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ONC 2015 Edition EHR Certification Criteria
The document proposes new 2015 Edition certification criteria for electronic health records (EHRs) to support continued progress on interoperability. It highlights proposals for new and revised criteria in areas like laboratory test results, clinical decision support, implantable medical devices, care transitions, and quality reporting. The document argues that more incremental rulemaking allows for nimbler policy, reduces burden on EHR developers, and better aligns regulations with evolving industry standards and needs. Public comment is sought on the 2015 Edition proposals as well as potential 2017 Edition criteria.
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ONC 2015 Edition EHR Certification Criteria
- 1. ONC 2015 EditionEHR Certification Criteria Notice of Proposed Rulemaking Tuesday, February 25, 2014 Jacob Reider Jodi Daniel Steve Posnack
- 2. By the end: •Why a 2015 Edition? – 30,000ft and 10ft • Certification Policy Perspective – Past – Present – Future • Highlights: – 2015 Edition Proposals – 2017 Edition topics under consideration 1
- 3. Certification Big Picture •Why certification? – For meaningful use incentives it’s required by law (HITECH) – In general, certification provides assurance and accountability – Creates a “gold baseline” in a sense • ONC’s role as a coordinator, convener, & enabler – Certification program policy as a service to others – “Policy API” for convergence – a method through which industry and other Federal policy and program needs can be met with mutually beneficial outcomes. • Means to reduce overall regulatory burden (“compliance fast-track”) 2
- 4. The future: 3-yearONC Rulemaking Roadmap (milestones reflect best guestimates) CY 2014 Q1 Q2 Q3 CY 2015 Q4 Q1 Q2 Q3 CY 2016 Q4 Q1 Q2 Q3 Q4 MU2 EP Start Date 2015Ed NPRM Public Comment 2015Ed Final 2017Ed & MU3 NPRM NPRM Public Comment 2017Ed & MU3 Final Final 2018Ed NPRM Public Comment 2018Ed Final Announced Anticipated MU3 EH Start Date 3
- 5. Major Certification RulemakingsTimeline by Proposed Rule/IFR Release 2011 Edition 2014 Edition 2015 Edition Published January 2010 Published March 2012 Published February 2014 Permanent Certification Program Final Rule January 2011 4
- 6. Huh!?, what!?, whya 2015 Edition!? • Our commitment to see continued incremental progress toward greater interoperability for providers, individuals, and their families. – 2012 was last time we proposed updated standards and implementation guides for certification. • The rulemaking gives HIT developers earlier and clearer “standards policy” direction. – This rulemaking includes proposals we are ready to make to improve already existing certification criteria. – Better positions HIT developers to respond to our near future 2017 Edition rulemaking, which we will publish jointly with CMS’ MU Stage 3 rulemaking. • Gap certification between the 2014 Edition and 2015 Edition and then between the 2014/2015 Editions and 2017 Edition could significantly expedite certifications and reduce regulatory burden. 5
- 7. 2011 Permanent CertificationProgram Final Rule & Gap Certification • Included the concept of “gap certification” • Gap certification means the certification of a previously certified Complete EHR or EHR Module(s) to: 1. All applicable new and/or revised certification criteria adopted by the Secretary at subpart C of this part based on the test results of a NVLAP-accredited testing laboratory; and 2. All other applicable certification criteria adopted by the Secretary at subpart C of this part based on the test results used to previously certify the Complete EHR or EHR Module(s). 6
- 8. Chronological Composition (New/Revised/Unchanged) ofCertification Criteria Editions by Year Ambulatory 2011 Edition Inpatient 100% N (baseline) 100% N (baseline) n = 33 n = 32 50% R n= 9 2015 Edition 30% N 22 20% U 2014 Edition 13 51% R 33% R 15% 28 18 8 27% N 23 n = 10 52% U n= 22% U 12 53% U N n= 32% R 15% 28 17 8 N Bottom line: • Over 50% of the 2015 Edition certification criteria are eligible for gap certification • Possible for an HIT developer to get a 2015 Edition certification without retesting 7
- 9. What does moreincremental rulemaking accomplish? • Less change between editions of certification criteria. • Makes rulemaking more nimble, better able to keep up with industry updates. • Provides ample opportunity for public comment and earlier visibility into potential policy directions. 8
