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The Standards Landscape Connecting the Healthcare Environment :

The Standards Landscape Connecting the Healthcare Environment Ed Tripp President Edward S. Tripp and Associates, Inc.

Disclaimer:

Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, Drug Information Association Inc., DIA and DIA logo are registered trademarks. All other trademarks are the property of their respective owners. 2

Key Messages:

Key Messages There are key connection areas between Pharmaceutical Companies and the Health Care Community Standards are emerging that will enable electronic collection and sharing of clinical data A new business model will emerge and those that engage early will have an advantage.

Some History - HIT and Pharma Related Standards:

Some History - HIT and Pharma Related Standards 4 Red =HIT Blue =Pharma Green =Shared

The Healthcare Standards Environment:

The Healthcare Standards Environment 5 Healthcare Communities Standards Domains Payers Physicians Patients Submissions Government Bio/Pharma Industry Transparent, secure information flow and interoperability Prescribing / Labeling Clinical data Patient safety 1 Government 2 Clinical research 3 Healthcare providers 4 Physicians 5 Payers 6 Patients 7 Other

The HITECH Act:

The HITECH Act 6 2004 2009 2010 2011 2015 2016 + President George W. Bush creates Office of National Coordinator for Health Information Technology Goal: Interoperable Electronic Medical Records by 2014 Recovery Act passed into law, providing incentives for achieving “meaningful use” of EHR by 2015, and authorizing financial penalties for failure to comply October 2010 Incentive payments commence for eligible hospitals January 2011 Medicare bonus payments to eligible hospitals and providers that meet meaningful use criteria January 2015 Commence reimbursement penalties for non-compliance of Meaningful Use of EHR January 2016 Bonus payments for Meaningful Use expire Eligible Provider Bonus 2011 2012 2013 2014 2015 Program Year 1 2 3 4 5 Bonus Payment ($’000) 15* 12* 8 4 2 * Early Adopters: Maximum of $18K available for realizing meaningful use in 2011 or 2012 Hospital Non-Compliance 2015 2016 2017+ Program Year 1 2 3 Adjustment Factor* ¼ ½ ¾ * Net Reduction b ased on Market Basket Updates

Highlights from Meaningful Use:

Highlights from Meaningful Use Stage 1 - 2011 Record Demographics (preferred language, gender, race, ethnicity, date of birth, data and cause of death in the event of mortality) for at least 50% of unique Inpatients and Emergency Department (ED) patients. Stage 3 - 2015 Record Demographics (preferred language, gender, race, ethnicity, date of birth, data and cause of death in the event of mortality) for at least 90% of unique Inpatients and Emergency Department (ED) patients. 7

Highlights from Meaningful Use:

Highlights from Meaningful Use Stage 1 2011 Record and Chart changes in vital signs (height, weight, blood pressure, calculate and display BMI, plot and display growth charts for children 2-20 years old, including BMI) for at least 50% of inpatients and ED patients. Stage 3 2015 Record and Chart changes in vital signs (height, weight, blood pressure, calculate and display BMI, plot and display growth charts for children 2-20 years old, including BMI) for at least 80% of inpatients and ED patients. 8

Highlights from Meaningful Use:

Highlights from Meaningful Use Stage 1 2011 Incorporate 40% of clinical lab test results into EHR as structured data. Stage 3 2015 Incorporate 90% of clinical lab test results into EHR as structured data and reconcile with structure lab orders . 9 These slides share just 3 of the 28 criteria

SPL Overview:

SPL Overview HL7 Structured Product Labeling XML standard implemented in 2005 Used to transmit Labeler Code, Drug Establishment Registration, Drug Listing and Content of Labeling Now there are more than 24,000 drugs listed on DailyMed http://dailymed.nlm.nih.gov/dailymed

SPL in Clinical Use:

SPL in Clinical Use Case study presented in 2010 by Medicos Consultants In use at Evelyn Jordan Center Outpatient Clinic Integrated into EMR Workflow Elements Provides for SPL Lookup and Monograph Comparison Full text searching enabled Remote access

SPL and EMR Workflow Elements:

SPL and EMR Workflow Elements

Clinical Trial Registration and Results (CTRR) Project:

Clinical Trial Registration and Results (CTRR) Project An HL7 project to develop a single harmonized message for use by sponsors to provide information to Clinical Trial registries around the world. Benefit to patients and medical researchers Consistent information globally Benefit to Sponsors and Health Authorities Efficient use of resource Consistent information globally Expected date of implementation February 2012 Future development to provide status updates and study results

Proposed CT Registration Environment:

Proposed CT Registration Environment 14 CTRR Harmonized Message Sponsors Registries www.bridgmodel.org

HL7 EHR Clinical Research Functional Profile:

HL7 EHR Clinical Research Functional Profile ANSI Standard Released July 2009 The EHRCR Functional Profile is intended to provide high-level requirements necessary for using electronic health record data for regulated clinical research, and to further provide a roadmap toward an evolutionary process of integrating the environment that provides both patient care and data for clinical research. 15

Structure of EHR CRFP:

Structure of EHR CRFP Defines the Conformance Criteria as: Essential Now, Essential Future Optional

Clinical Research Filtered Query (CRFQ) Service Functional Model:

Clinical Research Filtered Query (CRFQ) Service Functional Model Description: The CRFQ service is provided by a repository, either an EHR Repository or a Protocol Repository 17

CRFQ Core component of:

CRFQ Core component of EHR for Clinical Research (EHR4CR) aims to design and demonstrate a scalable and cost-effective approach to interoperability between Electronic Health Record systems (EHRs) and Clinical Research 10 Pharmaceutical Companies and 22 Public Partners (Academia, Hospitals and SMEs) Funded by the Innovative Medicines Initiative (IMI) programme 18

Summary:

Summary Standards for HIT and the bio/pharmaceutical industry are converging. The way clinical studies are conducted and information is gather and shared will be vastly different from today’s models. Those who begin to understand the standards and begin to engage with them will be at a competitive advantage in the future. 19

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