HL7 Officer Elections are now open, I'm running for Chair, please VOTE (for me).

The CDA Book is sometimes listed for Kindle here and it is also SHIPPING from Amazon! See here for Errata

Saturday, July 30, 2011

IHE ITI Technical Framework XDW Supplement for 2nd Public Comment


IHE Community,

IHE IT Infrastructure Technical Framework Supplement Published for Public Comment

The IHE IT Infrastructure Technical Committee has published the following supplement to the IHE IT Infrastructure Technical Framework for Public Comment on July 29, 2011

  • Cross-Enterprise Document Workflow - Rev. 2.0 (XDW)
The document is available for download at http://www.ihe.net/Technical_Framework/public_comment.cfm. Comments submitted by August 26, 2011 will be considered by the IT Infrastructure Technical Committee in developing the trial implementation version of the supplement.  Comments should be submitted at http://www.ihe.net/iti/iticomments.cfm 

For a bit more detail, see John Moehrke's post.

Friday, July 29, 2011

A Vision Shift

Vision shift was the title of one of the first slides we reviewed at the HL7 Board Retreat this week.  It appears below.


Today
Tomorrow
Follow the curve
Ahead of the curve
Stovepipes and silos
Systemness
Policy advice
Policy advocacy
Clinical focus
Clinical to also enable financial
Incremental growth
Vigorous growth
Doing too much with too little 
Having the resources to do it right 
Hope for adoption
Enable adoption
Believe in value
Demonstrate value

The left hand column is where HL7 is today.  The right hand column is where we want to be.  This is feedback from the HL7 Advisory Council, but feedback that was widely acknowledged on the HL7 Board as both truth and vision.

I was impressed by the vision presented here.  I was even more deeply impressed by the work of the business model tiger team in their preliminary framework for a business plan.  I was astounded by the action taken by the board today to operationalize those parts of the framework that are ready to be initiated, and the trust they placed in the HL7 executive leadership to do so.

Some few have been following a discussion that Arien Malec started with the XKCD cartoon that's been making the rounds, and that Wes Rishel followed up on (if you cannot see it, ask Wes to make it public).  Not one person on the HL7 Board or the Advisory Committee is a social media geek, and I don't think any of them present are on Google+.  Yet, this slide, and the subsequent actions of the board seem as if they were designed to be a direct response to some of Wes's critiques.

There are some follow up actions for other members to craft a communications plan about what was decided today, so I won't go into all of the details.  In short, there are some very positive outcomes about making HL7 more accessible to others, demonstrating value, encouraging cross enterprise architecture thinking (systemness), and enabling, rather than hoping for adoption.  It's not about what do we have that can solve your problem (I have a hammer, show me your nails), but rather, let us think about what the real stakeholder pain points are, and how we might help to address them, with what we have today, or with what we could be doing ourselves or in conjunction with others.

Who knows, perhaps the next ONC S and I initiative that you hear about could originate from an idea started from within HL7.


Thursday, July 28, 2011

Market Adoption Data Sources for IHE XDS and related Profiles

Twice now in the past week I've been asked for market data on IHE XDS and related profile adoption, directly or derivatively from one querant ... ONC.  I'm not a marketer, but I know some resources where you can scan for data on this.  By the way, as far as IHE XDS goes, I'll bet there is more freely available information than on any other interoperability specification.  I challenge you to find this kind of data available on any other interoperability specification without paying a pretty penny for it (Market Analysts take note, people want this data!).

I'll start with the Where in the World is XDS Map which is a crowd-sourced map of XDS implementations. I started that a couple of years ago in response to a query broadcast by a market analyst from Gartner. As Wes points out, people have a lot of incentive to get on the map, but not to update it. I do a refresh every now and then from a number of sources (the HIMSS Interoperability Showcase is a great place to learn about these implementations). But that was February, and this is July, and my notes from them are still sitting on my desk because other things have been more pressing.

Another good source is IHE Integration statements, which you can get to via the IHE Connectathon testing results site.  Any system listed there shows what profiles a vendor has TESTED.  If there is a folder next to the vendor, that provide a link to their integration statements, which can be inspected to determine what systems are shipping with a particular profile.

A third source is the IHE Integration Statement registry that has recently been rolled out.  I know there are systems missing from that, for a variety of reasons, including the newness of that system.

A fourth source is the Open Source list that I keep track of.  These don't often have published integration statements nor registration entries.

A large number of systems in the US are using CONNECT Open source, and they keep track of adopters on this page (which is another one of my data sources for map updates).

Lastly, although in part probably due to the XDS Map, which I originally created for a one person audience. Gartner published it's Hype Cycle for Healthcare Provider Technologies and Standards, 2010 last year (around this time). IHE moved from Sliding into the Trough to Climing the Slope.  The author of that report (my audience) was asking some of the same kinds of questions about XDS adoption more than a year and a half ago as ONC is asking now.

So, if you want data about adoption of XDS, I've given you some great places to start.  It's neither in my skills, nor my role1 to put the rest of it together for you, but at least you have a good starting point.

   Keith

P.S. HIE industry, please take note. People are asking about your deployments. To add entries to the XDS map, just contact me for access.

I do work for a vendor with products in this space.  Any market intelligence that I have that is NOT public knowledge isn't something that I can freely share with others -- sorry.

Wednesday, July 27, 2011

A Wickedly Fresh look at CDA through Microdata and HTML5

So I said yesterday that I had an idea forming in the back of my head around Microdata and CDA Release 3. It ties into a previous post on using XHTML to represent CDA R3 Narrative, and goes even one step further to eliminate Version 3 XML representation from the document altogether, replacing the V3 modeling with Microdata.

In HTML5 Microdata, there are five important new attributes supporting microdata that can appear on any element.

  • itemscope - A boolean attribute indicating the presence of a new semantic item in the content.
  • itemtype - A URL giving the definition of the item's type, only allowed on elements that define items.
  • itemprop - The name of property on an item.  It may be used in conjunction with itemscope and itemtype to define a property returning an item.
  • itemid - A globally unique identifier (in URL form) for the item.
  • itemref - A pointer to a set of identifiers where additional properties can be found (vitally important).
If you understand how objects are put together in JavaScript as bags of named properties, you should be able to understand Microdata pretty easily. 


Now, what we need to be able to do is to map an HL7 Version 3 model onto microdata.  That is what an ITS does by the way, maps the HL7 models into a representation.

These Property bags that microdata creates can represent just about anything you want them to, including the full RIM based model.

