1. Timeline & Milestones: Certification & Standards NPRM Stage 2 Health IT Standards Committee, March 29, 2011 Doug Fridsma, MD, PhD Director Office of Interoperability & Standards 1

2. Agenda Key Milestones and Timeline Strategic Principles for Standards and Certification Draft Core Themes for Standards and Certification Discussion 2

3. TIMELINE AND MILESTONES 3

4. Key Milestones and Timelines 4 Q2 2011 Q3 2011 Q4 2011 Q1 2012 Q2 2012 Q3 2012 Q4 2012 Q1 2013 Final Rule Published NPRM Published NPRM Drafted

5. Key Timeline Constraints NPRM must be drafted and undergo regulatory clearance well before publication Publication of final rule must allow for –Comment period –Analysis of comments –Rule drafting and regulatory clearance Certification tests must be developed, vetted and implemented by ONC-ACB EHRs and EHR modules must have lead-time for –Software development –Certification –Upgrade/installation and training 5

6. STRATEGIC PRINCIPLES 6

7. The best way to predict the future is to invent it Alan Kay 7 The future is already here – it's just not very evenly distributed William Gibson The problem with the future is that it keeps turning into the present Calvin and Hobbes Quotes

8. Key Principles for Standards and Certification Criteria Standards and Certification for the sake of –Meaningful use –Improved care, improved health, decreased costs –Confidence and trust –Individual empowerment –Rapid learning and innovation Standards and Criteria should couple low regret and high leverage 8

9. For Discussion: Core Themes Pragmatic vocabulary –Reduce alternatives in vocabularies –Code subsets that drive 95% of volume and value –Inclusive of laboratory reports, care transitions, public health, quality measures Upgrade from paper to electronic data transmission –Reduce alternatives and increase specificity of data transmission standards –Health Information Exchange –Lab, individual engagement, public health –Major focus on standards for care transitions Down-payment on transport for PCAST, query/retrieve Update NWHIN specifications to include content and transport standards for MU 9

10. VOCABULARY 10

11. For Discussion: Philosophy for Vocabulary Work with HITSC and NLM on pragmatic subsets for –Problems –Medications and medication reactions/allergies –Results Constrain for success –Converge to a single vocabulary for a particular purpose –Focus on ambulatory domain, quality reporting and public health –Focus on interoperability only, not internal representation –Work to address 95% most commonly used elements and certify on that 95% subset –Certify on ability to consume data where EHR does not understand the code Name the standard in rulemaking, “late bind” the 95% subset in testing 11

12. UPGRADE TO ELECTRONIC 12

13. For Discussion: Core specifications needed Directed Exchange Bundle –Transport –Certificates –Directories Lab Results –Ambulatory results IG –Associated vocabulary Public Health (ELR, VXU/Q/R, reportable conditions) –Refined IGs + vocabulary subsets 13

14. For Discussion: Core Specifications Needed Transitions of Care –Directed Exchange –Content vocabularies for Medications Medication reactions/allergies Problems Results –Common content sections + transition specific content sections –Refinement/updates to existing content standards Include the individual (publish to PCHR as core transition) 14

15. DOWNPAYMENT ON THE FUTURE 15

16. For Discussion: Query/Retrieve, PCAST Need to explore “low regret” standards for future information exchange needs to support innovation and a learning healthcare system Candidates include: –Synchronous secure transport (e.g., SOAP + TLS + WS-Security and HTTP + TLS + OAuth2) –Subset of current NWHIN specifications for exchange –Metadata for a universal exchange language derived from existing exchange standards –Distributed queries to support risk adjustment, quality reporting, public health 16

17. DISCUSSION 17