The December HIT Standards Committee Meeting

 by John Halamka, Life as a Healthcare CIO


We began the meeting by relating our standards trajectory to today's agenda.

Our outstanding standards issues for discussion include

1. Content
Continued discussion of GreenCDA on the wire and overview of Stan Huff's CIMI initiative

Standardizing DICOM image objects for image sharing and investigating other possible approaches (e.g., cloud based JPEG2000 exchange).   Consider image transfer standards, image viewing standards, and image reporting standards.

Query Health i.e. I2B2 distributed queries that send questions to data instead of requiring consolidation of data

Simplify the specification for quality measures to enhance consistency of implementation.

The December meeting included an overview of Query Health and Quality measure standards, leaving the discussion of GreenCDA/CIMI and DICOM to our 2012 meetings.

2. Vocabulary
Extend the quality measurement vocabularies to clinical summaries
Lab ordering compendium

The December meeting included a discussion of the lab ordering compendium, leaving the discussion of clinical summary vocabularies to our 2012 meetings.

3. Transport
Specify how the metadata ANPRM be integrated into the health exchange architecture

Additional NwHIN standards development (hearing re Exchange specification complexity, review/oversight of the S&I framework work on Exchange specifications simplification).   Further define secure RESTful transport standards.

Accelerate provider directory pilots (Microdata, RESTful query/response that separates the transaction layer from the schema) and rapidly disseminate lessons learned.

The December meeting included an update on the provider directory and certificate components of transport

Our first presentation was an NCVHS update on ACA Section 10109 by Walter Suarez.

The Committee emphasized the need to coordinate NCHVS work and HITSC work given that division between administrative and clinical data is becoming less distinct over time

Our second presentation was an Implementation Workgroup Update by Liz Johnson about testing procedures that support the certification process.

The committee emphasized the need to pilot these procedures, ensuring they are as simple as possible and reflect a practical evaluation of the functionality intended to support policy goals.

Next, Doug Fridsma and Rich Elmore gave an ONC update.   Rich Elmore described the Query Health initiative, as referenced in my previous blog post about sending questions to data (rather than sending data to registries). 

The committee endorsed the work and noted that further research will be needed to link patients across multiple databases to avoid double counting individuals in quality measure denominators.  The work of Jeff Jonas, as described in my earlier blog post about linking identity.

Doug updated the committee about the S&I Framework initiatives - Transitions of Care, Lab Results, Provider Directories, Data Segmentation (for privacy protection), and electronic submission of medical documentation for Medicare review.

We then discussed a preliminary framework for HITSC 2012 Workplan to ensure the items in the standards trajectory listed above are completed in 2012 as we continue to prepare for meaningful use stage 3.

A great meeting.

The November HIT Standards Committee

by John Halamka, Life as a Healthcare CIO, November 16, 2011

Today, the HIT Standards Committee shifted gears from the Summer Camp work on Meaningful Use Stage 2 and began new interoperability efforts.

We began the meeting with a presentation by Liz Johnson and Judy Murphy about the Implementation Workgroup's recommendations to improve the certification and testing process.   These 15 items incorporate the Stage 1 experience gathered from numerous hospitals and eligible professionals.   If ONC and NIST can implement this plan, many stakeholders will benefit.  The Committee approved these recommendations without revision.

Next, we focused on content, vocabulary and transport standards.

In my October HIT Standards Committee blog post, I noted that HITSC should work on the following projects:

Content
*Continued refinement of the Consolidated CDA implementation guides and tools to enhance semantic interoperability including consistent use of business names in "Green" over-the-wire standards.
*Simplifying the specification for quality measures to enhance consistency of implementation.
*Standardizing DICOM image objects for image sharing and investigating other possible approaches.   We'll review image transfer standards, image viewing standards, and image reporting standards.
*Query Health - distributed queries that send questions to data instead of requiring consolidation of the data

Vocabulary
*Extending the quality measurement vocabularies to clinical summaries
*Finalizing a standardized lab ordering compendium

Transport
*Specifying how the metadata ANPRM be integrated into health exchange architectures
*Supporting additional NwHIN standards development (hearings about Exchange specification complexity, review/oversight of the S&I Framework projects on simplification of Exchange specifications).   Further defining secure RESTful transport standards.
*Accelerating provider directory pilots (Microdata, RESTful query/response that separates the transaction layer from the schema) and rapidly disseminating lessons learned.

