§ 164.501 Definitions.

As used in this subpart, the following terms have the following meanings

§ 164.501 Definitions.

As used in this subpart, the following terms have the following meanings:

Marketing means to make a communication about a product or service a purpose of which is to encourage recipients of the communication to purchase or use the product or service.

Marketing excludes a communication made to an individual:

(1) To describe the entities participating in a health care provider network or health plan network, or to describe if, and the extent to which, a product or services (or payment for such product or service) is provided by a covered entity or included in a plan of benefits;

(2) For treatment of that individual; or

(3) For case management or care coordination for that individual, or to direct or recommend alternative treatments, therapies, health care providers, or settings of care to that individual.

[Proposed clause (3), above, replaces the phrase “in the course of managing the treatment of that individual” (underlined in the clause (1)(ii)(B) in the right column) to conform to the definition of “health care operations.”]

[This proposed revision also eliminates the distinction between written and oral communications. See deleted clause (2).]

Marketing means to make a communication about a product or service a purpose of which is to encourage recipients of the communication to purchase or use the product or service.

[The remaining clauses, which appear below, would be deleted.]

(1) Marketing does not include communications that meet the requirements of paragraph (2) of this definition and that are made by a covered entity:

(i) For the purpose of describing the entities participating in a health care provider network or health plan network, or for the purpose of describing if and the extent to which a product or service (or payment for such product or service) is provided by a covered entity or included in a plan of benefits; or

(ii) That are tailored to the circumstances of a particular individual and the communications are:

(A) Made by a health care provider to an individual as part of the treatment of the individual, and for the purpose of furthering the treatment of that individual; or

(B) Made by a health care provider or health plan to an individual in the course of managing the treatment of that individual, or for the purpose of directing or recommending to that individual alternative treatments, therapies, health care providers, or settings of care.

(2) A communication described in paragraph (1) of this definition is not included in marketing if:

(i) The communication is made orally; or

(ii) The communication is in writing and the covered entity does not receive direct or indirect remuneration from a third party for making the communication.

Proposed Revisions, Federal Register, 3/27/2002

Existing Language, Final Rule, 12/28/2000

§164.508 Uses and disclosures for which an authorization is required.

(a) Standard: authorizations for uses and disclosures.

§164.508 Uses and disclosures for which an authorization is required.

(a) Standard: authorizations for uses and disclosures.

[No changes proposed to (1)]

(1) Authorization required: general rule. Except as otherwise permitted or required by this subchapter, a covered entity may not use or disclose protected health information without an authorization that is valid under this section. When a covered entity obtains or receives a valid authorization for its use or disclosure of protected health information, such use or disclosure must be consistent with such authorization. 

[See AIS Side-by-Side, “Authorizations” for proposed change to (2).]

(2) Authorization required: psychotherapy notes.

(3) Authorization required. Marketing.

(i) Notwithstanding any other provision of this subpart other than §164.532, a covered entity must obtain an authorization for any use or disclosure of protected health information for marketing, except if the communication is in the form of:

(A) A face-to-face communication made by a covered entity to an individual; or

(B) A promotional gift of nominal value provided by the covered entity.

(ii) If the marketing is expected to result in direct or indirect remuneration to the covered entity from a third party, the authorization must state that such remuneration is expected.

[Proposed rule would add a new (3), at left]

Proposed Revisions, Federal Register, 3/27/2002

Existing Language, Final Rule, 12/28/2000

§ 164.514 Other requirements relating to uses and disclosures of protected health information.

§ 164.514 Other requirements relating to uses and disclosures of protected health information.

(e) [Removed and reserved]

[(e) would be deleted in its entirety]

(e)(1) Standard: uses and disclosures of protected health information for marketing.

A covered entity may not use or disclose protected health information for marketing without an authorization that meets the applicable requirements of § 164.508, except as provided for by paragraph (e)(2) of this section.

(2) Implementation specifications: requirements relating to marketing. (i) A covered entity is not required to obtain an authorization under § 164.508 when it uses or discloses protected health information to make a marketing communication to an individual that:

(A) Occurs in a face-to-face encounter with the individual;

(B) Concerns products or services of nominal value; or

(C) Concerns the health-related products and services of the covered entity or of a third party and the communication meets the applicable conditions in paragraph (e)(3) of this section.

(ii) A covered entity may disclose protected health information for purposes of such communications only to a business associate that assists the covered entity with such communications.

(3) Implementation specifications: requirements for certain marketing communications. For a marketing communication to qualify under paragraph (e)(2)(i) of this section, the following conditions must be met:

(i) The communication must:

(A) Identify the covered entity as the party making the communication;

(B) If the covered entity has received or will receive direct or indirect remuneration for making the communication, prominently state that fact; and

(C) Except when the communication is contained in a newsletter or similar type of general communication device that the covered entity distributes to a broad cross-section of patients, enrollees, or other broad groups of individuals, contain instructions describing how the individual may opt out of receiving future such communications.

(ii) If the covered entity uses or discloses protected health information to target the communication to individuals based on their health status or condition:

(A) The covered entity must make a determination prior to making the communication that the product or service being marketed may be beneficial to the health of the type or class of individual targeted; and

(B) The communication must explain why the individual has been targeted and how the product or service relates to the health of the individual.

(iii) The covered entity must make reasonable efforts to ensure that individuals who decide to opt out of receiving future marketing communications, under paragraph (e)(3)(i)(C) of this section, are not sent such communications.