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Showing posts with label IOM Committee on Patient Safety and Health Information Technology. Show all posts
Showing posts with label IOM Committee on Patient Safety and Health Information Technology. Show all posts
The Health Information Management Systems Society (HIMSS) is the large health IT vendor trade group in the U.S.  At a Sept. 21, 2012 HIMSS blog post, John Casillas, Senior Vice President of HIMSS Financial-Centered Systems and HIMSS Medical Banking Project dismisses concerns about health IT with the refrain:

... To argue that the existence of something good for healthcare in many other ways, such as having the right information at the point of care when it’s needed, is actually bad because outliers use it to misrepresent claims activity is deeply flawed.

Through the best use of health IT and management systems, we have the opportunity to improve the quality of care, reduce medical errors and increase patient safety. Don’t let the arguments of some cast a cloud over the critical importance and achievement of digitizing patient health records.

Surely, no one can argue paper records are the path forward. Name one other industry where this is the case. I can’t.

Let’s not let the errors of a few become the enemy of good.

The ethics of these statements from a non-clinician are particularly perverse.

The statement "Don’t let the arguments of some cast a cloud over the critical importance and achievement of digitizing patient health records" is particularly troubling.

When those "some" include organizations such as FDA (see FDA Internal 2010 memo on HIT risks, link) and IOM's Committee on Patient Safety and Health Information Technology (see 2012 report on health IT safety, link) both stating that harms are definite but magnitude unknown due to systematic impediments to collecting the data, and the ECRI Institute having had health IT in its "top ten healthcare technology risks" for several years running, link, the dismissal of "clouds" is unethical on its face.

These reports indicate that nobody knows if today's EHRs improve or worsen outcomes over good paper record systems or not.  The evidence is certainly conflicting (see here).

It also means that the current hyper-enthusiasm to roll out this software nationwide in its present state could very likely be at the expense of the unfortunate patients who find themselves as roadkill on the way to the unregulated health IT utopia.

That's not medicine, that's perverse human subjects experimentation without safeguards or consent.

As a HC Renewal reader noted:

Astounding hubris, although it does seem to be effective.  Such is PC hubris.  Who could ever call for reducing the budget of the NIH that is intended to improve health.  Has health improved?  No.

So why does a group with spotty successes if not outright failure never get cut?  It’s not the results, it’s the mission that deserves the funding.  So it’s not the reality of HIT, it’s the promise, the mission, that gets the support.  Never mind the outcome, it’s bound to improve with the continued support of the mission.

Is this HIMSS VP aware of these reports?  Does he even care?

Does he believe patients harmed or killed as a result of bad health IT (and I know of a number of cases personally through my advocacy work, including, horribly, infants and the elderly) are gladly sacrificing themselves for the greater good of IT progress?

It's difficult to draw any other conclusion from health IT excuses such as proffered, other than he and HIMSS simply don't care about unintended consequences of health IT.

Regarding "Surely, no one can argue paper records are the path forward" - well, yes, I can.  (Not the path 'forward', but the path for now, at least, until health IT is debugged and its adoption and effects better understood).  And I did so argue, at my recent posts "Good Health IT v. Bad Health IT: Paper is Better Than The Latter" and "A Good Reason to Refuse Use of Today's EHR's in Your Health Care, and Demand Paper".  I wrote:

I opine that the elephant in the living room of health IT discussions is that bad health IT is infrequently, if ever, made a major issue in healthcare policy discussions.

I also opine that bad health IT is far worse, in terms of diluting and decreasing the quality and privacy of healthcare, than a very good or even average paper-based record-keeping and ordering system.  


This is a simple concept, but I believe it needs to be stated explicitly. 

A "path forward" that does not take into account these issues is the path forward of the hyper-enthusiastic technophile who either deliberately ignores or is blinded to technology's downsides, ethical issues, and repeated local and mass failures.

If today's health IT is not ready for national rollout, e.g., causes harms of unknown magnitude (e.g., see this query link), results in massive breaches of security as the "Good Reason" post above, and mayhem such as at this link, then:

The best - and most ethical - option is to slow down HIT implementation and allow paper-based organizations and clinicians to continue to resort to paper until these issues are resolved.  Resolution needs to occur in lab or experimental clinical settings without putting patients at risk - and with their informed consent.

