{"id":"https://openalex.org/W4410705023","doi":"https://doi.org/10.1038/s41746-025-01697-w","title":"Classification grid and evidence matrix for evaluating digital medical devices under the European union landscape","display_name":"Classification grid and evidence matrix for evaluating digital medical devices under the European union landscape","publication_year":2025,"publication_date":"2025-05-24","ids":{"openalex":"https://openalex.org/W4410705023","doi":"https://doi.org/10.1038/s41746-025-01697-w","pmid":"https://pubmed.ncbi.nlm.nih.gov/40413360"},"language":"en","primary_location":{"id":"doi:10.1038/s41746-025-01697-w","is_oa":true,"landing_page_url":"https://doi.org/10.1038/s41746-025-01697-w","pdf_url":"https://www.nature.com/articles/s41746-025-01697-w.pdf","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://www.nature.com/articles/s41746-025-01697-w.pdf","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5015945628","display_name":"Magali Boers","orcid":null},"institutions":[{"id":"https://openalex.org/I186903577","display_name":"University of Luxembourg","ror":"https://ror.org/036x5ad56","country_code":"LU","type":"education","lineage":["https://openalex.org/I186903577"]},{"id":"https://openalex.org/I4210109663","display_name":"Ministry of State","ror":"https://ror.org/01r2j1v82","country_code":"LU","type":"government","lineage":["https://openalex.org/I4210109663"]},{"id":"https://openalex.org/I4210101141","display_name":"Luxembourg Institute of Health","ror":"https://ror.org/012m8gv78","country_code":"LU","type":"nonprofit","lineage":["https://openalex.org/I4210101141"]}],"countries":["LU"],"is_corresponding":true,"raw_author_name":"Magali Boers","raw_affiliation_strings":["Luxembourg Ministry of Health and Social Security, Luxembourg, Luxembourg"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Luxembourg Ministry of Health and Social Security, Luxembourg, Luxembourg","institution_ids":["https://openalex.org/I4210101141","https://openalex.org/I186903577","https://openalex.org/I4210109663"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5117666462","display_name":"Aude Rochereau","orcid":null},"institutions":[{"id":"https://openalex.org/I4210092716","display_name":"Sant\u00e9 Publique France","ror":"https://ror.org/00dfw9p58","country_code":"FR","type":"other","lineage":["https://openalex.org/I4210092716"]}],"countries":["FR"],"is_corresponding":false,"raw_author_name":"Aude Rochereau","raw_affiliation_strings":["Mission num\u00e9rique en sant\u00e9, Haute Autorit\u00e9 de Sant\u00e9, Saint-Denis, France"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Mission num\u00e9rique en sant\u00e9, Haute Autorit\u00e9 de Sant\u00e9, Saint-Denis, France","institution_ids":["https://openalex.org/I4210092716"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5116092174","display_name":"Louisa St\u00fcwe","orcid":null},"institutions":[{"id":"https://openalex.org/I4210103743","display_name":"Ministry of Health","ror":"https://ror.org/016dxxy13","country_code":"LA","type":"government","lineage":["https://openalex.org/I4210103743"]}],"countries":["LA"],"is_corresponding":false,"raw_author_name":"Louisa Stuwe","raw_affiliation_strings":["Digital Health Delegation, French Ministry of Health, Paris, France"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Digital Health Delegation, French Ministry of Health, Paris, France","institution_ids":["https://openalex.org/I4210103743"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5008614857","display_name":"Lorena San Miguel","orcid":"https://orcid.org/0000-0002-7155-7303"},"institutions":[{"id":"https://openalex.org/I4210129284","display_name":"Belgian Health Care Knowledge Centre (KCE)","ror":"https://ror.org/02depad46","country_code":"BE","type":"healthcare","lineage":["https://openalex.org/I4210129284"]}],"countries":["BE"],"is_corresponding":false,"raw_author_name":"Lorena San Miguel","raw_affiliation_strings":["KCE - Federaal Kenniscentrum voor de Gezondheidszorg - Centre F\u00e9d\u00e9ral d'Expertise des Soins de Sant\u00e9, Brussels, Belgium"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"KCE - Federaal Kenniscentrum voor de Gezondheidszorg - Centre