{"id":"https://openalex.org/W3112320859","doi":"https://doi.org/10.1038/s41746-020-00371-7","title":"Advancing digital health: FDA innovation during COVID-19","display_name":"Advancing digital health: FDA innovation during COVID-19","publication_year":2020,"publication_date":"2020-12-17","ids":{"openalex":"https://openalex.org/W3112320859","doi":"https://doi.org/10.1038/s41746-020-00371-7","mag":"3112320859","pmid":"https://pubmed.ncbi.nlm.nih.gov/33335250"},"language":"en","primary_location":{"id":"doi:10.1038/s41746-020-00371-7","is_oa":true,"landing_page_url":"https://doi.org/10.1038/s41746-020-00371-7","pdf_url":"https://www.nature.com/articles/s41746-020-00371-7.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","license_id":"https://openalex.org/licenses/cc-by","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/s41746-020-00371-7.pdf","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5058281574","display_name":"Kushal T. Kadakia","orcid":"https://orcid.org/0000-0002-9539-7682"},"institutions":[{"id":"https://openalex.org/I1320320070","display_name":"United States Food and Drug Administration","ror":"https://ror.org/034xvzb47","country_code":"US","type":"government","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Kushal Kadakia","raw_affiliation_strings":["U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA","institution_ids":["https://openalex.org/I1320320070"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5015817454","display_name":"Bakul Patel","orcid":"https://orcid.org/0000-0002-1264-1783"},"institutions":[{"id":"https://openalex.org/I1320320070","display_name":"United States Food and Drug Administration","ror":"https://ror.org/034xvzb47","country_code":"US","type":"government","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Bakul Patel","raw_affiliation_strings":["U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA","institution_ids":["https://openalex.org/I1320320070"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5101729403","display_name":"Anand Shah","orcid":"https://orcid.org/0000-0002-0573-8448"},"institutions":[{"id":"https://openalex.org/I1320320070","display_name":"United States Food and Drug Administration","ror":"https://ror.org/034xvzb47","country_code":"US","type":"government","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Anand Shah","raw_affiliation_strings":["U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. anand.shah@fda.hhs.gov","U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA"],"raw_orcid":"https://orcid.org/0000-0002-0573-8448","affiliations":[{"raw_affiliation_string":"U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. anand.shah@fda.hhs.gov","institution_ids":["https://openalex.org/I1320320070"]},{"raw_affiliation_string":"U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA","institution_ids":["https://openalex.org/I1320320070"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":3,"corresponding_author_ids":["https://openalex.org/A5058281574"],"corresponding_institution_ids":["https://openalex.org/I1320320070"],"apc_list":{"value":3060,"currency":"USD","value_usd":3060},"apc_paid":{"value":3060,"currency":"USD","value_usd":3060},"fwci":4.6195,"has_fulltext":true,"cited_by_count":51,"citation_normalized_percentile":{"value":0.95339367,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":89,"max":100},"biblio":{"volume":"3","issue":"1","first_page":"161","last_page":"161"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11519","display_name":"Digital Mental Health Interventions","score":0.9682999849319458,"subfield":{"id":"https://openalex.org/subfields/3202","display_name":"Applied Psychology"},"field":{"id":"https://openalex.org/fields/32","display_name":"Psychology"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},"topics":[{"id":"https://openalex.org/T11519","display_name":"Digital Mental Health Interventions","score":0.9682999849319458,"subfield":{"id":"https://openalex.org/subfields/3202","display_name":"Applied Psychology"},"field":{"id":"https://openalex.org/fields/32","display_name":"Psychology"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T13417","display_name":"Biomedical Ethics and Regulation","score":0.965499997138977,"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"}},{"id":"https://openalex.org/T11446","display_name":"Mobile Health and mHealth Applications","score":0.958299994468689,"subfield":{"id":"https://openalex.org/subfields/3600","display_name":"General Health