Healthcare IT Amateur Kathleen Sebelius Resigns - Good Riddance

The Secretary of the U.S. Department of Health and Human Services (HHS) is resigning.<br /><br />Press reports say she is resigning in large part due to the Exchange Website debacle.<b>   </b>This from the New York Times:<b><br /></b><br /><blockquote class="tr_bq"><b>Health Secretary Resigns After Woes of HealthCare.gov</b><br /><a href="http://www.nytimes.com/2014/04/11/us/politics/sebelius-resigning-as-health-secretary.html?_r=0" target="_blank">http://www.nytimes.com/2014/<wbr></wbr>04/11/us/politics/sebelius-<wbr></wbr>resigning-as-health-secretary.<wbr></wbr>html?_r=0</a><br /><br />... Officials said Ms. Sebelius, 65, made the decision to resign and was not forced out <span style="color: red;"><b><i>[Yeah, right - SS]</i></b></span>. But the frustration at the White House over her performance had become increasingly clear, as administration aides worried that the crippling problems at HealthCare.gov, the website set up to enroll Americans in insurance exchanges, <b>would result in lasting damage to the president’s legacy.</b></blockquote><br />It's not as if there's no literature out there on how to create good health IT.  Doing so is not a state secret.  Simple (and free, unlike the hundreds of millions spent on incompetent <a href="http://en.wikipedia.org/wiki/Beltway_bandits">beltway-bandit</a> 'consultants') Google searches on the term <a href="https://www.google.com/search?q=%22healthcare+IT+failure%22">"healthcare IT failure"</a> or similar return ample resources that could have prevented the "lasting damage to the president's legacy."<br /><br />Way to go, Ms. Ex-Secretary.  Another health IT amateur bites the dust, as my early computer mentor, Philadelphia's George Washington High School math instructor Fred Holzwarth (<a href="http://www.historicbuckscounty.org/nths/HISTORIA/PDF/Historia_Nov2005.pdf">http://www.historicbuckscounty.org/nths/HISTORIA/PDF/Historia_Nov2005.pdf</a>) would have said.<br /><br />However, even worse ... far worse ...<br /><br />Under this Secretary of the Department of Health and Human Services, the principal watchdog agency over medicine and medical device safety under her aegis, the FDA, found that:<br /><br /><blockquote class="tr_bq">... products with health management heath IT functions, <b>includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software.</b><br /><br />Products with health management health IT functions are of<b> sufficiently low risk</b> and thus, if they <b>meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them.</b> </blockquote><br /><div style="margin-bottom: 0in;">Thus, patients are condemned to injury and death, probably at ECRI Deep Dive study levels [1], for the foreseeable future (see my post on that FDA decision at my April 9, 2014 post <a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html"> <style type="text/css">P { margin-bottom: 0.08in; }</style></a><b>"FDA on health IT risk: reckless, or another GM-like political coverup?"</b> at <a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>).</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">This is especially outrageous at the time massive investigations are ongoing about the 13 deaths caused by apparent coverups of a faulty General Motors <i>ignition switch.</i></div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">It was your FDA agency, Ms. Ex-Secretary.  You own that decision.</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">Good Riddance, indeed.  </div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">The person at this link: <a href="http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html">http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html</a> would certainly agree, if she were alive; she is not thanks to the very devices your FDA just perversely found to be of "sufficiently low risk."</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">-- SS</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">Note:</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;"><span style="font-size: x-small;">[1]  In 9 weeks in 36 PSO-member hospitals, 171 IT mishaps sufficient to cause harm were voluntarily reported; 8 injuries occurred, some severe, and 3 deaths may have been the result.  See <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>.</span></div>

Healthcare IT Amateur Kathleen Sebelius Resigns - Good Riddance

The Secretary of the U.S. Department of Health and Human Services (HHS) is resigning. Press reports say she is resigning in large part due t...

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Regulation of HIT by federal independent agency vs. federal executive agency / Open criminal probe of GM recall

