1. do I have access to enough high quality data?
The use of artificial intelligence (AI) helps to simplify complex work steps in many medical areas. As an example, it assists in the diagnosis of disease patterns or has a supportive effect on its treatment.
However, as in all areas of medical technology, manufacturers must also fulfil specific regulatory requirements in order to enable the use of AI for medical products.
What assumptions underlie the questions?
Artificial intelligence is only as intelligent as the data on which it is based. If an AI receives faulty or subjective data, the system is no longer reliable either. It is therefore particularly important to check the data sets it contains.
Not only the quantity of data is crucial. For an AI to be able to act meaningfully, it needs data for all decision cases that can potentially have an influence.
The ISO/IED TR 29119-11 and TR 24027 to 24029 standards currently apply to AI-based systems in Europe. An Artifact Intelligence Act (AIA) for the European Union is also currently in preparation.