HL 7 Electronic Health Record System EHRS Functional

HL 7 Electronic Health Record System (EHR-S) Functional Model and Standard and Personal Health Record System (PHR-S) Functional Model EFMI STC 2010 John Quinn HL 7 CTO © 2002 -2010 Health Level Seven International®, Inc. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International, Inc. Reg. U. S. Pat & TM Off May 2010

EHR vs. EHR-S l EHR l The underlying single, logical patient record l The data elements comprising the record l Serving as the legal record l EHR-S l Software that provides functionality to: l Manage and maintain the health record l Accomplish various clinical, research, and business purposes of the health record l May be monolithic system or system of systems © 2002 -2010 Health Level Seven International®, Inc. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International, Inc. Reg. U. S. Pat & TM Off 2 May 2010

PHR - EHR: What Are the Differences? l EHR l Provider or Health Service controlled l Business, operations and legal record l Captures clinical, administrative, financial data l PHR l Typically controlled/managed by patient or their representative l Captures patient’s health/healthcare info across multiple providers and includes self-entered data l Not a legal record © 2002 -2010 Health Level Seven International®, Inc. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International, Inc. Reg. U. S. Pat & TM Off 3 May 2010

How It Started - Request from US Govt l May, 2003: US Centers for Medicare and Medicaid Services asked l US Institute of Medicine for guidance on care delivery functions l IOM & HL 7 to coordinate development of a functional model for an EHR system, not transaction-oriented interchanges l Needed as basis for pay for performance © 2002 -2010 Health Level Seven International®, Inc. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International, Inc. Reg. U. S. Pat & TM Off 4 May 2010

From DSTU to HL 7 Standard l Approved July 2004 as a draft standard for trial use (DSTU) l 2 year period to continuously improve DSTU, become an HL 7 standard l Core, not exhaustive, functionality l Good enough for industry to begin using as a standard l Approved February 2007 as full normative HL 7 standard © 2002 -2010 Health Level Seven International®, Inc. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International, Inc. Reg. U. S. Pat & TM Off 5 May 2010

The EHR-S Functional Model Is Not… Is… l A messaging specification l l An EHR record specification l l An implementation specification (what, why, not how) l Does not prescribe technology l Does not dictate how functions must be implemented (e. g. , user interface, database design) © 2002 -2010 Health Level Seven International®, Inc. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International, Inc. Reg. U. S. Pat & TM Off An EHR system specification A reference list of functions that may be present in an EHR-S (the “what”) l Enables consistent expression of functionality l Provides flexibility for innovation and product differentiation l Gold standard, sensitive to what can practically be done by a system, future system development 6 May 2010

EHR-S Functional Model at a Glance Functions describe the behavior of an EHR system in useroriented language © 2002 -2010 Health Level Seven International®, Inc. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International, Inc. Reg. U. S. Pat & TM Off 7 May 2010

EHR-S Functional Model & Standard l Function names & statements provide a reference list of functions that: l May be present in an EHR-S l Are understandable from a user’s perspective l Enable consistent expression of functionality l Conformance criteria l Required/mandatory: The system SHALL… l Preferred: The system SHOULD… l Optional: The system MAY… © 2002 -2010 Health Level Seven International®, Inc. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International, Inc. Reg. U. S. Pat & TM Off 8 May 2010

The Structure of the Functional Model ID# Ty pe DC. 1. 1. 1 F Name Identify and Maintain a Patient Record Statement/Description Statement: Identify and maintain a single patient record for each patient. Description: A single record is needed for legal purposes, as well as to organize it unambiguously for the provider. Health information is captured and linked to the patient record. Static data elements as well as data elements that will change over time are maintained. The patient is uniquely identified, after which the record is tied to that patient. Combining information on the same patient, or separating information where it was inadvertently captured for the wrong patient, helps maintain health information for a single patient. In the process of creating a patient record, it is at times advantageous to replicate identical information across multiple records, so that such data does not have to be reentered. For example, when a parent registers children as new patients, the address, guarantor, and insurance data may be propagated in the children’s records without having to re-enter them. See Also S. 1. 4. 1 S. 2. 2. 1 S. 3. 1. 2 S. 3. 1. 5 IN. 2. 1 IN. 2. 3 Conformance Criteria 1. The system SHALL create a single logical record for each patient. 1. The system SHALL provide the ability to create a record for a patient when the identity of the patient is unknown. 1. The system SHALL provide the ability to store more than one identifier for each patient record. 1. The system SHALL associate key identifier information (e. g. , system ID, medical record number) with each patient record. 1. The system SHALL provide the ability to uniquely identify a patient and tie the record to a single patient. 1. The system SHALL provide the ability, through a controlled method, to merge or link dispersed information for an individual patient upon recognizing the identity of the patient. 1. IF health information has been mistakenly associated with a patient, THEN the system SHALL provide the ability to mark the information as erroneous in the record of the patient in which it was mistakenly associated and represent that information as erroneous in all outputs containing that information. 1. IF health information has been mistakenly associated with a patient, THEN the system SHALL provide the ability to associate it with the correct patient. 1. The system SHALL provide the ability to retrieve parts of a © 2002 -2010 Health Level Seven International®, Inc. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International, Inc. Reg. U. S. Pat & TM Off patient record using a primary identifier, secondary identifiers, or other information which are not identifiers, but could be used to help identify the patient. 9 May 2010

