{"id":"https://openalex.org/W4394767434","doi":"https://doi.org/10.1038/s41746-024-01098-5","title":"Navigating the U.S. regulatory landscape for neurologic digital health technologies","display_name":"Navigating the U.S. regulatory landscape for neurologic digital health technologies","publication_year":2024,"publication_date":"2024-04-12","ids":{"openalex":"https://openalex.org/W4394767434","doi":"https://doi.org/10.1038/s41746-024-01098-5","pmid":"https://pubmed.ncbi.nlm.nih.gov/38609447"},"language":"en","primary_location":{"id":"doi:10.1038/s41746-024-01098-5","is_oa":true,"landing_page_url":"https://doi.org/10.1038/s41746-024-01098-5","pdf_url":"https://www.nature.com/articles/s41746-024-01098-5.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/s41746-024-01098-5.pdf","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5034118829","display_name":"Neil A. Busis","orcid":"https://orcid.org/0000-0002-4603-4586"},"institutions":[{"id":"https://openalex.org/I57206974","display_name":"New York University","ror":"https://ror.org/0190ak572","country_code":"US","type":"education","lineage":["https://openalex.org/I57206974"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Neil A. Busis","raw_affiliation_strings":["Department of Neurology, NYU Grossman School of Medicine, New York, NY, USA. Neil.Busis@nyulangone.org","Department of Neurology, NYU Grossman School of Medicine, New York, NY, USA"],"raw_orcid":"https://orcid.org/0000-0002-4603-4586","affiliations":[{"raw_affiliation_string":"Department of Neurology, NYU Grossman School of Medicine, New York, NY, USA. Neil.Busis@nyulangone.org","institution_ids":["https://openalex.org/I57206974"]},{"raw_affiliation_string":"Department of Neurology, NYU Grossman School of Medicine, New York, NY, USA","institution_ids":["https://openalex.org/I57206974"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5072501749","display_name":"Dilshad Marolia","orcid":null},"institutions":[{"id":"https://openalex.org/I4210086933","display_name":"NYU Langone Health","ror":"https://ror.org/005dvqh91","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210086933"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Dilshad Marolia","raw_affiliation_strings":["NYU Langone Health System, New York, NY, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"NYU Langone Health System, New York, NY, USA","institution_ids":["https://openalex.org/I4210086933"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5020845978","display_name":"Robert A. Montgomery","orcid":"https://orcid.org/0000-0001-5894-0589"},"institutions":[{"id":"https://openalex.org/I4210086933","display_name":"NYU Langone Health","ror":"https://ror.org/005dvqh91","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210086933"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Robert Montgomery","raw_affiliation_strings":["Clinical Affairs and Ambulatory Care, NYU Langone Health System, New York, NY, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Affairs and Ambulatory Care, NYU Langone Health System, New York, NY, USA","institution_ids":["https://openalex.org/I4210086933"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5013357095","display_name":"Laura J. Balcer","orcid":"https://orcid.org/0000-0002-5136-4539"},"institutions":[{"id":"https://openalex.org/I57206974","display_name":"New York University","ror":"https://ror.org/0190ak572","country_code":"US","type":"education","lineage":["https://openalex.org/I57206974"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Laura J. Balcer","raw_affiliation_strings":["Department of Neurology, NYU Grossman School of Medicine, New York, NY, USA","Department of Ophthalmology, NYU Grossman School of Medicine, New York, NY, USA","Department of Population Health, NYU Grossman School of Medicine, New York, NY, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Neurology, NYU Grossman School of Medicine, New York, NY, USA","institution_ids":["https://openalex.org/I57206974"]},{"raw_affiliation_string":"Department of Ophthalmology, NYU Grossman School of Medicine, New York, NY, USA","institution_ids":["https://openalex.org/I57206974"]},{"raw_affiliation_string":"Department of Population Health, NYU Grossman School of Medicine, New York, NY, USA","institution_ids":["https://openalex.org/I57206974"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5031416421","display_name":"Steven Galetta","orcid":"https://orcid.org/0000-0003-3781-7324"},"institutions":[{"id":"https://openalex.org/I57206974","display_name":"New York University","ror":"https://ror.org/0190ak572","country_code":"US","type":"education","lineage":["https://openalex.org/I57206974"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Steven L. Galetta","raw_affiliation_strings":["Department of Neurology, NYU Grossman School of Medicine, New York, NY, USA","Department of Ophthalmology, NYU Grossman School of Medicine, New York, NY, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Neurology, NYU Grossman School of