Now Is Not the Time for Regulations on NwHIN Governance

In the hyper partisan atmosphere of a national election there is a great debate on the proper role of government and the utilization of regulations versus free market approaches. I have always believed the meme promulgated by Tim O'Reilly and others that government functions best as a platform for innovation in the role of convener and collaborator. This is one of the bedrock principles of government 2.0. I'd encourage you to read "Open Government"  if this is a topic you are interested in. There is a great deal of overlap between open government and health information technology, especially as we look to digitize health records and provide interoperability while engaging patients in their care.

I have long thought that one of the best agencies within the federal government exemplifying government 2.0 and open government principles is the Office of the National Coordinator (ONC) for Health IT (see my post here for previous examples). Dr. Farzad Mostashari, the current National Coordinator, has continued and improved on this tradition. An example of that is the flexible and thoughtful approach taken to governance and health information exchange.

When the ONC asked for comments on their proposed governance for the nationwide health information network there was a chorus of responses that resoundingly asked to put the brakes on and take a more measured approach. One of the primary issues the governance attempted was to help create a framework for a strong trust fabric, which is necessary for health data exchange to scale. The rules were meant to provide the policies necessary to create and maintain this network of networks that would result in robust nationwide exchange. The HITECH has specific language which requires the ONC to establish a governance mechanism for the nationwide health information network.

NwHIN RFI had 66 questions regarding areas of proposed governance focusing on 5 areas:

• The establishment of a set of conditions for trusted exchange (CTEs)
• Validation process for entities to demonstrate conformance to the CTEs (and subsequently become an Network Validated Entity (NVE))
• Processes to update and retire CTEs
• Establishment of a process to classify the readiness of technical standards and implementation specifications to support interoperability related CTEs
• Approaches for monitoring and transparent oversight

There was very strong push back from the exchange community and many industry stakeholders were concerned that the process was moving much too quickly and a lighter approach should be considered. I joined with many groups in the process of responding to the RFI and shared many of these concerns. The NwHIN Power Team of the HIT Standards Committee also had some similar concerns. Across the board the comments indicated that the community thought that regulation at this time would actually slow the development of trusted exchange if it is implemented prematurely. And with the emerging governance activities of Healtheway for the eHealth Exchange (formerly NwHIN Exchange) and the work being done by DirectTrust.org to develop a strong trust fabric for the Direct community, a regulatory framework could actually stifle the process.

Well, the ONC was listening and have responded with a new approach. Dr. Mostashari and Jodi G. Daniel, JD, MPH who serves as Director of the Office of Policy and Planning at ONC gave an update to the HIT Policy Committee  on September 6, 2012 to outline their new approach to governance. Dr. Mostashari also posted a blog on the topic. It is important to note that the statutory requirement is to establish a governance mechanism, and that may not necessarily require rulemaking, but could leverage existing mechanisms. In any event there is no current legislative timeline requirement, so I appreciate that ONC is taking their time and being careful and flexible in their approach. I would encourage everyone to watch the webinar below:

ONC’s Proposed Strategy on Governance for the Nationwide Health Information Network Following Public Comments on RFI 

Governance for a Nationwide Health Information Network

The National Coordinator for Health Information Technology (the National Coordinator) is required by section 3001(c)(8) of the Public Health Service Act to establish a governance mechanism for the Nationwide Health Information Network (NwHIN). Through the newly published Request for Information (RFI), public comment will be sought on proposals and options relevant to the governance mechanism currently under consideration. Based on the public comments received, the National Coordinator will issue a subsequent notice of proposed rulemaking (NPRM) to formally propose a governance mechanism for the NwHIN.

Steven Posnack, Director of the Federal Policy Division, ONC gives an excellent overview during the National eHealth Collaborative’s NeHC University on May 11, 2012 of the rule, his slides are available HERE,  and I encourage you to watch the video below:



Governance for a Nationwide Health Information Network

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