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IVD Industry Connectivity Consortium
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IICC develops and promotes a unified IVD connectivity standard.
IICC develops and promotes a unified IVD connectivity standard.

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FHIR Connectathon 19 in Baltimore to feature testing opportunity for IICC LIVD (LOINC to In Vitro Diagnostic)

The FHIR Connectathon will be held Saturday Sept 29 and Sunday Sept 30 at the Hyatt Regency Baltimore Inner Harbor, Baltimore, MD prior to the Sept. HL7 Working Group Meeting. It will feature several tracks, including testing of LIVD (LOINC to In Vitro Diagnostic) on FHIR, the standard for health care data exchange published by HL7®.

LIVD defines the digital publication of LOINC using vendor defined IVD tests associated with a set of predefined LOINC codes. It assures that laboratory personnel select the appropriate LOINC codes for IVD test used by their laboratory. It also allows LIS systems to automatically map the correct IVD vendor test result to a LOINC code. The objective of LIVD on FHIR is for IVD vendors to make their publication available at least as a file (e-mail, downloadable, CD, website link) or on a FHIR server.

The Connectathon is a great format where participants can get together and test their software implementation of updates to FHIR using real-world scenarios in an informal and live way. For more information:

http://wiki.hl7.org/index.php?title=FHIR_Connectathon_19














#interoperability #ivd #HL7 #FHIR #LIVD
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FDA encourages the adoption of the IVD Industry Connectivity Consortium’s LIVD format for distribution of LOINC codes for IVD tests

The US Food and Drug Administration published a Guidance for Industry and Food and Drug Administration Staff, titled ”Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests” in which it encourages the adoption of the IVD Industry Connectivity Consortium’s LIVD format for distribution of LOINC codes for IVD tests. The FDA recognizes LIVD as a consensus standard that contributes to greater semantic interoperability within and across laboratories.

LIVD (Digital Format for Publication of LOINC to Vendor IVD Test Results) defines the digital publication of LOINC using vendor defined IVD tests associated with a set of predefined LOINC codes. LIVD assures that laboratory personnel select the appropriate LOINC codes for IVD test used by their laboratory. It also allows LIS systems to automatically map the correct IVD vendor test result to a LOINC code.

For more information on LIVD go to http://ivdconnectivity.org/livd/

For a copy of the June 15, 2018 FDA Guidance for Industry and Food and Drug Administration Staff, titled ”Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests” go to
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM610636.pdf

The IVD Industry Connectivity Consortium (IICC) is a global, nonprofit organization dedicated to creating and encouraging adoption of a unified connectivity standard to reduce the cost and variability of data exchange between IVD devices and healthcare informatics in clinical laboratories. This will improve healthcare efficiency and patient care.

For more information contact:

Serge Jonnaert, President
IVD Industry Connectivity Consortium
+1(949)259-3807
serge.jonnaert@ivdconnectivity.org











#digitalhealth #healthIT #interoperability #medicaldevice #ivd #diagnostics #LOINC @CLN_AACC, @FierceMedDev, @MedscapePath, @ivdtechnology, @mnt_medicaldev, @med_diagnostics, @ldtimmerman, @TheDeviceGuy, @ivdt, @ClinicalDx, @Dark_Daily, @CLPmag, @LabMedica @LabManager @ADVANCEforLab @Clin_Chem_AACC @LabTestsOnline @CLN_AACC, @Pathologists @_AACC @labsoftnews, @CLSI_LabNews, @AdvaMedUpdate, @IBFmedtech
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IVD Industry Connectivity Consortium launches initiative to verify the applicability of its LAW Profile to microbiology

The IVD Industry Connectivity Consortium™ (IICC) today announced a new initiative to verify the applicability of its LAW Profile to microbiology. The Laboratory Analytical Workflow Profile (LAW) defines the physical connection, message definitions (based on the HL7 Messaging Standard v2.5.1), and workflow definitions between instruments, middleware, and LIS systems in the laboratory.

The IVD Industry Connectivity Consortium will start a new working group open to its members to establish that the existing IHE LAW profile (CLSI AUTO16) can be used by microbiology middleware. The expected outcome will be a guidance document describing how to implement the IHE LAW profile between microbiology instruments and LISs and middleware. If warranted, the working group will submit a change proposal to the IHE PaLM (Pathology and Laboratory Medicine) domain in order to update the LAW profile to accommodate specific microbiology requirements.

