Monday, March 20, 2017

Healthcare Blockchain use?

Today starts the "Healthcare Blockchain Summit". I wish I could be there. What makes a good use of Blockchain, while also helping Healthcare? What are the questions Blockchain proposals need to answer? Blockchain is the hot word right now, Gartner indicates that it is still on the Peak of Inflated Expectations.
Gartner estimates 90% of enterprise blockchain projects launched in 2015 will fail within 18 to 24 months. Part of the problem is that the majority of enterprise blockchain projects don’t actually require blockchain technology. In fact, these projects would probably be more successful if they did not utilize blockchain.
Gartner give fantastic reasons, that I very much agree with. I am not going to duplicate them here as they do a great job.

Blockchain is a public ledger that is maintained by an interested network of systems. One can make a private blockchain, with private parties; this is possible, but I would argue takes much of the value out of the blockchain system. The blockchain can be validated by anyone, regardless of if they are just looking, just joined as a participant, or are a long standing validating node.

So what does someone proposing a Healthcare use of blockchain need to answer?

  1. What problem being solved? Why is that problem not best solved with 'classic' database? The excuse that the problem has not been solved today is not an acceptable answer. The problem has likely not been solved yet because it is not valuable to solve, so throwing expensive infrastructure like blockchain at it is unlikely to succeed.
  2. How is Privacy protected? The nature of blockchain is that the information put on the block must be sufficient for all parties to Validate. Putting purely encrypted information, or just pointers to data protected elsewhere is not helpful. This is why I recommend NEVER to put healthcare data on the blockchain. Just because healthcare data can't be put on the blockchain does not mean that there is no use of blockchain in healthcare. It is just not a treatment use-case.
  3. How is Identity managed? The nature of blockchain is that it is a system that does not require Identity to be known. There is an Identity linked cryptographically to information and signatures on the blockchain. One can always expose your own identity. Is this necessary with the proposed system? Exposing Identity might not be a bad thing, but it must be addressed either way. This fact means that blockchain is a ready made Pseudonym, hence why I proposed it be used to advertise availability of de-identified data.
  4. How is value created? Blockchain are expensive. How do participants gain value from their participation in the Blockchain? With Bitcoin, the value is equivalent to money, and is gained through proof-of-work, where part of that proof-of-work grows the chain with blocks offered by other participants, where each of those participants offer some bitcoin to have their block included. With a proposal to use Blockchain for Healthcare, one must have a good answer for how value is created, transferred, and consumed. It does not, and likely won't, be the same system as bitcoin. Hence why it is likely a different use of Blockchain for a healthcare specific purpose. Like my proposal to use it for Research Notebooks

Blockchain is good for?

I don't think that healthcare data should go into the blockchain. But there is good value in using blockchain to ( a ) advertise availability of data, ( b ) publish terms (smart-contract) of use that when met unlock access, ( c ) Merkle tree signatures used to validate authenticity of data managed elsewhere, ( d ) track revisions, and ( e ) record (audit) access and use.

Healthcare Blockchain - Big-Data Pseudonyms on FHIR
Blockchain and Smart-Contracts applied to Evidence Notebook

Friday, March 3, 2017

Multiple formats of the same Document content

I propose that “The most technically advanced” document format be considered the Prime, with all of the other formats considered Transforms (XFRM) from that prime document. Thus if the Document Source can create a C-CDA 2.1; then that becomes the prime. Yet if a Document Source only can create a C32 and PDF, then the C32 would be the prime. In this way, regardless of if the secondary formats were actually derived from that prime document, they would be Registered as if they were. This enables a Document Consumer to follow the XFRM link to the Prime without needing to understand all the formats presented. The Document Consumer can also follow the XFRM links down to all the ‘equivalent’ formats to discover those to choose from.

details.....