There are some things though, that HTML5 already does that is CDA-like that should be preserved.  For example, there are elements to handle sections and their titles correctly so you can ignore the H1-H6 problem.  There are other elements that handle timestamps well.  So, you can interweave your V3 model into the narrative with a well-constructed Microdata ITS, and that model can come from any V3 Domain, and you can have a standardized RIM representation of it as well.  That RIM representation can be constructed directly from the HTML5 representation using some of the developing APIs.  This is remarkably simple stuff that could eventually make CDA R3 simply a profile of HTML5 + Microdata + an ITS.

It will be an interesting thing to explore in more detail.  BUT don't expect a specification in 90 days folks.  Let's let Microdata get out of the W3C process before we go gung ho into the NEXT S&I Framework process.  What I think we should be doing is experimenting with this now so that as the W3C further develops microdata, we can provide valuable feedback.

One thing I know I don't like (but could get used to) is the way itemref works.  I come from an NLP background.  In that space, you usually build semantic objects from the bottom up, not the top down.  When building from the bottom up, it's easy to find different parts of a thing in different places in the text.  For example, you could have three spans of text, on containing a test result, the next the normal range, and the last, the interpretation of it.  Spans 1 and 3 are part of the observation.  Span 2 is part of a reference range associated with it.  Each of these parts might be discovered by a separate NLP process, and want to be linked BACK to the item that it belongs to, rather than having the item link to all of its parts.  Either way works from a modeling standpoint, because an ID/IDREF link can be traversed in either direction.  Using itemref makes it easy (and possibly more efficient in existing parser implementations) to find the parts later.  Reversing the linkage so that the part points to the whole keeps the parts that you are examining (and possibly annotating with microdata) in one place.   The efficiency argument is based on the fact that many parser implementations will index items by their id.  But you could just as easily index an IDREF using a particular name to find all things that point to a particular id.  It's just that parsers today typically already maintain the ID index, and don't necessarily deal with one of IDREFs.

Tuesday, July 26, 2011

EHRA Web Cast: A Pragmatic Framework for Achieving HIE

A few months ago, the EHRA began a white-paper on HIE standards. This web-cast, open ro all interested parties (EHR Vendors and all others), reviews the results of that work. If you are involved in HIE activities at any level, I urge you to watch.

 

Good afternoon, EHR Association,

 

This Thursday, the Executive Committee and the Standards & Interoperability Workgroup are hosting an EHR Association web cast based on the recently published white paper “Supporting a Robust Health Information Exchange Strategy with a Pragmatic Transport Framework.” Registration details are below.  Please contact any of us with your comments and questions.

 

Carl Dvorak, EHR Association Chair, Epic

Charlie Jarvis, EHR Association Vice Chair, NextGen

Leigh Burchell, Allscripts

Pamela Chapman, e-MDs

Jason Colquitt, Greenway Medical

Mickey McGlynn, Siemens

Rick Reeves, CPSI

Justin Barnes, EHR Association Chair Emeritus, Greenway Medical

Mark Segal, EHR Association Vice Chair Emeritus, GE Healthcare

 

 

 

Thursday, July 28, 2011 10:30 am, Eastern Daylight Time

-------------------------------------------------------

To register for the online event

-------------------------------------------------------

1.    Go to https://himss.webex.com/himss/onstage/g.php?d=926703701&t=a&EA=agorden%40himss.org&ET=1189dea2523c7b96b88e10d5e8bcde1a&ETR=8cd3cd1987ab761bad3478f409bb73b9&RT=MiMxMQ==&p

2.    Click “Register”.

3.    On the registration form, enter your information and then click “Submit”.

 

Once the host approves your registration, you will receive a confirmation email message with instructions on how to join the event.

 

-------------------------------------------------------

For assistance

-------------------------------------------------------

You can contact Angie Gorden at:

agorden@himss.org

 


HTML5 BookReview



One of the "gimme's" at the O'Reilly HealthFoo event was a free e-Book (from O'Reilly of course).  Since I no longer code HTML pages for my day job, I'm a bit behind on the current state of affairs with HTML 5.  So, I picked out a likely sounding title from the list yesterday.  Today I downloaded, and just finished reading Mark Pilgrim's HTML5: Up and Running.  


As tech-books go, this one won't make the average uber-HTML-geek happy, but it fit my profile just fine.  The typical tech-book is either reference, or tutorial (some do both).  This book didn't fit either of those patterns.  It provided some interesting history of HTML at the beginning.  The biggest focus of the book was describing some key features of HTML5.

The key features Mark described were:
  • Article Structure
  • Canvas
  • Video and Audio tags
  • New Input Controls
  • Micro-Data
  • Offline Applications
  • Local Storage
  • Geolocation

He describes quickly the benefits of each, support for them in common browsers, and enough about how they work that your boss could understand it.  If you aren't an HTML uber-geek, this is a good place to get started, but don't expect to learn how to make wicked cool HTML 5 apps that run on tablets from this book.  It just doesn't go to that level of detail. 

Overall, its a good, quick overview of HTML 5.

-- Keith

P.S. I have an interesting idea to explore wrt microdata and CDA R3, that I'll talk more about later

Monday, July 25, 2011

Another Ad Hoc HealthIT Award

Those of you who have been reading for a while know the deal. For those who don't: This is an award I give out about 5 times a year to recognize a significant contribution to the development of Healthcare Standards. The contribution is often a singular one, and when it isn't, I don't do repeats in the same year. I'm the sole arbiter and judge. There is no contest or nomination period (although nominees are always welcome).

Over the last few weeks the HIT Community on Twitter has been voting on the #HIT100, and then the #HIT5, producing the #HIT1.  Not to upstage @theEHRGuy, but to add to the recognition that Social Media has had on Healthcare Standards, I decided that it was time to give a Harley to the person who best represented what it means to be involved in both.

The next winner of the Ad Hoc Harley is an individual who blogs about Healthcare Standards and Social Media, communicates regularly through Twitter, FaceBook and elsewhere, and who has been a leader in Social Media as it is related to Healthcare IT.  Through that person's actions, I've seen the development of at least one other HIT Social Media champion in the #HIT5, and the creation of yet one more tweet chat using their work as an example.

This certifies that 
Erica "@TheGr8Chalupa" Olenski of CorePoint Health


Has hereby been recognized for outstanding contributions to the forwarding of Healthcare Standardization through the Use of Social Media

Erica, thanks for all that you do, and for all the late nights you spend on #HITsm and other tweet chats. I can think of no-one else who's had a more direct effect on others in Healthcare Social Media.

   Keith

P.S.  Just for fun, I've timed this post to go out a couple minutes before the start of tonight's #HITsm tweet chat, with the appropriate hash tag.

What ARE you afraid of?

I read a post earlier today talking about concerns of a healthcare organization that would be sharing its data with its patients.  One of the concerns was that sharing the data (with a competitor) would make it easier for the patient to get care elsewhere.

