PCD Brief Profile Proposal 2008 REG WP

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1. Proposed Workitem: White Paper - Regulatory Considerations Deploying PCD Profiles

  • Proposal Editor: Todd Cooper
  • Editor: <Name of candidate Lead Editor for the Profile, if known>
  • Date: N/A (Wiki keeps history)
  • Version: N/A (Wiki keeps history)
  • Domain: PCD


2. The Problem

Since the IHE PCD is focused on use cases that include at least one regulated medical devices, the question often arises how the group addresses regulatory issues. Though it is simple enough to say that this is not formally the concern of the IHE PCD working group, there are numerous considerations that are made when developing the PCD technical framework, to ensure that the technologies do provide the support needed by these regulated systems.

Within the domain of health information technology (HIT), there is the further issue regarding when a system (including standalone software applications) are considered regulated medical devices or simply health software applications. Recent changes to the European Medical Device Directives (MDD) and the proposed FDA guidance on Medical Device Data Systems (MDDS) have helped resolve some of this issue, but there is still some confusion regarding how that relates to many systems that integrate various IHE profiles.

This white paper will provide an overview of the considerations that should be made when developing and deploying systems that integrate one or more IHE PCD profiles.

It is NOT the intent of this white paper to provide definitive guidance regarding the position that a given regulatory agency may take relative to a specific device or application.


3. Key Use Case

<Describe a short use case scenario from the user perspective. The use case should demonstrate the integration/workflow problem.>

<Feel free to add a second use case scenario demonstrating how it “should” work. Try to indicate the people/systems, the tasks they are doing, the information they need, and hopefully where the information should come from.>


4. Proposed Topics / Outline

<Provide the proposed topics / outline for the white paper>


5. Discussion

<Include additional discussion or consider a few details which might be useful for the detailed proposal>

<Why IHE would be a good venue to solve the problem and what you think IHE should do to solve it.>
<What might the IHE technical approach be? Existing Actors? New Transactions? Additional Profiles?>
<What are some of the risks or open issues to be addressed?>
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