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§170.315(d)(4) Amendments

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)(4) Amendments

Enable a user to select the record affected by a patient's request for amendment and perform the capabilities specified in paragraph (d)(4)(i) or (ii) of this section.

  1. Accepted amendment. For an accepted amendment, append the amendment to the affected record or include a link that indicates the amendment's location.
  2. Denied amendment. For a denied amendment, at a minimum, append the request and denial of the request in at least one of the following ways:
    1. To the affected record.
    2. Include a link that indicates this information's location.
Standard(s) Referenced

None

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 10-22-2015
Revision History
Version # Description of Change Version Date
1.0

Initial Publication

10-22-2015
Regulation Text
Regulation Text

§170.315 (d)(4) Amendments

Enable a user to select the record affected by a patient's request for amendment and perform the capabilities specified in paragraph (d)(4)(i) or (ii) of this section.

  1. Accepted amendment. For an accepted amendment, append the amendment to the affected record or include a link that indicates the amendment's location.
  2. Denied amendment. For a denied amendment, at a minimum, append the request and denial of the request in at least one of the following ways:
    1. To the affected record.
    2. Include a link that indicates this information's location.
Standard(s) Referenced

None

Certification Companion Guide: Amendments

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

Clarifications:

  • There is no standard required for this certification criterion.
  • This certification criterion’s focus is to support the instance where a HIPAA covered entity agrees or declines to accept a patient’s request for an amendment. [see also 77 FR 54174]
  • Amendments are not specified to a particular format (i.e., free text or scanned). [see also 77 FR 54175]
  • This certification criterion is meant to be a starting point from which more comprehensive capabilities and standards can be included to evolve over time, including greater standardization and automation. [see also 77 FR 54175]

Paragraphs (d)(4)(i) and (ii)

Technical outcome – A user can select a patient’s record, and:

  1. For an accepted amendment, the health IT either appends the amendment to the patient’s record or includes a link to the amendment’s location;
  2. For a denied amendment, the health IT appends the request and denial of the request either to the affected record or includes a link that indicates the location of this information.

Clarification:

  • The link is an alternative to appending the patient’s record and must convey to a user or enable a user to obtain the information associated with an amendment’s acceptance or denial. [see also 77 FR 54175]
  • We do not require that accepted or denied amendments be appended to specific data in order for compliance to be demonstrated. There is some flexibility with how accepted or denied amendments are appended to an individual’s protected health information, recognizing that the type and scope of an amendment will vary based on the circumstances. [see also 77 FR 54175]
    • For example, the affected record could include a link to documentation of an accepted or denied amendment, while still allowing, in the case of an accepted amendment, any necessary corrections to be incorporated directly into the record itself. [see also 77 FR 54175]

Content last reviewed on September 21, 2018
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