Last Friday, it was my pleasure to attended and present at the Harvard Food Law Society's TEDx conference, Forum on Food Policy. I had never been to Cambridge or Boston before, and I was struck by how European they feel compared to Seattle. The conference was a great success, thanks to the dedicated efforts of the Food Law Society's presidents Nate Rosenberg, Krista DeBoer, and many other volunteers.
Dr. Robert Lustig gave a keynote address on Thursday evening, which I unfortunately wasn't able to attend due to my flight schedule. From what I heard, he focused on practical solutions for reducing national sugar consumption, such as instituting a sugar tax. Dr. Lustig was a major presence at the conference, and perhaps partially due to his efforts, sugar was a central focus throughout the day. Nearly everyone agrees that added sugar is harmful to the nation's health at current intakes, so the question kept coming up "how long is it going to take us to do something about it?" As Dr. David Ludwig said, "...the obesity epidemic can be viewed as a disease of technology with a simple, but politically difficult solution".
Read more »
Harvard Food Law Society "Forum on Food Policy" TEDx Conference
Last Friday, it was my pleasure to attended and present at the Harvard Food Law Society's TEDx conference, Forum on Food Policy. I had never been to Cambridge or Boston before, and I was struck by how European they feel compared to Seattle. The conference was a great success, thanks to the dedicated efforts of the Food Law Society's presidents Nate Rosenberg, Krista DeBoer, and many other volunteers.
Dr. Robert Lustig gave a keynote address on Thursday evening, which I unfortunately wasn't able to attend due to my flight schedule. From what I heard, he focused on practical solutions for reducing national sugar consumption, such as instituting a sugar tax. Dr. Lustig was a major presence at the conference, and perhaps partially due to his efforts, sugar was a central focus throughout the day. Nearly everyone agrees that added sugar is harmful to the nation's health at current intakes, so the question kept coming up "how long is it going to take us to do something about it?" As Dr. David Ludwig said, "...the obesity epidemic can be viewed as a disease of technology with a simple, but politically difficult solution".
Read more »
Dr. Robert Lustig gave a keynote address on Thursday evening, which I unfortunately wasn't able to attend due to my flight schedule. From what I heard, he focused on practical solutions for reducing national sugar consumption, such as instituting a sugar tax. Dr. Lustig was a major presence at the conference, and perhaps partially due to his efforts, sugar was a central focus throughout the day. Nearly everyone agrees that added sugar is harmful to the nation's health at current intakes, so the question kept coming up "how long is it going to take us to do something about it?" As Dr. David Ludwig said, "...the obesity epidemic can be viewed as a disease of technology with a simple, but politically difficult solution".
Read more »
NIST on the EHR Mission Hostile User Experience: Blame the User? Nyet...
I have often had to respond to those who claim that EHR's don't cause medical errors, users do. That subset of the health IT irrationally exuberant seem common in the health IT industry and pundit channels.
NIST (The U.S. National Institute of Standards and Technology) has recently issued a draft report "NISTIR 7804: Technical Evaluation, Testing and Validation of the Usability of Electronic Health Records." It is available at http://www.nist.gov/healthcare/usability/upload/Draft_EUP_09_28_11.pdf (PDF).
I will have more to write about this report, but I found a passage and footnote early in the report striking.
Of note, from the new NIST draft report:
This passage, from page 10:
"Blame the user" as the default, reflex reply to clinical IT-related medical errors, and the "hold vendor harmless for defects" clauses that facilitate this excuse are now heading to the junkpile - in the clinic, hospital, and courtroom.
It is my hope that the the Wild West, free-for-all, cavalier, get out of jail free days of the health IT industry are coming to a close.
Hint to health IT industry: you may actually need to invest in people who know what they're doing, instead of hiring the cheapest labor possible. (See, for example, my Aug. 2010 post
"EPIC's outrageous recommendations on healthcare IT project staffing" for more on that issue.)
