Continuing to usher in a new wave of EHR technology changes, on September 11, 2014, the Office of the National Coordinator for Health Information Technology (“ONC”) adopted the “2014 Edition Release 2” final rule, which provides alternative criteria and approaches for the voluntary certification of heath information technology. The final rule, effective October 14, 2014, introduces regulatory flexibilities and general improvements to the certification processes.
First, the rule adopts a new (albeit smaller) subset of optional EHR Certification Criteria. Of the 57 proposed certification criteria in the February 26, 2014 notice of proposed rulemaking, the final rule adopts only ten optional and two revised EHR Certification Criteria. The Certification Criteria changes include:
1. The division of the “computerized provider order entry” criterion into three certification criteria, based on order-type capabilities (medications, laboratory, and diagnostic imaging);
2. The division of the “transitions of care” (“ToC”) certification criterion into separate content and transport capability measures;
3. The adoption of three separate transport method (formerly transmission) certification criteria (corresponding to the three transport standards found in 45 C.F.R. § 170.314(b)(1) and (2));
4. Shifting the “incorporation” requirements—which mandate the proper matching of patients to their transition of care/referral summaries—from the ToC certification criterion to the newly-adopted “clinical information reconciliation and incorporation certification” (“CIRI”) criterion;
5. The adoption of a “transmission to public health agencies—syndromic surveillance” certification criterion, which permits any electronic method for creating syndromic surveillance information (used to enhance detection of emerging infections and illnesses) for exchange; and
6. A change in the “automated numerator recording” certification criterion to make it optional for the purposes of excluding it from the 2014 Edition Complete EHR definition.
There are also two revised certification criteria. The final rule includes a modified “view, download, and transmit to 3rd party” (“VDT”) certification criterion (45 C.F.R. § 170.314(e)(1)), which allows flexibility in providing patients with an online means to view, download, and transmit certain data to third parties. The rule also includes a revised “safety-enhanced design” (“SED”) certification criterion that encompasses the optional CPOE and CIRI certification criteria discussed above.
Beyond the modifications to the optional and revised certification criteria, the final rule encompasses a second major change: proposed modifications to the ONC Health Information Technology (“HIT”) Certification Program. As a result, ONC has:
1. Discontinued the “Complete EHR” certification concept and definition;
2. Adopted an updated standard (ISO/IEC 17065) for the accreditation of ONC-Authorized Certification Bodies (“ACBs”);
4. Made optional the 2014 Edition “automated numerator recording” certification criterion, and made revisions to clearly require and permit EHR Module certification to either the “automated numerator recording” measure or the “automated measure calculation” measure in 45 C.F.R. §§ 170.314(g)(1) or (g)(2); and
5. Provided clarifying guidance for certification to the 2014 Edition “patient list creation” certification criterion, making clear that where EHR technology is presented for certification and does not include a capability to support “patient reminders,” it would not need to be certified to either the “automated numerator recording” measure or the “automated measure calculation” measure in 45 C.F.R. §§ 170.314(g)(1) or (g)(2).
In sum, despite the adoption of a much smaller subset of the proposals than set forth in the February 26, 2014 notice of proposed rulemaking, ONC anticipates that the final rule will provide increased flexibility and clarity, and will enhance the overall efficacy of the health information exchange.
For additional information, the accompanying Press Release may be found here.
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 The amendments to certain 45 C.F.R. Part 170 provisions—the amendatory instruction number 3 amendment to § 170.102, the amendments to §§ 170.205, 170.207, 170.210, 170.302, 170.304, 170.306, and the amendatory instruction number 18 amendment to § 170.550—are effective on March 1, 2015.