The November Committee agenda included a discussion of  Consolidated CDA, Quality Measures, and NwHIN Implementation Guides.

Doug Fridsma began with a discussion of the Consolidated CDAwork and the tools which support it.

The Committee had a remarkable dialog with more passion and unanimity than at any recent discussion.   We concluded:
*Simple XML that is easily implemented will accelerate adoption
*That simple XML should be backed by a robust information model.   However, implementers should not need expert knowledge of that model.  The information model can serve as a reference for SDOs to guide their work
*Detailed Clinical Models, as exemplified by Stan Huff's Clinical Information Modeling Initiative (CIMI) hold great promise.   Stan has assembled an international consensus group including those who work on
 -Archetype Object Model/ADL 1.5 openEHR
 -CEN/ISO 13606 AOM ADL 1.4
 -UML 2.x + OCL + healthcare extensions
 -OWL 2.0 + healthcare profiles and extensions
 -MIF 2 + tools HL7 RIM – static model designer

Their work may be much more intuitive than today's HL7 RIM as the basis for future clinical exchange standards.

*Rather than debate whether Consolidated CDA OR GreenCDA(simplified XML tagging) should be the over the wire format, the Committee noted that "OR" really implies "AND" for vendors and increases implementation burden.   The Committee endorsed moving forward with GreenCDA as the single over the wire format.   
*We should move forward now with this work, realizing that it will take 9-12 months and likely will not be included in Meaningful Use Stage 2, but it is the right thing to do.

Thus, the future Transfer of Care Summary will be assembled  from a simple set of clinically relevant GreenCDA templates, based on CIMI models, as needed to support various use cases.  There will be no optionality  - just a single way to express medical concepts in specific templates.

To support this approach, we'll need great modeling tools.    David Carlson and John Timm presented the applications developed to support the VA's Model Driven Health Tools initiative.  This software turns clinical models into XML and conformance testing tools.   The committee was very impressed.

Next, Avinash Shanbhag presented the ONC work on Quality Measures  that seeks to ensure quality  numerators and denominators are expressed in terms of existing EHR data elements captured as part of standard patient care workflows.

Avinash also presented an update on transport efforts, which include easy to use, well documented implementation guides for SMTP/SMIME and SOAP.   The work is highly modular and does not require that the full suite of NwHIN Exchange specifications be implemented for SOAP exchanges.

As part of the ongoing efforts to improve NwHIN Exchange, the HIT Standards Committee is seeking input from NwHIN implementers per this blog post.

Finally, Wil Yu updated the committee on the SHARP and other innovation programs. 

There will be a great body of challenging work to do in 2012.   What's needed after that?  The next 5 years will include many new regulations as healthcare reform is rolled out.   It's clear that the Standards Committee will have many topics to discuss.

The September HIT Standards Committee Meeting

by John Halamka, Life as  Healthcare CIO

Today was a big day - the end of Standards Summer Camp.   We presented the HIT Standards Committee work of the past 6 months and then attended a celebratory reception at the White House.

Judy Sparrow, the ONC "national coordinator" who orchestrated all our HITSC meetings, announced her retirement last month.   Jon Perlin and I presented her with a silver bowl, engraved with the words "The Standard Bearer".   Thanks for all you've done, Judy.

As we discussed our Summer Camp work during the meeting, we were guided by a few basic principles:

While it might not be perfect, does it represent the best we have at this point in history?
Does it point us in the right direction?
Is it the next step in an incremental approach to refining the standards and implementation guides?
Does it support our policy objectives?
Can we update it as needed going forward through the SDO community?

Doug Fridsma presented an overview of our Summer Camp activities to date:

The Metadata Analysis Power Team lea by Stan Huff completed the standards for patient identification, provenance (which organization generated the data), and security flags.   Simple XML constructs from CDA R2 and standard X.509 certificates were chosen for these requirements.

The Patient Matching Power Team led by Marc Overhage completed its analysis of best practices for patient matching, noting the types of demographics that should be captured in systems to optimize the sensitivity and specificity of patient matching applications.

