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AIS Side-by-Side Comparison of March 27 Proposed Modifications to Existing
HIPAA Regulatory Language

Business Associates

HHS Fact Sheet

Business Associates -- The current rule requires covered entities ‑ health plans, health care providers and clearinghouses ‑ to have contracts with their business associates to ensure the business associates protect the privacy of the information. The proposal includes model business associate contract provisions, to make it easier and less costly for covered entities to implement the requirements. The changes also would give covered entities (except for small health plans) up to an additional year to change existing contracts, easing the burden of renegotiating contracts all at once.

Preamble Discussion:
67 Federal Register
Discussion and modifications, pp. 14787, 14788
Model Business Associate Contract Provisions, p. 14809

AIS Regulatory Comparison

Provisions affected: §164.532, add new (d) and (e)

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:

Legend
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

Proposed Revisions, Federal Register, 3/27/2002

Existing Language, Final Rule, 12/28/2000

§ 164.502 Uses and disclosures of protected health information: general rules.

[No changes to §164.502(e), Standard: disclosures to business associates.]

§ 164.502 Uses and disclosures of protected health information: general rules.

[No changes to §164.502(e), Standard: disclosures to business associates.]

§ 164.504 Uses and disclosures: Organizational requirements.

[No changes to §164.504(e), Standard: business associate contracts.]

§ 164.504 Uses and disclosures: Organizational requirements.

[No changes to §164.504(e), Standard: business associate contracts.]

§ 164.532 Transition provisions.

Proposed Revisions, Federal Register, 3/27/2002

Existing Language, Final Rule, 12/28/2000

§ 164.532 Transition provisions.

§ 164.532 Transition provisions.

(d) Standard: Effect of prior contracts or other arrangements with business associates.

Notwithstanding any other provisions of this subpart, a covered entity, other than a small health plan, may disclose protected health information to a business associate and may allow a business associate to create, receive, or use protected health information on its behalf pursuant to a written contract or other written arrangement with such business associate that does not comply with §§164.502(e) and 164.504(e) consistent with the requirements, and only for such time, set forth in paragraph (e) of this section.

(e) Implementation specification: Deemed compliance. ‑ 

(1) Qualification. Notwithstanding other sections of this subpart, a covered entity, other than a small health plan, is deemed to be in compliance with the documentation and contract requirements of §§164.502(e) and 164.504(e), with respect to a particular business associate relationship, for the time period set forth in paragraph (e)(2) of this section, if:

(i) Prior to the effective date of this provision, such covered entity has entered into and is operating pursuant to a written contract or other written arrangement with a business associate for such business associate to perform functions or activities or provide services that make the entity a business associate; and

(ii) The contract or other arrangement is not renewed or modified from the effective date of this provision and until the compliance date set forth in §164.534.

(2) Limited deemed compliance period. A prior contract or other arrangement that meets the qualification requirements in paragraph (e) of this section, shall be deemed compliant until the earlier of:

(i) The date such contract or other arrangement is renewed or modified on or after the compliance date set forth in § 164.534; or

(ii) April 14, 2004.

(3) Covered entity responsibilities. Nothing in this section shall alter the requirements of a covered entity to comply with part 160, subpart C, of this subchapter and §§164.524, 164.526, 164,528 with respect to protected health information held by a business associate.

[New provisions.]

 

Back to the Proposed Modifications
To HIPAA Privacy Rule Page

 



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