{"id":"https://openalex.org/W4402597169","doi":"https://doi.org/10.1038/s41746-024-01254-x","title":"Regulatory responses and approval status of artificial intelligence medical devices with a focus on China","display_name":"Regulatory responses and approval status of artificial intelligence medical devices with a focus on China","publication_year":2024,"publication_date":"2024-09-18","ids":{"openalex":"https://openalex.org/W4402597169","doi":"https://doi.org/10.1038/s41746-024-01254-x","pmid":"https://pubmed.ncbi.nlm.nih.gov/39294318"},"language":"en","primary_location":{"id":"doi:10.1038/s41746-024-01254-x","is_oa":true,"landing_page_url":"https://doi.org/10.1038/s41746-024-01254-x","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":"review","indexed_in":["crossref","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://doi.org/10.1038/s41746-024-01254-x","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5100747879","display_name":"Yuehua Liu","orcid":"https://orcid.org/0000-0002-0312-6763"},"institutions":[{"id":"https://openalex.org/I141962983","display_name":"Shanghai University of Engineering Science","ror":"https://ror.org/0557b9y08","country_code":"CN","type":"education","lineage":["https://openalex.org/I141962983"]}],"countries":["CN"],"is_corresponding":true,"raw_author_name":"Yuehua Liu","raw_affiliation_strings":["School of Computer Engineering and Science, Shanghai University, Shanghai, China"],"affiliations":[{"raw_affiliation_string":"School of Computer Engineering and Science, Shanghai University, Shanghai, China","institution_ids":["https://openalex.org/I141962983"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5052119310","display_name":"Wenjin Yu","orcid":"https://orcid.org/0000-0002-1101-5588"},"institutions":[{"id":"https://openalex.org/I2801556517","display_name":"Ruijin Hospital","ror":"https://ror.org/01hv94n30","country_code":"CN","type":"healthcare","lineage":["https://openalex.org/I2801556517"]}],"countries":["CN"],"is_corresponding":false,"raw_author_name":"Wenjin Yu","raw_affiliation_strings":["United Imaging Healthcare, Institute for medical imaging technology in Shanghai Ruijin Hospital, Shanghai Jiaotong University, Shanghai, China. yuwenjin0517@gmail.com"],"affiliations":[{"raw_affiliation_string":"United Imaging Healthcare, Institute for medical imaging technology in Shanghai Ruijin Hospital, Shanghai Jiaotong University, Shanghai, China. yuwenjin0517@gmail.com","institution_ids":["https://openalex.org/I2801556517"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5049421085","display_name":"Tharam S. Dillon","orcid":"https://orcid.org/0000-0002-7527-129X"},"institutions":[{"id":"https://openalex.org/I196829312","display_name":"La Trobe University","ror":"https://ror.org/01rxfrp27","country_code":"AU","type":"education","lineage":["https://openalex.org/I196829312"]}],"countries":["AU"],"is_corresponding":false,"raw_author_name":"Tharam Dillon","raw_affiliation_strings":["Department of Computer Science and Information Technology, La Trobe University, Melbourne, Australia"],"affiliations":[{"raw_affiliation_string":"Department of Computer Science and Information Technology, La Trobe University, Melbourne, Australia","institution_ids":["https://openalex.org/I196829312"]}]}],"institutions":[],"countries_distinct_count":2,"institutions_distinct_count":3,"corresponding_author_ids":["https://openalex.org/A5100747879"],"corresponding_institution_ids":["https://openalex.org/I141962983"],"apc_list":{"value":3060,"currency":"USD","value_usd":3060},"apc_paid":{"value":3060,"currency":"USD","value_usd":3060},"fwci":3.2501,"has_fulltext":true,"cited_by_count":27,"citation_normalized_percentile":{"value":0.9250847,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":90,"max":100},"biblio":{"volume":"7","issue":"1","first_page":"255","last_page":"255"},"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":0.9994000196456909,"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":0.9994000196456909,"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/T10582","display_name":"Ethics in Clinical Research","score":0.9143999814987183,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"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/china","display_name":"China","score":0.8258946537971497},{"id":"https://openalex.org/keywords/focus","display_name":"Focus (optics)","score":0.6955887079238892},{"id":"https://openalex.org/keywords/regulatory-focus-theory","display_name":"Regulatory focus theory","score":0.44251346588134766},{"id":"https://openalex.org/keywords/business","display_name":"Business","score":0.3647778034210205},{"id":"https://openalex.org/keywords/political-science","display_name":"Political