{"id":"https://openalex.org/W7138919120","doi":"https://doi.org/10.1038/s41746-026-02552-2","title":"Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority","display_name":"Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority","publication_year":2026,"publication_date":"2026-03-19","ids":{"openalex":"https://openalex.org/W7138919120","doi":"https://doi.org/10.1038/s41746-026-02552-2","pmid":"https://pubmed.ncbi.nlm.nih.gov/41857339"},"language":"en","primary_location":{"id":"doi:10.1038/s41746-026-02552-2","is_oa":true,"landing_page_url":"https://doi.org/10.1038/s41746-026-02552-2","pdf_url":null,"source":{"id":"https://openalex.org/S4210195431","display_name":"npj Digital Medicine","issn_l":"2398-6352","issn":["2398-6352"],"is_oa":true,"is_in_doaj":true,"is_core":true,"host_organization":"https://openalex.org/P4310319908","host_organization_name":"Nature Portfolio","host_organization_lineage":["https://openalex.org/P4310319908","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Nature Portfolio","Springer Nature"],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"npj Digital Medicine","raw_type":"journal-article"},"type":"article","indexed_in":["crossref","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://doi.org/10.1038/s41746-026-02552-2","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5012027620","display_name":"Jasmine Chiat Ling Ong","orcid":"https://orcid.org/0000-0001-6916-5960"},"institutions":[{"id":"https://openalex.org/I2251586001","display_name":"Singapore General Hospital","ror":"https://ror.org/036j6sg82","country_code":"SG","type":"healthcare","lineage":["https://openalex.org/I2251586001"]},{"id":"https://openalex.org/I4210126319","display_name":"Duke-NUS Medical School","ror":"https://ror.org/02j1m6098","country_code":"SG","type":"education","lineage":["https://openalex.org/I165932596","https://openalex.org/I170897317","https://openalex.org/I4210126319"]}],"countries":["SG"],"is_corresponding":false,"raw_author_name":"Jasmine Chiat Ling Ong","raw_affiliation_strings":["Division of Pharmacy, Singapore General Hospital, Singapore, Singapore","Duke-NUS AI + Medical Sciences Initiative, Duke-NUS Medical School, Singapore, Singapore"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Division of Pharmacy, Singapore General Hospital, Singapore, Singapore","institution_ids":["https://openalex.org/I2251586001"]},{"raw_affiliation_string":"Duke-NUS AI + Medical Sciences Initiative, Duke-NUS Medical School, Singapore, Singapore","institution_ids":["https://openalex.org/I4210126319"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5130159094","display_name":"Yilin Ning","orcid":null},"institutions":[{"id":"https://openalex.org/I4210126319","display_name":"Duke-NUS Medical School","ror":"https://ror.org/02j1m6098","country_code":"SG","type":"education","lineage":["https://openalex.org/I165932596","https://openalex.org/I170897317","https://openalex.org/I4210126319"]}],"countries":["SG"],"is_corresponding":false,"raw_author_name":"Yilin Ning","raw_affiliation_strings":["Centre for Biomedical Data Science, Duke-NUS Medical School, Singapore, Singapore","Duke-NUS AI + Medical Sciences Initiative, Duke-NUS Medical School, Singapore, Singapore"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Centre for Biomedical Data Science, Duke-NUS Medical School, Singapore, Singapore","institution_ids":["https://openalex.org/I4210126319"]},{"raw_affiliation_string":"Duke-NUS AI + Medical Sciences Initiative, Duke-NUS Medical School, Singapore, Singapore","institution_ids":["https://openalex.org/I4210126319"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5129825800","display_name":"Mingxuan Liu","orcid":null},"institutions":[{"id":"https://openalex.org/I4210126319","display_name":"Duke-NUS Medical School","ror":"https://ror.org/02j1m6098","country_code":"SG","type":"education","lineage":["https://openalex.org/I165932596","https://openalex.org/I170897317","https://openalex.org/I4210126319"]}],"countries":["SG"],"is_corresponding":false,"raw_author_name":"Mingxuan Liu","raw_affiliation_strings":["Centre for Biomedical Data Science, Duke-NUS Medical School, Singapore, Singapore","Duke-NUS AI + Medical Sciences Initiative, Duke-NUS Medical School, Singapore, Singapore"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Centre for Biomedical Data Science, Duke-NUS Medical