NHIN Direct Face to Face Meeting
ONC Q&A with Doug Fridsma
August 17, 2010

Doug Fridsma, ONC
· At ONC, trying to get definition about what exactly NHIN is.
· Overall, NHIN is a set of standards, policies, and services that allow us to use the Internet for secured exchange of information.
· NHIN Connect: software to connect gateway to gateway.
· NHIN Exchange: people came together to exchange info, use Connect the specs to exchange info.
· NHIN Direct = series of specifications.
· To support Meaningful Use, we needed to have other ways to exchange info, it wasn’t one size fits all.
· Question for ONC: What is the best way to expand the kind of change and engage a wide audience, with government serving as a platform for people to do what they care about doing to work toward common goal?
· Aneesh Chopra will be on Commonwealth Blog and will be highlighting things happening at NHIN Direct.
· People see this initiative as something transformational.
· Services, standards and polices…now need some way to collect and organize so we don’t have duplication.
· Recent announcement that a series of contracts were awarded.
· ONC currently creating “Standards and Interoperability” framework
· Need to be maintained, kept track of, change with time and environment, and have a life cycle that needs to be supported.
· Start with use cases, storyboards and go all the way until those things in our head become 1s and 0s that computer understand.
· Within S&O framework, developing specs that are sufficiently robust and can be used for certification.
· Not acceptable to have specs with word docs linked to other word docs.
· Need computational ways of capturing our requirements and being able to manipulate.
· Within S & I framework need outward facing group using user stories.
· Using the National Information Exchange Model (NIEM), process around data interchange.
· If we can move discussions around harmonizing standards as far up the food chain as possible, we can make a lot better choices.
· Team will take user cases and translate into NIEM articles.
· Our hope is that as we make constraining choices and trace how decisions were made, and then produce something that is not a word but an executive summary and XMI or XML description for people to build tools.
· Can use XML to figure out specifications.
· At end of the day, NHIN Direct is an experiment to see if this is a good model for us to reproduce to develop specs.
· So far it has been a success. We’ve moved much further, much faster, in a way that will lead to the adoption of standards.
· Standards are only standards when people use them.
· Within healthcare reform bill, Section 1561: need to develop standards for insurance.
· Using NIEM to create eligibility criteria.
· Working with CMS exploring whether we can take quality measures, conceptually to see if data that gets exchanged can be mapped to the data we want to measure.
· S&I might not have an architectural overview, and Exchange keeps going.
· Goal: implementation of specs that are useful and specific, to lose some of the ambiguity.
· VLER project, mixed results (Beacon community for stage 2, stage 3 MU):
o Not specific enough, too much optionality, having trouble getting exchange to occur.
o Need to break down into building blocks.
Janet Campbell
· Question from Documentation Workgroup: Gateway Connect, Exchange, overall?
Doug Fridsma
· Within Gateway there are a series of services. CMS uses directed exchange, series of those things; connect specs that have gateway in front, then the adapter.
Janet Campbell
· So is there a way to refer to the standards in our documentation…a good noun?
Doug Fridsma
· Will think about it. Probably are other slides that outline what the terms are.
· Difficult to separate parts sometimes within Connect.
Arien Malec
· Difference between certification and MU: If I use NHIN Direct, will it qualify for MU?
Doug Fridsma
· Has to be very careful, speaking on behalf of the US government. CMS actually writes the checks.
· Issue: to quality for MU, need to use certified tools, and NHIN Direct is not part of the certification criteria.
· Want providers to have the capability to meet MU, so can buy piece of software…this one has been checked, it has everything I need…based on CMS criteria.
· Much of the work within stage 1 is about conformance to those standards. First, need certified EHR, then need to use in a meaningful way.
· But it is a very important question. Philosophically: don’t want to lock industry into set of standards that are two years old.
· Certification needs to not stand in the way of innovation.
· In the end, ONC and CMS have to make that call.
Question from Audience
· Is that question getting to them?
Doug Fridsma
· It is now.
· Trying to provide a floor and allowing people to move up.
· Rationale: you can’t hold someone accountable to a standard that doesn’t exist.
Gary Christensen
· I think what you are saying is the idea that you could use NHIN Direct to send info out of the EHR and it might not count for the certification?
Arien Malec
· There are people who tightly couple the certification with MU outcomes, but if you look at the NIST certification criteria, transport is left out. It starts and ends with a file.
Doug Fridsma
· One change from NPRM to final rule took REST and SOAP out of the certification criteria.
Gary Christensen
· Is there any doubt about the way you would qualify for MU?
Arien Malec
· Personally believes it is a process outcome, not conformance to specs.
· Certification requirements end with file import/export. Would be hard to meet MU by only getting certified.
Doug Fridsma
· ONC focuses on certification criteria on health records, CMS focuses on Meaningful Use.
Gary Christensen
· All EHR vendors have implemented, so it is a non-trivial answer.
Question from Audience
· If NHIN Direct is an experiment, what has happened in the past? Are there other projects that have not happened?
