California Bill 352 - aka sex and gender sensitivity

The following question(s) were asked today, and I figure my response is informative to a broader audience.

Has anyone implemented anything pertaining to this?


Prevent the disclosure, access, transfer, transmission, or processing of medical information related to gender affirming care, abortion and abortion-related services, and contraception to persons and entities outside of this state in accordance to this part.https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202320240AB352

I'm trying to think through how to go about it and it seems challenging. These are some initial thoughts.Resources should use security labels. Which ones?
There should exist valuesets that define codes which are considered sensitive.. it doesn't seem like any exist
Access by a user/practitioner might not be as challenging because we may be able to determine the state in which the practitioner is practicing via an OIDC claim or a business identifier.. not totally sure about that
Access by a system is potentially more difficult... client registrations would need to contain some assurance about the locale of the application. Some may not segment application registrations in such a way
Access by a patient seems like it would be straightforward, but perhaps not. The patient has the unfettered right to see the data. But, what if a fhir-based app they use has server/architecture outside of ca?
Perhaps a scope could be introduced: "i-am-outside-of-ca", or "i-am-inside-ca"
Must we perform partial hydration of resources? For example, if a portion of the resource is sensitive. If the Patient resource cannot be accessed, the rest of the ecosystem can loose meaning
Documents, Binaries, eg CDAs - must generate a version "for CA" and another for "not CA"
HIEs, QHINs, ...

Mohammad Jafari and I have done work on this in DS4P and IHE-PCF; we continue to refine this as part of our technical advisory participation in SHIFT. -- https://www.drummondgroup.com/shift/

Grahame is correct that GENDER would be the most specific sensitivity policy code. This could be the code used to tag data that is sensitive to GENDER, although this is actually a policy code. A more general approach would be to use the SEX code which is a more proper sensitivity indicator. Whichever of these codes you use to tag data, would then be used in the Consent resource to indicate how those tagged data are to be protected.

In IHE-PCF I have a use-case that shows how this is done using the advanced option
https://profiles.ihe.net/ITI/PCF/content.html#3584-advanced

As to the question on "There should exist a valueset that define codes which are considered sensitive..."
I will reference you to the Appendix P in the IHE-PCF
https://profiles.ihe.net/ITI/PCF/ch-P.html#p5-security-labeling-service-models

First, there was one attempt at creating these value-sets... they were done by SAMSA, they are quite old and are not currently maintained. The SHIFT project is looking for some proper organization and governance to take on the task of updating and maintaining these.

However, no matter how perfect a value-set is; it will always need local tweaking to your organizations use of codes, and will not address use-cases of second or third order relationships.

On blinding part of a resource... you are correct that this is dangerous area. It is an area that we chose in IHE to leave to later versions of the IHE-PCF; we needed basic profiling done first.... Partial resource redaction is likely to be a very specific thing, I expect that partial redaction will first appear in the Patient resource itself. That is to say that the gender extensions may be something that blinding might be seen as still useful for specific users (e.g. the food service doesn't need to see this). When doing blinding like this, there is also the policy on how to indicate that the resource itself is not complete, where we do have the SUBSETTED tag that is used for use-cases like _summary; but in the privacy blinding to indicate that data has been redacted is to send signal to recipient... POLICY is going to be the hard part, the technical implementation can be achieved once a policy is defined.

On the client is within CA or not... WOW, very dangerous territory.. I suspect that this is more risky than even sub resource redaction.

Note that the Gender Harmony workgroup did have some discussion on this, and also chose to defer solving it at this time.
https://build.fhir.org/ig/HL7/fhir-gender-harmony/#out-of-scope

Conclusion

The fact that this is not well described has nothing to do with the technical capability, we have that ready. The main problem is defining comprehensive policies and addressing the risks to privacy, security, safety, and effectiveness. 

Very likely that this bill could be used to get a bunch of people together to define policy and profile how to make it work. Forcing functions are always critical to change.

I think that the SHIFT workgroup is in the best position to address this. They have a very broad participation that can best see the whole picture... and I am on that project.

IHE Basic Audit Log Patterns using #FHIR AuditEvent

The Basic Audit Log Patterns (BALP) is a Content Profile that defines some basic and reusable AuditEvent patterns.

