My organization had to sue his company for non-working products a few years ago (link to PDF of civil complaint) .
Apparently other customers were unhappy as well. This from Reuters:
Allscripts shares plunge on weak outlook, board changes
Fri Apr 27, 2012 9:24am EDT
(Reuters) - Allscripts Healthcare Solutions Inc's shares plunged 42 percent in premarket trade on Friday, after the company forecast weak full-year earnings, hurt by software development costs and weaker bookings.
On Thursday, the healthcare information technology provider reported a lower-than-expected quarterly profit and also announced the resignation of its CFO, three directors and board Chairman Phil Pead.
Citigroup analyst George Hill said the results were strongly disappointing and downgraded the company's stock to "neutral" from "buy."
Hill said he was most troubled by the loss of long tenured CFO Bill Davis, who had been the public face of Allscripts to investors for many years.
"We suspect CEO Glen Tullman won a power struggle at the 11th hour leading to the board departures," Hill said.
"Too few customers are buying its products, due to lack of confidence or satisfaction," Barclays Capital analyst Lawrence Marsh wrote in a note.
Allscripts shares were trading at $9.27 in premarket trade. They had closed at $16.02 Thursday on the Nasdaq.
(Reporting by Shailesh Kuber in Bangalore; Editing by Joyjeet Das)
The statement 'too few customers are buying its products, due to lack of confidence or satisfaction', speaks volumes about the state of health IT in general in 2012.
That state includes eventual regulation after an IOM report on dubious safety, mission hostile user interfaces as identified by NIST and others that will require expensive remediation (due to the industry arrogantly ignoring this crucial issue for decades), 'glitches' due to poor or non-existent validation and quality control that will increasingly result in expensive litigation when patients are harmed, likely government investigations and clawbacks due to EHR-promoted upcoding, and an increasing awareness that many of the so-called miracle 'revolutionary' gains (as opposed to facilitation of medical practice) are largely illusory industry-promoted memes not based on robust, scientifically-generated evidence.
I'd pull out of this market - if I had any money invested in it. I have none, and never have, because I have great lack of confidence in the industry that began when I was first exposed to it and its leaders - that being in 1992.
I note that the HITECH component of ARRA, containing incentives and penalties related to health care information technology designed to accelerate the adoption of EHR systems, was advanced largely via advice to the President on the wonders of health IT. (I thought HITECH was a reckless, premature move destined to waste billions of dollars as did the erstwhile NPfIT in the NHS, and I still stand by that prediction.)
-- SS
4/27/12 Addendum:
EHR glitches like this and this never seem to affect patients...
-- SS
22 comments:
So Scott. How do you explain Epic's adding of new customers basically every week. Do you think their user interface modern and superb and easily accepted by all doctors? You are confusing one company's problems putting together the vendors it acquired with the overall logic of the ARRA stimulus. And if you dont think EMRs do any good here, try to explain why they work in Denmark?
You have a lot to contribute and I agree with many of your points, but I have never seen you advocate what the solution is--other than stop using what we have until something better magically comes along. How is that going to happen until we get general EMR use and then improve on it?
Matthew Holt writes:
I have never seen you advocate what the solution is--other than stop using what we have until something better magically comes along
Matthew,
Actually, I opine that you mistake the attitude of the industry for mine. An industry extant for decades that only now in 2011/2 starts to - and I emphasize starts to - get serious (under some duress) about safety, usability, quality, etc. is one that seems to believe health IT with magically achieve those goals.
I've made recommendations over the years towards "doing health IT well" up to and including recommending entire textbooks for the industry to master. (Also, pointing out how health IT has been "done poorly" itself is itself of great value to people with vision.)
I leave it to you to find my references -- as it's really irrelevant at this point. The IOM, NIST, Joint Commission, National Academies, ECRI Institute, NHS, and even a major med mal insurer have now chimed in on how not to do health IT poorly - and on how to do health IT right.
I cannot verify EPIC's customer base motivations and ROI, and more importantly, the user's reactions about the software, any "glitches", medical errors, or deaths that occurred as a result of, or contributed to, by the software. I can 't even look at bug reports in FDA MAUDE as I can, say, for Cerner clinical IT products. Surely EPIC has similar issues.
With such an information blackout,I cannot say anything other than the industry needs more transparency before it rolls out any product nationally, and EPIC is no different as any other under the lack of transparency.
As far as Denmark, the U.S. is not Denmark. HIT must be designed, developed, and implemented with social context in mind. Per the NYT: "Denmark’s success has much to do with the its small size, its homogeneous population and its regulated health care system — on all counts, very different from the United States."
What *does* work here is the question, and we are not on a very fast or efficient track to get there.
