The Health Insurance Portability and Accountability Act of 1996 (”HIPAA”)

The Teva Clozapine Patient Registry is a systematic active post-marketing surveillance program mandated by the Food and Drug Administration. Teva Pharmaceuticals, USA. is required to register patients, physicians, and pharmacies, collect patient identification information, WBC counts and ANC values and investigate adverse events.

The patient privacy regulations under HIPAA permit disclosure by health care professionals of "protected health information" to fulfill post-marketing surveillance requirements as mandated by the FDA without patient consent. See, 45 CFR Section 164.512 (b)(iii). For additional information you can visit:

http://www.fda.gov/medwatch/hipaa.htm
http://www.hhs.gov/ocr/hipaa/
http://www.hhs.gov/ocr/hipaa/finalmaster.html