F\u00e9d\u00e9ral d'Expertise des Soins de Sant\u00e9, Brussels, Belgium","institution_ids":["https://openalex.org/I4210129284"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5066832631","display_name":"Jochen Klucken","orcid":"https://orcid.org/0000-0001-6645-9437"},"institutions":[{"id":"https://openalex.org/I162487826","display_name":"Centre Hospitalier de Luxembourg","ror":"https://ror.org/03xq7w797","country_code":"LU","type":"healthcare","lineage":["https://openalex.org/I162487826"]},{"id":"https://openalex.org/I186903577","display_name":"University of Luxembourg","ror":"https://ror.org/036x5ad56","country_code":"LU","type":"education","lineage":["https://openalex.org/I186903577"]}],"countries":["LU"],"is_corresponding":false,"raw_author_name":"Jochen Klucken","raw_affiliation_strings":["Digital Medicine Group, Centre Hospitalier du Luxembourg, Luxembourg, Luxembourg","Luxembourg Centre for Systems Biomedicine (LCSB) University of Luxembourg, Esch-sur- Alzette, Luxembourg"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Digital Medicine Group, Centre Hospitalier du Luxembourg, Luxembourg, Luxembourg","institution_ids":["https://openalex.org/I162487826"]},{"raw_affiliation_string":"Luxembourg Centre for Systems Biomedicine (LCSB) University of Luxembourg, Esch-sur- Alzette, Luxembourg","institution_ids":["https://openalex.org/I186903577"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5063809763","display_name":"Fruzsina Mezei","orcid":"https://orcid.org/0000-0001-5924-9781"},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Fruzsina Mezei","raw_affiliation_strings":["EIT Health France, Paris, France"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"EIT Health France, Paris, France","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5093675193","display_name":"J\u00e9r\u00f4me Fabiano","orcid":null},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"J\u00e9r\u00f4me Fabiano","raw_affiliation_strings":["EIT Health France, Paris, France"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"EIT Health France, Paris, France","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5015193497","display_name":"Sandrine Boulet","orcid":"https://orcid.org/0000-0001-9863-5466"},"institutions":[{"id":"https://openalex.org/I4210091437","display_name":"Sorbonne Paris Cit\u00e9","ror":"https://ror.org/001z21q04","country_code":"FR","type":"other","lineage":["https://openalex.org/I4210091437"]},{"id":"https://openalex.org/I204730241","display_name":"Universit\u00e9 Paris Cit\u00e9","ror":"https://ror.org/05f82e368","country_code":"FR","type":"education","lineage":["https://openalex.org/I204730241"]},{"id":"https://openalex.org/I154526488","display_name":"Inserm","ror":"https://ror.org/02vjkv261","country_code":"FR","type":"government","lineage":["https://openalex.org/I154526488"]}],"countries":["FR"],"is_corresponding":false,"raw_author_name":"Sandrine Boulet","raw_affiliation_strings":["Inserm, Universit\u00e9 Paris Cit\u00e9, Inria, HeKA, Paris, France"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Inserm, Universit\u00e9 Paris Cit\u00e9, Inria, HeKA, Paris, France","institution_ids":["https://openalex.org/I154526488","https://openalex.org/I204730241","https://openalex.org/I4210091437"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5117666465","display_name":"Aymeric Perchant","orcid":null},"institutions":[{"id":"https://openalex.org/I4210103743","display_name":"Ministry of Health","ror":"https://ror.org/016dxxy13","country_code":"LA","type":"government","lineage":["https://openalex.org/I4210103743"]}],"countries":["LA"],"is_corresponding":false,"raw_author_name":"Aymeric Perchant","raw_affiliation_strings":["Digital Health Delegation, French Ministry of Health, Paris, France"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Digital Health Delegation, French Ministry of Health, Paris, France","institution_ids":["https://openalex.org/I4210103743"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5015249696","display_name":"Rosanna Tarricone","orcid":"https://orcid.org/0000-0002-2009-9357"},"institutions":[{"id":"https://openalex.org/I71209653","display_name":"Bocconi