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AIS Side-by-Side Comparison of March 27 Proposed Modifications to
Existing HIPAA Regulatory Language
Consent
HHS Fact Sheet
Consent
and Notice -- The proposal would promote access to care by removing
the consent requirements that would potentially interfere with the
efficient delivery of health care, while strengthening requirements
for providers to notify patients about their privacy rights and practices.
Specifically, the department received comments that the consent requirements
in the current rule interferes with pharmacists filling prescriptions,
referrals to specialists and hospitals, providing treatment over the
telephone, and emergency medical providers. Under the proposal, patients
would be asked to acknowledge receipt of the notice of privacy rights
and practices. This change would give patients the opportunity to
consider a provider's privacy policies before making health care decisions,
while eliminating barriers that could delay or block patients' access
to care. This change to consent only applies to uses and disclosures
for treatment, payment and health care operations (TPO) purposes.
Patient authorizations are still required to use and disclosure information
for non-TPO purposes.
Preamble
Discussion: 67
Federal Register pp. 14778, 14780
AIS Regulatory
Comparison
Provisions
Affected:
§164.502(a)(1)
§164.506, deleted and replaced; particularly (a) and (b) for consent
§164.532
How
to Read the Table
Proposed
changes from the March 27, 2002 Federal Register are in the
left column
Existing language, from the December 28, 2000 final rule, is in the
right column. The legend for changes is as follows:
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Legend
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Bold
underlined text = proposed revision.
Red text (or within a clause red text
with strikethrough) = language proposed for deletion
or revision.
[Bracketed text] = editor's note to change.
Regular text = Unchanged existing
language
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§164.506
Use and Disclosures to Carry Out Treatment, Payment, or Health Care
Operations.
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Proposed
Revisions, Federal Register, 3/27/2002
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Existing
Language,
Final Rule, 12/28/2000
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§ 164.506 Uses and
disclosures to carry out treatment, payment, or health care
operations.
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§ 164.506 Consent
for uses or disclosures to carry out treatment, payment,
or health care operations.
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(a) Standard:
Permitted uses and disclosures.
Except with
respect to uses or disclosures that require an authorization
under §164.508(a)(2) and (3), a covered entity may use or disclose
protected health information for treatment, payment, or health
care operations as set forth in paragraph (c) of this section,
provided that such use or disclosure is consistent with other
applicable requirements of this subpart.
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[§
164.506, Consent for uses or disclosures to carry out treatment,
payment, or health care operations, deleted in its entirety]
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(b) Standard:
Consent permitted.
(1)
A covered entity may obtain consent of the individual to use
or disclose protected health information to carry out treatment,
payment, or health care operations.
(2)
Consent of an individual under this paragraph shall not be effective
to permit a use or disclosure of protected health information
that is not otherwise permitted or required by this subpart.
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[new
(c) relating to disclosures of TPO to another entity. See AIS
Side-by-Side, “Disclosures for TPO of Another Entity.”]
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§ 164.502
Uses and disclosures of protected health information: general rules.
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Proposed
Revisions, Federal Register, 3/27/2002
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Existing
Language,
Final Rule, 12/28/2000
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§ 164.502 Uses and
disclosures of protected health information: general rules.
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§ 164.502 Uses and
disclosures of protected health information: general rules.
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(a)
Standard.
[No
changes to (a)(1)(I)]
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(a) Standard.
A covered entity may not use or disclose protected health information,
except as permitted or required by this subpart or by subpart
C of part 160 of this subchapter.
(1)
Permitted uses and disclosures. A covered entity is permitted
to use or disclose protected health information as follows:
(i)
To the individual;
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(ii) For treatment, payment, or health care operations,
as permitted by and in compliance with §164.506;
(iii)
As incident to a use or disclosure otherwise permitted or required
by this subpart, provided that the covered entity has complied
with the applicable requirements of §164.502(b), §164.514(d),
and §164.530(c) with respect to such otherwise permitted or
required uses or disclosures;
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[clauses
(ii) and (iii), below, are deleted and replaced]
(ii)
Pursuant to and in compliance with a consent that complies with
§ 164.506, to carry out treatment, payment, or health care operations;
(iii)
Without consent, if consent is not required under § 164.506(a)
and has not been sought under § 164.506(a)(4), to carry out
treatment, payment, or health care operations, except with respect
to psychotherapy notes;
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[No
changes to (iv) and (v).}
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(iv)
Pursuant to and in compliance with an authorization that complies
with § 164.508;
(v)
Pursuant to an agreement under, or as otherwise permitted by,
§ 164.510; and
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[conforming
change to (vi)]
(vi)
As permitted by and in compliance with this section, § 164.512,
or § 164.514(f), and (g).
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(vi)
As permitted by and in compliance with this section, § 164.512,
or § 164.514(e), (f), and (g).
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(2)
Required disclosures.
[No
changes to (2) Required disclosures.]
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(2)
Required disclosures. A covered entity is required to
disclose protected health information:
(i)
To an individual, when requested under, and as required by §§
164.524 or 164.528; and
(ii) When required
by the Secretary under subpart C of part 160 of this subchapter
to investigate or determine the covered entity's compliance
with this subpart.
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[For
modifications to (b) and (g), see AIS Side-by-Side, “Minimum
Necessary,” and “Parents and Minors.”]
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[No
other changes proposed to section.]
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§164.532
Transition provisions.
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Proposed
Revisions, Federal Register, 3/27/2002
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Existing
Language, Final Rule, 12/28/2000
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§ 164.532 Transition
provisions.
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§ 164.532 Transition
provisions.
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(a) Standard:
Effect of prior authorizations.
Notwithstanding
§§164.508 and 164.512(i), a covered entity may use or disclose
protected health information, consistent with paragraphs (b)
and (c) of this section, pursuant to an authorization or other
express legal permission obtained from an individual permitting
the use or disclosure of protected health information, informed
consent of the individual to participate in research, or a waiver
of informed consent by an IRB.
(b) Implementation
specification: Effect of prior authorization for purposes other
than research.
Notwithstanding
§164.508, a covered entity may use or disclose protected health
information that it created or received prior to the applicable
compliance date of this subpart pursuant to an authorization
or other express legal permission obtained from an individual
prior to the applicable compliance date of this subpart, provided
that the authorization or other express legal permission specifically
permits such use or disclosure and there is no agreed-to restriction
in accordance with §164.522(a).
[For
changes to provisions relating to (c) research and (d) business
associates, and (e) deemed compliance, see AIS Side-by-Side,
“Research” and “Business Associates” respectively.]
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[§164.532,
Transition provisions, deleted in its entirety replaced
with revised language.]
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Proposed Modifications
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