{"id":"https://openalex.org/W1578262187","doi":"https://doi.org/10.1136/jamia.1997.0040442","title":"Recommendations for Responsible Monitoring and Regulation of Clinical Software Systems","display_name":"Recommendations for Responsible Monitoring and Regulation of Clinical Software Systems","publication_year":1997,"publication_date":"1997-11-01","ids":{"openalex":"https://openalex.org/W1578262187","doi":"https://doi.org/10.1136/jamia.1997.0040442","mag":"1578262187","pmid":"https://pubmed.ncbi.nlm.nih.gov/9391932"},"language":"en","primary_location":{"id":"doi:10.1136/jamia.1997.0040442","is_oa":true,"landing_page_url":"https://doi.org/10.1136/jamia.1997.0040442","pdf_url":"https://academic.oup.com/jamia/article-pdf/4/6/442/28168883/4-6-442.pdf","source":{"id":"https://openalex.org/S129839026","display_name":"Journal of the American Medical Informatics Association","issn_l":"1067-5027","issn":["1067-5027","1527-974X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of the American Medical Informatics Association","raw_type":"journal-article"},"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"bronze","oa_url":"https://academic.oup.com/jamia/article-pdf/4/6/442/28168883/4-6-442.pdf","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5069987722","display_name":"Randolph A. Miller","orcid":null},"institutions":[{"id":"https://openalex.org/I125532205","display_name":"American Medical Informatics Association","ror":"https://ror.org/02bt45m31","country_code":"US","type":"nonprofit","lineage":["https://openalex.org/I125532205"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Randolph A. Miller","raw_affiliation_strings":["Affiliations of the authors: Past President (RAM), and President (RMG) of the American Medical Informatics Association, Bethesda, MD"],"affiliations":[{"raw_affiliation_string":"Affiliations of the authors: Past President (RAM), and President (RMG) of the American Medical Informatics Association, Bethesda, MD","institution_ids":["https://openalex.org/I125532205"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5109922865","display_name":"Reed M. Gardner","orcid":null},"institutions":[{"id":"https://openalex.org/I125532205","display_name":"American Medical Informatics Association","ror":"https://ror.org/02bt45m31","country_code":"US","type":"nonprofit","lineage":["https://openalex.org/I125532205"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Reed M. Gardner","raw_affiliation_strings":["Affiliations of the authors: Past President (RAM), and President (RMG) of the American Medical Informatics Association, Bethesda, MD"],"affiliations":[{"raw_affiliation_string":"Affiliations of the authors: Past President (RAM), and President (RMG) of the American Medical Informatics Association, Bethesda, MD","institution_ids":["https://openalex.org/I125532205"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":["https://openalex.org/A5069987722"],"corresponding_institution_ids":["https://openalex.org/I125532205"],"apc_list":{"value":3967,"currency":"USD","value_usd":3967},"apc_paid":null,"fwci":11.7303,"has_fulltext":true,"cited_by_count":102,"citation_normalized_percentile":{"value":0.98137289,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":90,"max":98},"biblio":{"volume":"4","issue":"6","first_page":"442","last_page":"457"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10350","display_name":"Electronic Health Records Systems","score":0.9972000122070312,"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"}},"topics":[{"id":"https://openalex.org/T10350","display_name":"Electronic Health Records Systems","score":0.9972000122070312,"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"}},{"id":"https://openalex.org/T11744","display_name":"Health Sciences Research and Education","score":0.9488000273704529,"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/T10582","display_name":"Ethics in Clinical Research","score":0.9370999932289124,"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"}}],"keywords":[{"id":"https://openalex.org/keywords/informatics","display_name":"Informatics","score":0.5977427363395691},{"id":"https://openalex.org/keywords/health-care","display_name":"Health care","score":0.5773643255233765},{"id":"https://openalex.org/keywords/health-informatics","display_name":"Health