메뉴 건너뛰기




Volumn 21, Issue SUPPL. 1, 2012, Pages 12-17

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

Author keywords

FDA; Mini sentinel; Organizational structure; Policies; Principles

Indexed keywords

ACCURACY; ARTICLE; COMPUTER SECURITY; CONFIDENTIALITY; CONFLICT OF INTEREST; FOOD AND DRUG ADMINISTRATION; HEALTH PROGRAM; HUMAN; INTERPERSONAL COMMUNICATION; LEADERSHIP; MEDICAL INFORMATION; MINI SENTINEL PROGRAM; ORGANIZATIONAL STRUCTURE; PATENT; POLICY; PRIORITY JOURNAL; PRIVACY;

EID: 84863393033     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.2242     Document Type: Article
Times cited : (50)

References (17)
  • 1
    • 84863405107 scopus 로고    scopus 로고
    • Mini-Sentinel Coordinating Center. Boston, MA. Available at: (accessed 28 June ).
    • Mini-Sentinel Coordinating Center. Boston, MA. Available at: (accessed 28 June 2011).
    • (2011)
  • 2
    • 84863401911 scopus 로고    scopus 로고
    • Mini-Sentinel Coordinating Center. Data Core. Mini-Sentinel: Overview and Description of the Common Data Model v1.1. Boston, MA, December Available at: (accessed 28 June 2011).
    • Mini-Sentinel Coordinating Center. Data Core. Mini-Sentinel: Overview and Description of the Common Data Model v1.1. Boston, MA, December 2010. Available at: (accessed 28 June 2011).
    • (2010)
  • 3
    • 84863397062 scopus 로고    scopus 로고
    • Federal Trade Commission. Fair Information Practice Principles. Washington, DC, June Available at: (accessed 28 June 2011).
    • Federal Trade Commission. Fair Information Practice Principles. Washington, DC, June 2007. Available at: (accessed 28 June 2011).
    • (2007)
  • 4
    • 84863401276 scopus 로고    scopus 로고
    • Note
    • 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. Washington, DC, February 2008. Available at: (accessed 28 June 2011).
  • 5
    • 84863397063 scopus 로고    scopus 로고
    • HIPAA and Common Rule Compliance in the Mini-Sentinel Pilot. July Available at: (accessed 28 June 2011).
    • Rosati K, Evans B, McGraw D. HIPAA and Common Rule Compliance in the Mini-Sentinel Pilot. July 2010. Available at: (accessed 28 June 2011).
    • (2010)
    • Rosati, K.1    Evans, B.2    McGraw, D.3
  • 6
    • 84863405106 scopus 로고    scopus 로고
    • US Department of Health and Human Services. Office for Civil Rights. The HIPAA Privacy Rule. 45 CFR Part 160 and Subparts A and E of Part 164. Available at: (accessed 28 June ).
    • US Department of Health and Human Services. Office for Civil Rights. The HIPAA Privacy Rule. 45 CFR Part 160 and Subparts A and E of Part 164. Available at: (accessed 28 June 2011).
    • (2011)
  • 7
    • 84863405108 scopus 로고    scopus 로고
    • HIPAA.com. HIPAA 'Protected Health Information': What Does PHI Include? January Available at: (accessed 28 June 2010).
    • HIPAA.com. HIPAA 'Protected Health Information': What Does PHI Include? January 2011. Available at: (accessed 28 June 2010).
    • (2011)
  • 8
    • 84863401279 scopus 로고    scopus 로고
    • Office of Management and Budget. Memorandum for the Heads of Executive Departments and Agencies: Safeguarding Against and Responding to the Breach of Personally Identifiable Information. Washington, DC, May 22, Available at: (accessed 18 July 2011).
    • Johnson, Clay III. Office of Management and Budget. Memorandum for the Heads of Executive Departments and Agencies: Safeguarding Against and Responding to the Breach of Personally Identifiable Information. Washington, DC, May 22, 2007. Available at: (accessed 18 July 2011).
    • (2007)
    • Johnson III, C.1
  • 9
    • 84863419176 scopus 로고    scopus 로고
