0. Healthcare Information Technology Standards Panel
Consumer Empowerment – Registration and Medication History
June 22, 2007

1. Consumer Empowerment Registration and Medication History
Scope
Deploy to targeted populations a pre-populated, consumer-directed and secure electronic registration summary. Deploy a widely available pre-populated medication history linked to the registration summary
Addresses core consumer empowerment enabling “connected PHRs”
Now recognized to be also applicable to EHR-to-EHR information exchange for interoperable patient charts with meds, allergies, problems, registration info.
A successful collaboration between HITSP and several HITSP member organizations developing base standards and implementation guides/profiles: ASTM, CAQH, CDC, FMT, HL7, IHE, NCPDP, X12, SNOMED

2. Consumer Empowerment Registration and Medication History

3. IS03 Consumer Empowerment Registration and Medication History
Developed in support of Harmonized Use Case for Consumer Empowerment (Registration and Medication History), March 19, 2006
Consumer creates account to host registration summary & medication history
Consumer visits Healthcare Provider and provides registration summary information
Authorized Healthcare Provider reviews medication history
Key Requirements/Functionality Enabled by the IS
Querying other organizations for data and matching to the consumer
Accessing, viewing, and sharing registration summaries and medication histories
Note: Security and privacy in the process of being addressed.

4. IS03 Consumer Empowerment Registration and Medication History Set of Constructs
Document
Document Description
HITSP/TP13
HITSP Manage Sharing of Documents Transaction Package
facilitates the registration, distribution and access of patient electronic health records across health enterprises
uses the Cross-Enterprise Document Sharing (XDS) Integrating the Healthcare Enterprise (IHE) Integration Profile
Based on ISO 15000
HITSP/TP22
HITSP Patient ID Cross-Referencing Transaction Package
deals with identifying and cross-referencing different patient attributes for the same patient.
leverages the IHE IT Infrastructure (ITI) Technical Framework (TF), Volume 2 (ITI TF-2) for Patient ID Feeds and Patient ID Cross-referencing (PIX).
Based on HL7 V2.5
HITSP/T23
HITSP Patient Demographics Query Transaction
provide a ‘list patients and their demographics’ query / ‘patient(s) and their demographics identified’ response message pair
Leverages the IHE IT Infrastructure Technical Framework, Volume 2 (ITI TF-2) for Patient Demographics Query (PDQ)

5. IS03 Set of Constructs (cont’d)
Document
Document Description
HITSP/C32
HITSP Registration and Medication History Document Content Component
describes the document content that summarizes a consumer’s registration and medication data information for the purpose of information exchange
the registration summary is restricted to the information consumers generally need to provide when visiting a physician, hospital, or pharmacy, such as:
Demographic information sufficient to help identify the consumer
Financial information sufficient for insurance eligibility checking and claims submission
Basic clinical information including allergies
the medication history (i.e., prescriptions and over-the-counter products) is the first clinical data section and includes a core medication summary that answers the question of “what medications are you currently taking” and provides a path to more complete medication history data exchange to support full medication management

6. Transaction Package TP-13 – Manage Sharing of Documents
Defines the methodology and metadata requirements for the registration, storage and retrieval of documents across repositories within an affinity domain
Calls out a subset of transactions defined in the IHE XDS Cross Document Sharing Specification, Dec 2006
ITI 14 Register Document Set
ITI 15 Provide and Register Document Set
ITI 18 Registry Stored Query
ITI 17 Retrieve Document
Key Concepts: Sharing of source attested documents, document content neutral, document registry, document repositories distributed or centralized.
pkg TP 13
«transaction package»
Manage Sharing of Documents +
docId = TP13
«composite standard»
IHE XDS
Provide & Register Document Set: ITI-15
Registry Stored Query: ITI-18
Register Document Set: ITI-14
Retrieve Document: ITI-17
«base standard»
ISO ebRS
implements
constrains

7. Transaction Package TP-13 Manage Sharing of Documents
Four Technical Actors, 4 Transactions:
A Document Source that publishes a document to a repository (architecture neutral: local, shared or central)
A Document Repository that stores the document and forwards high-level meta-data to Document Registry
A Document Registry that tracks meta-data about documents
A Document Consumer that queries the Document Registry, selects document of potential interest and retrieves one or more from the referenced Document Repositories.

