FDA Regulation of Health IT Systems Testimony

Attached is a pdf of the testimony of FDA’s Director of CDRH Jeff Shuren regarding Health Information Technology Policy. It discusses the need for active regulation FDA regulation, the possible approaches to regulation, and the regulatory basis for this. The Appendix provides some examples of adverse events associated with such systems. It identifies four categories:

1) Errors of commission, such as mixing up patient information
2) Errors of omission or transmission, such as loss or corruption of vital patient data
3) Errors in data analysis, including medication dosing errors
4) Incompatibility between systems which can lead to any of the above.

HIT Policy Committee Meeting Jeff Shuren Testimony

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Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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