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

Upcoming Training

Agile Methods for Medical Device and Health IT Software

One day course that expands on the software risk management topics covered in our IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software course. Essentially the same topics are covered but in greater depth with more attention to hands-on analysis of examples.

Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.