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42 U.S.C. § 17937 — Conditions on certain contacts as part of health care operations
Federal law — U.S. Code and appendices · legal_authorities
**(a) Marketing**
(1) **In general** — 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 communications** — 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 communi
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Source location: Title 42, Chapter 156, § 17937; chapter-156-health-information-technology.md
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**(a) Marketing**
(1) **In general** — 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 communications** — 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) **Reasonable in amount defined** — For 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 payment** — 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) Opportunity to opt out of fundraising** 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) Effective date** 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.
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Federal law — U.S. Code and appendices · legal_authorities
In this subchapter, except as specified otherwise:
(1) **Breach**
(A) *In general* — The term “breach” means the unauthorized acquisition, access, use, or disclosure of protected health information which compromises the security or privacy of such information, except where an unauthorized person to whom such information is disclosed would not reasonably have been able to retain such information.
(B) *Exceptions* — The term “breach” does not include—
(i) any unintentional acquisition, access, or use of protected health information by an employee or individual acting under the authority of a covered entity or business associate if—
(I) such acquisition, access, or use was made in good faith and within the course and scope of the employment or other professional relationship of such employee or individual, respectively, with the covered entity or business associate; and
(II) such information is not further acquired, accessed, used, or disclosed by any person; or
(ii) any inadvertent disclosure from an individual who is otherwise authorized to access protected health information at a facility operated by a covered entity or business associate to another similarly situated individual at 11 So in original. Probably should be followed by “the”. same facility; and
(iii) any such information received as a result of such disclosure is not further acquired, accessed, used, or disclosed without authorization by any person.
(2) **Business associate** — The term “business associate” has the meaning given such term in section 160.103 of title 45, Code of Federal Regulations.
(3) **Covered entity** — The term “covered entity” has the meaning given such term in section 160.103 of title 45, Code of Federal Regulations.
(4) **Disclose** — The terms “
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Federal law — U.S. Code and appendices · legal_authorities
Page 9075
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 17937
1 See References in Text note below.
1 So in original. The period probably should be a comma.
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
(a) Marketing
(1) In general
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 communications
A communication by a covered entity or
business associate that is described in sub-
paragraph (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 en-
tity receives or has received direct or indirect
payment in exchange for making such commu-
nication, except where—
(A)(i) such communication describes only
a drug or biologic that is currently being
prescribed for the recipient of the commu-
nication; and
(ii) any payment received by such covered
entity in exchange for making a communica-
tion described in clause (i) is reasonable in
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