healthy4u: Washington Post

How an interview for Kaiser Health News rekindled memories of health IT dysfunction in the 90's that persist in the 10's

I was interviewed in my home yesterday by Jay Hancock, Senior Correspondent, <a href="http://www.kaiserhealthnews.org/About.aspx" target="_blank">Kaiser Health News</a> about my background, how I got to the current point in my Healthcare Informatics career, my opinions on the state of health IT in 2012, and related matters for a possible article: <blockquote class="tr_bq">Kaiser Health News (KHN) is a nonprofit news organization committed to in-depth coverage of health care policy and politics. KHN’s mission is to provide high-quality coverage of health policy issues and developments at the federal and state levels. In addition, KHN covers trends in the delivery of health care and in the marketplace. KHN is an editorially-independent program of the <a href="http://www.kff.org/" shape="rect" target="_blank">Kaiser Family Foundation</a>, a non-profit private operating foundation, based in Menlo Park, Calif., dedicated to producing and communicating the best possible analysis and information on health issues. </blockquote> Mr. Hancock has quoted me regarding health IT in the past in his current role and when he was a reporter for the Baltimore Sun, for instance in the April 2012 article "<a href="http://www.washingtonpost.com/health-insurance-companies-push-to-diversify-raises-concerns/2012/04/27/gIQAWoSkoT_story.html" target="_blank">Health insurers’ push to diversify raises ethical concerns</a>" that appeared in the Washington Post as well, and the Nov. 2011 article "<a href="http://weblogs.baltimoresun.com/business/hancock/blog/2011/11/advice_to_hospitals_be_careful.html" target="_blank">Advice to hospitals: Be careful what you bill for</a>" in the Baltimore Sun. Mr. Hancock wanted to get an understanding of me, the person.  In doing so, I dug out some of my past technology "toys" to show him at the onset of the interview.  Ironically, doing so reminded me of some irritating occurrences in the past that both inform present views, and served as early experiences in why health IT suffers the problems it does. I will illustrate by showing some of the devices I presented to Mr. Hancock in order for him to better know my interests/knowledge of technology, and then presenting the unpleasant recollections that doing so brought on. Bear with me for a few moments (and pictures). I showed Mr. Hancock devices I'd built and/or used in teaching such as (click to enlarge): <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhNI2bBd1cOfE5MXq_R7FhoDuqo7tsA0MIEZM-DFZRq2L_RF0nbjYKfMTqCbBLXMf05XS_DIX3LXnmrJC14UHPKHVGxIqkzRF_p0dJtjzyaXY4Ku6kswyTxr4uM62C-SoiTDDjY3RX_XHqE/s1600/monitor.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="184" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhNI2bBd1cOfE5MXq_R7FhoDuqo7tsA0MIEZM-DFZRq2L_RF0nbjYKfMTqCbBLXMf05XS_DIX3LXnmrJC14UHPKHVGxIqkzRF_p0dJtjzyaXY4Ku6kswyTxr4uM62C-SoiTDDjY3RX_XHqE/s1600/monitor.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">An infrared-sensing heart monitor I built in 1980 during a clerkship in biomedical engineering, Boston University Hospital, 1980</td></tr></tbody></table> <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjLRMslJ-L6uo5Up8v3f8gW6Tpn1DsKPohhPgjvkTPgXFzTIiBvxK4QWY04-9OZAPrwntaxdyaXc3FpVl_eBpxroWG5Pbjs1u0pi9D_3uU0e6N2bsn44mmgGA3GlflHNkoBoRJWSjK3E_ET/s1600/monitor_inside.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="264" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjLRMslJ-L6uo5Up8v3f8gW6Tpn1DsKPohhPgjvkTPgXFzTIiBvxK4QWY04-9OZAPrwntaxdyaXc3FpVl_eBpxroWG5Pbjs1u0pi9D_3uU0e6N2bsn44mmgGA3GlflHNkoBoRJWSjK3E_ET/s1600/monitor_inside.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Inside the heart monitor.  I etched and drilled the printed circuit boards myself.</td><td class="tr-caption" style="text-align: center;"></td><td class="tr-caption" style="text-align: center;"></td></tr></tbody></table> <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjfaQ4LIqHZqETVHyBYLKV7nBObQVnYUWtTMyFPyCPsLa0TFUf7OPEyf3-MsobysGudPtzn-AikRxWl0IQF8mB_TPCoCWMEmHpu_WNA-6MKmEy2HZhMrPq1Ws_5mAQkjl5Vhi5uM9RwHF3N/s1600/pbox.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="264" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjfaQ4LIqHZqETVHyBYLKV7nBObQVnYUWtTMyFPyCPsLa0TFUf7OPEyf3-MsobysGudPtzn-AikRxWl0IQF8mB_TPCoCWMEmHpu_WNA-6MKmEy2HZhMrPq1Ws_5mAQkjl5Vhi5uM9RwHF3N/s320/pbox.