Category Archives: FHIR

#FHIR, CDS-Hooks, and Clinical Decision Support

This is a guest post written by Kevin Shekleton from Cerner, and first posted to the HL7 CDS email list. Reproduced here for wider availability by agreement with Kevin


TL;DR: CDS Hooks will be working with the HL7 Clinical Reasoning team to make sure our approaches are complementary, and to ensure that CDS Hooks is on a path to standardization. The CDS Hooks implementation community should expect no changes to our open, community-based development process (but should expect to see increased interest and engagement from the community).

As briefly mentioned a few days ago on an earlier thread, there is some news to share from the HL7 WGM a couple weeks ago. I didn’t share this immediately at that time because frankly, I wasn’t sure as to the details yet. Rather than posting a vague post I was waiting until we had a few more discussions before communicating this out. 🙂
During the WGM, I attended a joint meeting between the CDS, CQI, and FHIR-I working groups. During this meeting, one of the topics of discussion was a new project scope statement (PSS) to semantically align Clinical Reasoning to CDS Hooks. There was an acknowledgement by the HL7 working group of the support and interest CDS Hooks has within the EHR and CDS vendor communities, so ensuring Clinical Reasoning aligns (where/when possible) to CDS Hooks is beneficial to those planning to support both projects.
The CDS working group has been working on a model for clinical decision support within FHIR called Clinical Reasoning (formerly known as CDS on FHIR). I’ve fielded many questions from folks all asking the same thing: “What is the difference between Clinical Reasoning and CDS Hooks?”
At the end of the joint meeting, several of us stuck around afterwards to discuss the two projects in further detail. Specifically, we began to directly address that aforementioned question: “What is the difference between Clinical Reasoning and CDS Hooks?”. We all agreed that none of us have ever had a very clear response to that question, mainly because each of us have been focused on our respective projects and have not sat down recently to compare/contrast the specifics of our approaches and goals.
Bryn Rhodes (primary architect of Clinical Reasoning), Isaac Vetter (Epic), and I proceeded to work for the next 6 hours or so on educating each other on architecture specifics, projects goals, and design constraints of each project. In doing so, we came away with the following high level takeaways:
  • CDS Hooks is designed solely around the execution of external clinical decision support.
  • Clinical Reasoning was designed primarily around the definition, sharing, and execution of local clinical decision support. However, the project also defines capabilities for external decision support that are based on older specifications, resulting in the overlap with CDS Hooks.
Based upon our initial work that afternoon/night, we all agreed on several things:
  • Continuing our conversations was in the best interest of both projects.
  • Both projects should be complementary
  • The sweet spot of Clinical Reasoning is in the space of local CDS
  • The sweet spot of CDS Hooks is in the space of external CDS
To reflect this, we modified the aforementioned project scope statement to commit to continuing these discussions in 2017 with the goal of more directly aligning the projects. Specifically, we agreed to explore moving CDS Hooks as an independent entity within the HL7 CDS community to solve the problem of external CDS, leaving the current Clinical Reasoning project to focus on the problem of local CDS.
What does this mean to all of you who are implementing CDS Hooks?
Not much, actually. We’re not changing our focus or design. The simplicity and focus of CDS Hooks has been one of its best strengths which is evident in the broad support, interest, and ease of development within the community. We will not compromise that.
What does this mean for how the project is managed?
Again, not much. CDS Hooks will remain a consensus driven open source project using modern development practices and tooling and following its own independent release process. I think this has worked well for other projects like SMART. I am working on a more formal project governance (more on this later) that should allow us to continue operating as-is while simultaneously satisfying HL7’s requirements.
Additionally, all of the conversations and work we’re just now starting will be done in full view of the community. Any proposed changes to CDS Hooks will continue to be logged as Github Issues and discussed with those interested, we’ll still run Connectathon tracks to get implementer feedback, and we’ll continue to use this mailing list and Zulip for discussions.
How does this benefit CDS Hooks, Clinical Reasoning, and the community?
First, the entire CDS community will have a clear understanding of Clinical Reasoning and CDS Hooks as well as when it’s appropriate to use each approach.
Second, both projects are going to be strengthened by our continued joint work to align on shared needs, identify gaps, and work in complementary directions rather than potentially pulling in opposing directions.
Finally, having CDS Hooks published under HL7 will benefit organizations that are constrained to recommending or implementing HL7 standards.
I’m excited for the work we’re all going to do within the CDS standards communities and specifically, CDS Hooks. The community support around CDS Hooks has been outstanding and I’m looking forward to working towards a 1.0 releases of a CDS Hooks spec this year as well as our first production implementations.

