No change for Safety-Enhanced Design (aka usability) in ONC MU2.1

Safety-Enhanced Design

ONC proposed a “safety-enhanced design” (SED) certification criterion for the Proposed Voluntary Edition that was unchanged as compared to the 2014 Edition certification criterion.

ONC did, however, solicit public comment regarding whether ONC should modify the certification criterion. Specifically, ONC requested comment regarding whether:

  • the scope of SED should be expanded to include additional certification criteria;
  • formative usability tests should be explicitly required, or used as substitutes for summative testing;
  • there are explicit usability tests that should be required in addition to summative testing; and
  • there should be a minimum number of test subjects explicitly required for usability testing.


ONC received many comments in response to their request for comments.

Commenters suggested expanding the certification criteria covered in this criterion to criteria covering laboratory exchange, problems, and other areas. Conversely, other commenters recommended not expanding the certification criteria covered by the SED criterion.

Commenters were both for and against using actual formative usability tests with some suggesting testing to certain usability standards. Some commenters also suggested that there be a minimum number of test subjects, with a few commenters emphasizing that the test subjects and process should be objective.


ONC has not adopted this certification criterion because ONC has not adopted the Proposed Voluntary Edition. Rather, ONC has only adopted a small subset of the proposed certification criteria as optional 2014 Edition EHR certification criteria and made revisions to 2014 Edition EHR certification criteria that provide flexibility, clarity, and enhance health information exchange.

As proposed, this certification criterion would offer no value as an optional 2014 Edition certification criterion because it would be the same as the current 2014 Edition “safety-enhanced design” certification criterion.

ONC will, however, consider all the thoughtful comments ONC received regarding expanding the scope and testing of the SED certification criterion in relation to future rulemaking activity concerning a SED certification criterion.

ONC notes that they have revised the 2014 Edition SED certification criterion (§ 170.314(g)(3)) to include the three optional CPOE certification criteria and the optional CIRI certification criterion. ONC discusses these revisions in further detail under the discussions of CPOE and CIRI in section III.A.2 of their preamble.

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