March 2008 – DRAFT 1 Progress since Oct 2007 Third Party Greg Stadler and Jean Samuel

March 2008 – DRAFT 2 Third Party EHR 2 Third Party concept to differentiate: 1.Third party acting as an “honest” gate keeper between the data holder and anyone wanting to use the data, primarily to protect privacy (Trusted Third Party - TTP) 2.The Third Party acting as an information broker, in which various data sources are integrated and then made available via a single point of contact for those wishing to do medical research with it; sort of an information clearing house (Information Broker – IB) Progress to date focused on no. 1 above, in breakout to follow we’ll have time for both.

March 2008 – DRAFT 3 Objective - TTP  Develop clarity regarding the likely remit, role and responsibilities of a TTP and where such a third party organisation would fit into the EHR Clinical Research model.  Scope includes: –Identification of the rules and governance and behavioural characteristics with which EHR TPs must demonstrate. Governance: Knowledge maintenance Knowledge operationalisation Model contract Identification of the technical infrastructure and data management tools needed for EHR TPs to operate Appreciation of conflicts of interest

March 2008 – DRAFT 4 Progress - TTP  1 Feb 2008 – TeleConf to refine and agree project Charter  10 Feb 2008 – 1 Day workshop with representative experts from TTP service providers, Industry, Management Consultants and EuroREC. –Reviewed case studies showing current examples of TTP services provided today (IBM, Custodix) –Brainstormed Services required in an ideal TTP engagement –Aligned the ideal service provision to real life Clinical Research scenarios and mapped intersection –Reviewed high level governance –Reviewed high level example model contracts –Reviewed and documented obvious conflicts of interest  14-29/2 participants provide draft inputs from various sections. Jean Samuel and Greg Stadler pulled together the first draft document which was circulated to you all last week.

March 2008 – DRAFT 5 Conclusions and Next Steps  The first pass TTP Guidance document is very high level, very rough, but a good start!!  Next steps: –Circulate the draft to a wider audience, gather input, refine – Workshop 11 March –Finalise draft before end April 2008 –Decide where the document should be hosted, who should own it and where should it be published to maximise the value from it. –Publish by end June 2008.