In the FY2014 HHS budget-in-brief document (PDF at <a href="http://www.hhs.gov/budget/fy2014/fy-2014-budget-in-brief.pdf">http://www.hhs.gov/budget/fy2014/fy-2014-budget-in-brief.pdf</a>) on page 115, there's this:<br /><div class="gmail_extra"><br /><br /><div style="margin-left: 40px;"><b>Patient Safety and Health IT Usability</b><br />Patient safety and usability continue to be a focus for<br />ONC. <b>Working with federal partners AHRQ and FDA,</b><b><br />ONC will create the foundation for a patient<br />safety program that will be launched in FY 2014</b><b>called “The Patient Safety Plan”.</b> The Plan seeks<br />to ensure that health IT is safely designed and<br />implemented, medical staff are properly<br />informed and trained to use their health IT<br />systems, and a surveillance system is established<br />to monitor health IT related patient safety events<br />and ensure that unsafe conditions are corrected.</div></div><br />I believe the health IT industry now realizes some form of regulation is inevitable after, for example, revelations from medical malpractice insurers that a significant number of lawsuits involve the effects of health IT (see for instance my post "<b>Malpractice Claims Analysis Confirms Risks in EHRs</b>" at <a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html">http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html</a>).<br /><br />I also believe that industry and its pundits have pushed for the most favorable regulation possible.  This involves pushing for regulation by agencies with the least agency independence as possible, as I bring out below.  <br /><br />HHS along with its member branches FDA, AHRQ and ONC are <b>executive departments</b> of the US government  The legislation that governs the way such departments and agencies may propose and establish regulations is the <b>Administrative Procedure Act of 1946</b> (<a href="http://en.wikipedia.org/wiki/Administrative_Procedure_Act">http://en.wikipedia.org/wiki/Administrative_Procedure_Act</a>).<br /><br />First, it seems the executive branch is attempting to concentrate more power within itself over health IT through proposals like in the FY2014 HHS document.<br /><br />I also point out that that HHS (and its offices such as ONC, FDA etc.) are federal executive departments.  <a href="http://en.wikipedia.org/wiki/United_States_federal_executive_departments" target="_blank">http://en.wikipedia.org/wiki/<wbr></wbr>United_States_federal_<wbr></wbr>executive_departments</a>. These are <i>not entirely independent of presidential control</i>:<br /><br /><blockquote>"The heads of the federal executive departments, known as secretaries of their respective department, form the traditional Cabinet of the United States, an executive organ that<b> serves at the disposal of the president </b>and normally act as an advisory body to the presidency."</blockquote><br />In other words, the leaders serve at the pleasure of the President. <br /><br />This is as opposed to the executive department cousin, the federal independent agency, such as the NRC (Nuclear regulatory commission) and NTSB (national transportation safety board) that are independent agencies (<a href="http://en.wikipedia.org/wiki/Independent_agencies_of_the_United_States_government" target="_blank">http://en.wikipedia.org/wiki/<wbr></wbr>Independent_agencies_of_the_<wbr></wbr>United_States_government</a>):<br /><br /><blockquote>Independent agencies of the United States federal government are those agencies that exist outside of the federal executive departments (those headed by a Cabinet secretary). More specifically, the term may be used to describe agencies that, while constitutionally part of the executive branch, <b>are independent of presidential control, usually because the president's power to dismiss the agency head or a member is limited.</b></blockquote><br />It is no secret the administration is determined to push as rapid as possible rollout of health IT, come hell or high water, via HITECH, its coming penalties and other measures.  Its predecessor administration was a bit more genteel and circumspect in this regard.<br /><br />It is clear to me that, in the current political environment, <b>regulation by a federal executive agency is minimalist and will likely be politically ineffective, due to fear of its leadership of being dismissed if they upset the upper echelons.   </b><br /><br />I note that Jeffrey Shuren, a physician and attorney, director of FDA CDRH already stated in 2010 that "health IT is a political hot potato" as a reason that FDA "has <span style="font-size: 100%;">largely refrained from enforcing our regulatory requirements</span>."  See my April 2011 post <b>"FDA Decides Regulating Implantable Defibrillator Medical Devices a 'Political Hot Potato'; Demurs"</b> at <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html</a> for links to source.<br /><br />I believe it would be better to place the authority for health IT regulation under the aegis of a <i>federal independent agency</i>, whether an existing one or one created for that purpose, so that its leaders are more independent of executive branch control.<br /><br />-----<br /><br />I predict that without meaningful regulation, this is where the health IT industry will find itself in a few years.<br /><blockquote class="tr_bq"><a href="http://www.reuters.com/article/2014/03/11/us-autos-gm-recall-probe-idUSBREA2A1RZ20140311" target="_blank">http://www.reuters.com/<wbr></wbr>article/2014/03/11/us-autos-<wbr></wbr>gm-recall-probe-<wbr></wbr>idUSBREA2A1RZ20140311</a><br /><br />Reuters - <b>Federal prosecutors are examining whether General Motors is criminally liable for failing to properly disclose problems with some of its vehicles that were linked to 13 deaths and led to a recall last month</b>, according to a source familiar with the investigation.<br /><br />The New York-based probe is in its early stages, and the source did not elaborate on the legal theory behind the potential criminal liability.<br /><br />.. Federal investigators are reviewing information about how GM handled reports of problems with ignition switches that first came to light 10 years ago, according to the source.<br /><br />The federal probe by the U.S. attorney in Manhattan adds to a growing list of U.S. authorities examining the recall, which GM announced in February. The National Highway Traffic Safety Administration (NHTSA) previously opened an investigation into whether GM reacted swiftly enough in its recall.<br /><br /><b>Earlier <span class="aBn" data-term="goog_540420150" tabindex="0"><span class="aQJ">on Tuesday</span></span>, Reuters reported that a U.S. Senate committee chairman is seeking a hearing on the issue. The U.S. House Energy and Commerce Committee also ordered GM and NHTSA to turn over information about GM's ignition switch problems.</b><br /><br />The problems in some instances allowed the engine and other components, including front airbags, to turn off while the vehicle was traveling at high speed. More than 1.6 million older vehicles are affected.<br /><br />The failure is believed to be caused when weight on the ignition key, road conditions or some other jarring event causes the ignition switch to move out of the "run" position, turning off the engine and most of the car's electrical components mid-drive, with sometimes catastrophic results.<br /><br />GM has recommended that owners use only the ignition key with nothing else on the key ring.<br /><br />.. The House committee examining the GM issue, led by Michigan Republican Fred Upton, gave the company and NHTSA until <span class="aBn" data-term="goog_540420151" tabindex="0"><span class="aQJ">March 25</span></span> to turn over information about their responses to consumers' complaints about the problem.<br /><br />The committee has asked GM officials to provide a briefing no later than <span class="aBn" data-term="goog_540420152" tabindex="0"><span class="aQJ">March 18</span></span> on how GM has responded to reports of incidents since 2003 and its interaction with NHTSA since then on problems related to the ignition defect.<br /><br />Upton led the 2000 investigation into Firestone tire failures on Ford Motor Co vehicles, resulting in the TREAD Act that requires automakers to report complaints of defects to the NHTSA.<br /><br /><b>That law also makes it a crime to intentionally mislead the agency about defects that lead to serious accidents.</b><br /><br />... The person familiar with the criminal probe declined to discuss whether prosecutors were considering liability under the TREAD Act.</blockquote><br /> In fact, there is no good reason the health IT sector has been excluded from such actions, through an unprecedented regulatory accommodation this single healthcare sector has enjoyed for decades - namely, that of no true regulation at all.<br /><span class="userContent"> </span> <br /><br /><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/AVvXsEjAREJP0qSqoHqaCCq9y3x81HIJTzS6-HLSU3as_BIzCDOfNAHgX2WAaVEFDLHSYhUMaJFX_l6DHv-RxT00pyP3RJcFQfgbCqBsXJG_-xohfHQYOYO1jqYyqUUObqd3ro9ymPy1cI1ivlXh/s1600/dilbert.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="150" 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QFormat="true" Name="Subtle Emphasis"/> <w:LsdException Locked="false" Priority="21" SemiHidden="false" UnhideWhenUsed="false" QFormat="true" Name="Intense Emphasis"/> <w:LsdException Locked="false" Priority="31" SemiHidden="false" UnhideWhenUsed="false" QFormat="true" Name="Subtle Reference"/> <w:LsdException Locked="false" Priority="32" SemiHidden="false" UnhideWhenUsed="false" QFormat="true" Name="Intense Reference"/> <w:LsdException Locked="false" Priority="33" SemiHidden="false" UnhideWhenUsed="false" QFormat="true" Name="Book Title"/> <w:LsdException Locked="false" Priority="37" Name="Bibliography"/> <w:LsdException Locked="false" Priority="39" QFormat="true" Name="TOC Heading"/> </w:LatentStyles></xml><![endif]--><!--[if gte mso 10]><style> /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin-top:0in; mso-para-margin-right:0in; mso-para-margin-bottom:10.0pt; mso-para-margin-left:0in; line-height:115%; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"Times New Roman"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin;} </style><![endif]--> <br /><div class="MsoNormal">Sure, let's regulate a <s>potentially</s> proven dangerous healthcare technology, health IT (a glamor child of this administration) by a federal executive agency that serves "at the disposal" of the President ... instead of a federal independent agency, with ... uh ...better independence.  Great idea!</div></td></tr></tbody></table><br />-- SS<br /><br /><b>3/12/14 Addendum:</b><br /><br />Note this report of possible delays by the Department of Transportation on disclosure of GM ignition defects, by its National Highway Traffic Safety Administration branch, that caused fatalities and where disclosure could have (and finally now has) resulted in huge legal problems for GM.  GM is a company that was a centerpiece of the administration's economic interventions in recent years:<br /><br /><blockquote class="tr_bq"><b>Did the Obama White House Protect GM? </b><br /><br />Liz Peek<br />The Fiscal Times<br />March 12, 2014</blockquote><blockquote><a href="http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM">http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM</a><br /><br />Did the Obama administration purposefully hide problems with GM cars? Were they panicked that a massive recall of GM products would undermine one of President Obama’s most self-congratulatory campaign themes – that he “saved” Detroit’s auto industry?<br /><br />This is a tale of two car companies: GM, shining star in President Obama’s reelection galaxy, and Toyota, which became political fodder.<br /><br />The House Energy and Commerce Committee announced two days ago that it would undertake an investigation into why it took GM until quite recently to address a decade of complaints about stalling problems with several car models, <b>and why the National Highway Traffic Safety Administration did not demand a recall of the troubled lines earlier on</b>.  <b><span style="color: red;"><i>[Because they were afraid to? - ed.]</i></span></b>  Reports of unexpected stalling in Chevy Cobalts began to trickle in as early as 2003 when 7 incidents were relayed to NHTSA, according to The New York Times ... </blockquote><br />Read the whole article.<br /><br />The Department of Transportation is ... you guessed it ... a <a href="http://en.wikipedia.org/wiki/United_States_federal_executive_departments">federal executive agency</a>, not a federal independent agency.<br /><br />-- SS<br /><br /><br /><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;"><div class="field field-name-field-author-ref field-type-entityreference field-label-hidden"><div class="field-items"><div class="field-item odd"><a href="http://www.thefiscaltimes.com/Authors/P/Liz-Peek" rel="author">Liz Peek</a></div></div></div><span class="field field-name-field-source field-type-taxonomy-term-reference field-label-hidden"><span class="field-items"><span class="field-item odd first last">The Fiscal Times</span></span></span><br /><div class="field field-name-field-release-date field-type-datetime field-label-hidden"><div class="field-items"><div class="field-item odd"><span class="date-display-single">March 12, 2014</span></div></div></div><div class="field field-name-body field-type-text-with-summary field-label-hidden"><div class="field-items"><div class="field-item odd">Did the Obama administration purposefully hide problems with GM cars? Were they panicked that a massive recall of GM products would undermine one of President Obama’s most self-congratulatory campaign themes – that he “saved” Detroit’s auto industry?<br />This is a tale of two car companies: GM, shining star in President Obama’s reelection galaxy, and Toyota, which became political fodder.<br />The House Energy and Commerce Committee announced two days ago that it would undertake an investigation into why it took GM until quite recently to address a decade of complaints about stalling problems with several car models, and why the National Highway Traffic Safety Administration did not demand a recall of the troubled lines earlier on.  Reports of unexpected stalling in Chevy Cobalts began to trickle in as early as 2003 when 7 incidents were relayed to NHTSA, <a href="http://www.nytimes.com/2014/03/09/business/auto-regulators-dismissed-defect-tied-to-13-deaths.html?_r=0">according to The New York Times</a>.</div></div></div>- See more at: http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM#sthash.Ed9FH0ZD.dpuf</div><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;">National Highway Traffic Safety Administrationsuspected of causing many deaths:  "Did the Obama White House Protect GM?", The Fiscal TimesMarch 12, 2014, <a href="http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM">http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM</a>.Note that the Department of Transportation is ... you guessed it ... a <a href="http://en.wikipedia.org/wiki/United_States_federal_executive_departments">federal executive department</a>.</div><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;">Did the Obama White House Protect GM?</div><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;">Did the Obama White House Protect GM?</div>

Regulation of HIT by federal independent agency vs. federal executive agency / Open criminal probe of GM recall

In the FY2014 HHS budget-in-brief document (PDF at http://www.hhs.gov/budget/fy2014/fy-2014-budget-in-brief.pdf ) on page 115, there's t...

