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Information Technology Makes Healthcare Easier? Is This Industry Trying to Harm Patients? Part 6 of a Series

(Note: Part 1 of this series is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-idiots-part-1.html">here</a>, part 2 is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and.html">here</a>, part 3 is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and_24.html">here</a>, part 4 is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and_26.html">here</a>, part 5 is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and_27.html">here</a>, part 6 is <a href="http://hcrenewal.blogspot.com/2009/02/it-makes-healthcare-easier-is-this.html">here</a>, part 7 is <a href="http://hcrenewal.blogspot.com/2009/03/information-technology-makes-healthcare.html">here</a>, and part 8 is <a href="http://hcrenewal.blogspot.com/2009/03/malpractices-of-multitudes-mission.html">here</a>. 2011 addendums: a post that can be considered part 9 is <a href="http://hcrenewal.blogspot.com/2011/04/special-k-red-berries-mission-hostile.html">here</a>, part 10 is <a href="http://hcrenewal.blogspot.com/2011/12/ehr-mission-hostile-user-experience.html">here</a>.)  This post is part 6 of a series on the stunningly poor human engineering of production healthcare IT from major vendors, in use today at major medical centers. These devices provide a decidedly mission hostile user experience, yet with an almost religious fervor are being touted as cybernetic miracles to cure healthcare's ills. During the Sunday morning talk show "Roundtable" this morning, I saw an <a href="http://www-03.ibm.com/press/us/en/pressrelease/24405.wss">IBM ad touting the fact that they'd surpassed the petaflop mark</a> (built computers that can perform one thousand trillion floating point calculations per second). They touted how such computers will enable weather prediction, medical advances, solutions to social problems, and other cybernetic miracles. (Some of these miracles have been promised since the days of <a href="http://en.wikipedia.org/wiki/ENIAC">ENIAC</a> in the late 1940's.) Now, I am indeed amazed by such machines, and realize their value when utilized by competent domain experts overseeing equally competent analysts and programmers, ideally along with HCI (human computer interaction) experts who can help humans interact effectively with such computational high performance. One would think, though, in a culture where we can perform one thousand trillion calculations per second on large machines, and where consumer machines can perform pretty fast as well that we could do better in the human interface to healthcare IT: <blockquote style="font-family: arial;">As of 2008, the fastest PC <a href="http://en.wikipedia.org/wiki/Microprocessor" title="Microprocessor">processors</a> (quad-core) perform over 37 GFLOPS (Intel QX9775)<a href="http://en.wikipedia.org/wiki/FLOPS#cite_note-15" title=""></a> [that's 37 billion calculations per second - ed.] <a href="http://en.wikipedia.org/wiki/Graphics_processing_unit" title="Graphics processing unit">GPUs</a> in are considerably more powerful, for example, in the <a href="http://en.wikipedia.org/wiki/GeForce_8_Series" title="GeForce 8 Series">GeForce 8 Series</a> the nVidia 8800 Ultra performs around 576 GFLOPS on 128 processing elements ... There are now graphics cards such as the ATi Radeon HD 4870X2 which can run at over 2.4 TeraFLOPS [2.4 trillion calculations per second - ed.]</blockquote> Amazing. I used to support applications running on IBM <a href="http://en.wikipedia.org/wiki/PSeries">POWER</a>-based supercomputers far slower than 1000 trillion FLOPS for drug discovery at Merck, and chatted with those who used these supercomputers in molecular modeling, critical to drug discovery. Today's computing advances are indeed remarkable just a few years later. Here is where my disappointment arises. Health IT seems to be back in the <a href="http://en.wikipedia.org/wiki/TRS-80">TRS-80</a> days in terms of its failure to utilize these levels of computing power to create a mission friendly user experience and safer medical care. <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh3iYkQGuuf2x-7_cRR86BqI9620S4bzH4nRdfw8pkp2JNCdN3t2vcbgN17AR_j6Pnmk_JA4izcj8qYrPjS4DPHyW95nAJPTFS-gzqnXbExtDC3sQhlQQcBhaucYU8a4YagJeIbeTA2DBYC/s1600-h/trs80.