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

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

Consumer Empowerment Registration and Medication History

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.

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)

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

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.

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

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

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.

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

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 – 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 (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.

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 (404684003) concept.

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

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)

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

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

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.