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Healthcare Information Technology Standards Panel
Consumer Empowerment – Registration and Medication History
June 22, 2007
2Healthcare Information Technology Standards Panel
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
3Healthcare Information Technology Standards Panel
Consumer Empowerment Registration and Medication History
class CE Interoperability Specification
«interoperability specification»Consumer Empowerment
+ docId = IS03
«composite standard»IHE XDS
+ Provide & Register Document Set: ITI-15+ Query Registry: ITI-16+ Register Document Set: ITI-14+ Retrieve Document: ITI-17
«composite stand...IHE PIX
- PIX Query: ITI-9
«composite stand...CAQH CORE
«composite standard»Federal Medication
Terminologies
«base standard»ISO 15000 ebRS
«base standard»NCPDP SCRIPT
«base stand...X12N 270/271
«base standard»ASTM E2369
«base stand...LOINC
«base stand...HL7 CDA R2
«base standard»NDC RxNorm SPL
«base stand...ASTM/HL7 CCD
«transaction»Patient Demographics
Query
+ docId = T23
«composite stand...IHE PDQ
«component»Registration and Med History
Document Content
+ docId = C32
«transaction package»Patient ID Cross-
Referencing
+ docId = TP22
«transaction package»Manage Sharing of
Documents
+ docId = TP13
«base standard»HL7 V2.5 Message
constrains
constrainsconstrains
references
constrainsuses
constrains constrains
implements
contains
constrains
constrains
contains
constrains
contains
constrainsconstrains
contains
constrains
4Healthcare Information Technology Standards Panel
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.
5Healthcare Information Technology Standards Panel
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)
– Based on HL7 V2.5
6Healthcare Information Technology Standards Panel
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: 1. Demographic information sufficient to help identify the
consumer2. Financial information sufficient for insurance eligibility
checking and claims submission3. 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
7Healthcare Information Technology Standards Panel
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 15000 ebRS
implements
constrains
8Healthcare Information Technology Standards Panel
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.
Document Source
Document Consumer
Document Registry
Document Repository
Provide&Register
Document Set[ITI-15]
Register Document Set[ITI-14]
Retrieve Document
[ITI-17]
Registry Stored Query [ITI-18]
9Healthcare Information Technology Standards Panel
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-9Patient Id Feed: ITI-8
«base standard»HL7 V2.5 Message
constrains
constrains
10Healthcare Information Technology Standards Panel
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.
11Healthcare Information Technology Standards Panel
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
pkg T23
«transaction»Patient Demographics Query
+ docId = T23
«composite standard»IHE PDQ
«base standard»HL7 V2.5 Message
constrains
constrains
12Healthcare Information Technology Standards Panel
TransactionT23 Patient Demographics Query
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.
Patient Demographics Supplier
Patient Demographics Consumer
Patient Demographics Query [ITI-21]
13Healthcare Information Technology Standards Panel
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)
«composite stand...CAQH CORE
«composite standard»Federal Medication
Terminologies«base standard»NCPDP SCRIPT
«base stand...X12N 270/271
«base standard»ASTM E2369
«base stand...LOINC
«base stand...HL7 CDA R2
«base standard»NDC RxNorm SPL
«base stand...ASTM/HL7 CCD
«component»Registration and Med History
Document Content
+ docId = C32
constrains
constrains
references
constrainsmaps to
maps to constrains
constrains
maps to
«composite standard»
IHE IT Infrastructure
constrains
14Healthcare Information Technology Standards Panel
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
15Healthcare Information Technology Standards Panel
Use of Component C32 : Medications –Medications – Prescription and Non-Prescription and Non-Prescription ModulePrescription 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 (91723000) 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 (404684003) concept.
Data Element
Free Text Sig
Indicate Medication Stopped
Administration Timing
Frequency
Interval
Duration
Route
Dose
Site
Dose Restriction
Product Form
Delivery Method
Coded Product Name
Coded Brand Name
Free Text Product Name
Free Text Brand Name
Drug Manufacturer
Product Concentration
Type of Medication
Status of Medication
Indication
Patient Instructions
16Healthcare Information Technology Standards Panel
Use of Component C32 : Allergies and Drug Sensitivities ModuleAllergies 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 (404684003) concept.
