1. HIT
Standards
Committee
__________
September 21, 2010

2. AGENDA
HIT Standards Committee
September 21, 2010
9:00 a.m. to 2:15 p.m. [Eastern Time]
Washington Marriott Wardman Park Hotel
2660 Woodley Road, NW, Washington, DC
202-328-2000
9:00 a.m. CALL TO ORDER – Judy Sparrow
Office of the National Coordinator for Health Information Technology
9:05 a.m. Opening Remarks – David Blumenthal, National Coordinator for Health IT
9:15 a.m. Review of the Agenda – Jonathan Perlin, Chair
9:30 a.m. Vocabulary Task Force Briefing on Hearing
Jamie Ferguson, Chair
Betsy Humphreys, Co-Chair
10:15 a.m. Implementation Workgroup Update
Judy Murphy, Chair
Liz Johnson, Co-Chair
10:30 a.m. Standards & Interoperability Framework
Doug Fridsma, Office of the National Coordinator
12:30 p.m. LUNCH
1:15 p.m. Setting Priorities
Jonathan Perlin, Chair
Doug Fridsma, ONC
2:00 p.m. Public Comment
2:15 p.m. Adjourn

3. HEALTH INFORMATION TECHNOLOGY (HIT) STANDARDS COMMITTEE
Member Organization
Chair
Jonathan Perlin Hospital Corporation of America
Vice Chair
John Halamka Harvard Medical School
Members
Dixie Baker Science Applications International Corporation
Anne Castro BlueCross BlueShield of South Carolina
Christopher Chute Mayo Clinic College of Medicine
Janet Corrigan National Quality Forum
John Derr Golden Living, LLC
Linda Dillman Wal-Mart Stores, Inc.
James Ferguson Kaiser Permanente
Steven Findlay Consumers Union
Linda Fischetti Department of Veterans Affairs
Douglas Fridsma Arizona State University
C. Martin Harris Cleveland Clinic Foundation
Stanley M. Huff Intermountain Healthcare
Kevin Hutchinson Prematics, Inc.
Elizabeth Johnson Tenet Healthcare Corporation
John Klimek National Council for Prescription Drug Programs
David McCallie, Jr. Cerner Corporation
Judy Murphy Aurora Health Care
J. Marc Overhage Regenstrief Institute
Gina Perez Delaware Health Information Network
Wes Rishel Gartner, Inc.
Richard Stephens The Boeing Company
Sharon Terry Genetic Alliance
James Walker Geisinger Health System
Nancy J. Orvis Director, Health Standards Participation,
Department of Defense
Aneesh Chopra Chief Technology Officer, OSTP
Cita Furlani National Institutes of Standards and Technology

5. Health Information Technology Standards Committee
DRAFT
Summary of the August 30, 2010, Meeting
KEY TOPICS
1. Call to Order
Judy Sparrow, Office of the National Coordinator (ONC), welcomed participants to the 16th
meeting of the HIT Standards Committee (HITSC), which was being conducted virtually. She
reminded the participants that this was a Federal Advisory Committee meeting, with an
opportunity for the public to make comments. Following her opening remarks, she conducted
roll call.
2. Opening Remarks and Review of the Agenda
HITSC Chair Jonathan Perlin also welcomed participants to the meeting and reviewed the
agenda. In his opening remarks, Committee Co-Chair John Halamka noted that the final rule
still stands up well after 2 months of intense inspection. There is one mistake in the rule—the
incorrect version of the syndromic surveillance implementation guide was referenced. He asked
that any Committee members who identify or learn of any inconsistencies or questions about the
final rule to forward these to him, and he will collect and deliver this information.
Action Item #1: Minutes from the last HITSC meeting, held on July 28,
2010, were approved by consensus.
3. Enrollment Workgroup Update
Enrollment Workgroup Co-Chair Sam Karp updated the Committee on the progress of the
Enrollment Workgroup and presented final recommendations for approval. During its last
meeting (held the week prior to this meeting), the HIT Policy Committee (HITPC) reviewed and
approved these recommendations.
The Enrollment Workgroup has held five meetings and established four tiger teams to develop
these recommendations. Doug Fridsma of ONC led an internal team of staff and consultants to
examine the standards development at the state level. The Workgroup held a series of public
hearings and maintained a blog, from which it received public input.
Sam Karp presented the Workgroup’s first recommendation:
Recommendation 1.1: We recommend that federal and state entities administering health
and human services programs use the National Information Exchange Model (NIEM)
guidelines to develop, disseminate, and support standards and processes that enable the
consistent, efficient, and transparent exchange of data elements between programs and states.
HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 1