There is so much that is wrong with that attitude.  If you have to lock your customers in because they've already got an investment with you (their data in this case), and that is how you sustain your hold on them, then there is something fundamentally wrong with your business model.  This is true whether it is the data, or as I often experience in the standards space, an interface (e.g., for lab reporting).  What you should be focusing on is providing the best customer service to retain customers, not on "locking them in because you have their data."

If you believe that sharing your data with other healthcare providers will make it easier for customers to leave you, you need to ask yourself who benefits most by the sharing.  If it is your competitor, you need to provide better service to your customers, but sharing data only exposes an already existing weakness.  If it is you, you have nothing to be afraid of. If it is your customers who benefit most, then you already have the right attitude, and there is nothing to be afraid of either.

So, figure out what it is you are really afraid of, and fix that.  And you can start with providing your customers with better service by making their healthcare data more accessible to them as really good first step.

Thursday, July 21, 2011

HealthIT Standards Chat

OK, I've been dabbling in the #HITsm tweetchats, and I've decided now that I need to really take the plunge.  Here is my plan:

Every other Wednesday at 5:00 PM Eastern Time (to give @GrahameGrieve a 7:00am start) starting August 10th, I'm going to host a tweetchat on Healthcare Standards (hashtag #HITstd) every other week (it may become more frequent as there becomes demand).

I'll set the broad topics for the first few as follows:

August 10th: Clinical Document Architecture (CDA, CCD, C32, CDA Consolidation questions welcome)
August 24th: Integrating the Healthcare Enterprise, PCC, ITI and QRPH Domains
September 7th:  CCR with special guest @techydoc

The way it will work is that I'll start, introduce the topic, and then you ask your questions.  I and other experts and implementers who are participating will try to answer your question, or point you to where you can find your answers.  Not every question has an easy answer to write in 140 characters.  Some may result in blog posts later.  Some questions might be answered with IDK (I don't know).  We'll see what happens and how things evolve.

I'm gonna need some help here.  I know HL7 Version 2, Version 3, CDA, and IHE PCC and ITI profiles, and some from QRPH.  I need people who know NCPDP, X12, Direct and other specifications and standards to help.

The last few of minutes we'll wrap up with how to address outstanding answers needed, and may ask for input on subsequent topics.

   -- Keith

P.S.  Stay tuned for Monday's #HITsm Tweet-chat.  I have something fun up my sleeve.

The Evolution of a Problem and its Solution

One of the well received pieces of feedback on the IHE Reconciliation profile this week was about the maintenance of identifiers for information items produced as a result of a reconciliation process.  Essentially, if you incorporate a fact about a patient into your EHR that was externally sourced, you have to retain and reproduce the identifier you originally recieved with it.  We had made that a strong recommendation, but due to feedback, changed that to a requirement.

As a result, we needed to address another issue, which is how information evolves over time, and how its identity changes over time as well.

There are a number of interesting cases:
  1. Status Updates
  2. Changes in Treatment 
  3. Additions of new Information and relationships 
  4. Correction of Erroneous Information
  5. Disease Progression 
  6. Changes in Diagnosis
Status Updates
Status updates do NOT change the identity of an act that has been recorded.  Over time, order #### has been placed, shipped, canceled, received, paid et cetera.  Over time, diseases are active and resolved, treatments (e.g., medications) are active, completed, canceled or discontinued.  Et cetera.  If during the reconciliation process, you make a status change, it does not change the original identity of the item.   

Changes in Treatment
Medication X is discontinued, replaced by medication Y, or is used in a different dose and/or frequency are examples of this case.  In this case, the Status of the old medication is changed (to completed or , and a new medication information item is created with a new identity.  The status of the old item is changed to reflect the reason kind of change made.

If a medication was discontinued without replacement before it was expected to be finished normally, it would be marked as "aborted".  Marking an act as "aborted" is a cue that the act was terminated abnormally without any replacement.

If it was discontinued without replacement before it was expected to be finished normally, and a new medication replaces it, it should be marked as "obsolete".  The new information item can be marked as the previous acts replacement.  If dose or frequency are changed, it should be treated the same way.  Marking an act as obsolete is a cue that that you should look for a replacement.

If the medication completed normally (e.g., a three month prescription), and its replacement is different (in medication or dose), then it should be marked as completed, and the new information item with a new identity can be linked as its successor. 

Corrections
This old piece of data was incorrectly recorded, and a new piece of data replaces it.  Again, pretty easy.  In this case, the old information item has its status changed to "nullified", indicating that it was incorrect, and the new information item has a new identity, and can be marked as the replacement for the old one.  This kind of correction only applies when there have been mistakes in entry or reporting of the information, NOT when there have been mistakes in judgement (see changes in diagnosis below).

Additions
Let's say that you have an allergy with a known manifestation of hives.  Subsequently, it is determined that a new manifestation exists that is anaphylaxis.  The new manifestation has a new identity, but is attached to the old allergy and the identity of the old allergy does not change.  Similarly, you can have an assessment of the severity of a particular disease.  The assessment may change over time.  Each time it changes, it takes on a new identity, but the original observation to which it applies does not change its identity.

The addition of descriptive attributes previously unknown (e.g., a stop date), also would not change the identity of an information item.

Progression of Disease
Influenza can eventually result if not treated into pneumonia.  This is a natural progression of disease along a particular pathway.  In this particular case, the progression to pneumonia is a new observation on the patient with a new identity, and the previous observation can be retained as well with its existing identity, because both are true. Note, in this case, the "concern" act from which the influenza observation originated would have a new observation associated with it for the pneumonia.  The identity of the original concern does not change. There are cases where the diagnostic categories form a progression that excludes the previous category (e.g., Stage I Cancer vs. Stage 2 Cancer).  In these cases, the original observation

Changes in Diagnosis
This is the stickiest one to deal with.  A change in diagnosis is a new judgement, clearly, and that has a new identity.  However, I'm not sure what to do with the old one.  If the previously recorded diagnosis of X was made as the result of a clinical judgement, and it is incorrect, the following things are true statements:

  • A previous diagnosis was made that the patient had X.
  • That diagnosis was incorrect.
I think the right way to handle this one is that same as if you decide to change the treatment for a patient.  The old diagnosis is marked as "aborted" (NOT nullified).  

My reasoning is this:  The old diagnosis (or assessment) did exist.  Marking it as "aborted" indicates that the line of reasoning was prematurely terminated (e.g., in light of new information).  If instead, it had been marked as nullified, it would have indicated that the diagnosis was reported or entered incorrectly, which is in fact, NOT the case.  It may very well have been reported and entered correctly, but was made based on incomplete or incorrect information.  When a diagnosis is changed in this way, it indicates that the providers judgement has changed, and follows the recording pattern whether that judgement is about the condition the patient is suffering from, or the treatment they are given.