-- SS
Oct. 25, 2011 Addendum:
This comment (#5, October 25th, 2011 at 12:38 pm) by "a practicing front-end designer and application developer" over at HIStalk is quite interesting. The writer points out the differences between designers and developers, and opines that:
In health IT, empathy for the patient as well, I might add.
-- SS
NIST (The U.S. National Institute of Standards and Technology) has recently issued a draft report "NISTIR 7804: Technical Evaluation, Testing and Validation of the Usability of Electronic Health Records." It is available at http://www.nist.gov/healthcare/usability/upload/Draft_EUP_09_28_11.pdf (PDF).
I will have more to write about this report, but I found a passage and footnote early in the report striking.
Of note, from the new NIST draft report:
This passage, from page 10:
The EUP (EHR usability protocol) emphasis should be on ensuring that necessary and sufficient usability validation and remediation has been conducted so that use error [3] is minimized.This passage describes what I have termed a mission hostile user experience.
[3] “Use error” is a term used very specifically to refer to user interface designs that will engender users to make errors of commission or omission. It is true that users do make errors, but many errors are due not to user error per se but due to designs that are flawed, e.g., poorly written messaging [or lack of messaging, e.g., no warnings of potentially dangerous actions - ed.], misuse of color-coding conventions, omission of information, etc.
"Blame the user" as the default, reflex reply to clinical IT-related medical errors, and the "hold vendor harmless for defects" clauses that facilitate this excuse are now heading to the junkpile - in the clinic, hospital, and courtroom.
It is my hope that the the Wild West, free-for-all, cavalier, get out of jail free days of the health IT industry are coming to a close.
Hint to health IT industry: you may actually need to invest in people who know what they're doing, instead of hiring the cheapest labor possible. (See, for example, my Aug. 2010 post
"EPIC's outrageous recommendations on healthcare IT project staffing" for more on that issue.)
-- SS
Oct. 25, 2011 Addendum:
This comment (#5, October 25th, 2011 at 12:38 pm) by "a practicing front-end designer and application developer" over at HIStalk is quite interesting. The writer points out the differences between designers and developers, and opines that:
If you’re going to improve vendor design, it has to begin with an internal commitment to value designers and what they contribute to the product development process. They can not be an afterthought. There are very few companies with this mindset. Almost all HIT companies are developer-driven, so the first thought, and one that is promoted in this report, is to turn developers into designers. This will not work! A developer and a designer require two fundamentally different skill sets that are not easily transposed. Developers are trained to think rationally and analytically; design requires empathy for the user.
In health IT, empathy for the patient as well, I might add.
-- SS
Steve Jobs: Computer Geniuses and Medical Mysticism, a Very Bad Combination
Brilliant computer innovators may not be so brilliant in all domains.
It is well known, and well documented for many decades, that pancreatic cancer is often extremely aggressive and detected relatively late due to lack of early symptoms.
Its detection should lead to aggressive treatment ASAP, such as radiation/chemotherapy or the Whipple procedure, if the person is to survive.
I consider this tragic:
I would replace the term "doctor" above with the onomatopoeia imitating the noise made by females of the species Anas platyrhynchos.
Medical mysticism and "alternative therapies" may have their place, especially in hypochondriacs and for relatively minor problems (in my view, via the placebo effect), but not in dire, well studied conditions such as cancer of the pancreas. A brilliant computer entrepreneur, one of the world's best, may have been unnecessarily lost due to the seduction of medical mysticism.
In such diseases, sadly, an Apple a day does not keep the doctor - or the grim reaper - away.
-- SS
10/22/11 Addendum:
This story has a personal angle of sorts to it. In the early 1970's when I began my fascination with computers, I became friends with Hank, a brilliant computer programmer and fellow ham radio enthusiast, shown stting in this picture from the George Washington High School (Phila., PA) 1973 yearbook in front of our high school's DEC PDP-8/S:
Me (standing, right), Eric Benshetler (standing, left), and Hank O'Neill (sitting), 1973.