Opportunities Vacant in the #FHIR project

The FHIR team is continuing to grow, and has plenty of opportunities for more people to contribute.  Here are some of those opportunities:

Core FHIR spec

We’re looking for:

  • people from committees to work within committees to improve the definitions for resource, data type and profile elements and codes
  • implementers to work with the editors to develop further realistic high-quality examples that fill out resource usage
  • anyone who wants to work on proof-reading,
  • more committee members to learn how to edit specifications to give us more depth in the committees

Web Presence

We’re looking for:

  • a fhir.org web developer. If you know drupal, and you’re a member of the fhir+hl7 community, you can help with the various fhir.org services
  • more people to respond to questions on community.fhir.org

Reference Implementations

HAPI and the C# reference implementations would love to get more active contributors.

There are several roles:

  • first responder – answer questions about using them in various social media
  • tester – maintaining and extending the automated tests, and manually testing what can’t be automatically tested
  • documentation – contributing how-to and core documentation, and explaining how the RIs compare to the spec
  • committer – code contributors are also welcome

 

You can contribute to these as much as you like – a few hours here and there, up to full time.

If you’re interested in contributing in any of these roles, let me know (at grahame@hl7.org), and I’ll connect you up with the right team member.  We will be happy to provide support and direct you to necessary training material and documentation and/or set up mentor/mentee relationships to help you through the process.  If you’d like some justification to share with your manager/employer, we may be able to help there too.

If you have other ideas about how you’d like to assist, those would be welcome as well.

#FHIR and Alt-health

Unless you’ve been living under a rock, you’ve probably heard the terms ‘alt-right’ and ‘fake news’ by now. According to Wikipedia: “the alt-right (short for “alternative right”) is a loose group of people with far right ideologies who reject mainstream conservatism in the United States.” and “Fake news websites (also referred to online as hoax news) deliberately publish hoaxes, propaganda, and disinformation to drive web traffic inflamed by social media. Note: I’m well aware that Fake news websites aren’t confined to just the alt-right, but there’s a strong link between alt-right and fake news. It’s become clear, as time as progressed, that this is just another security risk in the eco-system that is the internet. Viruses, phishing, and now fake news. Something for Google and Facebook to work on – here’s some thoughts about that.

Waiting in the wings is something else I call ‘Alt-Health’ – the spread of bad healthcare advice running like wildfire through social media. One particular aspect of if – the anti-vaxxer campaign – that’s getting air time in the mainstream press, but it’s much broader problem than just that. Bad medical advice on the internet is nothing new – e.g. Google have a team devoted to working on the quality of web pages returned for medical related searches. But the spread of bad advice on social media is outside that. And it’s not always wrong advice, actually. Sometimes, it’s extremely good advice for one patient, but wrong for another patient. But it’s handed on as gospel – ‘this worked for me, so ignore your doctor and do what’s proven to work’… if only life were so simple. Looking forward, I expect that this is going to turn into an epidemic, as people turn away from complexity and cost, seeking simple solutions. What they’ll get is outright wrong or wrong in context, and it’s going to kill people. On the other hand, we know that while a lot of the advice is bad, it can also be very good as well. In some circumstances, better than the clinical advice a patient gets, particularly for rare diseases.

People are going to need trusted healthcare advisers to sort of good advice from bad advice. Unfortunately, there’s a challenge here: some advice will be 100% stupid and wrong (you can cure cancer by eating the right vitamins) while other advice will be 100% right and true (you should stay on the treatment advised by your clinical team, or talk to them if it’s not working out), but a lot of advice is going to fit into the category ‘or maybe true, depending on circumstances’.

That’s where FHIR enters the picture: the FHIR standard has the coverage of this space:

  • Patient’s can get their clinical data in the FHIR format – their past records, their diagnosis with supporting evidence, and their care plan
  • They can share their with their trusted adviser
  • As well, decision support services, criteria, quality measures, clinical evidence, provenance chains – all these can be represented in FHIR (including from the micro-patient communities that have the expertise)
  • We’re working with the biopharma industry to formalise trial data reporting too

Though there are many other standards at play here, FHIR is the one that links all this space together, and naturally fits into the web/internet eco-system.

So I believe that one of our key activities in the FHIR community over the next few years will be ensuring that the standards are in place to address the challenge that alt-health brings – that is, to enable clinical decision support to rank the reliability of random advice on the internet.

 

Support for Testing in the #FHIR Specification

On the last day of the baltimore meeting, a small group of us met to talk about the future of testing in the FHIR specification. In particular, the participants included both Aegis and Mitre, who develop Touchstone and Crucible respectively. Out small group made 3 decisions:

  1. We will work towards the adoption of a formal testing framework for FHIR interfaces
  2. We will simplify the existing TestScript resource
  3. We will draft and propose a TestReport resource

Taking these backwards:

The TestReport will contain a summary of the outcomes a test run – which tests were run, whether they passed, and references to a further information (logs, etc). It’s for helping to maintain current registries of implementations and outcomes. I’ll blog about this further once there’s a draft to look at.

