NIH Guidance on the HIPAA Privacy Rule
Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule
IRB Review Not Required for HIPAA Stand-Alone Authorizations for Research
HIPAA Documents regarding Investigator Sites:
Letter from OCR to Lilly regarding Authorizations for Research
HIPAA Authorizations: FDA Guidance
Guidelines for HIPAA language in ICF
ICF drop in language
HIPAA Info Sheet for Sites
Reviews Preparatory to Research
Stand-Alone HIPAA Authorization Form and Instructions
Letter to sites re: Quintiles is not a Business Associate
Quintiles HIPAA Plan
A Phase I Research Facility is NOT a HIPAA Covered Entity.doc
HIPAA Privacy Regulation
HIPAA Authorizations - FDA Guidance
Guidance for Industry: IRB Review of Stand-Alone HIPAA Authorizations
Notification Regarding Covered Entity Status
HIPAA Privacy Regulation
The Final Privacy Regulation was issued December 28, 2000 with the final Amendment on August 14, 2002 and a compliance date of April 14, 2003.
Quintiles' Letter to Secretary Thompson, US Department of Health and Human Services
Quintiles' Council on Data Protection has been carefully following the debate on privacy and data protection and recently sent a letter to Secretary Thompson of the U.S. Dept. of Health and Human Services. Read the letter .....
Statement regarding Quintiles data protection measures for inclusion in RFPs for CDS and SRS. Read more...
US-European Data Protection
Quintiles as a Harborite, Certification to the US-EU Safe Harbor effective January 5, 2005.
Quintiles Certification to the US-EU Safe Harbor: Click here to view the external website.
NOTES. 1) Data Transfer Agreements are still required for transferring personal data out of Europe to Quintiles sites outside the U.S. 2) Our vendor agreements have been revised for compliance with the Safe Harbor "ongoing transfer" requirements.
This website gives information on data protection rules from around the world. Click here to view the website.
For interpretation of these laws, contact council.data.protection@quintiles.com