HIT Standards Committee
Meeting
Wednesday, June 30, 2010
9:00 am ET
Agenda     Call to Order




1. Call to Order
      – Judy Sparrow, Office of the National Coordinator for Health
        ...
Agenda     Opening Remarks




1.    Call to Order

2. Opening Remarks
      – David Blumenthal, MD, MPP, National Coordin...
Agenda     Review of Agenda




1.    Call to Order
2.    Opening Remarks

3. Review of the Agenda
      – Jonathan Perlin...
Agenda     John Halamka




1.    Call to Order
2.    Opening Remarks

3. Review of the Agenda
      – John Halamka, ONC
4...
Agenda     ONC Update: NHIN Direct; Framework; Concept of Operations




1.    Call to Order
2.    Opening Remarks
3.    R...
Standards & Interoperability
                        Framework ConOps Overview:
                        How to operational...
Outline


»   The need for the S&I Framework
»   S&I Framework and NIEM
»   Process Overview
»   Roles and Key Artifacts
»...
The Need for an S&I Framework


• Managing the Lifecycle : There needs to be a controlled way to
manage all the activities...
S&I ConOps Organizing Principles

• Representative Participation:
       • ONC Strategic Plan affirms that this diversity ...
Mapping S&I Framework to NIEM




          Scenario               Map &     Assemble &
          Planning               M...
S&I NIEM Process Outline

Biz scenarios identified
by:                                           Publish IEPDs
• Health co...
Coordinating Iterative and Incremental S&I
Processes
• Not a “waterfall” Process: Developing and harmonizing
standards and...
S& I Overview of Roles and Controls


                                      Core artifacts
                               ...
Prioritization and Backlog Lists


                                      Strategic
                                      P...
Stakeholder coordination




   HITPC                   HIT SC


    VLER                    VLER


  NHIN CC             ...
NHIN Direct Example

 J            J         A     S               O           N               D               J          ...
NHIN Direct Project Consensus Proposal


» Currently in consensus process
   • Implementation group contains 60+ organizat...
NHIN Direct Project Consensus Proposal


» Supports SMTP + S/MIME as the minimum backbone
  protocol
   • Universal addres...
RFC 5322      Source HISP                   Destination HISP
    Headers + DNS
                         Locate
           ...
Where Next?


» Continued collaboration with HIT Policy Committee and HIT Standards
  Committee
   • Vetting of the consen...
Agenda     NHIN Governance




1.    Call to Order
2.    Opening Remarks
3.    Review of the Agenda
4.    ONC Update: NHIN...
HIT Standards Committee Meeting

Nationwide Health Information Network
Governance


June 30, 2010


                      ...
Current Request For FACA Committee Input
• Help us frame initial request for public input on
  nationwide health informati...
Background and Purpose of Rule Making
• HITECH directed the National Coordinator to “establish a
  governance mechanism fo...
Scope of Rulemaking for Nationwide Health
  Information Network Governance
Identify Governance Requirements in Domains of ...
Scope of Governance

• Should participation or compliance with nationwide
  health information network standards, services...
Business, Policy And Legal Requirements And
Expectations – Key Issues

• When should patient consent be required and for w...
Transparent Oversight – Key Issues

• Is there a role for federal and/or state oversight to
  monitor and address abusive ...
Enforcement and Accountability – Key Issues

• Should there be a certification or accreditation program
  for intermediari...
Identity Assurance – Key Issues

• Should there be identity assurance requirements for:
   – Provider access to clinical i...
Technical Requirements – Key Issues

• Do we need additional testing and oversight to assure
  participant conformance wit...
Discussion
Agenda     Tiger Team Update




1.    Call to Order
2.    Opening Remarks
3.    Review of the Agenda
4.    ONC Update: NH...
HIT Standards Committee
Privacy & Security Tiger Team Update


Deven McGraw, Co-Chair
Center for Democracy & Technology

P...
Broad Charge

 •   The Office of the National Coordinator for Health Information
     Technology (ONC) formed a Privacy & ...
Tiger Team Members

•   Deven McGraw, Center for Democracy & Technology, Co-Chair
•   Paul Egerman, Co-Chair
•   Dixie Bak...
Proposed Schedule of Topics

        June                    July                  August

• Organize Team        • Contin...
Message Handling in Directed Exchange

• What are the policy guardrails for message handling in Directed
  Exchange?

• Wh...
Categories of Message Handling

To frame the discussion, message handling has been classified into four
   categories:

A....
Recommendations

•   Unencrypted PHI exposure to an intermediary in any amount raises privacy
    concerns.

•   Fewer pri...
Establishing Exchange Credentials

We also addressed the question of whether establishing exchange “credentials”
  should ...
Discussion Regarding “NHIN Direct” Project

• The basic technical model for NHIN Direct should not
  involve intermediary ...
Agenda     Enrollment W G Update




1.    Call to Order
2.    Opening Remarks
3.    Review of the Agenda
4.    ONC Update...
HIT Policy & Standards Committees
Enrollment Workgroup

Aneesh Chopra, Chair
Chief Technology Officer, OSTP

Sam Karp, Co-...
Workgroup Members
Chair: Aneesh Chopra, Federal CTO
Co-Chair: Sam Karp, California Healthcare Foundation
Members:         ...
Section 1561 of Affordable Care Act

  1561. HIT Enrollment, Standards and Protocols. Not
   later than 180 days after the...
Enrollment Workgroup Charge

 • Inventory of standards in use, identification of gap,
   recommendations for candidate sta...
Potential Deliverables

 1. Inventory of standards-based data exchange in use
    today to enroll in health and human serv...
Potential Candidate Standards

• Core data elements
      • Name, address, residence, income, citizenship, etc.