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5308372357322955250" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh3iYkQGuuf2x-7_cRR86BqI9620S4bzH4nRdfw8pkp2JNCdN3t2vcbgN17AR_j6Pnmk_JA4izcj8qYrPjS4DPHyW95nAJPTFS-gzqnXbExtDC3sQhlQQcBhaucYU8a4YagJeIbeTA2DBYC/s320/trs80.jpg" style="cursor: pointer; display: block; height: 210px; margin: 0px auto 10px; text-align: center; width: 320px;" /></a>HIT user experience: trapped in the TRS-80 era?</div> Below is how a major healthcare IT system forces a user to do even a simple task, changing the starting date and time for a common medication.Let's count the steps required for what used to require one step: putting the instrument below to paper. <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiFXj4eVehB764m3ljNBTp3jE-6CxZlw6icBExGfzijZWgtPVJBUvohT404nBN9eDMyBY3qQOlH9qkDLVC2m5imQF9CFSdVFw4MxVA_ir4PKFjt6z-Jk_DcCEGV-6tlg5ZTOX190LD3Xs-W/s1600-h/pen.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5308281877911815090" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiFXj4eVehB764m3ljNBTp3jE-6CxZlw6icBExGfzijZWgtPVJBUvohT404nBN9eDMyBY3qQOlH9qkDLVC2m5imQF9CFSdVFw4MxVA_ir4PKFjt6z-Jk_DcCEGV-6tlg5ZTOX190LD3Xs-W/s320/pen.jpg" style="cursor: pointer; display: block; height: 153px; margin: 0px auto 10px; text-align: center; width: 225px;" /></a> Keep in mind, health IT is touted as improving the quality of healthcare, reducing errors, and reducing costs. Step one in the world of HIT (a world, as I said, of MIS-inspired inventory systems, not clinical tools for use by clinicians) involves hunting for, and then clicking "frequency" on a scrolling list of possible "order details", seen on the left of the screen below: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg01arsCdU_N-N0lKZkvqOwmppPc-5_m7V9qrMjL23NTQb1kqKIFC_WQGaxV71I20SR5_nRRSa45c2q-Ldm9JJHwRnlgwJvkQMWVM91gsMhGvE_CrTPIE9HU3dmnJ_qlvaW9kUFD0cfBalf/s1600-h/figure1.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5308029627092402370" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg01arsCdU_N-N0lKZkvqOwmppPc-5_m7V9qrMjL23NTQb1kqKIFC_WQGaxV71I20SR5_nRRSa45c2q-Ldm9JJHwRnlgwJvkQMWVM91gsMhGvE_CrTPIE9HU3dmnJ_qlvaW9kUFD0cfBalf/s320/figure1.jpg" style="cursor: pointer; display: block; height: 222px; margin: 0px auto 10px; text-align: center; width: 374px;" /></a>(click to enlarge)</div> The user then clicks on the "ellipsis button" at upper right, which produces a popup to display the "standard times" for B.I.D. (twice a day) meds: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhZa4XLjfFVR0leddg-h8vMJX1mU-APtEqUjDRJwBcukMNXdCHyNXkpMwHI5TQoFkeeV0HDN1Ep2f-nzmXVCE1O4Q9L9CmgFdx4HHmUmgZ6gIz6NTQjQ8qMIjWpiygyXusuvralV1-SFoWe/s1600-h/figure2.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5308029627188284594" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhZa4XLjfFVR0leddg-h8vMJX1mU-APtEqUjDRJwBcukMNXdCHyNXkpMwHI5TQoFkeeV0HDN1Ep2f-nzmXVCE1O4Q9L9CmgFdx4HHmUmgZ6gIz6NTQjQ8qMIjWpiygyXusuvralV1-SFoWe/s320/figure2.jpg" style="cursor: pointer; display: block; height: 225px; margin: 0px auto 10px; text-align: center; width: 374px;" /></a>(click to enlarge)</div> On the popup subscreen is a list of "standard medication adminstration times" or SMAT's. Here the BID times are shown as 0900 and 2100 (9 AM and 9 PM). To override these times, more screens, more clicks and more work is needed. The user must click on a "requested start date and time," which has defaulted by programmer edict to the CURRENT data and time. The user is warned in the "User Guide" about how to perform this function as follows- <blockquote style="font-family: arial;">CAUTION: If you do not change the [default] requested start data and time, the first dose will be scheduled for the current date and time.</blockquote> The "current time" here being 11:28 AM as on left: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgvlkfNul56B1G0YuqcjcdsVJUYoQLViYi36QjsqxsvPUz_Lg01hvfOiuxtSyRwRI_NP9wiqrI8eJc7zvisJqYy4Efv_IyTLnxIF_sZ7f1yOOW1oFT8eKSDC0iriDKYvtOofVw5p64EP1eL/s1600-h/figure3.