{"id":"https://openalex.org/W7160548852","doi":"https://doi.org/10.48550/arxiv.2605.04085","title":"Evaluating Patient Safety Risks in Generative AI: Development and Validation of a FMECA Framework for Generated Clinical Content","display_name":"Evaluating Patient Safety Risks in Generative AI: Development and Validation of a FMECA Framework for Generated Clinical Content","publication_year":2026,"publication_date":"2026-04-23","ids":{"openalex":"https://openalex.org/W7160548852","doi":"https://doi.org/10.48550/arxiv.2605.04085"},"language":null,"primary_location":{"id":"doi:10.48550/arxiv.2605.04085","is_oa":true,"landing_page_url":"https://doi.org/10.48550/arxiv.2605.04085","pdf_url":null,"source":{"id":"https://openalex.org/S4306400194","display_name":"arXiv (Cornell University)","issn_l":"2331-8422","issn":["2331-8422"],"is_oa":true,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I205783295","host_organization_name":"Cornell University","host_organization_lineage":["https://openalex.org/I205783295"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"Preprint"},"type":"preprint","indexed_in":["datacite"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://doi.org/10.48550/arxiv.2605.04085","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5107488300","display_name":"Lydie Bednarczyk","orcid":null},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Bednarczyk, Lydie","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5084199339","display_name":"Jamil Zaghir","orcid":"https://orcid.org/0000-0002-8209-6098"},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Zaghir, Jamil","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5135590956","display_name":"Julien Ehrsam","orcid":null},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Ehrsam, Julien","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5135637005","display_name":"Maria Tcherepanova","orcid":null},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Tcherepanova, Maria","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5004861147","display_name":"Christian Skalafouris","orcid":"https://orcid.org/0000-0002-1648-1422"},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Skalafouris, Christian","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5135537767","display_name":"Karim Gariani","orcid":null},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Gariani, Karim","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5088990072","display_name":"Catherine Geslin","orcid":null},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Geslin, Catherine","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5050901014","display_name":"Claire\u2010B\u00e9n\u00e9dicte Rivara","orcid":null},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Rivara, Claire-B\u00e9n\u00e9dicte","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5001683266","display_name":"Pascal Bonnabry","orcid":"https://orcid.org/0000-0002-8690-649X"},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Bonnabry, Pascal","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5032630764","display_name":"La\u00ebtitia Gosetto","orcid":"https://orcid.org/0000-0002-9432-2160"},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Gosetto, Laetitia","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5083182688","display_name":"Richard Dubos","orcid":null},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Dubos, Richard","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5064859584","display_name":"Mina Bjelogrlic","orcid":"https://orcid.org/0000-0002-6922-3283"},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Bjelogrlic, Mina","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5083072992","display_name":"Christophe Gaudet-Blavignac","orcid":"https://orcid.org/0000-0001-6527-5898"},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Gaudet-Blavignac, Christophe","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"last","author":{"id":"https://openalex.org/A5135633605","display_name":"Christian Lovis","orcid":null},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Lovis, Christian","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":null,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"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":0.6776000261306763,"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":0.6776000261306763,"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/T10028","display_name":"Topic