University","ror":"https://ror.org/05crjpb27","country_code":"IT","type":"education","lineage":["https://openalex.org/I71209653"]}],"countries":["IT"],"is_corresponding":false,"raw_author_name":"Rosanna Tarricone","raw_affiliation_strings":["Centre for Research on Health and Social Care Management (CERGAS), Government, Health and Not for Profit Division, SDA Bocconi School of Management, Milan, Italy","Department of Social and Political Science, Bocconi University, Milan, Italy"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Centre for Research on Health and Social Care Management (CERGAS), Government, Health and Not for Profit Division, SDA Bocconi School of Management, Milan, Italy","institution_ids":["https://openalex.org/I71209653"]},{"raw_affiliation_string":"Department of Social and Political Science, Bocconi University, Milan, Italy","institution_ids":["https://openalex.org/I71209653"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5064536114","display_name":"Francesco Petracca","orcid":"https://orcid.org/0000-0002-6076-6919"},"institutions":[{"id":"https://openalex.org/I71209653","display_name":"Bocconi University","ror":"https://ror.org/05crjpb27","country_code":"IT","type":"education","lineage":["https://openalex.org/I71209653"]}],"countries":["IT"],"is_corresponding":false,"raw_author_name":"Francesco Petracca","raw_affiliation_strings":["Centre for Research on Health and Social Care Management (CERGAS), Government, Health and Not for Profit Division, SDA Bocconi School of Management, Milan, Italy"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Centre for Research on Health and Social Care Management (CERGAS), Government, Health and Not for Profit Division, SDA Bocconi School of Management, Milan, Italy","institution_ids":["https://openalex.org/I71209653"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5117666461","display_name":"Barbara Hoefgen","orcid":null},"institutions":[{"id":"https://openalex.org/I123859907","display_name":"Federal Institute for Drugs and Medical Devices","ror":"https://ror.org/05ex5vz81","country_code":"DE","type":"funder","lineage":["https://openalex.org/I123859907"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Barbara Hoefgen","raw_affiliation_strings":["Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany","institution_ids":["https://openalex.org/I123859907"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5052852742","display_name":"Corinne Collignon","orcid":null},"institutions":[{"id":"https://openalex.org/I4210092716","display_name":"Sant\u00e9 Publique France","ror":"https://ror.org/00dfw9p58","country_code":"FR","type":"other","lineage":["https://openalex.org/I4210092716"]}],"countries":["FR"],"is_corresponding":false,"raw_author_name":"Corinne Collignon","raw_affiliation_strings":["Mission num\u00e9rique en sant\u00e9, Haute Autorit\u00e9 de Sant\u00e9, Saint-Denis, France"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Mission num\u00e9rique en sant\u00e9, Haute Autorit\u00e9 de Sant\u00e9, Saint-Denis, France","institution_ids":["https://openalex.org/I4210092716"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5078070306","display_name":"Sarah Zohar","orcid":"https://orcid.org/0000-0002-8429-2340"},"institutions":[{"id":"https://openalex.org/I4210091437","display_name":"Sorbonne Paris Cit\u00e9","ror":"https://ror.org/001z21q04","country_code":"FR","type":"other","lineage":["https://openalex.org/I4210091437"]},{"id":"https://openalex.org/I154526488","display_name":"Inserm","ror":"https://ror.org/02vjkv261","country_code":"FR","type":"government","lineage":["https://openalex.org/I154526488"]},{"id":"https://openalex.org/I204730241","display_name":"Universit\u00e9 Paris Cit\u00e9","ror":"https://ror.org/05f82e368","country_code":"FR","type":"education","lineage":["https://openalex.org/I204730241"]}],"countries":["FR"],"is_corresponding":false,"raw_author_name":"Sarah Zohar","raw_affiliation_strings":["Inserm, Universit\u00e9 Paris Cit\u00e9, Inria, HeKA, Paris, France. sarah.zohar@inserm.fr","Inserm, Universit\u00e9 Paris Cit\u00e9, Inria, HeKA, Paris, France"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Inserm, Universit\u00e9 Paris