Doug Fridsma
· Would not say past efforts have been unsuccessful. There are lots of ways to develop standards, as in through SDOs (standards development organizations), or other consortiums of folks who have come together.
· Within NHIN and specs, a lot of standardization comes from inside the government then is broadcast out
· We feel the closest we can get to engage the people affected by the problem is getting them involved in the solution.
· This as an open/collaborative process, federal government supports collaboration in a convening role, with all stakeholders represented. When we started we didn’t know what the outcome would be.
Rich Elmore
· MU and NHIN Direct, what is the connection?
· How will this go forward into stage 2?
Doug Fridsma
· Stage 1 as conformance to standards. Even the CCR may or may not have the degree of specificity we need for the free flow of information, for exchanging info and using in useful ways.
· Two options for transition to Stage Two
o 18-20 months
o Look out 4 years and decide what stage 2 should be
G. Denrick Reichard
· Vendors, community are looking very closely at criteria and adoption of electronic health records. To what degree have the MU standards co-opted this?
Doug Fridsma
· Bonus money from HITECH bill.
· Perception problem.
Arien Malec
· Congress is also in the mix, CMS doesn’t control all.
Janet Campbell
· Suggestion for description as used in NHIN Direct documentation: “however when NHIN Direct is used to securely transfer data, it may satisfy some stage of MU.”
Doug Fridsma
· When we talk about NHIN Direct, still within that safe zone but will soon need to clarify the boundary. A lot of people putting time, money energy into the wrong answer are a bad thing.
Arien Malec
· Still have to meet MU, but NHIN Direct can help you get there.
David Tao
· S&I framework RFPs?
Doug Fridsma
· All but 3 of the contracts have been awarded as of this week.
· Big tent meeting: all in the same room, mid-September.
· Not months to years but rather weeks to months.
· Lightning speed. Found out in December it all needed to be done by March.
David Tao
· When it’s all done, what happens differently than what happens today?
· What is the outcome, impact once it is complete?
Doug Fridsma
· Challenge: no one-stop shop that had all the things we needed. Standards based on particular user cases “silos of excellence.” Hopes that within S&O there is a place people can go to figure out what the building blocks might be, which is fundamentally different from how most S&O practices work. Usually there is sharing earlier in the process. Hopes it becomes a resource for people interested in exchange.
· Important to separate requirements from the technology used to solve the problem.
· Requirements: how healthcare is delivered and what we need to do to take care of patients?
· If we can separate that, allows innovation to occur on the other side, can move at the pace of technology.
· 5-10 years ago, would all be talking about Cobra…Lock in our requirements too tightly and we inhibit our ability to drive innovation
· At end of day, shared understanding of requirements, independent of the technology used to solve it, can spike innovation.
Question from Audience
· Publishing of standards by reference is in law.
Doug Fridsma
· There are other models out there, ability to issue guidance.
· Some agencies have a yearly cycle. That may be where we end up.
Question from Audience
· As an international company, get somewhat concerned about standards. Will standards be implementable across globe?
· If different standards are used inside the US, and different standards used elsewhere, the company really loses a lot of ability.
Doug Fridsma
· Not the goal. Meets with all the English-speaking standards guys.
· Some work went through ISO.
· Other thing: AZ19 should adopt standards for voluntary consensus organizations. Goal is to get to the implementation specs but not to develop new standards.
· Even within the SDO, look at HL7, US is dominating the international scene
· S&I finds gaps to engage.
· NHIN Direct Project: is there an SDO we can go to in order get this recognized as a national or international standard?
· Don’t want S&I do become another SDO.
Paul Tuten
· Question about policy, standards, services?
Doug Fridsma
· One approach: we’ll tell you what is needed in the directory, and how to use, and then have people create business models around it.
· Another: have government version
· With NHIN Exchange, they have a UDDI and a certificate authority which helps with authentification.
· But the question is what is the right mechanism to enable this to occur?
Jason Siegel
· As a vendor, would be helpful to have a site to send messages, validate transport. CDC does this.
Doug Fridsma
· Had a conversation this afternoon with NIST. Have a series of conformance tests, need to expand beyond data in/data out. Need also interoperability.
· Product-level conformance, manual conformance, interoperability which is automated.
· Need pre-validation tools so people can bang up against it while they are debugging it.
Question from Audience
· Core set v. Menu set: There seems to be a dependency between core set and menu set, i.e. clinical summary and lab results. We were hoping to not have to do lab results in the menu set. Is there another step?
Doug Fridsma
· For core/menu set questions defer to Tony of CMS.
· For certifications, all EHRs have to be certified because do not know which core/menu set a provider will need to meet.
Question from Audience
· Is CMS going to support NHIN Direct for admin transactions?
· Similar to SSA connect issue.
· Much easier way for CMS to get info.
Doug Fridsma
· Stay tuned, as this is only a recent issue.
· CMS recently joined Connect. CMS has many different user cases. They are not using NHIN Direct yet.