ONC Final Rule for 2015 Certification Criteria: Safety-enhanced design

The final rule for the ONC 2015 certification has been released.

The 550+ page document identifies a number of changes from the previously published proposed rule in direct response to a number of comments provided to ONC.

What follows are highlights of the Safety-enhanced Design (a.k.a. usability) section of the ONC 2015 certification edition. (The complete text appears on page 243 to 251 of the following document: https://www.federalregister.gov/articles/2015/10/16/2015-25597/2015-edit... )

2015 Edition Health IT Certification Criterion § 170.315(g)(3) (Safety-enhanced design)

For the 2015 Edition the following items need to be evaluated for usability:

  • Section 170.315(a)(1) Computerized provider order entry – medications
  • Section 170.315(a)(2) Computerized provider order entry – laboratory
  • Section 170.315(a)(3) Computerized provider order entry – diagnostic imaging
  • Section 170.315(a)(4) Drug-drug, drug-allergy interaction checks
  • Section 170.315(a)(5) Demographics (New)
  • Section 170.315(a)(6) Problem list (New)
  • Section 170.315(a)(7) Medication list
  • Section 170.315(a)(8) Medication allergy list
  • Section 170.315(a)(9) Clinical decision support
  • Section 170.315(a)(14) Implantable device list (New)
  • Section 170.315(b)(2) Clinical information reconciliation and incorporation
  • Section 170.315(b)(3) Electronic prescribing

ONC proposed to include seventeen (17) certification criteria (seven new), but in the final rule they have made 12 (twelve) be the final number of criteria. This is a 50 percent increase from the 8 (Eight) that was required for the 2014 certification edition (for Meaningful Use Stage 2.)

The Usability People conduct and report summative usability evaluations using the NISTIR 7742 Customized Common Industry Format Template for EHR Usability Testing—suitable for satisfying the Safety-enhanced Design criteria portion of your 2015 Edition Certification.

NISTIR 7742 Submission Requirements, New Requirements and Compliance Guidance

ONC now requires that Health IT developers include the specific information from the NISTIR 7742 “Customized Common Industry Format Template for Electronic Health Record Usability Testing. All of the data elements described in NISTIR 7742 and every section must be completed, including “major findings” and “areas for improvement.” ONC identified the requirements for the submission of the demographic characteristics of test participants. These test participant characteristics must reflect the audience of current and future users of the EHR.

In accordance with NISTIR 7804, ONC requires that the test scenarios be based upon an analysis of critical use risks for patient safety, which can be mitigated or eliminated by improvements to the user interface design.

Health IT developers must now select an industry standard User-Centered design process because compliance with this certification criterion requires submission of the name, description, and citation (URL and/or publication citation) of the process that was selected. Examples of method(s) that could be employed for UCD, including ISO 9241-11, ISO 13407, ISO 16982, ISO/IEC 62366, ISO 9241-210 and NISTIR 7741.

In the event that a health IT developer selects a UCD process that was not an industry standard (i.e., not developed by a voluntary consensus standards organization), but is based on one or more industry standard processes, the developer may name the process(es) and provide an outline of the process in addition to a short description as well as an explanation of the reason(s) why use of any of the existing UCD standards was impractical.

User Satisfaction

ONC will now also permit the submission of an alternative acceptable user satisfaction measure such as the (Single Ease-of-use Question, System Usability Scale, or Software Usability Measurement Inventory) to meet the requirements of this criterion. Stated another way, a health IT developer could meet the proposed NIST 7742 based approach for user satisfaction or provide documentation of an alternative acceptable user satisfaction measure.

Number of Test Participants

ONC has adopted a provision as part of this criterion that requires 10 participants per criterion/capability as a mandatory minimum for the purposes of testing and certification. ONC suggests that this number will balance any potential burden for health IT developers, including small developers.

However, they strongly encourage health IT developers to exceed the mandatory minimum in an effort to identify and resolve more problems.

Formative vs. Summative testing

ONC considered whether a standardized report of formative testing could be submitted as an alternative to the criteria for which summative testing would be required, if formative testing reflected a thorough process that has tested and improved the usability of a product. Ultimately ONC agreed with commenters that contend that formative testing should not be a substitute for summative testing for the purposes of this criterion.

Retesting and Certification

ONC-ACB determinations related to the ongoing applicability of the SED certification criterion to certified health IT for the purposes of inherited certified status (§ 170.550(h)), adaptations and other updates would be based on the extent of changes to user-interface aspects of one or more capabilities to which UCD had previously been applied.

In other words if you make a significant change to the user interface of your EHR, you may have to re-certify for Safety-enhanced Design

Additional information

2015 Edition Final Rule (pre-publication version): https://www.federalregister.gov/articles/2015/10/16/2015-25597/2015-edit... Note:

  • The 2015 Edition final rule provisions become effective on January 14, 2016, except for § 170.523(m) (adaptations/updates reporting) and (n) (complaints reporting), which are effective on April 1, 2016.
  • There is no comment period for this final rule.

For more information and guidance on the 2015 Edition Final Rule, please visit: https://www.healthit.gov/policy-researchers-implementers/2015-edition-fi... ONC has also included an Accessibility requirement in the 2015 Edition Certification. ONC Regulations: https://www.healthit.gov/policy-researchers-implementers/health-it-regul...