The March HIT Standards Committee Meeting

Today's HIT Standards Committee included important discussions about NHIN Direct and a new Interoperability Framework supported by several ONC RFPs.

We began the meeting with a summary of the work in progress.

The Clinical Operations Workgroup is focused on vocabulary starter sets and ensuring implementation guidance is available.

The Clinical Quality Workgroup is focused on quality measure retooling to ensure meaningful use measures are EHR friendly.

The Privacy and Security Workgroup is focused on understanding all the consent standards currently available from different Standards Development Organizations and implementation guide writers.

The Implementation Workgroup is focused on creating a starter kit to accelerate EHR adoption and interoperability. Yesterday, I summarized the Implementation Workgroup "starter kit" testimony. During the meeting today the Workgroup synthesized the 10 lessons learned from the testimony into 3 major themes :

*Provide transparency to all the available resources - funding, tools, and technologies
*Clarify the requirements of meaningful use data exchanges through the use of FAQs and other online resources
*Provide simple interoperability guides with enough detail and samples so that a typical IT professional could implement interoperability

We discussed the best way to include specific implementation guidance in the Interim Final Rule, realizing that legal restrictions may limit our choices. In our IFR comment letter we recommend that broad families of standards be specified along with detailed implementation guide "floors" which will be amended through guidance letters issued outside the regulation. This strategy enables short term specificity and long term evolution/innovation. If the legal interpretation is that we cannot issue implementation guidance letters outside of regulation, there are existing government models that we can consider as alternatives i.e.

*NIST issues regular updates to the Federal Information Processing Standards (FIPS)
*CMS issues regular updates to the Physician Quality Reporting Initiative (PQRI)
*Private sector organizations provide updated implementation guidance via voluntary consensus groups (i.e. CAQH, WEDI, IHE)
*Open source communities provide continuous version releases. Although not a regulation or a single solution, such work provides reference implementations that can be widely adopted by stakeholders and become defacto standards.

We'll await legal guidance to determine next steps.

Next, Doug Fridsma presented NHIN Direct. David Blumenthal offered an introduction that identified NHIN direct as a "project" not a "product" that is designed to be responsive to customer requests, especially from small practices.

NHIN Direct does not replace existing NHIN standards, policies, and software. Instead NHIN Direct will explore simple data transport strategies for point to point communication. Over the next 6 months, it will explore the use of SMTP/TLS, REST, and SOAP implementations with running code. It will provide a way to transport data, not the only way.

Data exchanges required by stage one of Meaningful Use include e-prescribing, public health lab reporting, syndromic surveillance, immunization, and patient summary exchange (both provider to provider and provider to patient). The scope of NHIN Direct does not include new content/vocabulary standards, master patient indexes, or aggregations of data for quality reporting. It's complementary to existing NHIN Connect work and state HIE efforts. It is not to be feared and there is no reason for states to slow existing efforts while the NHIN Direct experiment is in process.

Next, Doug presented a framework for interoperability comprised of 7 components.

*Use Case Development and functional requirements
*Standards development
*Harmonization of Core Concepts
*Implementation specifics
*Pilot Projects
*Reference Implementation
*Conformance Testing

Several RFPs have been issued to support these efforts. They will leverage the lessons learned from HITSP and I'm confident that the HITSP efforts will be foundational to this next phase of work. I see the Harmonization of Core Concepts RFP as the evolution of HITSP and I suspect many HITSP volunteers will be involved, regardless of how the contract is awarded.

This seven step process will use the National Information Exchange Model (NIEM) approach as means to organize the work. Important aspects of the work ahead include:

*A b ottom up process to define requirements based on data exchanges that are needed to achieve meaningful use and meet the business priorities of stakeholders
*Delivery of fully integrated, well specified implementation guidance
*Electronic test scripts to ensure conformance and an active feedback loop to improve standards once testing has identified deficiencies

David Blumenthal emphasized that NIEM approaches, although used by the Department of Justice and Homeland Security, have absolutely no possibility of facilitating entry of healthcare data into law enforcement databases.

Carol Bean and Steve Posnack reported on the Certification NPRM temporary and permanent processes. Key points included

*Certification applies equally to EHRs and EHR modules
*Permanent certification separates the testing lab function from the certification function
*There will be multiple testing labs and certification organizations that will compete on price and service offerings. Accreditation processes for testing labs and certification organizations will ensure consistency among service providers.
*Site certification methods will be used for self developed EHRs
*No double certification will be necessary i.e. a site could purchase vendor products which are certified and self build portions of an EHR which will be site certified. There is no need to seek additional certification for the combination of the built and bought products. Making them work together to achieve meaningful use is the responsibility of the implementing organization.

A great meeting today. I look forward to the work ahead as we continue to provide tools, technologies, and educational materials in support of meaningful use data exchanges.