Friday, April 11, 2014

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

... 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


RDGelzer, MD, MPH said...

Thank you for your essay Scot. I would caution against investing too much in this bit of Federal HIT theater though.

Considered it instead an act of theater. There are a lot of good folks in DC who work hard but perhaps should ask more questions about what is going on behind the scenes.

Having some teeny, tiny opportunities to peek behind the scenes, I give a reluctant nod to Secretary Sebelius's fidelity to an overarching policy that began in the Bush Administration. That policy was to push forward Health IT as a strategic objective, without assessment or regard for consequences AND structured to assure that the measurement of consequences would come only after the damage was done.

With that framework in mind, I would say that her resignation now is a brilliant move.

Secretary Sebelius carries out the door and distant from the Administration a lightning rod for convenient assignment of the accumulated static that the Feds must disperse over the months ahead. That "static" is the multi-Administration divergence of HIT policy from knowledge, Standards, safety, and security as core HIT requirements in Federal policies and programs.

We are already seeing this strategy succeed, as the press assigns her resignation the static generated over the dysfunctions of the Insurance Registries. Nobody who knew anything about the program had any expectation that it would do anything other than what it did. Call it HIT Policy Theater, Act 5, Scene 7. The resignation is Scene 8, further diverting any examination of the "designed to fail" policy that has been and remains the assurance of generations of heavy IT spending ahead.


1. Registration site was known far in advance to October 2013 launch that it would fail (ex: OIG Congressional testimony in July 2013that it had been de-funded for fulfilling its assigned role to test security of the registration system, warnings by contractors and IT-experts that the system specs were finalized too late to execute properly, expert articles in the weeks after failure explaining why the design principles used were failure paths.)

2. Barrage of reports from OIG and CBO from December 2013 thru March 2014 "documenting" the already well-known massive gaps in Federal ability to control EHR-mediated fraud, the absence of meaningful functions to protect security and integrity (non-alteration) of patient data, the absence of any evidence that Quality Reporting data was either reliable or less susceptible to gaming.)

RDGelzer, MD, MPH said...


In the months ahead, we can anticipate that, like the CEO of GM saying "That was the old GM", we will hear noise about a "New mandate at HHS".

My own naive hope is that the proposed replacement, from CBO, is going to gear up the accountability piece. However, I think that that is also likely to be more symbolic than real since, in my opinion, Federal economic policy has, at least partially, shifted from infusing the economy with billions of stimulus funds thru military spending to the health care sector as the "sink" for unaccountable Federal spending to drive R&D, employment, tech, etc.

There is some evidence of a substantive shift with the launch yesterday of an ONC workgroup targeting accuracy support in EHRs. I look forward to solving a puzzle though as the intro slides state "no authoritative sources" for auditable accuracy in HIT policy requirements. It is unclear how they might have overlooked 5 or more decades of knowledge on accuracy and data quality in informations systems, as well as 20+ years of knowledge and Standards specific to electronic health care records (ex: ASTM 1999, IEEE predating that, HL7 2001, HL7 2010, Public Health Act specifications on accuracy controls in Fed info systems and info sources, etc.) Also, the legal requirements for business records status would appear to put some bounds on Federal policy for EHR records as well. The story will long be continued as the project is underway and, for most, undoubtedly well-meaning.

Nonetheless, we surely must anticipate the continuation of HIT Policymakers' efforts to distract attention from "planned HIT obsolescence to assure economic stimulus". This policy strategy brings to mind 2 + 2 = 5.

Seeking a reminder of the main character in 1984, I came across this helpful summary at

Winston Smith is a fictional character and the protagonist of George Orwell's 1949 novel Nineteen Eighty-Four. The character was employed by Orwell as an everyman in the setting of the novel, a "central eye ... [the reader] can readily identify with".[1] Winston Smith works as a clerk in the Records Department of the Ministry of Truth, where his job is to rewrite historical documents so they match the constantly changing current party line. This involves revising newspaper articles and doctoring photographs—mostly to remove "unpersons," people who have fallen foul of the party. Because of his proximity to the mechanics of rewriting history, Winston Smith nurses doubts about the Party and its monopoly on truth. Whenever Winston appears in front of a telescreen, he is referred to as "6079 Smith W".

RDGelzer, MD, MPH said...