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But Don't Worry, Your Health Information is Secure: the Enforcers are Themselves Incompetent and Broke

Another in my <b>"But Don't Worry, Your Health Information is Secure"</b> series (see <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy</a>) ... a promise blindly made by the healthcare information technology hyper-enthusiasts<span style="color: #1f497d;">.</span><br /><br /><blockquote class="tr_bq"><span style="color: #1f497d;">The Office of the Inspector General for HHS just issued a report finding that the Office of Civil Rights (OCR), <i>which is charged with enforcing the HIPAA/HITECH law</i>, had itself failed to adequately protect the security of the health information it handled. Specifically OIG found that OCR “focused on system operability to the detriment of system and data security.”</span></blockquote><br /><span style="color: #1f497d;">From <b>“The Office for Civil Rights Did Not Meet All Federal Requirements in Its Oversight and Enforcement of the Health Insurance Portability and Accountability Act Security Rule”</b>, p. ii (Nov. 2013).  <a href="http://oig.hhs.gov/oas/reports/region4/41105025.asp">http://oig.hhs.gov/oas/reports/region4/41105025.asp</a></span><a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=cnmQxxd1ok6fZ7r1yAFMffFwO7p2yNAIzU9ZEphzhXivZep_Icu-CQf-7PEVpCAa1XTvDnjs5d4.&URL=http%3a%2f%2foig.hhs.gov%2foas%2freports%2fregion4%2f41105025.asp" style="color: purple;" target="_blank"></a><br /><br /><div class="line">Summary:</div><div class="line"><br /></div><blockquote class="tr_bq">The Office for Civil Rights (OCR) did not meet certain Federal requirements critical to the oversight and enforcement of the Health Insurance Portability and Accountability Act Security Rule (Security Rule). <b>OCR had not assessed risks, established priorities, or implemented controls for its Federal requirements to provide for periodic audits of covered entities to ensure their compliance with Security Rule requirements. </b>In addition, OCR's Security Rule investigation files did not contain required documentation supporting key decisions made <b>because management had not implemented sufficient controls, including supervisory review and documentation retention, to ensure investigators follow investigation policies and procedures for properly initiating, processing, and closing Security Rule investigations.</b> Further, OCR had not fully complied with Federal cybersecurity requirements for its information systems used to process and store investigation data because it focused on system operability <span style="color: red;"><i><b>[I presume they mean 'interoperability' - ed.]</b></i></span> to the detriment of system and data security.<br /><br />We recommended that OCR (1) assess the risks, establish priorities, and implement controls for its HITECH auditing requirements; (2) provide for periodic audits in accordance with HITECH to ensure Security Rule compliance at covered entities; (3) implement sufficient controls, such as supervisory reviews and documentation retention, to ensure policies and procedures for Security Rule investigations are followed; and (4) implement the National Institute of Standards and Technology Risk Management Framework for systems used to oversee and enforce the Security Rule. In its comments on our draft report, OCR generally concurred with our recommendations and described the actions it has taken to address them. In specific comments on our second recommendation, however, <b>OCR explained that no funds had been appropriated for it to maintain a permanent audit program and that funds used to support audit activities previously conducted were no longer available.</b></blockquote><br />The enforcers are themselves negligent, incompetent and broke.  And hospitals are expected to keep electronic protected health information secure? <br /><br />I comment no further.  What more could I possibly write?<br /><br />-- SS<br /><br /><b>Dec. 9, 2013 Addendum:</b><br /><br />This woman would probably agree that this is a problem<br /><br /><blockquote class="tr_bq">Dec. 9, 2013<br /><a href="http://www.thestar.com/news/gta/2013/11/28/disabled_woman_denied_entry_to_us_after_agent_cites_supposedly_private_medical_details.html">http://www.thestar.com/news/gta/2013/11/28/disabled_woman_denied_entry_to_us_after_agent_cites_supposedly_private_medical_details.html </a><br /><br /><b>Disabled woman denied entry to U.S. after agent cites supposedly private medical details</b><br /><br />A Toronto woman is shocked after she was denied entry into the U.S. because she had been hospitalized for clinical depression.<br /><br />Ellen Richardson went to Pearson airport on Monday full of joy about flying to New York City and from there going on a 10-day Caribbean cruise for which she’d paid about $6,000.<br /><br />But a U.S. Customs and Border Protection agent with the Department of Homeland Security killed that dream when he denied her entry.<br /><br />“I was turned away, I was told, because I had a hospitalization in the summer of 2012 for clinical depression,’’ said Richardson, who is a paraplegic and set up her cruise in collaboration with a March of Dimes group of about 12 others.<br /><br />The Weston woman was told by the U.S. agent she would have to get “medical clearance’’ and be examined by one of only three doctors in Toronto whose assessments are accepted by Homeland Security. She was given their names and told a call to her psychiatrist “would not suffice.’’<br /><br />At the time, Richardson said, she was so shocked and devastated by what was going on, she wasn’t thinking about how U.S. authorities could access her supposedly private medical information.<br /><br />“I was so aghast. I was saying, ‘I don’t understand this. What is the problem?’ I was so looking forward to getting away . . . I’d even brought a little string of Christmas lights I was going to string up in the cabin. . . . It’s not like I can just book again right away,’’ she said, referring to the time and planning that goes into taking a trip as a disabled person.<br /><br />Richardson said she’d had no discussion whatsoever with the agent at the airport about her medical history or background. </blockquote><br />Read the whole thing.<br /><br />-- SS

But Don't Worry, Your Health Information is Secure: the Enforcers are Themselves Incompetent and Broke

Another in my "But Don't Worry, Your Health Information is Secure" series (see http://hcrenewal.blogspot.com/search/label/med...

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Cybernetik Über Alles Again: HHS and Sebelius - Hospitals And Their Computers Have More Rights Than Patients

A Nov. 29, 2012 New York Times article by Reed Abelson entitled "<a href="http://www.nytimes.com/2012/11/29/business/medicare-is-faulted-in-electronic-medical-records-conversion.html" target="_blank">Medicare Is Faulted on Shift to Electronic Records</a>" observes that:<br /><br /><blockquote class="tr_bq">The conversion to electronic medical records — a critical piece of the Obama administration’s plan for health care reform — is “vulnerable” to fraud and abuse because of the failure of Medicare officials to develop appropriate safeguards, according to a sharply critical report to be issued Thursday by federal investigators <i><b><span style="color: red;">[the report from HHS OIG is </span><a href="https://oig.hhs.gov/oei/reports/oei-05-11-00250.pdf" target="_blank">here</a> <span style="color: #cc0000;">- ed.]</span></b></i> ... Medicare, which is charged with managing the incentive program that encourages the adoption of electronic records, has failed to put in place adequate safeguards to ensure that information being provided by hospitals and doctors about their electronic records systems is accurate. To qualify for the incentive payments, doctors and hospitals must demonstrate that the systems lead to better patient care, <b>meeting a so-called meaningful use standard</b> by, for example, checking for harmful drug interactions. <span style="color: red;"><i><b>[I note that meeting EHR "meaningful use" standards does not necessarily signify better care; the "standards" are experimental - ed.]</b></i></span></blockquote><br />Hospitals and doctors are lying about their EHR efforts, in order to gain incentive payments, it seems.<br /><br />In an article "<a href="http://www.publicintegrity.org/2012/11/29/11865/medicare-paid-36-billion-electronic-health-records-didnt-verify-quality-goals-were" target="_blank">IG says program is 'vulnerable' to abuse, better oversight needed</a>", Fred Schulte at the Center for Public Integrity notes:<br /><br /><blockquote class="tr_bq">... the Centers for Medicare and Medicaid Services has since paid out more than<b> $3.6 billion</b> to medical professionals who made the switch without verifying they are meeting the required quality goals, according to a new federal <a href="https://oig.hhs.gov/oei/reports/oei-05-11-00250.pdf">audit</a> to be released today </blockquote><br />Observes the CEO of the American Health Information Management Association:<br /><blockquote class="tr_bq"><br />“We’ve gone from the horse and buggy to the Model T, and we don’t know the rules of the road. Now we’ve had a big car pileup,” said Lynne Thomas Gordon, the chief executive of the American Health Information Management Association, a trade group in Chicago.  </blockquote><br />More Horse and Buggy than Model T.  At least the Model T was reasonably dependable.  <br /><br />Also mentioned is this:<br /><br /><blockquote class="tr_bq"><div itemprop="articleBody">House Republicans echoed these concerns in early October <a href="http://waysandmeans.house.gov/uploadedfiles/hhs_ehr_mu2_final.pdf" title="The letter to Ms. Sebelius.">in a letter</a> to Kathleen Sebelius, secretary of health and human services. Citing the Times article, they called for suspending the incentive program until concerns about standardization had been resolved. “The top House policy makers on health care are concerned that H.H.S. is squandering taxpayer dollars by asking little of providers in return for incentive payments,” said a statement issued at the same time by the Republicans, who are likely to seize on the latest inspector general report as further evidence of lax oversight. Republicans have said they will continue to monitor the program.</div><div itemprop="articleBody"><br /></div>In her letter in response, which has not been made public, Ms. Sebelius dismissed the idea of suspending the incentive program, arguing that it “<b>would be profoundly unfair to the hospitals and eligible professionals that have invested billions of dollars and devoted countless hours of work to purchase and install systems and educate staff</b>.”</blockquote><br /><br />I was taught "first, do no harm."  Fairness <i>to patients injured and killed</i> by this technology in its present "Horse and Buggy" state (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" target="_blank">buggy</a> being a particularly apropos term) seems not a matter of particularly high concern to HHS.   A suspension of incentives would slow the adoption rate down, necessary in order to "get the bugs" out of the technology before mass deployment and develop safety, validation and surveillance standards (currently non-existent), as I wrote in my Oct. 24, 2012 "<a href="http://hcrenewal.blogspot.com/2012/10/letter-to-us-senators-and.html" target="_blank">Letter To U.S. Senators and Representatives Who've Sought HHS Input On EHR Problems</a>."<br /><br />This is despite the fact that FDA, IOM and others have indicated the level of harm is <b>not known</b>, due to systematic impediments to diffusion of that knowledge (see IOM statements in the midsection of my post on health information technology hyper-enthusiasm <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">at this link</a>, and an internal FDA memo on HIT safety <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">at this link</a>).  <br /><br />HHS seems to care not about health and human services, or at best to be severely misguided.  "<a href="http://hcrenewal.blogspot.com/2011/10/cybernetik-uber-alles-computers-have.html" target="_blank">Cybernetik Über Alles</a>" seems their current credo.<br /><br />-- SS

Cybernetik Über Alles Again: HHS and Sebelius - Hospitals And Their Computers Have More Rights Than Patients

A Nov. 29, 2012 New York Times article by Reed Abelson entitled " Medicare Is Faulted on Shift to Electronic Records " observes th...

