{"id":"https://openalex.org/W2404584188","doi":"https://doi.org/10.3233/978-1-61499-203-5-337","title":"Software as a Medical Device: Regulatory Critical Issues","display_name":"Software as a Medical Device: Regulatory Critical Issues","publication_year":2013,"publication_date":"2013-01-01","ids":{"openalex":"https://openalex.org/W2404584188","doi":"https://doi.org/10.3233/978-1-61499-203-5-337","mag":"2404584188","pmid":"https://pubmed.ncbi.nlm.nih.gov/23388310"},"language":"en","primary_location":{"id":"doi:10.3233/978-1-61499-203-5-337","is_oa":false,"landing_page_url":"https://doi.org/10.3233/978-1-61499-203-5-337","pdf_url":null,"source":{"id":"https://openalex.org/S4210179765","display_name":"Studies in health technology and informatics","issn_l":"0926-9630","issn":["0926-9630","1879-8365"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310318577","host_organization_name":"IOS Press","host_organization_lineage":["https://openalex.org/P4310318577"],"host_organization_lineage_names":["IOS Press"],"type":"book series"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Studies in Health Technology and Informatics","raw_type":"book-chapter"},"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":null,"display_name":"Pelayo Sylvia","orcid":null},"institutions":[{"id":"https://openalex.org/I2279609970","display_name":"Universit\u00e9 de Lille","ror":"https://ror.org/02kzqn938","country_code":"FR","type":"education","lineage":["https://openalex.org/I2279609970"]},{"id":"https://openalex.org/I59807433","display_name":"Universit\u00e9 Lille Nord de France","ror":"https://ror.org/03btvgn05","country_code":"FR","type":"education","lineage":["https://openalex.org/I59807433"]}],"countries":["FR"],"is_corresponding":false,"raw_author_name":"Pelayo Sylvia","raw_affiliation_strings":["Universit\u00e9 Lille Nord de France, Lille, France. sylvia.pelayo@univ-lille2.fr"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Universit\u00e9 Lille Nord de France, Lille, France. sylvia.pelayo@univ-lille2.fr","institution_ids":["https://openalex.org/I59807433","https://openalex.org/I2279609970"]}]},{"author_position":"middle","author":{"id":null,"display_name":"Bras Da Costa Sabrina","orcid":null},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Bras Da Costa Sabrina","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5072047732","display_name":"N. Leroy","orcid":"https://orcid.org/0000-0002-2321-1017"},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Leroy Nicolas","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":null,"display_name":"Loiseau Séverine","orcid":null},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Loiseau Séverine","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"last","author":{"id":"https://openalex.org/A5000675346","display_name":"Marie-Catherine Beuscart-Z\u00e9phir","orcid":"https://orcid.org/0000-0002-1094-9311"},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Beuscart-Zephir Marie-Catherine","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":5,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":1.7258,"has_fulltext":false,"cited_by_count":7,"citation_normalized_percentile":{"value":0.92996109,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":89,"max":96},"biblio":{"volume":"183","issue":null,"first_page":"337","last_page":"42"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T13690","display_name":"Quality and Safety in Healthcare","score":0.9664999842643738,"subfield":{"id":"https://openalex.org/subfields/3607","display_name":"Medical Laboratory Technology"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T13690","display_name":"Quality and Safety in Healthcare","score":0.9664999842643738,"subfield":{"id":"https://openalex.org/subfields/3607","display_name":"Medical Laboratory Technology"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10804","display_name":"Health Systems, Economic Evaluations, Quality of Life","score":0.9607999920845032,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T13417","display_name":"Biomedical Ethics and Regulation","score":0.9602000117301941,"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/medical-software","display_name":"Medical software","score":0.8633856773376465},{"id":"https://openalex.org/keywords/directive","display_name":"Directive","score":0.8408125638961792},{"id":"https://openalex.org/keywords/medical-device","display_name":"Medical device","score":0.7508597373962402},{"id":"https://openalex.org/keywords/software","display_name":"Software","score":0.6094047427177429},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.5005648136138916},{"id":"https://openalex.org/keywords/engineering-management","display_name":"Engineering management","score":0.3834719657897949},{"id":"https://openalex.org/keywords/software-engineering","display_name":"Software engineering","score":0.35839229822158813},{"id":"https://openalex.org/keywords/risk-analysis","display_name":"Risk analysis (engineering)","score":0.3523944020271301},{"id":"https://openalex.org/keywords/software-development","display_name":"Software development","score":0.32703161239624023},{"id":"https://openalex.org/keywords/business","display_name":"Business","score":0.2535284161567688},{"id":"https://openalex.org/keywords/engineering","display_name":"Engineering","score":0.22489818930625916},{"id":"https://openalex.org/keywords/software-construction","display_name":"Software construction","score":0.12204256653785706},{"id":"https://openalex.org/keywords/biomedical-engineering","display_name":"Biomedical engineering","score":0.0643354058265686}],"concepts":[{"id":"https://openalex.org/C28143949","wikidata":"https://www.wikidata.org/wiki/Q3751111","display_name":"Medical software","level":5,"score":0.8633856773376465},{"id":"https://openalex.org/C2779547435","wikidata":"https://www.wikidata.org/wiki/Q1121492","display_name":"Directive","level":2,"score":0.8408125638961792},{"id":"https://openalex.org/C3020535179","wikidata":"https://www.wikidata.org/wiki/Q6554101","display_name":"Medical device","level":2,"score":0.7508597373962402},{"id":"https://openalex.org/C2777904410","wikidata":"https://www.wikidata.org/wiki/Q7397","display_name":"Software","level":2,"score":0.6094047427177429},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.5005648136138916},{"id":"https://openalex.org/C110354214","wikidata":"https://www.wikidata.org/wiki/Q6314146","display_name":"Engineering management","level":1,"score":0.3834719657897949},{"id":"https://openalex.org/C115903868","wikidata":"https://www.wikidata.org/wiki/Q80993","display_name":"Software