    • US Department of Justice. Office of Privacy and Civil Liberties. Overview of the Privacy Act of 1974, 2010 Edition. 5 U.S.C.§ 552a. Washington, DC, December 2010. Available at: (accessed 18 July 2011).
    • US Department of Justice. Office of Privacy and Civil Liberties. Overview of the Privacy Act of 1974, 2010 Edition. 5 U.S.C.§ 552a. Washington, DC, December 2010. Available at: (accessed 18 July 2011).
  • 10
    • 84863401277 scopus 로고    scopus 로고
    • US Department of Health and Human Services. Office for Civil Rights. OCR HIPAA Privacy. Minimum Necessary. 45 CFR 164.502(b), 164.514(d). Washington, DC, April Available at: (accessed 28 June 2011).
    • US Department of Health and Human Services. Office for Civil Rights. OCR HIPAA Privacy. Minimum Necessary. 45 CFR 164.502(b), 164.514(d). Washington, DC, April 2003. Available at: (accessed 28 June 2011).
    • (2003)
  • 11
    • 84863405111 scopus 로고    scopus 로고
    • QRX Legal Solutions, LLC. Evaluation of State Privacy Regulations in Relation to the Sentinel Initiative (Final). FDA-2009-N-0192-0014, July Available at: !documentDetail;D=FDA-2009-N-0192-0015 (accessed 30 January 2011).
    • QRX Legal Solutions, LLC. Evaluation of State Privacy Regulations in Relation to the Sentinel Initiative (Final). FDA-2009-N-0192-0014, July 2010. Available at: !documentDetail;D=FDA-2009-N-0192-0015 (accessed 30 January 2011).
    • (2010)
  • 12
    • 84862907574 scopus 로고    scopus 로고
    • Design considerations, architecture, and use of the Mini-Sentinel distributed data
    • Curtis L, Weiner M, Boudreau D, et al. Design considerations, architecture, and use of the Mini-Sentinel distributed data. Pharmacoepidemiol Drug Saf 2012; 21(S1): 23-31.
    • (2012) Pharmacoepidemiol Drug Saf , vol.21 , Issue.S1 , pp. 23-31
    • Curtis, L.1    Weiner, M.2    Boudreau, D.3
  • 13
    • 84856044282 scopus 로고    scopus 로고
    • Design for validation of acute myocardial infarction cases in Mini-Sentinel. Pharmacoepidemiol Drug Saf 2012
    • Cutrona SL, Toh D, Iyer A, et al. Design for validation of acute myocardial infarction cases in Mini-Sentinel. Pharmacoepidemiol Drug Saf 2012; 21(S1): 274-281.
    • , vol.21 , Issue.S1 , pp. 274-281
    • Cutrona, S.L.1    Toh, D.2    Iyer, A.3
  • 14
    • 84863419178 scopus 로고    scopus 로고
    • US Department of Health and Human Services. Office for Human Research Protections. Federal Policy for the Protection of Human Subjects ('Common Rule'). Available at: (accessed 28 June 2011).
    • US Department of Health and Human Services. Office for Human Research Protections. Federal Policy for the Protection of Human Subjects ('Common Rule'). Available at: (accessed 28 June 2011).
  • 15
    • 84863405112 scopus 로고    scopus 로고
    • US Department of Health and Human Services. Office for Civil Rights. The HIPAA Security Rule. 45 CFR Part 160 and Subparts A and C of Part 164. Available at: (accessed 18 July 2011).
    • US Department of Health and Human Services. Office for Civil Rights. The HIPAA Security Rule. 45 CFR Part 160 and Subparts A and C of Part 164. Available at: (accessed 18 July 2011).
  • 16
    • 84863405115 scopus 로고    scopus 로고
    • Federal Information Security Management Act of 2002 (FISMA). 44 U.S.C.§3541, et seq. Available at: (accessed 28 June 2011).
    • Federal Information Security Management Act of 2002 (FISMA). 44 U.S.C.§3541, et seq. Available at: (accessed 28 June 2011).
  • 17
    • 84863401283 scopus 로고    scopus 로고
    • Note
    • GPO Access. Electronic Code of Federal Regulations, Title 48. Federal Acquisition Regulations System (FAR) Clause 27.404-3(a)(1). Available at: (accessed 28 June 2011).


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.