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Letter To U.S. Senators and Representatives Who've Sought HHS Input On EHR Problems

Several members of Congress have written HHS demanding meetings on health IT issues such as upcoding, test overutilization, misuse of incentive programs, and other factors as <a href="http://ihealthtran.com/wordpress/2012/10/senate-republicans-send-letter-to-sebelius-with-concerns-over-meaningful-use/" target="_blank">here</a>.<br /><br />However, what was largely left out was the issue of safety.<br /><br />I've written this letter to the congresspeople who've written to HHS secretary Sebelius (PDF available <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/EHR_congress_letter_oct24_2012_final.doc" target="_blank">at this link</a>):<br /><br /><blockquote class="tr_bq"><div class="MsoNormal"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">October 24, 2012</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">To:</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Sens. Coburn, Burr, Roberts and Thune</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Reps. Ellmers, Camp, Herger, Upton and Pitts</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">United States</span><span style="font-family: Arial; font-size: 10.0pt;"> Congress</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Washington</span><span style="font-family: Arial; font-size: 10.0pt;">, DC</span><span style="font-family: Arial; font-size: 10.0pt;"></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Re:<span style="mso-spacerun: yes;">  </span>HITECH and healthcare information technology</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Dear Senators and Representatives,</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">I applaud your recent inquiries to HHS regarding critical issues related to healthcare information technology (EHRs, physician order entry, decision supporting systems, etc.)  Issues such as the possible role of these systems in upcoding and Medicare overbilling, test overutilization, abuse of incentives, etc. must be addressed.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">However, you did not address an issue probably more important to the public, indeed to us all as patients – that of health information technology <i style="mso-bidi-font-style: normal;">safety.</i></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Congress must be made aware that health IT exists in two forms:  <b style="mso-bidi-font-weight: normal;">good health IT </b>and<b style="mso-bidi-font-weight: normal;"> bad health IT</b>.  <span style="mso-bidi-font-weight: bold;">Bad health IT reduces safety, creates close calls, injures, kills, raises costs, and sacrifices information privacy and confidentiality, among other ill effects</span>.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Congress must also be made aware that unfortunately due to systemic impediments to free flow of information about health IT systems and lack of FDA or other independent industry regulation, bad health IT is rarely removed from the marketplace or fixed.  </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">FDA and its director of the Center for Devices and Radiological Health (CDRH), Jeffrey Shuren MD JD, testified to HHS in Feb. 2010 that “under the Federal, Food, Drug, and Cosmetic Act, health information technology software is a medical device”, but that FDA has “largely refrained from enforcing our regulatory requirements with respect to HIT devices.”  </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">To clarify about the two types of health IT:</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><b><span style="font-family: Arial; font-size: 10.0pt;">Good Health IT</span></b><span style="font-family: Arial; font-size: 10.0pt;"> provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes. </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><b><span style="font-family: Arial; font-size: 10.0pt;">Bad Health IT </span></b><span style="font-family: Arial; font-size: 10.0pt;">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. </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">The Agency for Healthcare Research and Quality (AHRQ) recently reported that the highest prevalence of medical technology safety issues was related to EHR systems.<span style="mso-spacerun: yes;">  </span>Even worse, there is a lack of reporting transparency. Harms are known of, but the magnitude admittedly unknown due to systematic impediments to reporting transparency, collection and analysis, as noted by FDA in a 2010 internal memo and IOM itself in its 2012 report on health IT safety.  This is unprecedented in modern medicine, violates patient’s rights, and under no circumstances should be considered acceptable.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">I personally know of adverse patient outcomes including death related to bad health IT that are unreported (even in a state that mandates reporting of medical incidents and serious events), as do numerous colleagues.<span style="mso-spacerun: yes;">  </span></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">The Institute of Medicine has just released a Discussion Paper written by experts in health information technology entitled “<b>Comparative User Experiences of Health IT Products: How User Experiences Would Be Reported and Used"  </b>(<a href="http://www.iom.edu/Global/Perspectives/2012/%7E/media/Files/Perspectives-Files/2012/Discussion-Papers/comparative-user-experiences.pdf" target="_blank">http://www.iom.edu/Global/Perspectives/2012/~/media/Files/Perspectives-Files/2012/Discussion-Papers/comparative-user-experiences.pdf</a>). The recommendations in this paper need to be put into place, and Congressional awareness of the issues and official inquiry as to when this will happen is essential.  </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">This paper’s recommendations will not happen without the oversight of Congress.  As stated in the paper itself, “Some medical and IT leaders have invested their reputations, and their organization’s time and money, in the software [implementation] program; complaints that expose large problems may not be appreciated or carried forward.” </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Some claim safeguards are already in place in the form of HHS certification of health IT.  </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Unfortunately, the HHS health IT certification guidelines do not have sufficient depth nor the correct focus to distinguish between bad health IT and good health IT.  Certification for MU does not look at real-world testing for safety, reliability and usability, for instance, under real loads, in actual clinical settings, and is not very thorough.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">On the other hand,  NASA, the pharmaceutical industry (via FDA's regulation of pharmaceutical research and manufacturing IT) and others dependent on mission-critical software have rigorous validation procedures to check for such factors, e.g., NASA’s "<a href="http://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/20040014965_2004000657.pdf" target="_blank">Certification Processes for Safety-Critical andMission-Critical Aerospace Software</a>" that includes rigorous testing to distinguish bad IT from good IT, and remediate or abandon the former.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">p. 6-7:  In order to meet most regulatory guidelines, developers <span style="mso-bidi-font-weight: bold;">must build a safety case</span> as a means of documenting the safety justification of a system. The safety case is a <span style="mso-bidi-font-weight: bold;">record of all safety activities</span> associated with a system throughout its life. Items contained in a safety case include the following:<br /><br />• Description of the system/software<br />• Evidence of <span style="mso-bidi-font-weight: bold;">competence of personnel</span>involved in development of safety-critical software and any safety activity<br />• Specification of <span style="mso-bidi-font-weight: bold;">safety requirements</span><br />• Results of <span style="mso-bidi-font-weight: bold;">hazard and risk analysis</span><br />• Details of <span style="mso-bidi-font-weight: bold;">risk reduction</span>techniques employed<br />• Results of design analysis showing that the <span style="mso-bidi-font-weight: bold;">system design</span> <span style="mso-bidi-font-weight: bold;">meets all required safety targets</span><br />• <span style="mso-bidi-font-weight: bold;">Verification and validation strategy</span><br />• Results of <span style="mso-bidi-font-weight: bold;">all verification and validation activities</span><br />• Records of<span style="mso-bidi-font-weight: bold;"> safety reviews</span><br />• Records of <span style="mso-bidi-font-weight: bold;">any incidents which occur throughout the life of the system</span><br />• Records of all changes to the system and<span style="mso-bidi-font-weight: bold;"> justification of its continued safety</span></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">These processes need to be put in place regarding healthcare IT as well, but will take much time and regulatory push on the industry to occur.  In the absence of truly rigorous testing, though, transparency is essential.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">The aforementioned IOM Discussion Paper outlines the creation of a nationwide post-marketing surveillance process and transparency on health IT usability problems, safety issues, billing fraud promotion, etc. is essential.  It recommends:</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">“Flight simulator”-like, thorough laboratory evaluation of test scenarios;</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">Point-of-use reporting by doctors and nurses on their experiences;</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">Third party–administered doctor and nurse surveys about their experiences with EHR systems;</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">Direct clinician-to-public reporting; and</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">A formalized system of hazards reporting from EHR systems.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">These measures are essential if the technology is to achieve the benefits of which it is theoretically capable, but not presently achieving despite the hundreds of billions of dollars being spent.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">In conclusion, I ask you to add to your inquiries the subject of health information technology safety.  That includes the need for HHS to develop a robust, transparent national reporting system for safety problems created by the technology, and a system to ensure that bad health IT is either fixed in a timely manner or removed from the marketplace.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Sincerely,</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Scot Silverstein, MD</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">-----------------------------------------------------------------</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Scot M. Silverstein, MD</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Adjunct faculty in Healthcare Informatics and IT (Sept. 2007-present)</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Assistant Professor of Healthcare Informatics and IT, and Director, Institute for Healthcare Informatics (2005-7)</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Drexel</span><span style="font-family: Arial; font-size: 10.0pt;"> University</span><span style="font-family: Arial; font-size: 10.0pt;"></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">College</span><span style="font-family: Arial; font-size: 10.0pt;"> of Information Science</span><span style="font-family: Arial; font-size: 10.0pt;"> and Technology</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">3141 Chestnut St.</span><span style="font-family: Arial; font-size: 10.0pt;">, Philadelphia, PA 19104-2875</span><span style="font-family: Arial; font-size: 10.0pt;"></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Email:<span style="mso-spacerun: yes;">  </span>sms88 AT drexel DOT edu </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Bio:<span style="mso-spacerun: yes;">  </span><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm">http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm</a> </span></div></blockquote><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;"></span></div><br /><br />I hope this letter has some beneficial effect.<br /><br />-- SS

Letter To U.S. Senators and Representatives Who've Sought HHS Input On EHR Problems

Several members of Congress have written HHS demanding meetings on health IT issues such as upcoding, test overutilization, misuse of incent...