engineering","level":1,"score":0.35839229822158813},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.3523944020271301},{"id":"https://openalex.org/C529173508","wikidata":"https://www.wikidata.org/wiki/Q638608","display_name":"Software development","level":3,"score":0.32703161239624023},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.2535284161567688},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.22489818930625916},{"id":"https://openalex.org/C186846655","wikidata":"https://www.wikidata.org/wiki/Q3398377","display_name":"Software construction","level":4,"score":0.12204256653785706},{"id":"https://openalex.org/C136229726","wikidata":"https://www.wikidata.org/wiki/Q327092","display_name":"Biomedical engineering","level":1,"score":0.0643354058265686},{"id":"https://openalex.org/C199360897","wikidata":"https://www.wikidata.org/wiki/Q9143","display_name":"Programming language","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D004864","descriptor_name":"Equipment and Supplies","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D004864","descriptor_name":"Equipment and Supplies","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D004864","descriptor_name":"Equipment and Supplies","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D005060","descriptor_name":"Europe","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005060","descriptor_name":"Europe","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005060","descriptor_name":"Europe","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012984","descriptor_name":"Software","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":false},{"descriptor_ui":"D012984","descriptor_name":"Software","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":false},{"descriptor_ui":"D012984","descriptor_name":"Software","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":false},{"descriptor_ui":"D012984","descriptor_name":"Software","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D012984","descriptor_name":"Software","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D012984","descriptor_name":"Software","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D017408","descriptor_name":"Guidelines as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D017408","descriptor_name":"Guidelines as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D017408","descriptor_name":"Guidelines as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D018795","descriptor_name":"Device Approval","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":false},{"descriptor_ui":"D018795","descriptor_name":"Device Approval","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":false},{"descriptor_ui":"D018795","descriptor_name":"Device Approval","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":false},{"descriptor_ui":"D018795","descriptor_name":"Device Approval","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D018795","descriptor_name":"Device Approval","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D018795","descriptor_name":"Device Approval","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D033161","descriptor_name":"Government Regulation","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D033161","descriptor_name":"Government Regulation","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D033161","descriptor_name":"Government Regulation","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true}],"locations_count":3,"locations":[{"id":"doi:10.3233/978-1-61499-203-5-337","is_oa":false,"landing_page_url":"https://doi.org/10.3233/978-1-61499-203-5-337","pdf_url":null,"source":{"id":"https://openalex.org/S4210179765","display_name":"Studies in health technology and informatics","issn_l":"0926-9630","issn":["0926-9630","1879-8365"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310318577","host_organization_name":"IOS Press","host_organization_lineage":["https://openalex.org/P4310318577"],"host_organization_lineage_names":["IOS Press"],"type":"book series"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Studies in Health Technology and Informatics","raw_type":"book-chapter"},{"id":"pmid:23388310","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/23388310","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":"Studies in health technology and informatics","raw_type":null},{"id":"pmh:oai:HAL:hal-01376784v1","is_oa":false,"landing_page_url":"https://hal.univ-lorraine.fr/hal-01376784","pdf_url":null,"source":{"id":"https://openalex.org/S4306402512","display_name":"HAL (Le Centre pour la Communication Scientifique Directe)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I1294671590","host_organization_name":"Centre National de la Recherche Scientifique","host_organization_lineage":["https://openalex.org/I1294671590"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Studies in Health Technology and Informatics, 2013, 183, pp.337-42","raw_type":"Journal articles"}],"best_oa_location":null,"sustainable_development_goals":[{"score":0.49000000953674316,"id":"https://metadata.un.org/sdg/17","display_name":"Partnerships for the goals"}],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W2426516946","https://openalex.org/W2395258756","https://openalex.org/W2414215938","https://openalex.org/W2403588076","https://openalex.org/W2441336121","https://openalex.org/W2404584188","https://openalex.org/W4287272794","https://openalex.org/W1601929374","https://openalex.org/W3135510786","https://openalex.org/W1984453419"],"abstract_inverted_index":{"The":[0],"revised":[1],"Medical":[2],"Device":[3],"Directive":[4],"has":[5],"been":[6],"adopted":[7],"by":[8],"the":[9,39,51],"EU":[10],"in":[11],"2010.":[12],"A":[13],"major":[14],"change":[15],"is":[16,22],"that":[17,30,49],"software":[18,48],"for":[19],"certain":[20],"purposes":[21],"now":[23],"considered":[24],"a":[25,31,54],"medical":[26,47,55],"device.":[27,56],"This":[28,57],"entails":[29],"new":[32],"view":[33],"needs":[34],"to":[35],"be":[36],"developed":[37],"on":[38],"design,":[40],"development,":[41],"evaluation":[42],"and":[43,64],"post-market":[44],"surveillance":[45],"of":[46,53],"meets":[50],"definition":[52],"paper":[58],"identifies":[59],"some":[60],"issues":[61],"at":[62],"stake":[63],"discusses":[65],"them.":[66]},"counts_by_year":[{"year":2024,"cited_by_count":1},{"year":2022,"cited_by_count":2},{"year":2021,"cited_by_count":1},{"year":2020,"cited_by_count":1},{"year":2014,"cited_by_count":2}],"updated_date":"2026-06-11T09:08:48.828518","created_date":"2025-10-10T00:00:00"}