Now that C-CDA 2.1 is emerging, the following situation becomes more prominent. The situation is that the same content could be encoded in various document format types.
  1. How do you publish in XDS/XCA a set of documents that cover the same content but are different in their encoding format? 
  2. How do Content Consumers perceive when they find a set of documents that seem to cover the same content but are different encoding format? 
  3. How do we prevent miscommunication, or misinterpretation, or worse duplicate attribution. 
Various document encoding formats:

specification
year
mime-type
format
C-CDA 2.1
2015
text/x-hl7-text+xml
urn:hl7-org:sdwg:ccda-structuredBody:2.1
C-CDA 1.1
2013?
text/x-hl7-text+xml
urn:hl7-org:sdwg:ccda-structuredBody:1.1
CCD
2007
text/xml
urn:ihe:pcc:xphr:2007
C32
2007
text/xml
urn:ihe:pcc:xphr:2007
CDAR2 structured
2005
text/xml

CDAR2 unstructured
2005
text/xml
urn:ihe:iti:xds-sd:pdf:2008
FHIR Document
2017
application/fhir+xml
application/fhir+json

PDF - rendered view of C-CDA using publishers stylesheet
2001
application/pdf

XDS-I
2005
application/dicom

CCR
2005
application/x-ccr

Bluebutton text
2013
text/plain



As you can see, C-CDA 2.1 is not really special, but it happens to be the thing that has just released and C-CDA 1.1 are laying around. As proof, FHIR Documents will re-open this discussion. Especially with the CDA-on-FHIR efforts. Thus although C-CDA 2.1 isn’t special, it is a nexus today.

Example using a Discharge Summary:

As an example of a document that might need to be published in multiple formats is a Discharge Summary for an Episode of Care. This use-case is the most clear as to why the very same content might be made available in multiple formats. Other document types are also possible.

Why publish multiple formats?

The main reason to publish multiple formats is for the benefit of various Document Consumer systems. Given a Health Information Exchange, or Nationwide Health Information Exchange, there will be a variety of capabilities and use-cases for the hundreds-thousands of various Document Consumers. Some of these Document Consumers might not be updated at each revision of the C-CDA specification, thus they can only consume an older format.

All this for the benefit of the Document Consumer, but it creates a problem for the Document Consumer too. How do they know that the very same content is represented in the different formats, vs that the different formats are actually about different content? Ideally they would have some way of discovering this short of retrieving all documents and comparing them.

A user should not be bothered by making a choice between various encoding formats, all for the same content. It would be best if the Document Consumer could automatically pick the ‘best’ format. This pick, might be:
  • simply because that Document Consumer only supports one format. Example might be an old piece of software that can only consume C32 (aka XPHR). 
  • might be because a Document Consumer is able to render one format better than another format for a given context. For example, a patient view versus a clinical view. A Patient Generated Health Data (PGHD) CDA document vs a CCDA CCD. 
  • might be a good workflow reason to show a PDF rendered view, as that specific rendered view was that of the Document Source (publisher). 

Not rewriting history

It should be noted that I am not talking about going back in history to create more formats of documents previously published. Revising history is against medical-records principle.

Those old formatted documents must forever be supported by Document Consumers. That is to say that a Document Consumer should never remove the functionality it has to consume older formats.

What I am focused on here is the front-edge of standards advancing. What happens as ‘new’ formats become supported by Document Source. And how to best support Document Consumer needs.

Potential Solution

It would seem that the closest representation in XDS is the transform (XFRM) association, because it means two representations of the same information, as opposed to RPLC, APND, etc. However, it may not always be right to say one is a transformation of the other. They could all have been created at the same time, from the same underlying EHR data, simply for the purpose of satisfying the largest range of clients. In this case, which one is prime?

That said, a Transform (XFRM) association in XDS does have a directionality component. It has a source side, and a transformed side. Thus to



use the Transform (XFRM) association we need to determine a directionality. I look to IHE PCC and IHE ITI to see if there is a precedent. There is similar use of Transform (XFRM) in XDS-SD, and also APPC. In both documented cases the directionality component is left to ‘local policy’. So it would seem that the IHE committees have not yet decided.


