Dear colleagues, Sandy Boyer sent me important information about the FDA's electronic package insert project. This is a subject that many of us are interested in and need to work with. Since she is not a subscriber, she could not post directly to the OpenHealth List. So, here is her email to me in its entirely.
Until she is able to subscribe, we can include her email address on our response and forward her message to the List (like I am doing now). Best regards, Andrew --- Andrew P. Ho, M.D. OIO: Open Infrastructure for Outcomes www.TxOutcome.Org ---------- Forwarded message ---------- Date: Sat, 30 Oct 2004 13:28:54 -0700 From: Sandy Boyer <[EMAIL PROTECTED]> Subject: Re: physician prescribing tool development Dr. Ho - I recently came across this thread on the openhealth-list regarding development of physician prescribing tools that will utilize electronic package inserts. A misconception is being perpetuated on that thread that I would like to correct. I have not been able to get on the list, so I hope you will share this. Gunther Schadow did not develop the Structured Product Labeling standard for package inserts. I was the FDA consultant in its design and the project leader on the HL7 committee responsible for its development. The editors of the standard are myself and Dr. Robert Dolin. In August 2004 it became an official HL7- and ANSI-approved standard and is available through HL7 (contact information is available at http://www.hl7.org). All labeling is to be submitted to FDA and made available to the public in this XML-based format by June 2005. It should be referenced as: Boyer SL, Dolin RH (eds). HL7 Structured Product Labeling, Release 1.0. Ann Arbor, MIch: Health Level Seven, Inc. 2004. Dr. Schadow's participation in the development of the standard was the same as that of numerous others in the HL7, who reviewed and commented on it as it went through balloting. We appreciate his contributions, as we do those of everyone who participated in the standards development process. A collaborative working group involving industry, vendors, and FDA representatives has developed an implementation guide and is currently in the process of initiating pilot testing of SPL for package inserts. If anyone would like any additional information about the standard, I would be more than happy to assist. (I'm located in Laguna Beach.) Sandy Boyer
