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AdvaMed Emphasizes Threshold Questions, Data Governance In Registry Principles

The trade group released revised data registry principles aimed at ensuring adequate data governance and containing “threshold questions” one should consider before implementing a registry as opposed to another form of information gathering.

AdvaMed released revised post-market medical device data registry principles, including questions that should be answered by parties to determine whether use of a registry is appropriate. The principles also emphasize the need for a strong governance process overseeing registry data collection.

“We feel that appropriate, comprehensive data governance is really essential for an effective registry that will produce benefit to patients,” said Jeff Secunda, an AdvaMed VP, during a Feb. 4...

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