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">A 3-transistor breadboard shortwave radio I built as a kid.</td></tr></tbody></table> <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhRBkW3a2lwQrI8Z1iqGOfk9HVmZYLs3atqSj2DqdhEAzgtbr11HcMJQ0UkAQuradR-gr4UeEQk1GcJDAnwyAxgC9PbIwQknRZtk7mnjajZDhoS7AnABcvRkc-EzIfRrIeVxrv0ereDyMJx/s1600/hw101.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="201" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhRBkW3a2lwQrI8Z1iqGOfk9HVmZYLs3atqSj2DqdhEAzgtbr11HcMJQ0UkAQuradR-gr4UeEQk1GcJDAnwyAxgC9PbIwQknRZtk7mnjajZDhoS7AnABcvRkc-EzIfRrIeVxrv0ereDyMJx/s1600/hw101.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">A somewhat more sophisticated radio kit.  My Heathkit HW-101 ham radio transceiver, built myself over several months when I was a medical trainee.  Also built its matching power supply box, not shown.</td></tr></tbody></table> <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEioHh-zMYfMv-DtCyWAxE4DsLkBTmP_l0mLMs4LSgcj90n_y6IplsjDBkyE5fFqKU7VaFeMbqzJf9r1R_TLMwZoUbeDVh-5PogmI3F1rJugTWpJcDwqRi_bzsz37ZnkqPL4sp6xJSA9sjxc/s1600/hw101_inside.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="275" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEioHh-zMYfMv-DtCyWAxE4DsLkBTmP_l0mLMs4LSgcj90n_y6IplsjDBkyE5fFqKU7VaFeMbqzJf9r1R_TLMwZoUbeDVh-5PogmI3F1rJugTWpJcDwqRi_bzsz37ZnkqPL4sp6xJSA9sjxc/s1600/hw101_inside.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">HW-101 innards, top view.  Not exactly a simple device.</td></tr></tbody></table> <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjMqX4MYZmY9Ir7PY_5ldAliBxLTsZaW_yERtsdfCgBKjFsTz04ptod_hZCir8n3L_GUh8EohaUfULwL7KGBc-PHpXtCFqlmDQHDvHnupKdFuvctFnTx0_2Ue6kktj9iodAFpu42cdWhvpY/s1600/hw101_under.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="243" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjMqX4MYZmY9Ir7PY_5ldAliBxLTsZaW_yERtsdfCgBKjFsTz04ptod_hZCir8n3L_GUh8EohaUfULwL7KGBc-PHpXtCFqlmDQHDvHnupKdFuvctFnTx0_2Ue6kktj9iodAFpu42cdWhvpY/s1600/hw101_under.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">HW-101 underside of chassis.  Each and every one of those solder connections was done by me.  In bulding it, I learned how each circuit worked (and had to debug it when, on initial powerup, smoke rose due to a defective ceramic capacitor and two bad tubes, one of which glowed a delightful cherry-red.)</td></tr></tbody></table> <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhxcE0GYwocATWczjbtZGBlKniF-7aPALWsis0MBi5u__4pa_VHxmCing_cd6seWbzIamDdbGL2CiAb957sOGYa2nPSKlt1COjY6apzsvGBinI_W8_jq3deMH0X-mlX_LisIeDZlwzOMtBm/s1600/h8.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="194" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhxcE0GYwocATWczjbtZGBlKniF-7aPALWsis0MBi5u__4pa_VHxmCing_cd6seWbzIamDdbGL2CiAb957sOGYa2nPSKlt1COjY6apzsvGBinI_W8_jq3deMH0X-mlX_LisIeDZlwzOMtBm/s1600/h8.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">My Heathkit H8 computer, introduced 1977.  Intel 8080 processor. One of the first personal computers.  In true minicomputer style, the 8080 general registers, accumulator/flags register, program counter, stack pointer, and memory addresses were directly accessible via the front panel pushbuttons and the split-octal display.</td></tr></tbody></table> <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjHGHE5EygfpJBKVtX14fYUUJfIBoAfLSl2qS0MnTelvSda98KbpWW7dgdhroNFhb12xExI1UQssJ9La2gOfpse1R4TrbQSAPkOCfLdcmzZdrMkQgnbzLH5xn0v7R0O1F3ZUqFeDd_KR7yN/s1600/h8_inside.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="251" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjHGHE5EygfpJBKVtX14fYUUJfIBoAfLSl2qS0MnTelvSda98KbpWW7dgdhroNFhb12xExI1UQssJ9La2gOfpse1R4TrbQSAPkOCfLdcmzZdrMkQgnbzLH5xn0v7R0O1F3ZUqFeDd_KR7yN/s1600/h8_inside.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Inside the H8.  I used this to teach computer and CPU architecture to Medical Informatics  postdoctoral fellows at Yale School of Medicine.  I did not, and do not believe healthcare IT leaders should be mere “appliance operators.” </td></tr></tbody></table> <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiaQg4SB7pJYQ5Qdi4e4ld8PE41FFf2XnL-l8kA0woZYT5-WCgiS7yayoTWkekfcNI91YlDZDecsp2FTk6sWrQ030m7RDX8CVoNVLS9EOgHCgZO0X3Z6eEOXpm4t93HVe7HUstW4GhetGce/s1600/vtos.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="249" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiaQg4SB7pJYQ5Qdi4e4ld8PE41FFf2XnL-l8kA0woZYT5-WCgiS7yayoTWkekfcNI91YlDZDecsp2FTk6sWrQ030m7RDX8CVoNVLS9EOgHCgZO0X3Z6eEOXpm4t93HVe7HUstW4GhetGce/s1600/vtos.