Stephen A. Weitzman
Co-Founder & Executive Director
saw5198@earthlink.net

Chair.
Peter H. Rheinstein
M.S., M.D. J.D.
Severn Health Solutions
Former FDA Senior Manager
Chair USAN Council

Peter Barton Hutt, LL.B, LL.M
Senior Counsel
Covington & Burling LLP
Former FDA Chief Counsel

Robert G. Donovan, MBA
Westport Business Solutions
Former Chair
Family Health Council

LeeAnn Stember
President, NCPDP
National Council For
Prescription Drug
Programs

James Schneider
Director of Operations
WETA Production Center


Phone 301-596-5564

Welcome to MedDATA Foundation's Site.
Our goal is to advance the use of Information Technology in support of the mission of the United States Food and Drug Administration, its global partners, and the industries it regulates through the better use of data.

Our initial effort as DataPharm Foundation was to assist FDA in automating the prescription drug label review process as a first step to "paperless labeling." We were part of a team with FDA, the National Library of Medicine and the Veterans Health Administration.  The project led to the creation of the DailyMed on the NLM website.

We have just completed the first phase of IRAI-Online with FDA support to create a rapidly searchable comprehensive repository of FDA (and other agencies that regulate FDA-regulated products) regulatory information and training materials in support of regulatory programs at academic universities. This project is designed to support the FDA's strategic plan for strengthening the potential and current workforce for innovative regulatory science agency wide.

                                       YOU CAN SIGN UP AT WWW.IRAI-ONLINE.ORG

We are organizing FDA-related primary and secondary information in logical order to aid novices or professionals for training, execution of mission, and industry compliance. Our effort will facilitate curriculum development; provide a "one stop" library; provide robust search tool capability for rapid identification of relevant information and access with print and distribution capabilities that can be integrated into FDA training courses and materials.

The library will become a self-sustaining effort of this 501(c)(3) foundation which will use any profits to fund scholarships, fellowships and other projects in support of academic institutions and FDA'€™s and its global partners' mission. A beta site is avalable for testing.  Please contact us if you are interested in helping us perfect this important public service. (saw5198@earthlink.net).

This second effort will make personalized medicine possible based upon sound decision support systems that access current reliable, statistically significant datasets for assisting in medical diagnosis and selection of best treatments for each individual patient. Those decisions will be based upon sound evidence gleaned from authoritative sources and, more importantly, a sound interoperable database system that allows the collection and use of clinical records of all patients while maintaining security and respecting privacy.

The new challenge that MedDATA will undertake is the fostering of an environment for data sharing and the cohesive and comprehensive development of a statistically significant dataset by disease or medicine cohort of patient clinical records to be made available to researchers and physicians. The data can then be gathered in common data formats and studied with any analytical tool set or clinical decision support system. This effort hopefully will contribute to reducing duplication of efforts in collecting and accessing patient data in the United States and eventually globally, to establishing uniformity in relational data amalgamation clinical information, and to providing simple access.

These efforts will be both technical and policy-oriented with the single objective of helping to reduce medical error, make our healthcare system more efficient, and reduce healthcare cost in the U.S. where the cost is twice that of other nations and in many cases, our outcomes are inferior to those of other nations.

MedDATA is a supporter of the Learning Health Community Principals in support of creating a viable LHS (Learning Health System) http://healthinformatics.umich.edu/initiatives/lhs/national-summit