www.hcltech.com Making communication in healthcare effective and compliant Integration via the HL7 Interface Engine by Somnath Mukherjee WHITEPAPER October 2014
TABLE OF CONTENTS ABSTRACT 3 BUSINESS PROBLEM: THE UNMANAGEABLE MULTIPLICITY OF SYSTEMS AND DATA FORMATS 3 CHALLENGES IN BUILDING HL7 INTERFACE 3 CREATING COMMUNICATION WITH HL7 INTERFACE ENGINE 4 DELIVERABLES TO FDA USING HL7 INTERFACE ENGINE 5 HL7-PRO: A TOOL TO SOLVE BUSINESS ISSUES 6 HL7-BASED REGULATORY INFORMATION EXCHANGE AUTOMATION THROUGH LIMS 6 SOLUTION BEYOND REGULATORY COMPLIANCE 7 CONCLUSION 7 REFERENCES 7 HCL LIFE SCIENCES & HEALTHCARE 8 LET S CONNECT 8 2014, HCL TECHNOLOGIES. REPRODUCTION PROHIBITED. THIS DOCUMENT IS PROTECTED UNDER COPYRIGHT BY THE AUTHOR, ALL RIGHTS RESERVED. 2
ABSTRACT The pharmaceutical regulatory bodies receive massive amounts of clinical research data in extremely disparate formats using a variety of proprietary standards. This makes it extremely difficult to do cross-study and application reviews. To overcome this problem, Food and Drug Administration (FDA) of United States of America has directed the industry to use Health Level Seven (HL7) Reference Information Model (RIM) towards a standardized approach to capture, receive and analyze study data to ensure unambiguous exchange of healthcare information. Moreover, in 2009, the International Conference on Harmonization (ICH) indicated that Regulated Product Submission standard (RPS) of HL7 would become the next major version (NMV) of Electronic Common Technical Document (ectd). The European Medicines Agency (EMA) is also planning for the implementation of RPS. Regulatory agencies from Europe, Canada and Japan are at varying levels of interest and participation. As laboratory test data and related information constitute the major component of regulatory data exchange, Laboratory Information Management Systems (LIMS) serving the pharmaceutical industry must have the capacity to exchange information in HL7 format. This paper is intended to highlight how best LIMS can be integrated with HL7 interface in order to automate the exchange of electronic message with regulatory authorities. BUSINESS PROBLEM: THE UNMANAGEABLE MULTIPLICITY OF SYSTEMS AND DATA FORMATS Pharmaceutical companies typically use a variety of complex software applications such as LIMS, Electronic Lab Notebook (ELN), Enterprise Resource Planning (ERP), Clinical Data Management Systems/ Clinical Trial Management System (CDMS/ CTMS), Hospital Information System (HIS), Scientific Data Management System (SDMS), Content Management System (CMS) and others from different vendors. Moreover, the health information is currently being recorded with widely varying levels of detail and structure including text, audio and video files. This language barrier makes it impossible to exchange electronic information among the stated systems. In order to reduce this complexity, there is a need for a universal framework, which will connect the systems without much trouble. As mentioned earlier, when we talk about regulatory information exchange in HL7 format, LIMS are the most important systems to be integrated with an inbuilt HL7 interface engine. CHALLENGES IN BUILDING HL7 INTERFACE There are several challenges to building HL7 interfaces. An HL7 interface requires a sending and receiving module in HL7 message format. Communicating applications may use HL7 or any other message format. Even when both the applications use HL7 message format, they rarely agree on the specific HL7 tag level information. In order to bridge the differences in messaging formats, modifications need to be made to the sending/ receiving modules or an interface engine is used in the middle to translate the messages. 2014, HCL TECHNOLOGIES. REPRODUCTION PROHIBITED. THIS DOCUMENT IS PROTECTED UNDER COPYRIGHT BY THE AUTHOR, ALL RIGHTS RESERVED. 3
CREATING COMMUNICATION WITH HL7 INTERFACE ENGINE An interface engine is designed to simplify connecting, maintaining, monitoring and sharing data between interfaces. It can take data from a sending application and filter it or change the format of the data to match each individual application s needs. This feature greatly reduces the number of individual endpoints required to communicate between applications, saving on costs of implementing an integrated system. An HL7 interface includes: y An export endpoint for the sending application y An import endpoint for the receiving application y A method of moving data between the two endpoints The following schematic diagram (Figure A) shows an interface between the pharmaceutical organization and the regulatory body through an HL7 interface engine (HL7-Pro). Pharmacetical Organisation HL7-Pro regulatory AGENCY Fig A: Schematic diagram of HL7 interface engine Let s translate the above diagram into real life example. The following diagram shows how a variety of LIMS applications, ERP/CDMS/HIS, etc. use this interface engine to communicate data with regulatory bodies such as FDA. On a separete note, this model can be extended to develop an intersystems middleware too (Figure B). LIMS1 HL7 version A LIMS2 HL7 version B HL7-Pro FDA ERP/ CDMS/ HIS XYZ messaging format Figure B: HL7 Interface Engine Leveraging Data In the above figure, the interface engine leveraged the data in the following manner: 1. It receives one message each from three different applications the LIMS1, LIMS2 and ERP/CDMS/HIS using various messaging format. 2014, HCL TECHNOLOGIES. REPRODUCTION PROHIBITED. THIS DOCUMENT IS PROTECTED UNDER COPYRIGHT BY THE AUTHOR, ALL RIGHTS RESERVED. 4
