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Tuesday, January 4, 2011

The ONC Permanent Certification Rule for MeaningfulUse

ONC released the Permanent Certification Rule yesterday.  You can find the text here.  There were no real surprises in the final rule.  Below is a quick summary of the important changes in the rule.     
  • ONC intends to address the governance for the NW-HIN through a separate rulemaking. (p22)
  • §170.501 revised to acknowledge the possibility for ONC-ACBs to certify “other types of HIT" (p22)
  • §170.501 revised to clearly state requirements that ONC-ACBs must follow to maintain their status (p22)
  • §170.510 now allows orgs to certify other types of HIT besides Complete/Modular EHRs (p24)
  • §170.503 now allows 30-day submission for qualified orgs to compete to serve as the ONC-AA (p31)
  • §170.503 now extends review period of ONC-AA submissions to 60 days (p31)
  • §170.503 and §170.504 revised to allow time for reconsideration of an application to become an ONC-AA (p33)
  • §170.503 National Coordinator to start process at least 180 days before expiration of current ONC-AA (p34)
  • ONC will issue an NPRM on improper conduct of ONC-AAs and consequences (p35) 
  • §170.520(c) revised to indicate that there shall be only one ONC-AA (the Highlander Clause) (p57)
  • §170.523(f) revised to use the term developers rather than vendors (p64)
  • §170.523(h) revised to state that an ACB may only certify HIT tested by a NVLAP-accredited lab...
  • ... using test tools and test procedures that have been approved by the National Coordinator (p83)
  • §170.503 revised to require consistent plan for objective, valid, and reliable surveillance by ONC-ACBs (p92)
  • §170.530 revised to set 6-month expiration barring reapplication for ONC-ACB status after denial. (p107)
  • §170.545(a) clarified to ensure Complete EHRs certified in accordance with ALL adopted criteria (p119)
  • Definitions of  “development site,” “deployment site,” and “remote certification” added to §170.502 (p143)
  • §170.557 to require an ONC-ACB to provide remote certification for both development and deployment sites (p143)
  • §170.565 revised to provide ONC with the discretion to suspend an ONC-ACB’s operations (p152)
  • §170.523(j) clarifies that a suspended ONC-ACB must refund fees paid by developers seeking to withdraw (p153)
  • §170.523(h) now permits ACBs to rely on the results of prior testing (by ATCB or ACB) if criteria unchanged. (p190)
  • §170.540 revised to state that an ACB will renew every three years instead of every two years (p201)

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