Winston Smith, lured into joining a secret organization whose aim is to undermine the dictatorship of "Big Brother", is actually being set up by O'Brien, a government agent. Captured and tortured, he eventually betrays his accomplice and lover, Julia. His freedom is finally and completely stripped when he accepts the assertion 2 + 2 = 5, a phrase that has entered the lexicon to represent obedience to ideology over rational truth or fact. Winston's death at the hands of the party is not depicted in the conclusion of the novel (aside from the simple statement "the long hoped-for bullet was entering his brain"), but is deeply foreshadowed at the start of the novel.

Like I said, FWIW.

Remember, Federal HIT Policy is 2 + 2 = 5

In sum, this all makes (perverse) sense if we remind ourselves that HIT policy acceleration started with the ARRA, an economic stimulus plan to get us out of the doldrums generated by another set of policy failures, the removal of effective supervision and loss of the last shred of moral decency in the subprime mortgage markets' uptake of collateralized debt obligations as falsified "investment" graded instruments as detailed in Michael Lewis's "The Big Short".

I hope someday Mr. Lewis writes the recent history of health care and health IT.

By the way, have you noticed that all the smoke and mirrors about Obamacare has essentially eliminated any discussion of the quality and safety of healthcare?

A salute to Secretary Sebelius as a good soldier. Perhaps her consciences just reached the breaking point when the Leaders pressed for 2 + 2 = 7? I'd like to think that "conscience" may be part of why ONC saw some exits in Q4.

In the meantime, truth-assurance being taken up in conscientious healthcare organizations, despite the strange, consumptive, and distracting influences of Federal HIT policy.



Reed D. Gelzer, MD, MPH
Co-Facilitator, HL7 Records Management and Evidentiary Support Workgroup
Trustworthy EHR, LLC.
Newbury, NH

InformaticsMD said...


A truly fascinating analysis.

I imagine that instead of the route taken of feeding the already bloated, dysfunctional HIT industry trough with taxpayer dollars via ARRA, the alternative - ONC's spending, say, a mere $$billion to have adapted an EHR the government already owned, VistA CPRS at the VA, to the commercial market would have been impossible in an environment as you describe.

... that policy was to push forward Health IT as a strategic objective, without assessment or regard for consequences AND structured to assure that the measurement of consequences would come only after the damage was done.

We certainly have that, and it continues with the recent FDA determination that the offending technology is "safe enough" to not merit real regulation.

I also note that, with all the health IT spending, little dent is made in "R&D, employment, tech, etc."

Pearls before swine.

-- SS

Steve Lucas said...

During the Clinton Administration there was a proposal to eliminate the Third Class Medical for private pilots flying small aircraft for personal use. This was stopped at the time by a doctor’s organization claiming a financial hardship. There was never an issue with the simple fact that this intrusion into the personal lives of pilots served any medical purpose or in any way enhanced public safety.

This issue has once again been brought to the fore and interestingly a government watchdog has stated the FAA medical system is dysfunctional and has no time lines or technical expertise to remedy a system that serves no purpose.

The solution put forth is more technology. These are the same people that brought us the Obamacare rollout. They interviewed doctors who said of course they want to maintain this standard and the IT people said with more money they can make it work.

The COI’s are self evident. The intrusion into the personal lives of pilots is indefensible and the power grab obvious. The failure of EMR’s is well documented and the solution to a failing system, with no medical necessity, is more technology, technology itself that is not subject to government approval.

We do not have to look hard to figure out why the Tamiflu debacle took place.

Steve Lucas

Anonymous said...

Will she go work for Epic? Just wondering.

Anonymous said...

"A salute to Secretary Sebelius as a good soldier. Perhaps her consciences just reached the breaking point when the Leaders pressed for 2 + 2 = 7? I'd like to think that "conscience" may be part of why ONC saw some exits in Q4."

Conscience? Doubt it. She exercised the 2+2=7 with the iron grip on the FDA. She is the genesis (or had the final word) of the statement of low risk of CPOE and CDS that has been highlighted above and earlier.

Anonymous said...

The HIT devices she pushed on behalf of Obama have not any record of being safe, effective, or usable. Hope her successor understands the reasons for the Federal Food Drug and Cosmetic Act and that the current iterations of EHR, CPOE, and CDS may do more harm than good. The issue must be studied.

InformaticsMD said...

Steve Lucas:

Computers seem to have become religion of sorts. Faith in their power is what drives the belief that "technology" will solve all ills.

Not to mention, the profits that accrue.

-- SS