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">My TRS-80 Model I running VTOS 4.0, a pre-IBM PC precursor to LDOS 5 and TRSDOS 6.  All were far superior to MS-DOS of any flavor in my opinion.</td></tr></tbody></table> <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhm2GpffAVXmQfo1n78BVq860ijo7GEmRcNpAb9ZX4p80_nuN3399P32r8UOg40-BBBGcwLMZbLsVb79GUGLdApiKm1vSN_zkt8rWuzBN0L7xjmJhLK2hYSnqmsbKu3gbCQL-PI96d60zY1/s1600/trs80_fix.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="244" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhm2GpffAVXmQfo1n78BVq860ijo7GEmRcNpAb9ZX4p80_nuN3399P32r8UOg40-BBBGcwLMZbLsVb79GUGLdApiKm1vSN_zkt8rWuzBN0L7xjmJhLK2hYSnqmsbKu3gbCQL-PI96d60zY1/s1600/trs80_fix.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">TRS-80 Model I about to undergo repair by me.</td></tr></tbody></table> As I mentioned before the pictures, unpacking from their storage boxes and showing this personal technology brought out numerous formative memories, and not always good ones, from my CMIO (Chief Medical Informatics Officer) days. Seeing all this, it may be easier to imagine why, as a CMIO in the mid 1990's I was offended when patronized by hospital IT personnel about how an information system  in an invasive cardiology cathlab, a critical care area, could not be moved from unstable Windows 3.1 to Windows NT to prevent frequent crashes and data loss because “Windows NT needed RAID disk arrays” and other B.S., and also by similar personnel patronizing me on my serious concerns about ICU patients put at risk of infection by improper hardware for a biohazard-prone environment.  (See <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story</a> and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU</a>.) I was further reminded about how I was alarmed by the selfsame hospital IT "experts", lacking healthcare and medical informatics knowledge and experience, simply ignoring my counsel, as if medicine was a harmless parlor game to be played, winner take all.  And likewise regarding hospital senior management who's hired me in the first place - at least one of whom expressed to me more concern for the career advancement of the IT staff than for patient safety. The latter ICU incident, in fact, directly led to my starting to write about health IT issues on the Web in 1998.  Sadly, my colleagues, as well as former students and mentees, tell me little has changed. That type of territorial, political behavior might perhaps be more appropriate (or at least hardly harmful) in a nail salon or pizza parlor, but not in an ICU or cardiac cath lab. Yet today's health IT domain is rife with leadership by health IT amateurs** [see note below] who patronize, bully and play nasty politics with healthcare informatics-educated clinicians and specialists, and accuse clinicians of being "Luddites" for resisting <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" target="_blank">bad health IT</a> pushed on them by hyperenthusiasts (<a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">Ddulites</a>) who ignore the downsides.   <blockquote class="tr_bq">Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealthinformation secure, protects patient privacy and facilitates better practice of medicine and better outcomes.  Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.   </blockquote> What is lost in these dysfunctional dynamics is that the true "customer" who suffers is the patient.  Patients come to the hospital sick and with expectations that the personnel there will put the patients' interests first.  If they are injured or leave in a pine box, they care little about whose political empires were threatened by internecine and/or industry battles over IT. Mr. Hancock's Kaiser Health News profile of me, if published, should prove interesting.   It will probably mention my own relative's injury and death related to health IT, and may cite the Complaint itself, a public document.   I will link to it when it if and when it appears. -- SS ** (Amateur, used in the same sense that I am a <a href="http://www.arrl.org/" target="_blank">radio amateur</a> licensed by the government after a series of written exams, but not a professional telecommunications engineer, knowing I would not want to, nor should be allowed to, lead a mission critical telecommunications project.) ----------------------- Feb. 18, 2013 Addendum: The article was published as <a href="http://hcrenewal.blogspot.com/2013/02/kaiser-health-newsphiladelphia-inquirer.html" target="_blank">here</a>. -- SS

