Making communication in healthcare effective and compliant

www.hcltech.com
Making communication in
healthcare effective
and compliant
Integration via the HL7 Interface Engine
bY Somnath Mukherjee
WHITEPAPER
October 2014
INTELLIGENT SCM – ACCELERATED BUSINESS TRANSFORMATION @ TECHNOLOGY
|
October 2014
TABLE OF CONTENTS
ABSTRACT3
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
CONCLUSION7
REFERENCES7
HCL LIFE SCIENCES & HEALTHCARE
8
LET’S CONNECT
8
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October 2014
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.
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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:
yy An export endpoint for the sending application
yy An import endpoint for the receiving application
yy 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
ERP/ CDMS/ HIS
XYZ messaging
format
HL7-Pro
FDA
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.
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INTELLIGENT SCM – ACCELERATED BUSINESS TRANSFORMATION @ TECHNOLOGY
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October 2014
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:
yy Clinical research study design, study participation and subject data report
yy Individual case safety report
yy Structured product labeling
yy Annotated ECG waveform data
yy Regulatory product submission
yy Product stability (eStability) report
yy Electronic health records
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October 2014
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.
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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
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INTELLIGENT SCM – ACCELERATED BUSINESS TRANSFORMATION @ TECHNOLOGY
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October 2014
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
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LET’S CONNECT
Please feel free to write to us at [email protected]
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.
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