The Secretary of the U.S. Department of Health and Human Services (HHS) is resigning.

Press reports say she is resigning in large part due to the Exchange Website debacle.   This from the New York Times:

Health Secretary Resigns After Woes of

... Officials said Ms. Sebelius, 65, made the decision to resign and was not forced out [Yeah, right - SS]. But the frustration at the White House over her performance had become increasingly clear, as administration aides worried that the crippling problems at, the website set up to enroll Americans in insurance exchanges, would result in lasting damage to the president’s legacy.

It's not as if there's no literature out there on how to create good health IT.  Doing so is not a state secret.  Simple (and free, unlike the hundreds of millions spent on incompetent beltway-bandit 'consultants') Google searches on the term "healthcare IT failure" or similar return ample resources that could have prevented the "lasting damage to the president's legacy."

Way to go, Ms. Ex-Secretary.  Another health IT amateur bites the dust, as my early computer mentor, Philadelphia's George Washington High School math instructor Fred Holzwarth ( would have said.

However, even worse ... far worse ...

Under this Secretary of the Department of Health and Human Services, the principal watchdog agency over medicine and medical device safety under her aegis, the FDA, found that:

... products with health management heath IT functions, includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software.

Products with health management health IT functions are of sufficiently low risk and thus, if they meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them.

Thus, patients are condemned to injury and death, probably at ECRI Deep Dive study levels [1], for the foreseeable future (see my post on that FDA decision at my April 9, 2014 post "FDA on health IT risk: reckless, or another GM-like political coverup?" at

This is especially outrageous at the time massive investigations are ongoing about the 13 deaths caused by apparent coverups of a faulty General Motors ignition switch.

It was your FDA agency, Ms. Ex-Secretary.  You own that decision.

Good Riddance, indeed.  

The person at this link: would certainly agree, if she were alive; she is not thanks to the very devices your FDA just perversely found to be of "sufficiently low risk."

-- SS


[1]  In 9 weeks in 36 PSO-member hospitals, 171 IT mishaps sufficient to cause harm were voluntarily reported; 8 injuries occurred, some severe, and 3 deaths may have been the result.  See

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