How an interview for Kaiser Health News rekindled memories of health IT dysfunction in the 90's that persist in the 10's

I was interviewed in my home yesterday by Jay Hancock, Senior Correspondent, Kaiser Health News about my background, how I got to the current point in my Healthcare Informatics career, my opinions on …

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06 Dec 2012

Insurers' diversification creating monopoly power and conflict of interest - quoted in the Washington Post

I am quoted in a Washington Post article today on potential conflicts of interest when medical payers/insurers acquire the firms that hospitals and doctors use to challenge medical payment denials: <blockquote class="tr_bq"> <a href="http://www.washingtonpost.com/health-insurance-companies-push-to-diversify-raises-concerns/2012/04/27/gIQAWoSkoT_story.html" target="_blank">"Health insurers’ push to diversify raises ethical concerns" </a> Washington Post Jay Hancock, Sunday, April 29 Like hospitals and doctors everywhere, Banner Health fights a daily battle to get paid by insurance companies and government agencies for the care it delivers.  So the hospital system hired a company called Executive Health Resources to fight back against the likes of Medicare and UnitedHealthcare when they deny claims or pay bills for less than what Banner thinks it is owed.</blockquote> Fair enough. <blockquote class="tr_bq">But Banner executives began to worry about EHR’s independence when the firm was acquired in 2010 by UnitedHealth Group, UnitedHealthcare’s parent. </blockquote> Issues can get a bit sticky under such an arrangement. I put it this way: <blockquote class="tr_bq"> Critics call United’s ownership of EHR a troubling conflict of interest that could give it confidential information about rivals as well as patients and limit EHR’s power to demand payment from its much larger corporate sister. “How is that ownership going to affect the mission of a company whose business is to extract more money from payers?” said Scot Silverstein, a physician and specialist in medical software and patient records at Drexel University. “Imagine going to a plaintiff’s lawyer to take your malpractice case and not knowing that plaintiff’s lawyer actually works for the hospital that you’re suing.”</blockquote> When payers acquire those who would challenge their payment denials, I worry about the consolidation of power being too great for the public good. As we learn, the relationship is somewhat stealthy: <blockquote class="tr_bq">... There is no mention of EHR’s ownership in the “Corporate Overview” section of its Web site or elsewhere on the site. Nor did the American Hospital Association identify EHR as a United subsidiary in September when it renewed its exclusive endorsement of EHR’s denial-fighting services. EHR pays the hospital association a fee for the endorsement. The group declined to disclose the amount.  </blockquote> The plot thickens: <blockquote class="tr_bq">Claims consultants such as EHR typically gain access to millions of patient records and confidential contracts between hospitals and insurers, industry officials say. If UnitedHealthcare, United’s insurance wing, gained access to that data, it would obtain “a huge business advantage” over insurance rivals as well as the hospitals, Kofman said.</blockquote> In today's healthcare business environment, "if" seems to me to be optimistic. Hancock goes further in the article: <blockquote class="tr_bq"> As insurers eager to add revenue streams convert themselves into diversified health-services companies, they often buy traditional business adversaries, including physician groups and hospital consultants such as EHR. They’re also buying technology companies and research firms that serve medical-care providers, raising questions not only about independence but about the privacy of patient information. </blockquote> A Georgetown professor, formerly a state insurance superintendent, gets to the heart of the matter, using United as but one example: <blockquote class="tr_bq"> “I am not convinced that, even with proper disclosure, that an entity owned by United could aggressively advocate against United’s interests,” said Mila Kofman, a Georgetown professor who was Maine’s insurance superintendent.</blockquote> This factoid is eye-opening: <blockquote class="tr_bq"> Appealing claims denials has become a huge, high-tech business, reflected in the more than $1 billion that United reportedly paid for EHR [Executive Health Resources].</blockquote> You might think there were better things to do with $1 billion besides administrative bloat - such as taking care of patients. We probably need new laws to catch up with the flurry of M&A's going on in healthcare between payers, the healthcare delivery sector, and the "referees" that mediate between them when disputes arise. Read the entire article at the WaPo link above.  The examples get even more convoluted. -- SS Addendum: Roy Poses notes: <blockquote class="tr_bq">This appears to be a newly recognized type of conflict of interest that contributes to the concentration of power in the US commercialized health care system.  While many people tout how our health care system is "competitive" and a "free market," it is ever more dominated by a decreasing number of enlarging organizations.  True health care reform would break up health care oligopolies. </blockquote> -- SS

