The issue of cybersecurity is a special concern for a number of industries, including the medical device industry. Quality healthcare depends on secure access to advanced medical technologies that use software and communications protocols to actively exchange vital patient information with other medical systems and devices. Cyber breaches impacting medical devices not only put the safety of individual patients at risk, but also severely compromises the quality of healthcare for people worldwide.
To help address the growing challenges of software-related cybersecurity concerns linked to medical devices, the International Electrotechnical Commission (IEC) has published IEC 81001-5-1, “Health software and health IT system safety, effectiveness and security—Part 5-1: Security—Activities in the product life cycle.” The standard is expected to gain Harmonized Standard status under the European Union’s (EU) Medical Device Regulation (2017/745, MDR).
In this white paper, we’ll discuss the state of medical device cybersecurity and provide details on the scope and requirements of IEC 81001-5-1. Get an overview of the implementation timeline for the standard, and how device manufacturers can integrate the standard’s requirements into their product development activities.