informatics","score":0.5604194402694702},{"id":"https://openalex.org/keywords/information-system","display_name":"Information system","score":0.486707478761673},{"id":"https://openalex.org/keywords/position-paper","display_name":"Position paper","score":0.4716210663318634},{"id":"https://openalex.org/keywords/software","display_name":"Software","score":0.4501844644546509},{"id":"https://openalex.org/keywords/medicine","display_name":"Medicine","score":0.4133925139904022},{"id":"https://openalex.org/keywords/business","display_name":"Business","score":0.3655458092689514},{"id":"https://openalex.org/keywords/knowledge-management","display_name":"Knowledge management","score":0.3301657438278198},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.3267061710357666},{"id":"https://openalex.org/keywords/world-wide-web","display_name":"World Wide Web","score":0.18182280659675598},{"id":"https://openalex.org/keywords/political-science","display_name":"Political science","score":0.17380329966545105}],"concepts":[{"id":"https://openalex.org/C191630685","wikidata":"https://www.wikidata.org/wiki/Q4027615","display_name":"Informatics","level":2,"score":0.5977427363395691},{"id":"https://openalex.org/C160735492","wikidata":"https://www.wikidata.org/wiki/Q31207","display_name":"Health care","level":2,"score":0.5773643255233765},{"id":"https://openalex.org/C145642194","wikidata":"https://www.wikidata.org/wiki/Q870895","display_name":"Health informatics","level":3,"score":0.5604194402694702},{"id":"https://openalex.org/C180198813","wikidata":"https://www.wikidata.org/wiki/Q121182","display_name":"Information system","level":2,"score":0.486707478761673},{"id":"https://openalex.org/C78780964","wikidata":"https://www.wikidata.org/wiki/Q7233193","display_name":"Position paper","level":2,"score":0.4716210663318634},{"id":"https://openalex.org/C2777904410","wikidata":"https://www.wikidata.org/wiki/Q7397","display_name":"Software","level":2,"score":0.4501844644546509},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.4133925139904022},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.3655458092689514},{"id":"https://openalex.org/C56739046","wikidata":"https://www.wikidata.org/wiki/Q192060","display_name":"Knowledge management","level":1,"score":0.3301657438278198},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.3267061710357666},{"id":"https://openalex.org/C136764020","wikidata":"https://www.wikidata.org/wiki/Q466","display_name":"World Wide Web","level":1,"score":0.18182280659675598},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.17380329966545105},{"id":"https://openalex.org/C199539241","wikidata":"https://www.wikidata.org/wiki/Q7748","display_name":"Law","level":1,"score":0.0},{"id":"https://openalex.org/C199360897","wikidata":"https://www.wikidata.org/wiki/Q9143","display_name":"Programming language","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D003199","descriptor_name":"Computer Systems","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D003199","descriptor_name":"Computer Systems","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D003199","descriptor_name":"Computer Systems","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007256","descriptor_name":"Information Systems","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D007256","descriptor_name":"Information Systems","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D007256","descriptor_name":"Information Systems","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D012984","descriptor_name":"Software","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D012984","descriptor_name":"Software","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D012984","descriptor_name":"Software","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D012986","descriptor_name":"Software Validation","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012986","descriptor_name":"Software Validation","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012986","descriptor_name":"Software Validation","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014486","descriptor_name":"United States Food and Drug Administration","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014486","descriptor_name":"United