Professions"},"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/digital-health","display_name":"Digital health","score":0.7561936974525452},{"id":"https://openalex.org/keywords/food-and-drug-administration","display_name":"Food and drug administration","score":0.7025080919265747},{"id":"https://openalex.org/keywords/coronavirus-disease-2019","display_name":"Coronavirus disease 2019 (COVID-19)","score":0.695824921131134},{"id":"https://openalex.org/keywords/agency","display_name":"Agency (philosophy)","score":0.6720477938652039},{"id":"https://openalex.org/keywords/pandemic","display_name":"Pandemic","score":0.5913745760917664},{"id":"https://openalex.org/keywords/telemedicine","display_name":"Telemedicine","score":0.5447214245796204},{"id":"https://openalex.org/keywords/business","display_name":"Business","score":0.5424206852912903},{"id":"https://openalex.org/keywords/health-care","display_name":"Health care","score":0.5007615089416504},{"id":"https://openalex.org/keywords/internet-privacy","display_name":"Internet privacy","score":0.44147029519081116},{"id":"https://openalex.org/keywords/public-relations","display_name":"Public relations","score":0.44015198945999146},{"id":"https://openalex.org/keywords/key","display_name":"Key (lock)","score":0.4334535300731659},{"id":"https://openalex.org/keywords/medicine","display_name":"Medicine","score":0.3656991124153137},{"id":"https://openalex.org/keywords/political-science","display_name":"Political science","score":0.2765968441963196},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.19087713956832886},{"id":"https://openalex.org/keywords/computer-security","display_name":"Computer security","score":0.1764158010482788},{"id":"https://openalex.org/keywords/risk-analysis","display_name":"Risk analysis (engineering)","score":0.16354584693908691},{"id":"https://openalex.org/keywords/sociology","display_name":"Sociology","score":0.11812344193458557},{"id":"https://openalex.org/keywords/disease","display_name":"Disease","score":0.11336579918861389},{"id":"https://openalex.org/keywords/infectious-disease","display_name":"Infectious disease (medical specialty)","score":0.09163248538970947}],"concepts":[{"id":"https://openalex.org/C2780433410","wikidata":"https://www.wikidata.org/wiki/Q5276090","display_name":"Digital health","level":3,"score":0.7561936974525452},{"id":"https://openalex.org/C3018890749","wikidata":"https://www.wikidata.org/wiki/Q204711","display_name":"Food and drug administration","level":2,"score":0.7025080919265747},{"id":"https://openalex.org/C3008058167","wikidata":"https://www.wikidata.org/wiki/Q84263196","display_name":"Coronavirus disease 2019 (COVID-19)","level":4,"score":0.695824921131134},{"id":"https://openalex.org/C108170787","wikidata":"https://www.wikidata.org/wiki/Q3951828","display_name":"Agency (philosophy)","level":2,"score":0.6720477938652039},{"id":"https://openalex.org/C89623803","wikidata":"https://www.wikidata.org/wiki/Q12184","display_name":"Pandemic","level":5,"score":0.5913745760917664},{"id":"https://openalex.org/C2779891985","wikidata":"https://www.wikidata.org/wiki/Q46994","display_name":"Telemedicine","level":3,"score":0.5447214245796204},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.5424206852912903},{"id":"https://openalex.org/C160735492","wikidata":"https://www.wikidata.org/wiki/Q31207","display_name":"Health care","level":2,"score":0.5007615089416504},{"id":"https://openalex.org/C108827166","wikidata":"https://www.wikidata.org/wiki/Q175975","display_name":"Internet privacy","level":1,"score":0.44147029519081116},{"id":"https://openalex.org/C39549134","wikidata":"https://www.wikidata.org/wiki/Q133080","display_name":"Public relations","level":1,"score":0.44015198945999146},{"id":"https://openalex.org/C26517878","wikidata":"https://www.wikidata.org/wiki/Q228039","display_name":"Key (lock)","level":2,"score":0.4334535300731659},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.3656991124153137},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.2765968441963196},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.19087713956832886},{"id":"https://openalex.org/C38652104","wikidata":"https://www.wikidata.org/wiki/Q3510521","display_name":"Computer security","level":1,"score":0.1764158010482788},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.16354584693908691},{"id":"https://openalex.org/C144024400","wikidata":"https://www.wikidata.org/wiki/Q21201","display_name":"Sociology","level":0,"score":0.11812344193458557},{"id":"https://openalex.org/C2779134260","wikidata":"https://www.wikidata.org/wiki/Q12136","display_name":"Disease","level":2,"score":0.11336579918861389},{"id":"https://openalex.org/C524204448","wikidata":"https://www.wikidata.org/wiki/Q788926","display_name":"Infectious