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5308029628468691810" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgvlkfNul56B1G0YuqcjcdsVJUYoQLViYi36QjsqxsvPUz_Lg01hvfOiuxtSyRwRI_NP9wiqrI8eJc7zvisJqYy4Efv_IyTLnxIF_sZ7f1yOOW1oFT8eKSDC0iriDKYvtOofVw5p64EP1eL/s320/figure3.jpg" style="cursor: pointer; display: block; height: 248px; margin: 0px auto 10px; text-align: center; width: 380px;" /></a>(click to enlarge)</div> Fantastic. The user must then change the requested start data and time to match the SMAT (standard medication administration time) for the first dose. Say they want the first dose to be given at 2100 (9 PM) tonight. In the screen below, the user changed this to 6/5/2006 at 2100 (9 PM) to match the SMAT time. The first dose is to be given at 2100 (9 PM) on the current night. <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgQfrjbyMJ6kb3YgoeKwqA0WO4_F-jdSTMUmKZ0txLa1U65OptDzStPRzToCseARboEnud4PpqVmCfstKa5HZta4DxMdAl6nZG3BshhHGIHNP5un6t6hHJI0_7aVMZQ3kAlMbMPRP51zQmH/s1600-h/figure4.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5308029630499616658" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgQfrjbyMJ6kb3YgoeKwqA0WO4_F-jdSTMUmKZ0txLa1U65OptDzStPRzToCseARboEnud4PpqVmCfstKa5HZta4DxMdAl6nZG3BshhHGIHNP5un6t6hHJI0_7aVMZQ3kAlMbMPRP51zQmH/s320/figure4.jpg" style="cursor: pointer; display: block; height: 182px; margin: 0px auto 10px; text-align: center; width: 350px;" /></a>(click to enlarge)</div> But they're not done yet! After signing the order, the clinician making the change (often a nurse) will need to click the eMAR (Electronic Medication Administration Record) tab. They must verify something called the "eMAR time frame setting" to be certain that this "time frame" is set for something called the "clinical range." See below: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjSc_pFbe3x2tEOSi4PUnW-HJdwjgknrtbsUhwzjpuCSe4LS71OnAdJbvhFLWNskvyeI1INugJm3T_hqNMpiSxsHY7a84Sfr-l1dMz1aAouRqsBJRy6TeQuRm47KeoXeojw4sBRM-mXSyef/s1600-h/figure5.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5308029629886659842" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjSc_pFbe3x2tEOSi4PUnW-HJdwjgknrtbsUhwzjpuCSe4LS71OnAdJbvhFLWNskvyeI1INugJm3T_hqNMpiSxsHY7a84Sfr-l1dMz1aAouRqsBJRy6TeQuRm47KeoXeojw4sBRM-mXSyef/s320/figure5.jpg" style="cursor: pointer; display: block; height: 60px; margin: 0px auto 10px; text-align: center; width: 344px;" /></a>(click to enlarge)</div> This act comes with a warning in the instruction manual: <blockquote style="font-family: arial;">CAUTION: Never limit the eMAR to your shift or to today only. Limiting your view of the eMAR may cause you to inadvertently create medication errors. (!) </blockquote>Inadvertently create medication errors? Really? Should be easy to fix with machines capable of trillions of calculations per second, no? No. The user is advised that if the eMAR timeframe is not set to "Clinical Range", all they need do is: Close the patient's chart, and log out of the health IT application. When you log on next time, the time frame will default to Clinical Range. Simple, no? Something we all want our doctors and nurses to be doing day in, day out for just this one simple function, no? Who designed such an interface? What kind of user experience is this, exactly? One designed to make clinical work easier? Perhap the HIT designers might seek a brain transplant or some other procedure to restore brain function, and then utilize the amazing computational power of modern IT and the advances in biomedical informatics, computational lingustics, parsers (used in building computer program compilers), etc. to allow a user to type in a command with an easily learned syntax such as: <blockquote style="color: red; font-family: arial;">> change Amoxicillin bid 0900 2100 start 06/05/2006</blockquote> and have the computer popup a verification window that asks: <blockquote face="arial"> Are you sure you want to change Amoxicillin to twice daily, 0900 and 2100 (9 AM and 9PM), starting Monday June 5 (Yes/no)? </blockquote>Or are such undergraduate level computer science feats beyond what's "a good business case" for the HIT vendors, thereby banking on the cognitive diligence of healthcare providers to make up for HIT stupidities? Are these vendors aware of fifty+ years of computer science, information science, biomedical informatics, HCI and other research? Who, exactly, is creating, testing and approving the clinician user experiences I am illustrating? Clinicians as technophobes when we're talking about poor IT such as presented in this series? My a**. In part 7 and on we shall start to see the "peek a boo, wild goose chase, go find your lab data" screens I've mentioned. -- SS

