The June HIT Standards Committee meeting

Today's HIT Standards Committee meeting had a rich agenda.

The recurring themes were the importance of governance, the interdependency of policy and technology, and the need for objective criteria to measure the appropriateness of standards choices.

We began our discussion with a presentation by Doug Fridsma of the ONC Standards and Interoperability Framework which includes use case development, harmonization of core concepts, implementation specifications, reference implementation/pilots, certification, and testing.

The intent of the Framework is to ensure standards gaps are filled as necessary to support meaningful use and healthcare reform. The Framework provides the means for managing the standards lifecycle, enabling re-use, and ensuring standards meet functional requirements. Although the Framework is comprised of 11 RFPs, it will function as a single process, guided by a Concept of Operations plan (ConOps). The principles driving the ConOps include representative participation, transparency and openness, responsiveness, accountability, and measurable/planned results.

Next, Arien Malec reviewed the NHIN Direct consensus proposal of the NHIN Direct effort. The NHIN Direct groups have suggested SMTP/TLS as the backbone with SMTP/TLS, REST or SOAP at the edges to communicate with a Health Internet Service Provider, which provides backbone exchange services.

After hearing the NHIN Direct presentation, the committee emphasized the importance of providing policy guidance to constrain the NHIN Direct technology implementations, the need for the HIT Standards Committee to serve as a "Board of Directors" reviewing NHIN Direct progress at key checkpoints, and the need to communicate the scope of the NHIN Direct project - what is considered part of the NHIN Direct effort and what is an additional service provided outside the scope of the project.

A policy example includes the notion that a HISP routing service need not examine the contents of the message during the routing process. Technology should be chosen that makes this policy possible.

A scope example includes the idea that a SOAP/XDR to SMTP or SMTP to SOAP/XDR converter should be something provided by NHIN Connect or the EHR vendor and not by the NHIN Direct project which is simple point to point communication, not standards conversion.

Next, Mary Jo Deering discussed NHIN Governance. The important takeaway from her presentation is that there will be a unified approach to NHIN Governance - not a collection of disconnected NHIN projects with their own governance. There will be hearings and ultimately regulation issued in 2011 to define NHIN Governance. The Standards Committee applauded this approach as it addressed the governance concerns we had with the NHIN Direct project.

Next, Deven McGraw presented the Privacy & Security Tiger Team Update. She outlined the general principles enumerated by the Tiger Team to ensure data exchange, especially NHIN Direct routing, discloses the least amount of data possible during transport. The Tiger Team created a framework describing 4 different kinds of intermediaries which support data exchanges. The Standards Committee recommended that the concept of intermediaries be replaced by the notion of "services" and that policies should apply to the types of services offered.

Aneesh Chopra presented the Enrollment Workgroup Update, a comprehensive plan to specify the eligibility and enrollment standards needed to support Healthcare Reform. Numerous new tools will be available to payers, providers, and patients to streamline administrative data flows. An early example of the kind of tools that will be created is Healthcare.gov, a new website that makes insurance information available to patients and will soon include comparative costs of insurance.

Janet Corrigan presented the Clinical Quality Workgroup Update outlining the progress on retooling existing 2011 quality measures and selecting 2013 measures.

Jamie Ferguson presented the Clinical Operations Workgroup Update: Electronic Document Standards for Discharge Summary & Other Encounter Summaries, describing a means to reuse templates for the creation of summary documents which support meaningful use data exchanges. Keith Boone provided an excellent summary of the discussion on his blog.

Finally, Steve Posnack and Carol Bean updated the Committee on the Temporary Certification Program. Numerous organizations have expressed interest in serving as Authorized Certification and Testing Bodies, so unlike the past there will be multiple bodies with market competition on price and service quality for certification services.

A great meeting which clarified many aspects of the NHIN Direct project, the Interoperability Framework plan, and the evolving governance of healthcare information exchange in the US.

I look forward to our July meeting, which will hopefully review the final standards rule and final meaningful use rule.

The Indian Health Service Interoperability Plan

As part of the Greater Boston Beacon Community Grant resubmission, the grant collaborators worked with the DOD/VA and Indian Health Service to ensure we could seamlessly exchange data required for care coordination and population health. Developing the plan required that we understood the interoperability strategy of the DOD/VA and Indian Health Service.

Today I'll focus on the Indian Health Service.

Here's a strategic overview of the IHS interoperability plan provided by IHS CTO Mike Danielson.

The architecture follows the NHIN Exchange approach using NHIN Connect software. Interactions with IHS will be "pulls" and "pushes" using XDS.b

IHS hopes to have widescale production use of their interoperability infrastructure by the end of 2011.