I propose that “The most technically advanced” document format be considered the Prime, with all of the other formats considered Transforms (XFRM) from that prime document. Thus if the Document Source can create a C-CDA 2.1; then that becomes the prime. Yet if a Document Source only can create a C32 and PDF, then the C32 would be the prime. In this way, regardless of if the secondary formats were actually derived from that prime document, they would be Registered as if they were. This enables a Document Consumer to follow the XFRM link to the Prime without needing to understand all the formats presented. The Document Consumer can also follow the XFRM links down to all the ‘equivalent’ formats to discover those to choose from.

This all said, there could be some policy reason why a different format is considered to be the prime by the Document Source. For example that the Document Source publishes in C-CDA 1.1, and uses a stylesheet transform to produce the C-CDA 2.1. This said, a Document Consumer should be able to rely on the top most (Prime) Transform as the most complete and accurate.

Robust Document Consumer

Given that whatever guidance we advocate would be adopted over time and not uniformly, a Document Consumer needs to handle whatever is available, and be robust to formats that are not understood. Unfortunately, there is probably not a fully deterministic way to go. For example, a given Document Source might adopt this guidance but other Document Source might not, so some but not all equivalent documents would have associations.

Unresolved technical issues:

The various formats are not fully equal. Clearly a PDF format doesn’t carry the fidelity of data that a C-CDA 2.1 can. There might be use case where this difference is not a problem, but any loss of fidelity is potentially problematic. Thus there must be some recognition that the various formats might all be “Transforms” (XFRM), but are not equal. This is why I recommend the prime be the most technically advanced, so that the number of hops away from the prime is an indication of potential loss of fidelity.

There is no obvious metadata place for this ‘completeness’ or ‘accuracy’ or ‘integrity’ evaluation recognition to be placed. There are Vocabulary available in the Value-Set (integrity) recommended for ConfidentialityCode… I am not yet ready to recommend this.

Conclusion

This is just a recommendation. It might kick off a discussion in IHE to write similar recommendations. Not clear if this is a ITI or PCC responsibility.


Attribution: Tone Southerland and Joe Lamy both helped me with the content. Thank you!


Keith covered this in a different way back in 2009. focused more on template inheritance -- Template Identifiers, Business Rules and Degrees of Interoperability -- with a cool graphic

Wednesday, January 25, 2017

Enabling Point-Of-Care Consent

Gathering Privacy Consent is never easy. A Patient, when they are healthy, has no interest in giving Consent for future actions. Mostly because they don't want to admit they might get sick in the future. Secondarily because they don't want to do unnecessary paperwork. Realistically, they just want healthcare to work, and not get in the way of them getting the best treatment. This is why many exchanges are moving toward an 'implied consent' that allows a patient to explicitly withdraw their authorization, but in the absence of any action by the Patient the data would be shared for "Treatment" purposes. This default behavior is only applied to "Treatment", not "Research" or other.

That said, Consent is still sometimes needed. It might be needed because the organization uses a Default of not sharing. It might be because the patient has sensitive health topics that require explicit consent to release. It might be because the patient has Withdrawn their authorization, but now wishes to enable one provider organization access for a visit, careplan, or episode of care.

Given XDS and XCA interactions that are often used in an Health Information Exchange (HIE), or a National Health Information Exchange (NHIE); there is no standards/profiled way to enable a
point-of-care consent gathering workflow. So today, if Consent is not already captured, and needed, then data access is blocked. Today the patient must go to the custodian organization and fulfill their consent workflow needs. This might be easy, through a web tool or phone call, but no matter how easy it is difficult when the Patient is not feeling well.

Consent Negotiation

So... there is a need to enable negotiation between a Custodian that needs a consent, and the Requesting organization that is at the Point-Of-Care... This is the problem that CareQuality is trying to enable. My understanding is that much of this comes from the experience of Epic in their CareEverywhere system. This is getting designed in CareQuality now. The approach should become a standard that anyone can use, hopefully through IHE XDS/XCA/XUA.

The basics are shown in the following interaction diagram. It starts with a normal XCPD or XCA request. The Responding Gateway will check if Authorization(AuthZ) is already enabled. In this case everything is okay, except that a Consent is needed. I say 'everything else is okay' because one needs to make sure the requesting organization is authorized to even ask, and are authorized to get point-of-care consent.

