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42 U.S.C. § 17936 — Conditions on certain contacts as part of
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
Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 17936
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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
amount;
(B)
each
of
the
following
conditions
apply—
(i) the communication is made by the
covered entity; and
(ii) the covered entity making such com-
munication obtains from the recipient of
the communication, in accordance with
section 164.508 of title 45, Code of Federal
Regulations, a valid authorization (as de-
scribed 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 busi-
ness associate on behalf of the covered en-
tity; and
(ii) the communication is consistent
with the written contract (or other writ-
ten 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 ‘‘rea-
sonable in amount’’ shall have the meaning
given such term by the Secretary by regula-
tion.
(4) Direct or indirect payment
For purposes of paragraph (2), the term ‘‘di-
rect or indirect payment’’ shall not include
any payment for treatment (as defined in sec-
tion 164.501 of title 45, Code of Federal Regula-
tions) 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, pro-
vide an opportunity for the recipient of the com-
munications 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 commu-
nications 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.)
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.
§ 17937. Temporary breach notification require-
ment for vendors of personal health records
and other non-HIPAA covered entities
(a) In general
In accordance with subsection (c), each vendor
of personal health records, following the dis-
covery of a breach of security of unsecured PHR
identifiable health information that is in a per-
sonal health record maintained or offered by
such vendor, and each entity described in clause
(ii), (iii), or (iv) of section 17953(b)(1)(A) of this
title, following the discovery of a breach of secu-
rity of such information that is obtained
through a product or service provided by such
entity, shall—
(1) notify each individual who is a citizen or
resident of the United States whose unsecured
PHR identifiable health information was ac-
quired by an unauthorized person as a result of
such a breach of security; and
(2) notify the Federal Trade Commission.
(b) Notification by third party service providers
A third party service provider that provides
services to a vendor of personal health records
or to an entity described in clause (ii), (iii).1 or
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Requested restrictions on certain disclosures of health information** In the case that an individual requests under paragraph (a)(1)(i)(A) of section 164.522 of title 45, Code of Federal Regulations, that a covered entity restrict the disclosure of the protected health information of the individual, notwithstanding paragraph (a)(1)(ii) of such section, the covered entity must comply with the requested restriction if—
(1) except as otherwise required by law, the disclosure is to a health plan for purposes of carrying out payment or health care operations (and is not for purposes of carrying out treatment); and
(2) the protected health information pertains solely to a health care item or service for which the health care provider involved has been paid out of pocket in full.
**(b) Disclosures required to be limited to the limited data set or the minimum necessary**
(1) **In general**
(A) *In general* — Subject to subparagraph (B), a covered entity shall be treated as being in compliance with section 164.502(b)(1) of title 45, Code of Federal Regulations, with respect to the use, disclosure, or request of protected health information described in such section, only if the covered entity limits such protected health information, to the extent practicable, to the limited data set (as defined in section 164.514(e)(2) of such title) or, if needed by such entity, to the minimum necessary to accomplish the intended purpose of such use, disclosure, or request, respectively.
(B) *Guidance* — Not later than 18 months after February 17, 2009, the Secretary shall issue guidance on what constitutes “minimum necessary” for purposes of subpart E of part 164 of title 45, Code of Federal Regulation.11 So in original. Probably should be “Regulations.” In issuing such guidan
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