States Food and Drug Administration","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014486","descriptor_name":"United States Food and Drug Administration","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D015510","descriptor_name":"Clinical Medicine","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D015510","descriptor_name":"Clinical Medicine","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D015510","descriptor_name":"Clinical Medicine","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D018795","descriptor_name":"Device Approval","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D018795","descriptor_name":"Device Approval","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D018795","descriptor_name":"Device Approval","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":4,"locations":[{"id":"doi:10.1136/jamia.1997.0040442","is_oa":true,"landing_page_url":"https://doi.org/10.1136/jamia.1997.0040442","pdf_url":"https://academic.oup.com/jamia/article-pdf/4/6/442/28168883/4-6-442.pdf","source":{"id":"https://openalex.org/S129839026","display_name":"Journal of the American Medical Informatics Association","issn_l":"1067-5027","issn":["1067-5027","1527-974X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of the American Medical Informatics Association","raw_type":"journal-article"},{"id":"pmid:9391932","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/9391932","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":"Journal of the American Medical Informatics Association : JAMIA","raw_type":null},{"id":"pmh:oai:pubmedcentral.nih.gov:61262","is_oa":true,"landing_page_url":null,"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":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"","raw_type":"Text"},{"id":"pmh:oai:pubmedcentral.nih.gov:61262","is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/61262","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":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"J Am Med Inform Assoc","raw_type":"Text"}],"best_oa_location":{"id":"doi:10.1136/jamia.1997.0040442","is_oa":true,"landing_page_url":"https://doi.org/10.1136/jamia.1997.0040442","pdf_url":"https://academic.oup.com/jamia/article-pdf/4/6/442/28168883/4-6-442.pdf","source":{"id":"https://openalex.org/S129839026","display_name":"Journal of the American Medical Informatics Association","issn_l":"1067-5027","issn":["1067-5027","1527-974X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of the American Medical Informatics Association","raw_type":"journal-article"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/17","display_name":"Partnerships for the goals","score":0.550000011920929}],"awards":[],"funders":[{"id":"https://openalex.org/F4320337372","display_name":"U.S. National Library of Medicine","ror":"https://ror.org/0060t0j89"}],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W1578262187.pdf","grobid_xml":"https://content.openalex.org/works/W1578262187.grobid-xml"},"referenced_works_count":70,"referenced_works":["https://openalex.org/W6294097","https://openalex.org/W100400927","https://openalex.org/W191089783","https://openalex.org/W1498754091","https://openalex.org/W1526365333","https://openalex.org/W1565448402","https://openalex.org/W1577496953","https://openalex.org/W1595041376","https://openalex.org/W1608737606","https://openalex.org/W1885527984","https://openalex.org/W1953412452","https://openalex.org/W1967846621","https://openalex.org/W1968013239","https://openalex.org/W1971040337","https://openalex.org/W1976047246","https://openalex.org/W1978544678","https://openalex.org/W1979778427","https://openalex.org/W1981848174","https://openalex.org/W1983277268","https://openalex.org/W1984431881","https://openalex.org/W1992927493","https://openalex.org/W1995914362","https://openalex.org/W1998647237","https://openalex.org/W2003504522","https://openalex.org/W2006363447","https://openalex.org/W2014929747","https://openalex.org/W2017086716","https://openalex.org/W2042702847","https://openalex.org/W2050095769","https://openalex.org/W2055718446","https://openalex.org/W2056433426","https://openalex.org/W2074706689","https://openalex.org/W2075671318","https://openalex.org/W2076056672","https://openalex.org/W2078746809","https://openalex.org