The Surveillance Implementation Guide Power Team led by Chris Chute chose one implementation guide  for each of the public health transactions - surveillance, reportable lab, and immunizations.   We had a spirited discussion about the optional fields in the implementation guides and made it clear that we want the core elements to be the certification criteria.   We do not want each state public health department to mandate different "optional" fields.   Our transmittal letter will note that EHRs that send the core set should meet the certification criteria.  Public health departments should accept this core set.   Optional fields are just that - optional items for future reporting needs.

Farzad Mostashari, National Coordinator, framed the important discussion of transport standards by noting that we must move forward, boldly specifying what is good enough.   If we specify nothing, the silos of data we have today in hospitals, clinician offices, pharmacies, and labs will persist.   There's a sense of urgency to act.

The NwHIN Power Team led by Dixie Baker presented its thoughtful analysis of the 10 standards guides included in NwHIN Exchange and the 2 standards guides included in NwHIN Direct.   This analysis was not a comparison of the two, but was an objective look at the suitability of each standards guide for its intended purpose to support aspects of transport functionality at a national scale.   The team did not discuss their suitability for use at the local, state, or regional scale.   The team did not declare "push or "pull" as a superior architecture.    Their thoughtful analysis led to a very robust discussion.    I'd summarize it as:

*Direct is low risk for the purpose intended, pushing data from point A to point B using SMTP/SMIME with an optional XDR (SOAP) connector.   Additional work needs to be done on certificate discovery, but that will use DNS and LDAP, two well adopted technologies.

*Exchange needs additional work to ensure it scales at a national level for pull and push transactions.   The S&I Framework teams are working on modular specifications that should enable a subset of Exchange components to be used, simplifying implementation and support.   The Standards Committee will seek additional testimony from Exchange implementers to learn more about their experience.

*It's worthwhile to think about additional transport standards that do not yet have well specified implementation guides, such as a combination of REST, oAuth and TLS - something that Facebook, Amazon, or Google would use to create a highly scalable transport architecture.

The ePrescribing of Discharge Meds Power Team led by Jamie Ferguson presented the use of HL7 2.2-2.51 transactions to support hospital information system workflows in a manner that is compatible with Medicare Part D.   We clarified that newer versions of HL7 2.x which are backward compatible should also be allowed.

The Clinical Quality Workgroup and Vocabulary Task Force led by Jamie Ferguson presented their transition plans for vocabularies, identifying the cross maps between vocabularies that need to be created and supported as we evolve from our current use of vocabularies to a future state in which there is one structured vocabulary per domain of medicine (problems, medications, labs, allergies etc).

Doug Fridsma then presented an overview of the Standards and Interoperability Framework activities and next steps:

Transitions of Care - Doug described a brilliant approach that incorporates simple XML, such as has been used in the CCR, with the expandability of the CCD.  He calls this next evolution of clinical summaries  "Consolidated CDA templates".  It's likely that the clinical summary certification criteria will evolve to a single XML format that is easy to use, fast to implement, expandable, based on a reference model, and human readable.   Well done!

Reportable Labs -  In the past, standards harmonizers struggled to balance simple, easy to implement lab specifications such as ELINCS with the comprehensive and full featured lab specifications from HITSP.   The S&I group created a foundation based on ELINCS that is expandable to include all the features of the HITSP specifications using a single HL7 2.51 implementation guide.   Amazing work.

Provider Directories - The S&I Framework team had the courage to admit that directory standards are still evolving and need more testing/piloting before selection.   DNS/LDAP approaches are likely to work well for certificate discovery.   Other aspects of directories such as provider routing addresses and electronic service capabilities may be stored in web pages (microdata), LDAP (HPD), or X12 274 directory structures.

Doug also described new works in progress - Query Health for distributed data mining, Data Segmentation to manage disclosures of protected health information, and Electronic Submission of Medical Documentation for transmission to Medicare review contractors.

Finally and very importantly, the Implementation Workgroup led by Liz Johnson and Judy Murphy presented the Implementation Workgroup certification criteria analysis.   We had a thoughtful discussion of each open issue and suggested a path forward for each certification item.

Truly an inspiring meeting - the most work we've ever done in a single day.

The delivery of Meaningful Use Stage 2 Standards and Certification criteria was recognized at a White House celebration by Aneesh Chopra, Chief Technology Officer and numerous members of the Obama administration senior staff.   Thanks so much to Aneesh and others for celebrating our work.

