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§170.315(d)(1) Authentication, access control, authorization

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)(1) Authentication, access control, authorization—

  1. Verify against a unique identifier(s) (e.g., username or number) that a user seeking access to electronic health information is the one claimed; and
  2. Establish the type of access to electronic health information a user is permitted based on the unique identifier(s) provided in paragraph (d)(1)(i) of this section, and the actions the user is permitted to perform with the technology.
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)(1) Authentication, access control, authorization—

  1. Verify against a unique identifier(s) (e.g., username or number) that a user seeking access to electronic health information is the one claimed; and
  2. Establish the type of access to electronic health information a user is permitted based on the unique identifier(s) provided in paragraph (d)(1)(i) of this section, and the actions the user is permitted to perform with the technology.
Standard(s) Referenced

None

Certification Companion Guide: Authentication, access control, authorization

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 criterion focuses on users that would be able to access electronic health information in the technology and not on external users that may make requests for access to health information contained in the technology for the purpose of electronic health information exchange. The latter case could require a different/additional security approach(es). [see also 77 FR 54249]
    • While this criterion does not specify a level of assurance, one-factor authentication would be minimally needed to satisfy this criterion. The developer has the discretion to satisfy this criterion above and beyond one-factor authentication. [see also 77 FR 54249]
    • A user could be a health care professional or office staff, someone who might interact directly with the technology or be software program or service. [see also 75 FR 44598]

    Paragraph (d)(1)(i)

    Technical outcome – A user’s unique identifier(s) (e.g., username or number) is/are verified as the one claimed prior to receiving access to electronic health information.

    Clarifications:

    • No additional clarifications available.

    Paragraph (d)(1)(ii)

    Technical outcome – Following the user’s authentication, the technology establishes permissions associated with the user’s ability to access electronic health information and the actions the user is permitted to perform with the technology.

    Clarifications:

    • No additional clarifications available.

    Content last reviewed on September 21, 2018
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