At the moment, they are watching the NHIN Direct project with great interest. Presumably, since the NHIN Direct effort will plug into the NHIN Exchange effort, small provider offices will be able to post clinical records to IHS via NHIN Direct. The strategy will become clearer as NHIN Direct evolves.

The ONC Privacy and Security Tiger Team

In many previous blogs, I've mentioned that privacy and security are foundational to healthcare information exchange. A suite of policies covering authentication, authorization, auditing, consent, transmission, and encryption constrains technology possibilities and thus empowers consensus processes to harmonize the security infrastructure that supports policy.

ONC has had many groups working on privacy in the Policy Committee, the Standards Committee, and the NHIN Workgroups. Now that Joy Pritts is the Privacy Officer for ONC (in essence the healthcare IT privacy officer for the country) she has unified all these disparate efforts into a single Tiger Team, focused on resolving many challenging healthcare information exchange policy issues over the next few months.

The members are all incredible people who really understand the domain

Paul Egerman, Co-Chair

Deven McGraw, Co-Chair, Center for Democracy & Technology

Dixie Baker, SAIC

Christine Bechtel, National Partnership for Women & Families

Rachel Block, NYS Department of Health

Neil Calman, The Institute for Family Health

Carol Diamond, Markle Foundation

Judy Faulkner, EPIC Systems Corp.

Gayle Harrell, Consumer Representative/Florida

John Houston, University of Pittsburgh Medical Center; NCVHS

David Lansky, Pacific Business Group on Health

David McCallie, Cerner Corp.

Wes Rishel, Gartner

Latanya Sweeney, Carnegie Mellon University

Micky Tripathi, Massachusetts eHealth Collaborative

They have already met numerous times, following a very aggressive schedule. Their early work has been to suggest policies that will support the NHIN Direct effort.

Their basic recommendation thus far is that protected healthcare information should not be exposed in routing, unless necessary for transmission from A to B. Standards that expose more information than necessary in metadata or mix metadata and content should be avoided.

Sometimes inspection of a content payload has value such as ensuring conformance with a standard or providing translation from one standard to another. However, from a policy perspective it is reasonable to say "The payload need not be inspected or changed during transmission”

Tomorrow, the Tiger Team is hosting an important Consumer Choice hearing.

The purpose of the hearing is to learn more about the capabilities of existing consumer choice technology and the potential for future development in this area. The morning session will focus on consumer choice technology in use today in health information exchange. A user of the technology will speak about their specific implementation of the technology, accompanied by a demonstration. The afternoon session will take a look at consumer choice technologies that are in the development stages for use within health information exchange. The developers have been invited to demonstrate either a prototype of the technology or its current use, and discuss its potential for further development within health information exchange.

I look forward to the work of the Tiger Team. When policy and technology are developed in parallel, each supporting the other, everyone wins.

The final Temporary Certification Rule

In the past, I've posted bookmarked versions of the Standards IFR, the Meaningful Use NPRM, and the Certification NPRM.

The final Temporary Certification Rule has just been published.

Robin Raiford bookmarked the Federal Register version. Thanks!

Interesting points in this rule include :

*To qualify for stimulus incentives, providers must use EHRs certified by an Authorized Testing and Certification Body (ATCB).

*Organizations can apply to become ATCB's starting July 1. The rule describes the process.

*There is no restriction on the number of ATCB's.

*There is no grandfather clause for previously certified EHRs by CCHIT i.e. everyone must re-certify everything.

*CCHIT must apply to become an ATCB. I spoke with Karen Bell, the CEO of CCHIT, and they will be submitting an application.

*EHRs certified under the ATCB program will remain certified when the permanent certification program replaces the temporary certification program. HHS expects that a final rule for the permanent certification program will be issued by Fall 2010 and that the permanent program will be in place in 2012.

Reconnecting With My Past

My 30th High School Reunion is August 14, 2010 at the Point Vicente Lighthouse in Palos Verdes, CA. I've not attended previous reunions and my schedule will likely not permit me to attend this one. I've not stayed in regular contact with anyone from my high school class, but I've exchanged a few emails via Facebook with my 1976-1980 friends.

Now that we're all approaching 50, we're curious about each other. What have we become, where have we been, where are we going?

This week I've had the opportunity to meet with 2 people I had not seen in 30 years.

In many of my blogs, I share lessons learned from my experience. What can I share about exploring my youth by meeting with friends from 30 years ago?