Insurers' diversification creating monopoly power and conflict of interest - quoted in the Washington Post

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29 Apr 2012

Can You Sue the Government? FDA Whistleblowers Sue Over Surveillance of Personal e-Mail

From the Washington Post: <blockquote><a style="font-weight: bold;" href="http://www.washingtonpost.com/world/national-security/fda-staffers-sue-agency-over-surveillance-of-personal-e-mail/2012/01/23/gIQAj34DbQ_story.html?sub=AR">FDA staffers sue agency over surveillance of personal e-mail</a> Ellen Nakashima and Lisa Rein January 29, 2012 The Food and Drug Administration secretly monitored the personal e-mail of a group of its own scientists and doctors after they [the scientists - ed.] warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients, government documents show. The surveillance — detailed in e-mails and memos unearthed by six of the scientists and doctors, who filed a lawsuit against the FDA in U.S. District Court in Washington last week — took place over two years as the plaintiffs accessed their personal Gmail accounts from government computers.</blockquote> While accessing Gmail from government computers was not a wise idea, since all traffic over an institutional PC and network can be monitored, these Gmails were apparently to members of Congress. <a href="http://www.washingtonpost.com/wp-srv/national/documents/fda-whistleblowers-3.html#document/p1/a43233"></a><blockquote><a href="http://www.washingtonpost.com/wp-srv/national/documents/fda-whistleblowers-3.html#document/p1/a43233">Copies of the e-mails</a> show that, starting in January 2009, the FDA intercepted communications with congressional staffers and draft versions of <a href="http://www.whistleblowers.org/">whistleblower complaints</a> complete with editing notes in the margins. The agency also took electronic snapshots of the computer desktops of the FDA employees and reviewed documents they saved on the hard drives of their government computers.</blockquote> See sample emails at link above. <blockquote>Information garnered this way eventually contributed to the harassment or dismissal of all six of the FDA employees, the suit alleges. All had worked in an office responsible for reviewing devices for cancer screening and other purposes.</blockquote> That's very unfortunate. It will be far more unfortunate if the warnings of the six, as in <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=lawsuit">this whistleblower case</a>, went unheeded, and patients are injured or die as a result. In that case, FDA bureaucrats might have been accessories to those injuries or deaths. <blockquote>“Who would have thought that they would have the nerve to be monitoring my communications to Congress?” said Robert C. Smith, one of the plaintiffs in the suit, a former radiology professor at Yale and Cornell universities who worked as a device reviewer at the FDA until his contract was not renewed in July 2010. “How dare they?” </blockquote> I, on the other hand, would have expected it. It would have been far more prudent to send such emails from a private home computer and ISP. <blockquote>The scientists and doctors denied sharing information improperly. The HHS inspector general’s office, which oversees FDA operations, <a href="http://www.washingtonpost.com/wp-srv/national/documents/fda-whistleblowers-2.html/#document/p1/a43237">declined to pursue an investigation</a>, finding no evidence of criminal conduct. It also said that the doctors and scientists had a legal right to air their concerns to Congress or journalists.FDA officials sought a second time that year to initiate action against the scientists and doctors. “We have obtained new information confirming the existence of information disclosures that undermine the integrity and mission of the FDA and, we believe, may be prohibited by law,” wrote Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, on June 28, 2010.The inspector general, after consulting with federal prosecutors, declined the second request, as well.</blockquote> The IG office seemed to find the behavior legal, but FDA bureaucrats apparently did not like non-team players. <blockquote>The FDA scientists and doctors, all of whom worked for the agency’s <a href="http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm115879.htm">Office of Device Evaluation</a>, said they first made internal complaints beginning in 2007 that the agency had approved or was on the verge of approving at least a dozen radiological devices whose effectiveness was not proven and that posed risks to millions of patients. Frustrated, they also brought their concerns to Congress, the White House and the HHS inspector general.Three of the devices risked missing signs of breast cancer, the scientists and doctors warned, according to documents and interviews. Another risked falsely diagnosing osteoporosis, leading to unnecessary treatments; one ultrasound device could malfunction while monitoring pregnant women in labor, risking harm to the fetus; and several devices for colon cancer screening used such heavy doses of radiation that they risked causing cancer in otherwise healthy people, the FDA scientists and doctors said.</blockquote> Permit me to wonder if <a href="http://hcrenewal.blogspot.com/search/label/regulatory%20capture">regulatory capture</a> played a role in these decisions. One might also wonder if complaints about electronic health records or other clinical IT, admitted by FDA to be a medical device "<a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">political hot potato</a>" they elected to not regulate, were also involved. <blockquote>... The first documented FDA interception was of an e-mail dated Jan. 29, 2009, shortly after the letter from Ferry. In it, device reviewer Paul T. Hardy asked a congressional aide, Joanne Royce, for assurances that “it is not a crime to provide information to the Congress about potential misconduct by another Agency employee.”Royce replied: “[Y]ou and your colleagues have committed no crime. . . . you guys didn’t even provide confidential business information to Congress.”</blockquote> The only 'crime' was apparently not being a 'team player', which on Healthcare Renewal <a href="http://hcrenewal.blogspot.com/2011/12/ehr-mission-hostile-user-experience.html">has been defined as</a> someone who is silent, or silenced, or a co-conspirator regarding managerial mediocrity, malfeasance, or madness. <blockquote>Hardy, who is among the six employees who filed the suit, was fired in November after a negative performance review; an internal FDA letter obtained in separate litigation quoted managers saying they did not “trust” him. Of the other five scientists and doctors, the suit says two did not have their contracts renewed, two suffered harassment and werepassed over for promotions, and one was fired.</blockquote> Trust him to do - what, I ask? Read the whole WaPo article. Plaintiff's lawyers need to be aware of this event, and I intend to make them aware. -- SS Feb. 13, 2012 addendum: A link to Darrell Issa's letter to FDA Commissioner Hamburg is <a href="http://hcrenewal.blogspot.com/2012/02/congressman-darrell-issa-fdas-email.html">here</a>. -- SS

