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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
        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
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
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
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
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
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
Outline


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




    6/30/2010
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
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
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
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
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
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
Prioritization and Backlog Lists


                                      Strategic
                                      Priorities




                                    Operational
                                     Priorities




                                    “Day to Day”
                                   Priorities within
                                   each functional
                                         team




  6/30/2010
Stakeholder coordination




   HITPC                   HIT SC


    VLER                    VLER


  NHIN CC                  NHIN TC


     FHA                    FHA




 6/30/2010
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
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
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
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
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
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
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
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
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.
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.
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?
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?
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)?
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)
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?
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?
Discussion
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
HIT Standards Committee
Privacy & Security Tiger Team Update


Deven McGraw, Co-Chair
Center for Democracy & Technology

Paul Egerman, Co-Chair


June 30, 2010
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
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
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
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.
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)
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.
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.
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.
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
HIT Policy & Standards Committees
Enrollment Workgroup

Aneesh Chopra, Chair
Chief Technology Officer, OSTP

Sam Karp, Co-Chair
California Healthcare Foundation

June 30, 2010
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
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.
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
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
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
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
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
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.
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
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
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
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
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
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
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
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
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
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.
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.
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.
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.
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
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
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
HIT Standards Committee
Clinical Operations Workgroup
Workgroup Update

Jamie Ferguson
Kaiser Permanente


John Halamka
Harvard University


30 June, 2010
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
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
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
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
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
Next Steps


• Seek HIT Standards Committee input

• Continue Workgroup discussions to create future
  recommendations to the full Committee
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
Steve/Carol




              HIT Standards Committee
              Temporary Certification Program

              Steve Posnack, ONC
              Carol Bean, ONC

              June 30, 2010
Adjourn




Meeting Adjourned

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HITSC 2010 06-30 slides

  • 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. 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. 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. 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. 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. 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. Outline » The need for the S&I Framework » S&I Framework and NIEM » Process Overview » Roles and Key Artifacts » Coordination 6/30/2010
  • 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. 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. 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. 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. 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. 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. Prioritization and Backlog Lists Strategic Priorities Operational Priorities “Day to Day” Priorities within each functional team 6/30/2010
  • 16. Stakeholder coordination HITPC HIT SC VLER VLER NHIN CC NHIN TC FHA FHA 6/30/2010
  • 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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?
  • 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. HIT Standards Committee Privacy & Security Tiger Team Update Deven McGraw, Co-Chair Center for Democracy & Technology Paul Egerman, Co-Chair June 30, 2010
  • 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. 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. 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. 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. 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. 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. 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. 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. 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. HIT Policy & Standards Committees Enrollment Workgroup Aneesh Chopra, Chair Chief Technology Officer, OSTP Sam Karp, Co-Chair California Healthcare Foundation June 30, 2010
  • 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. HIT Standards Committee Clinical Operations Workgroup Workgroup Update Jamie Ferguson Kaiser Permanente John Halamka Harvard University 30 June, 2010
  • 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. 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. 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. 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. 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. Next Steps • Seek HIT Standards Committee input • Continue Workgroup discussions to create future recommendations to the full Committee
  • 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. Steve/Carol HIT Standards Committee Temporary Certification Program Steve Posnack, ONC Carol Bean, ONC June 30, 2010