Cit\u00e9, Inria, HeKA, Paris, France. sarah.zohar@inserm.fr","institution_ids":[]},{"raw_affiliation_string":"Inserm, Universit\u00e9 Paris Cit\u00e9, Inria, HeKA, Paris, France","institution_ids":["https://openalex.org/I154526488","https://openalex.org/I204730241","https://openalex.org/I4210091437"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5046380772","display_name":"Alan G. Fraser","orcid":"https://orcid.org/0000-0001-7083-6995"},"institutions":[{"id":"https://openalex.org/I79510175","display_name":"Cardiff University","ror":"https://ror.org/03kk7td41","country_code":"GB","type":"education","lineage":["https://openalex.org/I79510175"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"A. G. Fraser","raw_affiliation_strings":["Biomedical Alliance in Europe, Brussels, Belgium","School of Medicine, Cardiff University, Cardiff, UK"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Biomedical Alliance in Europe, Brussels, Belgium","institution_ids":[]},{"raw_affiliation_string":"School of Medicine, Cardiff University, Cardiff, UK","institution_ids":["https://openalex.org/I79510175"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5032875770","display_name":"\u0414\u0438\u043c\u0438\u0442\u0440\u0430 \u041f\u0430\u043d\u0442\u0435\u043b\u0438","orcid":"https://orcid.org/0000-0003-2110-3335"},"institutions":[{"id":"https://openalex.org/I4210141167","display_name":"European Social Observatory","ror":"https://ror.org/04sc7sk27","country_code":"BE","type":"facility","lineage":["https://openalex.org/I4210141167"]}],"countries":["BE"],"is_corresponding":false,"raw_author_name":"D. Panteli","raw_affiliation_strings":["European Observatory, Brussels, Belgium"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"European Observatory, Brussels, Belgium","institution_ids":["https://openalex.org/I4210141167"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5015515154","display_name":"Enrico G. Caiani","orcid":"https://orcid.org/0000-0002-1770-6486"},"institutions":[{"id":"https://openalex.org/I93860229","display_name":"Politecnico di Milano","ror":"https://ror.org/01nffqt88","country_code":"IT","type":"education","lineage":["https://openalex.org/I93860229"]}],"countries":["IT"],"is_corresponding":false,"raw_author_name":"E. Caiani","raw_affiliation_strings":["Politecnico di Milano, Milano, Italy"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Politecnico di Milano, Milano, Italy","institution_ids":["https://openalex.org/I93860229"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5045192140","display_name":"Graham Dawson","orcid":"https://orcid.org/0000-0002-8361-300X"},"institutions":[{"id":"https://openalex.org/I4210108888","display_name":"University Alliance","ror":"https://ror.org/020pnfy52","country_code":"GB","type":"education","lineage":["https://openalex.org/I4210108888"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"G. Dawson","raw_affiliation_strings":["Biomed Alliance, Oxford, UK"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Biomed Alliance, Oxford, UK","institution_ids":["https://openalex.org/I4210108888"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5061981433","display_name":"Janne Haverinen","orcid":null},"institutions":[{"id":"https://openalex.org/I2799272722","display_name":"Oulu University Hospital","ror":"https://ror.org/045ney286","country_code":"FI","type":"healthcare","lineage":["https://openalex.org/I2799272722"]}],"countries":["FI"],"is_corresponding":false,"raw_author_name":"J. Haverinen","raw_affiliation_strings":["FinCCHTA, Oulu University Hospital, Oulu, Finland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"FinCCHTA, Oulu University Hospital, Oulu, Finland","institution_ids":["https://openalex.org/I2799272722"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5000143888","display_name":"L. Geris","orcid":null},"institutions":[{"id":"https://openalex.org/I157674565","display_name":"University of Li\u00e8ge","ror":"https://ror.org/00afp2z80","country_code":"BE","type":"education","lineage":["https://openalex.org/I157674565"]}],"countries":["BE"],"is_corresponding":false,"raw_author_name":"L. Geris","raw_affiliation_strings":["University of