• Messag...
Standards Requirements

 We need to conceptualize standards that might be useful
  and work across a variety of use cases ...
Draft Policy Principles - Reprise

 Standards and technologies must support and be in service to
    our policy goals:
 • ...
Draft Standards Principles - Reprise
•   Keep it simple - Think big, but start small. Recommend standards as
    minimal a...
Base Use Case – Draft – Under Discussion

Consumer-facing web portal that allows applicants to:
    » Identify available s...
This Base Use Case Supports Several Eligibility and
Enrollment Scenarios in 2014 – Draft Under Discussion
Makes recommenda...
Medicaid MAGI, MA,
                                      Exchange, State systems

                                        ...
Agenda      Clinical Quality W G Update




1.    Call to Order
2.    Opening Remarks
3.    Review of the Agenda
4.    ONC...
HIT Standards Committee
Quality Workgroup

Next Steps:
Quality Measures for 2013
Janet Corrigan, Chair
National Quality Fo...
Clinical Quality Workgroup Members

•   Janet Corrigan, Chair, National Quality Forum
•   Floyd Eisenberg, National Qualit...
Presentation at a Glance


•    Update on Retooling of Potential 2011 MU Measures

•    Results of the ONC Environmental S...
Measure Retooling Update
    Measure Retooling Update




• 44 Ambulatory Measures
• Use the Quality Data Set to identify ...
ONC Environmental Scan

Scan of 12 leading healthcare systems
Responses from 9 organizations:            ONC Environmental...
ONC Environmental Scan                              Table 1 – Environmental Scan




        Condition /
   Cross-Cutting ...
ONC Environmental Scan                                     Table 2 – Environmental Scan




      Condition /
   Cross-Cut...
ONC Environmental Scan                                   Table 3 – Environmental Scan




     Condition /
  Cross-Cutting...
ONC Environmental Scan                                          Table 4 – Environmental Scan




     Condition /
  Cross-...
NQF Fast Track Project – Two Objectives

1. Identify “types of measures” that might be appropriate for
   2013 with input ...
Next Step

•   NQF Report due July 2010

•   Intended to

    o Inform Policy Committee’s September discussions
      aime...
Agenda     Clinical Operations W G




1.    Call to Order
2.    Opening Remarks
3.    Review of the Agenda
4.    ONC Upda...
HIT Standards Committee
Clinical Operations Workgroup
Workgroup Update

Jamie Ferguson
Kaiser Permanente


John Halamka
Ha...
Problem Statement

• Implementers of CCR and CCD for transfers of care
  also need other standard document types, e.g.,:
 ...
Review: CCR and CCD

A CCD based document


CCD: A collection of templates representing core content for
healthcare summar...
Extending And Reusing Existing Templates In
                                    Other Documents


                        ...
Discussion points



• We plan to make recommendations to the Standards
  Harmonization entity as outlined in the Concept ...
Discussion points, continued

• Must enable more documents and reuse existing work

• May also recommend this direction fo...
Next Steps


• Seek HIT Standards Committee input

• Continue Workgroup discussions to create future
  recommendations to ...
Agenda     ONC Update: Temp Certification Program




1.    Call to Order
2.    Opening Remarks
3.    Review of the Agenda...
Steve/Carol




              HIT Standards Committee
              Temporary Certification Program

              Steve P...
Adjourn




Meeting Adjourned
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HITSC 2010 06-30 slides

