Get Ready for EHR and NwHIN Rules

Stage 2 Meaningful Use and NwHIN Governance Rules

Sometime in the next month three long awaited proposed rules from CMS and the ONC should be published. You can see below the links to the Unified Regulatory Agenda submission. These rules are under review by the Office of Management and Budget (OMB) and should be published in the Federal Register within the next month or so:

Medicare and Medicaid Electronic Health Record Incentive Program--Stage 2 (CMS-0044-P)

New and Revised Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology

Governance for a Nationwide Health Information Network

The Office of Information and Regulatory Affairs (OIRA) is located within the OMB. OIRA has a great dashboard that gives an overview of rules under review. This dashboard graphically presents information about rules under OIRA review through an easy-to-use interactive display, and it allows the public to sort rules by agency, length of review, state of rulemaking, economic significance, and international impacts. I will be following the rule making process closely and posting updates as information is available.

The NwHIN Governance rule is being done with a Advance Notice of Proposed Rulemaking (ANPRM). This is a step that entails publishing the agency's initial analysis of the subject matter, often asking for early public input on key issues. Any data or communications regarding the upcoming rule would be made available to the public for review. Occasionally, a board of potentially affected parties is comprised to do give-and-take bargaining over rulemaking subject-matter which would otherwise result in deadlocked opposition by an interested party. This is commonly called "negotiated rulemaking", and usually results in a more custom-tailored proposed rule.

Stage 2 Meaningful Use will be deferred for an extra year for those who attested in 2011

CONNECT Release 2.4

Thursday, March 25 there was a webinar on the newest version of CONNECT, an open source software and community that promotes IT interoperability in the healthcare system. CONNECT uses Nationwide Health Information Network (NHIN) standards and governance to make sure that health information exchanges are compatible with other exchanges being set up throughout the country. The webinar reviewed changes made to CONNECT as part of the 2.4 release. Presentation topics included:

• XDR Push Spec: The purpose of this specification is to provide the ability to "push" data for a given patient from one NHIE to another via configuration on the submission side. This is a different model of exchange than subscription because the sender decides who the data should go to and the receiver receives data on an appropriate available endpoint from the sources it authorizes.
• Support for UDDI (Service Registry) spec enhancements
• Subscriptions/Notifications; Secure Communications; Query by State; x.509 Certs
• Support for CRL (Certificate Revocation Lists) CA (Certificate Authority)
• Integrated Dynamic Document Assembly Components
• Universal Client support for Patient Discovery
• Authorization Framework enhancements: Support for two new SAML assertion fields
• Address Memory Consumption and Long Build Times
• Progress towards IDE Neutral Build Scripts

CONNECT Release 2.4 includes the initial trial implementation of a new NHIN service, Document Submission, which implements a push exchange pattern. Changes to the CONNECT architecture reflected in this Software Architecture Documentation are limited to minor revisions to include new Document Submission service. There are no other architectural changes.

The slides from the webinar are below and the audio will be posted:

3-17 HIT Policy Meeting

On March 17, 2010 the HIT Policy Committee met. There were reports from the Strategic Plan Workgroup, which outlined its vision of a “learning health system,” where patients, providers, government and technology will work together to generate knowledge to improve quality and clinical outcomes. The Certification/Adoption Workgroup reported on its patient safety focused meeting. And the NHIN Workgroup reported on its work and gave an update on the NHIN Direct project. There was also an update from the HIT Standards Committee and a report on the Certification NPRM. Tony Trenkle from CMS gave remarks on the over 200 NPRM comments received (of which 1/2 have been already read) and the process going forward (see analysis on Health System CIO Blog), while Jessica Kahn, also from CMS, discussed the Clinical Laboratory Improvement Amendments(CLIA).

Certification was a very important topic of the meeting. The NPRM proposing the establishment of certification programs for purposes of testing and certifying health information technology was issued earlier this month with a request for comments. The NPRM proposes a temporary certification program to assure the availability of Certified EHR Technology prior to the date on which health care providers seeking the incentive payments would begin to report demonstrable meaningful use of Certified EHR Technology. A permanent certification program will ultimately replace the temporary certification program.

My favorite slide is this one during the presentation on the Certification NPRM which Carol Bean, a Standards Harmonization Analyst at the Office of the National Coordinator, did a fine job of explaining:


















Another great slide was the animated version of Steven Posnak's explanation of how it works:

The audio is posted with the meeting materials below:

Download

• Agenda
  
• Strategic Plan Workgroup Update
  
  
  • Health IT Strategic Framework
    
• Certification/Adoption Workgroup Report on HIT Safety Hearing
  
  
  • Draft Summary and Recommendations
    
• NHIN Workgroup Report
  
• HIT Standards Committee Update
  
• Report on Certification NPRM
  
• Clinical Laboratory Improvement Amendments (CLIA)

NHIN Workgroup 3-16

The NHIN Workgroup met on March 16, 2010. The committee is working to create a set of recommendations for a policy and technical framework that allows the internet to be used for the secure and standards-based exchange of health information in a way that is both open to all and fosters innovation. This meeting focused primarily on the trust framework and the role of trust enabling organizations, while also touching on identity proofing and authentication. Another important discussion dealt with the implications of NHIN Direct for existing State HIE grantees planning efforts.

Understanding NHIN Direct will be very important to inform the work of states as they plan for HIE efforts. I love Dr. Fridsma's analogy: the NHIN Workgroup are providing the recipe (of specifications and services) that will allow the bakery (including state and local HIOs) to produce these delicious cakes of secure and meaningful exchange.

The audio is posted with the meeting slides below:

Download

Health Record Banks

The government is working to develop a nationwide health information network (NHIN), but it will require a system that can deliver a patient’s record completely, privately, and securely when requested. Much of that task rests on the health information exchange (HIE) model behind the NHIN.

The discussion of HIE models has barely begun, and the health record banking model is becoming a big part of the conversation. This model, based generally on financial banking, is the simplest solution to most data exchange problems. Health record banks centrally store copies of consumer’s health records, which providers deposit into the accounts. Consumers control which providers can contribute information and which providers and individuals can view their records.

The concept of a health record bank is simple: it would offer comprehensive information to providers about an individual, controlled by that individual, and stored in one secure location. Having patients control their health data is critical to the development of a NHIN. Patient-centered control is a central feature of the health record bank model. Patients would decide which healthcare organizations can access their records, and they could limit access to specific records.

There are many details that will still need to be worked out. The problem of establishing interoperability between different healthcare providers still exists for health record banks. Standardization needs to occur on a national level so that regional and state health record banks can communicate.

States that are planning health record banks may be ahead of the curve on developing true interoperability and ‘meaningful use’ of an electronic health records (EHR). Washington State’s experiment in consumer-controlled health records has begun a pilot phase, transforming the health record banking model from theoretical to actual testing. Earlier this year the Washington State Health Care Authority (HCA) announced the launch of three pilot sites that will try out the feasibility of a permanent statewide health record bank network. The Louisville (Kentucky) Health Information Exchange used a health record bank as the way to exchange patient information in building their HIE.

I think the health record bank model is an excellent idea. The Health Record Banking Alliance is a great place to get more information about how we can work together to create community repositories of electronic health records that are controlled by the patients. I can go to Montreal and pay for my dinner instantly with a swipe of my debit card, yet if I go the hospital twenty miles away, they need to make phone calls and burn up the fax lines to access my records. The records are printed, faxed, printed again and scanned into the receiving health information system (not very green is it). Technology has advanced tremendously in the last twenty years, yet we are still using these old methods for health information. We need to apply the same technology to our health information that we use for our financial information.