FHIR Consent March 25, 2016

Attendees

	Member Name			Member Name			Member Name
x	Johnathan ColemanCBCC Co-Chair		x	Kathleen Connor FM Co-Chair		x	John MoehrkeSecurity Co-Chair
x	Alexander Mense Security Co-Chair		.	Marty Prahl		x	Tarik Idris
x	Suzanne Gonzales-Webb CBCC Co-Chair		.	Diana Proud-Madruga		.	Pat Pyette
x	M'Lynda Owens		x	David Staggs		x	Glen Marshall
.	Rob Horn		.	Beth Pumo		x	William Kinsley
x	Serafina Versaggi		.	Russell McDonell		x	Ken Sinn (Canada)
x	Igor Sirkovich		x	[mailto: Andrew Rampolla (SSA)]		.	[mailto:

FHIR Consent Directive Project WiKi

Agenda

1. (05 minutes) Agenda Review, Attendance, Approve [http://wiki.hl7.org/index.php?title=FHIR_Consent_March_18,_2016 FHIR CD March 18 Meeting Minutes
2. (05 minutes) Review evolving document
3. (05 minutes) Discuss change Contract.topic/Contract.subject mini-use cases related to FM 9536 CP - "to be" pre-applied solution to consider how to specialize for CD profile.

What to call the three elements?

For Discussion

Kathleen's responses to John's questions about what FM will pre-apply for the following Contract elements:

• Contract.topic
• Contract.term.topic
• Contract.subject

Which Data Types?

1. Contract.topic [x] =  string|uri|Resource(Any)| Coding – bound to FHIR Resource Type, Document Type, and Document Class Value Sets
2. Contract.term.topic [x] = string|uri|Resource(Any)| Coding – bound to FHIR Resource Type, Document Type, Document Class Value Sets and v3 SecurityObservationValue (2.16.840.1.113883.1.11.20469)
3. Contract.subject [x] = string|uri|identifier|Resource(Any)

Cardinality

1. Contract.topic =  0..*
2. Contract.term.topic = 0..*
3. Contract.subject = 0..*

Short Description

1. Contract.topic = Context of the Contract
2. Contract.term.topic = Context of the Contract Term
3. Contract.subject = Contract Target Entity

Definition

1. Contract.topic = The matter of concern in the context of this agreement.
2. Contract.term.topic = The matter of concern in the context of this provision of the agreement.
3. Contract.subject = The target entity impacted by or of interest to parties to the agreement.

Requirements

Contract.topic

• In the context of a contract, the topic is the matter under consideration in regards to which specific rights, privileges, obligations, restrictions, and prohibitions are binding on any grantor and grantee parties upon the execution of the contract. 
• Given the wide range of contract topics, implementers need to be cognizant of the business use case for which they are designing a FHIR Contract, and narrowly specify the topic being represented with respect to the Contract.type and any specializing Contract.subtype. 
• The same topic, e.g., an asset such as a good or service, such as a real property, medical supply, insurance, information, a procedure or employment, or a manner of conduct, such adherence to a privacy, trust, or security policy, may be the topic of multiple types of contracts. 
• One way to determine the Contract.topic is to answer the question: “What is the object of negotiation?”
• Answer: The Contract.topic, which may be described with more detail in the [0..*]Contract.valuedItem @ [0..1] Contract.valuedItem.entity[x] Definition: Specific type of Contract Valued Item that may be priced. CodeableConcept|Reference(Any)
  • Contract.topic is “the what” that a grantor is exchanging with a grantee in return for some benefit. 
  • Contract.topic is “the what” to which any Contract.action is being applied for any stipulated Contract.action.reason. 
  • AContract.topic is “the what” governed by the execution of the contract to which any party’s rights, privileges, obligations, restrictions, and prohibitions apply.