1. Our memories for the past are selective and we tend to suppress anything unpleasant. When I was 18, I was indefatigable, my health was perfect, my responsibilities were few and my only anxieties included SATs scores, my GPA, and college applications. In retrospect, it seems an idyllic time, but was it? I've forgotten the adolescent angst of feeling rejected by the mainstream for being socially awkward. I've forgotten the uncertainty of not knowing what the future would bring. Trying to recapture the glories of the past is truly a quixotic task. Do I want to replay my high school years? Definitely not. I prefer living in present, savoring my family, worklife, and current dreams for the future.

2. Evaluating success is a subjective process. To me success is defined by the difference you make, not your bank account balance, the size of your house, the hot tub in your Learjet or your annual lifestyle burn rate. You can make a difference for a spouse, a child, a workplace or an industry. Only you can decide if you are satisfied with your life.

3. Asking "What if" questions is not useful. In my past I've made many choices - call them forks in the road. I was admitted to Yale, Brown, MIT, Johns Hopkins, Stanford, and UC Berkeley. I was rejected from Harvard. I chose to go to Stanford. I met my wife there. My daughter was born as a result. My early exposure to the computer industry, to entrepreneurship and leadership were a direct result of being in Silicon Valley from 1980-1984. In 1983, I turned down a leadership job at Microsoft (present value of stock options could be $100+ million). In 1983, I patented e-greeting cards and early multimedia technologies but the patents have not been enforced. I was admitted to several medical schools (but rejected from Harvard) and went to UCSF. I made a decision to pursue bioengineering and information technology even though I was advised in 1985 that these fields would not go anywhere. I could have chosen many other paths - I might be richer, I might be poorer, I might be famous, I might be unknown. It does not matter and there is no value in looking back.

4. You are as old as you think you are. I try to maintain a healthy lifestyle - vegan, caffeine-free, ensuring daily exercise, reserving time outdoors for mental health recovery, and limiting alcohol to a glass or two of wine per week. Rather than focus on the endurance I've lost or the increased recovery time I experience after strenuous workouts, I focus on how much better I feel than when I was a super-sized fast food, 2 latte a day, sedentary, overstressed person in my 30's. By thinking about wellness, I feel as good as I have ever felt. I look forward to increasing activities as my free time expands post retirement (whenever that might be) including walking the Appalachian Trail, trekking in Nepal, and exploring new activities that I've never had to time to investigate. Each of us measures our mental age differently. I think of 50 as the beginning of another stage of life, not a milestone of age.

5. The journey is more important than the destination. In my life, I've been a hobby shop clerk, a programmer, a manager, a leader, a doctor, a winemaker, a musician, a naturalist, a handyman, a father and a husband. Who knows what awaits. I treasure each of my experiences, and do not think of any of them as an endpoint. Along the way I've had some unusual experiences, great joys, and occasional sorrows. What defines me is not where I am today, but how I got here. Job titles, belongings, and the issues of the moment are ephemeral. A lifetime of experiences, relationships, and emotions define each individual.

It was great seeing old friends and thinking about our lives 30 years ago, but I'm happy to be who I am today, a result of all the good and bad decisions I've made.

Now forward, ever forward, to the next 30 years!

Formal Authority

I was recently told by a newly promoted IT leader, "I have a great new job with more responsibility but lacking more authority"

My response - none of us really have authority or if we do, we seldom use it.

In thinking about my own leadership life over the past week, I've had to make numerous decisions based on incomplete and contradictory information from stakeholders.

If I said something like "I'm the CIO and a Senior Vice President. Since I hold the top technology job, I have authority over all technology decisions and by command we will do X", my stakeholders would lose all respect for me.

In each case this week, I was handed complex issues with "he said/she said" controversy. It would have been easy to resolve the issues with a simple "formal authority" email to remove the issue from my queue. And my decisions would have been completely wrong.

Although listening to each side of the story takes time, it's the only way to understand the nuances and technical complexity to make a sound decision. Email is not a good way to resolve controversy.

First, I identified the stakeholders on each side of each issue and called them. After listening to their input, I outlined a governance process with objective criteria to evaluate the options. The stakeholders agreed to the process, the criteria, and the authority of a governance workgroup to make a decision.

Then, we set up meetings or phone calls where all the stakeholders could speak with each other, make their points, and come to consensus. If consensus could not be achieved, then a vote would be taken. If the vote was a tie, I would decide based on pros/cons assigned to the objective criteria.

Using this approach, we've brought most of the issues of the past week to closure and I've not had to use formal authority.

One consequence of this approach is that it does not create passionate winners and losers. It does not make the CIO the bad guy. When the next issue arises, stakeholders will trust the process and not even remember the controversies of the past.

When I was young, I believed that leaders had it easy - they had such power that they could just exercise their authority to make decisions and get work done.

The reality is that the more responsibility and visibility you have, the less formal authority you can exercise.

