2014 US Code
Title 42 - The Public Health and Welfare (Sections 1 - 18445)
Chapter 156 - Health Information Technology (Sections 17901 - 17953)
Subchapter III - Privacy (Sections 17921 - 17953)
Part A - Improved Privacy Provisions and Security Provisions (Sections 17931 - 17940)
Sec. 17936 - Conditions on certain contacts as part of health care operations
Publication Title | United States Code, 2012 Edition, Supplement 2, Title 42 - THE PUBLIC HEALTH AND WELFARE |
Category | Bills and Statutes |
Collection | United States Code |
SuDoc Class Number | Y 1.2/5: |
Contained Within | Title 42 - THE PUBLIC HEALTH AND WELFARE CHAPTER 156 - HEALTH INFORMATION TECHNOLOGY SUBCHAPTER III - PRIVACY Part A - Improved Privacy Provisions and Security Provisions Sec. 17936 - Conditions on certain contacts as part of health care operations |
Contains | section 17936 |
Date | 2014 |
Laws In Effect As Of Date | January 5, 2015 |
Positive Law | No |
Disposition | standard |
Source Credit | Pub. L. 111-5, div. A, title XIII, §13406, Feb. 17, 2009, 123 Stat. 268. |
Statutes at Large Reference | 123 Stat. 268 |
Public and Private Law | Public Law 111-5 |
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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) Payment for certain communicationsA 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) Reasonable in amount definedFor purposes of paragraph (2), the term "reasonable in amount" shall have the meaning given such term by the Secretary by regulation.
(4) Direct or indirect paymentFor 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) Opportunity to opt out of fundraisingThe 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) Effective dateThis section shall apply to written communications occurring on or after the effective date specified under section 13423.1
(Pub. L. 111–5, div. A, title XIII, §13406, Feb. 17, 2009, 123 Stat. 268.)
REFERENCES IN TEXTSection 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.
1 See References in Text note below.
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