{"id":"https://openalex.org/W7203535625","doi":"https://doi.org/10.5281/zenodo.21942390","title":"An Enterprise AI Assurance Framework for Biomedical Diagnostics: Integrating a Human Validation Boundary and a Multidimensional Assurance Score into a Lifecycle Governance Model","display_name":"An Enterprise AI Assurance Framework for Biomedical Diagnostics: Integrating a Human Validation Boundary and a Multidimensional Assurance Score into a Lifecycle Governance Model","publication_year":2026,"publication_date":"2026-08-13","ids":{"openalex":"https://openalex.org/W7203535625","doi":"https://doi.org/10.5281/zenodo.21942390"},"language":"en","primary_location":{"id":"doi:10.5281/zenodo.21942390","doi":"https://doi.org/10.5281/zenodo.21942390","is_oa":true,"landing_page_url":"https://doi.org/10.5281/zenodo.21942390","pdf_url":null,"source":{"id":"https://openalex.org/S2738238905","display_name":"Informatics","issn_l":"2227-9709","issn":["2227-9709"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","jufo-1","norway-1","poland-20","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310310987","host_organization_name":"Multidisciplinary Digital Publishing Institute","host_organization_lineage":["https://openalex.org/P4310310987"],"host_organization_lineage_names":["Multidisciplinary Digital Publishing Institute"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"article-journal"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["datacite","doaj"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://doi.org/10.5281/zenodo.21942390","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5133706693","display_name":"Rakesh Kumar Agrawal","orcid":"https://orcid.org/0009-0009-7113-5539","observed_orcids":["https://orcid.org/0009-0009-7113-5539"]},"institutions":[{"id":"https://openalex.org/I3132238960","display_name":"Institute of Electrical and Electronics Engineers","ror":"https://ror.org/01n002310","country_code":"US","type":"education","lineage":["https://openalex.org/I3132238960"]},{"id":"https://openalex.org/I4210120424","display_name":"Atos (United States)","ror":"https://ror.org/02m0v4a06","country_code":"US","type":"company","lineage":["https://openalex.org/I170138621","https://openalex.org/I4210120424"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Rakesh Kumar, Agrawal","raw_affiliation_strings":["Atos (United States)","Institute of Electrical and Electronics Engineers"],"raw_orcid":"https://orcid.org/0009-0009-7113-5539","affiliations":[{"raw_affiliation_string":"Atos (United States)","institution_ids":["https://openalex.org/I4210120424"]},{"raw_affiliation_string":"Institute of Electrical and Electronics Engineers","institution_ids":["https://openalex.org/I3132238960"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":["https://openalex.org/A5133706693"],"corresponding_institution_ids":["https://openalex.org/I3132238960","https://openalex.org/I4210120424"],"apc_list":{"value":1800,"currency":"CHF","value_usd":2172},"apc_paid":{"value":1800,"currency":"CHF","value_usd":2172},"fwci":1.299,"has_fulltext":false,"cited_by_count":1,"citation_normalized_percentile":{"value":0.86691399,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":91,"max":95},"biblio":{"volume":null,"issue":null,"first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11636","display_name":"Artificial Intelligence in Healthcare and Education","score":0.5160999894142151,"subfield":{"id":"https://openalex.org/subfields/2718","display_name":"Health Informatics"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T11636","display_name":"Artificial Intelligence in Healthcare and Education","score":0.5160999894142151,"subfield":{"id":"https://openalex.org/subfields/2718","display_name":"Health Informatics"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T12026","display_name":"Explainable Artificial Intelligence (XAI)","score":0.45559999346733093,"subfield":{"id":"https://openalex.org/subfields/1702","display_name":"Artificial Intelligence"},"field":{"id":"https://openalex.org/fields/17","display_name":"Computer Science"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T13295","display_name":"Safety Systems Engineering in Autonomy","score":0.01769999973475933,"subfield":{"id":"https://openalex.org/subfields/2213","display_name":"Safety, Risk, Reliability and Quality"},"field":{"id":"https://openalex.org/fields/22","display_name":"Engineering"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/biomedical-diagnostics","display_name":"biomedical diagnostics","score":0.9440000057220459},{"id":"https://openalex.org/keywords/trustworthy-ai","display_name":"trustworthy AI","score":0.9570000171661377},{"id":"https://openalex.org/keywords/ai-governance","display_name":"AI governance","score":0.4359999895095825},{"id":"https://openalex.org/keywords/clinical-decision-support","display_name":"clinical