{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,6]],"date-time":"2026-06-06T07:35:16Z","timestamp":1780731316081,"version":"3.54.1"},"reference-count":3,"publisher":"Wiley","issue":"S1","license":[{"start":{"date-parts":[[2012,1,19]],"date-time":"2012-01-19T00:00:00Z","timestamp":1326931200000},"content-version":"vor","delay-in-days":18,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Food and Drug Administration","award":["HHSF223200910006I"],"award-info":[{"award-number":["HHSF223200910006I"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2012,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>Successful implementation of a program of active safety surveillance of drugs and medical products depends on public trust. This article summarizes how the initial pilot phase of the FDA's Sentinel Initiative, Mini\u2010Sentinel, is being conducted in compliance with applicable federal and state laws. The article also sets forth the attributes of Mini\u2010Sentinel that enhance privacy and public trust, including the use of a distributed data system (where identifiable information remains at the data partners) and the adoption by participants of additional mandatory policies and procedures implementing fair information practices. The authors conclude by discussing the implications of this model for other types of secondary health data uses. Copyright \u00a9 2012 John Wiley &amp; Sons, Ltd.<\/jats:p>","DOI":"10.1002\/pds.2319","type":"journal-article","created":{"date-parts":[[2012,1,19]],"date-time":"2012-01-19T14:38:33Z","timestamp":1326983913000},"page":"18-22","source":"Crossref","is-referenced-by-count":60,"title":["A policy framework for public health uses of electronic health data"],"prefix":"10.1002","volume":"21","author":[{"given":"Deven","family":"McGraw","sequence":"first","affiliation":[{"name":"Center for Democracy &amp; Technology (CDT)  Washington DC 20006 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristen","family":"Rosati","sequence":"additional","affiliation":[{"name":"Coppersmith Schermer &amp; Brockelman PLC  Phoenix AZ 85004 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Evans","sequence":"additional","affiliation":[{"name":"Health Law &amp; Policy Institute University of Houston Law Center  Houston TX 77204\u20106060 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2012,1,19]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"Food and Drug Administration Amendments Act of 2007 Pub. L. 110\u201085 21 U.S. Code Annotated (U.S.C.A.) Section 355(k); Section 355(k)(3)(B)(i)\u2010(ii)(II)."},{"key":"e_1_2_9_3_1","unstructured":"FDA.The Sentinel Initiative: Access to Electronic Healthcare Data for More Than 25 Million Lives.FDACDER\/OMP Rockville; July 2010.http:\/\/www.fda.gov\/downloads\/Safety\/FDAsSentinelInitiative\/UCM233360.pdf(accessed 18 January 2011) (hereinafter Sentinel Report)."},{"key":"e_1_2_9_4_1","unstructured":"Rosati K Evans BJandMcGraw D.HIPAA and Common Rule Compliance in the Mini\u2010Sentinel Pilot White Paper of the Mini\u2010Sentinel Privacy Panel 2011 at 5.http:\/\/www.minisentinel.org\/work_products\/About_Us\/HIPAA and Common Rule Compliance in the Mini-Sentinel Pilot.pdf(accessed 17 January 2011) (hereinafter Mini\u2010Sentinel White Paper). We note that an explanation of the distinction between public health practice and public health research is beyond the scope of this paper."}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpds.2319","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpds.2319","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.2319","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,25]],"date-time":"2023-09-25T10:09:55Z","timestamp":1695636595000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.2319"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,1]]},"references-count":3,"journal-issue":{"issue":"S1","published-print":{"date-parts":[[2012,1]]}},"alternative-id":["10.1002\/pds.2319"],"URL":"https:\/\/doi.org\/10.1002\/pds.2319","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,1]]}}}