IICC collaborated with the IHE Pathology and Laboratory Medicine (PaLM) domain to develop the LAW Profile. LAW is currently being implemented by all major IVD companies.

For more information on the IVD Industry Connectivity Consortium and the IICC/IHE Laboratory Analytical Workflow (LAW) go to: www.ivdconnectivity.org

Contact: Serge Jonnaert
President – IVD Industry Connectivity Consortium
T: +1(949)259-3807
E: serge.jonnaert@ivdconnectivity.org









#digitalhealth #healthIT #interoperability #medicaldevice #ivd #diagnostics #LOINC @CLN_AACC, @FierceMedDev, @MedscapePath, @ivdtechnology, @mnt_medicaldev, @med_diagnostics, @ldtimmerman, @TheDeviceGuy, @ivdt, @ClinicalDx, @Dark_Daily, @CLPmag, @LabMedica @LabManager @ADVANCEforLab @Clin_Chem_AACC @LabTestsOnline @CLN_AACC, @Pathologists @_AACC @labsoftnews, @CLSI_LabNews, @AdvaMedUpdate, @IBFmedtech
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Registration for the IHE NA Connectahton 2018 (Jan 15-19) in Cleveland, OH is now open

http://www.iheusa.org/ihe-connectathon-registration
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IVD Industry Connectivity Consortium announces LIVD specification for digital publication of LOINC to vendor IVD test results in clinical laboratories
By: IVD Industry Connectivity Consortium

Chicago, IL – June 1, 2017 – The IVD Industry Connectivity Consortium (IICC) today announced the LIVD specification for digital publication of LOINC to vendor IVD test results in clinical laboratories. Along with the IICC/IHE LAW Profile soon to be recast as CLSI AUTO16 LIVD allows IVD instruments and IVD software systems to efficiently and unambiguously exchange test results, with vendor defined IVD tests associated with a set of predefined LOINC codes that identify the distinct observations produced by the test.

According to Ed Heierman, the IICC’s CTO “LIVD assures that laboratory personnel select the appropriate LOINC codes for vendor IVD test results used by their laboratory. It also allows LIS systems to automatically map the correct IVD vendor test result to a LOINC code.”

The LIVD specification outlines an IVD industry-defined format to facilitate the publication and exchange of LOINC codes for vendor IVD test results, based on either vendor IVD test transmission codes or manual test identification, for use by laboratory personnel or laboratory applications. The format can be used as-is by IVD software systems to automate the mapping between vendor IVD test transmission codes and LOINC codes, significantly reducing the risk of erroneously mapped test results and units of measure (UCUM).

“The LIVD Specification addresses a major pain point for today’s clinical laboratory” stated Serge Jonnaert, President of the IVD Industry Connectivity Consortium “Complementing the IICC/IHE LAW Profile, we finally have a true plug-and-play solution to interface IVD instruments to middleware and LIS systems. Clinical laboratories will no longer be subjected to outrageously high fees for custom connectivity implementations. With more vendors announcing products that will support both the IICC/IHE LAW Profile and LIVD Specification, Laboratory Managers and hospital CIOs should demand compliance to the standards in future tenders” he continued.

The LIVD specification was a collaborative effort between the IVD Industry Connectivity Consortium, IHE Pathology and Laboratory Medicine (PaLM), Regenstrief Center for Biomedical Informatics, the U.S. Centers for Disease Control and Prevention (CDC), and the U.S. Food and Drug Administration (FDA) as a result of the Workshops on Promoting Semantic Interoperability of Laboratory Data at the National Institutes of Health (NIH) in 2016. The LIVD specification adopts the same definition of interoperability laid out by the Office of the National Coordinator for Health IT (ONC) in its Interoperability Roadmap.

The LIVD initiative has already received numerous accolades:

“Development of this new common format for publishing mappings from IVD vendor test results to LOINC codes is major advance for interoperability of laboratory data. As IVD vendors make such mappings available, it will greatly improve the efficiency and consistency with which laboratories can deploy standard terminology in their information systems.”

