The Implementation Workgroup Testimony

Yesterday I spent the day in Washington with the HIT Standards Committee's Implementation Workgroup . The online forum to comment about standards adoption and implementation is now available.

The first article was posted by Aneesh Chopra, the US CTO. The second, my summary of the standards work thus far, will be posted this morning. Additional articles will be posted by others members of the HIT Standards Committee in the next week.

Whenever I hear testimony from teams of smart people, I try to distill everything I've heard into "Gold Star Ideas" - those themes that surfaced over and over. Here are a few:

1. We've learned from other industries that starting with simple standards works well. Mastering web transport standards such as REST takes minutes. Learning RSS takes an hour. Learning HTML takes a day. In the healthcare domain, I learned the basics of HL7 2.x, X12 and NCPDP in about a day.

2. Keep the standards as minimal as possible to support the business goal. Design for the little guy so that all participants can adopt the standard and not just the best resourced. Do not try to create a one size fits all standard - it will be too heavy for the simple use cases.

3. Start immediately rather than waiting for the perfect standard. Use early implementation experiences to create great documentation. Leave aspects of the standard open for future expansion and let innovation occur after adoption.

4. Declare a long term goal for new standards implementation but in the short term map what exists to new standards at the border of the organization rather than convert all existing legacy systems.

5. In early phases of implementation, allow ambiguity in the standard (what Adam Bosworth called Hysteresis) so that implementers can start simply and improve the completeness of their interfaces over time.

These are all reasonable principles. How do we apply them to the meaningful use standards we're all working on?

I asked one group of testifiers to tell me their views about the maturity of standards for the 4 required data exchanges in 2011. Here are their answers, interpreted against the 5 criteria above

ePrescribing - we have a mature standard (NCPDP Script 8.x) that is being enhanced to support new features (NCPDP Script 10.x) on a reasonable timeframe with minimal burden. We have test harnesses, middleware and clearinghouses that will accelerate adoption. We have an ecosystem of application developers. There is work to do to encourage more transactions to flow, but we're in generally good shape.

Lab - we have a mature standard for messaging (HL7 2.x), however we have numerous versions already implemented that will require mapping to HL7 2.51, since replacing all HL7 2.x in legacy systems will be burdensome. The real problem is not the HL7 but the lack of a single national lab compendium of the minimal set of LOINC codes for the most commonly ordered tests that should be implemented by all labs (commercial and hospital). CLIA is also an issue, requiring validation of every interface even if the same interfaced is cloned over and over for the same products. HITSP has already prepared a LOINC subset (700 codes instead of 20,000). The work ahead is part policy (reform CLIA) and part standards. The HIT Standards Committee has established a new workgroup on vocabularies and one of its first charges should be to ensure the appropriate LOINC subsets are available for general use. Regulation should require use of these subsets for lab ordering in 2013.

Administrative transactions (Benefits/Eligibility, Claims etc) - we have a mature standard for messaging (X12 4010) and transport (CAQH Core II). We have new enhancements on the way (X12 5010) that provide value. We have test harnesses, middleware, and clearinghouses that will accelerate adoption. We have many companies that build applications to support administrative transaction exchange. There is work to do to encourage more transactions to flow, but we're in generally good shape.

Quality - a consistent complaint is that every stakeholder (payers, government, specialty specific registries) require different quality measures with different data elements and definitions. There was broad agreement that the work the NQF has done and is doing to select a few consistent measures, with clearly defined data types, and retooling them to be EHR-based (not paper record) is the right thing to do. The measures will likely require controlled vocabularies and we need to be sure the right SNOMED-CT, LOINC, and RXNorm vocabularies plus mapping tools are available to report data in a normalized format for quality measurement.

My synthesis of the advice we received from all the panels is:

Creating controlled vocabularies/code sets is consistent with the simple standards goal. You can imagine an implementation guide that defines an XML format and then points to a website that contains publicly available vocabulary content (such as that developed by NLM or licensed for public use such as SNOMED-CT). Engineers would have no problem downloading and implementing a publicly available vocabulary code set.

Keep transport simple. Several testifiers noted that content and transmission should be separate standards, leveraging the web when possible for transport so that implementers do not need to learn new transport standards.

Get everyone to send the basics - medications (highlighted by everyone as a high value data exchange), problem lists, and labs before focusing on the esoteric.

Security is very important but privacy policy is even more urgent. We can very significantly constrain the number of security standards if a policy framework outlines our goals. For example - do we need a standard-based audit trail for every organization or is it sufficient to create a policy that an audit trail must be available to patients showing who accessed what and when?

What action items should we take?