6. In response to a question from Wes Rishel, Sam Karp explained that the group’s review of the
data elements has led it to believe that it is possible to conduct verification without states having
to change their systems, provided that the output of the 10-12 core data elements conforms with
NIEM exchange guidelines. Doug Fridsma noted that there was fairly good consistency across
all of the agencies with regard to collecting the required data. Some of the variability that was
identified related to business rules.
It was noted that there will be local autonomy for deciding how to use this system to exchange.
The next set of Enrollment Workgroup recommendations were as follows:
Recommendation 2.1: We recommend that federal agencies required by Section 1411 of the
Affordable Care Act (ACA) to share data with states and other entities for verification of an
individual’s initial eligibility, re-certification, and change in circumstances for ACA health
insurance coverage options (including Medicaid and CHIP), use a set of standardized Web
services that could also be used to support such eligibility determinations in other health and
human services programs such as SNAP and TANF.
To accomplish this recommendation, federal and state agencies should provide data
by individual, as opposed to household, to ensure the data can be used in a consumer-
mediated approach.
Recommendation 2.2: We recommend development of a federal reference software model,
implementing standards for obtaining verification of an individual’s initial eligibility, re-
certification and change in circumstances information from federal and state agencies, to
ensure a consistent, cost-effective, and streamlined approach across programs, states, and
community partners.
The initial build of this toolset should include interfaces to the federal agencies
referenced in Recommendation 2.1. In order to ensure comprehensive and timely
verification, additional interfaces to other Federal, State or other widely-available
data sources and tools should be added, including the National Directory of New
Hires, the Electronic Verification of Vital Events Record (EVVE) system, State
Income and Eligibility Verification (IEVS) systems, Public Assistance Reporting
Information System (PARIS), and the U.S. Postal Service Address Standardization
API tool.
In discussion, Wes Rishel noted that a key aspect of this tooling is that it must work with legacy
systems. Most of what is done now is based on JAVA, .net, and other modern systems, and it
will be important for the Committee to determine how to represent the legacy system
implementers. Sam Karp noted that new systems developed in the large states potentially will
have the ability to more easily interface with the exchange being discussed.
Workgroup Chair Aneesh Chopra then presented the next set of recommendations:
Recommendation 3.1: Federal and state agencies should express business rules using a
consistent, technology-neutral standard (e.g., OMG’s SBVR, WC3’s RIF, etc.). Upon
HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 2

7. identification of a consistent standard, federal and state agencies should clearly and
unambiguously express their business rules (outside of the transactional systems).
Recommendation 3.2: To allow for the open and collaborative exchange of information and
innovation, we recommend that the federal government maintain a repository of business
rules needed to administer ACA health insurance programs coverage options (including
Medicaid and CHIP), which may include an open source forum for documenting and
displaying eligibility, entitlement and enrollment business rules to developers who build
systems and the public in standards-based and human-readable formats.
To allow for seamless integration of all health and human services programs, business
rules for other health and human services programs such as SNAP and TANF should
be added to the repository over time.
The Committee’s discussion on these recommendations included the following points:
David McCallie noted that if the NIEM is managing the data element issue in a different
format or system, some of these elements do not have tools available as of yet. This could
lead to multiple independent repositories of information. Aneesh Chopra acknowledged that
this policy issue demonstrates the fact that a common language for this has not yet been
developed. Doug Fridsma noted that the NIEM process works well with data, but it does not
capture such behavioral aspects as business rules and what happens with the data. Work has
been ongoing to expand the functionality of the NIEM process to describe the service and
behavioral aspects for which the rules are going to be a part.
Chris Chute noted that the Business Rules Tiger Team has discussed this issue at length, and
the core view is that business rules cannot exist abstract from a data domain. The
expectation is that the business rules would have a clear cross-representation to the data
model. However, if the data, the program rules, and the deployment were consistent across
states, then there would be no need for business rules. The tiger team was trying to
document a set of rules once for deployment, such that those rules can be used everywhere.
Wes Rishel said that any process that leads an organization to state their business rules in a
way that others can understand would be beneficial.
David McCallie explained that if the goal is to develop a system that is deployable to
multiple environments, then expressing the rules in terms of deployment would mean there
would be almost infinite variations when program differences and state-to-state differences
are layered on.
Aneesh Chopra presented the Enrollment Workgroup’s fourth series of recommendations:
Recommendation 4.1: We recommend using existing Health Insurance Portability and
Accountability Act (HIPAA) standards (e.g., 834, 270, 271) to facilitate transfer of applicant
eligibility, enrollment, and disenrollment information between ACA health insurance
programs, coverage options (including Medicaid and CHIP), public/private health plans, and
other health and human service programs such as SNAP and TANF.
HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 3

8. Recommendation 4.2: We recommend further investigation of existing standards to
acknowledge a health plan’s receipt of an HIPAA 834 transaction and, if necessary,
development of new standards.
Nancy Orvis asked whether there has been a resolution of the issue of key code sets on
identifying a person. Farzad Mostashari replied that this issue has not yet been completely
resolved. Nancy Orvis noted that this represents a significant challenge; if there is still no
compatibility on what the set will be, then some of the hardest work is still to be done. There
cannot be common business rules if there is not a common understanding of what the data is.
Therefore, she suggested, Recommendation 4.2 needs to be stronger than it is, and needs to push
for more work to harmonize the code sets.
Aneesh Chopra then presented the Workgroup’s final set of recommendations, as follows:
Recommendation 5.1: We recommend that consumers have: (1) timely, electronic access to
their eligibility and enrollment data in a format they can use and reuse; (2) knowledge of how
their eligibility and enrollment information will be used, including sharing across programs
to facilitate additional enrollments, and to the extent practicable, control over such uses; and
(3) the ability to request a correction and/or update to such data.
This recommendation builds upon the Health Information Technology for Economic
and Clinical Health (HITECH) Act, which gave consumers the right to obtain an
electronic copy of their protected health information from HIPAA-covered entities,
including health plans and clearinghouses. Additional investigation into format and
content of such disclosures is needed.
Recommendation 5.2: We recommend that the consumer’s ability to designate third-party
access be as specific as feasible regarding authorization to data (e.g., read-only, write-only,
read/write, or read/write/edit), access to data types, access to functions, role permissions, and
ability to further designate third parties. If third-party access is allowed, access should be:
Subject to the granting of separate authentication and/or login processes for third
parties;
Tracked in immutable audit logs designating each specific proxy access and major
activities; and
Time-limited and easily revocable.
Recommendation 5.3: We recommend that state or other entities administering health and
human services programs implement strong security safeguards to ensure the privacy and
security of personally identifiable information. Specifically, we recommend the following
safeguards:
Data in motion should be encrypted. Valid encryption processes for data in motion
are those which comply, as appropriate, with NIST SP 800-52, 800-77, or 800-113, or
others which are Federal Information Processing Standards (FIPS) 140-2 validated.
Automated eligibility systems should have the capability to:
 Record actions related to the PII provided for determining eligibility. The
date, time, client identification, and user identification must be recorded when
HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 4