School, Singapore, Singapore","institution_ids":["https://openalex.org/I4210126319"]},{"raw_affiliation_string":"Duke-NUS AI + Medical Sciences Initiative, Duke-NUS Medical School, Singapore, Singapore","institution_ids":["https://openalex.org/I4210126319"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5004712973","display_name":"Yian Ma","orcid":null},"institutions":[{"id":"https://openalex.org/I4210126319","display_name":"Duke-NUS Medical School","ror":"https://ror.org/02j1m6098","country_code":"SG","type":"education","lineage":["https://openalex.org/I165932596","https://openalex.org/I170897317","https://openalex.org/I4210126319"]}],"countries":["SG"],"is_corresponding":false,"raw_author_name":"Yian Ma","raw_affiliation_strings":["Centre for Biomedical Data Science, Duke-NUS Medical School, Singapore, Singapore","Duke-NUS AI + Medical Sciences Initiative, Duke-NUS Medical School, Singapore, Singapore"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Centre for Biomedical Data Science, Duke-NUS Medical School, Singapore, Singapore","institution_ids":["https://openalex.org/I4210126319"]},{"raw_affiliation_string":"Duke-NUS AI + Medical Sciences Initiative, Duke-NUS Medical School, Singapore, Singapore","institution_ids":["https://openalex.org/I4210126319"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5129867983","display_name":"Liang Zhao","orcid":null},"institutions":[{"id":"https://openalex.org/I180670191","display_name":"University of California, San Francisco","ror":"https://ror.org/043mz5j54","country_code":"US","type":"education","lineage":["https://openalex.org/I180670191"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Liang Zhao","raw_affiliation_strings":["Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, CA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, CA, USA","institution_ids":["https://openalex.org/I180670191"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5112488187","display_name":"Kuldev Singh","orcid":null},"institutions":[{"id":"https://openalex.org/I97018004","display_name":"Stanford University","ror":"https://ror.org/00f54p054","country_code":"US","type":"education","lineage":["https://openalex.org/I97018004"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Kuldev Singh","raw_affiliation_strings":["Byers Eye Institute, Stanford University, Stanford, CA, USA","Stanford University School of Medicine, Stanford, CA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Byers Eye Institute, Stanford University, Stanford, CA, USA","institution_ids":["https://openalex.org/I97018004"]},{"raw_affiliation_string":"Stanford University School of Medicine, Stanford, CA, USA","institution_ids":["https://openalex.org/I97018004"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5002558627","display_name":"Robert T. Chang","orcid":"https://orcid.org/0000-0002-2950-7951"},"institutions":[{"id":"https://openalex.org/I97018004","display_name":"Stanford University","ror":"https://ror.org/00f54p054","country_code":"US","type":"education","lineage":["https://openalex.org/I97018004"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Robert T. Chang","raw_affiliation_strings":["Byers Eye Institute, Stanford University, Stanford, CA, USA","Stanford University School of Medicine, Stanford, CA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Byers Eye Institute, Stanford University, Stanford, CA, USA","institution_ids":["https://openalex.org/I97018004"]},{"raw_affiliation_string":"Stanford University School of Medicine, Stanford, CA, USA","institution_ids":["https://openalex.org/I97018004"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5072671828","display_name":"Silke Vogel","orcid":"https://orcid.org/0000-0002-6895-3567"},"institutions":[{"id":"https://openalex.org/I4210126319","display_name":"Duke-NUS Medical School","ror":"https://ror.org/02j1m6098","country_code":"SG","type":"education","lineage":["https://openalex.org/I165932596","https://openalex.org/I170897317","https://openalex.org/I4210126319"]}],"countries":["SG"],"is_corresponding":false,"raw_author_name":"Silke Vogel","raw_affiliation_strings":["Centre of Regulatory Excellence, Duke-NUS Medical School, Singapore, Singapore"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Centre of Regulatory Excellence, Duke-NUS Medical School, Singapore, Singapore","institution_ids":["https://openalex.org/I4210126319"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5037603455","display_name":"John