The Audit Log Patterns defined rely on the ATNA Profile for transport of the AuditEvent and query/retrieval of AuditEvents previously recorded. The patterns defined may be used as they are, or further refined to specific use-cases. Where a more specific audit event is defined, it should be derived off of these basic patterns. Thus, a more specific AuditEvent would be compliant with one or more of the AuditEvent patterns defined here.

This Implementation Guide is intended to be fully compliant with the HL7 FHIR specification, providing only use-case driven constraints to aid with interoperability, deterministic results, and compatibility with ATNA and other IHE Profiles.

ANY Secure Client and ANY Secure Server represent abstractions of any client/server actor grouped with an ATNA Secure Node or an ATNA Secure Application supporting the ATX: FHIR Feed Option, defined in the RESTful ATNA Supplement. Where ANY Secure Client and ANY Secure Server are involved in some communication that is an auditable event described in this Implementation Guide and for which some AuditEvent pattern is defined. The AuditEvent patterns defined here will be created and recorded [ITI-20] by the Secure Node or Secure Application that is grouped within the diagramed ANY Secure Client and the ANY Secure Server.

The double recording enables forensic analysis to detect failures better. Both audit events recorded will be different as the AuditEvent.source would identify the actor recording the event. Some actors will be able to populate the AuditEvent pattern given more fully, the lack of an element being populated is not a defect, but rather indicates that the actor did not have access to that data.
AuditEvent

AuditEvent Profiling

The AuditEvent resource is used to record that an auditable event has happened. These auditable events are usually security or privacy relevant, but may be for other purposes. The profiles of AuditEvent here are to support security and/or privacy use-cases. These profiles of AuditEvent can be used as is, or may be used to derive more specific profiles of AuditEvent for more specific use-cases.
Profiles

The following AuditEvent patterns are defined:

• RESTful activities (Create, Read, Update, Delete, Search)
• SAML Security Token
• OAuth Security Token
• Consent Authorized Decision Audit Message
• Privacy Disclosure Audit Message

Implemented in FHIR Servers

The following commonly used FHIR Servers have BALP implemented within them. You just need to turn it on. For more details:

• HAPI FHIR Server - https://hapifhir.io/hapi-fhir/docs/security/balp_interceptor.html 
• Firely FHIR Server - https://docs.fire.ly/projects/Firely-Server/en/latest/security/auditing.html
• Aidbox FHIR Repository - https://docs.aidbox.app/modules-1/logging-and-audit/audit-logging

HL7 Cyber Security Event - recordings available

 Announced this morning that HL7 and ONC are making available the recordings of the presentations given at the HL7 CyberSecurity Event. These presentations were very well done, and I encourage everyone to watch them all.

https://tinyurl.com/hl7sec

#HL7 #FHIR Security Education Event

Join me at the #HL7 #FHIR Security Education Event virtually this August 8 & 9! I'll be speaking on: 

1. 
   FHIR Security and Privacy for Developers
2. FHIR Security & Privacy Capabilities
3. FHIR Security Practical Application
4. FHIR Consent: How to record, assert, and evaluate: IHE Privacy Consents on FHIR

See the full agenda and register at: https://info.hl7.org/hl7-fhir-security-education-event

Patient Requested Restrictions

 Many in the USA are reviewing and preparing comments on HTI-1. I used to do this top to bottom, but don't really have a work driver to base my comments upon. So I now end up reviewing and commenting on very targeted sections.

As part of my advisory position on SHIFT

Shift (formerly Protecting Privacy to Promote Interoperability PP2PI) was founded in 2018 and formalized in 2020 with a mission to advance safe, equitable, and patient-empowered sharing of health information. To this end, the task force has gathered expert stakeholders across the industry with the purpose of maturing granular data segmentation standards and implementation guidance in order to sponsor patient-driven sharing of health information with informed consent and advance interoperability in a more equitable manner. Shift’s vision is to further a health care ecosystem in which better standards for clinical data sharing increase trust between patients, providers, and caregivers to improve quality of care and health equity.

I am reviewing "§ 170.315(d)(14) - Patient Requested Restrictions Certification Criterion" and providing comments. The total things said in HTI-1 is

(14) Patient requested restrictions.