9. electronic eligibility information is created, modified, deleted, or printed; and
an indication of which action(s) occurred must also be recorded.
 Generate audit logs. Enable a user to generate an audit log for a specific time
period and to sort entries in the audit log.
In Committee discussion, the following points were raised:
Kevin Hutchinson asked for clarification on the definition of a third party as referenced in
Recommendation 5.2. Would a provider of medical care be considered a third party?
Aneesh Chopra provided an example of the type of entity that these recommendations are
considering. The example was a non-profit organization advocating on behalf of a provider
to make sure that it is getting all of the benefits it is entitled to. The intent of
Recommendation 5.2 is that this arrangement be separately maintained, versus having the
organization simply use the provider’s log-in and password.
If the Workgroup’s recommendations are approved, the group will follow up with the
supporting material that is going to be provided in the appendices. The deadline for
completing this work is September 17, to move the material through the internal clearance
process to determine whether the recommendations will be accepted in full or in part and
then promulgated by the Secretary for states to use. The Workgroup recognizes that it is far
from being able to give the definitive implementation guidance that they would like to
provide.
In response to a question about the core data elements, Farzad Mostashari pointed Committee
members to Appendix B, which discusses this topic.
Wes Rishel suggested a line edit to Recommendation 3.1. After the first sentence, he
suggested the wording, “consistent with data standards developed under other
recommendations.”
Dixie Baker suggesting adding a reference to Fair Information Practices in Recommendation
5.1
Carol Diamond commented that it would be beneficial if all of the privacy and security
recommendations were organized within the context of the ONC framework (i.e., the Fair
Information Practices).
Farzad Mostashari said that, in terms of practical edits, this might translate to having a header
section for the privacy and security recommendations that discusses the overall privacy and
security framework and the Fair Information Practices, prior to the specific
recommendations.
Action Item #2: The recommendations of the Enrollment Workgroup
were approved by consensus, with line edits as described (i.e., adding
“consistent with data standards developed under other recommendations”
HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 5

10. to the end of the first sentence in Recommendation 3.1, and adding a
reference to Fair Information Practices in Recommendation 5.1).
4. Privacy and Security Tiger Team Recommendations
Deven McGraw and Paul Egerman presented the Privacy and Security Tiger Team’s
recommendations to the Committee, noting that last week the HITPC accepted these without
modifications. The team has been presenting various components of these recommendations to
the HITSC during previous meetings, and Committee member feedback has been incorporated
into the final product. The Committee received the team’s letter outlining the complete set of
recommendations. Some of the more salient recommendations were discussed during the
meeting.
The team’s overarching recommendation is that all entities involved in health information
exchange—including providers (individual and institutional) and third-party service providers
such as health information organizations (HIOs) and other intermediaries—should follow the full
complement of Fair Information Practices when handling personally identifiable health
information. Each set of recommendations is mapped to applicable Fair Information Practices
Principles.
Deven McGraw and Paul Egerman presented recommendations dealing with intermediaries and
third-party service providers, the trust framework to allow exchange among providers for the
purpose of treating patients, triggers for additional consent, meaningful consent attributes,
consent implementation guidance, and provider choice about participation in exchange models.
In discussion, the following points were made:
On the subject of granularity, Carol Diamond clarified that the team’s previous
recommendations were not necessarily “all or nothing.” If the provider is in control of the
exchange, then the provider and the patient can share some control over which information is
shared. This relates to what technology is used in the sharing.
John Halamka proposed an operational example involving e-prescribing. Checking a
patient’s eligibility is a non-persistent transaction: nothing is deposited in a repository. There
is nothing persistent in a check against the formulary. Then, there is a drug interaction
check, which would imply that the e-prescribing entity had a list of previous transactions.
Medication reconciliation is part of meaningful use, and that crosses the line into persistence.
The challenge here is the notion of achieving consent. There is participation in the
transaction but not the maintenance of history.
Kevin Hutchinson asked about which model would apply to e-prescribing, an HIO model or
a direct exchange model. The information used is not aggregated at a single point and then
delivered. Paul Egerman explained that the trigger for consent would be a place where the
medication profile from multiple providers is kept. If the information can be obtained from
other sources through direct exchange, then there would be no trigger. David McCallie
HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 6