Anything else is akin to the medical experimentation abuses of the past that led to current research subjects protections such as the "Ethical Guidelines & Regulations" used by NIH.

-- SS
5:55 AM

The following press release is very welcome, and speaks for itself.  There is a responsible voice in the government wilderness.  It is perhaps no surprise it comes from a Congresswoman who is also a registered nurse:

Ellmers Calls on Sebelius to Address Health IT Safety Concerns



Safety Risks and Health IT-Related Errors Cited in IOM Recommendations

WASHINGTON – House Small Business Subcommittee on Healthcare and Technology Chairwoman Renee Ellmers (R-NC) today sent a letter to Kathleen Sebelius, Secretary of Health and Human Services (HHS), inquiring about whether the Department has adopted the Institute of Medicine’s (IOM) recommendations for improving the safety of health information technology (IT).
The report, issued in November, recommended several steps to be taken by HHS and called for greater oversight by the public and private sectors. The Secretary was called upon by the IOM to issue a plan within 12 months to minimize patient safety risks associated with health IT and report annually on the progress being made.  The report further recommended that the plan should include a schedule for working with the private sector to assess the impact of health IT on patient safety, and recommended several other steps to help improve the safety of health IT.

Specifically, Chairwoman Ellmers has requested a copy of the Secretary’s plan to minimize patient safety risks, a description of health IT-related errors that have resulted in patient risks, injuries and deaths, and the status of the development of a mechanism for health IT vendors and users to report health IT-related deaths.  She said that because health IT has the promise to improve health care delivery for patients, physicians and other medical professionals, she remains eager to work with the Secretary to ensure that health IT is safe, effective and affordable.

In an August 11, 2011 letter to Secretary Sebelius, Chairwoman Ellmers said that a modern, well-equipped office is critical to the practice of medicine, and asked the Secretary to undertake a study of health IT’s adoption, benefits and cost effectiveness, including medical error rates.

On June 2, 2011, Chairwoman Ellmers’ Subcommittee held a hearing on the barriers to health IT that are encountered by physicians and other health professionals in small and solo practices.   At the hearing, physicians expressed strong concerns about the cost of purchasing and maintaining health IT systems, as well as the staff training and downtime necessary to implement such a system.  Chairwoman Ellmers noted health IT’s great potential to improve health care delivery, decrease medical errors, increase clinical and administrative efficiency and reduce paperwork.

For more than twenty-one years before being elected to Congress, Chairwoman Ellmers served as a registered nurse, focusing on surgical care as Clinical Director of the Trinity Wound Care Center and later helping to manage the family's small medical practice with her husband, Dr. Brent Ellmers, a licensed surgeon. As a registered nurse and the wife of a surgeon, Ellmers understands that a modern, efficient and well-equipped office is critical to the practice of medicine.    

This voice of sanity is quite welcome.  I've spoken with Rep. Ellmers' office, pointing them to my Drexel Univ. writings and materials and recommending Sebelius' reply be gone over with a fine-toothed comb, from the perspective of health IT realities, not merely from the perspective of the Ddulite's good intentions.  (I also introduced her staffer to the concept of the Ddulite, the HIT hyper-enthusiast who ignores all downsides and ethical concerns.)

I also pointed out the ethical lapse in IOM's position of "wait and see" while HIT is pushed nationally under penalty of law, at the cost of hundreds of billions of dollars, when their own report (along with reports from FDA here, JC here and others) admits they don't know the magnitude of benefits, risks and harms:

... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk.

Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.
[IOM (Institute of Medicine). 2012. Health IT and Patient Safety: Building Safer Systems for Better Care (PDF). Washington, DC: The National Academies Press, pg. S-2.]

As I wrote in my Nov. 2011 post "IOM Report - 'Health IT and Patient Safety: Building Safer Systems for Better Care' - Nix the FDA; Create a New Toothless Agency", the IOM's response to their own study was reckless and unethical (at best):

... The panel also recommends that the HHS secretary publicly report on the progress of health IT safety each year, beginning in 2012. If the secretary determines at any time that adequate safety progress has not been made, only then should the FDA take the regulatory lead and be given the resources to do so, the report recommends, adding that the agency should be developing a framework now to be prepared.

In the meantime, during each year of "watching for safety progress", innumerable patients are exposed to HIT's hazards and costs.  Pharma and other medical device industries are afforded no such special accommodation.

-- SS
7:06 AM