I note the ARRA "logic" if one can call it that was predictated on an assumption that health IT was ready for national rollout, and that we knew how to accomplish national rollout without wasting tens or hundreds of billions of dollars; or on a cavalier attitude if those responsible knew it wasn't ready. As I wrote, the decision was, IMO, highly premature.
Finally, I come back to ethical issues. How can incidents like this one in Rhode Island, potentially endangering thousands of patients, be considered so casually in terms of rolling out HIT nationally in the timeframes sought? That level of error is not possible without IT.
(continued below due to length)
(continued from above due to length)
How can massive security breaches, made possible only by IT, be met with such indifferent "oh well, stuff happens" attitudes?
Why does HIT receive such remarkable ethical special accommodation with respect to other technologies in medicine?
How is that going to happen until we get general EMR use and then improve on it?
Matthew, before I answer, I will state that what you suggest is not consistent with medical ethics as they are generally understood, even by our own government (see NIH and historical ethics guidelines here). It is what I call a "cart before the horse" approach not suitable for human subjects research.
My answer is: it should happen the same way it "happened" with drugs and other medical devices, at least since the FD&C Act was passed in the 1930's after the death of more than 100 patients due to the sulfanilamide/glycol debacle; the thalidomide debacle; the Tuskegee syphilis experiment, etc.
That is how it should have happened/be happening.
-- SS
Note:
On the FD&C Act's passage:
http://en.wikipedia.org/wiki/Elixir_sulfanilamide
Elixir sulfanilamide was an improperly prepared sulfanilamide medicine that caused mass poisoning in the United States in 1937. It caused the deaths of more than 100 people. The public outcry caused by this incident and other similar disasters led to the passing of the 1938 Federal Food, Drug, and Cosmetic Act
Holt states: "How is that going to happen until we get general EMR use and then improve on it?"
I am disappointed that someone of Holt's intellect is as naive and calloused as his statement demonstrates.
The statement advocates an unregulated experiment using the patients, doctors and nurses as guinea pigs to "improve on it" ultimately enriching the vendors as the unwitting and defenseless patients are killed and maimed for life by the toxicities of the EHR and CPOE devices Holt defends.
Holt has put the cart before the horse, as most vendor advocate zealots do.
The market waited too long to bring down Glen's company's stock price. The dangers of its devices have been well known for years, but no one was listening.
I would like to hear what he has to say to POTUS and the Congress now.
Keep writing just as you have been, Scot.
Title:
The gap between actual and mandated use of an electronic medication record three years after deployment
Author(s): Granlien, Maren Fich; Hertzum, Morten; Gudmundsen, Jette
Proceedings/Book: eHealth Beyond the Horizon - Get IT There (2008)
Pages:419-424
PMID:18487767
Abstract
Three years after the hospitals in one of Denmark’s five healthcare regions deployed an electronic medication record (EMR) four of eight main system facilities are used consistently by only 3%-37% of the hospital wards. Furthermore, four of eight mandated work procedures involving the EMR are followed consistently by only 13%-28% of wards. No system facility or work procedure is consistently adopted by more than 67%, respectively 48%, of wards. Barriers to adoption of the EMR include system factors, such as the EMR being perceived as prohibitively time consuming to use, as well as human factors, such as lack of knowledge, information, and training among clinicians. However, the prime barrier appears to be uncertainty about what the barriers concretely are and about the extent to which system facilities and work procedures are actually adopted. Three years after deployment it is apparent that time alone does not lead to consistent adoption. Rather, interventions are necessary to overcome the barriers.
http://www.wpi.edu/Pubs/E-project/Available/E-project-051010-054949/unrestricted/Danish_Health_IT_Project_Final_Report.pdf
Privacy of medical information is a low priority in Denmark due to the generally trusting mindset of Danish society. Most Danes trust that the government protects their privacy and are unaware of personal data collection and access. Danes can also find it difficult to use privacy technology, discouraging its use. Currently, Denmark works on a terms-of-use, “trust” system that leaves the door open for data to be compromised. Any doctors can access any patient’s data, and access is logged by the system and audited for illegal activity. However, only 1-10% of the logs are reviewed, creating large privacy risks for patients.
-----------
Each of Denmark’s regions is responsible for creating an EHR system or interoperability solution for hospitals within that region. The primary solution for nation-wide EHR is currently sundhed.dk, the eHealth portal. Healthcare providers can use the portal to gain access to patient data, but this solution is not directly interoperable with region-wide systems and only provides limited data. Multiple organizations in Denmark are working on developing better interoperability solutions across the country.
Health data standards are critical in making systems interoperable. Most organizations agree that Danish standards are not strict enough in how they can actually be implemented in systems, resulting in poor interoperability between systems. The lack of acceptable standards means that large vendors in Denmark tend ignore standards, so that when hospitals buy their systems, they are “locked in” to that vendor and cannot use solutions from other vendors.