  1. 1. HIT Standards Committee Meeting Wednesday, June 30, 2010 9:00 am ET
  2. 2. Agenda Call to Order 1. Call to Order – Judy Sparrow, Office of the National Coordinator for Health Information Technology 2. Opening Remarks 3. Review of the Agenda 4. ONC Update: NHIN Direct Specifications; Standards & Interoperability Framework; Concept of Operations 5. NHIN Governance 6. Lunch 7. Privacy & Security Tiger Team Update 8. Enrollment Workgroup Update 9. Clinical Quality Workgroup Update on Survey 10. Clinical Operations Workgroup: Electronic Document Standards for Discharge Summary & Other Encounter Summaries 11. ONC Update: Temporary Certification Program 12. Public Comment 13. Adjourn
  3. 3. Agenda Opening Remarks 1. Call to Order 2. Opening Remarks – David Blumenthal, MD, MPP, National Coordinator for Health Information Technology 3. Review of the Agenda 4. ONC Update: NHIN Direct Specifications; Standards & Interoperability Framework; Concept of Operations 5. NHIN Governance 6. Lunch 7. Privacy & Security Tiger Team Update 8. Enrollment Workgroup Update 9. Clinical Quality Workgroup Update on Survey 10. Clinical Operations Workgroup: Electronic Document Standards for Discharge Summary & Other Encounter Summaries 11. ONC Update: Temporary Certification Program 12. Public Comment 13. Adjourn
  4. 4. Agenda Review of Agenda 1. Call to Order 2. Opening Remarks 3. Review of the Agenda – Jonathan Perlin, Chair 4. ONC Update: NHIN Direct Specifications; Standards & Interoperability Framework; Concept of Operations 5. NHIN Governance 6. Lunch 7. Privacy & Security Tiger Team Update 8. Enrollment Workgroup Update 9. Clinical Quality Workgroup Update on Survey 10. Clinical Operations Workgroup: Electronic Document Standards for Discharge Summary & Other Encounter Summaries 11. ONC Update: Temporary Certification Program 12. Public Comment 13. Adjourn
  5. 5. Agenda John Halamka 1. Call to Order 2. Opening Remarks 3. Review of the Agenda – John Halamka, ONC 4. ONC Update: NHIN Direct Specifications; Standards & Interoperability Framework; Concept of Operations 5. NHIN Governance 6. Lunch 7. Privacy & Security Tiger Team Update 8. Enrollment Workgroup Update 9. Clinical Quality Workgroup Update on Survey 10. Clinical Operations Workgroup: Electronic Document Standards for Discharge Summary & Other Encounter Summaries 11. ONC Update: Temporary Certification Program 12. Public Comment 13. Adjourn
  6. 6. Agenda ONC Update: NHIN Direct; Framework; Concept of Operations 1. Call to Order 2. Opening Remarks 3. Review of the Agenda 4. ONC Update: NHIN Direct Specifications; Standards & Interoperability Framework; Concept of Operations – Arien Malec, ONC – Doug Fridsma, ONC 5. NHIN Governance 6. Lunch 7. Privacy & Security Tiger Team Update 8. Enrollment Workgroup Update 9. Clinical Quality Workgroup Update on Survey 10. Clinical Operations Workgroup: Electronic Document Standards for Discharge Summary & Other Encounter Summaries 11. ONC Update: Temporary Certification Program 12. Public Comment 13. Adjourn
  7. 7. Standards & Interoperability Framework ConOps Overview: How to operationally deliver on the vision of the framework HHS – ONC June 30, 2010 Doug Fridsma Acting Director, Office of Interoperability and Standards ONC 7
  8. 8. Outline » The need for the S&I Framework » S&I Framework and NIEM » Process Overview » Roles and Key Artifacts » Coordination 6/30/2010
  9. 9. The Need for an S&I Framework • Managing the Lifecycle : There needs to be a controlled way to manage all the activities within the standards and interoperability activities from identification of a needed capability to implementation and operations • Reuse: Standards development and harmonization efforts need to accommodate multiple stakeholders and business scenarios so as to ensure reuse across many communities. • Semantic Discipline: The work products need to be developed in a way to ensure computability and traceability throughout the entire lifecycle. 6/30/2010
  10. 10. S&I ConOps Organizing Principles • Representative Participation: • ONC Strategic Plan affirms that this diversity is purposeful and should be encouraged. • Framework needs to elicit capabilities and verify specifications, standards and guidelines across a broad range of stakeholders and communities. • Transparency and Openness: • Need to established trust in the framework processes. • Transparency and Openness of activities and work products will engender trust in the process. •Responsive: • Wide-scale, multi-community interoperability efforts can suffer agility due to scale. • The framework must ensure timely attention in addressing emerging issues while remaining flexible enough to accommodate planned activities. •Accountability: •While all work is collaborative, the framework must assign accountable roles for delivery of key artifacts. •Measureable and Planned Results: • One objective of the framework is to build the factory that can achieve milestones and make predictable progress in producing standards and specification. • The framework should measure schedules, level of effort, and other metrics in establishing and improving framework processes 6/30/2010
  11. 11. Mapping S&I Framework to NIEM Scenario Map & Assemble & Planning Model Document Analyze Build & Publish & Requirements Analyze Map and Validate Publish and Implement Implement Implementation, testing and Analyze Model Requirement s Requirement certification disciplines are s needed beyond NIEM Add service and behavior specification generation to NIEM 11
  12. 12. S&I NIEM Process Outline Biz scenarios identified by: Publish IEPDs • Health community to repository • ONC Use Case Publish & • Federal agencies Development Publish Implement Document in wiki Scenario • Business scenario • Use cases Planning Emergence Testing & Pilot Certification Elaborate tech and business requirements for Prioritize Continuous exchange Feedback • Generate IEPDs Identify relevant Implementation RI from UML model standards and Analyze Specifications • Package all gaps artifacts for Requirements IEPDs Assemble & Harmonize Document Standards Generate implementable Map & Model code from model Develop Build & Validate computable UML model for content and/or transactions = Governance = NIEM IEPD Decision = S&I Activity 12 Lifecycle Phase