science","score":0.30878937244415283},{"id":"https://openalex.org/keywords/law","display_name":"Law","score":0.10740643739700317}],"concepts":[{"id":"https://openalex.org/C191935318","wikidata":"https://www.wikidata.org/wiki/Q148","display_name":"China","level":2,"score":0.8258946537971497},{"id":"https://openalex.org/C192209626","wikidata":"https://www.wikidata.org/wiki/Q190909","display_name":"Focus (optics)","level":2,"score":0.6955887079238892},{"id":"https://openalex.org/C191160116","wikidata":"https://www.wikidata.org/wiki/Q3423709","display_name":"Regulatory focus theory","level":3,"score":0.44251346588134766},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.3647778034210205},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.30878937244415283},{"id":"https://openalex.org/C199539241","wikidata":"https://www.wikidata.org/wiki/Q7748","display_name":"Law","level":1,"score":0.10740643739700317},{"id":"https://openalex.org/C11012388","wikidata":"https://www.wikidata.org/wiki/Q170658","display_name":"Creativity","level":2,"score":0.0},{"id":"https://openalex.org/C120665830","wikidata":"https://www.wikidata.org/wiki/Q14620","display_name":"Optics","level":1,"score":0.0},{"id":"https://openalex.org/C121332964","wikidata":"https://www.wikidata.org/wiki/Q413","display_name":"Physics","level":0,"score":0.0}],"mesh":[],"locations_count":4,"locations":[{"id":"doi:10.1038/s41746-024-01254-x","is_oa":true,"landing_page_url":"https://doi.org/10.1038/s41746-024-01254-x","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:39294318","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/39294318","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:pubmedcentral.nih.gov:11410966","is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/11410966","pdf_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11410966/pdf/41746_2024_Article_1254.pdf","source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","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":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"NPJ Digit Med","raw_type":"Text"},{"id":"pmh:oai:doaj.org/article:445ebe5d0ca7466888d55d34792cc36c","is_oa":true,"landing_page_url":"https://doaj.org/article/445ebe5d0ca7466888d55d34792cc36c","pdf_url":null,"source":{"id":"https://openalex.org/S112646816","display_name":"SHILAP Revista de lepidopterolog\u00eda","issn_l":"0300-5267","issn":["0300-5267","2340-4078"],"is_oa":true,"is_in_doaj":true,"is_core":false,"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"npj Digital Medicine, Vol 7, Iss 1, Pp 1-11 (2024)","raw_type":"article"}],"best_oa_location":{"id":"doi:10.1038/s41746-024-01254-x","is_oa":true,"landing_page_url":"https://doi.org/10.1038/s41746-024-01254-x","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","score":0.44999998807907104,"display_name":"Partnerships for the goals"}],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":14,"referenced_works":["https://openalex.org/W1494192115","https://openalex.org/W2803760365","https://openalex.org/W2887382745","https://openalex.org/W2906295032","https://openalex.org/W2974839292","https://openalex.org/W3033545112","https://openalex.org/W3084438218","https://openalex.org/W3086667591","https://openalex.org/W3136907493","https://openalex.org/W3143784018","https://openalex.org/W4280488363","https://openalex.org/W4283757941","https://openalex.org/W4394717747","https://openalex.org/W4394857110"],"related_works":["https://openalex.org/W4391375266","https://openalex.org/W2748952813","https://openalex.org/W2130669815","https://openalex.org/W1974376575","https://openalex.org/W4379622723","https://openalex.org/W2505213637","https://openalex.org/W2322190746","https://openalex.org/W1522358894","https://openalex.org/W2774401847","https://openalex.org/W2602470606"],"abstract_inverted_index":{"This":[0],"paper":[1],"focuses":[2],"on":[3],"how":[4],"regulatory":[5,55],"bodies":[6],"respond":[7],"to":[8,52],"artificial":[9],"intelligence":[10],"(AI)-enabled":[11],"medical":[12,41],"devices.":[13],"To":[14],"achieve":[15],"this,":[16],"we":[17],"present":[18],"a":[19],"comparative":[20],"overview":[21],"of":[22,47],"the":[23,35,53,59,62],"United":[24],"States":[25],"(USA),":[26],"European":[27],"Union":[28],"(EU),":[29],"and":[30,64],"China.":[31],"Our":[32],"search":[33],"in":[34,44,57,61],"governmental":[36],"database":[37],"identified":[38],"59":[39],"AI":[40],"devices":[42],"approved":[43],"China":[45],"as":[46],"July":[48],"2023.":[49],"In":[50],"comparison":[51],"rules-based":[54],"approach":[56],"China,":[58],"approaches":[60],"USA":[63],"EU":[65],"are":[66],"more":[67],"standards-oriented.":[68]},"counts_by_year":[{"year":2026,"cited_by_count":10},{"year":2025,"cited_by_count":16},{"year":2024,"cited_by_count":1}],"updated_date":"2026-03-27T05:58:40.876381","created_date":"2025-10-10T00:00:00"}