Healthcare Information Technology Standards Panel Consumer Empowerment – Registration and...

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



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


IS03


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.


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


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


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


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]


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


constrains

constrains


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.


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


constrains

constrains


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]


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


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


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


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.


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


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


RHIO Health Plan / Intermediaries

PBM / Pharmacies

EHRSystem

PIX Consumer


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)


Consumer

RHIO

EHR Sys, or payer, or health plan

Select PHR


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)

PIX QueryPIX Consumer

EHR

INTEROPERABILITY SEQUENCE DIAGRAM


Consumer

RHIO

EHR Sys, or payer, or health plan

Select PHR


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)

PIX QueryPIX Consumer

EHR


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.

Healthcare Information Technology Standards Panel Consumer Empowerment – Registration and...

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