I would like to get the input from other HIT Standards Committee members, but action items seem to be

1. Work hard on vocabularies and try to get them open sourced for the entire community of stakeholders

2. Consider adding a simple REST-based transport method for point to point exchanges

3. Work jointly with the HIT Policy Committee to establish a privacy framework that enables us to constrain the number of security standards

4. As we continue our work, try to use the simplest, fewest standards to meet the need

5. Continue to gather feedback on the 2011 exchanges - eRx, Lab, Quality, Administrative - to determine if there are opportunities to enhance testing platforms and implementation guidance that will accelerate adoption.

I look forward to continued discussion.

That 70's Show

My parents recently remodeled their 1970's home, removing the formica, shag carpeting, and textured ceilings.

Seeing their modern home made me reflect on my personal history in 1976 when their home was built.

I had just started high school at Palos Verdes High. I was a cross country runner and a geeky engineering type wearing aviator glasses, a shaggy haircut and weighing 120 pounds. This photo is of me, Will Snow (my best friend from high school), and a team of engineers from Rockwell. We had the opportunity to tour the Columbia Space shuttle and explore its engine components as they were being built in Southern California. Will and I stay in touch and he recently completed a 125 mile bicycle ride for Multiple Sclerosis in honor of his first wife and my father. He's a senior engineer at SUN (now Oracle).

To give you a real flavor of the 1970's, take a look at my Prom picture (above), now 30 years old. Hillary Stoltz and I attended the prom in Santa Monica, with me in blue velvet including a frilly 1970's tuxedo shirt. By this time, my haircut was evolving to the short and simple way I wear it today. Hillary went to Georgetown and I went to Stanford. I've not reconnected with her since 1980.

The 1970's were a simpler time - no email, no mobile devices, no global village. The competition to get into college was easier and the pace of life was slower. The economy had its ups and downs, we had gas lines, and we had the disco craze (which I ignored). The folk music was soulful, the living was casual, and the fashions were awful.

It was a generally happy time that prepared me well for the challenges to come.

If any folks from my 1970's past are readers of my blog feel free to comment! I'd welcome an update from any of my high school cohort - Phil Talbert, David Kratz, Adrienne Lee, Hillary Stoltz, Gretchen Zimmerman, or Marcia Rorty.

Implementation and Adoption Hearings

Tomorrow from 9am to 4pm at the Omni Shoreham Hotel in Washington DC, the Implementation Workgroup of the HIT Standards Committee will hold hearings to identify enablers and barriers to the adoption and implementation and standards.

We've assembled a great group from non-healthcare industries, providers, vendors and quality measurement organizations. Testimony will include

Non-Healthcare Industries Panel

Skip Best and Davis Miller, Covisint

Adam Bosworth, XML and SQL

Clarence So, Salesforce.com

Providers Panel

Andy Wiesenthal, MD, Kaiser Permanente (IDN)

Dick Taylor, MD, CMIO, Providence Health, Portland, OR (IDN)

Rick Warren, VP/CIO, Allegiance Health, MI (Community Hospital)

Lisa Bewley, RN, VP/CIO, Regional West Medical Center, Scotts Bluff, NE (Community Hospital)

Louis Spikol, MD, Allentown, PA (Small Practice)

Floyd "Tripp" Bradd, MD, Front Royal, VA (Small Practice)

Vendors Panel

Rick Ratliff, SureScripts

Arien Malec, Relay Health

Sean Nolan, MicroSoft

Girish Kuman, eClinicalWorks

Chris Stevens, Orion Health

Quality Measures Panel

Ralph Brindis, American College of Cardiology

Richard Gliklich, CEO, Outcome Sciences

Jesse Singer, NYC Health

Barbara Rabson, Massachusetts Health Quality Partners

Jack Bowhan, Wisconsin Collaborative for Healthcare Quality

What kind of testimony can you expect?

In non-healthcare industries, standards have been used to coordinate the supply chain. What tools and techniques were used to encourage the entire manufacturing ecosystem to participate?

Do we need better educational materials such as implementation guides that include all the base standards so that there is no "indirection" - jumping between implementation guide websites and standards development organization websites?

Are there gaps in standards that need to be filled to encourage adoption in different healthcare environments?

The real purpose to the meeting is to encourage transparency and build a feedback loop that connects real world users of standards with the organizations that govern and create standards development.

During the meeting we'll kick off a new website that will enable the public to post comments about standards, privacy, and implementation experiences, including the ability to rank ideas via social networking tools. I'll post the URL to the new website tomorrow.

To participate in the meeting, join by audio conference or webcast.

I look forward to hearing your feedback!

"Project" and "Product" Certification

Last Friday night I testified to the President's Council on Science and Technology (PCAST). Many issues were discussed, but one of the most interesting was the idea of "project" verses "product" certification.