Data Element
Adverse Event Date
Adverse Event Type
Product Free-Text
Product Coded
Reaction Free-Text
Reaction Coded
Severity Free-Text
Severity Coded
SNOMED CT Preferred Terms
for Severity
SNOMED CT Code
mild 255604002
mild to moderate 371923003
moderate 6736007
moderate to severe 371924009
severe 24484000
fatal 399166001
SNOMED CT Preferred Terms for Adverse Event Type
SNOMED CT Code
Usage
propensity to adverse reactions 420134006 Used to record an adverse reaction.
propensity to adverse reactions to substance 418038007 Used to record an adverse reaction to an environmental agent.
propensity to adverse reactions to drug 419511003 Used to record an adverse reaction to a drug.
propensity to adverse reactions to food 418471000 Used to record an adverse reaction to a food.
allergy to substance 419199007 Used to record an allergy to an environmental agent.
drug allergy 416098002 Used to record an allergy to a drug.
food allergy 414285001 Used to record an allergy to a food.
drug intolerance 59037007 Used to record intolerance to a drug.
food intolerance 235719002 Used to record intolerance to a food.
17Healthcare Information Technology Standards Panel
DocumentConsumer Document
Repository/Registry
Query Documentsw x
Retrieve Docs(Reg/Med Doc)
BRetrieve Docs (Reg/Med Doc)
C
A
PIX Query
Zy
PIX Mgr
PIX Consumer
D
Consumer RHIO
Logon to PHR
a b
Health Plan / Intermediaries
PBM / Pharmacies
DocumentConsumer Document
Repository/Registry
Query Documentsc d
Retrieve Docs(Reg/Med Doc)
hRetrieve Docs (Reg/Med Doc)
g
g
PIX Query
fe
PIX Mgr
PIX Consumer
h PIX Consumer
DocumentRepository/Registry
DocumentSource
Provide & Register (Reg./Med. Doc) lk
DocumentSource
rq
Provide & Register
DocumentSource
vu
Provide & Register
PIX Query
PIX Queryts
PIX Mgr
po PIX Consumer
PIX Query
PIX Consumer
X12 270/271 Core
NCPDP SCRIPT 8.1
X12 270/271 Core
i j
m n
PHRService Provider
EHRSystem
CE – Scenario #2 – Customer Visits Health Care Provider and Provides Registration Summary Information
INTEROPERABILITY SEQUENCE DIAGRAM
18Healthcare Information Technology Standards Panel
RHIO Health Plan / Intermediaries
PBM / Pharmacies
EHRSystem
PIX Consumer
DocumentRepository/Registry
DocumentSource
Provide & Register (Reg./Med. Doc) lk
DocumentSource
rq
Provide & Register
Document Sourcevu
Provide & Register
PIX Query
PIX Queryts
PIX Mgr
po PIX Consumer
PIX Query
PIX Consumer
X12 270/271 Core
NCPDP SCRIPT 8.1
X12 270/271 Core
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)
19Healthcare Information Technology Standards Panel
Consumer
RHIO
EHR Sys, or payer, or health plan
Select PHR
DocumentRepository/Registry
Consumer Consent
DocumentSource
Provide & Register (Reg./Med. Doc)
View Reg/Med
Modify Reg/Med
CE – Implementation/Architecture Variant A – No RHIO is present – RHIO functions are assumed by PHR Service provider
PIX Mgr
PIX Identity Feed & Query
PIX Consumer
PHR Service Provider
View and IntegrateRegistration Data into EHR
DocumentConsumer
Query Documents
Retrieve Docs(Reg/Med Doc)
Retrieve Docs (Reg/Med Doc)
PIX QueryPIX Consumer
EHR
INTEROPERABILITY SEQUENCE DIAGRAM
20Healthcare Information Technology Standards Panel
Consumer
RHIO
EHR Sys, or payer, or health plan
Select PHR
DocumentRepository/Registry
Consumer Consent
DocumentSource
Provide & Register (Reg./Med. Doc)
View Reg/Med
Modify Reg/Med
EHR to EHR communication – Care Delivery Level Information
PIX Mgr
PIX Identity Feed & Query
PIX Consumer
PHR Service Provider
View and IntegrateRegistration Data into EHR
DocumentConsumer
Query Documents
Retrieve Docs(Reg/Med Doc)
Retrieve Docs (Reg/Med Doc)
PIX QueryPIX Consumer
EHR
21Healthcare Information Technology Standards Panel
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.