As I told the Standards Committee today, I am honored to serve with this team, the hardest working Federal Advisory Committee in government.  A milestone day for the country.

The August HIT Standards Committee Meeting

By John Halamka, Life as a Healthcare CIO

 The August meeting of the HIT Standards Committee (the 28th meeting of this FACA) was a milestone in parsimony.   As you'll see, we approved a set of vocabulary recommendations and public health standards that represent harmony as well the fewest number of standards possible for the intended purpose. 

Since April, we've been working hard on Summer Camp.   At our September meeting, we'll wrap up all that work and hand off the finished standards recommendations to ONC for regulation writing.

Per our Summer Camp plan, the August meeting included final recommendations on vocabulary standards for quality measures, final recommendations on all public health transactions, preliminary recommendations on patient matching, and preliminary recommendations on transport/security standards.   We also heard from the Standards and Interoperability Framework team about their work and the Implementation Workgroup on their review of Certification Criteria.

This was a powerful meeting, discussing the standards that so many people have been working on for the past decade - one vocabulary standard for each class of data used in quality measures, one approach to public health transactions, one approach to transfer of care summaries, one approach to laboratory results, and a building block approach to data transmission that supports the portfolio of health information exchange options.

We began with the final recommendations from the Clinical Quality Workgroup and Vocabulary Task force on vocabulary standards.   Per the marching orders we gave them, they selected one vocabulary standard for each domain - problems, medications, allergies, labs etc.    SNOMED-CT and LOINC are the default vocabularies used whenever possible.   The committee approved these recommendations by consensus with 2 caveats

-the Implementation Workgroup will be charged with ongoing review of the implementation burden of using these standards in a variety of settings
-the September meeting of the HIT Standards Committee will include discussion of a transition plan for those vocabulary standards required for Stage 1 that are being retired/replaced in Stage 2.

Marc Overhage presented best practices for patient matching, identifying the metadata that should be standardized in patient records and health information exchange.   These recommendations are complementary to the metadata standard recommendations in the Advanced Notice of Proposed Rulemaking, enabling stakeholders to optimize a patient matching strategy as needed for their applications using best practices and evidence from industry experience.

Chris Chute presented the recommendations for public health standards  - one HL7 2.51 implementation guide for surveillance, one HL7 2.51 implementation guide for immunizations and one HL7 2.51 implementation guide for reportable labs.   The optionality specified in meaningful use stage 1 was eliminated and the end result are simple un-ambiguous implementation guides for public health.

Dixie Baker presented the preliminary recommendations for building blocks that support data exchange in both "push" and "pull" models.   The key innovation in Dixie's is the process for reviewing existing standards for appropriateness, adoption, maturity, and currency.

Jitin Asnaani from ONC presented the S&I Framework update including Certificates, Lab Results, Transitions of Care, and Provider Directories. These will be reviewed and hopefully turned into guidance for ONC in the next few months.

Finally, Judy Murphy and Liz Johnson presented their work on certification criteria.

A remarkable meeting from a world class team.  I'm proud to be a part of it!

The July HIT Standards Committee Meeting

by John Halamka, Life as a Healthcare CIO


Farzad Mostashari, national coordinator for healthcare IT, began the meeting with a discussion of the issues we have always faced while harmonizing standards.  Standards that are widely adopted by the marketplace and are well tested make harmonization easy.  However, many standards are mature but not widely adopted or novel but not well tested.   We want to encourage innovation and use market adoption as a measure of our success.   It's clear that at times we'll have to consider new standards that seem very reasonable for the purpose intended and test them in real world scenarios before forcing top down adoption through regulation.   Bottom up adoption of standards that are implemented and improved by stakeholders is a better approach.  

