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The Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191, was enacted on August 21, 1996. Title II, Section 201 of HIPPA required that

"The Secretary and the Attorney General shall issue guidelines to carry out the program under paragraph (1)."

HIPAA required the Secretary to issue privacy regulations governing individually identifiable health information, if Congress did not enact privacy legislation within three years of the passage of HIPAA. Because Congress did not enact privacy legislation, HHS developed a proposed "Privacy Rule" and released it for public comment. After reviewing more than 54,000 public comments, HHS issued the official Privacy Rule December 28, 2000.

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