Li\u00e8ge, Li\u00e8ge, Belgium"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Li\u00e8ge, Li\u00e8ge, Belgium","institution_ids":["https://openalex.org/I157674565"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5076913080","display_name":"Marcus Guardian","orcid":null},"institutions":[{"id":"https://openalex.org/I4210128672","display_name":"EUnited (Belgium)","ror":"https://ror.org/03682w532","country_code":"BE","type":"company","lineage":["https://openalex.org/I4210128672"]}],"countries":["BE"],"is_corresponding":false,"raw_author_name":"M. Guardian","raw_affiliation_strings":["EUnetHTA, Brussels, Belgium"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"EUnetHTA, Brussels, Belgium","institution_ids":["https://openalex.org/I4210128672"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5011290739","display_name":"Martin Posch","orcid":"https://orcid.org/0000-0001-8499-8573"},"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":"M. Posch","raw_affiliation_strings":["Medical University of Vienna, Center for Medical Data Science, Vienna, Austria"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Medical University of Vienna, Center for Medical Data Science, Vienna, Austria","institution_ids":["https://openalex.org/I76134821"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5112133768","display_name":"R. Maspons Bosch","orcid":null},"institutions":[{"id":"https://openalex.org/I4210121249","display_name":"Ag\u00e8ncia de Qualitat i Avaluaci\u00f3 Sanit\u00e0ries de Catalunya","ror":"https://ror.org/01x7se580","country_code":"ES","type":"nonprofit","lineage":["https://openalex.org/I4210121249"]}],"countries":["ES"],"is_corresponding":false,"raw_author_name":"R. Maspons Bosch","raw_affiliation_strings":["Catalan Agency for Health Quality and Assessment, Barcelona, Spain"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Catalan Agency for Health Quality and Assessment, Barcelona, Spain","institution_ids":["https://openalex.org/I4210121249"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5068914703","display_name":"Reinhard Jeindl","orcid":"https://orcid.org/0000-0002-2620-9078"},"institutions":[{"id":"https://openalex.org/I4210104219","display_name":"Austrian Institute for Health Technology Assessment GmbH","ror":"https://ror.org/00v16df20","country_code":"AT","type":"nonprofit","lineage":["https://openalex.org/I4210104219"]}],"countries":["AT"],"is_corresponding":false,"raw_author_name":"R. Jeindl","raw_affiliation_strings":["HTA Austria - Austrian Institute for Health Technology Assessment GmbH, Vienna, Austria"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"HTA Austria - Austrian Institute for Health Technology Assessment GmbH, Vienna, Austria","institution_ids":["https://openalex.org/I4210104219"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5104684978","display_name":"Valentina Strammiello","orcid":null},"institutions":[{"id":"https://openalex.org/I4210131110","display_name":"European Federation of Allergy and Airways Diseases Patients Associations","ror":"https://ror.org/02j9tgd14","country_code":"BE","type":"nonprofit","lineage":["https://openalex.org/I4210131110"]}],"countries":["BE"],"is_corresponding":false,"raw_author_name":"V. Strammiello","raw_affiliation_strings":["European Patients\u2019 Forum, Brussels, Belgium","European Patients' Forum, Brussels, Belgium"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"European Patients\u2019 Forum, Brussels, Belgium","institution_ids":["https://openalex.org/I4210131110"]},{"raw_affiliation_string":"European Patients' Forum, Brussels, Belgium","institution_ids":["https://openalex.org/I4210131110"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5062906346","display_name":"Petra Hoogendoorn","orcid":"https://orcid.org/0000-0003-3824-648X"},"institutions":[{"id":"https://openalex.org/I2800006345","display_name":"Leiden University Medical Center","ror":"https://ror.org/05xvt9f17","country_code":"NL","type":"funder","lineage":["https://openalex.org/I2800006345"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"P. Hoogendoorn","raw_affiliation_strings":["National eHealth Living Lab, Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"National eHealth Living