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Hospitals and Doctors Use Health IT at Their Own Risk - Even if "Certified"

Due to my observations of confusion about health IT certification<span style="font-weight: bold;"> [1]</span>, and due to vague or incomplete seller language that could be misinterpreted by buyers (perhaps by design), I recently asked several ONC-ATCBs (HHS's Office of the National Coordinator for Health IT-Authorized Testing and Certification Bodies) the following.<br /><br />I sent this question via email to their "questions" email addresses:<br /><br /><blockquote>"Is EHR certification by an ATCB a certification of EHR safety, effectiveness, and a legal indemnification, i.e., certifying freedom from liability for EHR use of clinical users or organizations? Or does it signify less than that?"</blockquote><br />One ONC-ATCB provided the following in response to my request for information.<br /><br /><br /><div style="margin-left: 40px;">From: Trivedi, Amit V (ICSA Labs)<br />Sent: Thursday, February 16, 2012 11:22 AM<br />To: Scot Silverstein<br />Subject: RE: Form submission from: Contact Us<br /><br />Hello Scot,<br /><br />Thanks for your email. Certification by an ATCB signifies that the product or system tested has the capabilities to meet specific criteria published by NIST and approved by the Office of the National Coordinator. In this case the criteria are designed to support providers and hospitals achieve "Meaningful Use." A subset of the criteria deal with the security and patient privacy capabilities of the system.<br /><br />Here is a list of the specific criteria involved in our testing:<br /><a href="http://healthcare.nist.gov/use_testing/effective_requirements.html" target="_blank">http://healthcare.nist.gov/<wbr></wbr>use_testing/effective_<wbr></wbr>requirements.html</a><br /><br />In a nutshell, ONC-ATCB Certification deals with testing the capabilities of a system, some of them relate to patient safety, privacy and security functions (audit logging, encryption, emergency access, etc.).<br /><br /><span style="font-weight: bold;">What was suggested in the email below (freedom from liability for users of the system, etc.) would be out of scope for ONC-ATCB testing based on the given criteria. </span><span style="color: red; font-style: italic; font-weight: bold;">[I.e., certification criteria - ed.]</span> I hope that helps to answer your question.<br /><br />Thanks,<br /><br />Amit<br /><br />Amit Trivedi<br />Program Manager - Healthcare<br />ICSA Labs, an Independent Division of Verizon Business</div><br /><br /><span style="font-size: 100%;"><span style="font-size: 100%;"><b>Mar. 5, 2012 Addendum:</b>  I also received a response from another ONC-ATCB, the Drummond Group:</span></span><br /><span style="font-size: 100%;"><span style="font-size: 100%;"><br /></span></span><br /><blockquote><span style="font-size: 100%;"><span style="font-size: 100%;">From: Joani Hughes (Drummond Group)</span></span><br /><span style="font-size: 100%;"><span style="font-size: 100%;">Sent: Monday, March 05, 2012 1:06 PM</span></span><br /><span style="font-size: 100%;"><span style="font-size: 100%;">To: Scot Silverstein</span></span><br /><span style="font-size: 100%;"><span style="font-size: 100%;">Subject: RE: EHR certification question</span></span><br /><span style="font-size: 100%;"><span style="font-size: 100%;"><br /></span></span><span style="font-size: 100%;"><span style="font-size: 100%;">Per our testing team:</span></span><br /><span style="font-size: 100%;"><span style="font-size: 100%;"><br /></span></span><span style="font-size: 100%;"><span style="font-size: 100%;"><span style="color: #3366ff;">It is less than that. It does not address indemnification although a certification could be used as a conditional part of some other form of indemnification function, such as a waiver or TOA, but that is ultimately out of the scope of the certification itself. <b>Certification in this sense is an assurance that the EHR functions in way that could enable an eligible provider or eligible hospital to meet the CMS requirements of Meaningful Use Stage 1.</b> Or to restate it more directly, CMS is expecting eligible providers or eligible hospitals to use their EHR in “meaningful way” quantified by various quantitative measure metrics and eligible providers or eligible hospitals can only be assured they can do this if they obtain a certified EHR technology.</span></span></span><br /><span style="font-size: 100%;"><span style="font-size: 100%;"><br /></span></span><span style="font-size: 100%;"><span style="font-size: 100%;">Please let me know if you have any questions.</span></span><br /><span style="font-size: 100%;"><span style="font-size: 100%;"><br /></span></span><span style="font-size: 100%;"><span style="font-size: 100%;">Thank you,</span></span><br /><span style="font-size: 100%;"><span style="font-size: 100%;">Joani.</span></span><br /><span style="font-size: 100%;"><span style="font-size: 100%;"><br /></span></span><span style="font-size: 100%;"><span style="font-size: 100%;">Joani Hughes</span></span><br /><span style="font-size: 100%;"><span style="font-size: 100%;">Client Services Coordinator</span></span><br /><span style="font-size: 100%;"><span style="font-size: 100%;">Drummond Group Inc.</span></span></blockquote><span style="font-weight: bold;"><br /></span>These are direct and clear statements.<br /><br />My question was certainly answered. ONC cerification is <b>not </b>a safety validation, such as in a document from NASA on aerospace software safety certification, "<a href="http://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/20040014965_2004000657.pdf">Certification Processes for Safety-Critical and Mission-Critical Aerospace Software</a>" (PDF) which specifies at pg. 6-7:<br /><br /><blockquote>In order to meet most regulatory guidelines, developers <span style="font-weight: bold;">must build a safety case</span> as a means of documenting the safety justification of a system. The safety case is a <span style="font-weight: bold;">record of all safety activities</span> associated with a system throughout its life. Items contained in a safety case include the following:<br /><br />• Description of the system/software<br />• Evidence of <span style="font-weight: bold;">competence of personnel</span> involved in development of safety-critical software and any<br />safety activity<br />• Specification of <span style="font-weight: bold;">safety requirements</span><br />• Results of <span style="font-weight: bold;">hazard and risk analysis</span><br />• Details of <span style="font-weight: bold;">risk reduction</span> techniques employed<br />• Results of design analysis showing that the <span style="font-weight: bold;">system design</span> <span style="font-weight: bold;">meets all required safety targets</span><br />• <span style="font-weight: bold;">Verification and validation strategy</span><br />• Results of <span style="font-weight: bold;">all verification and validation activities</span><br />• Records of<span style="font-weight: bold;"> safety reviews</span><br />• Records of <span style="font-weight: bold;">any incidents which occur throughout the life of the system</span><br />• Records of all changes to the system and<span style="font-weight: bold;"> justification of its continued safety</span> </blockquote><br />Health IT testing conspicuously lacks attention to most of the aerospace software safety points above. <span style="font-style: italic;">I note that there appears to be no reasonable excuse for such omissions.</span><br /><br />IOM has recently studied the issue of HIT safety. IOM states in a Nov. 2011 report that HIT safety and safety testing is unsatisfactory, and has recommended HHS study it as well. IOM recommends HHS annually re-evaluate whether regulation is needed to improve safety, although IOM favors industry self-policing <span style="font-weight: bold;">[2]</span>.<br /><br />Thus, buyers and users of even "ONC certified" health IT <span style="font-weight: bold;">are not indemnified from liability</span> due to medical errors or problems caused by the health IT.<br /><br />Sellers who exaggerate the value of certification or imply its meaning is akin to FDA device approval, likewise, could be faulted for making false representations about their products.<br /><br />It would appear the sellers could potentially be sued for doing so by purchasers/users who themselves get into legal hot water due to EHR defects or other problems.<br /><br />-- SS<br /><br /><span style="font-size: 100%;">Note:<br /><br />[1] I believe confusion about EHR "certification" is in part due to the term itself. I raised objections to this term when it was first proposed based on my experience in pharma, suggesting what I felt was the more accurate expression "</span><span style="font-size: 100%; font-style: italic;">features qualification</span><span style="font-size: 100%;">" instead.<br /><br />[2] "Health IT and Patient Safety: Building Safer Systems for Better Care", Institute of Medicine of the National Academies, Nov. 2011, <a href="http://www.iom.edu/Reports/2011/Health-IT-and-Patient-Safety-Building-Safer-Systems-for-Better-Care.aspx">http://www.iom.edu/Reports/2011/Health-IT-and-Patient-Safety-Building-Safer-Systems-for-Better-Care.aspx</a><span style="font-size: 100%;"><br /></span></span><br /><span style="font-size: 100%;"><span style="font-size: 100%;"><br /></span></span>

Hospitals and Doctors Use Health IT at Their Own Risk - Even if "Certified"

Due to my observations of confusion about health IT certification [1] , and due to vague or incomplete seller language that could be misint...