Hank had a distrust of medicine. I last saw him when I was in Residency, when he visited my home to see my ham radio setup. He became a programmer working on military weapons systems, the B1B bomber I was told. I was told this, unfortunately, at his funeral just a few years ago. He'd developed a severe respiratory infection and tried to "tough it out."
He died at home, apparently of pneumonia. A few dollars worth of antibiotics would probably have saved him. At the funeral, his friends told me he spoke occasionally of his former computer friend who'd gone into medicine. I was quite sad at his funeral. All he'd needed to have done would have been to call me. I'm sure I could have talked him into treatment.
-- SS
It is well known, and well documented for many decades, that pancreatic cancer is often extremely aggressive and detected relatively late due to lack of early symptoms.
Its detection should lead to aggressive treatment ASAP, such as radiation/chemotherapy or the Whipple procedure, if the person is to survive.
I consider this tragic:
Jobs Tried Exotic Treatments to Combat Cancer, Book Says
New York Times
Steve Lohr
Oct. 21, 2011
... His early decision to put off surgery and rely instead on fruit juices, acupuncture, herbal remedies and other treatments — some of which he found on the Internet — infuriated and distressed his family, friends and physicians, the book says. From the time of his first diagnosis in October 2003, until he received surgery in July 2004, he kept his condition largely private ... Mr. Jobs put off surgery for nine months, a fact first reported in 2008 in Fortune magazine.
(Per Yahoo finance) ... he also was influenced by a doctor who ran a clinic that advised juice fasts, bowel cleansings and other unproven approaches, the book says, before finally having surgery in July 2004.
I would replace the term "doctor" above with the onomatopoeia imitating the noise made by females of the species Anas platyrhynchos.
Medical mysticism and "alternative therapies" may have their place, especially in hypochondriacs and for relatively minor problems (in my view, via the placebo effect), but not in dire, well studied conditions such as cancer of the pancreas. A brilliant computer entrepreneur, one of the world's best, may have been unnecessarily lost due to the seduction of medical mysticism.
In such diseases, sadly, an Apple a day does not keep the doctor - or the grim reaper - away.
-- SS
10/22/11 Addendum:
This story has a personal angle of sorts to it. In the early 1970's when I began my fascination with computers, I became friends with Hank, a brilliant computer programmer and fellow ham radio enthusiast, shown stting in this picture from the George Washington High School (Phila., PA) 1973 yearbook in front of our high school's DEC PDP-8/S:
Me (standing, right), Eric Benshetler (standing, left), and Hank O'Neill (sitting), 1973.Hank had a distrust of medicine. I last saw him when I was in Residency, when he visited my home to see my ham radio setup. He became a programmer working on military weapons systems, the B1B bomber I was told. I was told this, unfortunately, at his funeral just a few years ago. He'd developed a severe respiratory infection and tried to "tough it out."
He died at home, apparently of pneumonia. A few dollars worth of antibiotics would probably have saved him. At the funeral, his friends told me he spoke occasionally of his former computer friend who'd gone into medicine. I was quite sad at his funeral. All he'd needed to have done would have been to call me. I'm sure I could have talked him into treatment.
-- SS
Why 99 Percent of the Irrationally Exuberant About Health IT Need To Be Removed From Healthcare
At Roy Poses' cross post "Why 99 percent of health care should be angry" over at the KevinMD blog, I introduced a comment into the "eruption of controversy" (his term here) caused by his post.
My comment was on the topic of government and health IT:
A reply typical of the irrationally exuberant was added to the thread (emphases mine):
The articles challenge the beliefs in technological determinism common about health IT, i.e., that computers + medicine 'automagically' lead to better medicine, because, well, of the addition of computers, which must improve medicine, just - because.
