Whether we agree if he’s right right or wrong, if a device is causes the death of a patient because it malfunctions, it should be regulated. Here’s the rub, if the FDA regulates and an adverse event happens…and it’s not the EMR’s fault…the doc is on liable for incorrectly using the device and causing harm. Just like any other regulated medical device. See you in court, doc!

Its HIT EMRs and CPOEs are listed on the FDA website as having caused at least 3 of the deaths referred to in the Huff Post report.

I wonder if David Blumenthal will discuss the demise of CCHIT at the CCHIT Town Hall Meeting at HIMSS10. It is encouraging that Cerner has stepped up to the plate and will voluntarily submit its products for testing because “it’s the right thing to do.” How many other HIMSS EHRVA vendors are willing to do the same in the name of Patient Safety?

The vendors should voluntarily report any flaws as required. If not, the FDA will test and find the many ways these devices can harm a patient. Then CCHIT’s bogus “certification” lab will be exposed for what it was always meant to be: an organization created by HIMSS to drive up stocks for HIMSS’ EHRVA by rubber stamping its vendors products.

Patient Safety was never on the table! Senator Charles Grassley should push for a Congressional Hearing. Then HIMSS’ dirty little secrets will come tumbling out.

The tax payers have been duped!

Carl actually said, (via HuffPo), “(Regulation) might actually limit innovation and responsiveness when it is needed most.”

The implications of the two sentences are very different.