Per the Standards Summer Camp schedule, the July HIT Standards Committee meeting focused on

Vocabulary recommendations 
ePrescribing of discharged medications recommendations
Patient Matching recommendations
Syndromic Surveillance recommendations

Jim Walker, chair of the Clinical Quality workgroup, presented an overview of the vocabulary work done to support all our clinical coordination and quality measurement activities.  The charter for the group was to select the minimum number of vocabulary standards with the minimum number of values to meet the requirements of meaningful use stages 2 and 3.   Reducing the number of standards makes mapping between different vocabularies much easier.    The workgroup used SNOMED-CT and LOINC wherever possible and tried to select one vocabulary per domain (allergies, labs, medications etc).   Examples of their selections include

Adverse Drug effect - RxNorm for medications, SNOMED-CT for non-medication substances, SNOMED-CT for severity of reaction

Patient characteristics - ISO 639-2 for preferred language, HL7 for administrative gender, PHIN-VADS (Centers for Disease Control) for Race/Ethnicity

Condition/Diagnosis/Problem - SNOMED-CT

Non-lab Diagnostic study - LOINC for name, SNOMED-CT for appropriate findings, UCUM for Units

A rich discussion followed.  Points of concern included:
*Using RxNorm for all medications including vaccines, even though CVX is the required vaccine vocabulary for Meaningful Use stage 1.   We clarified this with an example from Beth Israel Deaconess Medical Center:

BIDMC uses First Data Bank as the medication vocabulary for its internal systems.  However, when BIDMC sends clinical summaries, it maps FDB to RxNorm for all drug names.  When BIDMC sends immunization records to public health, it uses CVX codes.   Thus, the HIT Standards Committee will not specify the vocabularies used within enterprise applications, just those vocabularies that are needed for specific purposes when data is transmitted between entities.

Next, Doug Fridsma began a discussion of our Summer Camp items, noting the many projects of the S&I framework are proceeding according to plan.

Scott Robertson presented the work of the Discharge Medications Power Team.  They recommended HL7 and NCPDP script as reasonable standards for sending discharge medication orders to hospital pharmacies and retail pharmacies.

Discussion followed regarding two specific points - their recommendations did not include a specific version of HL7, since existing Medicare Part D regulations do not specify an HL7 version.  The power team will make additional more specific HL7 recommendations.   There was discussion about the  specific aspects of RxNorm that constrain the way dose and route are specified.   The HIT Standards Committee members felt additional work was needed before mandating this level of specificity, so our recommendations will include RxNorm for medication name, but not additional specificity for dose and route vocabularies at this time.

Next, Marc Overhage presented the recommendations of thePatient Matching Power Team.   The scope of the Patient Matching work is to provide guidance to implementers who want to understand best practices for the use of demographics in machine to machine matching of patient identity.   Per the RAND Report, use of different fields results in variation of specificity and sensitivity.   Some fields such as social security number (or a subset of it) greatly increase specificity, resulting in fewer false positives such as matching the wrong patient.   However, social security number is controversial because of the potential for identity theft and the fact that immigrants may not have one.   The final report will take into account all these observations.

Chris Chute presented the recommendations of the Surveillance Implementation Guide Power Team, which aims to specify one implementation guide for each public health transaction.  They are studying the difference between HL7 2.31 and 2.51 as well as considering the potential for public health entities to use CDA constructs.

Dixie Baker presented a project plan for the NwHIN Power Team,which aims to specify a set of building blocks for secure transport of data in multiple architectures.

Finally, Judy Murphy and Liz Johnson presented their plans for the Implementation Workgroup, collecting lessons learned from  certification and attestation.

We're on track with Summer Camp.  Our next meeting in August will include the final recommendations for

Simple Lab Results 
Transitions of Care 
CDA Cleanup
Patient Matching
Vocabulary

Every meeting with the HIT Standards Committee (this was our 27th) brings us closer as a working team.   We're transparent and passionate, openly sharing all the issues and concerns about the standards we're selecting.  Coordination with all the moving parts (ONC, Policy Committee, S&I Framework)  keeps getting better and better.

Thus far, Summer Camp is a winner and I am confident we'll meet all our September deadlines for offering recommendations to ONC in preparation for Meaningful Use Stage 2 regulations.

The June HIT Standards Committee meeting

 by John Halamka, Life as a Healthcare CIO

The June HIT Standards Committee meeting followed the "Summer Camp" schedule precisely, and focused on health information exchange metadata (patient identifiers/provenance/privacy flags),  provider directories, patient matching, meaningful use stage 2 standards, quality measures, and feedback how to ease the burden of certification.