11. added that it is an issue of information control, and not where the information sits. The issue
is what controls are in place to guarantee that the access is appropriate.
Wes Rishel referenced a previous Veterans Health Administration hearing and explained that
one theme that arose from those discussions was that there is a tradeoff between how
granular the consent is and how difficult it is to explain options to the patient. This is part of
the difference between what is technically possible and what is practical.
Jonathan Perlin acknowledged that this is a complex dialog, including new forums that defy
traditional categorization. Additional work may be needed in standards classification of the
entities that are involved in these complex relationships.
5. Standards and Interoperability Framework
John Halamka noted that a series of Requests for Proposals (RFPs) were issued by the ONC, and
this Committee will provide some oversight for the work of the contract winners.
Doug Fridsma said that as they plan their work going forward, continued emphasis on
standardization and need to move towards increasingly computational specification
implementation are needed. Also, a mechanism so that standards can be manipulated by tools is
required. These tools need to be stored in repositories that can be used by those interested in
information exchange. Rather than a set of descriptions that would be difficult to harmonize, it is
important that they are linked from inception all the way through certification, implementation
specifications, and standards that can be tested for certification. This necessitates involving the
National Institute of Standards and Technology (NIST) and other entities early in the process.
The Standards and Interoperability (S&I) Framework is the framework by which the ONC will
manage this work, to promote interoperability and meaningful use. The S&I Framework is not
intended to develop new standards in and of itself, but it will help the ONC to work with health
care organizations throughout the health care community.
In a series of slides, Doug Fridsma explained the S&I Framework, and reviewed the following
characterizations of the 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.
Human consensus: Achieving human consensus is a prerequisite for computable
interoperability
HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 7

12. Within a few weeks, all of the contracts will be in place. Doug Fridsma showed a timeline
illustrating the contracts supporting the network. Contractors awarded so far include Deloitte,
Lockheed, and Stanley. The government will serve as a platform to support the work, creating a
neutral ground.
As part of this effort, there is a need to leverage the HIT community, to take professional
organizations, government agencies, and standards organizations, and ensure that all of their
work comes down to a harmonized set of standards and implementable specifications. The goal
is to solve real problems around meaningful use. The contractors will develop content exchange
standards, transportation standards, nomenclature and value sets, and throughout the process will
ensure that there are privacy and security standards to support the implementation specifications.
The S&I Framework will provide coordination across strategic, operational, and technical issues.
A top-down approach is needed to establish goals and an acceptance process. A bottom-up
method is necessary to involve the standards community.
Committee discussion followed, during which these points were raised:
John Halamka said that previous uses of NIEM framework have been in different kinds of
environments. He raised the possibility that this strategy may not fit into the health care
framework, with its existing infrastructures and platforms. Doug Fridsma acknowledged that
vigilant monitoring will be necessary. The process that NIEM undergoes to develop data
specifications is similar to the processes within other standards organizations, including
CDIP, HL7, and also the National Cancer Institute.
Stan Huff commented that he likes the overall approach and its collaborative nature. He
indicated that he did not have a clear picture of how the interoperability framework interacts
with the formal processes in the other standards development organizations. When a new
standard is needed, it may be possible to rapidly make a new prototype, but does that need to
go to ballot somewhere? Will existing standards organizations be used for this, or will ONC
become an “uber-standards” organization?
Doug Fridsma explained that the goal is to coordinate across all of the different standards-
development organizations (SDOs). The ONC will not serve as an “uber-standards”
organization, and it will not replace the work of SDOs. When impossibly tight timeframes
for standards development occur, it would be useful to have an organization that could come
up with a potential standard and then develop the transfer method, content, vocabulary, etc.
Then, that whole package can be handed to SDOs to make sure that they are appropriately
balloted. As it relates to this work, the government’s job is not to create standards, but to
identify the need for them.
Wes Rishel described a continuum, between SDOs and profiler and enforcer organizations.
The current NHIN Direct operation, for example, is a profiler. It did not define new
standards; rather, it decided how to pick among standards and create interfaces between
them. The Healthcare Information Technology Standards Panel (HITSP) is a profiler. One
of the advantages of the NIEM approach is that it can solve some of the problems that
HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 8

13. profiler organizations can have, but it can only do so if it acquires the right intellectual
property from the SDOs. He suggested that there be some sort of visioning process looking
downstream for standards that will be needed when there is time to actually use the benefits
of an SDO consensus process to obtain a broad perspective on the requirements and possible
solutions.
Doug Fridsma acknowledged that one unresolved issue involves intellectual property and
engagement with SDOs. He hopes that the Committee can provide some guidance in this
area. If solving problems requires multiple different groups to be able to come together and
bring their expertise to the table, it will be important for there to be a comprehensive policy
regarding the engagement of SDOs. They must be able to can contribute to those packages
and still have business models that are able to support the work in which they are engaged.
Nancy Orvis pointed to the business model and financing the maintenance of standards as the
underlying issue. For those who are trying to help as organizational providers or as
government agencies, it can be extremely complicated to determine all of the different levels
to which resources need to be assigned.
Carol Diamond suggested that it is time to operationalize this process. She reminded the
Committee that she has often discussed the interplay between policy and technology in the
formation of standards and implementation guides. Policy needs to be present in a visible
and required manner. Her sense now is that because there has been some progress on
information exchange, and because the ONC framework is in place, that those policies have
to be a part of the contracts that are active. They need to be integrated into the approach in a
very operational way. She commented that it would be detrimental if a situation arose in
which the implementation guide or other items have to be reworked, or the policy objectives
cannot be fulfilled, because the technical work was done out of sync.
Dixie Baker asked whether milestones and metrics have been established for measuring the
process. Doug Fridsma explained that this is one of the first charges of those who are
working on the contracts. Most of the contracts have been awarded within the last 3 weeks,
and there is still time to submit feedback and suggestions.
6. Vocabulary Task Force Update
Vocabulary Task Force Chair Jamie Ferguson shared information about the upcoming September
1 hearing that will be held by the Vocabulary Task Force. He explained that in March, the Task
Force held public hearings to answer questions about the national governance of terminology and
subsets related to meaningful use. A set of resultant recommendations was forwarded to the
National Coordinator. One of the themes that arose during those hearings was the desire for
“one-stop shopping,” to make it easy for implementers to have access to the required vocabulary
value sets and subsets. Therefore, the overall framing of the September 1 hearing is to gain input
and understand what would constitute the right set of requirements for infrastructure that would
provide this one-stop shopping.
HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 9