Information Technology Makes Healthcare Easier? Is This Industry Trying to Harm Patients? Part 6 of a Series

(Note: Part 1 of this series is here , part 2 is here , part 3 is here , part 4 is here , part 5 is here , part 6 is here , part 7 is here ...

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"Buried Data," a "Smoke-and-Mirrors Job" and a "Positive Spin" on a "Cursed Study"

Documents produced on discovery and recently unsealed during litigation suggested how <a href="http://www.astrazeneca-us.com/">AstraZeneca</a> handled clinical research data in the marketing of its atypical anti-psychotic drug <a href="http://www.seroquel.com/">Seroquel </a>(quetiapine). As <a href="http://www.bloomberg.com/apps/news?pid=20601087&sid=aS_.NqzMArG8&refer=home">reported by Bloomberg</a>, <blockquote> AstraZeneca Plc 'buried' unfavorable studies on its antipsychotic drug Seroquel, according to an internal e-mail unsealed as part of litigation over the medicine. The drugmaker failed to publicize results of at least three clinical trials of Seroquel and engaged in 'cherry picking' of data from one of those studies for use in a presentation, an AstraZeneca official said in a December 1999 e-mail unsealed yesterday under an agreement between the company and lawyers for patients. The London-based company faces about 9,000 lawsuits claiming it failed to properly warn users that Seroquel can cause diabetes and other health problems. 'The larger issue is how we face the outside world when they begin to criticize us for suppressing data,' John Tumas, an AstraZeneca publications manager, told colleagues in the e-mail. One unsealed document showed AstraZeneca officials considered Trial 15, one of the studies Tumas described as 'buried,' to be a problem because it didn’t produce favorable results on the issue of weight gain for patients taking the drug. Gaining weight can be a factor in the development of diabetes. Richard Lawrence, an AstraZeneca official, said in a February 1997 e-mail that the company had engaged in a 'great smoke-and-mirrors job' in dealing with U.S. and Canadian investigators on the trial’s results. 'Adopting the approach Don has outlined should minimize (and dare I venture to suggest) could put a positive spin (in terms of safety) on this cursed study,' Lawrence said in the e- mail. It isn’t clear from the e-mail which person Lawrence is referring to. In his December 1999 e-mail, Tumas said that AstraZeneca had 'buried trials 15, 31, 56,' and was considering a study listed as COSTAR. Details of the trials weren’t specified in the e-mail. Tumas chastised colleagues for using favorable data produced by Trial 15 without disclosing the full study results, according to his unsealed e-mail. 'There has been a precedent set regarding ‘cherry picking’ of data,' which was used in “the recent Velligan presentations,' he said. 'Thus far, I am not aware of any repercussions regarding interest in the unreported data.' The publications manager indicated that AstraZeneca had a favorable reputation for engaging in 'ethical behavior' when it came to disclosing study results on its drugs. 'We must decide if we wish to continue to enjoy this distinction,' Tumas wrote. 'The reporting of the COSTAR results will not be easy,' he added. 'We must find a way to diminish the negative findings. But, in my opinion, we cannot hide them.' </blockquote> So here we have more evidence about a big pharmaceutical company suppressing and manipulating data from the clinical research when its results proved unfavorable to its product. The unsealed evidence, when added to many other cases we have discussed, suggest that manipulation and suppression of clinical research data to support companies' vested interests is a common practice by commercial health care firms, including but not restricted to pharmaceutical, biotechnology, and device companies. As we have said before, suppression and manipulation of research amounts to post-hoc abuse of research subjects who volunteered their participation believing that it would advance science and health care. Furthermore, suppression and manipulation of research can deceive physicians into prescribing tests and treatments that will fail to help, or even harm patients, and deceive patients into thinking that they are getting the best possible tests and treatments, when, again what they are getting is ineffective or even harmful. In my humble opinion, there is an increasingly strong argument that clinical research should not be controlled, and probably should not be done at all by organizations with vested interests in the research producing results favorable to their products. See additional comments about the Seroquel litigation on the Clinical Psychology and Psychiatry blog <a href="http://clinpsyc.blogspot.com/2009/02/seroquel-becomes-zyprexa-part-2-but.html">here</a>, and the Carlat Psychiatry Blog <a href="http://carlatpsychiatry.blogspot.com/2009/02/of-seroquel-sex-and-secret-documents.html">here</a>. ADDENDUM (2 March, 2009) - See detailed comments on the apparent manipulation of a meta-analysis of Seroquel versus a "typical" anti-psychotic, haloperidol, <a href="http://clinpsyc.blogspot.com/2009/03/internal-documents-suggest-that.html">on the Clinical Psychology and Psychiatry Blog</a>.

"Buried Data," a "Smoke-and-Mirrors Job" and a "Positive Spin" on a "Cursed Study"

Documents produced on discovery and recently unsealed during litigation suggested how AstraZeneca handled clinical research data in the mar...