This doesn't solve every issue.  One thing I'm still struggling with is how to deal with "holds" or temporary suspensions of medications.  I believe the right way to handle this is to report every suspension event along side the medication event.  I think of suspensions to be a new event (an override of a previous decision based on temporary factors).  Reporting both allows the receiving provider to be aware that a patient is NOT currently taking their medications (e.g., due to a pending surgery).  However, I think what we need to do with this particular issue is call it out as being something that needs a profile without addressing it in the reconciliation profile.



PublicHealth should be Patient Centered Too

Some recent discussions got me to thinking about Public Health again, possibly because I've been spending a significant amount time with the IHE Quality, Research and Public Health technical committee and individual members this week.  Some time ago I wrote about "Taking Cost out of the System".  Let's list some of the activities that individual providers and organizations need to engage in with public health:
  • Reporting Immunizations
  • Getting Immunization Data (if you are lucky)
  • Reporting information to disease specific registries (e.g., Cancer)
  • Reporting Syndromic Surveillance Data
  • Reporting Notifiable and Reportable Laboratory Reports (and Orders)
  • Pediatric Lead Testing 
  • Early Hearing Screening
  • Reporting Birth information
Three of these are already part of Meaningful Use Stage 1 here in the US, and others are expected to become part of Stage 2.   With few exceptions, all of these different reports go to different silos, using different messages.

When we look at Federal law covering exchanges with public health, it is noted as an exception to the usual rule of "No PHI", although many public health agencies choose to limit the amount of PHI they receive to make their systems less costly and easier to work with.

I'd like us to think about a different model for dealing with public health.  It's not the "Send the question to the data" that Wes Rishel or I talked about in recent postings, either.  Who bears the burden of performing the query?  It's not public health, its the individual providers and organizations who would have to receive and process it.  That really doesn't make public health's life any easier.  There are just as many systems to send the queries to, the data is not "normalized" as it is when public health silos up, and the queries aren't quickly done for ad hoc purposes.

When a doctor treats a patient, the ideal today, is that he treats the whole patient.  The system may fall short of that, but it has certainly been expressed in the "patient-centric" focus.  Why should public health be any different. After all, public health is really dealing with an aggregate of patients (in the usual sense of the phrase, I realize public health also provides individual patient care, but that is a different sense of the commonly understood meaning).

What would happen if instead of every single provider having to figure out how to extract data from patient records they have on the patient, they were instead required to provide public health with a copy of this information (with a few notable exceptions).  It could be through an HIE, through Direct, or through some other transport mechanism.  Public health could then take those records, abstract from them what is needed to deal with:
  • Immunizations
  • Syndromic Surveillance
  • Disease Registries
  • Birth Records
  • Pediatric Lead Testing
  • Early Hearing Screening
  • Reportable and Notifiable Conditions
What happens to the way that public health is organized?  Well, for one, they'd have to pool their IT resources and eliminate redundancies.  Two, they'd be responsible for analyzing and routing the data that they need for public health functions to their internal functions, rather than making providers do that for each separate function.  Third, they'd have to get a lot better about security of the data that they centrally manage.

What would happen at the provider end?  Instead of having one or two interfaces that need to be managed for each public health function that would need to be supported by each provider organization, there would be only two (the outbound push to public health, and a way to query public health where necessary).  You could use the same standards being selected for clinical documentation being exchanged between healthcare providers, so that would eliminate another source of variation in the data.  Public health can then take the clinical data they need and distribute them where they need to go, with appropriate pseudonomization, abstraction, extraction and roll-up, et cetera.  If this were done at the state level, with local access, this could have an even greater impact.  Many organizations have to deal with multiple municipalities when communicating to public health.  Imagine the cost savings to providers that could occur by ripping out and throwing away dozens of unnecessary interfaces.  I've seen estimates of anywhere from $5K to $20K per interface (depending upon who makes the estimates and the complexity of the interfaces being discussed).  Even using a lowball figure, that savings could be significant to many provider organizations.

This is a pipe dream.  I don't see it happening, but not because it's technically unfeasible.  Politically and organizationally it isn't feasible.  You'd have to get multiple agencies to agree to share resources, and give something up (control and resources) in the process.  I heard someone report at an eHealth Connecticut conference five years ago that they figured the State could spend $5-10 million to set up a State HIE and still have twice as much savings left over if they were able to eliminate public health silos.  But could you imaging getting all of those state agencies to buy in?  What about the policy ramifications?  Actually, because public health has the HIPAA exemption that's not pre-empted by state law, they might also get around some of those. What about public response?  What, you are going to send all my medical records to the state?  The privacy barons would have a field day over that one, and certainly there are some technical barriers around what would be needed to be put into place to make them happy.  Oh, and then there's all the fine wording of all that public funding running around in public health.  That's why we had excellent surveillance mechanisms for H5N1 that completely failed us when we were hit with an H1N1 epidemic in the making.  That's not disease-centric thinking, that's even worse:  Serotypical thinking, and unfortunately, all to typical.

So of course, it's easier to create a new standard to work around all those other really complex issues.  I vacillate around the simplicity of the query model and the cost distribution that puts most of the work back on the provider.  Do I want to tackle an easy challenge and avoid the hard stuff that would provide even more savings?  I dunno.  It's 2:00 am.  Do I really need more work?

But, I cannot help thinking that one standard already supported by several hundred EHRs could replace three, four or even more standards used in public health exchanges.  All we need do is to stop public health from organizing themselves into disease-centric silos.

-- Keith

P.S.  Maybe what I should have said is that public health should be population centered.

Wednesday, July 20, 2011

IHE Call for Proposals Opens


Greetings IHE Community,

Call for Proposals Opens today, July 20 – September 5, 2011!
It is with great pleasure that we announce the beginning of the IHE annual planning cycle. IHE will solicit proposals for the 2012-2013 Profile Cycle in the IT Infrastructure (ITI), Patient Care Coordination (PCC) and Quality, Research & Public Health (QRPH) domains. The Call for Proposals opens today, July 20, and concludes September 5, 2011. Interested parties are invited to submit a brief proposal for new IHE Profiles and/or white papers to be considered for development in the 2012-2013 Profile Cycle. 
This e-mail describes the annual planning cycle process, including the Planning Proposal Evaluation Kickoff Meeting in October 2011, Proposal Review Planning Webinars that will lead up to the October meeting, and the Technical Proposal Evaluation Meeting in November 2011. Please continue reading for more details.
Help Promote IHE Call for Proposal:
All IHE members are invited to forward this announcement to their committee mailing lists and other interested parties.