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Former US Secretary of Health and Human Services Saunters Through Revolving Door, Ends Up as Director of Medtronic

There they go again.  Another US government health care leader, this time the top health care leader at the end of the previous George W Bush administration, has wound up in a leadership position in a big, for-profit health care corporation.  As per the press release <a href="http://www.bizjournals.com/twincities/news/2011/10/17/medtronic-board-leavitt-fda.html">published</a> in the Minneapolis-St Paul Business journal,<br /><blockquote>Mike Leavitt, the former Governor of Utah who also oversaw the Food and Drug Administration for four years, has been <em>elected to the board of Medtronic Inc</em>. <br /><br />Leavitt is the <em>founder and chairman of Leavitt Partners, which advices clients in the healthcare and food safety sectors</em>, according to a news release from Fridley-based Medtronic (NYSE: MDT).<br /><br />He served as governor of Utah from 1993 through 2003. Former President George W. Bush appointed Leavitt administrator of the Environmental Protection Agency in late 2003 and <em>secretary of Health and Human Services in January 2005. Leavitt served in that position into January 2009</em>.<br /><br />At Health and Human Services, <em>he oversaw the FDA and the Center for Medicare and Medicaid Services — two agencies that are important to Medtronic</em>, which makes medical devices.</blockquote><br />Mr Leavitt's full-time job is to chair <a href="http://leavittpartners.com/">Leavitt Partners</a>, which advertises that it "advises clients that invest in health care and food safety." It does not publicize its client list, but that list apparently includes Alliance Health Networks, whose press release noted that Leavitt Partners "will help it expand its presence in the US health industry and beyond "(look <a href="http://www.healthcareitnews.com/news/alliance-health-networks-gets-boost-leavitt-partners">here</a>); and Connextions, Inc, whose press release noted that it would work with Leavitt Partners to " refine existing health insurance exchange models for federal and state governments, as well as private sector organizations that are navigating health care reform law," (look <a href="http://www.businesswire.com/news/home/20110614005331/en/Connextions-Leavitt-Partners-Enter-Agreement-Bring-Health">here.</a>)<br /><br />Note that Mr Leavitt's official Department of Health and Human Services <a href="http://www.hhs.gov/secretary/dhhssec.html">biography</a> listed no training or experience in direct health care (or in biomedical sciences or the engineering of health care devices, for that matter.) Before he was Secretary of HHS, he was Governor of Utah, and before then, he was the CEO of an insurance company.  Since I very much doubt Mr Leavitt is a large Medtronic shareholder, it would appear that the rationale for his position on its board is his conectedness with other powerful health care insiders. <br /><br /><strong>Summary: the Revolving Door</strong><br /><br />Mr Leavitt did not transit the revolving door as quickly as did other health care leaders from that administration.  We <a href="http://hcrenewal.blogspot.com/2010/12/former-nih-director-spins-trhough.html">noted</a> in 2010 that the leaders of the US Food and Drug Administration (FDA), US National Institute of Health (NIH), and US Centers for Disease Control (CDC) at the end of the Bush administration had already gotten powerful positions in the health care corporate world.  Mr Leavitt is not the first recent former Secretary of HHS to become the director of a big health care corporation whose fortunes may be affected by what HHS does.  We <a href="http://hcrenewal.blogspot.com/2011/06/embedded-networks-of-influence-in.html">noted</a> in 2011 how rapidly the Secretary of HHS at the end of the William Clinton administration, Donna Shalala, signed up as a director for UnitedHealth.  We have also noted a variety of <a href="http://hcrenewal.blogspot.com/search/label/revolving%20doors">other examples</a> of the revolving door phenomenon. <br /><br />These examples suggest how the leaders of government health care agencies and health care corporations are becoming interchangeable, forming a giant embedded network of influence.  Furthermore, they suggest how top government health care leaders can now expect a cushy corporate position to open up as soon as they can legally accept it.  Whether government leaders who expect such future job opportunities will avoid offending possible corporate employers while in office, even if giving such offense would be good for patients' or the public's health, is an open question.  The answer, I fear, may be obvious.    <br /><br />These examples suggest that the US is becoming increasingly corporatist, a country dominated by an unholy alliance between top leaders of government and of large corporations, who are becoming increasingly interchangeable.  Another way of putting it is the country is increasingly dominated by an insider elite that manipulates the system for its own benefit.  <br /><br />A recent <a href="http://www.theatlantic.com/politics/archive/2011/10/can-an-overpaid-ceo-and-2-sleazy-union-lobbyists-unite-us/247302/">article</a> in the Atlantic juxtaposed two cases, one that of a CEO given a golden retirement package after presiding over the decline of his media company, and two union lobbyists who gamed the system to get outsized pensions.  While the first example would commonly draw condemnation from the left wing, and the second from the right, they are similar, and similar to those of  revolving doors we have discussed.   Author Conor Friedersdorf summarized the cases thus<br /><blockquote>neither the CEO nor the lobbyists were paid what they earned, nor were they compensated in a way that made the relevant stakeholders better off. Instead <em>they were taken care of in a way that reflected their elite insider status and their ability to take advantage of wrinkles in the system</em> while breaking no laws. In both cases, <em>less politically connected people -- other Gannett employees, Gannett shareholders, readers of Gannett newspapers, Illinois school teachers, and Illinois taxpayers -- were unjustly made worse off by what transpired</em>. <em>And isn't the overlapping ethic that guided the behavior of these people a big part of what's wrong with America?</em><br /><br />Behavior like theirs is one reason Americans on the right and left have recently taken to the streets. Ours is a society that has always tolerated inequality of wealth; and so long as some imperfect degree of fairness is maintained in the getting of material goods, the system functions smoothly. But if people feel that wealth they struggled to earn is being taken from them to pad the nest eggs of dishonorable union lobbyists; or that they're at risk of being fired from their $14 an hour job if they're ten minutes late, whereas their ultimate boss retires with an eight-figure package after presiding over plummeting stock prices and massive layoffs; people put in situations like that eventually revolt, if they've concluded that <em>injustice is the norm rather than an aberration. </em></blockquote><br />I would propose that the fundamental injustice of having an insider elite run health care so as to put their self-interest first is the basis of what has gone wrong with health care (and the rest of the country, and maybe the world.) If we do not have the courage to first say this out loud, and then restore some rationality and justice to the structure and leadership of health care, the spiral will continue downward.<br /><br /><strong>Additional Thought</strong><br /><br />I expect if any of the insider elite's defenders bother to read this, one argument they might propose is it was always thus.  How can one expect people who work as government leaders for a short time not to take advantage of the best possible job offers when they leave?  My answer is that an admittedly cursory look at history suggests it has not always been thus.  Using Wikipedia as an imperfect but quick source, I found that <a href="http://en.wikipedia.org/wiki/Joseph_A._Califano,_Jr.">Joseph A Califano Jr</a>, the last Secretary of Health, Education and Welfare under President Carter worked at a law firm, founded the National Center for Addiction and Substance Abuse, and wrote books after he left office.  He did serve on a corporate board (CBS), but not for a health care corporation.  <a href="http://en.wikipedia.org/wiki/Patricia_Roberts_Harris">Patricia Roberts Harris</a>, the first Secretary of HHS under President Carter, became a law professor.  <a href="http://en.wikipedia.org/wiki/Otis_R._Bowen">Dr Otis R Bowen</a>, the last Secretary of HHS under President Reagan, retired after that, but served on some non-profit boards and government committees.

Former US Secretary of Health and Human Services Saunters Through Revolving Door, Ends Up as Director of Medtronic

There they go again.  Another US government health care leader, this time the top health care leader at the end of the previous George W Bus...

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Congresswoman Renee Ellmers on Health IT Concerns

