Digital twin outputs shall only be generated, accessed, and used for explicitly defined and legally justified purposes. Their use shall be subject to appropriate validation, traceability, auditability, and human oversight mechanisms. Outputs produced by clinical digital twins shall not be considered authoritative clinical decisions, diagnoses, or treatment recommendations unless the applicable clinical governance, regulatory, conformity assessment, and legal requirements have been fulfilled. The architecture shall ensure that digital twin outputs are used within their intended scope and that responsibility for clinical decision-making remains with qualified healthcare professionals where required.