Nonprofit public health and patient safety organization, The Medical Device Innovation, Safety, and Security Consortium (MDISS), has announced it is developing a set of recommended practices and profiles for securing medical systems based on the normative requirements in the widely used ISA/IEC 62443 series of standards for industrial automation and control systems cyber security.
The intent is to share the information across the network of MDISS member organizations, which includes medical device manufacturers, healthcare software companies, hospital networks, and insurance companies.
Dr Dale Nordenberg, MDISS Executive Director, stated: “MDISS is committed to improving the state of cyber security in medical devices and systems to reduce risks to patients. We view the ISA/IEC 62443 standards as providing a solid basis for the development of comprehensive profiles and recommended practices in this area.”
The ISA/IEC 62443 standards are developed primarily by the ISA99 committee of the International Society of Automation, with simultaneous review and adoption by the Geneva-based International Electrotechnical Commission. ISA99 draws on the input of cyber security experts from across the globe in developing standards in a balanced, consensus process that is accredited by the American National Standards Institute. The standards are applicable to all industry sectors and critical infrastructure, providing a flexible and comprehensive framework to address and mitigate current and future security vulnerabilities in industrial automation and control systems.
Application to connected medical devices reflects the growing use of the standards across multiple sectors worldwide, pointed out long-time ISA99 Co-Chair Eric Cosman: “When we first formed the ISA99 committee, we deliberately stated our scope in terms of potential consequences rather than limiting ourselves to specific industries. This decision has served us well as the ISA/IEC 62443 standards not only have been applied across traditional manufacturing and industrial processing sectors, but also extended to rail transportation, building automation, and now medical systems.”
The MDISS announcement follows another recent indication of the widespread adoption of the ISA/IEC 62443 standards in which the United Nations Economic Commission for Europe confirmed it will integrate the standards into its forthcoming Common Regulatory Framework on Cybersecurity (CRF). The CRF will serve as an official UN policy position statement for the massive EU trade markets.