  13. 13. Coordinating Iterative and Incremental S&I Processes • Not a “waterfall” Process: Developing and harmonizing standards and service specifications across diverse communities necessitates concurrent, agile activities, not waterfall processes •Need for Structured Coordination: To manage coordination of the concurrent activities within the framework , we need well defined: • Artifacts • Roles • Decisions (Control Points) •Artifacts: To support the requirement of computable and traceable resultant artifacts, the S&I framework needs ensure the content and structure of the artifacts within the process are well defined and provide continuity within the activities and the tools. •Roles: Clear “ownership” of significant artifacts and activities must be assigned to ensure coordination, lack of duplication and discontinuity throughout the process. An example of this is the Use Case Stewart, but there are additional roles throughout the process. •Control Points: At points in an iterative and incremental process, prioritization, validation or approval of artifacts is required to ensure quality and alignment with goals. These points, and the approval entities need to be well defined for the framework to operate smoothly. 6/30/2010
  14. 14. S& I Overview of Roles and Controls Core artifacts are versioned and controlled Artifacts are “packaged” and released Each artifacts has a responsible role Artifacts and releases have prioritization and approval points, or “controls” 6/30/2010
  15. 15. Prioritization and Backlog Lists Strategic Priorities Operational Priorities “Day to Day” Priorities within each functional team 6/30/2010
  16. 16. Stakeholder coordination HITPC HIT SC VLER VLER NHIN CC NHIN TC FHA FHA 6/30/2010
  17. 17. NHIN Direct Example J J A S O N D J F M A M J J A S O N S&I and HITSC NHIN Direct Activities Implementation Reference Pilot Demonstration Specifications Implementation Projects Standards Development NHIN Inclusion HIT Standards Committee Review Activities Evaluation Use Case Development Harmonization of Implementation Reference Certification and Functional Requirements Core Concepts (NIEM framework) Specifications Implementation and Testing Other Standards Governance Evaluations Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) HITPC Activities HITPC P&S Tiger Team Policy Framework HITPC + HITSC Specification Policy Review
  18. 18. NHIN Direct Project Consensus Proposal » Currently in consensus process • Implementation group contains 60+ organizations representing – Providers (small, large) – Federal partners, State and Regional HIOs – EHR, PHR, HIE and national network organizations serving a variety of markets » Lessons learned: • Strong support for services that “meet providers where they are” and offer an upward migration path to comprehensive interoperability • Strong support for IHE profiled SOAP services by EHR and HIE technology vendors of all sizes and target markets • Existing health care standards need work to be policy neutral for these uses 6/30/2010
  19. 19. NHIN Direct Project Consensus Proposal » Supports SMTP + S/MIME as the minimum backbone protocol • Universal addressing • Secure transport of health information • Separation of address metadata from content metadata » Endorses use of strong content metadata » Supports XDR for existing and future NHIN Exchange participants » Encourages development of exchanges that support both SMTP and a modified XDR specification to support a bridge to NHIN Exchange 6/30/2010
  20. 20. RFC 5322 Source HISP Destination HISP Headers + DNS Locate Destination (s) SMTP + MIME (+XDM) S/MIME S/MIME Sign Verify POP/IMAP + SMTP + Reject TLS MIME S/MIME S/MIME (+XDM) Encrypt Decrypt SMTP + S/MIME SMTP + TLS SMTP Hold (encrypted) + Content S/MIM E SMTP + Send Receive TLS
  21. 21. Where Next? » Continued collaboration with HIT Policy Committee and HIT Standards Committee • Vetting of the consensus specifications against policy guidelines • Continued development of privacy and security policy framework » Detailed project work on: • Documentation and Testing • Security and Risk Analysis • Open Source Reference Implementation • Early Implementation Geographies » Work with IHE to modify XDR specification to better meet policy guidelines and usage needs 6/30/2010
  22. 22. Agenda NHIN Governance 1. Call to Order 2. Opening Remarks 3. Review of the Agenda 4. ONC Update: NHIN Direct Specifications; Standards & Interoperability Framework; Concept of Operations 5. NHIN Governance – Mary Jo Deering, ONC 6. Lunch 7. Privacy & Security Tiger Team Update 8. Enrollment Workgroup Update 9. Clinical Quality Workgroup Update on Survey 10. Clinical Operations Workgroup: Electronic Document Standards for Discharge Summary & Other Encounter Summaries 11. ONC Update: Temporary Certification Program 12. Public Comment 13. Adjourn
  23. 23. HIT Standards Committee Meeting Nationwide Health Information Network Governance June 30, 2010 Mary Jo Deering, PhD ONC, Office of Policy and Planning NHIN Policy and Governance Maryjo.deering@hhs.gov
  24. 24. Current Request For FACA Committee Input • Help us frame initial request for public input on nationwide health information network governance: what issues and questions should be included? – HITPC June 25, 2010: Guidance on governance for NHIN policies and services – HITSC June 30, 2010: Guidance on governance for NHIN standards • The slides that follow reflect our experiences and preliminary analysis • We have identified possible questions whose answers will shape the NPRM • We will be seeking additional input from the HITSC and HITPC in September to develop the NPRM
  25. 25. Background and Purpose of Rule Making • HITECH directed the National Coordinator to “establish a governance mechanism for the nationwide health information network.” – To be accomplished by rulemaking • Rulemaking would establish foundational policies and structures which would: – Engender trust – Assure effectiveness – Meet or exceed consumer expectations – facilitate use of the nationwide health information network • Recognize that some governance is in place (e.g., HIPAA Privacy and Security Rules); identify where complementary governance mechanisms are necessary for evolving nationwide health information network.
