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Making communication in healthcare effective and compliant - Integration via the HL7 Interface Engine

Making communication in healthcare effective and compliant - Integration via the HL7 Interface Engine

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.

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