{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T11:57:54Z","timestamp":1782907074028,"version":"3.54.5"},"reference-count":36,"publisher":"Oxford University Press (OUP)","issue":"1","funder":[{"name":"UTHealth Innovation for Cancer Prevention Research Training Program Post-Doctoral Fellowship"},{"DOI":"10.13039\/100004917","name":"Cancer Prevention and Research Institute of Texas","doi-asserted-by":"publisher","award":["#RP160015"],"award-info":[{"award-number":["#RP160015"]}],"id":[{"id":"10.13039\/100004917","id-type":"DOI","asserted-by":"publisher"}]},{"name":"The University of Texas System Grants Program","award":["#156374"],"award-info":[{"award-number":["#156374"]}]},{"DOI":"10.13039\/100000133","name":"The Agency for Healthcare Research and Quality","doi-asserted-by":"crossref","award":["1R01HS022895"],"award-info":[{"award-number":["1R01HS022895"]}],"id":[{"id":"10.13039\/100000133","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100000133","name":"Agency for Healthcare Research and Quality","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000133","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,4,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Health information technology (HIT) is intended to provide safer and better care to patients. However, poorly designed or implemented HIT poses a key risk to patient safety. It is essential for healthcare providers and researchers to investigate the HIT-related events. Unfortunately, the lack of HIT-related event databases in the community hinders the analysis and management of HIT-related events.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>Develop a standardized process for identifying HIT-related events from a Federal Drug Administration (FDA) database in order to create an HIT exclusive database for analysis and learning.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>The FDA Manufacturer and User Facility Device Experience (MAUDE) database, containing over 7-million reports about medical device malfunctions and problems leading to serious injury or death, was considered as a potential resource to identify HIT-related events. We developed a strategy of identifying and categorizing HIT-related events from the FDA reports through the application of a keyword filter and standardized expert review. Ten percent identified reports were reviewed to measure the consistency among experts and to initialize a database for HIT-related events.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>With the proposed strategy, we initialized an HIT-related event database with over 3500 reports, and updated the estimation of the HIT-related event proportion in the FDA MAUDE database to 0.46\u223c0.69%, up to 50,000 HIT-related events.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The proposed strategy for HIT-related event identification holds promise in aiding the understanding, characterization, discovery, and reporting of HIT-related events toward improved patient safety. The analysis of contributing factors under the 8-dimensional sociotechnical model shows that hardware and software, clinical content, and human\u2013computer interface were identified more frequently than the other dimensions.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jamiaopen\/ooy042","type":"journal-article","created":{"date-parts":[[2018,10,12]],"date-time":"2018-10-12T12:32:55Z","timestamp":1539347575000},"page":"179-186","source":"Crossref","is-referenced-by-count":13,"title":["Toward safer health care: a review strategy of FDA medical device adverse event database to identify and categorize health information technology related events"],"prefix":"10.1093","volume":"2","author":[{"given":"Hong","family":"Kang","sequence":"first","affiliation":[{"name":"School of Biomedical Informatics, The University of Texas Health Science Center at Houston, Houston, Texas, 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