Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Section 164.520(c) - Provision of Notice

12/28/2000

As in the proposed rule, all covered entities that are required to produce a notice must provide the notice upon request of any person. The requestor does not have to be a current patient or enrollee. We intend the notice to be a public document that people can use in choosing between covered entities.

For health plans, we proposed to require health plans to distribute the notice to individuals covered by the health plan as of the compliance date; after the compliance date, at enrollment in the health plan; after enrollment, within 60 days of a material revision to the content of the notice; and no less frequently than once every three years.

As in the proposed rule, under the final rule health plans must provide the notice to all health plan enrollees as of the compliance date. After the compliance date, health plans must provide the notice to all new enrollees at the time of enrollment and to all enrollees within 60 days of a material revision to the notice. Of course, the term "enrollees" includes participants and beneficiaries in group health plans.

Unlike the proposed rule, we do not require health plans to distribute the notice every three years. Instead, health plans must notify enrollees no less than once every three years about the availability of the notice and how to obtain a copy.

We also clarify that, in each of these circumstances, if a named insured and one or more dependents are covered by the same policy, the health plan can satisfy the distribution requirement with respect to the dependents by sending a single copy of the notice to the named insured. For example, if an employee of a firm and her three dependents are all covered under a single health plan policy, that health plan can satisfy the initial distribution requirement by sending a single copy of the notice to the employee rather than sending four copies, each addressed to a different member of the family.

We further clarify that if a health plan has more than one notice, it satisfies its distribution requirement by providing the notice that is relevant to the individual or other person requesting the notice. For example, a health insurance issuer may have contracts with two different group health plans. One contract specifies that the issuer may use and disclose protected health information about the participants in the group health plan for research purposes without authorization (subject to the requirements of this rule) and one contract specifies that the issuer must always obtain authorizations for these uses and disclosures. The issuer accordingly develops two notices reflecting these different practices and satisfies its distribution requirements by providing the relevant notice to the relevant group health plan participants.

We proposed to require covered health care providers with face-to-face contact with individuals to provide the notice to all such individuals at the first service delivery to the individual during the one year period after the compliance date. After this one year period, covered providers with face-to-face contact with individuals would have been required to distribute the notice to all new patients at the first service delivery. Covered providers without face-to-face contact with individuals would have been required to provide the notice in a reasonable period of time following first service delivery.

We proposed to require all covered providers to post the notice in a clear and prominent location where it would be reasonable to expect individuals seeking services from the covered provider to be able to read the notice. We would have required revisions to be posted promptly.

In the final rule, we vary the distribution requirements according to whether the covered health care provider has a direct treatment relationship with an individual, rather than whether the covered health care provider has face-to-face contact with an individual. See § 164.501 and the corresponding discussion in this preamble regarding the definition of indirect treatment relationship.

Covered health care providers that have direct treatment relationships with individuals must provide the notice to such individuals as of the first service delivery after the compliance date. This requirement applies whether the first service is delivered electronically or in person. Covered providers may satisfy this requirement by sending the notice to all of their patients at once, by giving the notice to each patient as he or she comes into the provider's office or facility or contacts the provider electronically, or by some combination of these approaches. Covered providers that maintain a physical service delivery site must prominently post the notice where it is reasonable to expect individuals seeking service from the provider to be able to read the notice. The notice must also be available on site for individuals to take on request. In the event of a revision to the notice, the covered provider must promptly post the revision and make it available on site.

Covered health care providers that have indirect treatment relationships with individuals are only required to produce the notice upon request, as described above.

The proposed rule was silent regarding electronic distribution of the notice. Under the final rule, a covered entity that maintains a web site describing the services and benefits it offers must make its privacy notice prominently available through the site.

A covered entity may satisfy the applicable distribution requirements described above by providing the notice to the individual electronically, if the individual agrees to receiving materials from the covered entity electronically and the individual has not withdrawn his or her agreement. If the covered entity knows that the electronic transmission has failed, the covered entity must provide a paper copy of the notice to the individual.

If an individual's first service delivery from a covered provider occurs electronically, the covered provider must provide electronic notice automatically and contemporaneously in response to the individual's first request for service. For example, the first time an individual requests to fill a prescription through a covered internet pharmacy, the pharmacy must automatically and contemporaneously provide the individual with the pharmacy's notice of privacy practices. An individual that receives a covered entity's notice electronically retains the right to request a paper copy of the notice as described above. This right must be described in the notice.

We note that the Electronic Signatures in Global and National Commerce Act (Pub. L. 106-229) may apply to documents required under this rule to be provided in writing. We do not intend to affect the application of that law to documents required under this rule.