{"id":"https://openalex.org/W2889071896","doi":"https://doi.org/10.3233/978-1-61499-858-7-180","title":"Effects of Medical Device Regulations on the Development of Stand-Alone Medical Software: A Pilot Study","display_name":"Effects of Medical Device Regulations on the Development of Stand-Alone Medical Software: A Pilot Study","publication_year":2018,"publication_date":"2018-01-01","ids":{"openalex":"https://openalex.org/W2889071896","doi":"https://doi.org/10.3233/978-1-61499-858-7-180","mag":"2889071896","pmid":"https://pubmed.ncbi.nlm.nih.gov/29726435"},"language":"en","primary_location":{"id":"doi:10.3233/978-1-61499-858-7-180","is_oa":false,"landing_page_url":"https://doi.org/10.3233/978-1-61499-858-7-180","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":"book-chapter","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":"https://openalex.org/A5046848347","display_name":"Kathrin Blagec","orcid":"https://orcid.org/0000-0001-6261-5260"},"institutions":[{"id":"https://openalex.org/I1327969474","display_name":"Statistics Austria","ror":"https://ror.org/030j5vf66","country_code":"AT","type":"government","lineage":["https://openalex.org/I1327969474"]}],"countries":["AT"],"is_corresponding":false,"raw_author_name":"Blagec Kathrin","raw_affiliation_strings":["Center for Medical Statistics, Informatics, and Intelligent Systems. Medical University of Vienna"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Center for Medical Statistics, Informatics, and Intelligent Systems. Medical University of Vienna","institution_ids":["https://openalex.org/I1327969474"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5035951898","display_name":"David Jungwirth","orcid":"https://orcid.org/0000-0002-4834-8909"},"institutions":[{"id":"https://openalex.org/I76134821","display_name":"Medical University of Vienna","ror":"https://ror.org/05n3x4p02","country_code":"AT","type":"education","lineage":["https://openalex.org/I76134821"]}],"countries":["AT"],"is_corresponding":false,"raw_author_name":"Jungwirth David","raw_affiliation_strings":["Center for Public Health. Medical University of Vienna"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Center for Public Health. Medical University of Vienna","institution_ids":["https://openalex.org/I76134821"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5042500910","display_name":"Daniela Haluza","orcid":"https://orcid.org/0000-0001-5619-2863"},"institutions":[{"id":"https://openalex.org/I76134821","display_name":"Medical University of Vienna","ror":"https://ror.org/05n3x4p02","country_code":"AT","type":"education","lineage":["https://openalex.org/I76134821"]}],"countries":["AT"],"is_corresponding":false,"raw_author_name":"Haluza Daniela","raw_affiliation_strings":["Center for Public Health. Medical University of Vienna"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Center for Public Health. Medical University of Vienna","institution_ids":["https://openalex.org/I76134821"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5082184364","display_name":"Matthias Samwald","orcid":"https://orcid.org/0000-0002-4855-2571"},"institutions":[{"id":"https://openalex.org/I1327969474","display_name":"Statistics Austria","ror":"https://ror.org/030j5vf66","country_code":"AT","type":"government","lineage":["https://openalex.org/I1327969474"]}],"countries":["AT"],"is_corresponding":false,"raw_author_name":"Samwald Matthias","raw_affiliation_strings":["Center for Medical Statistics, Informatics, and Intelligent Systems. Medical University of Vienna"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Center for Medical Statistics, Informatics, and Intelligent Systems. Medical University of Vienna","institution_ids":["https://openalex.org/I1327969474"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":2.3129,"has_fulltext":false,"cited_by_count":2,"citation_normalized_percentile":{"value":0.86845957,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":90,"max":95},"biblio":{"volume":"248","issue":null,"first_page":"180","last_page":"187"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T13248","display_name":"Healthcare Technology and Patient Monitoring","score":0.26409998536109924,"subfield":{"id":"https://openalex.org/subfields/2746","display_name":"Surgery"},"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/T13248","display_name":"Healthcare Technology and Patient Monitoring","score":0.26409998536109924,"subfield":{"id":"https://openalex.org/subfields/2746","display_name":"Surgery"},"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/T13690","display_name":"Quality and Safety in Healthcare","score":0.1071000024676323,"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/T10350","display_name":"Electronic Health Records Systems","score":0.09759999811649323,"subfield":{"id":"https://openalex.org/subfields/3605","display_name":"Health Information Management"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/medical-software","display_name":"Medical software","score":0.6487789154052734},{"id":"https://openalex.org/keywords/medical-device","display_name":"Medical device","score":0.5912768840789795},{"id":"https://openalex.org/keywords/software","display_name":"Software","score":0.4469001293182373},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.43958336114883423},{"id":"https://openalex.org/keywords/medicine","display_name":"Medicine","score":0.2834295332431793},{"id":"https://openalex.org/keywords/software-development","display_name":"Software development","score":0.256549596786499},{"id":"https://openalex.org/keywords/operating-system","display_name":"Operating system","score":0.11205190420150757},{"id":"https://openalex.org/keywords/biomedical-engineering","display_name":"Biomedical engineering","score":0.11088037490844727},{"id":"https://openalex.org/keywords/software-quality","display_name":"Software quality","score":0.09063738584518433}],"concepts":[{"id":"https://openalex.org/C28143949","wikidata":"https://www.wikidata.org/wiki/Q3751111","display_name":"Medical