DIN EN 80001-1 VDE 0756-1:2018-09

The implementation and use of connected medical devices or health software to support health IT systems and services entails risk. This international standard provides general requirements for applying risk management to Health Information Technology (HIT) systems by addressing the key properties of safety, effectiveness and both data and system security (including privacy) while engaging appropriate stakeholders. In this context, 'implementation' refers to the technology lifecycle phases and activities that are required after health software or medical devices have been released and made available to the market and are being prepared for connection and use.