Can You Sue the Government? FDA Whistleblowers Sue Over Surveillance of Personal e-Mail

From the Washington Post:FDA staffers sue agency over surveillance of personal e-mailEllen Nakashima and Lisa ReinJanuary 29, 2012The Food and Drug Administration secretly monitored the personal e-mai…

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30 Jan 2012

Washington Post Article: Electronic medical records not seen as a cure-all

Regarding the very well done Sunday Oct. 25, 2009 story in the Washington Post "<a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/10/24/AR2009102400967.html?hpid%3Dtopnews&sub=AR">Electronic medical records not seen as a cure-all</a>" by staff writer <a href="http://projects.washingtonpost.com/staff/articles/alexi+mostrous/">Alexi Mostrous</a> - signup may be required for access - I have several observations. (Not including the observation that Mr. Mostrous probably deserves an award for being the first major newspaper reporter to broach this topic in a serious and balanced manner.) First, I believe healthcare IT can live up to all the predictions made about its benefits - but only if done well. There is massive complexity behind those two words "done well", and that is HIT's key stumbling block in 2009. I believe we are only in the adolescent stage of knowing how to "do health IT well." Second, I should point out that the intended consequences of health IT include, among many other things, the following "hiding in plain sight" (i.e., not often verbalized) intended consequences: <ul><li>The improvement of medicine ... in the context of protection of patient rights established over centuries of development of modern medicine. </li></ul><ul><li>The improvement of IT itself through cross disciplinary collaboration between IT and medicine, of the science of IT (computer science), the social aspects of computerization ("sociotechnical issues"), and improvement of the our understanding of the intersection of medicine and computers.</li></ul> Instead, we largely have the opposite. Patients' rights are trampled, and hostility and territoriality has arisen between clinicians (including medical informaticists) and IT, groups that rarely if ever interacted in hospitals ten or twenty years ago. Of concern, when scientific study sections evaluate NIH grant proposals calling for testing of new IT that involves patients, patient protections and informed consent processes are a paramount concern since such activities are considered research. Yet, in implementing large clinical IT system in a hospital with new features, there are no formal regulations, and I'm not sure there's even IRB involvement in most cases. Patients do not get the chance to give informed consent to the use of these IT devices mediating their care. Why the difference? The unintended results of computerization efforts have also included suppression of research on sociotechnical issues and on informatics, which must include study of the downsides of HIT, and of the failures in addition to the study of the successes. That is scientific fact - there is no room for debate, no room for spin on the need for careful study of the downsides of any mission critical domain. One would think there to be a vibrant literature on these issues, Yet searches on massive biomedical databases such as PubMed on, say, "cerner electronic health record" (or other vendors as well) are disappointing to say the least. Further, my own website on HIT difficulties remains <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/content/documents/FINAL_Healthcare%20IT%20Failure_Oct_19_2006.ppt">nearly unique</a> (PPT) after ten years online. That is not bragging; it is a disturbing finding to me - symptomatic of an industry that somehow has managed to avoid serious scrutiny. In a field with downsides, there are: 1) those who know about the problems but fail to speak, 2) those who see the problems but fail to act, and 3) those who see, know and speak/write/research the problems. That said, now on to the Washington Post article: <blockquote>... bipartisan enthusiasm has obscured questions about the effectiveness of health information technology products, critics say. Interviews with more than two dozen doctors, academics, patients and computer programmers suggest that computer systems can increase errors, add hours to doctors' workloads and compromise patient care. </blockquote> I would include the bipartisan enthusiasm under the subject header of "irrational exuberance", which itself falls under the header of "lack of domain knowledge." That itself is a consequence of both failure to study the issues, and suppression of those issues by those with an interest in doing so. <blockquote>health IT's effectiveness is unclear. </blockquote> The literature is indeed conflicting, and the need for rigorous scientific study has never been more essential considering the commitment of tens of billions of dollars towards health IT. The time for story telling, marketing based on