07 August 2019

As the digitisation of health and care progresses, the number of connected digital health technologies is increasing. This is inevitably accompanied by a growing number of cybersecurity risks. European regulators have responded by introducing cybersecurity requirements for devices, systems and infrastructure in various regulatory frameworks, addressing both the healthcare sector specifically or the industry horizontally. This document outlines the different requirements, introduced by various legislative frameworks, that now our industry faces. It contains our recommendations for ensuring that medical devices and services in Europe remain secure.