Healthcare-related cybercrimes are on the rise and impact not only patients and healthcare providers, but also entire populations. For example, the 2024 ransomware attack on Change Healthcare in the USA forced several medical practices into bankruptcy, reducing the availability of services in their communities. And, in 2020, cybercriminals attacked Vaastamo in Finland to extort the provider, threatening to disclose patients’ confidential mental health and psychotherapy records. 

The complexity of medical and care information systems (MCIS) used by providers presents opportunities for malicious actors to penetrate an organization’s network, crawl its IT infrastructure and seize assets, with further potential to disrupt the ability to deliver care. Providers strive to be resilient to such threats with the support of technology producers and regulators making medical devices and information systems as secure as possible. Medical device manufacturers, in particular, have a significant role to play, which entails incorporating ‘security-by-design’ principles into their monitoring and therapy products as required by laws and directives such as those mandated in the European Commission’s Medical Device Regulation (MDR). 

Implementation of new legislation and related cybersecurity requirements creates unique challenges for all parties, and particularly for manufacturers who must meet the provisions of the ever-evolving regulatory framework. 'Security-by-Design' is important when producing medical devices used within connectivity and interoperability solutions. There are proven and reliable practices to support hospital clients in protecting medical device data and providing a safe environment in several aspects. 

System connectivity and interoperability need to be kept simple to remain effective, while MCIS subsystems are called upon to provide more and more insights supporting better care decisions. The promise of the next generation architecture is to decouple the data producers (the medical devices) from the data consumers (the clinical applications) using a medical device information platform (MDIP) that acts as an isolating backbone