disease (medical specialty)","level":3,"score":0.09163248538970947},{"id":"https://openalex.org/C36289849","wikidata":"https://www.wikidata.org/wiki/Q34749","display_name":"Social science","level":1,"score":0.0},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.0},{"id":"https://openalex.org/C199539241","wikidata":"https://www.wikidata.org/wiki/Q7748","display_name":"Law","level":1,"score":0.0}],"mesh":[],"locations_count":4,"locations":[{"id":"doi:10.1038/s41746-020-00371-7","is_oa":true,"landing_page_url":"https://doi.org/10.1038/s41746-020-00371-7","pdf_url":"https://www.nature.com/articles/s41746-020-00371-7.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","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"npj Digital Medicine","raw_type":"journal-article"},{"id":"pmid:33335250","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/33335250","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:doaj.org/article:e6cd3676b6b641c1a1a0670ff13db78c","is_oa":true,"landing_page_url":"https://doaj.org/article/e6cd3676b6b641c1a1a0670ff13db78c","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-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 3, Iss 1, Pp 1-3 (2020)","raw_type":"article"},{"id":"pmh:oai:pubmedcentral.nih.gov:7747714","is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/7747714","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":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"NPJ Digit Med","raw_type":"Text"}],"best_oa_location":{"id":"doi:10.1038/s41746-020-00371-7","is_oa":true,"landing_page_url":"https://doi.org/10.1038/s41746-020-00371-7","pdf_url":"https://www.nature.com/articles/s41746-020-00371-7.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","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"npj Digital Medicine","raw_type":"journal-article"},"sustainable_development_goals":[{"score":0.41999998688697815,"display_name":"Industry, innovation and infrastructure","id":"https://metadata.un.org/sdg/9"}],"awards":[],"funders":[],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W3112320859.pdf","grobid_xml":"https://content.openalex.org/works/W3112320859.grobid-xml"},"referenced_works_count":5,"referenced_works":["https://openalex.org/W2810394815","https://openalex.org/W2913351506","https://openalex.org/W3014307806","https://openalex.org/W3025989244","https://openalex.org/W3029122621"],"related_works":["https://openalex.org/W1580898361","https://openalex.org/W2302677685","https://openalex.org/W4280587861","https://openalex.org/W4200332661","https://openalex.org/W3021957403","https://openalex.org/W2038459974","https://openalex.org/W2025207717","https://openalex.org/W4281774645","https://openalex.org/W3197294368","https://openalex.org/W3130463450"],"abstract_inverted_index":{"Digital":[0],"health":[1,45,93,104],"products":[2],"have":[3],"played":[4],"an":[5],"important":[6],"role":[7],"in":[8,22],"the":[9,14,48,56,79,100],"COVID-19":[10],"response,":[11],"from":[12],"supporting":[13],"remote":[15,68],"monitoring":[16],"of":[17,39,58,102],"patients":[18,91],"to":[19,42,54,78],"enabling":[20],"continuity":[21],"data":[23],"collection":[24],"for":[25,61,67,84,90,99],"clinical":[26],"trials.":[27],"The":[28],"U.S.":[29],"Food":[30],"and":[31,64,92,96],"Drug":[32],"Administration":[33],"(FDA)":[34],"has":[35],"issued":[36],"a":[37],"number":[38],"temporary":[40],"policies":[41,77],"support":[43],"digital":[44,59,85,103],"innovation":[46],"during":[47],"pandemic,":[49],"such":[50],"as":[51],"guidance":[52],"documents":[53],"expand":[55],"use":[57],"therapeutics":[60],"psychiatric":[62],"disorders":[63],"medical":[65],"devices":[66],"patient":[69],"monitoring.":[70],"In":[71],"this":[72],"article,":[73],"we":[74],"contextualize":[75],"these":[76],"agency\u2019s":[80],"existing":[81],"regulatory":[82],"framework":[83],"health,":[86],"outline":[87],"key":[88],"considerations":[89],"care":[94],"providers,":[95],"identify":[97],"implications":[98],"future":[101],"innovation.":[105]},"counts_by_year":[{"year":2026,"cited_by_count":1},{"year":2025,"cited_by_count":5},{"year":2024,"cited_by_count":10},{"year":2023,"cited_by_count":9},{"year":2022,"cited_by_count":19},{"year":2021,"cited_by_count":6},{"year":2020,"cited_by_count":1}],"updated_date":"2026-01-13T01:12:25.745995","created_date":"2025-10-10T00:00:00"}