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Summary of the Privacy Rule
The Office for Civil Rights enforces the HIPAA Privacy Rule, which protects the privacy of individually identifiable health information; the HIPAA Security Rule, which sets national standards for the security of electronic protected health information; and the confidentiality provisions of the Patient Safety Rule, which protect identifiable information being used to analyze patient safety events and improve patient safety
Statutory and Regulatory Background
The Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191, was enacted on August 21, 1996. Sections 261 through 264 of HIPAA require the Secretary of HHS to publicize standards for the electronic exchange, privacy and security of health information. Collectively these are known as the Administrative Simplification provisions.
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 rule and released it for public comment on November 3, 1999. The Department received over 52,000 public comments. The final regulation, the Privacy Rule, was published December 28, 2000.2
In March 2002, the Department proposed and released for public comment modifications to the Privacy Rule. The Department received over 11,000 comments.The final modifications were published in final form on August 14, 2002.3 A text combining the final regulation and the modifications can be found at 45 CFR Part 160 and Part 164, Subparts A and E.
Who Must Follow These Laws
We call the entities that must follow the HIPAA regulations covered entities.
Covered entities include:
Health Plans, including health insurance companies, HMOs, company health plans, and certain government programs that pay for health care, such as Medicare and Medicaid.
Most Health Care Providers—those that conduct certain business electronically, such as electronically billing your health insurance—including most doctors, clinics, hospitals, psychologists, chiropractors, nursing homes, pharmacies, and dentists.
Health Care Clearinghouses—entities that process nonstandard health information they receive from another entity into a standard (i.e., standard electronic format or data content), or vice versa.
Who Is Not Required to Follow These Laws
Many organizations that have health information about you do not have to follow these laws.
Examples of organizations that do not have to follow the Privacy and Security Rules include:
life insurers,
employers,
workers compensation carriers,
many schools and school districts,
many state agencies like child protective service agencies,
many law enforcement agencies,
many municipal offices.