decision support","score":0.7329999804496765},{"id":"https://openalex.org/keywords/explainability","display_name":"explainability","score":0.8830000162124634},{"id":"https://openalex.org/keywords/ai-safety-evaluation","display_name":"AI safety evaluation","score":0.6549999713897705},{"id":"https://openalex.org/keywords/algorithmic-fairness","display_name":"algorithmic fairness","score":0.8659999966621399},{"id":"https://openalex.org/keywords/continuous-monitoring","display_name":"continuous monitoring","score":0.699999988079071},{"id":"https://openalex.org/keywords/ai-lifecycle-management","display_name":"AI lifecycle management","score":0.5410000085830688},{"id":"https://openalex.org/keywords/human-in-the-loop-validation","display_name":"human-in-the-loop validation","score":0.578000009059906}],"concepts":[{"id":"https://openalex.org/C157170001","wikidata":"https://www.wikidata.org/wiki/Q4781507","display_name":"Applications of artificial intelligence","level":2,"score":0.5946999788284302},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.5490999817848206},{"id":"https://openalex.org/C154945302","wikidata":"https://www.wikidata.org/wiki/Q11660","display_name":"Artificial intelligence","level":1,"score":0.462799996137619},{"id":"https://openalex.org/C106436119","wikidata":"https://www.wikidata.org/wiki/Q836575","display_name":"Quality assurance","level":3,"score":0.38760000467300415},{"id":"https://openalex.org/C63527458","wikidata":"https://www.wikidata.org/wiki/Q5133829","display_name":"Clinical decision support system","level":3,"score":0.36469998955726624},{"id":"https://openalex.org/C26517878","wikidata":"https://www.wikidata.org/wiki/Q228039","display_name":"Key (lock)","level":2,"score":0.36419999599456787},{"id":"https://openalex.org/C43214815","wikidata":"https://www.wikidata.org/wiki/Q7310987","display_name":"Reliability (semiconductor)","level":3,"score":0.3490000069141388},{"id":"https://openalex.org/C160735492","wikidata":"https://www.wikidata.org/wiki/Q31207","display_name":"Health care","level":2,"score":0.3488999903202057},{"id":"https://openalex.org/C107327155","wikidata":"https://www.wikidata.org/wiki/Q330268","display_name":"Decision support system","level":2,"score":0.30649998784065247},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.2879999876022339},{"id":"https://openalex.org/C56739046","wikidata":"https://www.wikidata.org/wiki/Q192060","display_name":"Knowledge management","level":1,"score":0.28040000796318054},{"id":"https://openalex.org/C195094911","wikidata":"https://www.wikidata.org/wiki/Q14167904","display_name":"Process management","level":1,"score":0.275299996137619},{"id":"https://openalex.org/C22607594","wikidata":"https://www.wikidata.org/wiki/Q5375150","display_name":"Enabling","level":2,"score":0.2648000121116638},{"id":"https://openalex.org/C153701036","wikidata":"https://www.wikidata.org/wiki/Q659974","display_name":"Trustworthiness","level":2,"score":0.2644999921321869},{"id":"https://openalex.org/C39389867","wikidata":"https://www.wikidata.org/wiki/Q380767","display_name":"Corporate governance","level":2,"score":0.25870001316070557},{"id":"https://openalex.org/C184356942","wikidata":"https://www.wikidata.org/wiki/Q830382","display_name":"Best practice","level":2,"score":0.25769999623298645},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.2529999911785126}],"mesh":[],"locations_count":2,"locations":[{"id":"doi:10.5281/zenodo.21942390","doi":"https://doi.org/10.5281/zenodo.21942390","is_oa":true,"landing_page_url":"https://doi.org/10.5281/zenodo.21942390","pdf_url":null,"source":{"id":"https://openalex.org/S2738238905","display_name":"Informatics","issn_l":"2227-9709","issn":["2227-9709"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","jufo-1","norway-1","poland-20","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310310987","host_organization_name":"Multidisciplinary Digital Publishing Institute","host_organization_lineage":["https://openalex.org/P4310310987"],"host_organization_lineage_names":["Multidisciplinary Digital Publishing Institute"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"article-journal"},{"id":"doi:10.5281/zenodo.21942391","doi":"https://doi.org/10.5281/zenodo.21942391","is_oa":true,"landing_page_url":"https://doi.org/10.5281/zenodo.21942391","pdf_url":null,"source":{"id":"https://openalex.org/S4306400562","display_name":"Zenodo (CERN European Organization for Nuclear Research)","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I67311998","host_organization_name":"European Organization for Nuclear