HHS publishes HIPAA enforcement rule, research guidance
HIPAA Weekly Advisor, April 18, 2003
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Although the Office for Civil Rights (OCR) will encourage voluntary compliance by covered entities, it can now fine facilities up to $100 for each privacy rule violation and up to $25,000 per year for similar violations of the same requirement.
The Department of Health and Human Services (HHS) published the first part of its HIPAA enforcement rule, "Civil Money Penalties: Procedures for Investigations, Imposition of Penalties, and Hearings," in the April 17 Federal Register.
HHS intends this interim rule to be the first installment of the "HIPAA Enforcement Rule," which will establish requirements for imposing civil money penalties. The interim final rule will be effective from May 19, 2003, to September 16, 2003, and HHS will accept public comments until June 16, 2003.
HHS also released a guidance April 16, addressing research under the final privacy rule. The guidance responds to concerns addressed in an April 9 letter from Stan Crosley, chief privacy officer for Eli Lily & Company and chair of the International Pharmaceutical Privacy Consortium. The guidance points out that the privacy rule does not require institutional review boards to review HIPAA authorizations used for research.
Go to http://www.hipaapro.com/news/hipaa_downloads.cfm to download PDFs of the enforcement rule and research guidance.
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