2. Then the engine filters and compiles the data to send it as per the needs of the FDA in HL7 format. The reverse is also possible when the information received by this interface engine from FDA can be filtered for specific applications. 3. Next, the engine converts the data into different formats by using a map to translate the received format into the format needed for the receiving application. DELIVERABLES TO FDA USING HL7 INTERFACE ENGINE A LIMS-HL7 interface engine can help the pharmaceutical industry by streamlining submission of regulatory information with two-way electronic communication as per HL7 standard and allowing interoperability within the organization. Various FDA regulatory data exchange forms and their management through HL7-Pro are summarized in the following figure: Figure C: Deliverables to FDA using HL7 interface engine It is evident from the above figure that there are at least seven types of information/ reports to be submitted to FDA. They are: y Clinical research study design, study participation and subject data report y Individual case safety report y Structured product labeling y Annotated ECG waveform data y Regulatory product submission y Product stability (estability) report y Electronic health records 2014, HCL TECHNOLOGIES. REPRODUCTION PROHIBITED. THIS DOCUMENT IS PROTECTED UNDER COPYRIGHT BY THE AUTHOR, ALL RIGHTS RESERVED. 5
Moreover, information exchange is an iterative process requiring information sending, updating, correction and addition/deletion from time to time. HL7-Pro has to extract and pool data from various systems including CTMS/CDMS, HIS, LIMS and ERP to generate the required regulatory report. Again, the information received in response from the regulatory body has to be filtered and directed towards specific applications. The whole process can be summarized in the following diagram: Figure D: Regulatory information exchange with FDA and inter-operatibility using HL7 interface engine HL7-PRO: A TOOL TO SOLVE BUSINESS ISSUES In submitting an estability report of a pharmaceutical company to FDA, HL7-Pro can extract and pool data from various systems of that organization including LIMS, ERP and CTMS, and send the report to FDA in HL7 format. FDA, in return, when acknowledging the acceptance through an HL7 message, the HL7-Pro will accept, interpret and direct it to the ERP system in its native format for storage. HL7-BASED REGULATORY INFORMATION EXCHANGE AUTOMATION THROUGH LIMS HL7 messaging exchange functions can be incorporated into the basic LIMS core through a HL7 middleware module (HL7-Pro) to construct HL7 messages flexibly on a segment by segment basis as per the customer-specific rules. This will allow HL7 message exchange automation with regulatory authorities and within/between organizations, facilitating interoperability between diverse information management systems through HL7 messaging exchange. Moreover, its service will not be confined to a particular LIMS alone and can be used as a compatible standalone plug-in tool with any other LIMS, making it capable of HL7 messaging exchange. 2014, HCL TECHNOLOGIES. REPRODUCTION PROHIBITED. THIS DOCUMENT IS PROTECTED UNDER COPYRIGHT BY THE AUTHOR, ALL RIGHTS RESERVED. 6
Recently, HCL has launched a revolutionary LIMS called LabIMS, a one-stop solution for complete laboratory automation and information management. LabIMS offers a low cost solution, robust and flexible SaaS (Software as a service) based architecture, repeatable and easy to rollout, single-sign-on feature, along with all the basic LIMS features. It is capable of automating pharma regulatory message exchange in HL7 environment through its inbuilt HL7-Pro module. SOLUTION BEYOND REGULATORY COMPLIANCE HCL s LabIMS HL7-Pro module can help an organization in many ways other than just automating the electronic submission of regulatory information and electronic health records. These features include data exchange and interoperability between diverse organizations/information systems, flexible construction of electronic messages combining various input systems and their presentation as per customerspecific rules (For example, intensive care, cardiology, office practice in one country or primary care in another country), and efficient exchange of multimedia files (such as thin layer chromatography plate images, spectral diagram, chromatogram, or scanned documents/images.) among others. CONCLUSION In the present scenario, information exchange automation in HL7 messaging format is a must for the pharmaceutical industry to effectively manage regulatory compliances. HCL s LabIMS integrated with HL7-Pro module can help them in this regard, along with a large number of additional outstanding features for an added advantage. REFERENCES 1. www.hl7.org, retrieved on 22.10.2010, HL7 2. Lilliam Rosario, FDA Data Standards: An Update. drug information association 3. Ann Neuer (June 22, 2009). Will Regulated Product Submission (RPS) Trump ectd? Bio-IT World 4. HL7 Introduction, Messaging and Theory: Copyright 2008 OTech, Inc. 5. http://www.fda.gov/forindustry/datastandards/studydatastandards/, retrieved on 22.10.2010 FDA 6. Lilliam Rosario. FDA Data Standards: An Update; Drug Information association, November 2009 7. An Introduction to Structured Product Labeling: Aug 2009, Product Development Company 8. ICH-HL7 Regulated Product Submissions GlobalSubmit.com. 2009 9. Ann Neuer (June 22, 2009). Will Regulated Product Submission (RPS) Trump ectd?. Bio-IT World. http://www.bio-itworld.com/news/2009/06/23/ RPS-trumps-ectd.html 2014, HCL TECHNOLOGIES. REPRODUCTION PROHIBITED. THIS DOCUMENT IS PROTECTED UNDER COPYRIGHT BY THE AUTHOR, ALL RIGHTS RESERVED. 7