A letter on Health IT from Congresswoman <a href="http://ellmers.house.gov/index.cfm?sectionid=94&sectiontree=2,94">Renee Ellmers</a>, (R) NC, Chairwoman of the U.S. House of Representative's Committee on Small Business, Subcommittee on Healthcare and Technology was just sent to Secretary of the Dept. of Health and Human Services Kathleen Sebelius.<br /><br />The themes in the letter will be familiar to readers of Healthcare Renewal.<br /><br />A PDF copy of the letter can be downloaded by clicking below, and the text follows.<br /><br /><br /><div style="text-align: center;"><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh_2qirVMyivJO381vV0HLJ5llEXSAZTVTTq38vhgR-RkUBW0XIKs_CJQR43Sxm1tjdVyB8YkT_9FcRqSwIU02xHFgfYVe4TnyG4852AOTTRfq0U1PbZEmb8qgX06yZPn2b4IDfipISDnDD/s1600/ellmers.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5639969911782066050" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh_2qirVMyivJO381vV0HLJ5llEXSAZTVTTq38vhgR-RkUBW0XIKs_CJQR43Sxm1tjdVyB8YkT_9FcRqSwIU02xHFgfYVe4TnyG4852AOTTRfq0U1PbZEmb8qgX06yZPn2b4IDfipISDnDD/s320/ellmers.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 246px; height: 320px;" /></a><span style="font-size:85%;">(<a style="font-weight: bold;" href="http://smbiz.house.gov/UploadedFiles/Health_IT_Concerns_Sebelius_8.11.11.pdf">click here</a> to download PDF)</span><br /></div><br /><br />Here is the text, along with several comments:<br /><blockquote><br />August 11, 2011<br /><br />The Honorable Kathleen Sebelius<br />Secretary<br />U.S. Department of Health and Human Services<br />200 lndependence Avenue, S.W.<br />Washington, DC 20201<br />Via Facsimile: 202. 690.7380<br /><br />Dear Secretary Sebelius:<br /><br />The House Small Business Committee, on which I serve, is required by the Rules of the House to study and investigate the problems of all types of small businesses. This jurisdiction extends to matters concerning small businesses and health care. I chair the Committee’s Subcommittee on Healthcare and Technology.<br /><br />On June 2, 2011, the Subcommittee held a hearing on the barriers to health information technology that are encountered by physicians and other providers in small practices. At the hearing, physicians testified that the cost to purchase and maintain a health IT system, is addition to staff training and downtime during the transition to health IT, are significant burdens for small practices. These barriers mere mentioned even by physicians who believe health IT would ultimately benefit their practices. Providers at the hearing also stated their concern about the Medicare reimbursement penalties that will be assessed against providers who do not demonstrate “meaningful use” of health IT by 2015.<br /><br />One of the frequently mentioned benefits of health IT has been a reduction in medical errors. However, recent news reports have noted incidents of health IT errors. An article in Sunday’s <span style="font-style: italic;">Pittsburgh Post-Gazette</span> <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[a series, actually, </span><a style="font-weight: bold; font-style: italic;" href="http://hcrenewal.blogspot.com/2011/05/healthcare-renewal-cited-in-pittsburgh.html">here</a><span style="font-weight: bold; font-style: italic;"> <span style="color: rgb(255, 0, 0);">and</span> </span><a style="font-weight: bold; font-style: italic;" href="http://www.post-gazette.com/pg/11219/1165767-114-0.stm?cmpid=nationworld.xml">here</a><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">- ed.] </span>cited a baby who was killed while computerized IV equipment prepared a lethal dose of an intravenous sodium chloride solution. The machine did not catch the pharmacy technician’s error. The article also noted that when a hepatitis C-positive kidney was accidentally transplanted from a live donor into a recipient, the physician team missed the electronic records alert, and the physicians complained that their electronic records system is cumbersome and difficult to adjust to any one physician’s needs.<br /><br /><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[You can be sure that my writings on health IT mission hostility, poor quality, lack of regulation, etc. as well as the cases of health IT-related injury and death I know of, including that of my own relative, will find their way to Rep. Ellmer's office - ed.]</span><br /><br />The Journal of the American Medical Association recently published a study of almost 4,000 computer-generated prescriptions that were received by a pharmacy chain. The report found that 12 percent of the prescriptions contained errors, which, the report said, is consistent with error rates with handwritten prescriptions. <span style="font-weight: bold; font-style: italic;"><span style="color: rgb(255, 0, 0);">[I wrote about that</span> </span><a style="font-weight: bold; font-style: italic;" href="http://hcrenewal.blogspot.com/2011/06/electronic-medication-prescribing-magic.html">here</a><span style="font-weight: bold; font-style: italic;"> <span style="color: rgb(255, 0, 0);">- ed.]</span></span><br /><br />A modern, well-equipped office is critical to the practice of medicine, and <span style="font-weight: bold;">health IT offers promise to all medical professionals.</span> <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[But only when done well - and there is massive complexity behind those simple two words "done well" that is poorly recognized and/or ignored - ed.] </span>Health IT has the potential to improve health care delivery, decrease medical errors, increase clinical and administration efficiency, and reduce paperwork.<br /><br />We most do all we can to ensure a commitment to our health care system and patient care. As technology rapidly evolves, <span style="font-weight: bold;">I ask that you consider a study of health IT’s adoption, benefits and cost effectiveness.</span> <span style="font-weight: bold; font-style: italic;"><span style="color: rgb(255, 0, 0);"><br /><br />[Cart before the horse when being done AFTER a national multi-billion dollar rollout is put into law,</span> <a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html">as I wrote here</a>, <span style="color: rgb(255, 0, 0);">but better late than never - ed.]</span> </span><br /><br />As part of the study, I hope you will also consider medical error rates — both human and technological --so that all errors can he better assessed and prevented.<br /><br /><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[I have been calling for this for years now - ed.]</span><br /><br />Sincerely,<br />Renee Ellmers<br /><br />Chairwoman<br />Subcommittee on Healthcare and Technology<br />House Committee on Small Business </blockquote><br />I find this letter from a leading member of the House of Representatives remarkable. Importantly, Chairwoman Ellmers has a medical background (HHS Secretary Sebelius, to my knowledge, does not). Here is part of Chairwoman Ellmer's <a href="http://en.wikipedia.org/wiki/Renee_Ellmers">background</a> from Wikipedia:<br /><br /><blockquote>In 1990, she graduated with a <span style="font-weight: bold;">Bachelor of Science degree in Nursing</span>. Ellmers worked as a nurse in Beaumont Hospital's surgical intensive care unit. In North Carolina, she was clinical director of the Trinity Wound Care Center in Dunn.</blockquote><br />The only other letters like it asking questions like this that I know of came from a Republican Senator to the HIT vendors, Sen. Grassley of Iowa (see <a href="http://hcrenewal.blogspot.com/2009/10/washington-post-emrs-no-cure-all-sen.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/01/grassley-asks-hospitals-about.html">here</a>). Sen. Grassley also wrote directly on HIT problems to HHS Secretry Sebelius on Feb. 24, 2010; see the letter <a href="http://www.scribd.com/doc/27483558/Grassley-Feb-24-Letters">here</a>.<br /><br />-- SS

Congresswoman Renee Ellmers on Health IT Concerns

A letter on Health IT from Congresswoman Renee Ellmers , (R) NC, Chairwoman of the U.S. House of Representative's Committee on Small Bus...

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ONC Workgroup Document Misindentification - Just the Type of Computer "Glitch" That Can Kill People