software","level":5,"score":0.6487789154052734},{"id":"https://openalex.org/C3020535179","wikidata":"https://www.wikidata.org/wiki/Q6554101","display_name":"Medical device","level":2,"score":0.5912768840789795},{"id":"https://openalex.org/C2777904410","wikidata":"https://www.wikidata.org/wiki/Q7397","display_name":"Software","level":2,"score":0.4469001293182373},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.43958336114883423},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.2834295332431793},{"id":"https://openalex.org/C529173508","wikidata":"https://www.wikidata.org/wiki/Q638608","display_name":"Software development","level":3,"score":0.256549596786499},{"id":"https://openalex.org/C111919701","wikidata":"https://www.wikidata.org/wiki/Q9135","display_name":"Operating system","level":1,"score":0.11205190420150757},{"id":"https://openalex.org/C136229726","wikidata":"https://www.wikidata.org/wiki/Q327092","display_name":"Biomedical engineering","level":1,"score":0.11088037490844727},{"id":"https://openalex.org/C117447612","wikidata":"https://www.wikidata.org/wiki/Q1412670","display_name":"Software quality","level":4,"score":0.09063738584518433}],"mesh":[{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D010865","descriptor_name":"Pilot Projects","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D010865","descriptor_name":"Pilot Projects","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D010865","descriptor_name":"Pilot Projects","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012984","descriptor_name":"Software","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D012984","descriptor_name":"Software","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D012984","descriptor_name":"Software","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D015203","descriptor_name":"Reproducibility of Results","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D015203","descriptor_name":"Reproducibility of Results","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D015203","descriptor_name":"Reproducibility of Results","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016494","descriptor_name":"Computer Security","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016494","descriptor_name":"Computer Security","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016494","descriptor_name":"Computer Security","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D062307","descriptor_name":"Medical Device Legislation","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D062307","descriptor_name":"Medical Device Legislation","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D062307","descriptor_name":"Medical Device Legislation","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D063731","descriptor_name":"Mobile Applications","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D063731","descriptor_name":"Mobile Applications","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D063731","descriptor_name":"Mobile Applications","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true}],"locations_count":2,"locations":[{"id":"doi:10.3233/978-1-61499-858-7-180","is_oa":false,"landing_page_url":"https://doi.org/10.3233/978-1-61499-858-7-180","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:29726435","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/29726435","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}],"best_oa_location":null,"sustainable_development_goals":[{"score":0.5899999737739563,"id":"https://metadata.un.org/sdg/9","display_name":"Industry, innovation and infrastructure"}],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W2403588076","https://openalex.org/W2404584188","https://openalex.org/W4287272794","https://openalex.org/W1601929374","https://openalex.org/W3135510786","https://openalex.org/W1984453419","https://openalex.org/W2318630301","https://openalex.org/W2800240732","https://openalex.org/W4319431859","https://openalex.org/W2001672965"],"abstract_inverted_index":{"BACKGROUND:":[0],"Medical":[1],"device":[2],"regulations":[3,33,64],"which":[4],"aim":[5],"to":[6,14,19,53,97,116,139,164],"ensure":[7],"safety":[8,161],"standards":[9,162],"do":[10],"not":[11],"only":[12],"apply":[13],"hardware":[15],"devices":[16],"but":[17],"also":[18],"standalone":[20,41,72],"medical":[21,40,71,132],"software,":[22],"e.g.":[23],"mobile":[24],"apps.":[25],"OBJECTIVES:":[26],"To":[27],"explore":[28],"the":[29,35,60,66,78,95,119,125],"effects":[30,84,142],"of":[31,39,49,62,70,91],"these":[32],"on":[34,65,85,143,149],"development":[36,67],"and":[37,68,88,102,113,130,152],"distribution":[38,69],"software.":[42,73,133],"METHODS:":[43],"We":[44],"invited":[45],"a":[46],"convenience":[47],"sample":[48],"130":[50],"domain":[51],"experts":[52],"participate":[54],"in":[55,128],"an":[56],"online":[57],"survey":[58],"about":[59],"impact":[61],"current":[63],"RESULTS:":[74],"21":[75],"respondents":[76],"completed":[77],"questionnaire.":[79],"Participants":[80],"reported":[81],"slight":[82],"positive":[83,141],"usability,":[86],"reliability,":[87],"data":[89],"security":[90],"their":[92],"products,":[93],"whereas":[94],"ability":[96],"modify":[98],"already":[99],"deployed":[100],"software":[101,144],"customization":[103],"by":[104],"end":[105],"users":[106],"were":[107,122],"negatively":[108],"impacted.":[109],"The":[110],"additional":[111],"time":[112],"costs":[114],"needed":[115,138],"go":[117],"through":[118],"regulatory":[120],"process":[121],"perceived":[123],"as":[124],"greatest":[126],"obstacles":[127],"developing":[129],"distributing":[131],"CONCLUSION:":[134],"Further":[135],"research":[136],"is":[137],"compare":[140],"quality":[145],"with":[146],"negative":[147],"impacts":[148],"market":[150],"access":[151],"innovation.":[153],"Strategies":[154],"for":[155],"avoiding":[156],"over-regulation":[157],"while":[158],"still":[159],"ensuring":[160],"need":[163],"be":[165],"devised.":[166]},"counts_by_year":[{"year":2025,"cited_by_count":1},{"year":2019,"cited_by_count":1}],"updated_date":"2026-07-15T18:14:33.161393","created_date":"2025-10-10T00:00:00"}