opinion, name calling, leap-of-faith extrapolations of light year dimensions, and other forms of pseudoscience and non-science are over. The time for objective study is now. <blockquote>The Senate Finance Committee has amassed a thick file of testimony alleging serious computer flaws from doctors, patients and engineers unhappy with current systems. </blockquote> Being the ranking member of that committee, Sen. Grassley has a fiduciary responsibility to protect Medicare and Medicaid patients (and one might argue, to protect all patients since those programs often serve as models for private insurers). In that regard, the investigation he has initiated is part of his responsibility as a ranking member of Congress. Politics aside (and there are those who will resort to ad hominem "political witch hunt" arguments), he would have been negligent if he had not initiated an inquiry. Sen. Grassley has taken on the pharma industry and the government's Food and Drug Administration itself, such as in this recent article "<a href="http://news.yahoo.com/s/ap/20091026/ap_on_he_me/us_fda_unproven_drugs">FDA fails to follow up on unproven drugs</a>" where he concluded from a GAO study he ordered that "FDA has fallen far short of where it should be for patient safety." He seems quite serious about medical safety. If only others in Congress had done their job similarly regarding national finance, we might now not be in the worst economic crisis since '29 with many major industries failing. <blockquote>David Blumenthal, the head of health technology at the Department of Health and Human Services, acknowledged that the systems had flaws. "But the critical question is whether, on balance, care is better than before," he said. "I think the answer is yes." </blockquote> This sounds uncomfortably like how a pharmaceutical company might respond to doubts about drug effectiveness and safety. In reality it's really irrelevant what he "thinks." Where's the data? Is this a political statement, a personal belief, or a statement backed up by scientific fact that is not cast into doubt by other research results? Our own National Research Council, Joint Commission, and other international organizations have written about their doubts and concerns about HIT [as that IT is designed and implemented in 2009]. If there is rigorous, systematic research weighing pro's and con's to back this assertion, I wish it would be published. For his statement is really saying "we don't really know how many systems have flaws, we know some do, and we don't really know the full extent of the impact of those flaws, but because there can be some benefits, let's spend $50+ billion before we know the extent of the problems and fix them." I point out research from Harvard forty years ago, when Harvard informatics pioneer Dr. Octo Barnett published the "Ten Commandments of HIT." Two of those commandments were: <blockquote>... 8. Thou shall be concerned with realities of the cost and projected benefit of the computer system [i.e., ROI - ed.] 10. Be optimistic about the future, supportive of good work that is being done, passionate in your commitment, but always guided by a fundamental skepticism.</blockquote> The full set is in <a href="http://hcrenewal.blogspot.com/2009/10/medical-informatics-pharma-health-it.html">this post</a>. Somewhere in the past 40 years, the rigorous ROI evaluations (which also must include systematic evaluations of risk, as any businessperson knows) and the fundamental skepticism seem to have gotten lost. <blockquote>Over the next two months, Blumenthal will finalize the definition of "meaningful use," the standard that hospitals and physicians will have to reach before qualifying for health IT stimulus funds.</blockquote> This is an example of putting the cart before the horse, and is a semantically-based, self contained logical fallacy of sorts. If a health IT system is harmful, the term "meaningful use" is itself Orwellian. If we don't know if HIT is beneficial, or have doubts, then such as term presupposes that health IT is inherently beneficial. A better term would have been "good faith use" - use based on the faith or hope that health IT will have an overall positive effect. The term "meaningful use" jumps the gun and is more a political slogan than a "meaningful term." <blockquote>"If you look at other high-risk industries, like drug regulation or aviation, there's a requirement to report problems," said David C. Classen, an associate professor of medicine at the University of Utah who recently completed a study on health IT installations. </blockquote> This is obvious, the reasons for it are obvious, and the reasons why health IT needs a requirement for problems reporting (one aspect of post-marketing surveillance, the "Phase IV" study as it is known in pharma) is obvious. Yet in 2009, no such requirement exists (see my post "<a href="http://hcrenewal.blogspot.com/2009/10/out-policy-is-to-always-have-unabashed.html">Our Policy Is To Always Have