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A G E N D A

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

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

HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 1

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 2

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 3

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 4

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 5

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 6

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 7

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 8

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 9

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 10

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).

1

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

22

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

3

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

4

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

3

5

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

6

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

4

7

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.”

8

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.

5

9

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

1

HIT Standards CommitteeImplementation 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

2

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 ETOctober 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

3

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”?

4

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 ?

1

1

HIT STANDARDS COMMITTEEDRAFT:

S&I Framework Principles and Processes

1

2

KICK-OFF

S&I Framework

2

3

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.

4

ONC Standards and Interoperability Framework

Tools and Services(Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)

(Stanley)

Use Case Development

and Functional

Requirements

(Accenture)

Standards

Development

(TBD)

Certification

and Testing

(Stanley/Deloitte)

Harmonization of

Core Concepts

(Deloitte)

Implementation

Specifications

(Deloitte)

Pilot Demonstration

Projects

(Lockheed Martin)

Reference

Implementation

(Lockheed Martin)

3

5

Standards and Interoperability Organizational

Structure

Standards and Interoperability

Standards National Health

Information NetworkCertification

and Testing

FHA

Standards

TeamsNHIN Teams Certification

Team

FHA Teams

Use Cases

(Accenture)

Standards

Development

(TBD)

Harmonization

(Deloitte)

Spec Factory

(Deloitte)

Architecture

Reference

Implementations

(Lockheed Martin)

Emergent Pilots

(Lockheed Martin)

Tools

(Stanley)

Operations

(Stanley)

Certification

(Stanley/Deloitte)

Test

Infrastructure

(Stanley/Deloitte)

CONNECT

(TBD)

6

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.

4

7

The IEPD Artifacts

IEPDs contain both

required and

recommended

artifacts

Required : Bold

Recommended : Italic

Note: Best

practices for most

organizations

include many of the

optional artifacts

listed here

• Business Process

• Use Cases

• Sequence

Diagrams

• Business Rules • Business

Requirements

• Exchange Content

Model

• Mapping

Document

• Subset Schema

• Exchange

Schema

• XML Wantlist

•Constraint Schema

•Extension Schema

•Main Document

• IEPD Catalog

• IEPD Metadata

•Sample XML

Instances

•XML Stylesheets

Scenario Planning

Analyze Requirements

Map & Model

Build & Validate

Assemble & Document

Publish & Implement

No required artifacts. Publish the IEPD

to a repository and implement the

exchange

8

S&I NIEM Harmonization Strategy

» 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

and NIEM Health

Human

Services

Human Services

5

9

Capability

Elaboration

Capability

Formulation

Construction Release &

Publication

Use Case

Development

Spec

Development

Harmonization

Reference Impl

Cert &Testing

S&I Development Phases

S&I Governance

Health

Community

Participants

Scenario PlanningAnalyze

RequirementsMap & Model

Build &

Validate

Assemble &

Document

Pub. &

Impl.NIEM Lifecycle

S&I NIEM Process Harmonized

10

Addressing Challenges for the Health Information

Exchange Model

Challenge Approach

Existence of disparate health information

exchange standards and specifications

and implementation approaches

Map exchange requirements to existing

standards & specifications and address any

gaps, duplications, or overlaps

Harmonization and management of

several well-established, large

vocabularies for semantic interoperability

Leverage existing vocabulary repositories (e.g.

PHIN VADS), coordinate with Unified Medical

Language System (UMLS), and collaborate with

standards development organizations

Usability of existing HIT exchange

protocols and specifications

Use NIEM processes and adapt supporting

tools to create computable, useable

implementation specifications

NIEM only addresses data content, but

transaction behavior and security

provisions are necessary for health

information exchange

Adapt structure and content of S&I IEPD to

incorporate transport and security aspects of

exchange

Compatibility of S&I IEPDs with existing

NIEM infrastructure and tools, as well as

existing health information exchange

protocols

Develop and adapt NIEM and health

information technology tools and framework to

support NHIN goals

6

11

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

12

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)

7

13

Specification ModelsNIEM Processes and ArtifactsS&I Activities

Harmonization of

Core Concepts

Implementation

Specifications

Reference

Implementation

and Pilots

Business Processes,

Use Cases

Business Rules,

Business

Requirements

Exchange Content

Model, Mapping

Document

Exchange Schema,

Subset/Constraint

Schema,

Main Document,

IEPD Catalog, IEPD

Metadata, Sample

XML

Vision Document,

Process Model

Use Case Model,

Interaction Model,

Domain Model

Behavior Model

Domain Model

Web Services

Schema and WSDL

Use Case

Development

and Functional

Requirements

Certification and

Testing

CIM

PIM

PSM

Scenario Planning

Analyze

Requirements

Map and Model

Publish and

Implement

Build and Validate

Assemble and

Document

Model Centric Solution - NIEM

14

Prioritization and Backlog Lists

Strategic

Priorities

Operational

Priorities

“Day to Day”

Priorities within

each functional

team

8

15

What’s Next

» 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

» Promotes transparency and collaboration from broad range of health stakeholders

Scenario

Planning

Map &

Model

Analyze

Requirements

Build &

Validate

Assemble &

Document

Publish &

Implement

Use Case

Development

and Functional

Requirements

Standards

Development

Certification

and Testing

Harmonization of

Core Concepts

(NIEM framework)

Implementation

Specifications

Pilot

Demonstration

Projects

Reference

Implementation

NIEM IEPD Lifecycle

16

CURRENT LESSONS

S&I Framework

9

17

Lessons Learned: NHIN Direct

Focused

Collaboration

A Thousand

Flowers Bloom

Command

and Control

Low High

Participation

Lo

wH

igh

Focus

» Consensus Driven Process

» Open Collaboration

» Established core guiding

principles

» Driven by business needs and

elaborated use cases

» Real world pilot

implementation

» Establish executive

sponsorship and workgroup

leads

18

Lessons Learned: Eligibility and Enrollment

Focused

Collaboration

A Thousand

Flowers Bloom

Command

and Control

Low High

Participation

Lo

wH

igh

Focus

» Dedicated resource(s) to drive

project and decision making

» Clearly defined problem

statement at project initiation

» Define expectations for

desired artifacts

» Promote community

enthusiasm

» Leverage tools to increase

efficiencies

10

19

ISSUES TO DISCUSS

S&I Framework

20

Coordination

Priority Setting

Evaluating Artifacts

S&I Framework

Issues and Challenges (1)

Issues and Challenges

» How and when do we get input from

other stakeholders including those

outside of meaningful use?

» VLER

» Federal partners

» Other stakeholders

» How do we foster multiple working

groups and create a unified view of

priorities?

HITSC HITPC

Sustainable Operations

Shared Infrastructure

11

21

How do we create simple, easy to implement specifications

that will drive adoption?

S&I Framework Challenges (2)

» 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

22

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?

12

23

S&I Framework Priorities

» 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)

Prioritization needs to accommodate broad stakeholder needs, account

for breadth and depth of available expertise, and support a long term

growth strategy