The reason I write that the reply was typical of the irrationally exuberant is due to the interrelationship between irrationality, logical fallacy, and absence of evidence. These characteristics are usually present in the writings proffered by those so afflicted - and, to those with vested interests in health IT, a.k.a. conflicts of interest, I should add.
I replied:
I've replied to so many irrationally exuberant commenters on this very blog, that I could have authored the reply above in my sleep.
Two points:
1. My reply and its links (and the source those links lead to) can and should be used as a "template" by clinicians to educate themselves, to reply to the health IT irrationally exuberant in their organizations, and to those in government prematurely pushing this technology onto clinicians;
2. The health IT irrationally exuberant, being irrational, ill-informed, and often markedly resistant to education, need to be removed from healthcare entirely. Their cavalier attitudes about cybernetic medical experiments are dangerous, and have no place in medical affairs. Such people impede, rather then help remediate the quality, safety, usability, and efficacy of health IT. In doing so, they contribute to increased risk and to actual patient harm. The irrationally exuberant are part of the problem, not part of the solution.
-- SS
My comment was on the topic of government and health IT:
As one of Roy Poses' co-bloggers and a Medical Informaticist, I can say with certainty that government involvement in healthcare has been disastrous. Specifically, via ONC, ARRA and the HITECH Act, prematurely pushing still-experimental healthcare information technology on an unsuspecting medical profession (for the most part) and public. See "An updated reading list on health IT" at http://tinyurl.com/emrreadingl..., and the personal aftermath of this technology "A Diary of EHR-Initiated Tragedy" at http://tinyurl.com/ehrtragedy .
A reply typical of the irrationally exuberant was added to the thread (emphases mine):
Note that this reply came after I presented a link to a long list of articles, more than 50, with links to each article or its abstract for ease of reference, and a personal account of healthcare IT failure.What are you basing your "certainty" on? The examples discussed in the links sound like a case of bad configuration of an EMR. It could also be a just a poor solution from a vendor. Do you know if these were even a certified applications? I would like to suggest not painting all EMR implementations and the overall value of EMR’s from a single, albeit tragic, example. [I.e., an "anecdote" - ed.] A well implemented EMR, configured in collaboration with an organization’s physicians, has been repeatedly proven to reduce medical and medication errors. Why would any educated person, including legislators and executives, support the use of a tool that would increase harm, not safety.
Education aside, we will all be patients at some point so our innate need for self preservation would seem contrarian to arbitrary investments in useless technology to manage our care. Our current health delivery method produces far more harm than the new technology being implemented to address it. We need to embrace technology and make it work for us rather than putting our heads in the sand. Take the following quote as an example:
"That it will ever come into general use, notwithstanding its value, is extremely doubtful because its beneficial application requires much time and gives a good bit of trouble, both to the patient and to the practitioner because its hue and character are foreign and opposed to all our habits and associations." - The London Times, 1834 commenting on the "stethoscope"
The articles challenge the beliefs in technological determinism common about health IT, i.e., that computers + medicine 'automagically' lead to better medicine, because, well, of the addition of computers, which must improve medicine, just - because.
The reason I write that the reply was typical of the irrationally exuberant is due to the interrelationship between irrationality, logical fallacy, and absence of evidence. These characteristics are usually present in the writings proffered by those so afflicted - and, to those with vested interests in health IT, a.k.a. conflicts of interest, I should add.
I replied:
You are lacking references supporting your arguments, which in themselves display logical fallacy.
I urge all readers to see my linked references list at the top of this thread, examine some of them (such as Jon Patrick's work on gross EHR defects, the ECRI Institute's Top Ten List of Healthcare Hazards, Romano et al.'s "Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality" and others).
There are articles from reputable sources indicating today's health IT, lacking cognitive support and other necessities for clinicians (such as per the National Research Council itself in an investigation led by health IT pioneers Octo Barnett and William Stead, see http://www8.nationalacademies.... ) does not improve quality of care, and can cause harm.