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A Call For Congressional Investigation Of The HIT Industry - Is This Industry Trying to Harm Patients? Part 5 of a Series

(Note: Part 1 of this series is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-idiots-part-1.html">here</a>, part 2 is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and.html">here</a>, part 3 is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and_24.html">here</a>, part 4 is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and_26.html">here</a>, part 5 is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and_27.html">here</a>, part 6 is <a href="http://hcrenewal.blogspot.com/2009/02/it-makes-healthcare-easier-is-this.html">here</a>, part 7 is <a href="http://hcrenewal.blogspot.com/2009/03/information-technology-makes-healthcare.html">here</a>, and part 8 is <a href="http://hcrenewal.blogspot.com/2009/03/malpractices-of-multitudes-mission.html">here</a>. 2011 addendums: a post that can be considered part 9 is <a href="http://hcrenewal.blogspot.com/2011/04/special-k-red-berries-mission-hostile.html">here</a>, part 10 is <a href="http://hcrenewal.blogspot.com/2011/12/ehr-mission-hostile-user-experience.html">here</a>.) In this installment of illustrating defects in today's contemporary health IT, I was going to present more sketches (since contractual clauses between HIT vendors and hospitals tend to forbid sharing of actual screens or defects) of the "let's play peek a boo" variety. I will present them in part 6 instead. These are screens in which clinicians must scroll extensively to, say, match an INR with a coumadin dose, FiO2 with oximetry result, match systolic with diastolic blood pressure, search around nearly empty screens to reveal a single value many rows down, enter a few common diagnoses via the "clickorrhea" of almost fifty clicks, and other patent absurdities from technology touted as "improving medicine." I am using part 5 to present another issue: A call for investigation of the HIT device industry, its development, marketing, talent management, contracting, QC, and information sharing practices on bugs and defects. I have now become aware of organizations with defects/clinician complaint lists for contemporary HIT including CPOE, EHR etc. amounting to well over a hundred pages in one case, and well over a thousand individual items in another, and numerous unquantified but relevant in-betweens. I recently also received this from a correspondent with expertise in user interaction design: <blockquote>A funny story [that is actually not funny at all - ed.] When I managed Operating room systems for a hospital the vendor was [major vendor, name redacted]. The UI was awful. Though the implementation had many problems (prior to my taking the job) circulating nurses were livid. Some actually filed a complaint with the state's department of health claiming the new system endangered patient safety. Alas, the "inspection" ruled it was not endangering patients. [I'm sure the inspectors had significant healthcare IT and informatics domain expertise. Well, no, actually - ed.] One day I was talking to a representative from [major vendor]. I mentioned their peculiar UI and the guy just didn't get it. He went on to tell me how a single programmer designed and developed the UI all by himself in about a month!!! He thought this was really impressive! I realized in horror, the UI we were seeing every day represented the limited mind of a single technology obsessed programmer who applied his sense of architecture and programming to the patient care routines of operating rooms all across the country. The electronic chart contained the same fields as old papers forms, but the forms took about 3 minutes to fill while the electronic version took 15 AND while that is somewhat acceptable for long cases [I'd say a doable waste of time, not "acceptable" -ed.], many cases are short, from 15 to 30 minutes and that with the new system the nurse had even less time to take care of the patient - their major responsibility.</blockquote> This is simply stunning. I might also add "frightening." The following comes from a person with interest in usability: <blockquote style="font-family: arial;">I am working at the [name redacted] University Hospital. I asked several [another major HIT vendor] reps about their screen design and why they do not implement better ones. They said there is not a business case to spend the money upfront to do a proper Information Architecture Plan.</blockquote> I other words, if this is true (and I believe it is from my own experiences with numerous vendors), an HIT company's profits override the issues of a mission hostile user experience and cognitive overload of clinicians. The "business case" means "their profit." Looked at another way, physicians and other clinicians' cognitive energies serve as a bank for HIT vendor deficiencies and unwillingness to develop an appropriate and acceptable user experience. How many patients and clinicians subject to these devices know about these issues? I am going to go out on a limb here, similar to 1998 when I became one of the first (to my knowledge) to publicly stick my neck out with what at that time was a controversial website on HIT failures. Its title was "Medical Informatics and leadership of clinical computing", now <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm" target="blank">here </a> under a new title. I had hoped that the HIT field's problems would diminish with the passage of time and with very direct exposure that all was not well. Instead, it appears the HIT industry and products have gotten worse. The existence of lists of a thousand+ HIT defects in major healthcare organizations, some resulting in clinician complaints about patient endangerment, and unshareable due to contractual gag clauses common in this industry, is simply intolerable. I am told many of these defects will likely never be fixed. I have only scratched the surface in reporting on these issues, being forced to do generic screen sketches, at my <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and_26.html" target="blank">series here </a>. There is no spin, no excuse, no dialog that can forgive such a situation. One must ask how products with thousands of defects could get into production. The existence of such lists is prima facie evidence that this industry is itself defective and that these devices are experimental - with clinicians and patients as unconsenting participants. Further, the shielding of the industry from liability on the "learned intermediary" basis is prima facie evidence of misuse of such laws. Even "learned clinicians" are being cognitively taxed and overloaded by these devices; they do not have unlimited cognitive capacity to deal with these defects. I believe this scenario is likely far worse than any practice I saw in pharma. It is becoming more clear to me and a number of my like minded colleagues that, as in pharma and the other medical device industries: <ul><li>A congressional investigation of the HIT industry's development, marketing, talent management, contracting, QC, and information sharing practices (on bugs, UI problems and other defects) is warranted; </li></ul><ul><li>These defect lists need to be public record so the public can evaluate whether their consent to be subjects of these devices is warranted;</li></ul><ul><li>Vendors should not be immune to liability for defects caused by cavalier IT development, testing and talent management practices; the article "Failure to Provide Clinicians Useful IT Systems: Opportunities to Leapfrog Current Technologies", Methods Inf Med 2008; 47: 4–7, by Ball et al. (PDF <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Why%20HIT%20has%20failed_Ball_2008.pdf">here</a>) spells out some of these issues;</li></ul><ul><li>A societal process needs to be set up in parallel to those other two biomedical industries, pharma and [physical] medical devices, of staged clinical trials, validation, and regulation of HIT [virtual] devices by impartial bodies with appropriate, unconflicted expertise on board. "Finding a Cure: The Case for Regulation And Oversight of Electronic Health Records Systems", Harvard Journal of Law & Technology 2008 vol. 22, No. 1, by Hoffman and Podgurski (PDF <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/regulation_and_oversight_hoffman.pdf">here</a>) presents a case for oversight;</li></ul><ul><li>The evaluation needs to go far beyond the CCHIT features and functionality check, an almost useless evaluation criteria in my mind, directly to usability and effectiveness. For a good summary of CCHIT's deficits see p. 132-134 (p. 30-32 of the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/regulation_and_oversight_hoffman.pdf">PDF</a>) in the Harvard Journal of Law & Technology article above. The major problem in HIT seems not absence of features, but a mission hostile user experience.</li></ul> From the latter Harvard Journal of Law & Technology article: <blockquote face="arial">The benefits of EHR systems will outweigh their risks only if these systems are developed and maintained with rigorous adherence to the best software engineering and medical informatics practices and if the various EHR systems can easily share information with each other. Regulatory intervention is needed to ensure that these goals are achieved. Once EHR systems are fully implemented, they become essential to proper patient care, and their failure is likely to endanger patient welfare.</blockquote> Indeed. Mine may sound like a radical position, but it is not. The existence of such secretive lists and lack of transparency is a highly significant problem. There is no other industry I know of that can push devices with hundreds or thousands of defects, some safety critical and others enhancing risk, onto the public, while preventing dissemination of defect lists. Imagine an aircraft industry where planes in the sky or air control devices have thousands of defects, some potentially leading to collisions or crashes. Pharma is being pushed to release negative trials results, for example. These issues need to be addressed in Washington before we dump $20 billion+ into a defective industry, instead of providing those funds for needed patient care of the poor and uninsured. -- SS

