The International Electrotechnical Commission (IEC) plans to issue the new cybersecurity standard IEC 81001-5-1 soon. It deals with how IT security must be considered in the software life cycle.
As a special standard for health software, it supplements for example IEC 62304 and can close gaps that urgently need to be closed. The EU is already planning to harmonize IEC 81001-5-1, currently with the target date May 24, 2024.
Due to the fact that Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR) contain specific requirements on cybersecurity in their annexes I, manufacturers should consider adopting the corresponding standard if applicable.
Source: International Organization for Standardization