Wednesday, March 30, 2011

The March HIT Standards Committee Meeting

The March HIT Standards Committee meeting focused on the Stage 2 Meaningful Use work ahead, the Direct Project, certificate management, provider directories, devices, and plans to ensure the certification process has the tools and scripts it needs to reduce the burden on vendors and self-certifiers.

Farzad Mostashari, Acting National Coordinator, began the meeting with a discussion of the trajectory we're on.   We're guided by policy outcomes - improved quality, safety, and efficiency.   The work in 2011 will include the regulatory effort to finalize Stage 2 of Meaningful Use and its accompanying standards and certification criteria.   Efforts will be guided by the new Federal HIT Strategic Plan and will require the hard working teams of volunteers that staff the Policy committee, the Standards committee and numerous other working groups such as the Institute of Medicine Learning Healthcare System group, the PCAST workgroup, and the Privacy/Security Tiger Team.   It will be a busy year.

Doug Fridsma  reviewed  the Timeline and Milestones for NPRM Stage 2, noting the NPRM draft needs to be completed in Q3 2011, the NPRM will be published Q4 2011, and the final rule will be published Q1 2012.   This means that the work on the standards needs to be completed this Summer.   Timing for Stage 2 is going to be tight because certification tests must be developed, ?vetted, and implemented by certification bodies so that  EHRs have lead-time for software development, certification, upgrade/installation, and training by October 1, 2012.   The work ahead is in 4 areas:

1. Vocabulary - we need to reduce the optionality and alternatives for vocabularies and code sets.   Multiple vocabularies create significant complexity for vendors and users.  We need a library of constrained codesets that comprise 95% of transactional volume and value i.e. 300 LOINC codes are sufficient for 98% of all ordered lab tests.

2. Upgrade from paper to electronic data transmission - we need to increase the specificity of data transmission standards (i.e. Direct, Connect, Exchange should support most point to point and query/response use cases).   A major focus of standards work should be the content, vocabulary and transmission standards needed for care transitions.

3. President's Council of Advisors on Science and Technology (PCAST) - we should implement pilots and experiments which will provide the foundation for the kinds of query/response transactions suggested by the PCAST report.

4.  The Nationwide Health Information Network specifications should be upgraded to include content and transport standards needed for meaningful use.

Next, Arien Malec reviewed the real world experience deploying Direct.  Feedback has been generally positive and lessons learned include issues of certificate management and challenges of integration into complex corporate email systems.  The Standards Committee was very pleased with the progress and looks forward to upcoming Best Practices and Compliance guides.

Jim Walker accepted the position of Chair of the Clinical Quality Workgroup.   The Workgroup scope includes reducing barriers to implementation of quality measures, focusing on the cost/benefit of gathering the necessary data elements from the EHR including exclusionary criteria.

Dixie Baker presented the Privacy & Security Standards Workgroup Recommendations for Certificate Management   The committee accepted all 3 recommendations made by the Workgroup including:
*Requirements and evaluation criteria for digital certificates
*Need for investigation of alternatives for cross-certifying digital certificate issuers with the Federal Bridge (important for interoperability between non-Federal and Federal organizations)
*Policy Questions for the HIT Policy Committee related to creating a trust fabric for health information exchange

Next, Walter Suarez presented the specifications for entity level provider directories based on input from the HIT Policy Committee.   Standards will be needed for
*Directory Structure and Content
*Submission of directory entries to a National Registry via a publication/posting protocol
*A directory query language

On April 13, the Policy Committee will finish its requirements for Individual Level Provider Directories (ILPDs).  By May, the Privacy and Security Workgroup will present its standards recommendations for both entity level and individual level provider directories.   Although there is much work needed to harmonize standards for the entire directory ecosystem. In the short term, the most important work is the ability of an EHR to query a provider directory.   That is likely to be a stage 2 certification item.

Jamie Ferguson presented a summary of the March 28 Device Hearings.   Major themes were
*Consumers and patients need device interoperability to be inexpensive and easy
*The last mile of connectivity into home devices is currently a barrier
*EHRs need a place to collect device and patient submitted data
*Incentives need to be aligned so that clinicians are willing to accept and review device data
*Patient identity needs to be specified in the transactions between the device and the EHR/PHR
*Standards need to support end to end communication from the device to the EHR and not just to/from intermediaries/hubs/service providers.
*Device interoperability should be included in Stage 3, not Stage 2

Finally, Judy Murphy and Liz Johnson presented their plan for ensuring future NIST scripts and supporting tools reduce the burden of certification including such items as
*the need to pilot scripts
*the need to ensure medications and labs in the scripts are clinically reasonable
*the need to ensure certification criteria such as security requirements are easily testable
*clarifying how modules can be assembled, inheriting the certification characteristics of each
*ensuring the availability of tools needed to test every standards-based transaction

A great meeting.   We're all committed to creating standards and certification criteria for Stage 2 that will address the needs of all our stakeholders.


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