Danish laws on healthcare can be confusing for healthcare providers. Many different groups disagree on whether or not the current legislation for health IT is adequate. Conflicting laws on health and laws on service can simultaneously apply to the healthcare industry, raising a question of which law to follow during what times. There are also no organizations that help system vendors implement patient privacy according to legal regulations.
Matthew's question: "How do you explain Epic's adding of new customers basically every week. ??"
The users I know call it the cream of the crap. Care processes are disrupted, patients are neglected, but ther is a benefit: upcoding is easy with beautiful 6 page progress notes obfuscating the key points of care.
Scott--
2 points. 1) you said it was Allscripts unhappy customers proving that we should be throwing ARRA $$ at EMRs. You know and I know that Epic has just as many detractors and probably as many UI problems as the others, but it's been very successful and was before ARRA. (And yes I agree with you on the no-talk contracts and lack of open bug reporting)
@) (and this is more important) While we might love to have a Danish system what we have in place is going to determine the IT we put in. I am all for you, Ross Kopell and even Deb Peel (Lord help me--did I really write that?) holding the systems and industry;s feet to teh fire on how to do EMRs better. But the not-too-casual reader (e.g. me) having read your posts here over the years would conclude that we were better off sticking with paper. You should see Paul Levy's great article here as to why the EMR with all its flaws is better than that option. And going back to paper is not the equivalent of putting in the FDA for IT, it's the equivalent of stopping the use of all drugs
So really this comes down to marketing. If you dont think we should just go back to paper, you should create a little set of bullet points or paragraph of what we should do instead and run it in every article.
Matthew Holt writes:
"So really this comes down to marketing. If you dont think we should just go back to paper, you should create a little set of bullet points or paragraph of what we should do instead and run it in every article."
Matthew,
Thank you for the interesting suggestion.
It shall receive all the consideration it is due.
-- SS
Anonymous April 27, 2012 9:37:00 PM EDT said...
I am disappointed that someone of Holt's intellect is as naive and calloused as his statement demonstrates. The statement advocates an unregulated experiment using the patients, doctors and nurses as guinea pigs to "improve on it"
You you must break a few eggs to make an omelet.
Here's one such broken egg: link.
-- SS
Anonymous April 28, 2012 9:40:00 AM EDT said...
"How do you explain Epic's adding of new customers basically every week. ??" The users I know call it the cream of the crap.
Again, under a cloak of secrecy that exists in this healthcare sector, it is uncertain what is really going on.
Anyone who advocates health IT rollout nationally in the near time frame, under conditions of impaired information flow (e.g., as per IOM below), is reckless IMO.
-----------------
... 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.
[From 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.]
Holt said: "You should see Paul Levy's great article here as to why the EMR with all its flaws is better than that option."
Uhh, I do not think so. All I need are lab data, a user friendly MAR, and images at hand to write constructive progress notes and orders. The viewing of contemporaneous entries benefits of paper can not be equaled by EHR and CPOE devices.
What is "great" about Paul Levy's article, or the author himself, exactly?
Levy never had to use the the user unfriendly, time wasting, error promoting, patient endangering devices. He, just like so many of the HIT zealots and ddulites, pontificate about HIT benefits never having used it to manage the care of multiple critically ill patients, nor has he been the defendant in a med mal case due to neglect facilitated by the CPOE device.
Is not Levy the same guy at BIDMC who had some probity problems with an employee he hired?
Anonymous of 28 April, 3:41 PM -
Your last sentence implies an ad hominem fallacy.
Whether or not he did have "probity problems," which I don't think is settled, they would not have had an effect on the correctness or applicability of his arguments.
Good point, Dr. Poses. However, the point I raise in context to the comment relates to judgment, not correctness or applicability.
Re: Anonymous April 28, 2012 3:41:00 PM EDT
1. I agree with Roy Poses' comment above. let's leave out ad hominem (attacks against the person) and stick with ideas.
2. Re: "You should see Paul Levy's great article here as to why the EMR with all its flaws is better than that option."
As I've repeatedly written, and as the IOM recently wrote (and the FDA, JC, and others before), there is a relative 'blackout' on diffusion of information regarding the drawbacks of health IT, for numerous reasons. The literature is also conflicting on benefits.
We therefore cannot, in 2012, truly know what is "better." We hope the IT is better, but cannot say for sure if it is, yet, in its present form and environment. Anyone who comes up with reasons otherwise is speculating. Speculation is fine, but is not a basis for setting local, regional or national healthcare policy.
Those who simply ignore this crucial point about lack of data/conflicting data demonstrate flawed critical thinking skills.
What is needed is industry transparency, controlled clinical trials and comparative effectiveness research (e.g., of one EHR product vs. another), evidence-based IT change and evolution, and the other accouterments of responsible human subjects-based medical research known for many decades.