Medicine, New York, NY, USA","institution_ids":["https://openalex.org/I57206974"]},{"raw_affiliation_string":"Department of Ophthalmology, NYU Grossman School of Medicine, New York, NY, USA","institution_ids":["https://openalex.org/I57206974"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5001622901","display_name":"Scott N. Grossman","orcid":"https://orcid.org/0000-0001-7033-5226"},"institutions":[{"id":"https://openalex.org/I57206974","display_name":"New York University","ror":"https://ror.org/0190ak572","country_code":"US","type":"education","lineage":["https://openalex.org/I57206974"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Scott N. Grossman","raw_affiliation_strings":["Department of Neurology, NYU Grossman School of Medicine, New York, NY, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Neurology, NYU Grossman School of Medicine, New York, NY, USA","institution_ids":["https://openalex.org/I57206974"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":6,"corresponding_author_ids":["https://openalex.org/A5034118829"],"corresponding_institution_ids":["https://openalex.org/I57206974"],"apc_list":{"value":3060,"currency":"USD","value_usd":3060},"apc_paid":{"value":3060,"currency":"USD","value_usd":3060},"fwci":9.1351,"has_fulltext":true,"cited_by_count":9,"citation_normalized_percentile":{"value":0.97171019,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":90,"max":99},"biblio":{"volume":"7","issue":"1","first_page":"94","last_page":"94"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10804","display_name":"Health Systems, Economic Evaluations, Quality of Life","score":0.995199978351593,"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"}},"topics":[{"id":"https://openalex.org/T10804","display_name":"Health Systems, Economic Evaluations, Quality of Life","score":0.995199978351593,"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/T11636","display_name":"Artificial Intelligence in Healthcare and Education","score":0.9745000004768372,"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"}},{"id":"https://openalex.org/T10598","display_name":"Cardiac pacing and defibrillation studies","score":0.9609000086784363,"subfield":{"id":"https://openalex.org/subfields/2705","display_name":"Cardiology and Cardiovascular Medicine"},"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/risk-analysis","display_name":"Risk analysis (engineering)","score":0.5402095317840576},{"id":"https://openalex.org/keywords/medicaid","display_name":"Medicaid","score":0.5032817721366882},{"id":"https://openalex.org/keywords/software-deployment","display_name":"Software deployment","score":0.4479946494102478},{"id":"https://openalex.org/keywords/business","display_name":"Business","score":0.4443356692790985},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.4202289581298828},{"id":"https://openalex.org/keywords/health-care","display_name":"Health care","score":0.35787123441696167},{"id":"https://openalex.org/keywords/computer-security","display_name":"Computer security","score":0.35273659229278564},{"id":"https://openalex.org/keywords/process-management","display_name":"Process management","score":0.3225589096546173}],"concepts":[{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.5402095317840576},{"id":"https://openalex.org/C2776534028","wikidata":"https://www.wikidata.org/wiki/Q1141363","display_name":"Medicaid","level":3,"score":0.5032817721366882},{"id":"https://openalex.org/C105339364","wikidata":"https://www.wikidata.org/wiki/Q2297740","display_name":"Software deployment","level":2,"score":0.4479946494102478},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.4443356692790985},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.4202289581298828},{"id":"https://openalex.org/C160735492","wikidata":"https://www.wikidata.org/wiki/Q31207","display_name":"Health care","level":2,"score":0.35787123441696167},{"id":"https://openalex.org/C38652104","wikidata":"https://www.wikidata.org/wiki/Q3510521","display_name":"Computer security","level":1,"score":0.35273659229278564},{"id":"https://openalex.org/C195094911","wikidata":"https://www.wikidata.org/wiki/Q14167904","display_name":"Process management","level":1,"score":0.3225589096546173},{"id":"https://openalex.org/C50522688","wikidata":"https://www.wikidata.org/wiki/Q189833","display_name":"Economic growth","level":1,"score":0.0},{"id":"https://openalex.org/C111919701","wikidata":"https://www.wikidata.org/wiki/Q9135","display_name":"Operating system","level":1,"score":0.0},{"id":"https://openalex.org/C162324750","wikidata":"https://www.wikidata.org/wiki/Q8134","display_name":"Economics","level":0,"score":0.0}],"mesh":[],"locations_count":4,"locations":[{"id":"doi:10.1038/s41746-024-01098-5","is_oa":true,"landing_page_url":"https://doi.org/10.1038/s41746-024-01098-5","pdf_url":"https://www.nature.com/articles/s41746-024-01098-5.