Table 1.

Digital- and AI-guided/-enabled personalised drug and cell therapy and therapy management in oncology.

#	Digital- and AI-guided/-enabled personalised drug and cell therapy and therapy management approach	Summary of transition to implementation
1	Clinical decision support (CDS) systems that facilitate therapy planning43	Some approaches are advanced in approval pathways and others are in early implementation. In the US, some have a non-device status not requiring specific regulatory approval43
2	Precision diagnostics (including companion and complementary diagnostics59), and AI-based multi-cancer early detection (MCED) tests10,117	Some approaches are advanced in approval pathways and others are in early implementation. In the US some are available under clinical laboratory waiver (US118)
3	Drug companion apps that personalise therapy regime management and adaptation53,72,73	Some approaches are in late development and clinical validation
4	personalised ATMP design9,20–23	Some approaches are in late development and clinical validation
5	Digital twins as an emerging concept in diagnosis and therapy - integrate near-real-time patient data management with simulation-/model-based diagnosis and therapy design and monitoring91,93 and generalist medical AI approaches of broad purpose medical AI32,68	largely theoretical/ research concepts not yet in as generalised approaches in approval pathways