Healthcare IT Amateur Kathleen Sebelius Resigns - Good Riddance

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 HealthCare.gov
http://www.nytimes.com/2014/04/11/us/politics/sebelius-resigning-as-health-secretary.html?_r=0

... 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 HealthCare.gov, 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 (http://www.historicbuckscounty.org/nths/HISTORIA/PDF/Historia_Nov2005.pdf) 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 http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html).

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: http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html 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

Note:

[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 http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html.

Cybernetik Über Alles Again: HHS and Sebelius - Hospitals And Their Computers Have More Rights Than Patients

A Nov. 29, 2012 New York Times article by Reed Abelson entitled "Medicare Is Faulted on Shift to Electronic Records" observes that:

The conversion to electronic medical records — a critical piece of the Obama administration’s plan for health care reform — is “vulnerable” to fraud and abuse because of the failure of Medicare officials to develop appropriate safeguards, according to a sharply critical report to be issued Thursday by federal investigators [the report from HHS OIG is here - ed.] ... Medicare, which is charged with managing the incentive program that encourages the adoption of electronic records, has failed to put in place adequate safeguards to ensure that information being provided by hospitals and doctors about their electronic records systems is accurate. To qualify for the incentive payments, doctors and hospitals must demonstrate that the systems lead to better patient care, meeting a so-called meaningful use standard by, for example, checking for harmful drug interactions. [I note that meeting EHR "meaningful use" standards does not necessarily signify better care; the "standards" are experimental - ed.]

Hospitals and doctors are lying about their EHR efforts, in order to gain incentive payments, it seems.

In an article "IG says program is 'vulnerable' to abuse, better oversight needed", Fred Schulte at the Center for Public Integrity notes:

... the Centers for Medicare and Medicaid Services has since paid out more than $3.6 billion to medical professionals who made the switch without verifying they are meeting the required quality goals, according to a new federal audit to be released today

Observes the CEO of the American Health Information Management Association:

“We’ve gone from the horse and buggy to the Model T, and we don’t know the rules of the road. Now we’ve had a big car pileup,” said Lynne Thomas Gordon, the chief executive of the American Health Information Management Association, a trade group in Chicago. 

More Horse and Buggy than Model T.  At least the Model T was reasonably dependable. 

Also mentioned is this:

House Republicans echoed these concerns in early October in a letter to Kathleen Sebelius, secretary of health and human services. Citing the Times article, they called for suspending the incentive program until concerns about standardization had been resolved. “The top House policy makers on health care are concerned that H.H.S. is squandering taxpayer dollars by asking little of providers in return for incentive payments,” said a statement issued at the same time by the Republicans, who are likely to seize on the latest inspector general report as further evidence of lax oversight. Republicans have said they will continue to monitor the program.

In her letter in response, which has not been made public, Ms. Sebelius dismissed the idea of suspending the incentive program, arguing that it “would be profoundly unfair to the hospitals and eligible professionals that have invested billions of dollars and devoted countless hours of work to purchase and install systems and educate staff.”

I was taught "first, do no harm."  Fairness to patients injured and killed by this technology in its present "Horse and Buggy" state (buggy being a particularly apropos term) seems not a matter of particularly high concern to HHS.   A suspension of incentives would slow the adoption rate down, necessary in order to "get the bugs" out of the technology before mass deployment and develop safety, validation and surveillance standards (currently non-existent), as I wrote in my Oct. 24, 2012 "Letter To U.S. Senators and Representatives Who've Sought HHS Input On EHR Problems."

This is despite the fact that FDA, IOM and others have indicated the level of harm is not known, due to systematic impediments to diffusion of that knowledge (see IOM statements in the midsection of my post on health information technology hyper-enthusiasm at this link, and an internal FDA memo on HIT safety at this link). 

HHS seems to care not about health and human services, or at best to be severely misguided.  "Cybernetik Über Alles" seems their current credo.

-- SS