A Call For Congressional Investigation Of The HIT Industry - Is This Industry Trying to Harm Patients? Part 5 of a Series

( Note: Part 1 of this series is here , part 2 is here , part 3 is here , part 4 is here , part 5 is here , part 6 is here , part 7 ...

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Blogger connects to Google Friend Connect

When we introduced <a href="http://googleblog.blogspot.com/2008/09/follow-your-favorite-blogs.html">the Following feature for Blogger</a> last fall, we wanted to help you connect with fans of your own blog and discover communities of people who share your interests. It has been exciting to see Following grow over the past few months, to say the least. With nearly three million communities of followers on Blogger blogs, and with one person following a blog every second, we've been looking for ways to help these communities continue to thrive. As a first step toward that goal, today we are integrating the Blogger Following feature with <a href="http://www.google.com/friendconnect">Google Friend Connect</a>. Not only does this make it easier for anyone to follow a Blogger blog, but also it gives your blog expanded visibility across the web as your followers join other sites and share their activities with their friends. Blogger joins an open network of websites already using Friend Connect and visitors can now follow any Blogger blog by signing in with their Google, Yahoo, AOL, or OpenID credentials. The blogs that readers start to follow will appear alongside the other Friend Connect sites they've already joined. Additionally, you can find some new blogs and websites to join by checking out the profiles of other followers. This video shows you how to follow a blog: <object height="344" width="425"><param name="movie" value="http://www.youtube.com/v/s60ZgFnCTNs&hl=en&fs=1"><param name="allowFullScreen" value="true"><param name="allowscriptaccess" value="always"><embed src="http://www.youtube.com/v/s60ZgFnCTNs&hl=en&fs=1" type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" height="344" width="425"></embed></object> If you have a Blogger blog and you're already using the Followers gadget, you don't need to do anything to get these new features up and running — we've already migrated all of the existing Followers gadgets to the new version with Friend Connect. To learn more, visit our blog post on <a href="http://buzz.blogger.com/2009/02/friendconnect-grow-your-blogs-community.html">Blogger Buzz</a>. Posted by Mendel Chuang, Product Marketing Manager, Google Friend Connect

Blogger connects to Google Friend Connect

When we introduced the Following feature for Blogger last fall, we wanted to help you connect with fans of your own blog and discover commu...