(i) For any data expressed in the standards in § 170.213, enable a user to flag whether such data needs to be restricted from being subsequently used or disclosed as set forth in 45 CFR § 164.522; and

(ii) Prevent any data flagged pursuant to paragraph (d)(14)(i) of this section from being included in a use or disclosure.

I have provided comments to SHIFT, and what they include is up to that organization. The following is purely my words.

First, I am very glad to see advancements in Patient ability to request and get the restrictions they desire. The state of the art in the USA is that Patients have next to nothing resembling Privacy Consent, all while their data are flowing to places that Patient would never imagine their data flowing.

However, I think that a regulation should focus on outcomes, not how to achieve those outcomes. Meaning the text in the regulation should be expressing the kinds of patient requested restrictions that must be allowed, and not expressing that a "flag" on data should be used. Why do I express this? Because systems design is very specific to the current systems design. Tagging all of the data in an EHR is non trivial, and there is not good advice on how to do that well, say nothing of how to do it without fail.

However, if we had expressions of the kinds of restrictions that are needed by Patients and express these in a prioritized listing; then creative systems designs can be done to achieve those goals. Some may choose to use data "flags", but some may find that their data already have attributes that they could leverage.

I have been working on a new Implementation Guide from IHE on this topic - Patient Consent on FHIR (PCF). And within that specification there is a set of steppingstones: Basic, Intermediate, and Advanced. The Basic is not easy, but is also not hard given many possible designs, and it is what is necessary to build both the Intermediate and Advanced alternatives. Advanced is using security sensitivity tagging, and is what is most of the time referred to as "Data Segmentation for Privacy (DS4P)". One can go directly to Advanced, and not implement the Intermediate. Intermediate is a set of use-cases that are high-value privacy consent needs, that do NOT require data to have security sensitivity tagging.

So, I would prefer that ONC change their (i) and (ii) clause to be expressing use-cases in terms of the resulting behavior and eliminate wording about how one must achieve that behavior.

I would be happy if ONC recognized the IHE-PCF, but it is just in Public-Comment right now, and thus is not ready to be referenced yet. It should be by the time they finish their comments.

 Preferences vs Consent

Another read of the HTI-1 is that there around the definitions in HIPAA for Patient Requested Restrictions and a healthcare organizations requirements under medical records retention and safety. HIPAA is very careful to give the right to patients to Request Restrictions, but then indicates clearly that the healthcare organization (Covered Entity) is not compelled to accept the restriction request. This has been used to keep the current status Quo where no restrictions are supported. I read the new ONC text to express a need to accept some of these restrictions. As I indicated above, if that was more clearly defined as to the kinds of restrictions that must be implemented, then it would be far more clear what is needed to be done here. 

Some other people have read the ONC text to demand that the healthcare organization must accept all restrictions without limits and without human intervention. I can understand this read, but I certainly hope it was not the intended read. 

I have been working to express the distinction between the Patient Request, and the rules that an organization agrees to enforce. Where the Patient Request is referred to as "Privacy Preferences". Privacy Preferences would not be constrained by what is possible to constrain, although they might be in a structured and coded format. These Privacy Preferences could be taken as input to a workflow on Privacy Consent with an organization. The Organization here has responsibility to maintain the data, such as a treatment organization. The Organization has regulated responsibilities, like Medical Records Retention and Medical Safety. Thus the Organization has some limits on what they can restrict. The result is a Privacy Consent, where a Privacy Consent is a binding agreement between the Patient (or their delegate) and the Organization(s) holding data.  The following diagram is in the IHE-PCF Appendix P

Conclusion

There is so much more in the IHE-PCF that I can't cover here. The maturity of this specification would likely put it outside the window of what the ONC could reference, however the fact that it is in development should be seen as a positive move toward a future that has this kind of support. The real request to ONC is to change the wording of the requirements to not include "how" one achieves support for Patient Requested Restrictions, but rather itemizes the high value use-cases and the outcome of a system that supports those use-cases. This focus on "outcomes" and less on "how" will result in the solution sooner rather than later.