The new thing, highlighted in YELLOW, is that the Responder can inform the Requester that getting specific consent types would allow more information to be exposed. This can be detected by the Requesting organization, it is also backward compatible so that a Requesting organization that doesn't know about this new capability can continue as today with no data available. A Requesting organization can look at the policy choices offered, it can get one of them from the patient, it stores the result locally, and tries the same transaction again with an Assertion that they have achieved the specific consent. The Responding gateway would now see the Assertion and allow disclosure of the data according to the asserted policy. From that point forward that partner would include this Assertion in all requests, and the Responder would continue to disclose under that policy.

Closing the Loop

This works on a Partner-by-Partner basis. This also relies on the Partner that gets a consent to maintain that consent onbehalf of the Responding organization.

An augmentation being discussed is to somehow get the Consent paperwork back to the Responding organization. This might be through the exchange, this might be by postal mail or FAX.  CareQuality is going to enable a the exchange based pathway, through adding additional elements to indicate that the paperwork is available online. This additional element might be false to begin, and change to true a day or a week later.

It also easy to Query for consent documents. The Provider X might set a timer and query each day until it appears.

Once this is received by the Responding organization it is possible for that organization to record the consent and have it affect ALL partners. This is not part of the CareQuality system, but rather is a potential policy decision a Responding organization could make.

This is a developing system, so it is not fully defined. I expect it to continue to develop this winter and spring. I would hope it is then brought to IHE for standardization next year.

Past articles on Patient Privacy controls (aka Consent, Authorization, Data Segmentation)

Tuesday, January 24, 2017

FHIR Connectathon has changed and it is good

I have been unable to attend HL7 WGM for a year, a problem that is now better.  This means that when I attended the FHIR Connectathon 14, prior to the HL7 Workgroup Meeting in San Antonio TX, I was shocked to experience the new FHIR Connectathon. This is good change on many levels. The others from the FHIR core-team have seen the changes over-time, so the transition is not as shocking as it was for me.

In past years, FHIR connectathon was more focused on people trying to use the core FHIR specification. This resulted in discussions to help understand the core concepts, core interaction models, core vocabulary, core data-types, and core Resources. This also resulted in corrections to the FHIR specification, so that future people would understand right from the specification. Other discussions were on toolkits, and how to make the toolkit better. There were discussions on how to implement a general purpose FHIR server. There were discussions on how to implement clients, starting from general concepts. The rumbling within the room was very focused on the FHIR core, and basic understanding.

This year, FHIR connectathon was more of a 'workgroup' meeting. More specifically, an "Agile" "Open-Workplace". There were a 16 distinct tracks. These are focus areas. All of them are broader concepts than one Resource, most are more of a 'workflow'.
Each of these were centered around one or more round tables. Where the table included various implementers interested in the topic, and a leader for the topic. What happens is very natural, they would discuss what the goal was, and adjust the goal organically as they progressed. They would try the basics that are described in the above links, but they would evolve based on the results. 

What really was a shocker is that Security and Privacy became a topic at most of these tables. 

Historically we have just pointed at SMART for security. SMART is a 'good enough' solution for the purposes of hackathons. SMART is not likely to be a good enough solution for production. This is a topic to be covered in much more detail in the coming months. SMART is now a project within HL7, so it will need some formal recognition, and framing. 

There was also interest in the basics of service discovery, patient data location, policy bridging, service response behavior, etc. All the kind of things that an operational environment will need to figure out. None of these were decided conclusively. BUT the very fact that they were talked about is evidence that FHIR Connectathon has changed... and it is good... 

FHIR has matured, it is growing up. It is not yet ready to fly away from the nest. But it is definitely no longer an infant.


Monday, January 16, 2017

IHE on FHIR

IHE is still relevant in a FHIR world. But FHIR has changed the world, and IHE needs to adjust to this new world.

Profiling is still needed

The concept of profiling FHIR is still needed. The difference today is that FHIR is ready and instrumented to be Profiled. It even has a set of Profiles coming from HL7. This is not a threat, this is an opportunity for IHE.

