{"id":"https://openalex.org/W4400937397","doi":"https://doi.org/10.1186/s44247-024-00098-5","title":"From an idea to the marketplace: identifying and addressing ethical and regulatory considerations across the digital health product-development lifecycle","display_name":"From an idea to the marketplace: identifying and addressing ethical and regulatory considerations across the digital health product-development lifecycle","publication_year":2024,"publication_date":"2024-07-24","ids":{"openalex":"https://openalex.org/W4400937397","doi":"https://doi.org/10.1186/s44247-024-00098-5","pmid":"https://pubmed.ncbi.nlm.nih.gov/39130168","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/11308106"},"language":"en","primary_location":{"id":"doi:10.1186/s44247-024-00098-5","doi":"https://doi.org/10.1186/s44247-024-00098-5","is_oa":true,"landing_page_url":"https://doi.org/10.1186/s44247-024-00098-5","pdf_url":"https://bmcdigitalhealth.biomedcentral.com/counter/pdf/10.1186/s44247-024-00098-5","source":{"id":"https://openalex.org/S4387286688","display_name":"BMC Digital Health","issn_l":"2731-684X","issn":["2731-684X"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","jufo-1","norway-1","vabb-shw"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"BMC Digital Health","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://bmcdigitalhealth.biomedcentral.com/counter/pdf/10.1186/s44247-024-00098-5","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5001385550","display_name":"Emily A. Largent","orcid":"https://orcid.org/0000-0002-7536-5077","observed_orcids":["https://orcid.org/0000-0002-7536-5077"]},"institutions":[{"id":"https://openalex.org/I79576946","display_name":"University of Pennsylvania","ror":"https://ror.org/00b30xv10","country_code":"US","type":"education","lineage":["https://openalex.org/I79576946"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Emily A. Largent","raw_affiliation_strings":["Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA","Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Blockley Hall, Room 1403, 423 Guardian Drive, Philadelphia, PA, 19104, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA","institution_ids":["https://openalex.org/I79576946"]},{"raw_affiliation_string":"Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Blockley Hall, Room 1403, 423 Guardian Drive, Philadelphia, PA, 19104, USA","institution_ids":["https://openalex.org/I79576946"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5012342239","display_name":"Jason H. Karlawish","orcid":"https://orcid.org/0000-0002-6880-2865","observed_orcids":["https://orcid.org/0000-0002-6880-2865"]},"institutions":[{"id":"https://openalex.org/I79576946","display_name":"University of Pennsylvania","ror":"https://ror.org/00b30xv10","country_code":"US","type":"education","lineage":["https://openalex.org/I79576946"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Jason Karlawish","raw_affiliation_strings":["Department of Medicine, Department of Medical Ethics and Health Policy, Department of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Medicine, Department of Medical Ethics and Health Policy, Department of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA","institution_ids":["https://openalex.org/I79576946"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5114375005","display_name":"Anna Wexler","orcid":"https://orcid.org/0000-0002-6723-9038","observed_orcids":["https://orcid.org/0000-0002-6723-9038"]},"institutions":[{"id":"https://openalex.org/I79576946","display_name":"University of Pennsylvania","ror":"https://ror.org/00b30xv10","country_code":"US","type":"education","lineage":["https://openalex.org/I79576946"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Anna Wexler","raw_affiliation_strings":["Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA","institution_ids":["https://openalex.org/I79576946"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5001385550"],"corresponding_institution_ids":["https://openalex.org/I79576946"],"apc_list":{"value":1990,"currency":"USD","value_usd":1990},"apc_paid":{"value":1990,"currency":"USD","value_usd":1990},"fwci":5.2316,"has_fulltext":true,"cited_by_count":11,"citation_normalized_percentile":{"value":0.95761071,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":93,"max":99},"biblio":{"volume":"2","issue":"1","first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11446","display_name":"Mobile Health and mHealth Applications","score":0.3425000011920929,"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"}},"topics":[{"id":"https://openalex.org/T11446","display_name":"Mobile Health and mHealth Applications","score":0.3425000011920929,"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"}},{"id":"https://openalex.org/T11636","display_name":"Artificial