{"id":"https://openalex.org/W4387942646","doi":"https://doi.org/10.5771/9783748918912-303","title":"Chapter 3: Non-Invasive Prenatal Testing","display_name":"Chapter 3: Non-Invasive Prenatal Testing","publication_year":2023,"publication_date":"2023-01-01","ids":{"openalex":"https://openalex.org/W4387942646","doi":"https://doi.org/10.5771/9783748918912-303"},"language":"en","primary_location":{"id":"doi:10.5771/9783748918912-303","doi":"https://doi.org/10.5771/9783748918912-303","is_oa":true,"landing_page_url":"http://dx.doi.org/10.5771/9783748918912-303","pdf_url":"https://www.nomos-elibrary.de/10.5771/9783748918912-303.pdf?download_full_pdf=1&page=1","source":{"id":"https://openalex.org/S4306463667","display_name":"Nomos Verlagsgesellschaft mbH & Co. KG eBooks","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/P4310319939","host_organization_name":"Nomos","host_organization_lineage":["https://openalex.org/P4310319939"],"host_organization_lineage_names":["Nomos"],"type":"ebook platform"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Between Ethical Oversight and State Neutrality","raw_type":"book-chapter"},"volume":{"id":"https://openalex.org/W4387942589","display_name":"Between Ethical Oversight and State Neutrality"},"type":"book-chapter","is_traditional":true,"indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://www.nomos-elibrary.de/10.5771/9783748918912-303.pdf?download_full_pdf=1&page=1","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5073699665","display_name":"Irene Domenici","orcid":"https://orcid.org/0000-0001-5651-0745","observed_orcids":["https://orcid.org/0000-0001-5651-0745"]},"institutions":[],"countries":[],"is_corresponding":true,"raw_author_name":"Irene Domenici","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":["https://openalex.org/A5073699665"],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":"303","last_page":"394"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T13275","display_name":"Medical and Health Sciences Research","score":0.9009000062942505,"subfield":{"id":"https://openalex.org/subfields/3308","display_name":"Law"},"field":{"id":"https://openalex.org/fields/33","display_name":"Social Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},"topics":[{"id":"https://openalex.org/T13275","display_name":"Medical and Health Sciences Research","score":0.9009000062942505,"subfield":{"id":"https://openalex.org/subfields/3308","display_name":"Law"},"field":{"id":"https://openalex.org/fields/33","display_name":"Social Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T10978","display_name":"Prenatal Screening and Diagnostics","score":0.06849999725818634,"subfield":{"id":"https://openalex.org/subfields/2735","display_name":"Pediatrics, Perinatology and Child Health"},"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/T13417","display_name":"Biomedical Ethics and Regulation","score":0.009600000455975533,"subfield":{"id":"https://openalex.org/subfields/2910","display_name":"Issues, ethics and legal aspects"},"field":{"id":"https://openalex.org/fields/29","display_name":"Nursing"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/non-invasive-prenatal-testing","display_name":"non-invasive prenatal testing","score":0.9990000128746033},{"id":"https://openalex.org/keywords/medical-device-regulation","display_name":"medical device regulation","score":0.7070000171661377},{"id":"https://openalex.org/keywords/ce-marking","display_name":"CE marking","score":0.5509999990463257},{"id":"https://openalex.org/keywords/patient-safety","display_name":"patient safety","score":0.47699999809265137}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.37928590178489685},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.37086957693099976}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.5771/9783748918912-303","doi":"https://doi.org/10.5771/9783748918912-303","is_oa":true,"landing_page_url":"http://dx.doi.org/10.5771/9783748918912-303","pdf_url":"https://www.nomos-elibrary.de/10.5771/9783748918912-303.pdf?download_full_pdf=1&page=1","source":{"id":"https://openalex.org/S4306463667","display_name":"Nomos Verlagsgesellschaft mbH & Co. KG eBooks","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/P4310319939","host_organization_name":"Nomos","host_organization_lineage":["https://openalex.org/P4310319939"],"host_organization_lineage_names":["Nomos"],"type":"ebook platform"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Between Ethical Oversight and State Neutrality","raw_type":"book-chapter"}],"best_oa_location":{"id":"doi:10.5771/9783748918912-303","doi":"https://doi.org/10.5771/9783748918912-303","is_oa":true,"landing_page_url":"http://dx.doi.org/10.5771/9783748918912-303","pdf_url":"https://www.nomos-elibrary.de/10.5771/9783748918912-303.pdf?download_full_pdf=1&page=1","source":{"id":"https://openalex.org/S4306463667","display_name":"Nomos