IHE has a set of 10 profiles today (MHD, PDQm, PIXm, mACM, (m)ATNA, CMAP, GAO, RECON, DCP, MHD-I). These mostly are basic profiles, where a basic profile is not a complex profile, one that simply points to a FHIR Resource as the solution for a defined problem. This is helpful to the audience, but not adding much value. It is this lack of value-add that makes what IHE has done today with FHIR Profiling to seem to conflict with core FHIR.

Given that FHIR needs to be Profiled is a fact. A Profile is fundamentally a set of constraints and interactions applied to a Standard, to achieve a specific purpose. This is just as true with FHIR as with any other standard. 

IHE Needs to focus on Larger profiles. The basics of transaction (http RESTful -- for FHIR) is not helpful. But there are many larger workflows, larger data integrity, larger system-of-systems.

FHIR is Profile Instrumented

FHIR is ripe for being Profiled, and is ---Instrumented--- to be profiled. That is that it has mechanisms built into the specification to make Profiling more easy, effective, repeatable, reusable, and discoverable.

IHE needs to modernize

  • Audience expects use of Conformance resources and tools (see above) 
  • can only publish PDF – FTP is not good 
  • does not have a usable mechanism for creation, publication, and maintenance of vocabulary, value-set, and URL 
  • can’t publish conformance constraints in technical format (XML, JSON) 
  • PDF clunky, not hyper-linked, not helpful with programming tools 
  • Audience can’t find IHE if they start at the FHIR specification 
  • Yet, those Implementation Guides that use FHIR.ORG are found 
  • IHE has little development and deployment community engagement 
  • FHIR has multiple tools to help outreach and interaction with community 
  • IHE has email 
  • IHE workgroups are randomly engaged and acting different 

IHE needs to leverage FHIR 

IHE should not fear HL7, HL7 should not fear IHE. But working together with defined and distinct purpoose is best for both.

IHE supports FHIR.ORG. It is my understanding that FHIR.ORG is where activities outside of the specification will happen. Much of the things IHE does are in this space. This includes the tooling capability and support for profiling, but also involves community engagement.
IHE Profiles of FHIR must be ‘built’ using FHIR “IG Publisher” . They would be Balloted and published by IHE. The normal IHE supplement (pdf) might be okay, or need slight changes to Volume 2 (Volume 1 is good). Possibly a new Volume 5 to “hold” technical pointers from FHIR “IG Publisher”. This because today's format of Volume 2 is overly complex for a FHIR profile, especially http REST transport. Besides the Supplement form, the Technical bits would be published on FHIR Registry with pointers back to the IHE
IHE and HL7 Leadership engagement needed. We have gotten this far based on Individual efforts, but the scale of the solution is to big for individual efforts. We need formal agreements, formal sponsorship, and formal recognition. I think the time is ripe now.

Tuesday, January 10, 2017

FHIR documents in XDS

How does one put a FHIR Document into XDS?
How does one find a FHIR Document in XDS?

Both questions are asking very similar things. The key is the XDS fundamental metadata element mimeType. Let me explain...

XDS, more broadly the whole Document Sharing family, including XDS, XCA, XDR, XDM, and MHD. With a set of more narrow IHE Profiles in DSUB, MPQ, SeR, and MU.

To learn more on Document Sharing, start here:  Eating an Elephant -- How to approach IHE documentation on Health Information Exchange (HIE)

So the Document Sharing family is a Content Agnostic mechanism for sharing Patient specific Documents. Where the only thing that fixed is that this is an exchange for 
  • Patient Specific content -- so all the documents must be about a specified patient
  • Document format -- so it is not a REST server.
Metadata -- all the other metadata in XDS is there to help with searching or navigating through the documents than have been shared to find the right one to retrieve.

Initially Document Sharing was about 'historic' documents. That is a document is published, and in the future it can be discovered and retrieved. Thus the Document is "Shared".  Later it gained support for "On-Demand" documents. That is a document that is created when it is retrieved. An On-Demand document is still a document, it is just created a the time it is retrieved, and thus contains the current knowledge about that patient at the time.  Both of these might still be needed for FHIR Documents.

