The organizational structure and governing principles of the Food and Drug Administration's Mini-Sentinel pilot program-Reference-Cited by-同舟云学术

The organizational structure and governing principles of the Food and Drug Administration's Mini-Sentinel pilot program

Published:2012-01 Issue: Volume:21 Page:12-17
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Forrow Susan¹,Campion Daniel M.²,Herrinton Lisa J.³,Nair Vinit P.⁴,Robb Melissa A.⁵,Wilson Marcus⁶,Platt Richard¹

Affiliation:

1. Department of Population Medicine; Harvard Pilgrim Health Care Institute and Harvard Medical School; Boston MA USA

2. Outcome Sciences, Inc.; Washington DC USA

3. Kaiser Permanente Center for Effectiveness and Safety Research; Oakland CA USA

4. Humana; Miami FL USA

5. Office of Medical Policy, Center for Drug Evaluation and Research; Food and Drug Administration; Silver Spring MD USA

6. HealthCore, Inc.; Wilmington DE USA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.2242/fullpdf

Reference17 articles.

1. Mini-Sentinel Coordinating Center www.mini-sentinel.org 2011

2. Mini-Sentinel Coordinating Center Data Core. Mini-Sentinel: Overview and Description of the Common Data Model v1.1 2010 http://www.mini-sentinel.org/work_products/Data_Activities/Mini-Sentinel_CommonDataModel_v1.1.pdf

3. Federal Trade Commission Fair Information Practice Principles 2007 http://www.ftc.gov/reports/privacy3/fairinfo.shtm

4. Markle Foundation. Center for Democracy & Technology Connecting for Health Policy Brief. Beyond Consumer Consent: Why We Need a Comprehensive Approach to Privacy in a Networked World 2008 http://www.markle.org/sites/default/files/20080221_consent_brief.pdf

5. Rosati K Evans B McGraw D HIPAA and Common Rule Compliance in the Mini-Sentinel Pilot 2010 http://mini-sentinel.org/work_products/About_Us/HIPAA_and_CommonRuleCompliance_in_the_Mini-SentinelPilot.pdf

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