I’ll comment on #2 in time, when we have a draft for people to consider.

For #1, a testing framework, we have several motivations for this:

  • It’s well known that a problem with testing processes like IHE is that under the right care (e.g. configuration) and with some judicious off-road modifications, systems can pass their IHE testing – but that often doesn’t equate to conformant implementations in practice
  • Many systems undergo stringent testing in-house in continuous builds, but real world integrations are extremely hard to test
  • As a consequence, applications are often poorly tested prior to upgrade
  • Every real clinical system I’ve worked with has had test patients so that staff can check how the system works. In Australia, custom is that the patients are called Donald Duck, Mickey Mouse, etc. Staff just have to magically ‘know’ that these are test patients, and they pollute stats etc a little
  • One near exception is the Australian MyHR, for which there was no test system, and no possibility of test patients. In practice, people trying to use it had to use their own personal records as test patients (many told me that they did this, and bits of those records drifted into the media)

We’d like to normalise testing – to make clear expectations about how production systems could be tested, and to start encouraging production systems to actually provide such support. Two key corollaries of this – administrators can download the official tests (e.g. IHE, or others) and run them against their system with robots playing the part of the the other system. And also, the testing framework starts to acquire a clinical safety role – adminstrators can add new tests to their own automated tests for the application (e.g. prior to upgrade or configuration change) and assure themselves that known system requirements with regard to system safety are assured. Note that this is something you can only do in the context of a fully configured and linked system of systems – which is why support for testing in production systems is so important in this regard.

Anywhere, he’s a set of ideas to get people thinking about how this all might work:

  • Resources on the FHIR API are either ‘Production’ or ‘Test’. There will be a ‘test’ tag that labels all the test resources accordingly. No tag = not testing
  • Resources labelled ‘test’ are allowed to refer to production records (e.g. for configuration) , but never the other way around
  • Requests may be labelled ‘test only’ or ‘test and production’. Default is production.
  • Clients that have either ‘test’ or ‘test-only’ on requests SHALL indicate clearly to users that this is the case
  • Operations on test resources that use production resources internally on the server (e.g. $expand) are allowed in ‘test only mode’
  • Conformance resource : add a ‘testCompartment’ : boolean flag where true means that the system offers the same services as in production, but in test mode
  • If a system supports a test compartment, it also supports a $clear operation on the test compartment – it clears all the records associated with the test compartment (including audit records), so to reset for an automated test run
  • Testable Systems can be the target of a test engine that executes a set of tests, and which can produce a test report for archival / comparison purposes
  • System administrators can write tests against their system – e.g. clinical safety focused using TestScripts – and these test scripts can cross multiple systems
  • Systems are allowed to make their own arrangements regarding multiple test compartents (e.g. per authorised user)

Anyone with any engineering experience will immediately recognise that implementing this set of requirements is a major design undertaking. It’s not going to happen quickly in existing EHRs, unless s conceptually similar system already exists – but I’ve never seen one.

But if we regularise the interface, and the test servers implement it (not too hard in my server) – then we might encourage movement in this direction gradually, and that would make it cheaper to deliver truly reliable systems….

#FHIR – Adding Identifier to Reference

One of the more controversial sessions at the Baltimore meeting was where we discussed task 10659:  Reference should support logical references

This is a difficult subject because it relates to handling and exchanging information where a formal URL based view of the world is incomplete. In effect, that means, from a purist point of view, the world is already broken. This makes effective resolution difficult; at best, the resolution is also going to be broken – but is it broken in the least unuseful way? – that’s a bad place to try and get consensus from.

Further, in the FHIR framework, the Reference data type is clearly FMM level 5 – it’s been hammered everywhere from the beginning and is production in all sorts of places. And we’ve said that we won’t make breaking changes to FMM level 5 artefacts without consultation with the users. What’s not clear, though, is whether any of the changes that were proposed in the extensive discussion leading up to the quarter devoted to the task (see, for example, here and here) were actually breaking changes.

The outcome of the meeting was that we would add an Identifier to the Reference data type. Given the background, there was fairly strong consensus for the change, but it wasn’t complete. As a consequence, we said that we would define the change, let everyone look at it for a month, and see if any argument comes up that we had not considered.

So I’ve made the changes: see the Reference data type in the current build. Implementers are encouraged to evaluate the impact of this addition in their implementations, and share their findings on the FHIR email list.

Note: since this is not strictly a breaking change, this is not strictly consulting the implementers before making a breaking change 😉