Modeling","score":0.06800000369548798,"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/T11710","display_name":"Biomedical Text Mining and Ontologies","score":0.04410000145435333,"subfield":{"id":"https://openalex.org/subfields/1312","display_name":"Molecular Biology"},"field":{"id":"https://openalex.org/fields/13","display_name":"Biochemistry, Genetics and Molecular Biology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/failure-mode-effects-and-criticality-analysis","display_name":"Failure mode, effects, and criticality analysis","score":0.8440999984741211},{"id":"https://openalex.org/keywords/usability","display_name":"Usability","score":0.760699987411499},{"id":"https://openalex.org/keywords/failure-mode-and-effects-analysis","display_name":"Failure mode and effects analysis","score":0.6039999723434448},{"id":"https://openalex.org/keywords/patient-safety","display_name":"Patient safety","score":0.5864999890327454},{"id":"https://openalex.org/keywords/reliability","display_name":"Reliability (semiconductor)","score":0.46219998598098755},{"id":"https://openalex.org/keywords/risk-assessment","display_name":"Risk assessment","score":0.4156000018119812},{"id":"https://openalex.org/keywords/identification","display_name":"Identification (biology)","score":0.39800000190734863}],"concepts":[{"id":"https://openalex.org/C30098461","wikidata":"https://www.wikidata.org/wiki/Q909342","display_name":"Failure mode, effects, and criticality analysis","level":3,"score":0.8440999984741211},{"id":"https://openalex.org/C170130773","wikidata":"https://www.wikidata.org/wiki/Q216378","display_name":"Usability","level":2,"score":0.760699987411499},{"id":"https://openalex.org/C66283442","wikidata":"https://www.wikidata.org/wiki/Q1389268","display_name":"Failure mode and effects analysis","level":2,"score":0.6039999723434448},{"id":"https://openalex.org/C2779328685","wikidata":"https://www.wikidata.org/wiki/Q1475557","display_name":"Patient safety","level":3,"score":0.5864999890327454},{"id":"https://openalex.org/C43214815","wikidata":"https://www.wikidata.org/wiki/Q7310987","display_name":"Reliability (semiconductor)","level":3,"score":0.46219998598098755},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.4374000132083893},{"id":"https://openalex.org/C12174686","wikidata":"https://www.wikidata.org/wiki/Q1058438","display_name":"Risk assessment","level":2,"score":0.4156000018119812},{"id":"https://openalex.org/C116834253","wikidata":"https://www.wikidata.org/wiki/Q2039217","display_name":"Identification (biology)","level":2,"score":0.39800000190734863},{"id":"https://openalex.org/C2909711754","wikidata":"https://www.wikidata.org/wiki/Q7100785","display_name":"Ordinal Scale","level":2,"score":0.36649999022483826},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.33550000190734863},{"id":"https://openalex.org/C200601418","wikidata":"https://www.wikidata.org/wiki/Q2193887","display_name":"Reliability engineering","level":1,"score":0.31769999861717224},{"id":"https://openalex.org/C189430467","wikidata":"https://www.wikidata.org/wiki/Q7293293","display_name":"Ranking (information retrieval)","level":2,"score":0.310699999332428},{"id":"https://openalex.org/C2778755073","wikidata":"https://www.wikidata.org/wiki/Q10858537","display_name":"Scale (ratio)","level":2,"score":0.2849999964237213},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.2768999934196472},{"id":"https://openalex.org/C2779343474","wikidata":"https://www.wikidata.org/wiki/Q3109175","display_name":"Context (archaeology)","level":2,"score":0.2732999920845032},{"id":"https://openalex.org/C63527458","wikidata":"https://www.wikidata.org/wiki/Q5133829","display_name":"Clinical decision support system","level":3,"score":0.27320000529289246},{"id":"https://openalex.org/C168167062","wikidata":"https://www.wikidata.org/wiki/Q1117970","display_name":"Component (thermodynamics)","level":2,"score":0.26460000872612},{"id":"https://openalex.org/C32896092","wikidata":"https://www.wikidata.org/wiki/Q189447","display_name":"Risk