Intelligence in Healthcare and Education","score":0.1931000053882599,"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/T14396","display_name":"Healthcare Regulation","score":0.09539999812841415,"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/digital-health-products","display_name":"digital health products","score":0.8899999856948853},{"id":"https://openalex.org/keywords/product-development-cycle","display_name":"product development cycle","score":0.8009999990463257},{"id":"https://openalex.org/keywords/ethics","display_name":"ethics","score":0.6309999823570251},{"id":"https://openalex.org/keywords/regulation","display_name":"regulation","score":0.7940000295639038},{"id":"https://openalex.org/keywords/commercialization","display_name":"commercialization","score":0.7310000061988831},{"id":"https://openalex.org/keywords/health-technology-regulation","display_name":"health technology regulation","score":0.6549999713897705},{"id":"https://openalex.org/keywords/ethical-issues","display_name":"ethical considerations","score":0.6169999837875366},{"id":"https://openalex.org/keywords/digital-health-tools","display_name":"digital health tools","score":0.5569999814033508}],"concepts":[{"id":"https://openalex.org/C194304873","wikidata":"https://www.wikidata.org/wiki/Q1967338","display_name":"Product lifecycle","level":3,"score":0.582554817199707},{"id":"https://openalex.org/C90673727","wikidata":"https://www.wikidata.org/wiki/Q901718","display_name":"Product (mathematics)","level":2,"score":0.566923975944519},{"id":"https://openalex.org/C55587333","wikidata":"https://www.wikidata.org/wiki/Q1133029","display_name":"Engineering ethics","level":1,"score":0.5084208846092224},{"id":"https://openalex.org/C19351080","wikidata":"https://www.wikidata.org/wiki/Q1395034","display_name":"New product development","level":2,"score":0.4967537522315979},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.4830630421638489},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.4751662611961365},{"id":"https://openalex.org/C2778917124","wikidata":"https://www.wikidata.org/wiki/Q7309705","display_name":"Regulatory science","level":2,"score":0.425750732421875},{"id":"https://openalex.org/C195094911","wikidata":"https://www.wikidata.org/wiki/Q14167904","display_name":"Process management","level":1,"score":0.4142114520072937},{"id":"https://openalex.org/C56739046","wikidata":"https://www.wikidata.org/wiki/Q192060","display_name":"Knowledge management","level":1,"score":0.3585476279258728},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.256958544254303},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.2480950653553009},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.20684459805488586},{"id":"https://openalex.org/C162853370","wikidata":"https://www.wikidata.org/wiki/Q39809","display_name":"Marketing","level":1,"score":0.1451435387134552},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"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/C2524010","wikidata":"https://www.wikidata.org/wiki/Q8087","display_name":"Geometry","level":1,"score":0.0}],"mesh":[],"locations_count":4,"locations":[{"id":"doi:10.1186/s44247-024-00098-5","doi":"https://doi.org/10.1186/s44247-024-00098-5","is_oa":true,"landing_page_url":"https://doi.org/10.1186/s44247-024-00098-5","pdf_url":"https://bmcdigitalhealth.biomedcentral.com/counter/pdf/10.1186/s44247-024-00098-5","source":{"id":"https://openalex.org/S4387286688","display_name":"BMC Digital Health","issn_l":"2731-684X","issn":["2731-684X"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","jufo-1","norway-1","vabb-shw"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"BMC Digital Health","raw_type":"journal-article"},{"id":"pmid:39130168","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/39130168","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,"listed_in":[],"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":"BMC digital health","raw_type":"Journal Article"},{"id":"pmh:oai:pubmedcentral.nih.gov:11308106","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/11308106","pdf_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11308106/pdf/nihms-1993115.