Digitized care has become the norm, with system interconnectivity (“Smart Hospital”) and hospital-at-home technology rising to meet staff shortage concerns and industry demands for efficiency. As the Vitalis “Cybersecurity in the Healthcare and Welfare Sector” Conference Track points out, this digitization has served to highlight the urgent need for healthcare providers and manufacturers to comprehensively protect healthcare operations.

When evaluating security in a digital operating environment, it is easy to put full focus on Information and Cyber Security. However, there is a third aspect that we should remember: the patient. The risk that cybersecurity vulnerabilities pose to patients has been a driving force in the introduction of stringent laws and regulations throughout Europe.

Regulations like the EU-MDR and the NIS-2 Directive set strict requirements for both manufacturers and healthcare providers to protect patient safety and data integrity. These requirements enshrine key standards in both the manufacturing and operation of critical infrastructure, spanning risk management, supply chain security, and cyber hygiene. And this is only the beginning, in the near future more regulations will be introduced that sets even more strict requirements regarding cybersecurity, examples are the Cyber Resilience Act, the Radio Equipment Directive, etc. What do all these regulations mean for us and our patients, how to maintain our medical devices to safeguard patient safety, stay secure and at the same time comply to the increasing regulatory pressure