management","level":2,"score":0.25049999356269836}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.48550/arxiv.2605.04085","is_oa":true,"landing_page_url":"https://doi.org/10.48550/arxiv.2605.04085","pdf_url":null,"source":{"id":"https://openalex.org/S4306400194","display_name":"arXiv (Cornell University)","issn_l":"2331-8422","issn":["2331-8422"],"is_oa":true,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I205783295","host_organization_name":"Cornell University","host_organization_lineage":["https://openalex.org/I205783295"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":null,"is_accepted":false,"is_published":null,"raw_source_name":null,"raw_type":"Preprint"}],"best_oa_location":{"id":"doi:10.48550/arxiv.2605.04085","is_oa":true,"landing_page_url":"https://doi.org/10.48550/arxiv.2605.04085","pdf_url":null,"source":{"id":"https://openalex.org/S4306400194","display_name":"arXiv (Cornell University)","issn_l":"2331-8422","issn":["2331-8422"],"is_oa":true,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I205783295","host_organization_name":"Cornell University","host_organization_lineage":["https://openalex.org/I205783295"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"Preprint"},"sustainable_development_goals":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":[],"abstract_inverted_index":{"Objectives:":[0],"Large":[1],"language":[2],"models":[3],"(LLMs)":[4],"are":[5],"increasingly":[6],"used":[7],"for":[8,34,58,184,191,218,236],"clinical":[9,45,68,123,226],"text":[10],"summarization,":[11],"yet":[12],"structured":[13,163,232],"methods":[14],"to":[15,43,50,107],"assess":[16],"associated":[17],"patient":[18,63,220],"safety":[19,64,221],"risks":[20,65,240],"remain":[21],"limited.":[22],"Failure":[23],"Mode,":[24],"Effects,":[25],"and":[26,52,71,89,146,151,162,188,193,209,233],"Criticality":[27],"Analysis":[28],"(FMECA)":[29],"provides":[30,230],"a":[31,54,81,231],"proactive":[32],"framework":[33,57,104,168,217,229],"systematic":[35,219],"risk":[36,222],"identification":[37,187],"but":[38],"has":[39],"not":[40],"been":[41],"adapted":[42,98,158],"LLM-generated":[44,67,225],"content.":[46],"This":[47,211],"study":[48,212],"aimed":[49],"develop":[51],"validate":[53],"novel":[55],"FMECA":[56,92],"the":[59,126,133,214],"prospective":[60],"assessment":[61,223],"of":[62,83,224],"in":[66],"summaries.":[69,227,244],"Materials":[70],"Methods:":[72],"An":[73],"interdisciplinary":[74],"expert":[75],"panel":[76],"(n":[77],"=":[78],"8)":[79],"developed":[80],"taxonomy":[82],"failure":[84,143,171,185],"modes":[85,172],"through":[86],"literature":[87],"review":[88],"brainstorming.":[90],"Standard":[91],"dimensions":[93],"(occurrence,":[94],"severity,":[95],"detectability)":[96],"were":[97,154],"into":[99,174],"5-point":[100],"ordinal":[101],"scales.":[102],"The":[103,166,228],"was":[105,140,197],"applied":[106],"36":[108],"discharge":[109],"summaries":[110,134],"from":[111,125],"four":[112],"patients,":[113],"generated":[114],"by":[115,242],"an":[116,157],"open":[117],"LLM":[118],"(GPT-OSS":[119],"120B)":[120],"using":[121,156],"real-world":[122],"data":[124],"Geneva":[127],"University":[128],"Hospitals.":[129],"Reviewers":[130],"independently":[131],"annotated":[132],"across":[135],"two":[136],"rounds.":[137],"Inter-rater":[138,176],"reliability":[139],"assessed":[141],"at":[142],"mode,":[144],"severity":[145,192],"detectability":[147,194],"score":[148],"levels.":[149],"Usability":[150,160,196],"content":[152],"validity":[153],"evaluated":[155],"System":[159],"Scale":[161],"feedback.":[164],"Results:":[165],"final":[167],"comprised":[169],"14":[170],"organized":[173],"categories.":[175],"agreement":[177,183,190],"improved":[178],"between":[179],"rounds,":[180],"reaching":[181],"moderate-to-substantial":[182],"mode":[186],"good":[189,200],"scoring.":[195],"rated":[198],"as":[199],"(mean":[201],"SUS:":[202],"79.2/100),":[203],"with":[204],"high":[205],"evaluator":[206],"confidence.":[207],"Discussion":[208],"Conclusion:":[210],"presents":[213],"first":[215],"FMECA-based":[216],"reproducible":[234],"method":[235],"identifying":[237],"clinically":[238],"relevant":[239],"caused":[241],"these":[243]},"counts_by_year":[],"updated_date":"2026-07-28T07:46:37.118299","created_date":"2026-05-08T00:00:00"}