8. TP22 – Patient Identity Cross-Referencing
Defines the methodology for identifying and cross-referencing different patient attributes for the same patient.
Underlying source material is from the IHE IT Infrastructure (ITI) Technical Framework (TF), Volume 2 (ITI TF-2), specifically:
ITI-8: Patient Identity Feed [§3.8.1]
ITI-9: Pix Query [§3.9.1]
used by any system capable of performing real-time HL7 query and response and/or unsolicited patient demographic feed transactions.
Key Concepts
Patient Identity Demographics, HL7 Query/Response
pkg TP22
«transaction package»
Patient ID Cross-Referencing +
docId = TP22
«composite standard»
IHE PIX -
PIX Query: ITI-9
Patient Id Feed: ITI-8
«base standard»
HL7 V2.5 Message
constrains

9. Transaction Package TP22: Patient ID Cross-Referencing
Three Technical Actors and Two Transactions
The Patient Identity Source which creates, updates or merges Identities and communicates them with the Patient Id Cross-Reference Manager
The Patient Id Cross-Reference Manager that manages those identities and links them across identification domains (Process and Algorithm are not specified by HITSP as they are an application function within the Technical Actor).
The Patient Id Cross-Reference Consumer which queries to link on Id in one identification domain to Ids in one or more other identification domains.

10. T23 – Patient Demographics Query
Defines the methodology for obtaining a patient identity (or list of patient identities) that match a provided set of patient demographics
From the IHE IT Infrastructure (ITI) Technical Framework (TF), Volume 2 (ITI TF-2), specifically:
ITI-21: Patient Demographics Query [§3.21.1] used by any system capable of performing real-time HL7 query and response and/or unsolicited patient demographic feed transactions
Key Concepts
Patient Identity Demographics, HL7 Query/Response

11. TransactionT23 Patient Demographics Query
Supplier
Consumer
Patient
Demographics
Query [ITI -
21]
Two Technical Actors, One Transaction
The Patient Demographic Supplier which manages the demographics traits of persons.
The Patient Demographics Consumer which issues a Patient Demographics Query to the Patient Demographics Supplier with some person traits, and receives in response one or more matching persons with those respective traits.

12. C32 – Registration and Medication History Document Content
Describes the document content that summarizes a consumer’s registration and medication data information for the purpose of information exchange with a Personal Health Record (PHR)
Uses document content description for the required data elements provided in:
HL7 Implementation Guide: CDA Release 2 – Continuity of Care Document (CCD), Release 1.0, April 01, 2007
with additional clarifications and specifications as appropriate
Key Concepts
HL7 Clinical Document Architecture Release2, HL7 V3 Reference Information Model (RIM), Continuity of Care Medical Summary, Implementation Guide, Object Identifier (OID)
«component»
Registration and Med History
Document Content +
docId = C32
constrains
maps to
constrains
constrains
«composite stand...
«base stand...
CAQH CORE
LOINC
«composite standard»
IHE IT Infrastructure
maps to
«composite standard»
Federal Medication
constrains
Terminologies
«base standard»
NCPDP SCRIPT
constrains
«base stand...
X12N 270/271
references
«base stand...
ASTM/HL7 CCD
maps to
«base standard»
constrains
NDC RxNorm SPL
«base stand...
«base standard»
HL7 CDA R2
ASTM E2369

13. IS03 Use of C32 Registration and Medication History Document Content
Specific content modules each with multiple data elements include:
Personal Information -- Languages Spoken
Support -- Healthcare Provider
Insurance Provider -- Allergies and Drug Sensitivity
Condition -- Medications – Prescription and Non-Prescription
Pregnancy -- Advance Directives
Comments -- Information Source
The Reg/Med document, as a whole, contains a designated author that is the consumer and/or their designated agent, such as the parent of a minor child

14. Use of Component C32 : Medications – Prescription and Non-Prescription Module
Key Specifications that extend CCD for medications:
Route of Administration: Value drawn from FDA route of administration
Dose: Unit attribute, if present, coded using Unified Code for Units of Measures (UCUM).
Site: a value descending from the SNOMED CT Anatomical Structure ( ) hierarchy.
Product Form: from dosage form - FDA dosage form – source NCI Thesaurus.
Product name or brand name coded using RxNorm, or NDC. When only the class of the drug is known, it shall be coded using NDF-RT. FDA Unique Ingredient Identifier codes (UNII) codes may be used when there are no suitable codes in the other vocabularies to identify the medication.
Indication coded using the VA/KP Problem List Subset of SNOMED CT (terms descending from clinical finding ( ) concept.

15. Use of Component C32 : Allergies and Drug Sensitivities Module
Key Specifications that extend CCD for allergies and drug sensitivities:
Adverse Event Type: see below. Support tiered level of specifics.
Severity: see below
Product causing the adverse event coded to UNII for Food and substance allergies, or RxNorm when to medications, or NDF-RT when to classes of medications.
Reaction coded using the VA/KP Problem List Subset of SNOMED CT (terms descending from clinical finding ( ) concept.

