HIT Standards Committee: NHIN to build on interop initiatives, filling 'gaps

To move the Nationwide Health Information Exchange (NHIN) from a set of broad policies to production systems, the Office of the National Coordinator for Health IT (ONC) must translate strategy into operational actions, according to Doug Fridsma, MD, PhD, acting director of the Office of Interoperability and Standards at ONC. Fridsma made his comments during a presentation with Arien Malec, coordinator for the NHIN Direct, ONC.

The process of translating strategy into actions is best predicated on policy-driven criteria—including a process for dealing with dissent. It’s also important to build on existing standards efforts when possible, he said. “The challenge is not to be constrained by what has been done before,” said Fridsma. 

The Office of Interoperability and Standards organized its work based on five principles. “I’m not presenting you a final plan, but these are the principles we’re thinking about," he said.

Those principles are:

1. Representative participation: “It’s important to have good representation from standards and interoperability experts,” he said. At every step, “when we talk about developing use cases, harmonizing standards, unambiguous representations of data, [and] implementation specifications and how they might be used and tested, there has to be a spectrum of people who participate and provide input into that process.”
2. Transparency: “What we need to do has to be out there in public. We need to be able to have working documents; we need to be able to share things that are under review and that means leveraging things like wikis,” he said.
3. Responsiveness: “We also need to be responsive, need to move quickly to develop things that solve people’s problems, but at the same time provide enough time for deliberative thought about things and to be able to get adequate input.”
4. Accountability: “Different people need to have different responsibilities for different parts of the process,” Fridsma said. “As we think about putting all these pieces together, ONC serves a coordinating role in large part, but there is [a need for] people who can be stewards, perhaps, [who] can shepherd things through this process.”
5. Milestones & metrics: "We can predictively have processes that we can follow, that we can improve. If we produce a new thing every two or three weeks, it’s very disruptive to people who are trying to actually develop systems. If we wait two or three years, it’s also very disruptive because we don’t actually move together. It’s important to think about how to organize the process so we get measurable, planned results.”

The Standards and Interoperability (S&I) Framework includes use case development, harmonization of core concepts, implementation specifications, reference implementation and certification and testing. “It has to be an iterative, incremental process” in which people take small pieces and rapidly iterate them, said Fridsma.

“When we think about the NHIN, we think about it in terms for standards, services and policies. The S&I framework tries to document and help articulate what those standards are and what those services are. Implementation testing and certification becomes another piece,” he said.

Harmonization of standards will be iterative, as requirements are analyzed and mapped to data elements and services: “If we want this to be done in the open, it means we’ll have to designate things as being a draft, or working. And we will need some way to say ‘this has been reviewed and tested and been approved.' This is not meant to be a waterfall process, but we do need structured coordination,” Fridsma said.

In addition, the Office of Standards and Interoperability is trying to coordinate needs of the HIT Policy Committee with regard to policies for meaningful use and to produce standards to help with insurance eligibility. There are also the NHIN Coordinating Committee and Federal Health Architecture to be considered. The committee is also working with the Department of Veterans Affairs and Department of Defense’s Virtual Lifetime Electronic Record initiative to ensure NHIN support, he said.

“I envision that we will have input from one side of the equation from a variety of stakeholders and we will have a process in which we develop these implementation specs based on the [five] principles…and will try to make this iterative and incremental, and from that will come our certification and testing criteria and clear descriptions of the services, standards and policies that we need to help support this work,” Fridsma concluded.

During the question and comment period that followed Fridsma's presentation, ONC Chairman David Blumenthal, MD, keynote speaker at the event, added: “Congress was clear what it wanted to happen when it enacted HITECH. It didn’t say how that should be done. ONC is tasked with making that happen, I think we’re agnostic as to process, but not as to the results: drive development of standards in whatever way is most effective to realize that goal.”

Standards Committee members commented following the presentation. Some of those comments were:

• The S&I framework needs a principle of consensus-based decision-making—there needs to be a defined process, structure for achieving decisions about recommendation.
• The framework also needs an education and outreach component needed to help industry understand all the products that will be coming out.
• Consensus works best when it’s achieved by small group of people over a short group of time. Bringing 100 people to a decision that passes for consensus is not the same thing.