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A policy framework for public health uses of electronic health data.
Pharmacoepidemiol Drug Saf. 2012 Jan; 21 Suppl 1:18-22.PD

Abstract

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-Sentinel, is being conducted in compliance with applicable federal and state laws. The article also sets forth the attributes of Mini-Sentinel 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.

Authors+Show Affiliations

Center for Democracy & Technology, Washington, DC 20006, USA. deven@cdt.orgNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

22262589

Citation

McGraw, Deven, et al. "A Policy Framework for Public Health Uses of Electronic Health Data." Pharmacoepidemiology and Drug Safety, vol. 21 Suppl 1, 2012, pp. 18-22.
McGraw D, Rosati K, Evans B. A policy framework for public health uses of electronic health data. Pharmacoepidemiol Drug Saf. 2012;21 Suppl 1:18-22.
McGraw, D., Rosati, K., & Evans, B. (2012). A policy framework for public health uses of electronic health data. Pharmacoepidemiology and Drug Safety, 21 Suppl 1, 18-22. https://doi.org/10.1002/pds.2319
McGraw D, Rosati K, Evans B. A Policy Framework for Public Health Uses of Electronic Health Data. Pharmacoepidemiol Drug Saf. 2012;21 Suppl 1:18-22. PubMed PMID: 22262589.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A policy framework for public health uses of electronic health data. AU - McGraw,Deven, AU - Rosati,Kristen, AU - Evans,Barbara, PY - 2012/1/21/entrez PY - 2012/1/25/pubmed PY - 2012/5/10/medline SP - 18 EP - 22 JF - Pharmacoepidemiology and drug safety JO - Pharmacoepidemiol Drug Saf VL - 21 Suppl 1 N2 - 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-Sentinel, is being conducted in compliance with applicable federal and state laws. The article also sets forth the attributes of Mini-Sentinel 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. SN - 1099-1557 UR - https://www.unboundmedicine.com/medline/citation/22262589/A_policy_framework_for_public_health_uses_of_electronic_health_data_ L2 - https://doi.org/10.1002/pds.2319 DB - PRIME DP - Unbound Medicine ER -