14. Which of these requirements would have the highest priority for achieving meaningful use?
Other overarching questions guiding the hearing include: what do you think a one-stop shop
means? Which requirements are urgent? What would be a staged approach to creating such an
environment? Each of the 23 panelists will be asked a series of questions relating to their unique
experiences and perspectives. The panelists are divided into four sets: (1) value set developers;
(2) end users, with a focus on clinicians, hospitals, and medical centers; (3) EHR vendors; and
(4) vendors, developers, and implementers of technical services from the commercial and
government sectors.
Jamie Ferguson also noted that the Vocabulary Task Force’s parent group, the Clinical
Operations Workgroup, has been in discussions with Aneesh Chopra regarding the need for
better understanding in terms of standards for remote sensing. Examples include collecting data
on vital statistics in hospital and clinical settings and remote sensor data for home and other
remote settings. The Clinical Operations Workgroup will plan a hearing on this topic.
7. Implementation Workgroup Update
Implementation Workgroup Chair Judy Murphy noted that the group is in transition. The
Workgroup is developing a new member list and expanding its membership to draw in additional
experts who have implementation experience. The Implementation Workgroup has rewritten its
broad charge as follows: “To bring forward real-world implementation experience into the HIT
Standards Committee recommendations, with emphasis on strategies to accelerate the adoption
of proposed standards or mitigate barriers, if any.”
The Implementation Workgroup’s next meeting is scheduled for September 15 and will include
an orientation for new members.
8. Public Comment
David Tau of Siemen explained that his understanding is that the document being prepared by
the ONC to tie together the S&I Framework will explain how the public and vendors can be
engaged. He asked when that document will be made available. Doug Fridsma explained that it
will be difficult to finalize this until all of the contracts have been awarded.
SUMMARY OF ACTION ITEMS
Action Item #1: Minutes from the last HITSC meeting, held on July 28, 2010, were approved
by consensus.
Action Item #2: The recommendations of the Enrollment Workgroup were approved by
consensus, with line edits as described (i.e., adding “consistent with data standards developed
under other recommendations” to the end of the first sentence in Recommendation 3.1, and
adding a reference to Fair Information Practices in Recommendation 5.1).
HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 10

16. HIT Standards Committee
Vocabulary Task Force
Report From Task Force Hearing Sept. 1-2, 2010
Jamie Ferguson
Kaiser Permanente
Betsy Humphreys
National Library of Medicine
21 September, 2010
Vocabulary Task Force Members
Chair Organization Co-Chair Organization
Jamie Ferguson Kaiser Permanente Betsy Humphreys National Library of Medicine
Members
Donald Bechtel Accredited Standards Organization X12
Chris Brancato HHS/ONC
Lisa Carnahan NIST
Christopher Chute Mayo Clinic
Bob Dolin HL7
Greg Downing HHS
Floyd Eisenberg National Quality Forum
Doug Fridsma HHS/ONC
Marjorie Greenberg HHS/CDC
Patricia Greim Veterans Affairs
Amy Gruber CMS
John Halamka Harvard Medical School
Stan Huff Intermountain Healthcare
John Klimek NCPDP
Clem McDonald National Library of Medicine
Stuart Nelson National Library of Medicine
Marc Overhage Regenstrief Institute
Marjorie Rallins American Medical Association
Dan Vreeman Regenstrief Institute
Jim Walker Geisinger
Andrew Wiesenthal IHTSDO (SNOMED)
2
1

17. Review: Subject of Hearing
• General questions:
1. What are the requirements for a centralized infrastructure to
implement “one-stop shopping” for obtaining value sets,
subsets, and vocabularies for meaningful use?
2. Which requirements or functionalities are urgent, i.e.,
absolutely required to support “meaningful use”? Which
would be most useful immediately? What would be a staged
approach over time to get to the desired end state?
• Detailed questions:
– 15 detailed questions addressed the panelists’ operational
experience and views in support of the general questions
3
Review: Structure of Hearing
• Panel 1, Value Set Publishers
• Panel 2, End User Implementers of EHR technology
• Panel 3, EHR Vendors and Canadian Perspectives
• Panel 4, Providers of Terminology Services
• 24 Panelists represented a mix of the public and private sectors
including developers of health measures, standards organizations,
academic researchers, small office providers, large health systems,
EHR vendors and terminological specialists
• Format: Short introductory presentations by panelists, followed by
one hour to two hours Task Force Q&A discussion with the panel
4
2