C. W. Lim","orcid":"https://orcid.org/0000-0002-4286-4937"},"institutions":[{"id":"https://openalex.org/I4210126319","display_name":"Duke-NUS Medical School","ror":"https://ror.org/02j1m6098","country_code":"SG","type":"education","lineage":["https://openalex.org/I165932596","https://openalex.org/I170897317","https://openalex.org/I4210126319"]}],"countries":["SG"],"is_corresponding":false,"raw_author_name":"John C. W. Lim","raw_affiliation_strings":["Centre of Regulatory Excellence, Duke-NUS Medical School, Singapore, Singapore"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Centre of Regulatory Excellence, Duke-NUS Medical School, Singapore, Singapore","institution_ids":["https://openalex.org/I4210126319"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5012097248","display_name":"I Leng Tan","orcid":"https://orcid.org/0009-0005-5049-3725"},"institutions":[{"id":"https://openalex.org/I157582758","display_name":"SingHealth","ror":"https://ror.org/04me94w47","country_code":"SG","type":"healthcare","lineage":["https://openalex.org/I157582758"]}],"countries":["SG"],"is_corresponding":false,"raw_author_name":"Iris Siu Kwan Tan","raw_affiliation_strings":["Artificial Intelligence Office, Singapore Health Services, Singapore, Singapore"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Artificial Intelligence Office, Singapore Health Services, Singapore, Singapore","institution_ids":["https://openalex.org/I157582758"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5092757835","display_name":"Oscar Freyer","orcid":"https://orcid.org/0000-0003-3323-2492"},"institutions":[{"id":"https://openalex.org/I4210108778","display_name":"Fresenius (Germany)","ror":"https://ror.org/01v376g59","country_code":"DE","type":"company","lineage":["https://openalex.org/I4210108778"]},{"id":"https://openalex.org/I4405269091","display_name":"Else Kr\u00f6ner Fresenius Center for Digital Health","ror":"https://ror.org/031x70h91","country_code":"DE","type":"education","lineage":["https://openalex.org/I4210162051","https://openalex.org/I4405269091","https://openalex.org/I78650965"]},{"id":"https://openalex.org/I78650965","display_name":"Technische Universit\u00e4t Dresden","ror":"https://ror.org/042aqky30","country_code":"DE","type":"education","lineage":["https://openalex.org/I78650965"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Oscar Freyer","raw_affiliation_strings":["Else Kr\u00f6ner Fresenius Center for Digital Health, TUD Dresden University of Technology, Dresden, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Else Kr\u00f6ner Fresenius Center for Digital Health, TUD Dresden University of Technology, Dresden, Germany","institution_ids":["https://openalex.org/I78650965","https://openalex.org/I4210108778","https://openalex.org/I4405269091"]}]},{"author_position":"middle","author":{"id":null,"display_name":"Stephen Gilbert","orcid":null},"institutions":[{"id":"https://openalex.org/I4210108778","display_name":"Fresenius (Germany)","ror":"https://ror.org/01v376g59","country_code":"DE","type":"company","lineage":["https://openalex.org/I4210108778"]},{"id":"https://openalex.org/I4405269091","display_name":"Else Kr\u00f6ner Fresenius Center for Digital Health","ror":"https://ror.org/031x70h91","country_code":"DE","type":"education","lineage":["https://openalex.org/I4210162051","https://openalex.org/I4405269091","https://openalex.org/I78650965"]},{"id":"https://openalex.org/I78650965","display_name":"Technische Universit\u00e4t Dresden","ror":"https://ror.org/042aqky30","country_code":"DE","type":"education","lineage":["https://openalex.org/I78650965"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Stephen Gilbert","raw_affiliation_strings":["Else Kr\u00f6ner Fresenius Center for Digital Health, TUD Dresden University of Technology, Dresden, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Else Kr\u00f6ner Fresenius Center for Digital Health, TUD Dresden University of Technology, Dresden, Germany","institution_ids":["https://openalex.org/I78650965","https://openalex.org/I4210108778","https://openalex.org/I4405269091"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5129883804","display_name":"Danielle S. Bitterman","orcid":null},"institutions":[{"id":"https://openalex.org/I1283280774","display_name":"Brigham and Women's Hospital","ror":"https://ror.org/04b6nzv94","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1283280774","https://openalex.org/I48633490"]},{"id":"https://openalex.org/I136199984","display_name":"Harvard