FHIR is more popularly known for the access model using http REST. That is where there is a server that holds current version of the knowledge. Systems can "Create", "Read", "Update", and "Delete" (CRUD) the knowledge using the https protocol. 

FHIR has a Document model. It is abstractly very similar to CDA, but uses all the more simple Resources and Encoding that FHIR has to offer. A FHIR Document is contained in a Bundle, and has a Composition, and all kinds of other stuff.  There is also a workgroup creating transforms from/to CDA -- CDA on FHIR. I am not here t give a tutorial on FHIR Documents, but need it clear that FHIR has the Document concept.

This is where the question comes from... If I have a FHIR Document, how would I publish that into XDS? If I want FHIR Document, how would I find them in my XDS system?  -- or more broadly any of the Document Sharing, because this applies to XDM (Direct Secure Messaging), and other...

So the FHIR Document, is Patient specific... so it should be clear how the Patient identity is related.

Key to FHIR Documents in XDS

The key is that XDS has a metadata element "mimeType". It is this that is the differentiates CDA from FHIR. So for a FHIR document the mimeType is either going to be:

  • XML: application/fhir+xml
  • JSON: application/fhir+json

FormatCode might be more powerful

The XDS formatCode holds the indicator of the technical format that the document follows. This is most of the time a URN that is defined in an IHE Profile, or other external body. This is very possible with FHIR Documents too.

I expect a set of FHIR specific "Implementation Guide", which is FHIR concept of an IHE Profile. of FHIR Documents to happen, these 'profiles' would have FHIR 'StructureDefinition' based constraints. The unique identifier for that StructureDefinition would go into the formatCode.

All the other metadata simply explain the content. 

All the other metadata is just as applicable to a FHIR Document is it is to CDA, PDF, DICOM, or any other format. Note that XDS is happy to carry proprietary formats like WORD too.


Sunday, January 8, 2017

NIST brings Privacy forward - NIST IR 8062


It is so good to see NIST bring Privacy out of the closet. I promoted the "hints of Privacy" that are deep within NIST 800-53, but always needed to enhance with a harmonized set of  Privacy Principles as a Framework, Privacy Impact Assessment, and Privacy Risk Management.

I lead my previous employer to create a "Design Engineering Privacy and Security Framework". This leveraged the NIST frameworks, especially SP 800-53, but we added an overall framework to bring in Privacy as equal goal to Security and Safety. Then added Privacy Impact Assessment to discover and manage risks to Privacy. Bringing in Safety is important in Healthcare, especially Medical Devices, as balancing the Risk Management plans between the three is important to get all three optimally reduced with all as low as possible.  My Venn is speaking to the kinds of technical controls available to address the risk domains. Nothing is ever clean bright line...

It is great to see NIST bring forward Privacy in the NIST IR 8062 - An Introduction to Privacy Engineering and Risk Management (in Federal Systems) as a distinct, yet related. 

Their stated purpose:
For purposes of this publication, privacy engineering means a specialty discipline of systems engineering focused on achieving freedom from conditions that can create problems for individuals with unacceptable consequences that arise from the system as it processes PII. This definition provides a frame of reference for identifying a privacy-positive outcome for federal systems and a basis for privacy risk analysis that has been lacking in the privacy field.
The great news about this is that their goal is to speak to those developing IT systems. Most of the other Privacy Frameworks are targeting those that are running IT systems. Even Privacy-By-Design, which declares it is 'design', is more about deployment than software or database design. Software engineers have trouble with these frameworks as they are not the prime audience. These other frameworks are speaking toward business management, and business risk. There is a need to speak to the engineering level audience.

NIST writes standards for the USA Federal Government, thus this standard is targeted for IT 'in Federal Systems'. This is more about NIST scope. This has NOTHING to do with the usefulness or global applicability of this specification.

The publication of NIST IR 8062 - An Introduction to Privacy Engineering and Risk Management (in Federal Systems) is just the start. I have hopes that these will refine and get more useful as experience using the NIST Privacy framework happens.