  26. 26. Scope of Rulemaking for Nationwide Health Information Network Governance Identify Governance Requirements in Domains of the HIE Trust Framework • Agreed Upon Business, Policy and Legal Requirements: All participants will abide by an agreed upon a set of rules, including (but not necessarily limited to) compliance with applicable law and act in a way that protects the privacy and security of the information and is in accordance with consumer/patient expectations. • Transparent Oversight : Oversight of the exchange activities to assure compliance. Oversight should be as transparent as possible. • Enforcement and Accountability: Each participant must accept responsibility for its exchange activities and answer for adverse consequences. • Identity Assurance: All participants need to be confident they are exchanging information with whom they intend and that this is verified as part of the information exchange activities. • Technical Requirements: All participants agree to comply with some minimum technical requirements necessary for the exchange to occur reliably and securely.
  27. 27. Scope of Governance • Should participation or compliance with nationwide health information network standards, services and policies (or a subset) be: – Optional – Preferred – “seal of approval”/nationwide health information network brand – Mandatory • How and where should governance apply? • What are appropriate levers of governance? – When should they be applied? – Under what conditions?
  28. 28. Business, Policy And Legal Requirements And Expectations – Key Issues • When should patient consent be required and for what? – Populate RLS – Disclose/reuse PHI – More granular (e.g. particular data elements) • What requirements are necessary to assure data integrity and quality? • Should requirements (for consent, data use, etc.) vary by exchange model? – Exchange participants (query and lookup) – Directed secure routing (known endpoints) • How should we specify appropriate purposes for using, exchanging and reusing data and minimize data required for transactions?
  29. 29. Transparent Oversight – Key Issues • Is there a role for federal and/or state oversight to monitor and address abusive market behaviors? • Is there a need for a federal mechanism of oversight over information exchange organizations? • What are the appropriate federal and state roles? • How can transparency and open processes be assured for setting nationwide health information network policies and technical requirements? • How can transparency, oversight and accountability be assured for the nationwide health information network (e.g., auditing and alert capabilities, patient access, correction, redress)?
  30. 30. Enforcement and Accountability – Key Issues • Should there be a certification or accreditation program for intermediaries (e.g., HISPs) or participants (e.g., Exchange)? If so: – Key roles for certifying / accrediting body – Certification / accreditation requirements – Limits of certification / accreditation • What other types of enforcement and accountability measures should be considered? – Regulatory requirements – Contractual mechanisms (with federal government, between participants)
  31. 31. Identity Assurance – Key Issues • Should there be identity assurance requirements for: – Provider access to clinical information systems/data? – Patient/consumer access? – For participation in nationwide health information network transactions? • Should there be mechanisms to validate identity assurance processes and mechanisms, e.g., certification or accreditation?
  32. 32. Technical Requirements – Key Issues • Do we need additional testing and oversight to assure participant conformance with nationwide health information network technical requirements? Potential mechanisms: – Threshold for exchanging with federal agencies/government contracts – Certification/meaningful use – Government identifying best practices • What level of interoperability in the nationwide health information network is required to meet policy goals?
  33. 33. Discussion
  34. 34. Agenda Tiger Team Update 1. Call to Order 2. Opening Remarks 3. Review of the Agenda 4. ONC Update: NHIN Direct Specifications; Standards & Interoperability Framework; Concept of Operations 5. NHIN Governance 6. Lunch 7. Privacy & Security Tiger Team Update – Deven McGraw, Chair 8. Enrollment Workgroup Update 9. Clinical Quality Workgroup Update on Survey 10. Clinical Operations Workgroup: Electronic Document Standards for Discharge Summary & Other Encounter Summaries 11. ONC Update: Temporary Certification Program 12. Public Comment 13. Adjourn
  35. 35. HIT Standards Committee Privacy & Security Tiger Team Update Deven McGraw, Co-Chair Center for Democracy & Technology Paul Egerman, Co-Chair June 30, 2010
  36. 36. Broad Charge • The Office of the National Coordinator for Health Information Technology (ONC) formed a Privacy & Security Tiger Team under the auspices of the HIT Policy Committee to address privacy and security issues related to health information exchange that must be resolved over the summer. • Members of the Tiger Team are comprised of individuals from the HIT Policy Committee and the HIT Standards Committee as well as National Committee on Vital and Health Statistics
  37. 37. Tiger Team Members • Deven McGraw, Center for Democracy & Technology, Co-Chair • Paul Egerman, Co-Chair • Dixie Baker, SAIC • Christine Bechtel, National Partnership for Women & Families • Rachel Block, NYS Department of Health • Neil Calman, The Institute for Family Health • Carol Diamond, Markle Foundation • Judy Faulkner, EPIC Systems Corp. • Gayle Harrell, Consumer Representative/Florida • John Houston, University of Pittsburgh Medical Center; NCVHS • David Lansky, Pacific Business Group on Health • David McCallie, Cerner Corp. • Wes Rishel, Gartner • Micky Tripathi, Massachusetts eHealth Collaborative • Latanya Sweeney, Carnegie Mellon University
  38. 38. Proposed Schedule of Topics June July August • Organize Team • Continue Directed • Governance • Address issues of Exchange • Final Report to message handling • Develop policy Policy Committee in Directed framework for other on August 19 Exchange HIO models • Report to Policy • Address issues of: Committee on June • Consumer 25 Choice/Consent • Consumer Choice • Sensitive Data Technology Hearing • Interstate on 6/29 Exchange • Report to Policy Committee on July 21
  39. 39. Message Handling in Directed Exchange • What are the policy guardrails for message handling in Directed Exchange? • Who is responsible for establishing “trust” when messages are sent? – The terms “message handling” and “directed exchange” refer to transporting patient data from one known provider to another where both providers are directly involved in the care of the patient who is the subject of the information. We assume communication channels are encrypted.
