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§170.315(a)(12) Family health history

Updated on 08-25-2021
Regulation Text
Regulation Text

§ 170.315 (a)(12) Family health history

Enable a user to record, change, and access a patient's family health history in accordance with the familial concepts or expressions included in, at a minimum, the version of the standard in §170.207(a)(4).

Standard(s) Referenced
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
1.2

Changed language from self-declaration to attestation 

08-25-2021

Testing components

Attestation: As of September 21, 2017, the testing approach for this criterion is satisfied by attestation.

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

 

System Under Test

ONC-ACB Verification

The health IT developer will attest directly to the ONC-ACB to conformance with the §170.315(a)(12) Family health history requirements.

The ONC-ACB verifies the health IT developer attests conformance to the §170.315(a)(12) Family health history requirements.

 

 

Archived Version:
Updated on 06-15-2020
Regulation Text
Regulation Text

§ 170.315 (a)(12) Family health history

Enable a user to record, change, and access a patient's family health history in accordance with the familial concepts or expressions included in, at a minimum, the version of the standard in §170.207(a)(4).

Standard(s) Referenced
Revision History
Version # Description of Change Version Date
1.0

Initial Publication

10-22-2015
1.1

Added clarification for the testing and certification of “familial concepts or expressions”.

12-18-2015
1.2

Removed “unstructured/free text recording” clarification.

03-18-2016
1.3

Further clarification provided for the structured coding and representation of familial relationship.

02-17-2017
1.4

Updated the Security requirements per 21st Century Cures Act. 

06-15-2020

Certification Companion Guide: Family health history

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

Privacy and Security: This certification criterion was adopted at § 170.315(a)(12). As a result, an ONC Authorized Certification Body (ONC-ACB) must ensure that a product presented for certification to a § 170.315(a) criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.

  • The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (a) criterion unless it is the only criterion for which certification is requested.
  • As a general rule, a product presented for certification only needs to be presented once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, exceptions exist for § 170.315(e)(1) “View, download, and transmit to 3rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated.
  • § 170.315(d)(2)(i)(C) is not required if the scope of the Health IT Module does not have end-user device encryption features.

Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.

  • 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.
Table for Privacy and Security
Technical Explanations and Clarifications

Technical outcome – The health IT permits users to record, change, and access a patient’s family health history according to the September 2015 Release of SNOMED CT®, U.S. Edition.

Clarifications:

  • Health IT Modules can present for certification to a more recent version of SNOMED CT®, U.S. Edition than the September 2015 Release per ONC’s policy that permits certification to a more recent version of certain vocabulary standards. [see also 80 FR 62612]
  • ONC provides the following object identifier (OID) to assist developers in the proper identification and exchange of health information coded to certain vocabulary standards.
    • The SNOMED CT® OID: 2.16.840.1.113883.6.96. [see also 80 FR 62612]
  • Health IT developers have the discretion to code associated family health history questions in the manner they choose (e.g., including but not limited to LOINC®). [see also 80 FR 62624]
  • At a minimum, the health IT must enable a user to record, change, and access information about a patient’s first degree relative within the said patient’s record. However, health IT does not need be able to access the records of the patient’s first degree relatives for certification. [see also 77 FR 54174]
  • ONC's intent with “familial concepts and expressions” is to focus on the first degree relative’s diagnosis. For testing and certification, at a minimum, a system must be able to demonstrate that it can record, change, and access this diagnosis and the familial relationship in a codified manner using SNOMED CT®. The developer has the flexibility to determine how the system will represent the codified familial relationship, pre- or post-coordinated.