Unabashed Faith In The Computer</a>" for more on why we need reporting requirements.) Why do these requirements simply not exist in HIT? <blockquote>"It's been a complete nightmare," said Steve Chabala, an emergency room physician at St. Mary Mercy Hospital in Livonia, Mich., which switched to electronic records three years ago. "I can't see my patients because I'm at a screen entering data." Last year, his department found that physicians spent nearly five of every 10 hours on a computer, he said. "I sit down and log on to a computer 60 times every shift. Physician productivity and satisfaction have fallen off a cliff." </blockquote> The industry in the past has called such physicians "luddites", "resistant to change", "stubborn" etc. However, <a href="http://www.nizkor.org/features/fallacies/ad-hominem.html">argumentum ad hominem</a> is a fallacious mode of argument that has no place in a scientific field such as biomedicine. There also seems to be quite a lot of such concerns expressed by a large number of physicians, nurses, etc., and dismissing their concerns with a wave of the hand is cavalier in the extreme - again, these are first principles, without room for argument or debate. Let's study the issues rigorously and scientifically before resorting to ad hominem. <blockquote>Other doctors spoke of cluttered screens, unresponsive vendors and illogical displays. "It's a huge safety issue," said Christine Sinsky, an internist in Dubuque, Iowa, whose practice implemented electronic records six years ago.</blockquote> See my eight part series on mission hostile clinical IT <a href="http://www.tinyurl.com/hostileuserexper">here</a> for examples of what Dr. Sinsky is referring to. <blockquote>She emphasized that electronic records have improved her practice. "We wouldn't want to go back," she said. "But EHRs are still in need of significant improvement."</blockquote> Yes, not cancellation, but improvement. And, quite importantly, before tens of billions of dollars are spent. Hospitals and physician offices are not an IT development laboratory, since the users of these facilities (patients) have very special rights and the clinicians, very special obligations and responsibilities. <blockquote>Legal experts say it is impossible to know how often health IT mishaps occur. Electronic medical records are not classified as medical devices, so hospitals are not required to report problems.</blockquote> That after decades of HIT development, sales and implementation we cannot know with certainty how often mishaps occur is, quite simply, a scandal of major proportions. Quoting an old <a href="http://en.wikipedia.org/wiki/The_House_of_God">House of God</a> law, #10: "if you don't take a temperature, you can't find a fever." Another applicable aphorism seen on another discussion board: "you can only be so negligent or craven before the only remaining rationale is that you intended the result." <blockquote>"Doctors who report problems can lose their jobs," Hoffman said. </blockquote> I've taken risks with my own career in criticizing health IT, as have my colleagues. Hoffman is not exaggerating. <blockquote>"Hospitals don't have any incentive to do so [speak out about problems with HIT] and may be in breach of contract if they do." </blockquote> Imagine the outcry if the same prevailed regarding drugs or medical devices. The cemeteries would be lined with people whose epitaph could read "we bury our mistakes." <blockquote>While orange-shirted vendor employees "ran around with no idea how to work their own equipment," the internist said, doctors struggled to keep chronically ill patients alive. "I didn't go through all my training to have my ability to take care of patients destroyed by devices that are an impediment to medical care." </blockquote> This gets to issues I first raised in my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm">website on HIT difficulties</a>: who are these IT personnel, and what are their qualifications, exactly, to be working in mission critical medical environments? How is their competence evaluated? I think these are questions that need to be answered. -- SS

Washington Post Article: Electronic medical records not seen as a cure-all

Regarding the very well done Sunday Oct. 25, 2009 story in the Washington Post "Electronic medical records not seen as a cure-all" by staff writer Alexi Mostrous - signup may be required for access - …

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25 Oct 2009

Washington Post: EMR's No Cure-All; Sen. Grassley Sends Letter of Inquiry to health IT vendors

Washington Post: EMR's No Cure-All; Sen. Grassley Sends Letter of Inquiry to health IT vendors

Senator Grassley has sent a letter out to ten major health IT vendors seeking information on health IT problems and flaws. The letter can be retrieved from this link (PDF) at the Washington Post. Re…

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24 Oct 2009

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