  40. 40. Categories of Message Handling To frame the discussion, message handling has been classified into four categories: A. No intermediary involved (exchange is direct from message originator to message recipient) B. Intermediary only performs routing and has no access to unencrypted PHI (message body is encrypted and intermediary does not access unencrypted patient identification data) C. Intermediary has access to unencrypted PHI (i.e., patient is identifiable) - but does not change the data in the message body) D. Intermediary opens message and changes the message body (format and/or data)
  41. 41. Recommendations • Unencrypted PHI exposure to an intermediary in any amount raises privacy concerns. • Fewer privacy concerns for directed exchange are found in models A and B above, where no unencrypted PHI is exposed. • Models C and D involve intermediary access to unencrypted PHI, introducing privacy and safety concerns related to the intermediary’s ability to view and/or modify data. Clear policies are needed to limit retention of PHI and restrict its use and re-use. • Our team may make further privacy policy recommendations concerning retention and reuse of data, Model D also should be required to make commitments regarding accuracy and quality of data transformation. • Intermediaries who collect and retain audit trails of messages that include unencrypted PHI should also be subject to policy constraints. • Intermediaries that support Models C and D require contractual arrangements with the message originators in the form of Business Associate agreements that set forth applicable policies and commitments and obligations.
  42. 42. Establishing Exchange Credentials We also addressed the question of whether establishing exchange “credentials” should be centralized or decentralized (i.e., who holds the “trust”?) • The responsibility for maintaining the privacy and security of a patient's record rests with the patient's providers. For functions like issuing digital credentials or verifying provider identity, providers may delegate that authority to authorized credentialing service providers. • To provide physicians and hospitals (and the public) with some reassurance that this credentialing responsibility is being delegated to a “trustworthy” organization, the federal government (ONC) has a role in establishing and enforcing clear requirements and policies about the credentialing process, which must include a requirement to validate the identity of the organization or individual requesting a credential. • State governments can, at their option, also provide additional rules for these authorized credentialing service providers.
  43. 43. Discussion Regarding “NHIN Direct” Project • The basic technical model for NHIN Direct should not involve intermediary access to unencrypted PHI (i.e., models A and B above). • HHS should develop regulations, guidance and/or best practices to promote greater transparency to patients about direct electronic exchange of health information. – Regional Extension centers should also play a role in helping providers to be transparent to patients about direct electronic exchange using this model.
  44. 44. Agenda Enrollment W G Update 1. Call to Order 2. Opening Remarks 3. Review of the Agenda 4. ONC Update: NHIN Direct Specifications; Standards & Interoperability Framework; Concept of Operations 5. NHIN Governance 6. Lunch 7. Privacy & Security Tiger Team Update 8. Enrollment Workgroup Update – Aneesh Chopra, Chair – Sam Karp, Co-Chair 9. Clinical Quality Workgroup Update on Survey 10. Clinical Operations Workgroup: Electronic Document Standards for Discharge Summary & Other Encounter Summaries 11. ONC Update: Temporary Certification Program 12. Public Comment 13. Adjourn
  45. 45. HIT Policy & Standards Committees Enrollment Workgroup Aneesh Chopra, Chair Chief Technology Officer, OSTP Sam Karp, Co-Chair California Healthcare Foundation June 30, 2010
  46. 46. Workgroup Members Chair: Aneesh Chopra, Federal CTO Co-Chair: Sam Karp, California Healthcare Foundation Members: Ex Officio/Federal: • Cris Ross SureScripts Sharon Parrott, O/S, HHS • James Borland Social Security Administration Nancy DeLew, HHS • Jessica Shahin U.S. Department of Agriculture Penny Thompson, CMS/HHS • Stacy Dean Center on Budget & Policy Priorities Henry Chao, CMS/HHS • Steve Fletcher CIO, Utah Gary Glickman, OMB • Reed V. Tuckson UnitedHealth Group John Galloway, OMB • Ronan Rooney Curam David Hale, NIH • Rob Restuccia Community Catalyst Paul Swanenberg, SSA • Ruth Kennedy Louisiana Medicaid Department David Hansell, Administration for • Ray Baxter Kaiser Permanente Children & Families, HHS • Deborah Bachrach Consultant Julie Rushin, IRS • Paul Egerman Businessman Farzad Mostashari, ONC • Gopal Khanna CIO, Minnesota Doug Fridsma, ONC • Bill Oates CIO, City of Boston Claudia Williams, ONC • Anne Castro Blue Cross/Blue Shield South Carolina • Oren Michels Mashery • Wilfried Schobeiri InTake1 • Bryan Sivak CTO, Washington, DC • Terri Shaw Children’s Partnership • Elizabeth Royal SEIU • Sallie Milam West Virginia, Chief Privacy Officer • Dave Molchany Deputy County Executive, Fairfax County
  47. 47. Section 1561 of Affordable Care Act 1561. HIT Enrollment, Standards and Protocols. Not later than 180 days after the enactment, the Secretary, in consultation with the HIT Policy and Standards Committees, shall develop interoperable and secure standards and protocols that facilitate enrollment in Federal and State health and human services programs through methods that include providing individuals and authorized 3rd parties notification of eligibility and verification of eligibility.
  48. 48. Enrollment Workgroup Charge • Inventory of standards in use, identification of gap, recommendations for candidate standards for federal and state health and human service programs in following areas: – Electronic matching across state and Federal data – Retrieval and submission of electronic documentation for verification – Reuse of eligibility information – Capability for individuals to maintain eligibility information online – Notification of eligibility
  49. 49. Potential Deliverables 1. Inventory of standards-based data exchange in use today to enroll in health and human services 2. Candidate standards for data elements and messaging 3. Proposed process to fill in gaps to rapidly turn "requirements" into working prototypes/live implementations to deliver world class eligibility and enrollment services