Daniel J. Vreeman, PT, DPT, MS
Director, LOINC and Health Data Standards Regenstrief Center for Biomedical Informatics

“The standard LIVD digital format produced by IICC and major IVD manufactures will enable IVD manufactures to distribute electronic mappings between their internal test codes and universal test identifiers (LOINC codes). This effort will accelerate the inclusion of universal LOINC codes in laboratory reports to clinicians and health care systems because it will eliminate the additional laboratory effort now needed to figure out the right LOINC code for each laboratory test. The increasing use of universal LOINC codes in laboratory reports will unleash the same wave of efficiency and quality improvements as bar codes did for grocers and retailers. The effort by IVD manufacturers to produce the LIVD format is a spectacular example of good corporate citizenship that will yield many benefits to the health of the nation.”

Clem J. McDonald, MD
Director, Lister Hill National Center for Biomedical Communications, National Institutes of Health

“Innovation can only occur once standardization has taken place. Much of the innovative laboratory result analytics being done in research at Geisinger Health System would be difficult, if not impossible, without first applying LOINC to our 350+ million laboratory results for accurate identification. LOINC also provides a platform from which to normalize laboratory result values for a given LOINC code to a single unit of measure, which further streamlines the analytics process. IICC’s LIVD digital format for vendor publication of LOINC content is a significant step forward that will support a laboratory’s ability to not only adopt LOINC but to also maintain LOINC information over time.”

John Snyder, DTR, RDN
Henry Hood Center for Health Research, Geisinger Health Systems

“As one of the participants in this initiative, MDIC strongly believes that the work will greatly enhance information interoperability with accuracy and consistency between IVD vendors and clinical laboratories. Adoption and implementation of this new common format will facilitate efficiency in IVD evidence generation including clinical studies and real-world evidence”

Jing Xie, PhD
Vice President, Clinical Affairs, Medical Device Innovation Consortium (MDIC)

The enhanced vendor test format contains extended data elements, including the manufacturer, the instrument model, an instrument universal identifier (UID), the vendor transmission code, vendor specimen description, vendor result description, the test name, as well as optional data elements (e.g. a reference ID to the package insert, additional instructions or comments related to the test). The proposed data exchange format uses JSON (JavaScript Object Notation), a lightweight, global industry standard format with a simple syntax that is also human readable.

The LIVD specification and related samples can be downloaded from:

http://ivdconnectivity.org/livd/

The LIVD specification and IICC/IHE LAW Profile will be demonstrated at the 69th AACC Annual Scientific Meeting & Clinical Lab Expo in San Diego, CA (July 30–August 3) at the IICC booth #1955.

Contact:

Serge Jonnaert
President – IVD Industry Connectivity Consortium
/ President, tensei llc
/ Board Member, At-Large – IHE International
T: +1(949)259-3807
E: serge.jonnaert@tensei.com

Logical Observation Identifiers Names and Codes (LOINC) is a database and universal standard for identifying medical laboratory observations. First developed in 1994, it was created and is maintained by the Regenstrief Institute, a US nonprofit medical research organization. LOINC was created in response to the demand for an electronic database for clinical care and management and is publicly available at no cost. Reference labs, healthcare organizations, U.S. federal agencies, insurance companies, software vendors, in vitro diagnostic testing companies, and more than 45,300 registered users from 165 countries use LOINC to move data seamlessly between systems.

LOINC® is a registered United States trademark of Regenstrief Institute, Inc. All other trademarks cited herein are the property of their respective owners.












#digitalhealth #healthIT #interoperability #medicaldevice #IQCP #ivd #diagnostics @OpenQAP, @interopshowcase, @MedInterop, @ehrandhit, @eHealthDC, @HealthStandards, @HIMSS, @ONC_HealthIT, @HITNewsTweet, @CLN_AACC, @FierceMedDev, @MedscapePath, @ivdtechnology, @mnt_medicaldev, @med_diagnostics, @ldtimmerman, @TheDeviceGuy, @ivdt, @ClinicalDx, @Dark_Daily, @CLPmag, @LabMedica @LabManager @ADVANCEforLab @Clin_Chem_AACC @LabTestsOnline @CLN_AACC, @Pathologists @_AACC @labsoftnews, @CLSI_LabNews, @AdvaMedUpdate, @IBFmedtech @RelayHealth, @HITleaders, @HDMmagazine, @CDC_eHealth, @WHO, @Health_IT@meddevicegroup, @MedDeviceGurus, @FDAcdrhIndustry, @medtecheurope, @medicaldevices, @QmedNews, @MedTechWorld, @Rock_Health,
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VITEK® 2 System connectivity enhanced with support for the ICC/IHE LAW Profile and LOINC®