- 10. Resource Allocation Comparison: Rulemakingvs HIT Developer (no incremental rules) 100% MU1 2-year gap MU1 MU2 3-year gap MU1 MU2 MU3 0% Published 2010 “2011 Edition” Published 2012 “2014 Edition” Published 2015 “2017 Edition” ?-year gap
- 11. Resource Allocation Comparison: Rulemakingvs HIT Developer (with incremental rules) 100% MU1 MU2 MU1 MU1 MU2 MU3 2-year gap 2-year gap 1-year gap 1-year gap 0% Published 2010 “2011 Edition” Published 2012 “2014 Edition” Published 2014 “2015 Edition” Published 2015 Published 2016 “2017 Edition” “2018 Edition”
- 12. The 2015 EditionNPRM Section-by-Section (Public Display (double spaced) Version) • Pgs 1-21: boilerplate & executive summary • Pgs 21-129: 2015 Edition Proposals – (& 2017 Edition Comment requests) • Pgs 129-139: Definitions & 2014 vs 2015 tables • Pgs 139-154: ONC HIT Certification Program • Pgs 154-185: 2017 Edition Topics Under consideration • Pgs 185-241: Impact analysis and regulatory text 11
- 13. 2015 Edition highlights •Lab orders & CLIA compliance – Computerized Provider Order Entry (CPOE) for lab order IG – Incorporate lab test results updated IG • Clinical Decision Support (CDS) – Propose the adoption of the Health eDecisions work. • Requirements for computable CDS as well as interface requirements needed to request CDS guidance from a CDS supplier. • Implantable device list – Record and display the unique device identifiers (UDIs) associated with a patient’s implanted devices 12
- 14. 2015 Edition highlights(2) • Transitions of Care – Propose to separately test and certify: • “Content” capabilities (i.e., Consolidate CDA); and • “Transport” capabilities (i.e., Direct Project specification). – Propose to require testing to an “edge protocol” implementation guide – Propose a new “performance standard” that would require EHR technology to successfully receive Consolidated CDA’s no less than 95% of the time. – Data quality constraints to improve patient matching 13
- 15. 2015 Edition highlights(3) • Patient Population Filtering for CQMs – Ability to create different patient population groupings by, for example: • practice site • primary and secondary insurance • Syndromic Surveillance – Propose to revise the 2014 Edition version as well as adopt a 2015 Edition that mirrors those revisions • Add certification alternatives for CDA and QRDA III standards 14
- 16. 2015 Edition highlights(4) • Non-Percentage-Based Measures – Re-proposed in response to OIG recommendation • Transmission – Four separate certification criteria for transmission – Newest includes Direct + Delivery Notification 15
- 17. ONC HIT CertificationProgram/Definitions • “Complete EHR” certification – Propose to discontinue • Outlived original intent • Misnomer – Only applies to scope of all certification criteria not entire product • Exceeds the flexibility now provided in the Certified EHR Technology definition • Not necessarily “complete” – No guarantee that it will included all CQM capabilities – May not include capabilities designated as “optional” certification criteria 16
- 18. ONC HIT CertificationProgram/Definitions (2) • Non-MU EHR Technology Certification – Propose to remove existing regulatory burden that would require EHR technology designed for non-MU purposes to include MU measure calculation capabilities in order to get certified. – Propose to permit “MU EHR Modules” and “non-MU EHR Modules” to be certified. The latter would not need to include the MU-specific measure calculation capabilities to get certified. • “Certification Packages” – Logical groupings of certification criteria 17
- 19. 2017 Edition TopicsUnder Consideration 1. Additional Patient Data Collection – Disability information – US Military Service – Work Information Industry/Occupation 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. Medication Allergy Coding Certification Policy for EHR Modules and Privacy and Security Provider Directories Oral Liquid Medication Dosing Medication History Blue Button + 2D Barcoding Duplicate Patient Records Disaster Preparedness Certification of Other Types of HIT and for Specific Types of Health Care Settings – – Best way to distinguish beyond “EHR technology” Specific types of health care settings 18
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