Lab, Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands","institution_ids":["https://openalex.org/I2800006345"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5012969374","display_name":"Markus Kalliola","orcid":null},"institutions":[{"id":"https://openalex.org/I4210108647","display_name":"Sitra","ror":"https://ror.org/01hffx244","country_code":"FI","type":"government","lineage":["https://openalex.org/I4210108647"]}],"countries":["FI"],"is_corresponding":false,"raw_author_name":"M. Kalliola","raw_affiliation_strings":["Finnish Innovation Fund Sitra, Helsinki, Finland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Finnish Innovation Fund Sitra, Helsinki, Finland","institution_ids":["https://openalex.org/I4210108647"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5044118124","display_name":"Johannes Ahlqvist","orcid":null},"institutions":[{"id":"https://openalex.org/I4210108647","display_name":"Sitra","ror":"https://ror.org/01hffx244","country_code":"FI","type":"government","lineage":["https://openalex.org/I4210108647"]}],"countries":["FI"],"is_corresponding":false,"raw_author_name":"J. Ahlqvist","raw_affiliation_strings":["Finnish Innovation Fund Sitra, Helsinki, Finland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Finnish Innovation Fund Sitra, Helsinki, Finland","institution_ids":["https://openalex.org/I4210108647"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5007574843","display_name":"Vincent Vercamer","orcid":null},"institutions":[{"id":"https://openalex.org/I4210163772","display_name":"Ministry of Health","ror":"https://ror.org/053ykx779","country_code":"SZ","type":"government","lineage":["https://openalex.org/I4210163772"]}],"countries":["SZ"],"is_corresponding":false,"raw_author_name":"V. Vercamer","raw_affiliation_strings":["Digital Health Delegation, French Ministry of Helath, Paris, France"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Digital Health Delegation, French Ministry of Helath, Paris, France","institution_ids":["https://openalex.org/I4210163772"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5120863545","display_name":"J. Spony","orcid":null},"institutions":[{"id":"https://openalex.org/I4210131110","display_name":"European Federation of Allergy and Airways Diseases Patients Associations","ror":"https://ror.org/02j9tgd14","country_code":"BE","type":"nonprofit","lineage":["https://openalex.org/I4210131110"]}],"countries":["BE"],"is_corresponding":false,"raw_author_name":"J. Spony","raw_affiliation_strings":["European Patients\u2019 Forum, Brussels, Belgium","European Patients' Forum, Brussels, Belgium"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"European Patients\u2019 Forum, Brussels, Belgium","institution_ids":["https://openalex.org/I4210131110"]},{"raw_affiliation_string":"European Patients' Forum, Brussels, Belgium","institution_ids":["https://openalex.org/I4210131110"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5068468648","display_name":"Marco Marchetti","orcid":"https://orcid.org/0000-0002-5275-5769"},"institutions":[{"id":"https://openalex.org/I4210147969","display_name":"Pontifical University of Saint Thomas Aquinas","ror":"https://ror.org/03wbwwy70","country_code":"IT","type":"education","lineage":["https://openalex.org/I4210147969"]}],"countries":["IT"],"is_corresponding":false,"raw_author_name":"M. Marchetti","raw_affiliation_strings":["AQUAS, Rome, Italy"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"AQUAS, Rome, Italy","institution_ids":["https://openalex.org/I4210147969"]}]}],"institutions":[],"countries_distinct_count":12,"institutions_distinct_count":31,"corresponding_author_ids":["https://openalex.org/A5015945628"],"corresponding_institution_ids":["https://openalex.org/I186903577","https://openalex.org/I4210101141","https://openalex.org/I4210109663"],"apc_list":{"value":3060,"currency":"USD","value_usd":3060},"apc_paid":{"value":3060,"currency":"USD","value_usd":3060},"fwci":3.0037,"has_fulltext":true,"cited_by_count":6,"citation_normalized_percentile":{"value":0.91740798,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":96,"max":99},"biblio":{"volume":"8","issue":"1","first_page":"304","last_page":"304"},"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":0.9868000149726868,"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":0.9868000149726868,"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"}}],"keywords":[{"id":"https://openalex.org/keywords/european-union","display_name":"European