16. INTEROPERABILITY SEQUENCE DIAGRAM
PHR
Service Provider
EHR
System
Consumer
RHIO
Health Plan / Intermediaries
PBM / Pharmacies
Logon to PHR a b
PIX Consumer
PIX Query
PIX Mgr c d
Query Documents e f
Retrieve Docs
(Reg/Med Doc)
Document
Consumer g
Retrieve Docs (Reg/Med Doc) h
Document
Repository/
Registry g h
PIX Consumer
Document
Repository/
Registry
Source
Provide & Register
(Reg./Med. Doc) l k r q v u
PIX Query t s
PIX Mgr p o
X12 270/271 Core
NCPDP SCRIPT 8.1 i j m n
Document
Consumer
Repository/
Registry
Query Documents w x
Retrieve Docs
(Reg/Med Doc) B
Retrieve Docs (Reg/Med Doc) C A
PIX Query Z y
PIX Mgr
PIX Consumer D
INTEROPERABILITY SEQUENCE DIAGRAM
CE – Scenario #2 – Customer Visits Health Care Provider and Provides Registration Summary Information

17. Health Plan / Intermediaries PBM / Pharmacies
RHIO
EHR
System
Health Plan / Intermediaries
PBM / Pharmacies
PIX Consumer
Document
Repository/
Registry
Source
Provide & Register
(Reg./Med. Doc) l k r q
Document Source v u
PIX Query t s
PIX Mgr p o
X12 270/271 Core
NCPDP SCRIPT 8.1 i j m n
Populating the RHIO with a Consumers Registration and Medication Information
Uses PIX Query (TP13) to Correctly Identify the Consumer [i-j, m-n, q-t]
Physicians Provide & Register a Registration and Medication Document (C32) with Information Available in EHR System (self-generated or received from other sources) [k-l]
Health Plans & PBMs/Pharmacies Provide & Register C32 Document Directly to RHIO [ o-p, s-v] or via the EHR-System (using X12 or NCPDP transactions)

18. INTEROPERABILITY SEQUENCE DIAGRAM
Consumer
PHR Service Provider
EHR Sys, or payer, or health plan
RHIO
Document
Repository/
Registry
Select PHR
Consumer Consent
PIX Identity Feed & Query
PIX Consumer
Document
Source
Provide & Register
(Reg./Med. Doc)
View Reg/Med
Modify Reg/Med
EHR
PIX Query
PIX Mgr
PIX Consumer
Query Documents
Retrieve Docs
(Reg/Med Doc)
Document
Consumer
Retrieve Docs (Reg/Med Doc)
INTEROPERABILITY SEQUENCE DIAGRAM
CE – Implementation/Architecture Variant A – No RHIO is present – RHIO functions are assumed by PHR Service provider
View and Integrate
Registration Data into EHR

19. EHR to EHR communication – Care Delivery Level Information
Consumer
PHR Service Provider
EHR Sys, or payer, or health plan
RHIO
Document
Repository/
Registry
Select PHR
Consumer Consent
PIX Identity Feed & Query
PIX Consumer
Document
Source
Provide & Register
(Reg./Med. Doc)
View Reg/Med
Modify Reg/Med
EHR
PIX Query
PIX Mgr
PIX Consumer
Query Documents
Retrieve Docs
(Reg/Med Doc)
Document
Consumer
Retrieve Docs (Reg/Med Doc)
EHR to EHR communication – Care Delivery Level Information
View and Integrate
Registration Data into EHR

20. Strength of IS-03: synergy between its four constructs
Effective interoperability:
Independent conforming implementations will interoperate (all dimensions of interoperability covered, including sharing/selective access, transport and identity mgt).
Semantic Interoperability with core clinical content:med, allergies, problems/conditions, and real-world clipboard information.
Designed to empower equally the consumers and their providers (PHR-PHR, PHR-EHR, EHR-EHR) with the same level of robustness.
Practical interoperability:
Standards that already have “implementation feasibility” validated (IHE Connectathon, HIMSS Interoperability Demonstration) with a significant number of implementations (prototype and commercial).
Flexible interoperability:
Designed to allow “receivers of information” to operate at various level of richness:
display (browser+any CDA style sheet)
Import the “entire document”
Import discrete coded data
Secured and Private interoperability:
6 Security Constructs in development by HITSP (October 2007) to support IS-03.