{"id":"https://openalex.org/W3000753370","doi":null,"title":"What medical writers need to know about regulatory approval of mobile health and digital healthcare devices","display_name":"What medical writers need to know about regulatory approval of mobile health and digital healthcare devices","publication_year":2019,"publication_date":"2019-09-01","ids":{"openalex":"https://openalex.org/W3000753370","mag":"3000753370"},"language":"en","primary_location":{"id":"mag:3000753370","doi":null,"is_oa":false,"landing_page_url":"https://journal.emwa.org/artificial-intelligence-and-digital-health/what-medical-writers-need-to-know-about-regulatory-approval-of-mobile-health-and-digital-healthcare-devices/article/5259/what-medical-writers-need-to-know.pdf","pdf_url":null,"source":{"id":"https://openalex.org/S2765017934","display_name":"Medical Writing","issn_l":"2047-4806","issn":["2047-4806","2047-4814"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","poland-20","russia-white-list-4"],"host_organization":"https://openalex.org/P4310320547","host_organization_name":"Taylor & Francis","host_organization_lineage":["https://openalex.org/P4310320547","https://openalex.org/P4310320449"],"host_organization_lineage_names":["Taylor & Francis","Informa"],"type":"journal"},"license":null,"license_id":null,"version":null,"is_accepted":false,"is_published":false,"raw_source_name":"Medical Writing","raw_type":null},"volume":null,"type":"article","is_traditional":true,"indexed_in":[],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5088489110","display_name":"Andrea Bucceri","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Andrea Bucceri","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5108671099","display_name":"Peter Hornung","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Peter Hornung","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"last","author":{"id":"https://openalex.org/A5084482766","display_name":"Thomas M. Schindler","orcid":"https://orcid.org/0000-0002-7845-3048","observed_orcids":["https://orcid.org/0000-0002-7845-3048"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Thomas M. Schindler","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0002-7845-3048","affiliations":[]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.2271,"has_fulltext":false,"cited_by_count":1,"citation_normalized_percentile":{"value":0.56255419,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":87,"max":93},"biblio":{"volume":"28","issue":null,"first_page":"28","last_page":"33"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T14396","display_name":"Healthcare Regulation","score":0.9922000169754028,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"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/T14396","display_name":"Healthcare Regulation","score":0.9922000169754028,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11446","display_name":"Mobile Health and mHealth Applications","score":0.0020000000949949026,"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/T11649","display_name":"Pharmaceutical industry and healthcare","score":0.0006000000284984708,"subfield":{"id":"https://openalex.org/subfields/2910","display_name":"Issues, ethics and legal aspects"},"field":{"id":"https://openalex.org/fields/29","display_name":"Nursing"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/mobile-health","display_name":"mobile health","score":0.8920000195503235},{"id":"https://openalex.org/keywords/digital-health-devices","display_name":"digital health devices","score":0.9369999766349792},{"id":"https://openalex.org/keywords/regulatory-approval","display_name":"regulatory approval","score":0.9160000085830688},{"id":"https://openalex.org/keywords/medical-device-regulation","display_name":"medical device regulation","score":0.8199999928474426},{"id":"https://openalex.org/keywords/regulatory-documents","display_name":"regulatory documents","score":0.5619999766349792},{"id":"https://openalex.org/keywords/medical-writers","display_name":"medical writers","score":0.5690000057220459}],"concepts":[{"id":"https://openalex.org/C160735492","wikidata":"https://www.wikidata.org/wiki/Q31207","display_name":"Health care","level":2,"score":0.6204302906990051},{"id":"https://openalex.org/C108827166","wikidata":"https://www.wikidata.org/wiki/Q175975","display_name":"Internet privacy","level":1,"score":0.5449581742286682},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.5042563676834106},{"id":"https://openalex.org/C2778519782","wikidata":"https://www.wikidata.org/wiki/Q1974060","display_name":"Need to know","level":2,"score":0.47045576572418213},{"id":"https://openalex.org/C2780433410","wikidata":"https://www.wikidata.org/wiki/Q5276090","display_name":"Digital health","level":3,"score":0.4306184649467468},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.23547938466072083},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.2262905240058899},{"id":"https://openalex.org/C38652104","wikidata":"https://www.wikidata.org/wiki/Q3510521","display_name":"Computer security","level":1,"score":0.16408511996269226},{"id":"https://openalex.org/C199539241","wikidata":"https://www.wikidata.org/wiki/Q7748","display_name":"Law","level":1,"score":0.1293851137161255}],"mesh":[],"locations_count":1,"locations":[{"id":"mag:3000753370","doi":null,"is_oa":false,"landing_page_url":"https://journal.emwa.org/artificial-intelligence-and-digital-health/what-medical-writers-need-to-know-about-regulatory-approval-of-mobile-health-and-digital-healthcare-devices/article/5259/what-medical-writers-need-to-know.pdf","pdf_url":null,"source":{"id":"https://openalex.org/S2765017934","display_name":"Medical Writing","issn_l":"2047-4806","issn":["2047-4806","2047-4814"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","poland-20","russia-white-list-4"],"host_organization":"https://openalex.org/P4310320547","host_organization_name":"Taylor & Francis","host_organization_lineage":["https://openalex.org/P4310320547","https://openalex.org/P4310320449"],"host_organization_lineage_names":["Taylor & Francis","Informa"],"type":"journal"},"license":null,"license_id":null,"version":null,"is_accepted":false,"is_published":false,"raw_source_name":"Medical Writing","raw_type":null}],"best_oa_location":null,"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","score":0.46810001134872437,"display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W2104764991","https://openalex.org/W2587945454","https://openalex.org/W2441096390","https://openalex.org/W1488665817","https://openalex.org/W2101844713","https://openalex.org/W2141017166","https://openalex.org/W2772701299","https://openalex.org/W2810394815","https://openalex.org/W2289411278","https://openalex.org/W3094607983"],"abstract_inverted_index":null,"counts_by_year":[{"year":2021,"cited_by_count":1}],"updated_date":"2026-08-15T07:11:24.734988","created_date":"2020-01-30T00:00:00"}