All Proposals must follow the structure and format of the IHE Proposal Template (ftp DOCX file), specifically addressing the following:
  1. What is the problem you intend to address with this proposal, and how is that problem expressed in practice (e.g., a use case)?
  2. How would fixing this problem improve health care in practice?
  3. What specific components of standards could be used to solve this problem?
4.       Your proposal must identify one or more potential editor(s) in the event that the proposal is selected for further evaluation and development. If possible, please include some indication of the business case surrounding the situation when describing the problem. For example, is there an economic motivation for addressing this problem immediately?

Summary of IHE’s Multi-Phase Proposal Process:
1.       Submit Brief Proposals by September 5, 2011:
PCC, ITI and QRPH’s Call for Proposals opens July 20 and closes September 5, 2011. Submit a Brief Proposal with the attached form to the domain email listed below.

2.       Planning Committee’s Proposal Review Webinars:
        Save the Date! Webinars are held during the weeks of September 19 and 26, 2011 on WebEx.  Authors for all accepted proposals are required to present the Brief Proposal on the Planning Committee’s Proposal Review Webinar(s). The webinar dates for each domain will be announced in August 2011. Please anticipate participating in 1-3 webinars during the weeks of September 19 & 26, 2011.

3.       2012-2013 Planning Proposal Evaluation Kickoff:
Save the Date! October 11-13, 2011 in Oak Brook, IL.*
We urge those who submit proposals or white papers to attend the Proposal Evaluation Kickoff Meeting in person or by phone. In-person advocacy has proven to be the most effective way to ensure your brief proposal are understood and accepted by the committee. 

4.       2012-2013 Technical Committee Proposal Evaluation Meeting:
Save the Date! November 15-17, 2011 in Oak Brook, IL.*
Proposals that are accepted at the Planning Proposal Evaluation Kickoff Meeting and given to the IHE Technical Committee for review are required to write and present a detailed proposal during the Technical Proposal Evaluation Meeting.

Deadline: September 5, 2011 at 11:59 pm CST
Email the completed brief IHE Proposal template to the corresponding domain email address below before September 5, 2011 at 11:59pm CST.
Committee
Domain Email
Planning Co-Chair 1
Planning Co-Chair 2
PCC Planning Committee
Keith Boone
Dr. Michael J. McCoy
ITI Planning Committee
Karen Witting
Michael Nusbaum
QRPH Planning Committee
Didi Davis
Amit Popat

We look forward to working with you during the IHE 2012-2013 Profile Cycle. Please contact the IHE secretary at secretary@ihe.net if you have any additional questions or need further assistance.

* The dates for the October & November PCC, ITI and QPRH meeting are held on different days. Please open the attached meeting invites for the exact dates of your domain meeting. Additional information about these meetings will be sent out in August of 2011. Only IHE International Members are allowed to attend IHE Meetings. To apply for Free IHE International Membership click here.

Thank you,
IHE Patient Care Coordination, IT Infrastructure and Quality, Research and Public Health Planning Committee Co-Chairs

Keith Boone & Dr. Michael J. McCoy (PCC)
Karen Witting & Michael Nusbaum (ITI)
Didi Davis & Amit Popat (QRPH)



Nailed again...

(Used with Permission)

I wish I'd seen this when the CDA Consolidation project had started (even though I still support it). That's a perfect example of this particular case. Between the XKCD illustrator, Randall Munroe, and Scott Adam's Dilbert, I think our industry had been completely infiltrated.

-- Keith

IHE Week and FDA announces mHealth regulatory approach

Another IHE Week, this time preparing Trial Implementation Profiles. I'm on the hook for Reconciliation, and we have another couple dozen comments to go.  One of the surprising responses from commenters is that the profile should REQUIRE that external identifiers for problems, medications and allergies be preserved.  That is going to result in a quite a bit of new text (now I have to explain what changes the identity of an entry).  I'm pleased with this response.  We made it a strong recommendation, but not a requirement because I felt that many EHR vendors would not implement the profile if it were required.  Most systems would need to alter their basic tables to record the external identifier.  But experience with prior implementations indicates that this really is the best way to handle it, and I certainly agree with the sentiment.

I spent a good bit of time with IT Infrastructure on Monday discussing Cross Enterprise Document Workflow (pdf).  This profile is critical for Patient Care Coordination, even though it is coming out of IT Infrastructure.  Here's a brief pitch I'm giving on it tomorrow for another group:
  • In Ambulatory Care, providers are desperate for Workflow Management to track referrals, orders, and manage quality of care.
  • But their workflows are loosely coupled and ill-defined.
  • These need to integrate with well defined, tightly coupled workflows in a departmental system (e.g., imaging).
  • XDW uses industry workflow standards to describe Human Tasks that can be well integrated across both settings.
The replacement of CDA with Human Task as the standard to manage the tasks is more than appropriate, and @rjhorniii has done a great job leading the discussion, and getting me and one of my colleagues to agree on an approach.  You can expect some significant changes to the public comment version to come out of this meeting.

While at the meeting, the FDA came out with a proposed regulatory approach for mHealth devices and applications.  I haven't had a change to do more than skim it once.  I'll look over it in greater detail later.  One of the tweople I follow expressed surprise at the exclusion of Mobile devices being used as an EHR.  His interpretation was that EHRs were not medical devices.  In case you are curious, they also excluded EHRs from the Medical Device Data System rule.  It's not that EHRs aren't medical devices.  It's that FDA carefully classifies things so that something doesn't fall into competing classifications.  They may be issuing separate guidance on EHR systems, so they exclude anything that can be viewed as an EHR from the other rules and guidelines.  That way, when the EHR rule comes out, it will be clear WHICH regulations and procedures apply.

Tuesday, July 19, 2011

If you want to change a culture, start with its children

My kids are brilliant. If you don't believe me, just ask my wife.

-- Anonymous
Well, they are. Let me give you an example. Weekend before last, my youngest daughter (9) woke up on Saturday morning with an earache. I heard her crying in the living room and went to see what the problem was. She told me it felt like someone put a bowling ball in her ear. She had been swimming the day before and couldn't get all the water out, so I was pretty sure she had an ear infection. I called the pediatrician, but they don't open until 9:00 am on Saturday, so I called my practice's urgent care center, and they opened at 8:00am. Since it was about a 40 minute drive, I gave her some ibuprofin to help with the pain, and off we went.

To make the ride easier for her, I engaged her in conversation. She wanted to know what was going to happen at the office, and I explained how it worked. You didn't need to make an appointment, you just showed up. They would take her history, and the doctor would take her vital signs, record them in the EMR (she knows what that is because it is what daddy does), and then look at her ear, and probably prescribe some antibiotic and maybe some ear-drops to help with the pain. Then I told her that since her doctor is a "Meaningful User" of HIT, she could get a print-out of her record. Next I explained that everyone has a right to get a copy of there medical records, and that by law, in most cases, the doctor or the hospital has to give them to her (or in her case, her parents). And then I explained that since her doctor was already in Meaningful Use, she would not have to wait a long time to get them.