Profiles Can Be Derived from the FM Inpatient Outpatient Medication Admin Record Medication Administration Record Bed management Home Lifestyle Wellness Reminders Drug-Drug Interaction Notes Notes Results. Functions Reporting Results Reporting EHR-S Results Reporting Order Management Event Capture Event Capture Security Security Demographic Management Record Management © 2002 -2010 Health Level Seven International®, Inc. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International, Inc. Reg. U. S. Pat & TM Off 10 May 2010

Profiles Developed/Under Development l l l l Ambulatory Care Ambulatory Oncology Behavioral Health Child Health Clinical Research, Clinical Trials Dentistry e. Prescribing/Pharmacy Emergency Department Long Term Care Public Health Records Management & Evidentiary Support Vital Records, Statistics Reporting Also: Canadian EHR Blueprint 2015 (Infoway Project) © 2002 -2010 Health Level Seven International®, Inc. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International, Inc. Reg. U. S. Pat & TM Off 11 May 2010

Definitions: Fitting it all together Certification qualified bodies to do the testing and certification control board - advisory and arbiter Validation Process - policy and procedures for testing Conformance Testing Test suite, Test tool (test software, test scripts, test criteria) We are concerned with Profile Standard Conformance clause, conformance criteria © 2002 -2010 Health Level Seven International®, Inc. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International, Inc. Reg. U. S. Pat & TM Off 13 May 2010

Current Activities l Additional profiles under development l Including realm (country)-based profiles l Release 2 under development l ISO/HL 7 Joint Ballot (ISO 10781) l Personal Health Record System FM l DSTU, Release 1 normative under development l Also planned as ISO/HL 7 Joint Ballot l Incorporate HL 7 EHR Interoperability and EHR Lifecycle Model DSTUs © 2002 -2010 Health Level Seven International®, Inc. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International, Inc. Reg. U. S. Pat & TM Off 15 May 2010

Status of PHR-S FM Draft Standard for Trial Use Ballot The PHR-System Functional Model: l Balloted in November 2007 l Reconciliation Complete in March 2008 l Published as DSTU in July 2008 l Lists the functions that PHR systems shall, should or may perform l Provides support for a certification framework l Serves as an anchor point for PHR system interoperability © 2002 -2010 Health Level Seven International®, Inc. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International, Inc. Reg. U. S. Pat & TM Off 16 May 2010

Status of the International Standard l HL 7 has built on its solid foundation of international healthcare information technology standards by promoting the Electronic Health Record System Functional Model (EHR-S FM) to an ISO standard for Electronic Health Record System functionality l ISO 10781, published November 2009 © 2002 -2010 Health Level Seven International®, Inc. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International, Inc. Reg. U. S. Pat & TM Off 17 May 2010

Status of the International Standard l On May 11, 2010 ISO TC 215 WG 8 approved both NWIPs for HL 7 EHR/PHR System Functional Models. This was followed by a formal resolution approval by the full TC 215 Plenary Meeting on Thursday May 13. l The May 11 vote was unanimous (without abstention) on both NWIPs - comprising ~50 international experts. © 2002 -2010 Health Level Seven International®, Inc. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International, Inc. Reg. U. S. Pat & TM Off 18 May 2010

Status of the International Standard l On Thursday, 13 May, ISO TC 215 approved the Release 2 update to ISO 10781/HL 7 EHR System Functional Model as a preliminary work item. HL 7 plans to submit documents to the TC 215 Secretariat by 10 June and expect the formal New Work Item Proposal to go to ballot by 1 July 2010. If all goes according to schedule the ballot will close prior to October when HL 7 and ISO meetings (in Cambridge, MA and Rotterdam respectively) occur. This item is being promoted through the ISO/HL 7 Pilot Agreement as an International Standard and will be jointly balloted by ISO and HL 7. © 2002 -2010 Health Level Seven International®, Inc. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International, Inc. Reg. U. S. Pat & TM Off 19 May 2010