18. Hearing Results: Major Themes 1
• Clarity is more important than simplicity and harmony (but not by much)
– Government must provide clarity, stability and predictability for vocabularies
– Clarity about what is required, of whom, for what intended purpose
– Clarity of future direction and vision is important
– Simplicity for users should be an overriding goal of the infrastructure
– Simplicity must be balanced by mechanisms for handling exceptions
• A comprehensive plan does not mean it should be done all at once
– Prioritize the most immediately useful content sets (value sets, subsets and
cross-maps) including maps of SNOMED CT to ICD-9-CM & ICD-10-CM
– Providing an enumerated list of codes is not enough for any value set
implementation, but not everything is needed at first because attributes may
be added over time to cultivate a more complete system
– Prioritize establishment of a US extension to SNOMED CT for rapid additions
needed by value set developers
• Intellectual property (IP) issues can be a significant barrier to adoption
and use of vocabulary content sets
– More on this later, hold discussion for now
5
Hearing Results: Major Themes 2
• Strong version management is absolutely critical for distribution of
vocabulary content sets, and expiration dates should be considered
• System performance, uptime, and security characteristics must define
infrastructure requirements
– Explore the possible uses of cloud technology and distributed solutions
• Value set context is important and unique – controls may be needed
– The intended use of a value set establishes suitability for a specific purpose
– “Off-label” use of value sets is sometimes highly problematic
– Information about “off-label” uses may be helpful
– Value set context and intent must be documented consistently
• Multi-stakeholder, cross-functional involvement in the development and
review of content sets should be facilitated by the one-stop shop
6
3

19. Hearing Results: Focus on IP (1 of 2)
• Despite a diversity of individual views, every panel cited Intellectual
Property (IP) restrictions and licensing as a barrier to vocabulary
implementation in MU
• The scope of vocabulary IP issues in MU encompasses all uses of
vocabulary IP that may be involved in complying with MU regulations:
– Vocabulary standards and extensions to standard vocabularies
– Derivative works including crossmaps and value sets
– Messaging standards that specify vocabularies, including HIPAA and MU
• Alternative solutions suggested by panelists were all over the map:
– Don’t allow monopolies for vocabularies/code sets that charge fees
– Government should pay national license fees for all standards it adopts
– Provider fees should recover a portion “X%” of national license costs
• Plea from hospitals and clinicians: “Make this simple for us.”
7
Hearing Results: Focus on IP (2 of 2)
• For IP issues, simplicity appears to trump both cost and mere clarity
• “I understand the need to pay for the standards I use in my EHR but I am not in
the business of tracking IP in my [medical office] practice.”
• “Of course free is better …[but] we do not mind mind a reasonable fee for IP – we
are used to that model – but you have to make it simple.”
• “Just tell me how much it costs but it has to be one check made out to one place.
Don’t make me figure it out [the IP] or I’ll never do it, it’s not worth it.”
• Panelist comments suggest a possible alternative solution:
– The Government or its agent could centrally administer license
payments for intellectual property it adopts and uses in MU. Separate
from the question of national licenses, this could potentially involve
federal negotiation of license fees on behalf of regulated entities and
federal payment processing. Each meaningful user would know his
or her obligation and where to send their one single payment for all
MU-related IP.
8
4

20. Next Steps
• HITSC discussion, input and guidance for the Task Force
• Task Force meetings are scheduled to develop our
recommendations and next steps
• HITSC may make recommendations to ONC
9
5

22. HIT Standards Committee
Implementation Workgroup
Judy Murphy, Aurora Health Care, Co-Chair
Liz Johnson, Tenet Healthcare, Co-Chair
September 21, 2010
Implementation Workgroup Member List
Co-Chairs Judy Murphy Aurora Health Care
Liz Johnson Tenet Healthcare Corporation
Members Rob Anthony Centers for Medicare & Medicaid/CMS [new]
Lisa Carnahan National Institute of Standards and Technology/NIST
Anne Castro BlueCross BlueShield of South Carolina
Simon P. Cohn Kaiser Permanente [new]
John Derr Golden Living, LLC
Carol Diamond Markle Foundation
Timothy Gutshall Iowa HIT Regional Extension Center [new]
Joseph Heyman Whittier IPA [new]
Kevin Hutchinson Prematics, Inc.
Lisa McDermott Cerner Corporation [new]
Nancy Orvis Dept. of Defense
Wes Rishel Gartner, Inc.
Cris Ross Lab Hub
Kenneth Tarkoff RelayHealth [new]
Micky Tripathi MA eHealth Collaborative
TBD Veterans Affairs/VA (Gregg Seppala will monitor) [new]
TBD Office of the National Coordinator/ONC [new]
Ex Officio Aneesh Chopra Chief Technology Officer, OSPT
1

23. Broad Charge
To bring forward “real-world” implementation
experience into the HIT Standards Committee
recommendations, with a special emphasis on
strategies to accelerate the adoption of
proposed standards, or mitigate barriers, if any.
Meeting held: September 15, 2010, 12:00 to 2:00 pm/ET
Future Meetings – first Thursday of the month, 2-3:30pm ET
October 7, 2010, 2:00 to 3:30 pm/ET
November 4, 2010, 2:00 to 3:30 pm/ET
December 2, 2010, 2:00 to 3:30 pm/ET
Preliminary List of Potential Activities
• Recommend that ONC create a publicly accessible
online report/dashboard to track implementation progress
(MU qualification, Regional Extension Centers, State
Programs, Beacon Communities, and NHIN)
– Don’t duplicate existing; post in one place what is already being
done through the various programs
– Specifically for MU, provide access to lists of:
• Vendors who completed certification
• Providers/hospitals who have registered with CMS
• Providers/hospitals who have attested to MU with CMS
• Providers/hospitals who have successfully achieved MU qualification
and will be receiving incentive payments
– Goal is to provide situational awareness and transparency, as
well as access to potential resources
2