IHE IT-Infrastructure Spring 2023

The IHE IT-Infrastructure committee continues to produce new and improved specifications for HIE interoperability. This spring we are publishing a supplement that was out for public-comment, a whitepaper that was out for public-comment. We are placing into Public-Comment an IG publisher formatted Profile that was previously published, and a brand-new Implementation Guide supporting Privacy Consents and enforcement.

All of these can be found on the IHE publications site: https://profiles.ihe.net The publications listed below are from the IT-Infrastructure Domain where these publications and instructions can be found.

Publications of past Public-Comment:

These two specifications were in public-comment this summer, and now are published for use.

Cross-Community Patient Discovery (XCPD) Health Data Locator and Revoke Option - Rev. 3.1  

The Cross-Community Patient Discovery (XCPD) Health Data Locator and Revoke Option Supplement enhances the existing IHE XCPD Integration Profile by adding two new capabilities. The first is the ability to exchange a list of health data locations, which enables Record Locator Services to interoperate with consumers wishing to discover the location of patient records within a health information exchange. The second is the ability to revoke a previously exchanged patient ID correlation, which is used in the case where patients in different health information communities were linked with XCPD, but must now be unlinked due to some circumstance such as patient merge.

This update is an editorial enhancement to the existing supplement which improves the layout of the standard by separating the Revoke interaction into a separate, isolated transaction. There are no functional changes in this update. Health IT Vendors should review this supplement and determine if the capabilities within meet their interoperability needs.

Document Sharing Across Network Topologies- Rev. 1.0  New! 

The Document Sharing Across Network Topologies White Paper expands upon the concepts in the Health Information Exchange White Paper by providing additional guidance on how existing document sharing communities can be interconnected to form a unified federated exchange ecosystem. This type of ecosystem typically emerges in environments composed of several jurisdictions that each began developing their own health information exchange and now wish to become interconnected.

This white paper primarily illustrates how such a network could be represented in a Mobile Care Services directory. It is intended to be read by HIE and Healthcare IT Executives and Architects, Standards Development Architects, and health data exchange stakeholders in academia.

New Public-Comment Supplements

These are new publications entering Public-Comment. We welcome comments from IHE members and those that are not IHE members. Both of these are very relevant to current developments in HealthIT.

Mobile Cross-Enterprise Document Data Element Extraction (mXDE)

The Mobile Cross-Enterprise Document Data Element Extraction (mXDE) Profile provides the means to access data elements extracted from shared structured documents. The profile enables the deployment of health data exchange infrastructures where fine-grained access to health data coexists and complements the sharing of coarse-grained documents and the fine-grained data elements they contain.

This update is primarily a conversion from the PDF supplement form to using the IG Publisher. This conversion enabled better and more comprehensive definition of the Provenance linkage between the derived FHIR clinical Resources and the source documents from the HIE. This Provenance definition is now in mXDE along with examples and requirements CapabilityStatement. This update also leverages the other IHE implementation guides that profile FHIR, and specifically the Basic Audit Log Patterns (BALP) for security and privacy audit logging.

 

Privacy Consent on FHIR (PCF)

The Privacy Consent on FHIR (PCF) Profile provides support for patient privacy consents and access control where a FHIR API is used to access Document Sharing Health Information Exchanges. This profile includes both Consent profiling and access controls profiling of oAuth access token.

 

This first release to Public Comment includes both Consent profiling and Access Control decisions and enforcement. The Consent profiling supports many Basic, Intermediate, and Advanced needs. There are a rudimentary set of privacy policies, and an Appendix that discusses the various attributes and considerations one must consider when writing the privacy policies to be used. This Appendix also includes discussion about refrains and obligations, the FHIR Consent fundamentals, and Security Labeling Service models. The PCF includes technical profiling on the oAuth (IUA) access token to enable decisions to be based on Consent and to carry residual rules for the enforcement point to enforce. The PCF includes technical profiling of the Consent with various complexity represented in Options to enable basic systems to improve over time to add features in support of intermediary and advanced use-cases. The profile includes 21 examples of Consents using the profiling, and for each of them shows the oAuth access token impact.

 

I will write more about the PCF in the future, but I think the IG explains itself well.

Details on who IHE is and how to engage are available on their web site. Comments are always welcome from anyone regardless of if you are an IHE member or not.