So next time you get promoted, accept the mantle of leadership knowing that you're accountable, but your only true power is leveraging the trust of your stakeholders.

And remember, for everything there is a process.

Decision Support Service Providers

In my recent Leiter Lecture, I spoke about the idea that decision support services should be available in the cloud. BIDMC has 2000 decision support rules. Brigham and Women's has 2000 decision support rules. They are entirely different rules maintained by two teams of experts. That's lunacy.

Shouldn't we have have a single set of evidence-based rules that everyone in the country can use?

But how would it work and what standards would be used?

I serve on the Board of AnvitaHealth (note the Conflict of Interest), which is working on this problem.

1. First, rules need to be authored by experts or gleaned from the literature and represented electronically in a decision support cloud.

2. Second, an XML form of patient history needs to be sent to the Decision Support Service Provider. For example, the problem list, medication list, recent labs, age, and gender could be sent in a Continuity of Care Document without specific patient identifiers.

3. Third, the Decision Support Service Provider should respond with clinical care advice, such as drug/drug interactions, alerts/reminders, or wellness guidance

Here's a concrete example. For brevity, I included only pertinent portions of the XML input data. The XML could contain any arbitrary length of data elements and codes sets.

Here's an example of an XML patient data input file (CCD is also natively supported)

The XML response is a realtime answer to every rule set run. Thousands can be executed in realtime (milliseconds). Here's an XML response that indicates two drug safety issues – a drug-disease (MAO+Hypertension) interaction and a dangerous drug-drug combination at severity level 1 (fetanyl-containing meds and MAO inhibitors)

Here's an XML response that indicates a laboratory gap in care. In this case, the patient is taking an ACE Inhibitor and does not have recent serum electrolytes. The compliance to this rule is thus false (underlined).

Thus, Anvita has defined clinical decision support (CDS) standards to transmit decision support recommendations from the service provider back to the EHR. I am unaware any widely implemented standards that do this today.

Additionally, the XML response object is hierarchical. Any response (drug safety, gap in care, etc) can be drilled down further to any level of detail, including the drug package insert, for example. However, for speed of response, Anvita returns portions of the XML response initially.

Additional details from Anvita:

1. The patient data set (longitudinal health record) can be sent to Anvita’s web service as XML or CCD. Anvita’s XML anticipates and extends attributes necessary for decision support, such as presence or absence of different types of dialysis, which are not yet required by CCD.

2. Anvita’s engine includes (a) decision support function requests (e.g., check drug dose, get formulary, find safety-check therapeutic alternatives, find gaps in care) and also (b) utilities, such as: search functions using descriptions within codesets like CPT, NDCs, the ability to find all drugs within a therapeutic class, find all LOINCs that infer the same physiologic laboratory test, etc. Anvita utilitizes freely available vocabularies for maintaining local dictionaries, their synchronization, and taxonomies. The modularity of (a) and (b) allows homegrown systems and next-generation applications to be developed without having to deal with the complexity of thousands of pages of implementation guides pertaining to drug databases, industry codes like CPT, LOINC, NDC, semantic interoperability between non-congruent databases (due to the Anvita Thesaurus), as well as coding of hundreds of quality/ performance measures that Anvita provides out of the box (e.g., HEDIS), in a plug-and-play fashion.

3. A decision support request, posed as XML, returns a response object for that request. The response XML can include drug safety analysis, gaps in care analysis and scoring, formularies, cumulative radiation exposure, etc. Therefore, Anvita is a generalizable, semantic search engine that executes in realtime as a web service. Anvita’s realtime capability not only enables decision support at the Point of Care, but business functions such as electronic prior authorization using EHR data (e.g., high tech imaging).

4. The analytical responses can be delivered as either XML (for instantaneous consumption at the Point of Care) or written directly to an alerts database (for population analytics). The analytical database can be viewed/queried directly by Anvita’s web-based tool or it can mined by 3rd party business intelligence tools (e.g., Cognos, Business Objects, JasperSoft, Pentaho).

5. Anvita also has supporting tools that include:

a. A Rules Authoring application, so that a non-technical specialty society or policy group (e.g,. NQF-endorsed entities) can author computable performance measures without any software coding at the atomic level

b. A Rules Management application, so that local organizations and physicians can decide and configure which rules to run (e.g., Meaningful Use), including the rules they’ve authored themselves and that might be proprietary (e.g., electronic prior-authorization criteria).

I do not present this as an advertisement for Anvita, but as a generalizable, modular approach to decision support in the cloud that could be implemented by many companies instead of duplicating expert resources in every hospital and health information exchange.

Decision Support Service Providers is a concept that is ready for prime time.