Farzad Mostashari, National Coordinator, began the meeting by highlighting the importance of taking first steps on early health information exchange use cases.  The notion of creating a standard envelope around data that identifies the patient and the sender of the data enables many transactions.   Supporting privacy flags enables the recipient of the data to obtain necessary consents before viewing data and to store the data optimally to respect patient privacy preferences (such as special locked areas for mental health, substance abuse or HIV related data).   Privacy flags may not be needed if the patient is the source of the data or the patient gives consent to disclose and consent to view directly to the provider at the point of care. 

Stan Huff led the metadata discussion and reviewed the work that has been done to date on patient ID and provenance standards.   For patient ID, we considered many options but selected a very simple XML construct based on a streamlined CDA R2 header.  This XML has nothing healthcare specific such as OIDs in it.   For provenance, we considered many options but selected a very simple XML construct based on a streamlined CDA R2 header and X.509 certificates for digital signature.  The signature could be an institution, a department, or an individual, as needed by the use case.   For Privacy we considered many options and recommended a CDA R2 Header with a simple vocabulary to indicate that sensitive data is present.   The list of sensitive data types could include mental illness, substance abuse, sexually transmitted disease data, HIV data, domestic violence data etc. or it could be a simple indicator that sensitive data is present.  Specifying such a vocabulary is future work.

A robust discussion followed about privacy flags.   Here are important clarifications

1. During transmission, the envelope of metadata plus the payload of content is fully encrypted and so the metadata is not readable until it arrives inside the organization or to the person authorized to read it. 

2.  Much of the time, no privacy flags are needed because the patient will be the source of the data and will elect what to disclose to whom.   Privacy flags would likely be needed when data is assembled from multiple sources and is received by a provider who needs to obtain special consent before viewing it or apply special protections before storing it.

3.  A privacy flag would enable data to be automatically routed to specially protected areas of the EHR.

4.  The CDA R2 header standards are used millions of times per day throughout the world but this subset of them and constrained specifications of how/when they are used should be tested before regulations require them for specific transactions.

5.  The recommendation to use CDA R2 headers for metadata is the beginning of a formal ONC process to seek comment, feedback and stakeholder engagement regarding their use.

Based on all these clarifications, the HIT STandards Committee approved the use CDA R2 header for metadata as a formal recommendation to ONC as it begins the NPRM process.

Next, Dixie Baker and Walter Suarez presented Provider Directory recommendations.   At last month's meeting, they suggested the use of LDAP/IHE HPD standards and received  feedback that these standards were not the best fit for cross organizational/federated directory lookup.   They reconsidered the possibilities and examined DNS as a means to find IP addresses and certificates, the concept of a Top-Level-Domain as a means to create a uniform, secure way to retrieve directory information about healthcare organizations (of note, ICAAN announced that such Top Level Domains will soon be very easy to create), and the use ofmicroformats/microdata as a means of creating simple federated lookups for provider directory information that cannot be stored in DNS, such as street address and phone number.  Web pages containing such data can be secured with Extended Validation certificates to provide identity verification of the entity publishing the information i.e. it really is Beth Israel Deaconess publishing the directory information about Beth Israel Deaconess.  Summarizing their recommendations for provider directories:

1.  DNS should be used for certificate retrieval per the Direct Specification plus web pages with microformats/microdata should be used for additional directory information.   These web pages can be federated via standard search engine technology.

2.  A Top level domain can be considered in the future, but there is no need to implement one now.

The HIT Standards Committee approved this recommendation as input to the S&I framework process.

Next, Doug Fridsma let a discussion of progress on "Summer Camp".

Marc Overhage presented the work on patient matching, noting that the work of the group is to specify those data elements that can be used to match patients, achieving a reasonable balance of sensitivity and specificity i.e. it's ok to occasionally not find a patient's record, but it is very bad to find the wrong record.   The team is not specifying the matching algorithm such as exact match, probabilistic match, partial match (first six letters of last name), Soundex or other approaches.   Their work to date suggests using patient name, gender, date of birth and numeric identifiers (such as driver's license number, payer member number, last 4 of SSN etc.).   It does not preclude the possibility that new identifiers such as an opt in patient healthcare ID, a DIRECT address, or other identifier could be included in the future.

Dixe Baker presented an overview of the Nationwide Health Information Network power team effort which will create a set of building blocks encompassing all the requirements of the existing NwHIN Exchange standards and Direct standards.   Their final report will be presented in September.

Steve Posnack presented the Standards and Certification Criteria codeset update that enables the latest version of SNOMED-CT, LOINC and CVX to be included in Certification testing.