These articles should raise caution in any physician, nurse or hospital contemplating use of this technology. These reports should not be cavalierly ignored, but should be a flag for great caution. The point is, with the literature conflicting, the technology should be considered experimental and caution used when deployed on human subjects. That includes both patients and clinicians, the former who can be injured or killed, the latter whose careers can be ruined through computer-caused or computer-aggravated errors. [Note: in health IT experiments, clinicians are, in fact, also experimental subjects - ed.]
Re: "The examples discussed in the links sound like a case of bad configuration of an EMR" - you omit the existence of clinical IT defects and problems such as poor software engineering causing unreliability, mission hostile human-computer interfaces (e.g., see http://www.tinyurl.com/hostile... ), incorrect or incomplete decision support algorithms, terminological problems, and other issues. You seem to indicate the findings in the reading list may be "anecdotal." A crushing reply to that line of thought, from an expert in Australia, is here: http://hcrenewal.blogspot.com/... .
As far as "certification" of HIT, this has little if anything to do with safety, reliability, usability, etc. ( e.g,, see http://hcrenewal.blogspot.com/... ). "Certification" of health IT is not validation of safety, usability, efficacy, etc., but a pre-flight checklist of features, interoperability, security and the like. The certifiers admit this explicitly. See the CCHIT web pages for example.
You use the logical fallacy of "appeal to authority" - or show severe naivete - in asking "why would any educated person, including legislators and executives, support the use of a tool that would increase harm, not safety."
"We need to embrace technology and make it work for us rather than putting our heads in the sand" - I ask - why now, if the technology is not ready? This seems like an appeal to novelty and perhaps the bandwagon fallacy (see http://www.nizkor.org/features... ).
Regarding your 1834 London Times quote, that was in a time before the human subjects experimentation guidelines such as the Belmont Report, World Medical Association Declaration of Helsinki, Guidelines for Conduct of Research Involving Human Subjects at NIH, the Nuremberg Code, and others came into being.
That said, the use of the 1834 stethoscope analogy is a type of red herring fallacy (http://www.nizkor.org/features... ). A stethoscope and enterprise clinical IT have little in common, the latter being potentially harmful to the point of causing patient death through interference in clinical care. (I note that if the 1834 story was brought up as an allusion to doctors and nurses who dislike today's IT being "Luddites" or the like, then that's an ad hominem fallacy.)
We as a society have supposedly learned something since 1834 regarding experimental medical devices. Or have we? FDA's Jeffrey Shuren MD, JD, Director of CDRH has admitted explicitly that health IT are medical devices with definite, but unknown, levels of risk - FDA stats "may represent only the tip of the iceberg in terms of the HIT-related problems that exist" were the exact words. That is prima facie evidence the devices are experimental.
However FDA refrains from regulating them under the FD&C Act, as they do pharma IT, other medical devices, drugs, etc. because they are a political "hot potato" - as at http://hcrenewal.blogspot.com/... , http://hcrenewal.blogspot.com/..., and http://hcrenewal.blogspot.com/... ).
As is customary at Healthcare Renewal, at those three posts are links to source, quoted in full context.
I've replied to so many irrationally exuberant commenters on this very blog, that I could have authored the reply above in my sleep.
Two points:
1. My reply and its links (and the source those links lead to) can and should be used as a "template" by clinicians to educate themselves, to reply to the health IT irrationally exuberant in their organizations, and to those in government prematurely pushing this technology onto clinicians;
2. The health IT irrationally exuberant, being irrational, ill-informed, and often markedly resistant to education, need to be removed from healthcare entirely. Their cavalier attitudes about cybernetic medical experiments are dangerous, and have no place in medical affairs. Such people impede, rather then help remediate the quality, safety, usability, and efficacy of health IT. In doing so, they contribute to increased risk and to actual patient harm. The irrationally exuberant are part of the problem, not part of the solution.
-- SS
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