Here's the significance.

In Massachusetts, Partners Healthcare and Beth Israel Deaconess use home built EHR solutions based on Intersystems Cache. We both use Sun's eGate (now Oracle) and Intersystems Ensemble as middleware. We both use datamarts/data warehouses based on extracts from our clinical systems to support quality reporting, performance measurement and research. We both use NEHEN as our healthcare information exchange.

We'll achieve meaningful use via this combination of applications with many moving parts. Its totality provides the tools our stakeholders need. We need to certify the sum of the "project" and not the individual "products".

"Project" certification can be empowering in other ways.

Imagine that innovative products such as Microsoft Healthvault/Amalga or Google Health offer services to aggregate data from multiple data sources as part of quality reporting. They can become accelerators of meaningful use.

Imagine that a Modular EHR (such as Quest's Care360) plus a Healthcare Information Exchange can store the lab and medication data needed to coordinate care. Quest and iPhone app innovators can accelerate meaningful use.

My experience is that federated authorship - harnessing the talents of many companies and individuals - leads to the most rapid innovation.

Of course, some of the most advanced aspects of meaningful use, such as comprehensive decision support, may require larger, fully integrated EHRs. But other aspects such as the data exchanges required for 2011 - eRx, Lab, Quality reporting, and administrative transactions - can be empowered by assembling multiple products and services.

Since the theme of the work of the HIT Standards Committee for the next few months will be accelerating standards adoption and implementation (more on this in my blog tomorrow), encouraging all stakeholders to innovate by creating reusable components in support of meaningful use seems timely.

As the Notice of Proposed Rulemaking (NPRM) is written to define the certification process, I encourage policymakers to certify "projects" in addition to "products", encouraging innovation. I have no direct influence on this work, but I am hopeful that industry and clinician stakeholders will provide this input to those writing the policies.

Accelerating Implementation of Laboratory Standards

On October 20, the Information Exchange Workgroup of the HIT Policy Committee heard testimony from laboratory information exchange experts and stakeholders.

The agenda and testifiers included:

Business Issues related to the Electronic Exchange of Laboratory Data

▪ Mike Nolte, GE Health Systems

▪ Vasu Manjrekar, eClinicalWorks

▪ Phil Marshall, WebMD

▪ Tim Ryan, Quest Diagnostics

▪ Susan Neill, Texas Department of State Health Services

Business Issues related to the Electronic Exchange of Laboratory Data

▪ Laura Rosas, New York City Primary Care Information Project

▪ Sarah Chouinard, Primary Care Systems, Inc. and Community Health Network

▪ Raymond Scott, Axolotl Corporation

▪ Areg Boyamyan and Jim Timmons, Foundation Library

Regulatory and Policy Issues

▪ Joy Pritts, Georgetown University Health Policy Institute

▪ Don Horton, LabCorp

▪ Jonah Frohlich, California Health and Human Service Agency

▪ Walter Sujansky, Sujansky & Associates

You'll find an unofficial transcript here. (Thanks Brian!)

The major themes of the day were

1) Labs are complicated - there is great variation in the standards used, vocabularies adopted, and the way labs are ordered (there is no universal ordering compendium, but this is a project that HITSP and the HIT Standards Committee are working on)

2) CLIA is considering allowing “simultaneous delivery” of results to a Health Information Exchange instead of just to the ordering clinician

3) State laws are highly heterogeneous, as is enforcement

4) We need adoption and implementation of robust messaging and vocabulary standards. We should focus on the 300-400 tests that make up the vast majority of ambulatory lab transactions, and create a national mapping for those.

5) Lab results/ordering according to a well-defined national standard should be part of EHR certification

6) Meaningful use payments to hospitals should be contingent on their delivering outpatient labs according to the same standards recommended for EHR vendor certification. (I agree with this - BIDMC has committed that all its lab delivery to external organizations will use HITSP and HIT Standards Committee recommended standards in time for 2011 Meaningful Use payments.)

7) EHRs need to be conformance tested against specific standards to reduce the cost of interfaces.

A great day of testimony. I know that change is difficult but universal adoption of the HITSP Lab Result Capabilities, which provide significant implementation guidance for HL7 2.51 messaging, LOINC, UCUM, and SNOMED-CT will reduce the cost of lab interfacing. This, combined with the HITSP Lab ordering Capabilities to be completed by January, will accelerate adoption and implementation.

I support universal conformance testing of products for certification and a requirement for all stakeholders to use these standards as part of meaningful use criteria to claim stimulus funds.

Since 2011 data exchanges for meaningful use require Laboratory result exchange, there is urgency to do this. Over the next few months, the HIT Standards Committee will be spending a great deal of time discussing the ways to reduce barriers and enhance adoption so that we achieve the interoperability we need.

