PubMed

Towards a feature-based regulatory benchmark for user-centred SaMD design in cancer care.

PMID: 42173550 · 2026-05-22

S, a, b, a, , K, h, e, i, r, i, n, e, j, a, d, ;, , C, h, r, i, s, t, o, p, h, e, r, , L, , B, r, e, t, t, ;, , R, o, b, e, r, t, , L, , D, a, v, i, s, ;, , D, a, v, i, d, , L, , S, c, h, w, a, r, t, z, ;, , A, r, a, s, h, , S, h, a, b, a, n, -, N, e, j, a, d

学術誌BMJ health & care informatics

年2026-05-22

PMID42173550

抄録

Software as a medical device (SaMD) is increasingly central to cancer care, yet current regulatory frameworks from the International Medical Device Regulators, the US Food and Drug Administration and the European Medical Device Regulation lack clear premarket standards for evaluating usability, accessibility and emotional/cultural appropriateness for intended users. This gap is particularly problematic in oncology, where patients, caregivers and clinicians navigate high cognitive load, emotional

公式ソース

PubMedで見る →

データはPubMed / NCBIから取得しています。全文および最新情報は必ず公式記録をご確認ください。