10. RCRIM Project Proposal Regulated Product Submission. hl7.org. May 2005 11. HL7 Regulated Product Submissions Goals and Scope. hl7.org. 21 April 2006 12. Electronic Health Records Overview 2006, The MITRE Corporation, McLean, Virginia 13. Donald T. Mon. HL7 EHR System Functional Model and Standard HIMSS Annual Conference, March, 2010 14. Why Do I Need an Interface Engine? http://www.corepointhealth.com/whitepapers/ why-do-i-need-hl7-interface-engine, @ corepointhealth HCL LIFE SCIENCES & HEALTHCARE HCL is a leading provider of Life Sciences and Healthcare Business and Technology services. We are the chosen service provider for enabling new growth drivers for our clients, providing them with industry leading best practices, taking care of their compliance needs and ensuring goldstandard process cycle times. Our clientele includes seven of the top ten global pharmaceutical companies, seven of the top ten medical devices companies, six of the top ten health plans, three of the top five CRO s and two of the top three data providers. Equipped with certified technology experts and domain specialists, HCL offers services in critical areas of the life sciences and healthcare eco system such as drug discovery, clinical development, drug safety, regulatory compliance, manufacturing and plant automation, commercial, Healthcare analytics, Population Health Management [PHM], mhealth, member experience management [MEM], fraud, waste and abuse management [FWA]. LET S CONNECT Please feel free to write to us at contact.lsh@hcl.com ABOUT THE AUTHOR Somnath Mukherjee PMP Certified professional having more than 18 years of technical, strategy and compliance consulting experience in lab informatics specializing in services to the regulated life sciences and pharmaceutical industry. He has expertise in building Practice, Competency Centre, and in global informatics systems (LIMS, CDS, SDMS, ELN) in the regulated life sciences. Focus on leveraging expertise in lab informatics strategy, implementation, enterprise integration, validation, process improvement, delivery management and team facilitation. Possess experience to lead a team to achieve sustainable growth in Revenue. 2014, HCL TECHNOLOGIES. REPRODUCTION PROHIBITED. THIS DOCUMENT IS PROTECTED UNDER COPYRIGHT BY THE AUTHOR, ALL RIGHTS RESERVED. 8
ABOUT HCL About HCL Technologies HCL Technologies is a leading global IT services company working with clients in the areas that impact and redefine the core of their businesses. Since its emergence on the global landscape, and after its IPO in 1999, HCL has focused on transformational outsourcing, underlined by innovation and value creation, offering an integrated portfolio of services including software-led IT solutions, remote infrastructure management, engineering and R&D services and business services. HCL leverages its extensive global offshore infrastructure and network of offices in 31 countries to provide holistic, multi-service delivery in key industry verticals including Financial Services, Manufacturing, Consumer Services, Public Services and Healthcare & Life sciences. HCL takes pride in its philosophy of Employees First, Customers Second which empowers its 91,691 transformers to create real value for customers. HCL Technologies, along with its subsidiaries, had consolidated revenues of US$ 5.4 billion, for the Financial Year ended as on 30 th June 2014 (on LTM basis). For more information, please visit www.hcltech.com About HCL Enterprise HCL is a $6.5 billion leading global technology and IT enterprise comprising two companies listed in India HCL Technologies and HCL Infosystems. Founded in 1976, HCL is one of India s original IT garage start-ups. A pioneer of modern computing, HCL is a global transformational enterprise today. Its range of offerings includes product engineering, custom & package applications, BPO, IT infrastructure services, IT hardware, systems integration, and distribution of information and communications technology (ICT) products across a wide range of focused industry verticals. The HCL team consists of over 96,000 professionals of diverse nationalities, who operate from 31 countries including over 505 points of presence in India. HCL has partnerships with several leading global 1000 firms, including leading IT and technology firms. For more information, please visit www.hcl.com Hello there! I am an Ideapreneur. I believe that sustainable business outcomes are driven by relationships nurtured through values like trust, transparency and flexibility. I respect the contract, but believe in going beyond through collaboration, applied innovation and new generation partnership models that put your interest above everything else. Right now 95,000 Ideapreneurs are in a Relationship Beyond the Contract with 500 customers in 31 countries. How can I help you?