Cool Technology of the Week

I'm sitting at Logan Airport awaiting a plane to Washington to testify at a meeting of the President's Council of Advisors on Science and Technology at the National Academic of Sciences.

A few minutes ago, I noticed that the tarmac was empty of planes and numerous black SUVs appeared. Then I noticed a few military folks running around the roof of Terminal C. I looked to the north and saw a large 747 approaching - Air Force One.

Realizing that today is Friday and its time for my Cool Technology blog, I'd like to declare Air Force One the cool technology of the week. I've always wondered what electronics are on board. Here's an overview from HowStuffWorks

"The most remarkable feature on the plane is it's extensive electronics. It has 85 onboard telephones, a collection of two-way radios, fax machines and computer connections. It also has 19 televisions and assorted office equipment. The phone system is set up for normal air to ground connections and secure lines. The president and his staff can reach just about anybody in the world while cruising tens of thousands of feet in the air.

The onboard electronics include about 238 miles of wiring (twice the amount you'd find in a normal 747). Heavy shielding is tough enough to protect the wiring and crucial electronics from the electromagnetic pulse associated with a nuclear blast.

Some of the most interesting parts of the plane -- it's advanced avionics and defenses -- are classified. But the Air Force asserts the two planes are definitely military aircraft, designed to withstand an air attack. Among other things, the plane is outfitted with electronic counter measures (ECM) to jam enemy radar. The plane can also eject flares to throw heat-seeking missiles off course."

And where did all those black SUVs and support equipment come from? In advance of every Air Force One flight, the Air Force crew sends C141 Starlifter cargo carrier planes, carrying the president's motorcade to the destination. This collection of bulletproof limousines and vans, loaded with weaponry, keeps the president safe on the ground.

Air Force One is effectively a secure, mobile data center - that's cool!

The Books on My Nightstand

A year ago I wrote about the books on my nightstand. Here's an update of what I'm currently reading:

The Deadly Dinner Party by Jonathan Edlow - a great collection of medical mysteries written by my colleague in the BIDMC emergency department. You'll find hard to solve cases with diagnoses such as botulism, typhoid, and bath water infected with tropical organisms from piraña. House meets Sherlock Holmes.

The Lady and the Monk by Pico Iyer - The story of world traveler Pico Iyer's year in Kyoto and his immersion into Japanese culture. As a fan of Japan, I can certainly relate to the rich experiences he describes in his travels. Some folks have suggested that my disciplined life, black attire, and continual pursuit of a simpler existence gives me a monk-like character.

The China Study by T. Colin Campbell - A great overview of the relationship between nutrition and health, including the consequences of eating an animal-based diet.

Food for Life by Neal Barnard - I've been chatting with a few policymakers about the importance of nutrition and recently exchange emails with Dr. Barnard. In the book, he suggests his own food groups (grains, vegetables, fruits, and legumes), then discusses the positive impact of a vegan diet on health.

Blue Book of Bike Repair by Calvin Jones - Having recently replaced my hybrid mountain bike drive train , I found this book by the Park Tool Company to be an invaluable guide to modern bicycle components and repair.

Mushrooms Demystified by David Aurora - This book is the mycologists bible and is what I use for the hundreds of mushroom consults I do every year. I recently worked with the ICU team at BIDMC on an Amanita ingestion and this book was a great guide for me.

Dogs and Demons by Alex Kerr - Alex is a great observer of Japanese culture and he explains how the Japanese economy is built on public works projects that are destroying the natural beauty of the country.

Anthology of Japanese Literature by Donald Keene - Donald Keene is the finest editor of Japanese traditional literature for English Language readers. This book contains selections of just about every genre of Japanese literature from No plays to novels.

A self published book of sonnets - 30 years ago when I was 17 I wrote sonnets in memory while cycling up and down the California coast one summer. My 16 year old daughter is writing sonnets in her AP English class, so I pulled my collection from my archives. Here's a sample (I was 17 at the time, so be kind)

An Ageless Plea

If old age brings the wisdom new lives seek,

Then why am I here writing all alone?

With well earned trophies of triumphs to speak,

An withered hands that built your cornerstone.

For pity I won't grovel or request,

Remember - what I've done you'll later do.

And if you somehow think your youth is best,

Remember - what I am will soon be you.

Through years of angst and conflict I have run,

Though now in worthless solace I'm confined.

Replaced as some machine whose task is done,

An obsolescent prisoner of time.

I stare through frozen windows in self doubt,

Wondering if it's colder in or out.

The books I wrote a little later in college were actually published and you'll find them on Amazon.

Other than my own works, I can highly recommend these books as great reads.