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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