University","ror":"https://ror.org/03vek6s52","country_code":"US","type":"education","lineage":["https://openalex.org/I136199984"]},{"id":"https://openalex.org/I4210117453","display_name":"Dana-Farber Cancer Institute","ror":"https://ror.org/02jzgtq86","country_code":"US","type":"facility","lineage":["https://openalex.org/I4210117453"]},{"id":"https://openalex.org/I4210161994","display_name":"Dana-Farber Brigham Cancer Center","ror":"https://ror.org/05rgrbr06","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1283280774","https://openalex.org/I4210117453","https://openalex.org/I4210161994","https://openalex.org/I48633490"]},{"id":"https://openalex.org/I48633490","display_name":"Mass General Brigham","ror":"https://ror.org/04py2rh25","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I48633490"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Danielle S. Bitterman","raw_affiliation_strings":["Artificial Intelligence in Medicine (AIM) Program, Mass General Brigham, Harvard Medical School, Boston, MA, USA","Department of Radiation Oncology, Brigham and Women's Hospital/Dana-Farber Cancer Institute, Boston, MA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Artificial Intelligence in Medicine (AIM) Program, Mass General Brigham, Harvard Medical School, Boston, MA, USA","institution_ids":["https://openalex.org/I48633490","https://openalex.org/I136199984"]},{"raw_affiliation_string":"Department of Radiation Oncology, Brigham and Women's Hospital/Dana-Farber Cancer Institute, Boston, MA, USA","institution_ids":["https://openalex.org/I4210161994","https://openalex.org/I1283280774","https://openalex.org/I4210117453"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5127685837","display_name":"Xiaoxuan Liu","orcid":null},"institutions":[{"id":"https://openalex.org/I1308923049","display_name":"University Hospitals Birmingham NHS Foundation Trust","ror":"https://ror.org/014ja3n03","country_code":"GB","type":"healthcare","lineage":["https://openalex.org/I1308923049"]},{"id":"https://openalex.org/I3133184724","display_name":"University College Birmingham","ror":"https://ror.org/042ver755","country_code":"GB","type":"education","lineage":["https://openalex.org/I3133184724"]},{"id":"https://openalex.org/I79619799","display_name":"University of Birmingham","ror":"https://ror.org/03angcq70","country_code":"GB","type":"education","lineage":["https://openalex.org/I79619799"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"Xiaoxuan Liu","raw_affiliation_strings":["College of Medicine and Health, University of Birmingham, Birmingham, UK","University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"College of Medicine and Health, University of Birmingham, Birmingham, UK","institution_ids":["https://openalex.org/I3133184724","https://openalex.org/I79619799"]},{"raw_affiliation_string":"University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK","institution_ids":["https://openalex.org/I1308923049"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5130048229","display_name":"Alastair K. Denniston","orcid":null},"institutions":[{"id":"https://openalex.org/I1308923049","display_name":"University Hospitals Birmingham NHS Foundation Trust","ror":"https://ror.org/014ja3n03","country_code":"GB","type":"healthcare","lineage":["https://openalex.org/I1308923049"]},{"id":"https://openalex.org/I3133184724","display_name":"University College Birmingham","ror":"https://ror.org/042ver755","country_code":"GB","type":"education","lineage":["https://openalex.org/I3133184724"]},{"id":"https://openalex.org/I79619799","display_name":"University of Birmingham","ror":"https://ror.org/03angcq70","country_code":"GB","type":"education","lineage":["https://openalex.org/I79619799"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"Alastair K. Denniston","raw_affiliation_strings":["College of Medicine and Health, University of Birmingham, Birmingham, UK","University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"College of Medicine and Health, University of Birmingham, Birmingham, UK","institution_ids":["https://openalex.org/I3133184724","https://openalex.org/I79619799"]},{"raw_affiliation_string":"University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK","institution_ids":["https://openalex.org/I1308923049"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5130003731","display_name":"Nan