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Are Health IT Designers, Testers and Purchasers Trying to Harm Patients? Part 4 of a Series

Are Health IT Designers, Testers and Purchasers Trying to Harm Patients? Part 4 of a Series

( Note: Part 1 of this series is here , part 2 is here , part 3 is here , part 4 is here , part 5 is here , part 6 is here , part 7 ...

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Translate between 41 languages with Google Translate

Google Translate recently added <a href="http://translate.google.com.tr/">Turkish</a>, <a href="http://translate.google.co.th/">Thai</a>, <a href="http://translate.google.hu/">Hungarian</a>, <a href="http://translate.google.ee/">Estonian</a>, <a href="http://translate.google.com/?hl=sq">Albanian</a>, <a href="http://translate.google.com.mt/">Maltese</a>, and <a href="http://translate.google.com/?hl=gl">Galician</a> to the mix. The rollout of these seven additional languages marks a new milestone: automatic translations between 41 languages (1,640 language pairs!). This means we can now translate between languages read by <a href="http://googleblog.blogspot.com/2008/07/hitting-40-languages.html">98% of Internet users</a>. In just a few years, the machine translation group within <a href="http://research.google.com/">Google Research</a> has taken its initial research system from two languages to 41 languages and is now handling millions of translation requests a day. For several languages, Google Translate is the first freely available machine translation system for these languages. Of course, there's always room for improvement, and we're working hard to improve translation quality. Our statistical models are built from vast quantities of monolingual and translated texts using automated machine learning techniques. It's exciting and satisfying to work on a product that can help people access content they may otherwise be unable to understand. We've heard stories of people using Google Translate to help them do business internationally, and we've seen many websites (e.g., New York's <a href="http://www.mta.info/">Metro Transit Authority</a>) and blogs add the <a href="http://translate.google.com/translate_tools?hl=en&sl=ur&tl=fr">Google Translate My Page Gadget</a> to their pages to make their content more accessible to people from all over the world. Whenever I personally travel, I do lots of research on the web to figure out what to see and do, and where to stay and eat. With Translate, I'm able to use the <a href="http://translate.google.com/translate_s?hl=en">cross-language search</a> feature to find and access the latest info (e.g., restaurant recommendations, most recent trains/bus schedules, special events, etc.), which is often only available in the local language. More importantly, Translate provides people who may not otherwise have a lot of web content available in their own language with access to the wealth of content on the truly worldwide web. Posted by Jeff Chin, Product Manager

Translate between 41 languages with Google Translate

Google Translate recently added Turkish , Thai , Hungarian , Estonian , Albanian , Maltese , and Galician to the mix. The rollout of these ...

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Three Troubled Device Companies: ArthroCare, Stryker, AM2PAT