That is the only ethical way to "get health IT right."
-- SS
Re: "The gap between actual and mandated use of an electronic medication record three years after deployment" and http://www.wpi.edu/Pubs/E-project/Available/E-project-051010-054949/unrestricted/Danish_Health_IT_Project_Final_Report.pdf @ April 28, 2012 8:56:00 AM EDT:
The situation with HIT in Denmark and other Scandinavian countries is far from utopian.
In fact, it's ironic Scandinavia was brought up as a benchmark, for the Swedish Medical Products Agency - as reported on this blog - that issued a release "Improving patient safety in the EU: Many Medical Information Systems should be classified as Medical Devices" and a report "The Medical Products Agency’s Working Group on Medical Information Systems: Project summary" (PDF).
They note:
An increasing number of serious incidents, with IT-systems involved, have been reported from the health care sector in recent years [but largely covered up in part due to contractual gag clauses on HIT sales and resultant violations of healthcare leadership fiduciary responsibilities - see this link - ed.] In most of these cases, existing regulatory regimes have not been applied, either by manufacturers or by health care providers. As a result, the assessment of safety issues has become unclear because the manufacturer’s responsibility is vague.
In the latter report, the SMPA working group on HIT writes:
"The Working group believes that software intended for a medical purpose must be regarded as a
"device" and expressions such as "project", "service" and similar must be avoided describing a
Medical Information System. This approach has advantages since a product safety regulation, such as
the Medical Device directives, can be applied and the product will have:
- a defined intended use
- defined and documented specifications
- a manufacturer with a clear responsibility until the delivery is accepted
- a controlled ”Post Market” surveillance"
In other words, their recommendations regarding the health IT industry parallel mine with respect to regulation, accountability, and a belief that these are medical devices that, due to serious IT-related incidents of unknown magnitude, should be subject to the same scrutiny, transparency and accountability as any device-mediated human subjects research.
These issues are axiomatic, and so is how to find material on the issues in the age of the Internet.
Healthcare and health IT amateurs (used in the sense that I am a radio amateur) seem to take the condescending view of our readership (not just here, but elsewhere in the past including on this blog) that, because I am former Yale faculty in Medical Informatics, ran a science library for what was once the most respected multinational pharmaceutical research lab in the world, etc., these things are not obvious to the 'hoi polloi' who read this blog. Therefore every post of mine should be accompanied by a policy statement on how health IT should be done, lest the hoi polloi think I recommend paper for all time.
I, however, have more respect for our readership.
-- SS
I have used these devices of several main stream vendors on real live (some are now dead) patients, including the vendor featured above.
Dr. Silverstein is spot on in his comments and ideas.
It is insanity that doctors are being directed by non doctors to use medical devices that do not have a proven safety record.
M. Holt is an example of an industry pundit non physician who trumpets that message as if it were a bumper sticker.
Since he has never used the devices he espouses, it would appear that he is out of his league with such comments. He simply does not have the experience or expertise for his comments to doctor users to be meaningful.
Additionally, is he so critical of Dr. Silverstein because he is jealous of Dr. Silverstein's expertise, credentials, breath of knowledge and creativity?
Just wondering.
It is insanity here with meaningfully dangerous devices.
Bullet points for Matthew to consider to improve the sad lot of today's HIT systems:
Require IRB monitoring of the experiment.
Require informed consent, including risk of unexpected death.
Require informed consent for doctors who use the device and provide feedback to the vendors.
Require informed consent for nurses.
Publish a deinsentified list of all adverse events and near misses.
Publish screen shots of those that are user unfriendly and deceptive.
Publish the durations of delays in care.
Publish the downtime and crashes of any duration.
Publish the qualifications of those making decisions on purchasing and implementation.
Publish the contractiual obligations of the hospitals.
Protect doctors and nurses who complain and report from retaliation and sham peer review.
There are others for Matthew . These are a good start for someone who is concerned but never used the systems.
Anonymous April 29, 2012 1:03:00 PM EDT said...
He simply does not have the experience or expertise for his comments to doctor users to be meaningful.
I cannot comment regarding Mr. Holt specifically, but I do opine that I'm tired of being patronized on health IT by non-clinicians and those lacking formal graduate or post-doctoral education in the domain.
Therefore I've decided to bring my expertise to an environment where those without legitimate experience are generally banned - the courtroom - or where they will rapidly be exposed by attorneys under my advisement as not really knowing what they're talking about.
-- SS
Oh, and Anonymous April 29, 2012 1:03:00 PM EDT, thanks for the compliment.
-- SS
Anonymous April 29, 2012 4:11:00 PM EDT said:
These are a good start for someone who is concerned but never used the systems.
Recommendations I wrote in 1999 are still online here, and (tragically) are still relevant.
-- SS
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