Liu","orcid":null},"institutions":[{"id":"https://openalex.org/I165932596","display_name":"National University of Singapore","ror":"https://ror.org/01tgyzw49","country_code":"SG","type":"education","lineage":["https://openalex.org/I165932596"]},{"id":"https://openalex.org/I170897317","display_name":"Duke University","ror":"https://ror.org/00py81415","country_code":"US","type":"education","lineage":["https://openalex.org/I170897317"]},{"id":"https://openalex.org/I4210126319","display_name":"Duke-NUS Medical School","ror":"https://ror.org/02j1m6098","country_code":"SG","type":"education","lineage":["https://openalex.org/I165932596","https://openalex.org/I170897317","https://openalex.org/I4210126319"]}],"countries":["SG","US"],"is_corresponding":true,"raw_author_name":"Nan Liu","raw_affiliation_strings":["Centre for Biomedical Data Science, Duke-NUS Medical School, Singapore, Singapore. liu.nan@duke-nus.edu.sg","Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA. liu.nan@duke-nus.edu.sg","Duke-NUS AI + Medical Sciences Initiative, Duke-NUS Medical School, Singapore, Singapore. liu.nan@duke-nus.edu.sg","NUS Artificial Intelligence Institute, National University of Singapore, Singapore, Singapore. liu.nan@duke-nus.edu.sg","Pre-hospital & Emergency Research Centre, Health Services Research & Population Health, Duke-NUS Medical School, Singapore, Singapore. liu.nan@duke-nus.edu.sg"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Centre for Biomedical Data Science, Duke-NUS Medical School, Singapore, Singapore. liu.nan@duke-nus.edu.sg","institution_ids":["https://openalex.org/I4210126319"]},{"raw_affiliation_string":"Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA. liu.nan@duke-nus.edu.sg","institution_ids":["https://openalex.org/I170897317"]},{"raw_affiliation_string":"Duke-NUS AI + Medical Sciences Initiative, Duke-NUS Medical School, Singapore, Singapore. liu.nan@duke-nus.edu.sg","institution_ids":["https://openalex.org/I4210126319"]},{"raw_affiliation_string":"NUS Artificial Intelligence Institute, National University of Singapore, Singapore, Singapore. liu.nan@duke-nus.edu.sg","institution_ids":["https://openalex.org/I165932596"]},{"raw_affiliation_string":"Pre-hospital & Emergency Research Centre, Health Services Research & Population Health, Duke-NUS Medical School, Singapore, Singapore. liu.nan@duke-nus.edu.sg","institution_ids":["https://openalex.org/I4210126319"]}]}],"institutions":[],"countries_distinct_count":4,"institutions_distinct_count":18,"corresponding_author_ids":["https://openalex.org/A5130003731"],"corresponding_institution_ids":["https://openalex.org/I165932596","https://openalex.org/I170897317","https://openalex.org/I4210126319"],"apc_list":{"value":3060,"currency":"USD","value_usd":3060},"apc_paid":{"value":3060,"currency":"USD","value_usd":3060},"fwci":18.3269,"has_fulltext":false,"cited_by_count":3,"citation_normalized_percentile":{"value":0.99123774,"is_in_top_1_percent":true,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":98,"max":99},"biblio":{"volume":"9","issue":"1","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":0.7925999760627747,"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":0.7925999760627747,"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/T11642","display_name":"Genomics and Rare Diseases","score":0.024399999529123306,"subfield":{"id":"https://openalex.org/subfields/1311","display_name":"Genetics"},"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"}},{"id":"https://openalex.org/T13417","display_name":"Biomedical Ethics and Regulation","score":0.01590000092983246,"subfield":{"id":"https://openalex.org/subfields/2737","display_name":"Physiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/multidisciplinary-approach","display_name":"Multidisciplinary approach","score":0.7142999768257141},{"id":"https://openalex.org/keywords/generative-grammar","display_name":"Generative grammar","score":0.566100001335144},{"id":"https://openalex.org/keywords/health-care","display_name":"Health care","score":0.4300000071525574},{"id":"https://openalex.org/keywords/medical-device","display_name":"Medical device","score":0.2994000017642975},{"id":"https://openalex.org/keywords/biomedicine","display_name":"Biomedicine","score":0.2946999967098236},{"id":"https://openalex.org/keywords/medline","display_name":"MEDLINE","score":0.2784999907016754}],"concepts":[{"id":"https://openalex.org/C22467394","wikidata":"https://www.wikidata.org/wiki/Q849359","display_name":"Multidisciplinary