Healthcare
Standards: IEC 62443, IEC 81001-5-1, IEC 80001-1, IEC/TR 80001-2-x, IEC/TR 60601-4-5; IEC 62304; IEC 82304
Legislation: MDR, NIS2, GDPR, CSA
IEC 81001-5-1 focuses on producers of “medical software”. This encompasses not only medical devices, but also other software used in healthcare. The EU is currently planning to harmonise IEC 81001-5-1, with a current target date of May 2024.
In addition to the aforementioned compliance with statutory regulations, certification offers further, demonstrable benefits, such as:
- Improved processes, products and services
- Improved response to incidents and risk management
- Excellent company reputation and the trust of clients
- Greater competitiveness on foreign markets
- Strengthening of cooperation with healthcare providers
In this respect, IEC 62443 also deals with the relationship with health delivery organisations (HDO), which share responsibility for cyber security with producers. One of the goals, for example, is to ensure that operators of IT systems have sufficient information about the secure operation of products from the producers.
Operators must, for example, inform producers immediately about problems with IT security so that they can work together to find a solution quickly.