"We can ask them for the record, do you want it?" I asked her. "Yes, I want it." She told me. "When we're done, you can look at it. And if there is anything wrong with it, you can tell them to fix it. They have to respond to you, and tell you at least if they are going to or not." I told her. "It's the law. There is this thing called HIPAA (not HIPPOs), that makes sure you can do that." "OK." She said.

By the time the visit started, her ear only felt like it had a baseball in it (or so she reported). And during the visit, I asked the doctor if he could print out her record for her. He said he would as soon as he finished writing it up. He then dug out his iPhone and started calculating her dose. I asked him what app he was using for that. He told me, and I laughed, and said, I have that same app on my iPad. "Are you a practioner?" He asked. No, just a healthcare IT geek with an iPad I said. He computed her dose, order the antibiotics, and we talked about whether he should prescribe ear-drops for pain management. "Given that she woke up crying," I said, "let's go ahead and do that."

So he placed that order too. He then handed me a printed set of patient instructions regarding her treatment that described her problem and how it was being treated, and what we should do if it didn't work. He came back a few moments later with the completed visit report and hand it to her (not me -- which was the whole point for me). We left to go to the pharmacy to pick up her meds.

On the way there, she read through her record. She asked me questions about what stuff meant. When we got to the vital signs section, she said: "Daddy, it says here that they took the Oxygen off my right hand, but they used my left." So, I told her that she was good to spot that and that she needed to write them a letter to tell them about the mistake. I figured that this was a great way to drive home the lesson.

When we got to the pharmacy, we had to go through the "Insurance Card" rigamarole because I gave her nickname rather than her legal name to the doctor, and they didn't have her on file (or so they thought). We fixed that. Then the pharmacist told me that the insurance was going to cover the anitbiotics, but not the ear-drops. "OK, thats fine," curious, but not interested in battling with the pharmacist. He then went to fetch an "Ear-wax removal kit". I looked at it and said, "No, that's wrong." I asked my daughter to run out to the car to get her records. She ran out and back, and we showed the pharmacist what the doctor's records had said. Then he showed me the e-prescription that they recieved. There was a mismatch. The drug listed in her chart was "Ear Drops (some chemical name with percentage in solution)", but what was on the printed version of what had been recieved via the ePrescription message just ended before the parenthetical clarification, just: Ear Drops.

So my daughter learned that having her records helped with stuff like that, too.

Then I called the office, to tell them about the mixup, but they apparently don't have a procedure to deal with that kind of error report. I know who to talk to there, so I'll fix that later.

Last Sunday, while I was reading, I heard my daughter working out the letter with her mother that she is going to send to the place that saw her. I'm going to write one too and send it with her letter. We'll address it to the HIPAA compliance officer, so that I know it will get the appropriate attention.

My daughter won't forget this lesson, and she's learned something exceedingly valuable that will help her when she is responsible for her own healthcare, something that not many people are really aware of. Last Saturday, I got to spend an hour with @Lygeia and several other patient advocates at Health Foo. We talked about how to get patient engagement. I recalled parts of this story to the group, and pointed out that by the time a person leaves high school, they are able to balance a check-book and write a resume, but they are not at all trained to deal with doctors, choose an insurance policy, or manage their own interactions with the healthcare system. These are necessary life skills that we need to teach our children. Because if you want a society to change, you need to start with its children. So, you might think that its funny that ONC is going to use cartoons to teach Health IT, but I really don't. I think its brilliant, just like my daughter.

-- Keith

Update: Not to be outdone by her sister, my eldest went to the pediatrician's this morning. Diagnosed with Swimmer's ear and Otis Media. She's picking up an electronic copy of her records mid-week on disk! When asked why she wants them, "I wanna be an e-patient!" she said to them. I think we need to declare a week for e-pediatric patients.

Monday, July 18, 2011

The HIT100

After a couple of weeks of anticipation, the HIT100 tallies are finally out.  I was very grateful to finish in second place, just behind Brian Ahier in a very close race.  Michael Planchart e-mailed me his results spreadsheet so I could post it here.  Others (Nate Osit for one), have also posted the list on their blogs.

And just as he finished, theEHRGuy posted a new set of instructions for selecting the #HIT5 and #HIT1.  I've extracted them from the twitter stream below:

Just when you thought the fun was over now we have to choose our #HIT5 and #HIT1 #healthIT heroes! Instructions below:

  • Those that scored above 12 will have an opportunity to have their place in #HIT5 and #HIT1. The top #HealthIT ranks. 
  • Those that scored above 12 must abstain from voting. Please do not re-tweet votes since they will be ignored. 
  • Please do not reply to votes. 
  • The tweep that gets most votes from this round wins the #HIT1 place in history. Others fall in the #HIT5 according to their scores. 
  • Vote like this: #HIT100 My #HIT5 vote goes to @twitterhandlehere #HealthIT
  • Deadline for voting (according to a recent tweet by @theEHRGuy) is Thursday, July 21st.

I've made it easy for you.  In the list below, if you click on the link, it will take you to twitter with a correctly formatted vote.  Please follow Mike's instructions to make it easy for him to do the final tally.  I'm pretty sure Twitter folk don't fit the profile of people who like to wait.


PositionTwitter HandleNominations
76sonalpatel_HIT4
76poikonen4
76meducate4
76marxists4
76lostonroute664
76Jsamplesgmt4
76JohnSharp4
76jimtate4
76HealthIT4
76HealthEugene4
76harrygreenspun4
76GrahameGrieve4
76GovHITeditor4
76EMRDailyNews4
76EHRoutlook4
76drjosephkim4
76dirkstanley4
76danamlewis4
76cyberslate4
76cristianliu4
76CorepointHealth4
76blogbrevity4
76billians4
76Anthony_Guerra4
76anitasamarth4
63RossMartin5
63RMartinBoulder5
63richelmore5
63omowizard5
63lisacrymes5
63IngaHIStalk5
63HITNewsTweet5
63hitconsultant5
63GailZahtz5
63fierceEMR5
63erikpupo5
63ElinSilveous5
63Andrewspong5
52todd_park6
52ShimCode6
52rilescat6
52RichmondDoc6
52realworldhl76
52jkvedar6
52jbselz6
52HIMSS6
52gnayyar6
52cindythroop6
52BarbaraFicarra6
40WTeeGreen7
40MicrosoftMD7
40MedicalQuack7
40kevinmd7
40KentBottles7
40JessPKahn7
40jasoncolquitt7
40fredtrotter7
40FairCareMD7
40Egrunden7
40bobcoffield7
40acowatch7
33westr8
33tedeytan8
33pjmachado8
33ftvelasco8
33ekivemark8
33EdBennett8
33CLOUDHealth8
29PhilBauman9
29john_chilmark9
29HITExchange9
29histalk9
27jonmertz10
27HealthyThinker10
26jimmyweeks11
22VinceKuraitis12
22HITAdvisor12
22healthblawg12
22aviars12
18HealthStandards13
18faisal_q13
18Cascadia13
18boltyboy13
15susannahfox14
15Lygeia14
15Farzad_ONC14
13ReginaHolliday16
132healthguru16
12jhalamka17
10MatthewBrowning18
10ej_butler18
9Perficient_HC20
8janicemccallum21
7EMRAnswers22
6lizasisler23
4NateOsit26
4ePatientDave26
3TheGr8Chalupa31
2motorcycle_guy35
1ahier36

Based on comments by @omowizard and @ej_butler, I equalized rankings of those with equal votes.