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:38609447","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/38609447","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:pubmedcentral.nih.gov:11014948","is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/11014948","pdf_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11014948/pdf/41746_2024_Article_1098.pdf","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"},{"id":"pmh:oai:doaj.org/article:e861d8d98427489291486f68fda3ff90","is_oa":true,"landing_page_url":"https://doaj.org/article/e861d8d98427489291486f68fda3ff90","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 7, Iss 1, Pp 1-5 (2024)","raw_type":"article"}],"best_oa_location":{"id":"doi:10.1038/s41746-024-01098-5","is_oa":true,"landing_page_url":"https://doi.org/10.1038/s41746-024-01098-5","pdf_url":"https://www.nature.com/articles/s41746-024-01098-5.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":[{"display_name":"Industry, innovation and infrastructure","score":0.4300000071525574,"id":"https://metadata.un.org/sdg/9"}],"awards":[],"funders":[],"has_content":{"pdf":true,"grobid_xml":false},"content_urls":{"pdf":"https://content.openalex.org/works/W4394767434.pdf"},"referenced_works_count":27,"referenced_works":["https://openalex.org/W2547333777","https://openalex.org/W2775539030","https://openalex.org/W2795761008","https://openalex.org/W2898332744","https://openalex.org/W3093779917","https://openalex.org/W4206450794","https://openalex.org/W4206816283","https://openalex.org/W4206991706","https://openalex.org/W4207078741","https://openalex.org/W4210870382","https://openalex.org/W4210899496","https://openalex.org/W4212879173","https://openalex.org/W4226057566","https://openalex.org/W4226342811","https://openalex.org/W4281706229","https://openalex.org/W4298150010","https://openalex.org/W4310781642","https://openalex.org/W4319984390","https://openalex.org/W4378906615","https://openalex.org/W4382795652","https://openalex.org/W4383186800","https://openalex.org/W4383186985","https://openalex.org/W4387424974","https://openalex.org/W4388406339","https://openalex.org/W4391144321","https://openalex.org/W4391990172","https://openalex.org/W4391998463"],"related_works":["https://openalex.org/W2281130122","https://openalex.org/W3121145236","https://openalex.org/W3145365445","https://openalex.org/W2145833305","https://openalex.org/W4200076348","https://openalex.org/W4387241509","https://openalex.org/W1974171884","https://openalex.org/W2951611134","https://openalex.org/W2150198561","https://openalex.org/W2770234245"],"abstract_inverted_index":{"Digital":[0],"health":[1,100],"technologies":[2,117],"(DHTs)":[3],"can":[4,158],"transform":[5],"neurological":[6],"assessments,":[7],"improving":[8],"quality":[9],"and":[10,27,43,47,64,72,78,98,105,118,130,150,172],"continuity":[11],"of":[12,29,135,161],"care.":[13],"In":[14],"the":[15,18,25,55],"United":[16],"States,":[17],"Food":[19],"&":[20,68],"Drug":[21],"Administration":[22],"(FDA)":[23],"oversees":[24],"safety":[26,129],"efficacy":[28],"these":[30,115,162],"technologies,":[31],"employing":[32],"a":[33,125],"detailed":[34],"regulatory":[35],"process":[36],"that":[37],"classifies":[38],"devices":[39],"based":[40],"on":[41],"risk":[42,147],"requires":[44],"rigorous":[45],"review":[46],"post-market":[48],"surveillance.":[49],"Following":[50],"FDA":[51],"approval,":[52],"DHTs":[53,139,167],"enter":[54],"Current":[56],"Procedural":[57],"Terminology,":[58],"Relative":[59],"Value":[60],"Scale":[61],"Update":[62],"Committee,":[63],"Centers":[65],"for":[66],"Medicare":[67],"Medicaid":[69],"Services":[70],"coding":[71,96],"valuation":[73],"processes":[74],"leading":[75],"to":[76,109,113],"coverage":[77],"payment":[79],"decisions.":[80],"DHT":[81],"adoption":[82,160],"is":[83],"challenged":[84],"by":[85,165],"rapid":[86],"technologic":[87],"advancements,":[88],"an":[89],"inconsistent":[90],"evidence":[91],"base,":[92],"marketing":[93],"discrepancies,":[94],"ambiguous":[95],"guidance,":[97],"variable":[99],"insurance":[101],"coverage.":[102],"Regulators,":[103],"policymakers,":[104],"payers":[106],"will":[107],"need":[108],"develop":[110],"better":[111],"methods":[112],"evaluate":[114],"promising":[116,163],"guide":[119],"their":[120],"deployment.":[121],"This":[122],"includes":[123],"striking":[124],"balance":[126],"between":[127],"patient":[128],"clinical":[131],"effectiveness":[132],"versus":[133],"promotion":[134],"innovation,":[136],"especially":[137],"as":[138],"increasingly":[140],"incorporate":[141],"artificial":[142],"intelligence.":[143],"Data":[144],"validity,":[145],"cybersecurity,":[146],"management,":[148],"societal,":[149],"ethical":[151],"responsibilities":[152],"should":[153],"be":[154],"addressed.":[155],"Regulatory":[156],"advances":[157],"support":[159],"tools":[164],"ensuring":[166],"are":[168],"safe,":[169],"effective,":[170],"accessible,":[171],"equitable.":[173]},"counts_by_year":[{"year":2026,"cited_by_count":3},{"year":2025,"cited_by_count":5},{"year":2024,"cited_by_count":1}],"updated_date":"2026-06-13T06:13:01.061226","created_date":"2025-10-10T00:00:00"}