{"id":79688,"date":"2026-03-20T08:28:00","date_gmt":"2026-03-20T07:28:00","guid":{"rendered":"https:\/\/www.teoresigroup.com\/?p=79688"},"modified":"2026-03-19T14:38:23","modified_gmt":"2026-03-19T13:38:23","slug":"cybersecurity-by-design-iec-81001-5-1","status":"publish","type":"post","link":"https:\/\/www.teoresigroup.com\/de\/news\/cybersecurity-by-design-iec-81001-5-1\/","title":{"rendered":"Cybersecurity by Design \u2013 IEC 81001-5-1"},"content":{"rendered":"\n
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In the context of medical device design, cybersecurity plays a central role. After addressing the regulatory aspects related to the Medical Device Regulation (MDR) 2017\/745<\/strong> and exploring hardware and software solutions to meet cybersecurity requirements, this new article focuses on the concept of Security-by-Design<\/strong> as defined in the IEC 81001-5-1:2021 standard<\/strong>.<\/p>\n\n\n\n

The standard defines the activities required to ensure the security of health software<\/strong> throughout its lifecycle processes. Health software refers to software intended to manage, maintain, or improve the health of individuals, or software developed to be incorporated into a medical device.<\/p>\n\n\n\n

In this context, security becomes an objective to be addressed from the earliest stages of software development, according to the Security-by-Design<\/strong> approach.<\/p>\n\n\n\n

The standard also recalls several concepts introduced in IEC 62304<\/strong>, which defines software lifecycle processes for medical devices. While IEC 62304 focuses on safety<\/strong>, IEC 81001-5-1 introduces specific requirements related to security<\/strong>, such as security requirements<\/strong> and activities dedicated to securing software architecture.<\/p>\n\n\n\n

One of the key elements of the standard is the defense-in-depth approach<\/strong>, which involves implementing multiple layers of protection within the system architecture to protect critical system components<\/strong> and reduce the impact of potential attacks.<\/p>\n\n\n\n

The standard also identifies several secure design best practices<\/strong>, including:<\/p>\n\n\n\n