George Hripcsak and Josh Seidman presented an overview of Meaningful Use Stage 2.   In the next few weeks, ONC will determine what gaps need to be filled with new standards specifications.

Jim Walker presented the Clinical Quality Workgroup Update as the group continues to simplify the computation of measures and reduce the level of effort to comply with the quality reporting requirements of meaningful use.

Jamie Ferguson and Betsy Humphreys presented the Vocabulary Task Force Update.  Soon, standards subsets will be available that will reduce the burden of implementation and compliance with meaningful use vocabulary standards adoption.

Judy Murphy and Liz Johnson presented the Implementation Workgroup Update.   They are completing data gathering and analysis of feedback on the certification process and ways in which it can be improved for stage 2.

A very productive meeting.   I look forward to the July meeting and the work ahead on Meaningful Use Stage 2 standards.

The December HIT Standards Committee

by John Halamka, Life as a Healthcare CIO


The December HIT Standards Committee focused on a review of the President's Council of Advisors on Science and Technology (PCAST) report, a review of the Standards and Interoperability Framework Priorities, and a review of NHIN Direct (now called the Direct Project).  

We began the meeting with an introduction from Dr. Perlin in which he noted that reports by commissions such as PCAST need to be read, not for their details, but for their directionality.  We should ask about the trajectory the experts think we should be on and how/when should it modify our current course.   Dr. Blumenthal also offered an introduction to the PCAST discussion, noting that the White House fully supports and encourages interoperability, suggesting that we should accelerate the priority of healthcare information exchange in the progression from Meaningful Use stage 1 to 3.

We discussed the origins and history of the PCAST report.  The President asked PCAST how health IT could improve the quality of healthcare and reduce its cost, and whether existing Federal efforts in health IT are optimized for these goals. In response, PCAST formed a working group consisting of PCAST members and advisors in both healthcare and information technology.

The working group held meetings in Washington, D.C., on December 18, 2009, and in Irvine, California, on January 14 15, 2010, as well as additional meetings by teleconference. The viewpoints of researchers, policy analysts, and administrators from government, healthcare organizations, and universities were presented and discussed.

A draft report developed by the working group was submitted to the Health and Life Sciences committee of PCAST. That committee submitted the draft to several outside reviewers, who made valuable suggestions for improvements.  From the working group draft, the additional input, and its own discussions, the Health and Life Sciences committee produced the present report, which was discussed and endorsed (with some modifications) by the full PCAST in public session on July 16, 2010.

A disclaimer at beginning of report notes "Working Group members participated in the preparation of an initial draft of this report. They are not responsible for, nor necessarily endorse, the final version of this report as modified and approved by PCAST."

We identified a number of key themes in the report
1.  The foundation for healthcare information exchange should be built on an XML-based Universal Exchange Language
2.  Data elements should be separable from documents
3.  Metadata should identify characteristics of each data element i.e. how it was recorded, by whom and for what patient
4.  Privacy controls should integrate patient consent preferences with metadata about the data available for exchange
5.  Search engine technology/data element access service indexing at a national level will accelerate data element discovery
6.  Data reuse with patient consent for clinical trials and population health is a priority

The key ideas from the discussion included:
a.  Thinking at a national scale is good to avoid creating regional health information exchange silos
b.  Messaging (such as HL7 2.x)  is still going to be needed to support event-based transactional workflows
c.  The strength of the PCAST report is in supporting exchange models that require aggregation - research, epidemiology, and unanticipated interactions such as Emergency Department visits http://geekdoctor.blogspot.com/2010/09/unconscious-in-emergency-department.html
d.  For some uses such as communication among providers, encounter summaries which provide structured and unstructured data in context, are more useful than data elements
e.  Many data elements are not useful on their own and a module/collection of data elements would be better i.e. Allergies should include the substance, onset date, the type of reaction, the severity of the reaction, and the level of certainty of the reaction (your mother reported it based on a distant memory verses a clinician observed it happening).   To understand how best to collect data elements into modules, clinical data models would be very helpful.
f.  Since information is going to exchanged among multiple parties, metadata will need to include the provenance of the data, so that data is not duplicated multiple times i.e.  Hospital A sends data to Hospital B and C.    C requests a copy of B's data (which includes B and A) and it should be possible to avoid storing a duplicate of A's data which C already has.
f.  We should proceed with the health information exchange work already in progress to achieve interoperability in support of Meaningful Use stage 1 and not derail current efforts.
g.  Finely grained privacy (to the data element level) will be challenging to implement and maintain.  Tagging elements with privacy characteristics is very hard because societal attitudes about the sensitivity of data elements may change over time.  HIV testing used to be a rare event, so the presence of an HIV test alone (not its result) could be concerning.   Today  1/3 of Americans have had an HIV test, generally as part of getting life or health insurance, so the presence of a test is no longer a stigma.
h.  The national scope suggested includes using web search engine technology to keep a data element index, identifying what data is available for what patients and where.   The policy and security issues of doing this are greater than the technology challenges.