/W2081671363","https://openalex.org/W2083113253","https://openalex.org/W2096150188","https://openalex.org/W2116651548","https://openalex.org/W2120429076","https://openalex.org/W2126334656","https://openalex.org/W2128716459","https://openalex.org/W2146980252","https://openalex.org/W2150596136","https://openalex.org/W2163959304","https://openalex.org/W2174728636","https://openalex.org/W2180456856","https://openalex.org/W2262036978","https://openalex.org/W2326845225","https://openalex.org/W2412567242","https://openalex.org/W2469172133","https://openalex.org/W2910794168","https://openalex.org/W4230779446","https://openalex.org/W4235818323","https://openalex.org/W4244299810","https://openalex.org/W4247174244","https://openalex.org/W4251589065","https://openalex.org/W4285719527","https://openalex.org/W4290258202","https://openalex.org/W4295683089","https://openalex.org/W4298263551","https://openalex.org/W4299158792","https://openalex.org/W4299576665","https://openalex.org/W4301757412","https://openalex.org/W4302221947","https://openalex.org/W6607796701","https://openalex.org/W6631642405","https://openalex.org/W6679174141","https://openalex.org/W6692900141","https://openalex.org/W6841181299"],"related_works":["https://openalex.org/W2397677514","https://openalex.org/W1495820741","https://openalex.org/W2990177913","https://openalex.org/W1451471413","https://openalex.org/W2138729887","https://openalex.org/W2401910071","https://openalex.org/W4323056170","https://openalex.org/W2126732312","https://openalex.org/W4302329558","https://openalex.org/W2096609042"],"abstract_inverted_index":{"In":[0,16],"mid-1996,":[1],"the":[2,34,57,61,66,71,75,82,88,92,99,129,165,172],"FDA":[3,173,177],"called":[4],"for":[5,33,94,197],"discussions":[6],"on":[7,128,187],"regulation":[8,36,178],"of":[9,20,39,53,77,102,109,116,131,142,153,156,169],"clinical":[10,40,110,143,182,192],"software":[11,41,144,183],"programs":[12],"as":[13],"medical":[14],"devices.":[15],"response,":[17],"a":[18,134,154],"consortium":[19,58,105,138],"organizations":[21],"dedicated":[22],"to":[23],"improving":[24],"health":[25],"care":[26],"through":[27],"information":[28,150],"technology":[29],"has":[30],"developed":[31],"recommendations":[32],"responsible":[35],"and":[37,46,98,113,119,146,161,167,185],"monitoring":[38,118],"systems":[42,170,184,189],"by":[43,148],"users,":[44],"vendors,":[45],"regulatory":[47,120],"agencies.":[48],"Organizations":[49],"assisting":[50],"in":[51,133],"development":[52],"recommendations,":[54],"or":[55],"endorsing":[56],"position":[59],"include":[60],"American":[62,83,89,100],"Medical":[63,72],"Informatics":[64],"Association,":[65,74,87,91],"Computer-based":[67],"Patient":[68],"Record":[69],"Institute,":[70],"Library":[73],"Association":[76],"Academic":[78],"Health":[79,84],"Sciences":[80],"Libraries,":[81],"Information":[85,96],"Management":[86],"Nurses":[90],"Center":[93],"Healthcare":[95],"Management,":[97],"College":[101],"Physicians.":[103],"The":[104,137],"proposes":[106],"four":[107,114],"categories":[108],"system":[111,151],"risks":[112],"classes":[115],"measured":[117],"actions":[121],"that":[122,171],"can":[123,174],"be":[124],"applied":[125],"strategically":[126],"based":[127],"level":[130],"risk":[132],"given":[135],"setting.":[136],"recommends":[139],"local":[140],"oversight":[141],"systems,":[145],"adoption":[147],"healthcare":[149],"developers":[152],"code":[155],"good":[157],"business":[158],"practices.":[159],"Budgetary":[160],"other":[162],"constraints":[163],"limit":[164],"type":[166],"number":[168],"regulate":[175],"effectively.":[176],"should":[179],"exempt":[180],"most":[181],"focus":[186],"those":[188],"posing":[190],"highest":[191],"risk,":[193],"with":[194],"limited":[195],"opportunities":[196],"competent":[198],"human":[199],"intervention.":[200]},"counts_by_year":[{"year":2024,"cited_by_count":2},{"year":2023,"cited_by_count":2},{"year":2022,"cited_by_count":1},{"year":2021,"cited_by_count":3},{"year":2020,"cited_by_count":2},{"year":2017,"cited_by_count":4},{"year":2016,"cited_by_count":4},{"year":2015,"cited_by_count":3},{"year":2014,"cited_by_count":1},{"year":2013,"cited_by_count":3},{"year":2012,"cited_by_count":3}],"updated_date":"2026-04-21T08:09:41.155169","created_date":"2025-10-10T00:00:00"}