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§170.315(d)(11) Accounting of disclosures

Version 1.1 Updated on 09-21-2017
Revision History
Version # Description of Change Version Date
1.0

Final Test Procedure

01-08-2016
1.1

As of September 21, 2017, Test Procedure has been moved to Attestation/Developer self-declaration only.

09-21-2017
Regulation Text
Regulation Text

§170.315 (d)(11) Accounting of disclosures

Record disclosures made for treatment, payment, and health care operations in accordance with the standard specified in §170.210(d).

Standard(s) Referenced

Applies to entire criterion

§ 170.210(d) Record treatment, payment, and health care operations disclosures. The date, time, patient identification, user identification, and a description of the disclosure must be recorded for disclosures for treatment, payment, and health care operations, as these terms are defined at 45 CFR 164.501.

Testing components

Gap Eligible
Self-Declaration: As of September 21, 2017, the testing approach for this criterion is satisfied by self-declaration.

The archived version of the Test Procedure is attached below for reference.

System Under Test

Test Lab Verification

The health IT developer submits their self-declaration to the ONC-ATL.

The Tester verifies the self-declaration document contains all of the required data elements.

 

Archived Version:
Version 1.0 Updated on 12-18-2015
Revision History
Version # Description of Change Version Date
1.0

Initial Publication

12-18-2015
Regulation Text
Regulation Text

§170.315 (d)(11) Accounting of disclosures

Record disclosures made for treatment, payment, and health care operations in accordance with the standard specified in §170.210(d).

Standard(s) Referenced

Applies to entire criterion

§ 170.210(d) Record treatment, payment, and health care operations disclosures. The date, time, patient identification, user identification, and a description of the disclosure must be recorded for disclosures for treatment, payment, and health care operations, as these terms are defined at 45 CFR 164.501.

Certification Companion Guide: Accounting of disclosures

This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 2015 Edition final regulation. It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the 2015 Edition final rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed.
 

 

Certification Requirements

Quality management system (§ 170.315(g)(4)) and accessibility-centered design (§ 170.315(g)(5)) must be certified as part of the overall scope of the certificate issued to the product.

  • When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, the QMS’ need to be identified for every capability to which it was applied.
  • When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively the developer must state that no accessibility-centered design was used.
Technical Explanations and Clarifications

 

Applies to entire criterion

Technical outcome – The health IT records disclosures that are made for treatment, payment, and health care operations as these terms are defined at 45 CFR 164.501.

Clarifications:

  • We expect that the date, time, patient identification, user identification, and the description of each disclosure would be automatically recorded by the health IT. [see also 77 FR 54252]
  • A “description of the disclosure” could be a free text field that includes any information that could be readily and electronically associated with the disclosure. For example, some descriptive information could be included (e.g., the words “treatment,” “payment,” or “health care operations”) separately or together as a general category. [see also 75 FR 44623 and 77 FR 54252]

Content last reviewed on September 21, 2018
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