A provocative title indeed.<br /><br />The Office of the National Coordinator's Health IT Standards Committee Implementation Workgroup recently had a meeting, Jan. 10-11, 2010.<br /><br />They've posted the testimony and supporting documents here: <a href="http://healthit.hhs.gov/portal/server.pt?open=512&objID=1482&&PageID=17128&mode=2">http://healthit.hhs.gov/portal/server.pt?open=512&objID=1482&&PageID=17128&mode=2</a> .<br /><br />I've copied & pasted these document links directly from the site, at 12:45 PM EST 1/14/2011:<br /><br /><ul><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949955/quespanels-implwg-11011_pdf">Instructions and Questions for Panelists [PDF - 381 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949969/biosketch-implwg-11011_pdf">Presenter Bio Sketch [PDF - 549 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949965/ureachtstmny-implwg-11010_pdf">Paul Kleeberg, MD [PDF - 443 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949962/udridgeph-implwg-11011_pdf">Dan Nelson -Testimony [PDF - 330 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949950/famhlthtstmy-implwg-11011_pdf">Lisa Levine [PDF - 125 KB]<br /></a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949944/cchittst-impwg-11011_pdf">CCHIT -Testimony [PDF - 95 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949956/raytst-implwg-11011_pdf">Alisa Ray -Testimony [PDF - 219 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949970/daikerbio-imwg-11011_pdf">Patricia Daiker - Bio [PDF - 75 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949974/medhost-implwg-11011_pdf">Medhost [PDF - 100 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949946/cernertstmny-implwg-11011_pdf">Cerner - Testimony [PDF - 716 KB]<br /></a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949945/application_vnd_ms-powerpoint">John Travis [PPT - 486 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949975/wkgpspch-implwg-11011_pdf">Brad Melis [PDF - 100 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949951/hammertstmy-ipwg-11011_pdf">Hammer -Testimony [PDF - 214 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949957/reedtstmy-implwg-11011_pdf">Linda Reed - Testimony [PDF - 320 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949964/updfuzypresnt-implwg-11011_pdf_%282%29">James Fuzy [PDF - 146 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949948/colemantstmny-11011-implwg_pdf">Reid W. Coleman [PDF - 164KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949966/whtleytst-implwg-11011_pdf">Careen Whitley -Testimony [PDF - 238 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949941/application_vnd_ms-powerpoint">Lyle Berkowitz Presentation [PPT - 325 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949940/berkowitz-implwg-11011_pdf">Lyle Berkowitz -Testimony [PDF - 289 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949954/murrytstmy-impwg-11011_pdf">Robert Murray -Testimony [PDF - 135 KB]</a></span> </li><li style="font-weight: bold;"><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949949/drummond-imwg-11011_pdf">Willa Drummond [PDF - 135 KB]</a></span> </li><li style="font-weight: bold;"><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949972/drumexsum-imwg-11011_pdf">Willa Drummond - Vital Sync System Test Bed [PDF - 128 KB]</a></span> </li><li style="font-weight: bold;"><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949972/drumexsum-imwg-11011_pdf">Willa Drummond - Collection of Problem Scenarios from Professional List Serve [PDF - 255 KB]</a></span> </li><li style="font-weight: bold;"><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_0_5448_1482_17128_43/http%3B/wci-pubcontent/publish/onc/public_communities/u_z/wg_month_pages/imple_feb/files/4b_drummond_adoptertimeline__3_.pdf">Willa Drummond - Timeline [PDF - 413 KB]</a> <a style="color: red; text-decoration: none;" title="Accessibility Compliance Disclaimer" href="http://www.blogger.com/post-edit.g?blogID=9551150&postID=9064943742526930453#disclaimer">*</a></span> </li><li style="font-weight: bold;"><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949972/drumexsum-imwg-11011_pdf">Willa Drummond - Ten Commandments for Computerized Healthcare Information Systems [PDF - 431 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949958/sadjatstmy-implwg-11011_pdf">Richard Sadja -Testimony [PDF - 291 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949959/scherpbier-imwg-11011_pdf">Harm Scherpbier [PDF - 24 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949961/suntstmny-implwg-11011_pdf">Sunquist -Testimony [PDF - 542 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949939/ahctstmony-implwg-11011_pdf">Nanvy Vogt -Testimony [PDF - 44 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949947/christian-impwg-11011_pdf">Chuck Christian [PDF - 95 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949952/mccolmbio-implwg-11011_pdf">Denni McColm -Bio [PDF - 78 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949953/mccolm-implwg-11011_pdf">Denni McColm -Testimony [PDF - 449 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949943/branzell-impwg-11011_pdf">Russ Branzell [PDF - 13 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_0_5448_1482_17128_43/http%3B/wci-pubcontent/publish/onc/public_communities/u_z/wg_month_pages/imple_feb/files/5b_bowesrevtestimony.pdf">Len Bowes [PDF - 301 KB]</a> <a style="color: red; text-decoration: none;" title="Accessibility Compliance Disclaimer" href="http://www.blogger.com/post-edit.g?blogID=9551150&postID=9064943742526930453#disclaimer">*</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_0_5448_1482_17128_43/http%3B/wci-pubcontent/publish/onc/public_communities/u_z/wg_month_pages/imple_feb/files/1_gillettcongressional_testimony_final.pdf">Gillette Congressional Tesimony [PDF - 163 KB]</a></span><a href="http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_0_5448_1482_17128_43/http%3B/wci-pubcontent/publish/onc/public_communities/u_z/wg_month_pages/imple_feb/files/1_gillettcongressional_testimony_final.pdf"><br /></a></li></ul><br />The problem is, <span style="font-weight: bold;">some of the URL's are simply wrong, </span><span>including several of the ones I've bolded.</span><br /><br />For instance, I tried to download Dr. Willa Drummond's documents:<br /><br /><ul><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949949/drummond-imwg-11011_pdf">Willa Drummond [PDF - 135 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949972/drumexsum-imwg-11011_pdf">Willa Drummond - Vital Sync System Test Bed [PDF - 128 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949972/drumexsum-imwg-11011_pdf">Willa Drummond - Collection of Problem Scenarios from Professional List Serve [PDF - 255 KB]</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_0_5448_1482_17128_43/http%3B/wci-pubcontent/publish/onc/public_communities/u_z/wg_month_pages/imple_feb/files/4b_drummond_adoptertimeline__3_.pdf">Willa Drummond - Timeline [PDF - 413 KB]</a> <a style="color: red; text-decoration: none;" title="Accessibility Compliance Disclaimer" href="http://www.blogger.com/post-create.g?blogID=9551150#disclaimer">*</a></span> </li><li><span style="font-size:85%;"><a href="http://healthit.hhs.gov/portal/server.pt/document/949972/drumexsum-imwg-11011_pdf">Willa Drummond - Ten Commandments for Computerized Healthcare Information Systems [PDF - 431 KB]</a></span> </li></ul><br />The links for "<span style="font-weight: bold;">Collection of Problem Scenarios from Professional List Serve</span>" and "<span style="font-weight: bold;">Ten Commandments for Computerized Healthcare Information Systems</span>" are simply <span style="font-style: italic;">wrong</span>.<br /><br />They lead to the incorrect documents as of this writing.<br /><br />By experimentation (borne of experience!), I found I could locate the correct documents by manually altering a number in the URL.<br /><br />For example, to locate the "<span style="font-style: italic;">Problem Scenarios</span>" document whose URL is linked as:<br /><br /><a href="http://healthit.hhs.gov/portal/server.pt/document/949972/drumexsum-imwg-11011_pdf"></a><blockquote><a href="http://healthit.hhs.gov/portal/server.pt/document/949972/drumexsum-imwg-11011_pdf">http://healthit.hhs.gov/portal/server.pt/document/949972/drumexsum-imwg-11011_pdf</a></blockquote><br />I had to alter the number 949972 to <span style="font-weight: bold;">949973</span>, like this:<br /><a href="http://healthit.hhs.gov/portal/server.pt/document/949973/drumexsum-imwg-11011_pdf"><br /></a><blockquote><a href="http://healthit.hhs.gov/portal/server.pt/document/949973/drumexsum-imwg-11011_pdf">http://healthit.hhs.gov/portal/server.pt/document/<span style="font-weight: bold;">949973</span>/drumexsum-imwg-11011_pdf</a></blockquote><br />I further had to experiment to find the "<span style="font-style: italic;">Ten Commandments</span>" document, also erroneously listed as at this URL ...<br /><br /><a href="http://healthit.hhs.gov/portal/server.pt/document/949972/drumexsum-imwg-11011_pdf"></a><blockquote><a href="http://healthit.hhs.gov/portal/server.pt/document/949972/drumexsum-imwg-11011_pdf">http://healthit.hhs.gov/portal/server.pt/document/949972/drumexsum-imwg-11011_pdf</a></blockquote><br />... but actually here at <span style="font-weight: bold;">949971</span>:<br /><a href="http://healthit.hhs.gov/portal/server.pt/document/949971/drumexsum-imwg-11011_pdf"><br /></a><blockquote><a href="http://healthit.hhs.gov/portal/server.pt/document/949971/drumexsum-imwg-11011_pdf">http://healthit.hhs.gov/portal/server.pt/document/<span style="font-weight: bold;">949971</span>/drumexsum-imwg-11011_pdf</a></blockquote><br />Presumably these erroneous indices will be fixed at some point. Are they due to computer and/or software error, or human error -- as in medicine, due to busy schedules, cognitive overload from a suboptimal IT user experience, and other factors?<br /><br />I do not consider these errors "minor" or at all humorous. <span style="font-weight: bold;">Leadership by example</span> - through fine attention to detail - in a supposed "HITECH" paperless-medicine promoting government organization - is what I expect.<br /><br />Similar "misidentification" errors in EHR systems can and do cause medications to be missed or given to the wrong patient - such as in the example at the Trinity Healthcare System as mentioned in my post "<a href="http://hcrenewal.blogspot.com/2010/08/huffington-post-investigative-fund-fda.html">Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight</a>" where an EHR "upgrade" caused considerable risk:<br /><br /><blockquote>... Computers at a major Midwest hospital chain went awry on June 29, posting some doctors’ orders to the wrong medical charts in a few cases and possibly putting patients in harm’s way.<br /><br />The digital records system “would switch to another patient record without the user directing it to do so,” said Stephen Shivinsky, vice-president for corporate communications at Trinity Health System<strong>. </strong>Trinity operates 46 hospitals, most in Michigan, Iowa and Ohio.<span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);"><br /><br />[In other words, data entered by clinicians was going into the wrong charts. How many charts were involved? Does the hospital system even know, I wonder? - ed.]</span><br /><br />Less than two weeks later, an unrelated glitch caused Trinity to shut down its $400 million system for four hours at 10 hospitals in the network because<span style="font-weight: bold;"> electronic pharmacy orders weren’t being delivered to nurses for dispensing to patients</span>, he said.</blockquote><br />See the many questions I raised about this episode at the followup post "<a href="http://hcrenewal.blogspot.com/2010/08/more-on-huffington-post-investigative.html">More on Huffington Post Investigative Fund: "FDA, Obama Digital Medical Records Team at Odds over Safety Oversight</a>." (I understand that the initial "fix" to the problem of "orders going to the wrong chart" was to prevent clinicians from opening more than one chart at a time, thus further interfering with clinicians' work.)<br /><br />"Glitches" cause sometimes crucial data to be lost, and even patients to be harmed or killed (e.g., see the gray banner at top of my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">site on HIT failure</a>, and my recent post "<a href="http://hcrenewal.blogspot.com/2011/01/ehr-problems-no-theyre-merely.html">EHR Problems? No, They're Merely Anecodotal; the Truth Must Be That I Attract Bad Electrons and Stale Bits</a>" on this blog).<br /><br />Ironically, the First Commandment in the mislinked Ten Commandments document above is:<br /><br /><blockquote>"The Computer shall find and collate all data generated by other computers."<br /><br /></blockquote>Perhaps it should read:<br /><br /><blockquote>"The Computer shall find and <span style="font-weight: bold;">correctly </span>collate all data generated by other computers."</blockquote><br />-- SS<br /><br /><span style="font-weight: bold;">1/14 addendum:</span><br /><br /> I looked specifically for those documents as my first retrievals on the HHS site due to past correspondence with Dr. Drummond. The pinball machine then tilted. <br /><br />Perhaps it is simply those bad electrons and stale bits that follow me around once more.

ONC Workgroup Document Misindentification - Just the Type of Computer "Glitch" That Can Kill People

A provocative title indeed. The Office of the National Coordinator's Health IT Standards Committee Implementation Workgroup recently had...

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