  50. 50. Potential Candidate Standards • Core data elements • Name, address, residence, income, citizenship, etc. • Messaging • Checking eligibility and enrollment • Consumer matching across systems • Retrieving and sending “packages” of verification information including income, employment, citizenship • Communicating enrollment information • Privacy and security • Secure transport • Authentication
  51. 51. Standards Requirements We need to conceptualize standards that might be useful and work across a variety of use cases or architectures which might include: • Front end user-facing consumer portal* to conduct initial eligibility checks and obtain and forward verification information • Comprehensive eligibility system for Health and Human Services programs • State or Federal exchange portals * online, mail and telephone based systems
  52. 52. Draft Policy Principles - Reprise Standards and technologies must support and be in service to our policy goals: • Consumer at the center • Make enrollment process less burdensome; simplify eligibility process and make it seamless • Enter/obtain information once, reuse for other purposes • Make it easier for consumers to move between programs • Focus on 2014 world
  53. 53. Draft Standards Principles - Reprise • Keep it simple - Think big, but start small. Recommend standards as minimal as required to support necessary policy objective/business need, and then build as you go. – Don’t rip and replace existing interfaces that are working (e.g., with SSA etc.) – Advance adoption of common standards where proven through use (e.g., 270/271). • Don’t let “perfect” be the enemy of “good enough” Go for the 80 percent that everyone can agree on. – Opportunity to standardize the core, shared data elements across programs. – Cannot represent every desired data element. • Keep the implementation cost as low as possible – May be possible to designate a basic set of services and interfaces that can be built once and used by or incorporated by states. – Opportunity to accelerate move to web services • Do not try to create a one-size-fits-all standard that add burden or complexity to the simple use cases – Opportunity to describe data elements and messaging standards that would be needed regardless of the architecture or precise business rules selected.
  54. 54. Base Use Case – Draft – Under Discussion Consumer-facing web portal that allows applicants to: » Identify available services for which they might be eligible » Conduct initial screening and enrollment checks » Retrieve electronic verification information from outside sources » Determine eligibility or forward eligibility “packet” (screening information and verification information) to programs for final determination » Store and re-use eligibility information
  55. 55. This Base Use Case Supports Several Eligibility and Enrollment Scenarios in 2014 – Draft Under Discussion Makes recommendations more flexible, durable and useful » Scenario One: Exchange portal • Screening, verification and eligibility for 2014 MAGI-eligible group: Medicaid, CHIP and exchange • Send/receive applicant information “packets” with Medicaid » Scenario Two: Medicaid/TANF/SNAP portal • Screening, verification and eligibility for residual Medicaid, TANF, and SNAP. • Send/receive applicant information “packets” with exchange • Re-use eligibility information to screen for other programs » Scenario Three: Combined portal • All of Medicaid, CHIP, Exchange; other combinations
  56. 56. Medicaid MAGI, MA, Exchange, State systems Diagram Check Current 1 2 Enrollment: Initial Check other systems 3 for existing coverage; first Obtain Screening: Applicant match using single identifier, Verification Info: IEVS provides basic probabilistic formula, or Electronically verify other method; then obtain identity, residency, VR demographic info enrollment info citizenship, household size, income, IRS DMV etc. SSA DHS 4b Portal makes State eligibility decision Determine 4 systems Eligibility: Portal Method 4a sends will depend Enrollment eligibility on system 5 packet to capabilities. Notification program Send eligibility info to to Portal other programs Program (human services, etc.) makes eligibility decision 6 Send enrollment information to plans
  57. 57. Agenda Clinical Quality W G Update 1. Call to Order 2. Opening Remarks 3. Review of the Agenda 4. ONC Update: NHIN Direct Specifications; Standards & Interoperability Framework; Concept of Operations 5. NHIN Governance 6. Lunch 7. Privacy & Security Tiger Team Update 8. Enrollment Workgroup Update 9. Clinical Quality Workgroup Update on Survey – Janet Corrigan, Chair – Floyd Eisenberg, Workgroup member 10. Clinical Operations Workgroup: Electronic Document Standards for Discharge Summary & Other Encounter Summaries 11. ONC Update: Temporary Certification Program 12. Public Comment 13. Adjourn
  58. 58. HIT Standards Committee Quality Workgroup Next Steps: Quality Measures for 2013 Janet Corrigan, Chair National Quality Forum Floyd Eisenberg National Quality Forum June 30, 2010
  59. 59. Clinical Quality Workgroup Members • Janet Corrigan, Chair, National Quality Forum • Floyd Eisenberg, National Quality Forum • John Derr, Golden Living, LLC • Judy Murphy, Aurora Health • Marc Overhage, Regenstrief • Rick Stephens, Boeing • James Walker, Geisinger • Jack Corley, HITSP • John Halamka, Harvard Medical School • Walter Suarez, Kaiser Permanente
  60. 60. Presentation at a Glance • Update on Retooling of Potential 2011 MU Measures • Results of the ONC Environmental Scan of Leading Health Systems • Overview of NQF Fast Track Project
  61. 61. Measure Retooling Update Measure Retooling Update • 44 Ambulatory Measures • Use the Quality Data Set to identify data elements • Apply logic in human readable format • Provide lists of codes (value sets) for each data element
  62. 62. ONC Environmental Scan Scan of 12 leading healthcare systems Responses from 9 organizations: ONC Environmental Scan • American Board of Family Medicine • Geisinger Health System • Mayo Clinic • Kaiser Permanente • Aurora Healthcare • Tenet Healthcare • Interim Healthcare • PointRight • National Association of Home Care and Hospice
  63. 63. ONC Environmental Scan Table 1 – Environmental Scan Condition / Cross-Cutting Area Performance Measure* Diabetes HbA1c<7% Diabetic Screen for Peripheral Neuropathy Monitoring HbA1c and LDL in Patients with Diabetes Tobacco use in Diabetic Patients Preventive Services Breast Cancer Screening Colon Cancer Screening Rate Cervical Cancer Screening Rates Flu Vaccination Obesity Weight Management Hypertension High Blood Pressure * Yellow highlighting indicates the measure or a comparable measure is included in the set delivered to HHS.
