U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES


Proposed Standards for Privacy of Individually Identifiable Health Information

Statutory Requirement

Section 264 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191, enacted August 21, 1996, requires that, if legislation establishing privacy standards is not enacted “by the date that is 36 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall promulgate final regulations containing such standards not later than the date that is 42 months after the date of the enactment of this Act.”

The statutory deadline for Congress to enact legislation was August 21, 1999. Absent legislation, HHS has developed its proposed rule.

Overview

The proposed rule would:

Scope

a. Entities covered by the proposed rule

b. Health information covered by the proposed rule (“Protected health information”)

General rules

We propose that covered entities be prohibited from using or disclosing health information except: as authorized by the patient, or as explicitly permitted by the regulation. The regulation would permit use and disclosure of health information without authorization for purposes of health care treatment, payment and operations, and for specified national policy activities under conditions tailored for each type of such permitted use or disclosure.

Disclosures without authorization for health care treatment, payment, and operations

Uses and disclosures with individual authorization

Permissible uses and disclosures for purposes other than treatment, payment and operations

Individual rights

The proposed rule would provide several basic rights for individuals with respect to protected health information about them. Individuals would have:

Administrative requirements and policy development and documentation

This proposed rule would require providers and payers to develop and implement basic administrative procedures to protect health information and the rights of individuals with respect to that information.

Scalability

We propose privacy standards that covered entities must meet, but leave the detailed policies and procedures for meeting these standards to the discretion of each covered entity.

Preemption

Pursuant to HIPAA, this rule will preempt state laws that are in conflict with the regulatory requirements and that provide less stringent privacy protections, with specified exceptions for certain public health functions and related activities.

Enforcement

What this proposed rule does not do