Saturday, July 16, 2011

What's a Health Foo

This morning I saw a tweet / four square checkin from Brian Ahier (@ahier: "Health Foo" at Logan Airport (BOS) with 69 others. I responded: What is health foo and how long are you in Boston. We spent a bit of time together at HIMSS last year and the year before and since I live nearby, I thought it would be a good idea to get in touch. He responds back, "Healthcare Unconference .. leaving Sunday". I wonder to myself how a healthcare unconference happens in Boston and I don't hear about it.

Later that same day, Nate DeNiro (@unclenate asks me to follow him (I thought I already had been, so I did) so he could DM me. He also sent me a link on more information about Health Foo. I get a later invite from him to the event (it is invitation only).

So, I shifted my one call for the day up an hour, and headed into Cambridge, back to an office I used to work in more than a decade ago.

What is an Unconference? Well, to answer that question, you have to think about what a conference is. A bunch of people pay to go hear other people that might be interesting speak about topics they might be interested in, and the topics are chosen by the conference organizer. An unconference twists that around. First of all, O'Reilly Media is sponsoring this event, and Microsoft is making the space available, so attendees don't need to pay to get in (but they do need to be interesting). Secondly, other than time blocks, nothing is preset.

So, we spend several hours talking, grabbed a beer from the foo bar (Yes, it is called that), and introduce ourselves to each other. Then we have a short formal session where we learn what foo is about, how it got started, and how to do it. Foo it turns out, stands for "Friends of O'Reilly (Media)", and the whole thing started during the .COM bust when O'Reilly had a bunch of unused space that they wanted to do something interesting with.

After the formal session, we went out to develop the agenda. THere were sticky notes and several large boards where you could describe a session you wanted to run, and put it in a time slot and a room. I decided to do a session called "Is there a standard 4 that?", basically to help various folks share their knowledge about IT standards and their possible uses. If you are on twitter or buzz or G+ or FB tomorrow, I might call on you to help, because we are looking to crowd source answers to questions I may know nothing about on standards. So I put my sticky up. Then @Lygea posted one at the same time opposite mine that I wanted to attend, so I moved it to a different slot. Then @ePatientDave did the same thing, so I moved it again, but this time after Fred Trotter's session (that I'll be helping him with) on What is the Health Internet.

The foo goes on from 10:00 to 8:00 pm, at which point their with be several 5 minute Ingnite sessions. I have no clue what they are, but I'm cooking something up for one anyway. I'll report on that tomorrow.

While I'd love to hang out with this crew all weekend, unfortunately, I have family committments, and so won't be able to spend Sunday morning with them. But even so, it will be very interesting. While there were probably a dozen people at Health Foo that I already know (some quite well), there are many others completely outside my usual comfort space. That's the whole point. Get interesting people and ideas together and see what flows.

On a side note: I had an interesting conversation with @Farzad_ONC at the meeting about a blog post that I basically wrote with about a three person audience. He remembered it better than I did. That rocked, since he was at the top of that list.

Thursday, July 14, 2011

News around the HL7 CDA

The CDA Consolidation project reached a major milestone today as the Structured Documents Workgroup voted to approve the ballot reconciliation for posting.  This reconciliation addressed over 500 comments since the HL7 Working Group meeting in May, just less than two months ago.  That's a major amount of work.  There's still quite a bit left to do, and another ballot forthcoming that could result in a similar volume of work.  Even so, congratulations are in order.

As part of that, one of the things we finally resolved was how to deal with how to say that the patient is on no medications, or that it is unknown if the patient is taking any medications.  We based that off of work that I reported on here in the last couple of days.  We did make one minor modification which I will correct on those pages tomorrow.  In stating that it is unknown whether a patient is on medications, I incorrectly stated that the medication is unknown, as Grahame Grieve pointed out comments two days ago.  We fixed that by replacing that unknown with a general code indicating "medication" (and the same would be true for allergies and problems).

We also developed a more clear statement around the requirements for locations of entries in a section.  The Consolidation guide requires "direct" containment of the required acts within the section, whereas previous guides required them to be in the section or in any subordinate section.  That was clarified, and we further agreed that while they must be contained within an entry contained directly within the section, we did not require them to be immediately within that entry.  The rationale for this is to support enhancements such as those found in the IHE Reconciliation profile which I've discussed previously.

A couple of days ago the ONC Transitions of Care Project developed its initial ecosystem consensus statement recommending CDA Release 2 as the standard to use to convey information necessary for Transitions of Care.  That consensus statement has yet to be finalized (it should be by next week), but I'm hopeful that it will go forward pretty much as stated (There are a few things I want to review, and one suggestion that might be contentious).

Finally, there are several things happening at the same time that should enable closer cooperation between IHE and HL7 on the development of IHE profiles.  The "Activities with other SDOs" report that I give on Sunday at the HL7 WGM as the HL7 assigned liason to IHE will still occur.  A new initiative will probably happen at the next HL7 that will help HL7 and its partners like IHE to develop goals and objectives around those collaborations.  I look forward to that discussion.

Wednesday, July 13, 2011

Starting new Religion?

I spent some time yesterday on a call regarding yet another government agency's interest in interoperability in Healthcare IT.  It seems, with the advent of meaningful use, interconnected healthcare IT applications and devices, that Interoperability has become the new religion.  As with any new "fad", a lot of previously uninvolved organizations are trying to see how they can capitalize upon it and the existing stakeholders are looking at how they should do so also.

There are a few things that I would hope by now we all realize, but they bear repeating, because quite honestly, I don't think some of the newcomers are aware of this yet.