union","score":0.7183635234832764},{"id":"https://openalex.org/keywords/grid","display_name":"Grid","score":0.5474118590354919},{"id":"https://openalex.org/keywords/matrix","display_name":"Matrix (chemical analysis)","score":0.5098689794540405},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.48122739791870117},{"id":"https://openalex.org/keywords/grid-cell","display_name":"Grid cell","score":0.4385388493537903},{"id":"https://openalex.org/keywords/data-science","display_name":"Data science","score":0.3697779178619385},{"id":"https://openalex.org/keywords/geography","display_name":"Geography","score":0.2932989299297333},{"id":"https://openalex.org/keywords/business","display_name":"Business","score":0.24369782209396362},{"id":"https://openalex.org/keywords/materials-science","display_name":"Materials science","score":0.12176200747489929},{"id":"https://openalex.org/keywords/international-trade","display_name":"International trade","score":0.11520922183990479}],"concepts":[{"id":"https://openalex.org/C2910001868","wikidata":"https://www.wikidata.org/wiki/Q458","display_name":"European union","level":2,"score":0.7183635234832764},{"id":"https://openalex.org/C187691185","wikidata":"https://www.wikidata.org/wiki/Q2020720","display_name":"Grid","level":2,"score":0.5474118590354919},{"id":"https://openalex.org/C106487976","wikidata":"https://www.wikidata.org/wiki/Q685816","display_name":"Matrix (chemical analysis)","level":2,"score":0.5098689794540405},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.48122739791870117},{"id":"https://openalex.org/C2983008078","wikidata":"https://www.wikidata.org/wiki/Q863495","display_name":"Grid cell","level":3,"score":0.4385388493537903},{"id":"https://openalex.org/C2522767166","wikidata":"https://www.wikidata.org/wiki/Q2374463","display_name":"Data science","level":1,"score":0.3697779178619385},{"id":"https://openalex.org/C205649164","wikidata":"https://www.wikidata.org/wiki/Q1071","display_name":"Geography","level":0,"score":0.2932989299297333},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.24369782209396362},{"id":"https://openalex.org/C192562407","wikidata":"https://www.wikidata.org/wiki/Q228736","display_name":"Materials science","level":0,"score":0.12176200747489929},{"id":"https://openalex.org/C155202549","wikidata":"https://www.wikidata.org/wiki/Q178803","display_name":"International trade","level":1,"score":0.11520922183990479},{"id":"https://openalex.org/C159985019","wikidata":"https://www.wikidata.org/wiki/Q181790","display_name":"Composite material","level":1,"score":0.0},{"id":"https://openalex.org/C13280743","wikidata":"https://www.wikidata.org/wiki/Q131089","display_name":"Geodesy","level":1,"score":0.0}],"mesh":[],"locations_count":6,"locations":[{"id":"doi:10.1038/s41746-025-01697-w","is_oa":true,"landing_page_url":"https://doi.org/10.1038/s41746-025-01697-w","pdf_url":"https://www.nature.com/articles/s41746-025-01697-w.pdf","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:40413360","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/40413360","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:HAL:hal-05084641v1","is_oa":true,"landing_page_url":"https://hal.science/hal-05084641","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":"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 Digital Medicine, 2025, 8 (1), pp.304. &#x27E8;10.1038/s41746-025-01697-w&#x27E9;","raw_type":"Journal articles"},{"id":"pmh:oai:doaj.org/article:1ee0fb698408467db144efc1c8099578","is_oa":true,"landing_page_url":"https://doaj.org/article/1ee0fb698408467db144efc1c8099578","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":"cc-by-sa","license_id":"https://openalex.org/licenses/cc-by-sa","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"npj Digital Medicine, Vol 8, Iss 1, Pp 1-10 (2025)","raw_type":"article"},{"id":"pmh:oai:pubmedcentral.nih.gov:12103570","is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/12103570","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"},{"id":"pmh:oai:re.public.polimi.it:11311/1291451","is_oa":true,"landing_page_url":"https://hdl.handle.net/11311/1291451","pdf_url":null,"source":{"id":"https://openalex.org/S4306400312","display_name":"Virtual Community of Pathological Anatomy (University of Castilla La Mancha)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I79189158","host_organization_name":"University of Castilla-La Mancha","host_organization_lineage":["https://openalex.org/I79189158"],"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":null,"raw_type":"info:eu-repo/semantics/article"}],"best_oa_location":{"id":"doi:10.1038/s41746-025-01697-w","is_oa":true,"landing_page_url":"https://doi.org/10.1038/s41746-025-01697-w","pdf_url":"https://www.nature.com/articles/s41746-025-01697-w.pdf","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":[],"awards":[{"id":"https://openalex.org/G5923293615","display_name":"Statistical and AI based Methods for Advanced Clinical Trial CHallenges in Digital Health","funder_award_id":"ANR-22-PESN-0003","funder_id":"https://openalex.org/F4320320883","funder_display_name":"Agence Nationale de la Recherche"},{"id":"https://openalex.org/G6612625481","display_name":null,"funder_award_id":"France 2030","funder_id":"https://openalex.org/F4320320883","funder_display_name":"Agence Nationale de la Recherche"}],"funders":[{"id":"https://openalex.org/F4320320883","display_name":"Agence Nationale de la Recherche","ror":"https://ror.org/00rbzpz17"}],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4410705023.pdf","grobid_xml":"https://content.openalex.org/works/W4410705023.grobid-xml"},"referenced_works_count":5,"referenced_works":["https://openalex.org/W2590381210","https://openalex.org/W4223547393","https://openalex.org/W4285401036","https://openalex.org/W4385657620","https://openalex.org/W4403025650"],"related_works":["https://openalex.org/W4407141558","https://openalex.org/W2771645251","https://openalex.org/W4407141368","https://openalex.org/W4407777518","https://openalex.org/W4407777582","https://openalex.org/W2752705196","https://openalex.org/W4407777581","https://openalex.org/W3104253173","https://openalex.org/W4402515799","https://openalex.org/W4402515710"],"abstract_inverted_index":{"A":[0],"uniform":[1],"and":[2,10,73],"harmonised":[3],"taxonomy":[4,123],"of":[5,30,36,60,65,83,106,110,140,145],"Digital":[6],"Medical":[7],"Devices":[8],"(DMDs)":[9],"their":[11,18],"evidence-based":[12,128],"evaluation":[13,113],"are":[14,55],"essential":[15],"to":[16,79,136],"ensure":[17],"integration":[19],"into":[20],"healthcare":[21],"systems":[22],"across":[23,148],"the":[24,31,58,97,104,107,119,143,149],"European":[25,40],"Union":[26],"(EU).":[27],"As":[28],"part":[29],"Taskforce":[32],"for":[33,43],"Harmonised":[34],"Evaluation":[35],"DMDs,":[37],"a":[38,63,111],"Common":[39],"Classification":[41],"Grid":[42],"DMDs":[44,141],"(CEUGrid-DMD)":[45],"associated":[46,125],"with":[47,126],"an":[48,127],"Evidence":[49],"Matrix":[50],"is":[51],"developed.":[52],"These":[53],"tools":[54],"based":[56],"on":[57],"mapping":[59],"existing":[61],"frameworks,":[62],"survey":[64,76,98],"Health":[66],"Technology":[67],"Assessment":[68],"(HTA)":[69],"practices,":[70],"consensus":[71],"meetings":[72],"workshop.":[74],"The":[75],"was":[77],"sent":[78],"32":[80],"national":[81],"representatives":[82],"HTA":[84,91,146],"bodies":[85,92],"from":[86,93],"18":[87],"EU":[88],"countries.":[89],"Ten":[90],"nine":[94],"countries":[95],"completed":[96],"while":[99],"others":[100],"could":[101],"not,":[102],"in":[103,118,142],"absence":[105],"effective":[108],"implementation":[109],"DMD":[112],"framework.":[114],"This":[115],"work":[116],"results":[117],"CEUGrid-DMD":[120],"including":[121],"four":[122],"categories,":[124],"matrix.":[129],"Overall,":[130],"this":[131],"first":[132],"version":[133],"should":[134],"help":[135],"converge":[137],"scientific":[138],"assessments":[139],"context":[144],"Regulations":[147],"EU.":[150]},"counts_by_year":[{"year":2026,"cited_by_count":3},{"year":2025,"cited_by_count":3}],"updated_date":"2026-05-16T08:24:45.110214","created_date":"2025-10-10T00:00:00"}