It was quite a week in the medical device business. Arthrocare Last week we discussed the shenanigans at <a href="http://www.arthrocare.com/">ArthroCare</a> Corporation <a href="http://hcrenewal.blogspot.com/2009/02/another-troubled-device-company.html">here</a>. Since then, more information has come out about in the Austin Business Journal <a href="http://www.bizjournals.com/austin/stories/2009/02/16/daily26.html">provided more information </a>about these improper practices: <blockquote> While the internal review, being conducted with the assistance of outside counsel Latham & Watkins LLP, is not yet complete, the ArthroCare’s audit committee has reviewed evidence that indicates that the company’s spine unit engaged in and may have caused others to engage in improper practices in certain instances by: * seeking separate reimbursement from insurers for company products in connection with procedures which were contractually reimbursed on a global basis; * making inaccurate statements in claims submitted to insurers regarding the place where particular procedures were performed; * providing physicians and insurers with descriptions of company technologies which had the effect of circumventing payor policies that did not cover such technologies; * recommending and advocating to physicians the use of a Current Procedural Terminology code to identify its coblation nucleoplasty technology that was not approved by the American Medical Association and may have not properly described the procedure that was performed. These improper practices identified so far may have occurred since at least 2006. Investigators were informed that certain sales and marketing personnel within the spine unit provided physicians and their billing staff with merchandise and administrative services at no charge potentially in exchange for their utilization of the company’s products. The audit committee has determined that company personnel at all levels lacked adequate health care compliance training and that company billing personnel lacked adequate training and supervision in insurance reimbursement requirements. In addition to considering and implementing remediation efforts, the committee is undertaking a review of such practices in other business units. </blockquote> Stryker Meanwhile, the New York Times <a href="http://www.nytimes.com/2009/02/20/business/20bone.html">reported</a> about <a href="http://www.stryker.com/en-us/index.htm">Stryker</a>: <blockquote> A Justice Department inquiry into Stryker’s marketing of human bone growth products has resulted in guilty pleas by former company sales representatives. One former sales official pleaded guilty two weeks ago, and another one did in November, court documents show. Stryker, a leading maker of medical devices, and the United States attorney’s office in Boston, which is conducting the inquiry, declined to comment. A spokeswoman for the attorney’s office said the investigation was continuing. The inquiry, which began last year, involves several issues, according to court papers and Stryker filings with the Securities and Exchange Commission. The questions include whether Stryker abused a federal exemption that authorized it to sell only limited quantities of its bone growth products for 'humanitarian' reasons, according to the documents. The two former sales officials pleaded guilty to charges that they had promoted off-label use of the products even though they knew that such use had earlier caused problems in some patients. The products in question are used by surgeons to aid the growth of bones that fail to heal properly. </blockquote> This case is not the only one raising ethical questions about Stryker's management. <blockquote> The inquiry poses new complications for Stryker, which is already operating under federal oversight as a result of an earlier Justice Department investigation of kickbacks paid by makers of artificial hips and knees to doctors. </blockquote> We posted about this previous issue, first <a href="http://hcrenewal.blogspot.com/2007/10/stryker-biomet-depuy-orthopedics-zimmer.html">here</a>, most recently <a href="http://hcrenewal.blogspot.com/2008/06/more-multi-million-dollar-orthopods.html">here</a>. AM2PAT Last, but most assuredly not least, was a story, (<a href="http://www.newsday.com/services/newspaper/printedition/wednesday/health/ny-hssyri256048602feb25,0,1308141.story">here</a> reported by Newsday) about AM2PAT: <blockquote> Federal authorities are hunting the mastermind behind a 'horrific case' in which bacteria-laden syringes shipped from an Angier, N.C., plant sickened hundreds of people and killed five. Two men pleaded guilty Monday in U.S. District Court in Raleigh for their roles in ignoring sterility standards at the former AM2PAT Inc. plant. The court heard of conditions at the plant more consistent with a Third World textile factory than a pharmaceutical facility. The men - plant manager Aniruddha Patel and quality control director Ravindra Kumar Sharma - were each sentenced to 4 1/2 years in prison for fraud and allowing tainted drugs into the marketplace. They were rewarded with a relatively light sentence in exchange for information about chief executive Dushyant Patel, whose company sold $6.9 million worth of heparin and saline syringes in 2006-07 that did not undergo proper sterility testing. Dushyant Patel, indicted late last week on 10 charges that include fraud and selling adulterated medical devices, has not been arrested. Authorities think he may have fled to his homeland in India and are seeking help from Interpol. Syringes from AM2PAT were pulled from the market early last year, and the Angier plant shuttered after an outbreak of Serratia, a bacterial infection, hit patients in Colorado, Texas, Illinois, Florida and other states. On Monday, prosecutors laid out a scheme before Judge Terrence Boyle in which the plant's operators routinely failed to follow sterility rules to keep production running faster. The drugs were not produced at the plant, but were loaded into syringes there, then shipped. The plant was subject to U.S. Food and Drug Administration requirements for its production. The syringes were supposed to be loaded in a 'clean room,' with employees in caps and gowns and air carefully ventilated to keep germs from spreading. A photograph entered into evidence Monday shows a 'clean room' refreshed with a common window fan held together with duct tape. In another photo, women work on an assembly line under lamps, surrounded by what look like green plastic recycling bins. Once the syringes were loaded with drugs, each batch was required to be held for two weeks, while employees tested for bacteria and other contaminants. If bacteria were cultured from the medicines, the whole batch should have been held back. That wasn't happening, court documents show. Batches of syringes went straight from the production line into the marketplace, with Sharma falsifying manufacturing dates to make it appear to regulators that requisite quality tests had been done. And when tests were done, results were ignored. </blockquote> Note first that none of these cases was isolated, in that each of these companies had questions raised about management behavior before (at Arthrocare, about accounting; at Stryker, about marketing and payments to doctors; at AM2PAT, raised by health care professionals about quality of its products.) In the US, we are undergoing yet another great debate about health care reform. Two big issues are the high cost and questionable quality of our health care. All three of these cases involved behavior that could have raised costs. Two may have had indirect effects on quality. One may have directly caused patient death and disease. Yet, even after executive arrogance, misbehavior, self-interest, and corruption have lead to the global financial meltdown, we are still not really addressing such behavior as a cause of our global health care crisis.

Three Troubled Device Companies: ArthroCare, Stryker, AM2PAT

It was quite a week in the medical device business. Arthrocare Last week we discussed the shenanigans at ArthroCare Corporation here . Sinc...

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