Contract.term.topic

• Contract.term.topic = A contract term topic is typically about a portion of the topic which has additional or specialized rights, privileges, obligations, restrictions, and prohibitions that are binding on any grantor and grantee parties upon the execution of the contract. 
• Contract.term.topic may be described in more detail in the [0..*] Contract.term.valuedItem @[0..1] Contract.term.valuedItem [x] Definition: Specific type of Contract Provision Valued Item that may be priced. CodeableConcept|Reference(Any) [See Contract.topic Requirements for further elaboration on this requirement.]

Notes

Contract.topic

• The Contract.topic may be an application for or offer of a policy or service (e.g., uri to a consent directive form or a health insurance policy), which becomes the Contract once accepted by both the grantor and grantee. 
• The Contract Resource may function simply as the computable representation of the executed contract, which may be the attached to the Contract Resource as the “binding” or as the “friendly” electronic form.  For example, a Contract Resource may be automatically populated with the values expressed in a related QuestionnaireResponse. 
• However, the Contract Resource may be considered the legally binding contract if it is the only “executed” form of this contract, and includes the signatures as *The Contract Resource may function as the computable representation of an application or offer in a pre-executed Contract if the grantor has not entered any values.  In this case, it is populated with values in a “legal” form of the application or offer or by the values in an associated Questionnaire.  If the grantor has filled in the legal form or the associated Questionnaire Response, then these values are used to populate a pre-executed Contract Resource.
• If the Contract.topic is considered an application or offer, then the policy is often required to be attached as the “legal” basis for the application to ensure “informed consent” to the contract, and that any discrepancy between the application and the policy are interpreted against the policy.  Implementers should check organizational and jurisdictional policies to determine the relationship among multiple representations of a contract pre- and post-execution.

Contract.term.topic

• The Contract.term.topic, as a Contract Resource subpart, is handled in the same manner as the Contract Resource as discussed above.   

Contract.subject

• The Contract.subject is an entity that has some role with respect to the Contract.topic and Contract.topic.term, which is of focal interest to the parties to the contract and likely impacted in a significant way by the Contract.action/Contract.action.reason and the Contract.term.action/Contract.action.reason. 
• In many cases, the Contract.subject is a Contract.signer if the subject is an adult; has a legal interest in the contract; and incompetent to participate in the contract agreement.

Examples and Comments

Contract.topic Datatype Examples

• string

1. [Use Case A] Parcel Number 512801000 Property Local Section 23 Township 19 Range 2W Property Address 2010 Boston Harbor Road [Contract.type = Real Estate Purchase and Sales Agreement]
2. [Use Case B] All Patient Health Information held by Happy HIE [Contract(ConsentDirective).type = Opt-in with restrictions]
3. [Use Case C] Little Red Corvette License Number C27550 [Contract.type = Automobile Sales Agreement]
4. [Use Case D] eHealth Exchange DURSA [Contract.type = Trust Agreement]
5. [Use Case E] DirectTrust Trust Bundle [Contract.type = Trust Agreement]

• uri

1. [Use Case F] Florida Universal Patient Authorization for Limited Disclosure [Contract(ConsentDirective).type = Opt-in with restrictions]
2. [Use Case G] Premera Blue Cross Preferred Gold 1000 [Contract.type = Individual health insurance policy]

• Reference(Any)

1. [Use Case H] Happy Clinic Office Location Resource [Contract.type = Lease Agreement]
2. [Use Case I] Most recent hospital inpatient stay Encounter Resources [Contract(ConsentDirective).type = Opt-in with restriction]
3. [Use Case J] Specific FHIR Diagnostic Reports pertaining to HIV [Contract(ConsentDirective).type = Opt-out with exceptions]

• Coding [Resource Type, Document Type, and Document Class Value Sets]  

1. [Use Case K] Any non-FHIR Diagnostic Report with DiagnosticReport.codedDiagnosis = HIV [Contract(ConsentDirective).type = Opt-out with exception]
2. [Use Case L] Any CDA Documents with Type = 11527-9 Psychiatry study [Contract(ConsentDirective).type = Opt-out with exception]
3. [Use Case M] Scanned Paper Form tagged as a LP173409-6 Advance directive [Contract.type = Advanced directive]