Verlagsgesellschaft mbH & Co. KG eBooks","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/P4310319939","host_organization_name":"Nomos","host_organization_lineage":["https://openalex.org/P4310319939"],"host_organization_lineage_names":["Nomos"],"type":"ebook platform"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Between Ethical Oversight and State Neutrality","raw_type":"book-chapter"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","score":0.7246000170707703,"display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[{"id":"https://openalex.org/F4320315747","display_name":"Amicus Therapeutics","ror":"https://ror.org/0328xw886"}],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4387942646.pdf","grobid_xml":"https://content.openalex.org/works/W4387942646.grobid-xml"},"referenced_works_count":12,"referenced_works":["https://openalex.org/W2081524835","https://openalex.org/W2343657153","https://openalex.org/W2462899390","https://openalex.org/W2618201450","https://openalex.org/W2810907393","https://openalex.org/W2905917304","https://openalex.org/W2972127627","https://openalex.org/W3000473629","https://openalex.org/W3154286152","https://openalex.org/W3175030657","https://openalex.org/W6601118399","https://openalex.org/W6633714969"],"related_works":["https://openalex.org/W4309603634","https://openalex.org/W3184024813","https://openalex.org/W4311130551","https://openalex.org/W4310555721","https://openalex.org/W4412109448","https://openalex.org/W7127360541","https://openalex.org/W4251063352","https://openalex.org/W3166732354","https://openalex.org/W4416004330","https://openalex.org/W6990629499"],"abstract_inverted_index":{"I.":[0],"NIPT":[1,191],"in":[2,12,16,63,89,220],"the":[3,19,24,30,38,46,61,69,83,87,99,122,130,138,150,165,174,178,188,196,206,210,224,233],"Private":[4],"SectorThe":[5],"first":[6],"non-invasive":[7],"prenatal":[8],"test":[9,39,88,123],"(NIPT)":[10],"available":[11],"Germany":[13],"was":[14,110,142,212,218],"marketed":[15],"2012":[17],"under":[18],"trade":[20],"name":[21],"PraenaTest":[22],"by":[23,98,116,223,242,257],"company":[25],"LifeCodexx.Under":[26],"\u00a7":[27,135,236],"3(1)(b)":[28],"of":[29,48,80,86,137,169,190],"former":[31],"Medical":[32,215,225],"Devices":[33,216,226],"Act":[34,217,228],"(Medizinproduktegesetz,":[35],"MPG)":[36],"1420":[37,213],"qualified":[40],"as":[41,239],"a":[42,54,78,93,146,185],"medical":[43,147,179],"device":[44,148,180],"for":[45,103,157],"detection":[47],"disability":[49],"and":[50,75,167,192,259],"therefore":[51],"only":[52],"required":[53],"CE":[55],"mark":[56],"to":[57,106,134,144,184,199,232],"be":[58,127],"placed":[59,128,204],"on":[60,68,129,149,187,195,205],"market":[62,70,84,151,207],"Germany.":[64],"1421":[65],"Its":[66],"placing":[67],"immediately":[71],"sparked":[72],"considerable":[73],"controversy":[74],"public":[76],"debate.After":[77],"series":[79],"articles":[81],"denouncing":[82],"entry":[85],"national":[90],"newspapers":[91],"1422":[92],"legal":[94,175],"expert":[95],"opinion":[96],"commissioned":[97],"Federal":[100],"Government":[101],"Commissioner":[102],"Matters":[104],"relating":[105],"Persons":[107],"with":[108],"Disabilities":[109],"released.":[111],"1423":[112],"The":[113,214],"opinion,":[114],"drafted":[115],"Klaus":[117],"Ferdinand":[118],"G\u00e4rditz,":[119],"argued":[120],"that":[121,159],"could":[124],"not":[125],"lawfully":[126],"market.":[131],"1424":[132],"According":[133,231],"4(1)":[136],"old":[139],"MPG":[140],"it":[141,201],"prohibited":[143],"place":[145],"when":[152],"there":[153],"were":[154],"reasonable":[155],"grounds":[156],"suspecting":[158],"they":[160],"directly":[161],"or":[162,171],"indirectly":[163],"endangered":[164],"safety":[166],"health":[168],"patients":[170],"third":[172],"parties.In":[173],"expert's":[176],"view":[177],"legislation":[181],"would":[182],"lead":[183],"ban":[186],"marketing":[189],"an":[193],"obligation":[194],"competent":[197],"authorities":[198],"prevent":[200],"from":[202],"being":[203],"1425":[208],"because":[209],"foetus":[211],"replaced":[219],"May":[221],"2021":[222],"Implementation":[227],"(Medizinprodukterecht-Durchf\u00fchrungsgesetz,":[229],"MPDG).1421":[230],"then":[234],"current":[235],"6(1)":[237],"MPG,":[238],"pointed":[240],"out":[241],"Huster,":[243],"'Der":[244],"Gemeinsame":[245],"Bundesausschuss":[246],"als":[247],"Ethikbeh\u00f6rde?'":[248],"(2017)":[249],"35(4)":[250],"MedR":[251],"p.":[252],"282,":[253],"283.1422":[254],"As":[255],"reported":[256],"Braun":[258],"K\u00f6nninger,":[260],"'Realizing":[261],"Responsibility.:":[262]},"counts_by_year":[],"updated_date":"2026-11-08T12:12:28.789561","created_date":"2023-10-26T00:00:00"}