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,"listed_in":[],"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":"acceptedVersion","is_accepted":true,"is_published":false,"raw_source_name":"BMC Digit Health","raw_type":"Text"},{"id":"pmh:oai:doaj.org/article:4d77c1241c1d4241a306af7c8eb27a7a","doi":null,"is_oa":true,"landing_page_url":"https://doaj.org/article/4d77c1241c1d4241a306af7c8eb27a7a","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,"listed_in":[],"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":"BMC Digital Health, Vol 2, Iss 1, Pp 1-11 (2024)","raw_type":"article"}],"best_oa_location":{"id":"doi:10.1186/s44247-024-00098-5","doi":"https://doi.org/10.1186/s44247-024-00098-5","is_oa":true,"landing_page_url":"https://doi.org/10.1186/s44247-024-00098-5","pdf_url":"https://bmcdigitalhealth.biomedcentral.com/counter/pdf/10.1186/s44247-024-00098-5","source":{"id":"https://openalex.org/S4387286688","display_name":"BMC Digital Health","issn_l":"2731-684X","issn":["2731-684X"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","jufo-1","norway-1","vabb-shw"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"BMC Digital Health","raw_type":"journal-article"},"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.8048999905586243,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[{"id":"https://openalex.org/G9000901288","display_name":"Penn Artificial Intelligence and Technology Collaboratory for Healthy Aging","funder_award_id":"P30AG073105","funder_id":"https://openalex.org/F4320337337","funder_display_name":"National Institute on Aging"}],"funders":[{"id":"https://openalex.org/F4320332161","display_name":"National Institutes of Health","ror":"https://ror.org/01cwqze88"},{"id":"https://openalex.org/F4320337337","display_name":"National Institute on Aging","ror":"https://ror.org/049v75w11"}],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4400937397.pdf","grobid_xml":"https://content.openalex.org/works/W4400937397.grobid-xml"},"referenced_works_count":55,"referenced_works":["https://openalex.org/W1797049784","https://openalex.org/W2049364112","https://openalex.org/W2064833338","https://openalex.org/W2095683801","https://openalex.org/W2136102480","https://openalex.org/W2150060517","https://openalex.org/W2175003652","https://openalex.org/W2408281124","https://openalex.org/W2417491767","https://openalex.org/W2757748198","https://openalex.org/W2806168037","https://openalex.org/W2809680745","https://openalex.org/W2906413184","https://openalex.org/W2946188105","https://openalex.org/W2946661638","https://openalex.org/W2963693643","https://openalex.org/W2981869278","https://openalex.org/W3004827741","https://openalex.org/W3005348902","https://openalex.org/W3015189254","https://openalex.org/W3016443966","https://openalex.org/W3021945802","https://openalex.org/W3082099334","https://openalex.org/W3111737151","https://openalex.org/W3114317161","https://openalex.org/W3120201827","https://openalex.org/W3122268774","https://openalex.org/W3159361580","https://openalex.org/W3161210420","https://openalex.org/W3185031028","https://openalex.org/W3187137195","https://openalex.org/W3189276371","https://openalex.org/W3201477013","https://openalex.org/W3203140867","https://openalex.org/W3208392943","https://openalex.org/W4200191097","https://openalex.org/W4200454910","https://openalex.org/W4205132659","https://openalex.org/W4224862227","https://openalex.org/W4242405845","https://openalex.org/W4281772028","https://openalex.org/W4294734191","https://openalex.org/W4296681072","https://openalex.org/W4296901644","https://openalex.org/W4299522758","https://openalex.org/W4302004063","https://openalex.org/W4307033686","https://openalex.org/W4307965115","https://openalex.org/W4315646960","https://openalex.org/W4322765941","https://openalex.org/W4366769460","https://openalex.org/W4379966367","https://openalex.org/W4383340806","https://openalex.org/W4386818308","https://openalex.org/W6959893798"],"related_works":["https://openalex.org/W6885127382","https://openalex.org/W3020379959","https://openalex.org/W6885093587","https://openalex.org/W7165544014","https://openalex.org/W7128161130","https://openalex.org/W3114317161","https://openalex.org/W3027255429","https://openalex.org/W4411529749","https://openalex.org/W2936033391","https://openalex.org/W2954915517"],"abstract_inverted_index":{"Widespread":[0],"adoption":[1],"of":[2,64,68],"digital":[3,36],"health":[4,11,13,37],"tools":[5],"has":[6],"the":[7],"potential":[8,23],"to":[9,48,66],"improve":[10],"and":[12,17,26,30,42,46],"care":[14],"for":[15],"individuals":[16],"their":[18],"communities,":[19],"but":[20],"realizing":[21],"this":[22],"requires":[24],"anticipating":[25],"addressing":[27],"numerous":[28],"ethical":[29,41],"regulatory":[31,43],"challenges.":[32],"Here,":[33],"we":[34],"help":[35],"tool":[38],"developers":[39],"identify":[40],"considerations":[44],"-":[45,52],"opportunities":[47],"advance":[49],"desirable":[50],"outcomes":[51],"by":[53],"organizing":[54],"them":[55],"within":[56],"a":[57,69],"general":[58],"product-development":[59],"lifecycle":[60],"that":[61],"spans":[62],"generation":[63],"ideas":[65],"commercialization":[67],"product.":[70]},"counts_by_year":[{"year":2026,"cited_by_count":5},{"year":2025,"cited_by_count":4},{"year":2024,"cited_by_count":2}],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2024-07-25T00:00:00"}