May the 4th be with you.

Transitioning Federated HIE from XCA to FHIR Query

I already have one proposal for the transition from the current Federated Health Information Exchange to supporting FHIR, that is based on a transition from CDA to FHIR-Documents. In that proposal, I make it clear that this is NOT an end-state, but rather a method to more smoothly transition. A key point of a smooth transition is that it does not stop what is working today, but provides methods of supporting the future for those early adopters. That proposal recognizes that today the communication pathway is XDS/XCA, and that communications pathway is content agnostic, meaning it can carry a FHIR-Document just as well as a CDA, PDF, JPEG, or TEXT document. 

Note that just because the content being published is a "Document" does not mean that it must be consumed as a document. There are solutions such as the one from IHE (Mobile Cross-Enterprise Data Element Extraction - mXDE) that shows how to decompose documents into FHIR Resources, and provides for proper Provenance back to the source Documents.

Federated FHIR Resource Servers

In this article I am going to add another step to the smooth transition. In this article I am going to show how we can leverage much of the infrastructure that has been put into nationwide federation of health information exchanges, while enabling communication that is natively FHIR Query/Retrieve. In this proposal the data holder never creates a "Document", they provide a FHIR Server endpoint that can be queried. This idea of having a FHIR Server endpoint is not new, it is the fundamental first step of any data holder.

What is missing is a federation mechanism that enables someone who needs data to find who has that data. We still need some way to discover the patient identity as known by the various parties participating in the federation, and determine which parties have data about that patient. Once you know the FHIR Server endpoints that have data, and the Patient identity at that endpoint; then you just use normal FHIR Query.

Note that "just use normal FHIR Query" is skipping the Security and Privacy aspects... I will get to those later. I mostly think that this is already addressed by the various security and privacy projects; they just haven't seen enough use to figure out where federation fits.

Federated Patient Record Location

We already have a functioning Patient Record Location standard that is being used with XCA to find the patient identities and locations where data are. The standard is XCPD. This standard is mostly used between the various communities, so is not something that a client app needs to care about. Yes, it is based on HL7 v3, and uses SOAP. I recognize that this is a drawback. My point is more that this is functional today, and it gives us what we need. Further the HL7 v3 and SOAP standard better supports the scale of federation that we need, something that http REST does not.

So, if we accept that XCPD can continue to be used to discover patient identities and locations where data are, then how do we determine the FHIR Server address? This is an important question as XCPD provides a "homeCommunityID" as the location, and that is an OID.

Converting homeCommunityID into a FHIR Server address

Fortunately, we already have the solution to this problem. 

Today, with XCA, the homeCommunityID needs to be converted into the address of the XCA endpoint, and this done with a centrally managed Directory. This centrally managed Directory is already managed for the purposes of supporting XCA, so it is already in place. This centrally managed Directory is already founded on FHIR. Mostly the FHIR Resources: Organization, OrganizationAffiliation, Location, and Endpoint.

It is the Endpoint resource that we need to further refine. Whereas it is understood how to define an XCA endpoint; we just need to have a flavor of Endpoint profiled to show a FHIR Server endpoint. Once we have that, then the normal FHIR Server processing progresses. Looking at the FHIR Server metadata endpoint, and oAuth well-known details.

There is a very important Whitepaper by IHE on "Document Sharing Across Network Topologies", that like this article clarifies is more than just Document Sharing, but also FHIR Server endpoint. Video introduction.

Intermediate or Direct

Now for the smooth transition:

1. A data holder can express that they both have XCA and FHIR endpoints. They don't need to choose which one they support.
2. Value-Add intermediaries can be expressed in this Directory as the endpoint for a given set of Organizations. 
3. Value-Add intermediaries can also implement mXDE to provide the FHIR Server support on behalf of Organizations that are not yet ready to transition.
4. Those that want data simply use the Federation discovery methods to find the patient identities and locations for a given patient, then lookup in the directory the alternatives for how to get data from that location and choose the best solution for them.

Like with the previous proposal to transition from CDA to IPS; the transition here is driven more by those that want to consume data, supported by the infrastructure and the data holders.

Thanks to Joe Lamy (AEGIS) for dialog resulting in this article.