The next step for the PCAST report will be ONC's naming of a multi-stakeholder workgroup to review the report in detail and make recommendations by April.

We next heard about the planned Implementation Workgroup hearing regarding certification, Meaningful Use, and healthcare information exchange.  On January 10-11, the Workgroup will learn about early adopter successes and challenges.

Next, the Clinical Operations Workgroup reported on its plans to consider vocabulary and content issues for devices - critical care, implantable, and home care.   Issues include universal device identification, ensuring data integrity, and interoperability of devices that may require a clinical data model to ensure the meaning of data communicated is understood by EHRs, PHRs, and devices.

We next considered the standards and interoperability framework priorities as outlined by Doug Fridsma.   The S&I Frameworkcontractors are working on clinical summaries,  templates documents, Laboratory results, Medication Reconciliation, Provider  Directories, Syndromic Surveillance, Quality, Population Health, Clinical Decision Support, Patient Engagement, EHR to EHR data exchange, and Value Sets.

Points raised during this discussion included the need to include policy discussions throughout the process of harmonizing and testing standards.    We agreed that the Clinical Operations workgroup should study these priorities and make recommendations based on real world implementation experience that will help ONC and the contractors focus on the gaps to be addressed such as patient identification and vocabularies/codes sets.

We discussed the HIT Policy Committee's request for the Standards Committee to work on Certificate Management standards.  The Privacy and Security Workgroup will make recommendations for organization to organization and server to server certificate standards.

We next considered the Privacy and Security Workgroup's evaluation of NHIN Direct.  The Workgroup concluded that certificate exchange should not be limited to certificates stored in Domain Naming Services (DNS) applications.  It also suggested that XDR (a SOAP transaction) be removed from the NHIN Direct Core specification, reducing the complexity and optionality of the specification.    The only debate that arose during this discussion revolved around the issue of rejecting an NHIN Direct message because it did not meet regulatory requirements.  Specifically, the Privacy and Security Workgroup recommended the following language -

"Destinations MAY reject content that does not meet Destination expectations. For instance, some Destinations MAY require receipt of structured data, MAY support only particular content types, and MAY require receipt of XDM structured attachments."

Here's a use case that illustrates the issue:

Federal Regulations require quality measures to be sent in PQRI XML as of 2012.

A doctor uses NHIN Direct to send an unstructured text message to CMS "I achieved the quality measures you wanted me to!"

What should CMS do?
1.  Reject the message as not compliant with Federal regulations, notifying the sender as to the reason
2.  Accept the message, but contact the sender out of band to specify the requirements
3.  Accept the message, but later send a functional acknowledgement via NHIN Direct that the contents of the message did not qualify for meaningful use reporting requirements
etc.

In an email dialog following the HIT Standards Committee, many members agreed tat that the message should be rejected with an error message that the contents of the message did not meet regulatory requirements.

At the meeting, we agreed that decisions to reject or accept messages are a matter of policy and that the HIT Standards Committee should only recommend technology that enables messages to be sent securely and error messages to be provided to the message sender if policy requirements are not met.

A great meeting with significant progress on the PCAST review, S&I Framework review, and  the NHIN Direct review.  

Next month, we'll hear more about certificates, provider directories, and PCAST.  It's clear that the work of the Policy Committee on Certificates and Provider Directories, the work of NHIN Direct, and the work of HIT Standards Committee are converging such that we will soon have a unified approach to transport that will rapidly accelerate transmission of the standardized content and vocabularies already required by Meaningful Use.