Andrea, I am unaware of any specific privacy requirements under CLIA, I believe that HIPAA would control. So I don't see conflict.
522a or the Privacy Act of 1974 dictates privacy on the Federal Agency Level - thus would govern all federal agencies, and their contractors. It also affects state and local government, and their contractors. It required the same rules for the contractors as it does for the agencies. It has numerous conflicts and overlaps with HIPAA, and deals with issues not included in HIPAA's Privacy Rule as well. A link for the reg is: http://www.hipaahelpnow.com/privacy_act_1974.htm Where this gets seriously complicated is for Federal Agencies who are also HIPAA Covered Entities. To date, I have not seen a comparison matrix of the two. Though HCCO will examine the requirements in some deal later on through it's harmonization initiatives. Another regulation that also affects HIPAA Privacy in significant ways is the ICH/FDA GCP. The GCP regulation with the most impact to Privacy AND Security is 21CFR11. You may find links to the specific components of GCP on http://www.hipaahelpnow.com/hipaa_regulations_regs.htm at the bottom of the page. 21CFR11 has profound impact for providers who engage in clinical trials, and it affects their patient records, privacy, and security (overlapping the Privacy and Security rules). Once we collectively get past Privacy compliance, and significant effort will be needed to harmonize these regulations and HIPAA, as well as FERPA, so as to enable the HIPAA covered entities to rationally address the parallel compliance efforts required. I would be happy to discuss these issues in more detail off-line, as well as anyone who would like to collaborate in comparative harmonization efforts. Tim McGuinness, Ph.D. Consulting Specialist in Regulatory Privacy, Security, and Application Compliance (HIPAA/ASCA/FDA/CMS-HCFA/ICH/ADA 508c), [EMAIL PROTECTED] <mailto:[EMAIL PROTECTED]> President, HIPAA Help Now [EMAIL PROTECTED] <mailto:[EMAIL PROTECTED]> www.hipaahelpnow.com <http://www.hipaahelpnow.com/> Executive Co-Chairman for Privacy, HIPAA Conformance Certification Organization (HCCO) www.hcco.us __________________________________________________________________ Phone: 727-787-3901 Cell: 305-753-4149 Fax: 240-525-1149 Instant Messengers: ICQ# 22396626 - MSN IM: [EMAIL PROTECTED] - Yahoo IM timmcguinness - AOL IM: mcguinnesstim __________________________________________________________________ =========================================================================== IMPORTANT NOTICE: This communication, including any attachment, contains information that may be confidential or privileged, and is intended solely for the entity or individual to whom it is addressed. If you are not the intended recipient, please notify the sender at once, and you should delete this message and are hereby notified that any disclosure, copying, or distribution of this message is strictly prohibited. Nothing in this email, including any attachment, is intended to be a legally binding signature. -----Original Message----- From: Zalewski Andrea [mailto:[EMAIL PROTECTED]] Sent: Thursday, September 26, 2002 11:40 AM To: [EMAIL PROTECTED] Subject: CLIA and USC 522a exemptions under Privacy Does anyone have specific information, or links to such information, regarding how CLIA and the USC 522a regulations affect the Privacy Rule? Andrea R. Zalewski Director of Quality Assurance and HIPAA HCA Physician Services "Quality is never an accident; it is the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives." -- Willa A. Foster The documents accompanying this transmission contain confidential privileged information. The information is the property of the sender and intended only for use by the individual or entity named above. The recipient of this information is prohibited from disclosing the contents of the information to another party. If you are neither the intended recipient or the employee or agent responsible fore delivery to the intended recipient, you are hereby notified that disclosure of contents in any manner is strictly prohibited. Please notify Andrea Zalewski by calling 615-373-7434 immediately if you received this information in error. To be removed from this list, go to: http://snip.wedi.org/unsubscribe.cfm?list=privacy and enter your email address. The WEDI SNIP listserv to which you are subscribed is not moderated. 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