  64. 64. ONC Environmental Scan Table 2 – Environmental Scan Condition / Cross-Cutting Area Performance Measure Healthcare Associated Decrease Use of Urinary Indwelling Catheters in Infections Patients 65 and Older SCIP-Inf-3 Prophylactic Antibiotics Discontinued Within 24 Hours After Surgery End Time SCIP-Inf-9 Postoperative Urinary Catheter Removal on Post-op Day 1 or 2 Safety Events Total Falls per 1,000 Patient Days Appropriate Use of High Risk Medications High-Risk Pressure Ulcer Prevention and Chronic Care Medication Management Medication Compliance * Yellow highlighting indicates the measure or a comparable measure is included in the set delivered to HHS.
  65. 65. ONC Environmental Scan Table 3 – Environmental Scan Condition / Cross-Cutting Area Performance Measure Patient experience HCAHPS Survey Scores Staffing Nursing Staffing Ratio Nursing Turnover Rates Skilled Nursing Chronic Care (CC) Percent of residents who have moderate to severe pain. Physical Restraints-Chronic Care (CC) Percent of residents with daily physical restraints. Care Transition Re-hospitalization measures Stratification of disposition based on discharge assessment * Yellow highlighting indicates the measure or a comparable measure is included in the set delivered to HHS.
  66. 66. ONC Environmental Scan Table 4 – Environmental Scan Condition / Cross-Cutting Area Performance Measure Home Care Acute Care Hospitalization after Home Health Episodes of Care Improvement in Management of Oral Medications Stabilization in Self Grooming Stabilization in Light Meal Preparation * Yellow highlighting indicates the measure or a comparable measure is included in the set delivered to HHS.
  67. 67. NQF Fast Track Project – Two Objectives 1. Identify “types of measures” that might be appropriate for 2013 with input from: • ONC Environmental scan of health systems • Comments on Potential MU11 Measures • Beacon Communities List of Measures • Gretsky Group • Other 2. Identify pathways to generate the desired types of measures within the requisite time frame: • Appropriate measures available • “Similar” measures available that might be adapted • Measures would need to be developed de novo
  68. 68. Next Step • NQF Report due July 2010 • Intended to o Inform Policy Committee’s September discussions aimed at identifying types of MU measures for 2013 o Identify time-sensitive measure development work that must get underway very quickly o Input to Standards Committee’s Fall work aimed at identifying specific measures available to satisfy Policy Committee’s recommended measure types
  69. 69. Agenda Clinical Operations W G 1. Call to Order 2. Opening Remarks 3. Review of the Agenda 4. ONC Update: NHIN Direct Specifications; Standards & Interoperability Framework; Concept of Operations 5. NHIN Governance 6. Lunch 7. Privacy & Security Tiger Team Update 8. Enrollment Workgroup Update 9. Clinical Quality Workgroup Update on Survey 10.Clinical Operations Workgroup: Electronic Document Standards for Discharge Summary & Other Encounter Summaries – Jamie Ferguson, Chair 11. ONC Update: Temporary Certification Program 12. Public Comment 13. Adjourn
  70. 70. HIT Standards Committee Clinical Operations Workgroup Workgroup Update Jamie Ferguson Kaiser Permanente John Halamka Harvard University 30 June, 2010
  71. 71. Problem Statement • Implementers of CCR and CCD for transfers of care also need other standard document types, e.g.,: – Inpatient Discharge Summary – ED Discharge Summary • These documents may contain specialized content not found in CCR or CCD, e.g.,: – Discharge Diet – Surgery Description – Surgical Operation Note Findings – Estimated Blood Loss – Chief Complaint
  72. 72. Review: CCR and CCD A CCD based document CCD: A collection of templates representing core content for healthcare summary documents with template content from CCR Family History Medications Problems Allergies Social History Vital Signs Payer Demographics .... CDA: A foundation standard enabling the definition of templates for a broad range of healthcare documents
  73. 73. Extending And Reusing Existing Templates In Other Documents A CDA based document compatible with CCD A CCD based document CCD Template content from CCR Chief Complaint Diagnosis Discharge Transport Mode of Surgical Finding New Section… Discharge Diet Family History Medications Problems Allergies Payer Social History Vital Signs Demographics .... CDA Identified by the CCD document ID number Identified by another identifier, e.g., an ED Discharge document ID number
  74. 74. Discussion points • We plan to make recommendations to the Standards Harmonization entity as outlined in the Concept of Operations plan • General direction of WG: Recommend that the process should standardize templated CDA sections to build upon and extend what was done in CCR and CCD • WG direction is consistent with NIST direction for testing
  75. 75. Discussion points, continued • Must enable more documents and reuse existing work • May also recommend this direction for attachments • Identification of complete documents assembled from templates: – A few complete documents might have complete document IDs, e.g., discharge summaries, ambulance services, etc. – Otherwise, a general method for identification should be devised • Embedded or concatenated identifiers would avoid enumerating a combinatorial explosion of complete documents assembled from templates • Coordination of templates with value set standards – E.g.,: value sets for hospital readmission measures could be coordinated with discharge summary template standards
  76. 76. Next Steps • Seek HIT Standards Committee input • Continue Workgroup discussions to create future recommendations to the full Committee
  77. 77. Agenda ONC Update: Temp Certification Program 1. Call to Order 2. Opening Remarks 3. Review of the Agenda 4. ONC Update: NHIN Direct Specifications; Standards & Interoperability Framework; Concept of Operations 5. NHIN Governance 6. Lunch 7. Privacy & Security Tiger Team Update 8. Enrollment Workgroup Update 9. Clinical Quality Workgroup Update on Survey 10. Clinical Operations Workgroup: Electronic Document Standards for Discharge Summary & Other Encounter Summaries 11.ONC Update: Temporary Certification Program – Steve Posnack, ONC – Carol Bean, ONC 12. Public Comment 13. Adjourn
  78. 78. Steve/Carol HIT Standards Committee Temporary Certification Program Steve Posnack, ONC Carol Bean, ONC June 30, 2010
  79. 79. Adjourn Meeting Adjourned

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