§17936 — Title 42 The Public Health and Welfare | U.S. Code

Summary

Says when a health-care provider or its business partner can treat a promotional message as a normal health-care operation under the privacy rules. If a message encourages people to buy or use a product or service, it usually is not a health-care operation unless it matches specific marketing types in the privacy rule. If the provider received payment to send such a marketing message, it generally is still not a health-care operation, except when one of three things is true: the message only describes a drug the person is already prescribed and any payment is reasonable; the provider sent the message and the person gave a valid written authorization; or a business associate sent the message for the provider and it follows their written contract. “Reasonable in amount” will be defined by the Secretary. “Direct or indirect payment” does not include payment for treatment as defined in the privacy rule. Written fundraising messages that are health-care operations must clearly let recipients opt out of future messages, and opting out counts as revoking authorization. These rules apply to written communications on or after the effective date in section 13423.

Title 42, §17936

The Public Health and Welfare — Source: USLM XML via OLRC

(a)(1)A communication by a covered entity or business associate that is about a product or service and that encourages recipients of the communication to purchase or use the product or service shall not be considered a health care operation for purposes of subpart E of part 164 of title 45, Code of Federal Regulations, unless the communication is made as described in subparagraph (i), (ii), or (iii) of paragraph (1) of the definition of marketing in section 164.501 of such title.

(2)A communication by a covered entity or business associate that is described in subparagraph (i), (ii), or (iii) of paragraph (1) of the definition of marketing in section 164.501 of title 45, Code of Federal Regulations, shall not be considered a health care operation for purposes of subpart E of part 164 of title 45, Code of Federal Regulations if the covered entity receives or has received direct or indirect payment in exchange for making such communication, except where—

(A)(i)such communication describes only a drug or biologic that is currently being prescribed for the recipient of the communication; and

(ii)any payment received by such covered entity in exchange for making a communication described in clause (i) is reasonable in amount;

(B)each of the following conditions apply—

(i)the communication is made by the covered entity; and

(ii)the covered entity making such communication obtains from the recipient of the communication, in accordance with section 164.508 of title 45, Code of Federal Regulations, a valid authorization (as described in paragraph (b) of such section) with respect to such communication; or

(C)each of the following conditions apply—

(i)the communication is made by a business associate on behalf of the covered entity; and

(ii)the communication is consistent with the written contract (or other written arrangement described in section 164.502(e)(2) of such title) between such business associate and covered entity.

(3)For purposes of paragraph (2), the term “reasonable in amount” shall have the meaning given such term by the Secretary by regulation.

(4)For purposes of paragraph (2), the term “direct or indirect payment” shall not include any payment for treatment (as defined in section 164.501 of title 45, Code of Federal Regulations) of an individual.

(b)The Secretary shall by rule provide that any written fundraising communication that is a healthcare operation as defined under section 164.501 of title 45, Code of Federal Regulations, shall, in a clear and conspicuous manner, provide an opportunity for the recipient of the communications to elect not to receive any further such communication. When an individual elects not to receive any further such communication, such election shall be treated as a revocation of authorization under section 164.508 of title 45, Code of Federal Regulations.

(c)This section shall apply to written communications occurring on or after the effective date specified under section 13423.11 See References in Text note below.

Notes & Related Subsidiaries

Editorial Notes

References in Text

section 13423, referred to in subsec. (c), means section 13423 of div. A of Pub. L. 111–5, which is set out as an

Effective Date

note under section 17931 of this title.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 12 months after Feb. 17, 2009, except as otherwise specifically provided, see section 13423 of Pub. L. 111–5, set out as a note under section 17931 of this title.

§17936 Conditions on Certain Contacts as Part of Health Care Operations

Summary

Title 42, §17936

Notes & Related Subsidiaries

Editorial Notes

References in Text

Effective Date

Statutory Notes and Related Subsidiaries

Effective Date

Citations & Metadata