A policy framework for public health uses of electronic health data

Pharmacoepidemiology and Drug Safety

Volumn 21, Issue SUPPL. 1, 2012, Pages 18-22

  Mcgraw, Deven ^a   Rosati, Kristen ^b   Evans, Barbara ^c  

^a Center for Democracy and Technology (CDT)   (United States)

^b Coppersmith Schermer and Brockelman PLC ^*  (United States)

^c UNIVERSITY OF HOUSTON   (United States)

Author keywords

Accountability; Compliance; Distributed; Health Insurance Portability and Accountability Act (HIPAA); Mini Sentinel Common Data Model (MSCDM); Policies; Privacy

Indexed keywords

ACCESS TO INFORMATION; ARTICLE; COMPUTER SECURITY; CONFIDENTIALITY; ELECTRONIC MEDICAL RECORD; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HEALTH INSURANCE; HOSPITAL POLICY; HUMAN; LAW; MODEL; PRIORITY JOURNAL; PRIVACY; PUBLIC HEALTH SERVICE; SENTINEL SURVEILLANCE; SENTINEL SYSTEM MODEL; SUBSTANCE ABUSE;

CONFIDENTIALITY; ELECTRONIC HEALTH RECORDS; EQUIPMENT AND SUPPLIES; EQUIPMENT SAFETY; HUMANS; MODELS, ORGANIZATIONAL; ORGANIZATIONAL POLICY; PHARMACEUTICAL PREPARATIONS; PILOT PROJECTS; PRODUCT SURVEILLANCE, POSTMARKETING; PUBLIC OPINION; TRUST; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84856036713     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.2319     Document Type: Article

References (3)

1. Food and Drug Administration Amendments Act of 2007, Pub. L. 110-85, 21 U.S. Code Annotated (U.S.C.A.) Section 355(k); Section 355(k)(3)(B)(i)-(ii)(II).
2. FDA. The Sentinel Initiative: Access to Electronic Healthcare Data for More Than 25 Million Lives.FDACDER/OMP, Rockville; July 2010. (accessed 18 January 2011) (hereinafter Sentinel Report).
3. Rosati, K, Evans, BJ and McGraw, D. HIPAA and Common Rule Compliance in the Mini-Sentinel Pilot White Paper of the Mini-Sentinel Privacy Panel 2011 at 5. (accessed 17 January 2011) (hereinafter Mini-Sentinel 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.