The HTA CG (Member State Coordination Group on Health Technology Assessment) has published General Principles concerning the use of Artificial Intelligence in the preparation of dossiers for Joint Clinical Assessment (JCA) within Health Technology assessment processes.
For the purposes of the General Principles document, AI is defines as:
“all models (including generative models) developed through the process of machine learning, regardless of the specific model architecture”.
While acknowledging the benefits of AI for increasing efficiency, the General Principles call attention to related risks, including potential compromise of the completeness, methodological quality, and rigour of a JCA. AI should, consequently, be used transparently and in an accountable way to ensure accuracy and reliability of output.
The General Principles include a number of elements to be taken into account by Health Technology Developers (HTDs) in preparation of dossiers for JCAs using AI:
HTDs are accountable for the content, method, and findings of the evidence synthesis presented in the dossier. This includes if and how AI is used in development of evidence and how related output is validated;
Where AI is used in preparation of a JCA dossier this must be clearly documented in the dossier. This includes identification of all AI assisted steps, outputs, or judgements;
At a minimum the JCA dossier should include:
the name, version, and date of the AI tool used;
the developer of the tool; and
the specific purpose(s) for which it was used.