bioMérieux has updated its VITEK® 2 system for automated identification and antimicrobial susceptibility testing with software version 8.01 that is fully compliant with the IICC/IHE Laboratory Analytical Workflow (LAW) profile. The IICC/IHE LAW profile defines plug-n-play connectivity between instruments, middleware, and LIS systems in the laboratory. An IICC founding member, bioMérieux successfully tested its LAW Profile implementation at three IHE Connectathons in the USA and Europe. With this new interface, VITEK® 2 system software version 8.01 also supports LOINC® codification. Implementation of this connectivity standard in the VITEK® 2 system will help improve healthcare lab efficiency and contribute to better patient care through increased reliability of test order data and patient test results.

http://ivdconnectivity.org/vitek-2-system-connectivity-enhanced-support-iccihe-law-profile-loinc/

+biomerieuxdiagnostic #LOINC @IHE #connectivity #clinicaldiagnostics #ivd
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IVD Industry Connectivity Consortium tackles vendor specific LOINC codes

The IVD Industry Connectivity Consortium (IICC) presented its proposal for vendors to use when publishing LOINC for their IVD Tests at the November 8 Workshop on Promoting Semantic Interoperability of Laboratory Data at the National Institutes of Health (NIH) in Bethesda, MD.

The workshop was organized by the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH) to receive and discuss input from industry stakeholders regarding proposed approaches to promoting the semantic interoperability of laboratory data between in vitro diagnostic devices and database systems, including laboratory information systems and electronic health records.

LOINC (Logical Observation Identifiers Names and Codes) is currently the main vocabulary for identifying laboratory and clinical observations to electronically report test results. Unfortunately, to use LOINC, laboratories must still map their local codes to terms in the standard, a process that remains unnecessarily complex and error-prone as there is not always a one-to-one relationship between the tests that are run on laboratory instruments and existing LOINC codes. Erroneous mapping can result in the reporting of incorrect patient test results, with potentially detrimental consequences. This also prevents the industry from adopting a true plug-and-play connectivity standard that guarantees 100% correct and effortless test mapping.

The new IICC approach, presented by Ed Heierman, should make it easier for laboratories to find the correct LOINC codes for the tests that they run on their instruments. The format is human readable, assuring that laboratory personnel select the appropriate LOINC codes for vendor IVD test results used by their laboratory. IVD software systems may also be able to automatically map the correct IVD vendor test result to a LOINC code.

The enhanced vendor test format would contain extended data elements, including the manufacturer, the instrument model, an instrument universal identifier (UID), the vendor transmission code, vendor specimen description, vendor result description, the test name, as well as optional data elements (e.g. a reference ID to the package insert, additional instructions or comments related to the test). The proposed data exchange format will use JSON (JavaScript Object Notation), a lightweight, global industry standard format with a simple syntax that is also human readable.

The proposed format will now be formalized in a draft specification that will be presented at the next workshop, scheduled for December. Any parties interested in receiving a copy of the specification should email info@ivdconnectivity.org
For more information on the IVD Industry Connectivity Consortium and the IICC/IHE Laboratory Analytical Workflow (LAW) go to: www.ivdconnectivity.org

Contact: Serge Jonnaert
President, tensei llc
/ President - IVD Industry Connectivity Consortium
/ Board Member, At-Large - IHE International
T: +1(949)259-3807
E: serge.jonnaert@tensei.com


#digitalhealth #healthIT #interoperability #ivd #diagnostics #connectivity #LOINC #HL7 #FDA #CDC @IVDConnectivity
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IVD Industry Connectivity Consortium (IICC) to present at Public Workshop on Promoting IVD Semantic Interoperability of Laboratory Data

The IVD Industry Connectivity Consortium (IICC) will present a JSON based vendor defined format for IVD Tests Documents using LOINC at the November 8 Public Workshop on Promoting IVD Semantic Interoperability of Laboratory Data. This should make it easier for laboratories to find the correct LOINC codes for the tests that they run on their instruments.
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A recent interview in @captodayonline about the future of clinical laboratory connectivity. @serge_jonnaert @tensei_llc
http://www.captodayonline.com/beyond-connectivity-middlewares-shifting-shape/
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