24. Preliminary List of Potential Activities
• Provide feedback/”reality test” to HITPC and HITSC’s
recommendations – does this make sense from an
implementation standpoint?
– Synergies
– Concerns
• Encourage/advertise use of existing resources such as
– Health IT Buzz Blog
– Federal Advisory Committee Blog
– Health IT Journey - Stories from the Road
– ONC FAQ’s
– CMS FAQ’s
Preliminary List of Potential Activities
• Evaluate and consider use of social networking tools to
connect people and learn form each others’
implementation efforts
• Provide clarity on MU specifications and resolve any
confusion on available resources (source of truth)
– Create a “Playbook” for MU
– Provide guidance on NHIN and NHIN Direct
– Help providers/hospitals determine how to bridge efforts re: MU
performance, quality measures and NHIN
• Clarify consumer expectations of EHR vendor
certification – what can they actually expect from a
“certified EHR product”?
3

25. Preliminary List of Potential Activities
• Consider a home for the questions that NIST is not able
to answer and a place to publish “lessons learned”
• Ascertain if it would make sense to create a version of
the NIST test scenarios for consumers to use in
evaluating their implementation/adoption of the EHR
• Determine what drives our Workgroup agenda
– Our understanding
– Input from others
– HITPC and HITSC’s policies and programs feedback
Next Steps
• Find out what ONC and CMS already have planned
and what they need our input or feedback on
• Prioritize activities
• Create a roadmap to begin work on the highest
priority items
• Add a member from public health to the Workgroup
• Determine metrics to measure our success as a
Workgroup - are we helpful / successful ?
4

27. HIT STANDARDS COMMITTEE
DRAFT:
S&I Framework
Principles and Processes
1
1
S&I Framework
KICK-OFF
2
1

28. S&I Mission
» Promote a sustainable ecosystem that drives increasing
interoperability and standards adoption
» Create a collaborative, coordinated, incremental standards
process that is led by the industry in solving real world
problems
» Leverage “government as a platform” – provide tools,
coordination, and harmonization that will support interested
parties as they develop solutions to interoperability and
standards adoption.
3
ONC Standards and Interoperability Framework
Standards Pilot Demonstration
Development Projects
(TBD) (Lockheed Martin)
Use Case Development
Harmonization of Implementation Reference Certification
and Functional
Core Concepts Specifications Implementation and Testing
Requirements
(Deloitte) (Deloitte) (Lockheed Martin) (Stanley/Deloitte)
(Accenture)
Tools and Services
(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
(Stanley)
4
2

29. Standards and Interoperability Organizational
Structure
Standards and Interoperability
Standards National Health Certification FHA
Information Network
and Testing
Standards NHIN Teams Certification FHA Teams
Teams Team
CONNECT
Use Cases Architecture Certification (TBD)
(Accenture) (Stanley/Deloitte)
Reference
Standards Implementations
Development (Lockheed Martin) Test
Infrastructure
(TBD) (Stanley/Deloitte)
Emergent Pilots
(Lockheed Martin)
Harmonization
(Deloitte)
Tools
(Stanley)
Spec Factory
(Deloitte) Operations
(Stanley) 5
What is an IEPD?
» An Information Exchange Package Documentation (IEPD)
is a collection of artifacts that describe the construction and
content of an information exchange
• Developed to provide the business, functional, and technical details
of the information exchange through predefined artifacts
• Created with a core set of artifacts in a prescribed format and
organizational structure to allow for consistency
• Designed to be shared and reused in the development of new
information exchanges through publication in IEPD repositories
• IEPDs contain design specifications for an information exchange
but may not include supplementary information such as
implementation decisions.
6
3

30. The IEPD Artifacts
• Sequence
IEPDs contain both Scenario • Business Process Diagrams
Planning • Use Cases
required and
recommended • Business Rules • Business
artifacts Analyze
Requirements
Requirements
Required : Bold • Exchange Content • Mapping
Map & Model Model Document
Recommended : Italic
• Subset Schema • XML Wantlist
Note: Best Build &
• Exchange •Constraint Schema
Validate
practices for most Schema •Extension Schema
organizations •Main Document •Sample XML
include many of the Assemble &
•IEPD Catalog Instances
Document
optional artifacts •IEPD Metadata •XML Stylesheets
listed here No required artifacts. Publish the IEPD
Publish &
to a repository and implement the
Implement
exchange 7
S&I NIEM Harmonization Strategy
Human
Services
Human Services
» ONC’s Office of Interoperability and Standards is building a Health
Information Exchange Model (NIEM Health) that is harmonized with
NIEM
» Health and Human Services petal to serve as bridge between NIEM 8
and NIEM Health
4

31. S&I NIEM Process Harmonized
Participants S&I Development Phases
Capability Capability Construction Release &
Formulation Elaboration Publication
Analyze Build & Assemble & Pub. &
NIEM Lifecycle Scenario Planning
Requirements
Map & Model
Validate Document Impl.
Use Case
Development
Harmonization
Spec
Development
Reference Impl
Cert &Testing
Health
Community
S&I Governance
9
Addressing Challenges for the Health Information
Exchange Model
Challenge Approach
Existence of disparate health information Map exchange requirements to existing
exchange standards and specifications standards & specifications and address any
and implementation approaches gaps, duplications, or overlaps
Harmonization and management of Leverage existing vocabulary repositories (e.g.
several well-established, large PHIN VADS), coordinate with Unified Medical
vocabularies for semantic interoperability Language System (UMLS), and collaborate with
standards development organizations
Usability of existing HIT exchange Use NIEM processes and adapt supporting
protocols and specifications tools to create computable, useable
implementation specifications
NIEM only addresses data content, but Adapt structure and content of S&I IEPD to
transaction behavior and security incorporate transport and security aspects of
provisions are necessary for health exchange
information exchange
Compatibility of S&I IEPDs with existing Develop and adapt NIEM and health
NIEM infrastructure and tools, as well as information technology tools and framework to
existing health information exchange support NHIN goals 10
protocols
5

