devices are sufficiently protected. The two main issues facing the healthcare industry are the security of their data systems and the security of the devices themselves.
This white paper provides an overview of how cybersecurity impacts on connected medical devices, and the regulatory developments surrounding this area. It will cover the difference between mobile apps and mobile medical devices, and will look at real world examples including cyberattacks on medical institutions.
Author: Jerry Miller, Senior Regulatory Consultant
Jerry is a Senior Regulatory Consultant with 20 years experience in regulatory and standards interpretation, spanning the fields of consumer products and environmental investigation.
At Compliance & Risks, Jerry performs international research and database creation for clients and acts as a subject matter expert on various laws and standards.