Lifecycle Assurance for AI-Enabled Clinical Software: A Systematic Literature Review (Supplementary Data and Replication Package)

Supplementary research materials accompanying the manuscript “Lifecycle Assurance for AI-Enabled Clinical Software: A Systematic Literature Review." The dataset covers 141 independent studies: 94 primary-practice studies and 47 framework contributions. It documents reported assurance practices, lifecycle coverage, evidence maturity, deployment and operational activities, regulatory engagement, and requirement-to-control-to-evidence mappings. This release includes:• Supplementary_Materials.pdf: review methods, search strings, eligibility rules, coding and appraisal criteria, selection summaries, and reviewer records.• Lifecycle_Assurance_Supplementary_Workbook.xlsx: the final study-level dataset, source rationales, classifications, appraisals, and calculated results.• Replication_Package_v1.0.0.zip: CSV data, Python scripts, reproduction instructions, decision records, and clearly labelled historical versions. Final maturity and regulatory classifications incorporate completed human reconciliation. The reviewer records distinguish the 68-study first-pass comparison from the subsequent 26-study review after exposure to the existing extraction. The scripts reproduce descriptive results, sensitivity analyses, joint-reporting measures, and initial reviewer-agreement statistics. Search-record and source-access limitations are documented in the accompanying materials.