SPL Implementation Working Group Technical Team

The Technical Team is responsible for working with
(a) RCRIM and the HL7 SPL modeler to suggest enhancements and to evaluate proposed changes to the SPL standard, and
(b) the vendor/user community and the FDA to identify and resolve technical issues encountered in the implementation of the standard.

The co-chairs are:
Myron Finseth, Medtronic, myron.finseth@medtronic.com
Gary Saner, Reed Technology, gsaner@reedtech.com
Keith Thomas, i4i, kthomas@i4i.com

The Technical Team meets by teleconference on alternate Monday's (starting on 1 February in 2010) from 2-3 pm Eastern Time, when there is material for discussion. Call-in information and the meeting agenda is emailed to team members prior to each teleconference. Membership is open to anyone; to join please email Keith Thomas at kthomas@i4i.com.

Current Activities:
1 Feb 2010 - SPL R5 (updated 1 Mar 2010)
Work has begun within HL7 on Release 5 of the SPL standard. The proposed changes consist primarily of extensions to the product model to accommodate more information about medical devices, and the restructuring of the way the standard is written so that the existing product model becomes an independent module, called the Common Product Model, for use in other HL7 standards. The end result is intended to be backward compatible with SPL R4; that is, though the schema will change SPL encoded according to R4 for drugs and biologicals will still be valid and conformant to FDA rules; R5 would be required for medical devices.


March 15, 2010, Terrie Reed, FDA CDRH, made a presentation to the Tech Team:

SPL R5 Working Documents

Dr. Gunther Schadow is in charge of the modeling effort. He has produced a DRAFT document for discussion outlining the key aspects of the SPL R5.

The latest version (1 March 2010) of this document can be displayed or downloaded by clicking the following link:

The first version (1 Feb 2010) is accessible below:

Meeting Minutes

Technical Team meeting minutes are housed on the HL7 SPL WIKI