Contract.term.topic Datatype Examples

• string

1. [Use Case A] Parcel Number 512801000 Utility Easement [Property sale encumbrance]
2. [Use Case B] Any Patient 42 CFR Part 2 or Title 38 Section 7332 governed substance abuse records held by Happy HIE [Contract.term.type = Opt-out]
3. [Use Case C] Traction tires and chains for Little Red Corvette [Contract.term.type = Sold separately]
4. [Use Case E] DirectTrust
5. [Use Case F] Florida Universal Patient Authorization for Limited Disclosure Purpose Section [Note:  A string may be used for a provision in a uri-retrievable contract, policy, application, or offer, which does not have retrievable uri for subparts such as provisions.]
6. [Use Case M] Scanned Paper Form tagged as a LP173409-6 Advance directive Organ Donation Section [Note:  A string may be used for a provision in an unstructured contract.]

• uri

1. [Use Case G] Premera In-Network Providers [Contract.term.type = Contract Benefit]
2. [Use Case D] eHealth Exchange DURSA Certificate Management [Contract.term.type =Entrust Agreement]

• Reference(Any)

1. [Use Case H] Happy Clinic Office EHR Device Resource [[Contract.term.type = Excluded from Lease Agreement]
2. [Use Case I] Most recent hospital inpatient stay Encounter Resources with Patient Account Resource that references HealthcareService.serviceType.type = 394587001 Psychiatry [Contract.term.type = Opt-out. Contract.term.action = Information Disclosure and Contract.action.reason = v3 SecurityObservationValue Payment Purpose of Use]
3. [Use Case J] Specific FHIR Diagnostic Reports pertaining to HIV test with negative DiagnosticReport.result  [Contract.term.type = Opt-in]

• Coding [FHIR Resource Type, Document Type, and Document Class Value Sets, and v3 SecurityObservationValue (2.16.840.1.113883.1.11.20469)]  

1. [Use Case E] DirectTrust Trust Bundle Patient Identify Proofing Level of Assurance [Contract.term.type = SecurityTrustAssuranceObservationValue (2.16.840.1.113883.1.11.20540)]
2. [Use Case K]  Any non-FHIR Diagnostic Report pertaining to HIV test with negative test result  [Contract.term.type = Opt-in]
3. [Use Case L] Any CDA Documents with Type = 11527-9 Psychiatry study [Contract(ConsentDirective).term.type = Opt-in with Contract.term.action = Information Disclosure and Contract.action.reason = v3 SecurityObservationValue Research Purpose of Use]  

Contract.subject

• string

1. [Use Case A] LLC that owns Parcel Number 512801000
2. [Use Case B] Patients with Happy HIE health information that include 42 CFR Part 2 or Title 38 Section 7332 governed substance abuse records  
3. [Use Case C] Jane Doe, owner of Little Red Corvette License Number C27550
4. [Use Case D] eHealth Exchange partner organizations
5. [Use Case E] Members of DirectTrust Trust Bundle

• uri

1. [Use Case G] Non-FHIR Premera member identifiers for subscriber and dependents

• identifier

1. [Use Case A] Nationally recognized identifier for the Parcel Number 512801000 owner
2. [Use Case B] Driver’s License for the owner of the Little Red Corvette
3. [Use Case G] Premera member identifier for subscriber or dependents
4. [Use Case K] Patient and Related Persons for non-FHIR Diagnostic Report pertaining to HIV test with negative test result  

§  [Use Case M] Organ Donor Patient or Driver’s License identifier o   Reference(Any) §  [Use Case H] Happy Clinic Office Owner Organization Resource §  [Use Case I] Patient Resource for most recent hospital inpatient stay Encounter Resources §  [Use Case J] Patient Resource and Related Person Resource [Patient partners] for FHIR Diagnostic Reports pertaining to HIV §  [Use Case L] Patient Resource and Related Person Resource [Personal Representative] for any CDA Psychiatry study