Research","host_organization_lineage":["https://openalex.org/I67311998"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"article-journal"}],"best_oa_location":{"id":"doi:10.5281/zenodo.21942390","doi":"https://doi.org/10.5281/zenodo.21942390","is_oa":true,"landing_page_url":"https://doi.org/10.5281/zenodo.21942390","pdf_url":null,"source":{"id":"https://openalex.org/S2738238905","display_name":"Informatics","issn_l":"2227-9709","issn":["2227-9709"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","jufo-1","norway-1","poland-20","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310310987","host_organization_name":"Multidisciplinary Digital Publishing Institute","host_organization_lineage":["https://openalex.org/P4310310987"],"host_organization_lineage_names":["Multidisciplinary Digital Publishing Institute"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"article-journal"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","score":0.6240000128746033,"display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W7212316141","https://openalex.org/W4300933612","https://openalex.org/W7160060453","https://openalex.org/W7136250785","https://openalex.org/W6991715773","https://openalex.org/W7165237111","https://openalex.org/W7155438700","https://openalex.org/W7215329528","https://openalex.org/W4416144270","https://openalex.org/W7168295317"],"abstract_inverted_index":{"Artificial":[0],"intelligence":[1,245],"(AI)":[2],"has":[3],"demonstrated":[4],"significant":[5],"potential":[6],"for":[7,64,74,86,230,253],"transforming":[8],"biomedical":[9,106,232,261],"diagnostics":[10,262],"through":[11,212],"advanced":[12],"pattern":[13],"recognition,":[14],"predictive":[15,52],"modeling,":[16],"and":[17,41,58,72,100,137,161,171,173,197,210,217,241,269],"clinical":[18,76,162,244],"decision":[19],"support.":[20],"However,":[21],"the":[22,81,96,148,175],"adoption":[23],"of":[24,103],"AI":[25,46,67,83,114,177,187,221,233,259],"systems":[26,68,234],"in":[27,260],"healthcare":[28,166],"remains":[29],"challenged":[30],"by":[31,124,263],"limitations":[32],"associated":[33],"with":[34,219],"explainability,":[35,192],"reliability,":[36,191],"safety,":[37,193],"fairness,":[38,194],"human":[39,134,195],"confidence,":[40,196],"continuous":[42,101,138],"operational":[43],"monitoring.":[44],"Current":[45],"evaluation":[47,123,183,222],"approaches":[48],"primarily":[49],"focus":[50],"on":[51],"performance":[53],"metrics,":[54],"such":[55],"as":[56],"accuracy":[57],"sensitivity,":[59],"while":[60],"providing":[61],"limited":[62],"mechanisms":[63],"assessing":[65],"whether":[66],"are":[69],"trustworthy,":[70,239],"interpretable,":[71],"suitable":[73],"real-world":[75],"environments.":[77],"This":[78,247],"study":[79],"proposes":[80],"Enterprise":[82],"Assurance":[84,115,178],"Framework":[85],"Biomedical":[87,176],"Diagnostics":[88],"(EAIA-BD),":[89],"a":[90,154,181,206,227,250,273],"human-centered":[91,267],"framework":[92,111,142,225],"designed":[93],"to":[94,256],"support":[95],"development,":[97],"evaluation,":[98,131],"deployment,":[99],"governance":[102],"trustworthy":[104],"AI-enabled":[105],"diagnostic":[107],"systems.":[108,246],"The":[109,141,200,224],"proposed":[110,201],"introduces":[112,143],"an":[113],"Intelligence":[116],"Layer":[117],"that":[118,165,185],"extends":[119],"beyond":[120],"conventional":[121],"model":[122,184,252],"integrating":[125,264],"reliability":[126],"assessment,":[127,133,214],"explainability":[128],"analysis,":[129,216],"safety":[130],"fairness":[132],"confidence":[135],"considerations,":[136],"monitoring":[139,198],"capabilities.":[140],"two":[144],"key":[145],"contributions:":[146],"(1)":[147],"Human":[149],"Validation":[150],"Boundary,":[151],"which":[152],"establishes":[153],"structured":[155],"interaction":[156],"point":[157],"between":[158],"AI-generated":[159],"recommendations":[160],"decision-making,":[163],"ensuring":[164],"professionals":[167],"retain":[168],"validation":[169],"authority":[170],"accountability;":[172],"(2)":[174],"Score":[179],"(BAAS),":[180],"multidimensional":[182],"measures":[186],"system":[188],"readiness":[189],"across":[190],"dimensions.":[199],"approach":[202],"is":[203],"developed":[204],"using":[205],"design":[207],"science":[208],"methodology":[209],"evaluated":[211],"expert-oriented":[213],"scenario-based":[215],"comparison":[218],"traditional":[220],"approaches.":[223],"provides":[226],"systematic":[228],"pathway":[229],"transitioning":[231],"from":[235],"accuracy-focused":[236],"models":[237],"toward":[238],"explainable,":[240],"continuously":[242],"assured":[243],"research":[248],"contributes":[249],"reference":[251],"organizations":[254],"seeking":[255],"responsibly":[257],"adopt":[258],"technical":[265],"performance,":[266],"validation,":[268],"lifecycle-based":[270],"assurance":[271],"into":[272],"unified":[274],"framework.":[275]},"counts_by_year":[{"year":2026,"cited_by_count":1}],"updated_date":"2026-11-08T12:12:28.789561","created_date":"2026-08-16T00:00:00"}
