Medical Devices

Public Workshop FDA/CDC/NLM Workshop on Promoting Semantic Interoperability of Laboratory Data, September 28, 2015

The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the National Library of Medicine (NLM) of the National Institutes of Health are announcing the following public workshop titled “FDA/CDC/NLM Workshop on Promoting Semantic Interoperability of Laboratory Data.”

The purpose of the workshop was to receive and discuss input from 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.

Date, Time and Location

This meeting was held September 28, 2015, beginning at 8:00 am – 5:00 pm at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993




8:00 – 8:15

Welcome & Introductions - Clem McDonald, NLM, and Bakul Patel, FDA

8:15 – 8:45

LOINC: Introduction and use for interoperability: Dan Vreeman, Regenstrief Institute

8:45 – 10:15

Adopting LOINC: Industry, the Laboratory, and Others:


  • Hans Buitendijk, Cerner

  • Rob Bush, Orchard Software

  • Maribeth Gagnon, Centers for Disease Control

  • Xavier Gansel, BioMérieux

  • Ed Heierman, Abbott

  • Steven Posnack, Office of the National Coordinator, DHHS

  • John Snyder, Geisinger Health Systems

  • Daniel Vreeman, Regenstrief Institute

10:30 – 11:00

Reporting results: SNOMED/UCUM and laboratory results - Jim Case, NLM

11:00 – 12:15

Standardized Reporting: Implementation and Use

  • Introduction: Clem McDonald, National Library of Medicine



1:15 – 1:35

UDI in Laboratory Interoperability - Leslie Steen, FDA

1:35 – 1:50

How SPL is designed to carry LOINC, SNOMED, and UCUM codes– Gunther Schadow, Pragmatic Data

1:50 – 2:10

LOINC/SNOMED for Research/Drug Approval - Mitra Rocca, FDA

2:10 – 3:00

3:15 – 4:45

Moving forward
Introduction: Dan Vreeman, Regenstrief Institute

  • Introductory comments: Steve Posnack, Office of the National Coordinator, DHHS


  • Raymond Aller, University of Southern California
  • Andrzej J. Knafel, Roche
  • William Mac Kenzie, Centers for Disease Control
  • Clem McDonald, National Library of Medicine
  • Bakul Patel, FDA Center for Devices and Radiological Health
  • Prashant Patel, Epic Software
  • Steve Posnack, Office of the National Coordinator, DHHS

4:45 – 5:00

Summary and Next Steps

Contact Us

For questions regarding workshop content please contact:
Steven Gitterman, Food and Drug Administration, WO 66 Rm 5518, 10903 New Hampshire Avenue, Silver Spring, MD 209930002, Tel: 3017966694, FAX: 3018472512, email:

Page Last Updated: 11/18/2015
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