  1. The industry doesn't need another definition of interoperability.  There is a standard one (actually several).  If your organization doesn't know what it is, it should definitely reconsider getting involved in a leadership position, because it hasn't been paying attention.
  2. The industry doesn't need another organization in the US to work under (unless it is an umbrella organization like the Canadian Standards Collaborative).  On the International front, there is already the Joint Initiative Council
  3. There are already more initiatives than any one person can reasonably keep track of.  If you cannot fit what you are trying to do in one of the existing initiatives, see what can be done to change that with the organizations sponsoring the existing work.  Many of them provide opportunities to create projects, including HL7 and IHE which are pretty easy to initiate.  You just need to find the right champions.
  4. In healthcare IT, the number of "experts" in the field is pretty limited (and thus, so is bandwidth).  This is evidenced by how you see most of the same faces over and over again at Healthcare IT standards (and related) meetings.  It's a pretty tight community, and most of us are connected either directly or indirectly through just a few hops.  Little goes on that we don't find out about pretty quickly.  The number of little birds that tweet (or mail, or plus, or call or ...) about this stuff just makes it impossible to keep anything under wraps for too very long.
Some strategies to think about for newcomers into Healthcare Standards:

  • Partner with existing players in the space.  Find out who they are and what they are doing.
  • Do some research and find the thought leaders already in the space.  Get them engaged and through them, get your projects moving forward. If you don't know who to ask, ask me.
  • Don't be afraid to enter into the development process with existing organizations.  If you truly have leadership potential, you will soon find yourself in that position. 
  • If you have critiques about the organization, share them directly with thought leaders in that organization in a constructive fashion.

Some strategies to think about for the existing stakeholders (e.g., IHE, DICOM, HL7, ASTM ...)

  • When you hear about a new "initiative", engage (and encourage them to engage) in a way that takes advantage of existing organizations, processes and expertise.
  • Be ready, willing and able to form coalitions with other organizations, and to engage with them in ways that meet their needs.
  • Listen to outside criticism, whether it is constructive or not (organizations that don't listen to criticism eventually don't survive).

Forming a new initiative is costly in time and effort.  You need to develop processes, governance, and infrastructure to make it work.  It takes time to develop these, and that's time that could be better spent solving the real problems. Starting a new project under already well established processes and governance with an organization that has the infrastructure to make it work is much easier, and you will find a ready pool of engaged volunteers from which to draw expertise.

Tuesday, July 12, 2011

How to say no...

Yesterday I posted a long write-up describing how to say I don't know.  Following up on some questions from yesterday, I'll explore how to say now.

First, let's summarize the bestiary we need to address:

  1. Patient is not on THIS drug.
  2. Patient is not on ANY drugs.
  3. Patient does not have THIS ailment.
  4. Patient does not have ANY ailment.
  5. Patient does not have THIS allergy.
  6. Patient does not have ANY allergy.
Two patterns here:

  1. Patient does not have / is not on a specific thing.
  2. Patient does not have / is not on any known thing.
Now, I didn't address this when dealing with unknown, because this is knowledge.  Forget the hedge implicit in "Patient has no known allergies."  No known is NOT the same as unknown, and is there to remind the reader that what is known does not necessarily cover every possibility that could occur.  I didn't know I was allergic to bee stings until I was exposed to them.  A close friend developed an allergy to wheat products later in life, possibly as a result of some other illness.

Patterns 1 and 2 above correspond very closely to patterns 2 and 3 from yesterday.

Pattern #1
A specific thing is not present.

Specific Problem Not Present
<entry>
<observation classCode="OBS" moodCode="EVN" negationInd="true"> <code code="64572001" displayName="Disease" codeSystem="2.16.840.1.113883.6.96"/> <value xsi:type="CD" code="38341003" displayName="Hypertensive Disorder" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/> </observation> </entry> Specific Medication Not Present <entry> <substanceAdministration moodCode="EVN" classCode="SBADM" negationInd="true"> <consumable> <manufacturedProduct> <manufacturedLabeledDrug> <code code="81839001" displayName="anticoagulant drug" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/> </manufacturedLabeledDrug> </manufacturedProduct> </consumable> </substanceAdministration> </entry> Specific Allergy Not Present <entry> <observation classCode="OBS" moodCode="EVN" negationInd="true"> <code code="106190000" displayName="Allergy" codeSystem="2.16.840.1.113883.6.1"/> <value xsi:type="CD" code="300916003" displayName="Latex Allergy" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/> <participant typeCode='CSM'> <participantRole classCode='MANU'> <playingEntity classCode='MMAT'> <code code="111088007" displayName="latex" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/> </playingEntity> </participantRole> </participant> </observation> </entry>

Pattern #2
Nothing is present.

No Known Problems
<entry>
 <observation classCode="OBS" moodCode="EVN" negationInd="true">
  <code code="64572001" displayName="Disease" 
   codeSystem="2.16.840.1.113883.6.96"/>
  <value xsi:type="CD" code='64572001' displayName='Disease'
   codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMED CT'/>
 </observation>
</entry>

No Known Medications
<entry>
 <substanceAdministration moodCode="EVN" classCode="SBADM" negationInd="true">
  <consumable>
   <manufacturedProduct>
    <manufacturedLabeledDrug>
     <code code='410942007' displayName='Drug or Medicament' 
codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMED CT'/>
    </manufacturedLabeledDrug>
   </manufacturedProduct>
  </consumable>
 </substanceAdministration>
</entry>

No Known Allergies
<entry> <observation classCode="OBS" moodCode="EVN" negationInd="true"> <code code="106190000" displayName="Allergy" codeSystem="2.16.840.1.113883.6.1"/> <value xsi:type="CD" nullFlavor="NA"/> <participant typeCode='CSM'> <participantRole classCode='MANU'> <playingEntity classCode='MMAT'> <code code='413477004' displayName='Allergen or Pseudoallergen' codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMED CT'/> </playingEntity> </participantRole> </participant> </observation> </entry>

The close relationship of these negated assertions to yesterday's unknowns is no accident. Negation is one end of the scale of knowledge about a thing, a positive assertion is the other end, and unknowns fit right in the middle along an axis of uncertainty.

Tommorow, I won't be writing about how to say yes, or at least I hope I won't. To do that, you'd simply follow pattern #1 above, and use negationInd="false" (which is what the default value SHOULD be in CDA, but isn't.) Grahame's assertion that lack of negationInd specifies that negationInd is NULL, while technically correct, is A) not obvious, and B) dangerous, especially in the presence of assumed defaults. The most common way of reporting observations in CDA doesn't require the use of negationInd at all, and the assumption is that it is set to false. This should be added as an errata for CDA Release 2.0. We'll fix that in CDA Release 3.

Keith


This post was updated on July 18th to reflect adjustments made by the HL7 Structured Documents Workgroup based on feedback from Grahame Grieve. The key change was in using a general code rather than unknown for pattern 2. A similar change was made for Smells like Unknown...