How should 2015 certification critera interact with FDA Software Precertification Program?
jmandel opened this issue · comments
[w]e welcome comments on these and other aspects of our proposed “recognition” approach, including the 2015 Edition certification criteria that should be eligible for “recognition.”
we request comment on whether ONC should establish new regulatory processes tailored towards recognizing the unique characteristics of health IT (e.g., EHR software) by looking first at the health IT developer, rather than primarily at the health IT presented for certification, as is currently done under the Program.
We also welcome more specific comments on the health IT developer criteria for such an approach and what the Conditions and/or Maintenance of Certification requirements should be to support such an approach