approach","level":2,"score":0.7142999768257141},{"id":"https://openalex.org/C39890363","wikidata":"https://www.wikidata.org/wiki/Q36108","display_name":"Generative grammar","level":2,"score":0.566100001335144},{"id":"https://openalex.org/C56739046","wikidata":"https://www.wikidata.org/wiki/Q192060","display_name":"Knowledge management","level":1,"score":0.47110000252723694},{"id":"https://openalex.org/C160735492","wikidata":"https://www.wikidata.org/wiki/Q31207","display_name":"Health care","level":2,"score":0.4300000071525574},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.4066999852657318},{"id":"https://openalex.org/C539667460","wikidata":"https://www.wikidata.org/wiki/Q2414942","display_name":"Management science","level":1,"score":0.3921999931335449},{"id":"https://openalex.org/C2522767166","wikidata":"https://www.wikidata.org/wiki/Q2374463","display_name":"Data science","level":1,"score":0.3682999908924103},{"id":"https://openalex.org/C55587333","wikidata":"https://www.wikidata.org/wiki/Q1133029","display_name":"Engineering ethics","level":1,"score":0.3598000109195709},{"id":"https://openalex.org/C195094911","wikidata":"https://www.wikidata.org/wiki/Q14167904","display_name":"Process management","level":1,"score":0.3580999970436096},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.3465000092983246},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.31709998846054077},{"id":"https://openalex.org/C3020535179","wikidata":"https://www.wikidata.org/wiki/Q6554101","display_name":"Medical device","level":2,"score":0.2994000017642975},{"id":"https://openalex.org/C66782513","wikidata":"https://www.wikidata.org/wiki/Q864601","display_name":"Biomedicine","level":2,"score":0.2946999967098236},{"id":"https://openalex.org/C2779473830","wikidata":"https://www.wikidata.org/wiki/Q1540899","display_name":"MEDLINE","level":2,"score":0.2784999907016754},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.26829999685287476},{"id":"https://openalex.org/C2988170871","wikidata":"https://www.wikidata.org/wiki/Q11000047","display_name":"Healthcare system","level":3,"score":0.2653000056743622},{"id":"https://openalex.org/C110354214","wikidata":"https://www.wikidata.org/wiki/Q6314146","display_name":"Engineering management","level":1,"score":0.2648000121116638},{"id":"https://openalex.org/C167966045","wikidata":"https://www.wikidata.org/wiki/Q5532625","display_name":"Generative model","level":3,"score":0.2623000144958496},{"id":"https://openalex.org/C138816342","wikidata":"https://www.wikidata.org/wiki/Q189603","display_name":"Public health","level":2,"score":0.2565000057220459},{"id":"https://openalex.org/C12713177","wikidata":"https://www.wikidata.org/wiki/Q1900281","display_name":"Perspective (graphical)","level":2,"score":0.2556999921798706},{"id":"https://openalex.org/C3018838755","wikidata":"https://www.wikidata.org/wiki/Q31207","display_name":"Medical care","level":2,"score":0.2535000145435333}],"mesh":[],"locations_count":4,"locations":[{"id":"doi:10.1038/s41746-026-02552-2","is_oa":true,"landing_page_url":"https://doi.org/10.1038/s41746-026-02552-2","pdf_url":null,"source":{"id":"https://openalex.org/S4210195431","display_name":"npj Digital Medicine","issn_l":"2398-6352","issn":["2398-6352"],"is_oa":true,"is_in_doaj":true,"is_core":true,"host_organization":"https://openalex.org/P4310319908","host_organization_name":"Nature Portfolio","host_organization_lineage":["https://openalex.org/P4310319908","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Nature Portfolio","Springer Nature"],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"npj Digital Medicine","raw_type":"journal-article"},{"id":"pmid:41857339","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/41857339","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"NPJ digital medicine","raw_type":null},{"id":"pmh:oai:doaj.org/article:95bf25e596b4409689a22989359a9516","is_oa":false,"landing_page_url":"https://doaj.org/article/95bf25e596b4409689a22989359a9516","pdf_url":null,"source":{"id":"https://openalex.org/S4306401280","display_name":"DOAJ (DOAJ: Directory of Open Access Journals)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"npj Digital Medicine, Vol 9, Iss 1 (2026)","raw_type":"article"},{"id":"pmh:oai:pubmedcentral.nih.gov:13168469","is_oa":true,"landing_page_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13168469/","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":"other-oa","license_id":"https://openalex.org/licenses/other-oa","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"NPJ Digit Med","raw_type":"Text"}],"best_oa_location":{"id":"doi:10.1038/s41746-026-02552-2","is_oa":true,"landing_page_url":"https://doi.org/10.1038/s41746-026-02552-2","pdf_url":null,"source":{"id":"https://openalex.org/S4210195431","display_name":"npj Digital Medicine","issn_l":"2398-6352","issn":["2398-6352"],"is_oa":true,"is_in_doaj":true,"is_core":true,"host_organization":"https://openalex.org/P4310319908","host_organization_name":"Nature Portfolio","host_organization_lineage":["https://openalex.org/P4310319908","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Nature Portfolio","Springer Nature"],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"npj Digital Medicine","raw_type":"journal-article"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/17","display_name":"Partnerships for the goals","score":0.4664587676525116}],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":62,"referenced_works":["https://openalex.org/W1965717563","https://openalex.org/W2018588587","https://openalex.org/W2087351221","https://openalex.org/W2597254324","https://openalex.org/W3080484018","https://openalex.org/W3121368818","https://openalex.org/W3136552952","https://openalex.org/W3136960503","https://openalex.org/W3153651148","https://openalex.org/W3155216088","https://openalex.org/W3180354797","https://openalex.org/W3188572136","https://openalex.org/W4225161532","https://openalex.org/W4286488857","https://openalex.org/W4289528766","https://openalex.org/W4292367079","https://openalex.org/W4296101834","https://openalex.org/W4297239116","https://openalex.org/W4297243326","https://openalex.org/W4315436255","https://openalex.org/W4320730661","https://openalex.org/W4361213613","https://openalex.org/W4380538374","https://openalex.org/W4385575330","https://openalex.org/W4385708976","https://openalex.org/W4386110494","https://openalex.org/W4386230622","https://openalex.org/W4386867830","https://openalex.org/W4387821331","https://openalex.org/W4387966489","https://openalex.org/W4389917881","https://openalex.org/W4389992596","https://openalex.org/W4390943000","https://openalex.org/W4393867901","https://openalex.org/W4394943312","https://openalex.org/W4395026179","https://openalex.org/W4395053803","https://openalex.org/W4396730918","https://openalex.org/W4399210436","https://openalex.org/W4399737726","https://openalex.org/W4399940463","https://openalex.org/W4400324908","https://openalex.org/W4401759680","https://openalex.org/W4401820448","https://openalex.org/W4402057292","https://openalex.org/W4402313440","https://openalex.org/W4402348202","https://openalex.org/W4402564190","https://openalex.org/W4402748869","https://openalex.org/W4402794779","https://openalex.org/W4403420201","https://openalex.org/W4403420208","https://openalex.org/W4403547550","https://openalex.org/W4404787535","https://openalex.org/W4405079446","https://openalex.org/W4406152263","https://openalex.org/W4406649544","https://openalex.org/W4408967642","https://openalex.org/W4409157497","https://openalex.org/W4409695426","https://openalex.org/W4411829726","https://openalex.org/W4414564500"],"related_works":[],"abstract_inverted_index":{"The":[0],"integration":[1],"of":[2,30,38,68],"generative":[3],"AI":[4],"(GenAI)":[5],"and":[6,17,32,50,63],"large":[7],"language":[8],"models":[9],"(LLMs)":[10],"in":[11,55],"healthcare":[12],"presents":[13],"both":[14],"unprecedented":[15],"opportunities":[16],"challenges,":[18],"necessitating":[19],"innovative":[20],"regulatory":[21,56],"approaches.":[22],"In":[23],"this":[24],"perspective,":[25],"we":[26],"discuss":[27],"the":[28,36,66],"risks":[29],"GenAI":[31,47],"LLM-based":[33],"medical":[34,40],"devices,":[35],"limitations":[37],"current":[39],"device":[41],"regulation":[42],"frameworks":[43],"when":[44],"applied":[45],"to":[46],"or":[48],"LLMs,":[49],"advocate":[51],"for":[52],"global":[53],"collaboration":[54],"science":[57],"research":[58],"through":[59],"engaging":[60],"multidisciplinary":[61],"expertise":[62],"focusing":[64],"on":[65],"needs":[67],"diverse":[69],"populations.":[70]},"counts_by_year":[{"year":2026,"cited_by_count":3}],"updated_date":"2026-06-29T08:53:18.405633","created_date":"2026-03-20T00:00:00"}