32. Requirements for a Model Centric Approach
» The modeling approach used by the S&I Framework must
• Provide traceability from Use Case and Requirements
through to one or more implementations
• Provide semantic and syntactic modeling constructs to
support defining the information and behavior that are
part of exchanges
• Support the need to harmonize with existing standards
defined at different levels of abstraction
• Be adoptable by different organizations
• Be able to integrate into NIEM process
11
Model-Centric Solution - MDA
» Base S&I Framework modeling on the 3 OMG/MDA model
abstractions.
• Computational Independent Model (CIM)
• Platform Independent Model (PIM)
• Platform Specific Model (PSM)
» Define a mechanism to show traceability from Use Cases and
Functional Requirements through to technical bindings defined in a
PSM.
» Define a flexible modeling foundation by which different types of
specifications can be defined.
» Provides ability for multiple technology bindings for the same set of
logical specifications (multiple PSMs)
12
6

33. Model Centric Solution - NIEM
S&I Activities NIEM Processes and Artifacts Specification Models
Use Case
Development Business Processes, Vision Document,
Scenario Planning
and Functional Use Cases Process Model
Requirements
CIM
Business Rules, Use Case Model,
Harmonization of Analyze
Business Interaction Model,
Core Concepts Requirements
Requirements Domain Model
Map and Model Exchange Content
Implementation
Model, Mapping Behavior Model
Specifications
Document Domain Model PIM
Reference Exchange Schema,
Build and Validate
Implementation Subset/Constraint
and Pilots Schema, Web Services PSM
Schema and WSDL
Assemble and Main Document,
Certification and Document IEPD Catalog, IEPD
Testing Metadata, Sample
XML
Publish and
Implement 13
Prioritization and Backlog Lists
Strategic
Priorities
Operational
Priorities
“Day to Day”
Priorities within
each functional
team
14
7

34. What’s Next
Pilot
Standards
Demonstration
Development
Projects
Use Case
Harmonization of
Development Implementation Reference Certification
Core Concepts
and Functional Specifications Implementation and Testing
(NIEM framework)
Requirements
Scenario Map & Assemble &
Planning Model Document
Analyze Build & Publish &
NIEM IEPD Lifecycle
Requirements Validate Implement
» Create a NIEM Health standards harmonization process and governance framework
» Establish roadmap for existing NHIN standards, MU harmonization, and non-MU
health information exchange specifications
» Establishes a repeatable, iterative process for developing widely reusable,
computable implementation specifications
» Establishing the tooling and repositories needed
» Establishing the practices and guidelines for modeling
» Enables semantic traceability so that useable code can be traced back to original
requirements and definitions
15
» Promotes transparency and collaboration from broad range of health stakeholders
S&I Framework
CURRENT LESSONS
16
8

35. Lessons Learned: NHIN Direct
High
» Consensus Driven Process
Focused » Open Collaboration
Command Collaboration
and Control » Established core guiding
principles
Focus » Driven by business needs and
elaborated use cases
A Thousand » Real world pilot
Flowers Bloom
implementation
» Establish executive
Low
Low High
sponsorship and workgroup
leads
Participation
17
Lessons Learned: Eligibility and Enrollment
High
» Dedicated resource(s) to drive
Focused project and decision making
Command Collaboration
and Control » Clearly defined problem
statement at project initiation
Focus » Define expectations for
desired artifacts
A Thousand » Promote community
Flowers Bloom enthusiasm
» Leverage tools to increase
Low
Low High efficiencies
Participation
18
9

36. S&I Framework
ISSUES TO DISCUSS
19
Issues and Challenges (1)
Issues and Challenges
HITSC HITPC
» How and when do we get input from
other stakeholders including those
Coordination outside of meaningful use?
Priority Setting » VLER
Evaluating Artifacts » Federal partners
» Other stakeholders
» How do we foster multiple working
S&I Framework groups and create a unified view of
Sustainable Operations priorities?
Shared Infrastructure
20
10

37. S&I Framework Challenges (2)
How do we create simple, easy to implement specifications
that will drive adoption?
» How do we facilitate access to SDO standards for providers and
support sustainable business models?
• Engaging the SDO community
• Developing a “one stop shop” for implementation specifications
» How do we foster community and industrial participation to support
balanced representation and diverse priorities?
• Identifying champions for S&I lifecycle initiatives
• Engage communities throughout S&I Framework
• Identifying demonstrable pilot programs
• Engaging and incentivizing volunteers from existing community
21
S&I Framework Open Questions cont.
» What are the appropriate interface points with HITSC through S&I
Framework lifecycle?
• Establish priorities, approve implementation specifications,
• Identifying appropriate decision makers at S&I control points
• Identifying appropriate roles and participants in the governance of
S&I Framework
» How do we identify and select tools as shared resources that foster
collaboration?
• Establishing and adhering to agreed upon modeling conventions
• Tools to support artifact lifecycle management and dissemination
» How do we extend NIEM to accommodate needs of health care
domain?
22
11

38. S&I Framework Priorities
Prioritization needs to accommodate broad stakeholder needs, account
for breadth and depth of available expertise, and support a long term
growth strategy
» What should our priorities be for the next six months, twelve months,
twenty-four months? From among…
• Meaningful Use Stage 1
• Meaningful Use Stage 2 & 3
• NHIN Exchange
• NHIN Direct
• Health Care Reform
• VLER
• New use cases (lab, pharmacy, content specifications)
23
12