healthy4u: ONC

As the Door Turns - The Ongoing Interchange of Leaders Among Large Health Care Corporations, Those who Represent Them, and Government

The revolving door is the two-way conduit between leadership positions in government and industry that helps to enable health care, and maybe all of society, to be run by a group of insiders who can move easily between large or influential health care organizations and the government bodies that are supposed to regulate, oversee, and enforce laws relevant to them. It has been three months since our last <a href="http://hcrenewal.blogspot.com/2013/12/for-whom-door-revolves-from-for-profit.html">update</a> on the <a href="http://hcrenewal.blogspot.com/search/label/revolving%20doors">revolving door</a> as it applies to health care, so here is our latest effort, according to the chronological order of the initial media coverage.  Foundation Leader with Ties to Eli Lilly and to Former Synthes CEO to the White House As <a href="http://www.nytimes.com/2013/12/13/us/politics/new-obama-adviser-brings-corporate-ties.html">reported </a>by the New York Times in December, 2013, new White House senior adviser John D Podesta, who founded and ran the nominally non-profit organization Center for American Progress, had multiple ties to health care corporations and their leaders, e.g., to pharmaceutical maker Eli Lilly, <blockquote class="tr_bq">The pharmaceutical giant Eli Lilly was also a donor because of what it said was the Center for American Progress’s advocacy for patients’ rights — and just as the debate heated up in Washington over potential cuts to the Medicare program that covers Lilly’s most profitable drugs.</blockquote> Although, for the record, <blockquote class="tr_bq">Neera Tanden, the president of the Center for American Progress, said in an interview that the group frequently takes positions that conflict with the corporate agendas of its donors, including companies like Eli Lilly. </blockquote> Also an important but somewhat less obvious linkage was described thus by the Times,  <blockquote class="tr_bq"> In addition, he earned $90,000 as a consultant to the HJW Foundation of West Chester, Pa, according to an aide working with him on the disclosure report he is preparing. HJW is a nonprofit group run by Hansjörg Wyss, a billionaire businessman and major contributor to the Center for American Progress.</blockquote> What the Times did not say about Mr Wyss was that he is the former CEO of Synthes, a Swiss based medical device company, since merged into Johnson and Johnson   As we <a href="http://hcrenewal.blogspot.com/2011/12/it-was-best-of-times-it-was-worst-of.html">wrote</a> in 2011, <blockquote class="tr_bq"> Synthes USA, the American branch of a Swiss based device company, first settled charges that it had been paying surgeons with company stock to use its products in its clinical trials in 2009 (see <a href="http://hcrenewal.blogspot.com/2009/05/synthes-settles-agrees-to-stop-giving.html">this post</a>).  Then prosecutors alleged that these were not really rigorous trials. Instead, for marketing purposes, executives of Synthes subsidiary Norian persuaded surgeons to use its Norian XR product in a case series of spine surgery patients and then publish the results.  Three patients who received the product for this 'off-label' use died.  This scheme was alleged to have been directed by "person no. 7," whom journalists identified as the company CEO, Hansjorg Wyss (see post <a href="http://hcrenewal.blogspot.com/2009/06/synthes-indicted.html">here</a>.)   In an unusual move, the prosecutors indicted four company executives, who then pleaded guilty.  They did not take any further action against Wyss, who turns out to be one of the world's richest men (see post <a href="http://hcrenewal.blogspot.com/2009/12/person-no-7-also-known-as-83rd-richest.html">here</a>).</blockquote> However, at the time the former executives were sentenced, one of the executive's attorney's claimed, <blockquote class="tr_bq">Wyss was the undisputed leader of the company. 'He made some of the very critical decisions that put the trials on the ultimate pathway,' Gurney said. 'The culture of an organization is set at the top.'</blockquote> Former Deputy White House Press Secretary to Global Strategy Group, Whose Clients Include Pfizer, Purdue Pharma, and WellPoint As reported by the National Journal in December, 2013, <blockquote class="tr_bq">Bill Burton Old gig: Deputy White House press secretary New gig: Formed and ran Priorities USA Action, a super PAC that raked in more than $75 million during the 2012 campaign; recently joined the public affairs firm Global Strategy Group as a managing director. Clients <a href="http://globalstrategygroup.com/about/#our-clients">include</a> GE, Cisco, American Express, Comcast, and Pfizer.</blockquote> Other health care clients include health insurance company Empire BCBS, pharmaceutical company Purdue Pharma, and for-profit health insurance company WellPoint Former National Health Information Technology Coordinator to Get Real Health As <a href="http://www.govhealthit.com/news/former-national-coordinator-lends-credo-vision-patient-engagement-company">reported</a> by Government HealthIT in February, 2014, <blockquote class="tr_bq">Three months after leaving the federal government, [former National Coordinator for Health Information Technology] Farzad Mostashari, MD, is joining the board of directors at the patient engagement company Get Real Health. The big-thinking, bow-tied public health veteran is currently studying accountable care policies full-time at the Brookings Institution, and said he’s joining the Get Real Health board to help it '‘stay’ real as it innovates and serves patients and providers.' The Rockville, Maryland-based company was founded in 2000, starting out as a connected health consulting outfit and then, after working with Microsoft’s HealthVault in 2007, launching its own health technology in 2012, the InstantPHR patient engagement platform.</blockquote> From CareScience Inc to National Coordinator for Health Information Technology to Health Evolution Partners The <a href="http://www.govhealthit.com/news/former-national-coordinator-lends-credo-vision-patient-engagement-company">article</a> about Dr Mostashari also mentioned in passing a more complicated set of transitions involving an earlier national coordinator for health care information technology.    <blockquote class="tr_bq">Mostashari is not the only former national coordinators to step into the health IT private sector after federal service. David Brailer, MD, the first appointee to the role of the national coordinator for health IT, is now running the San Francisco private equity firm Health Evolution Partners.</blockquote> But in fact, according to his rather glowing Wikipedia <a href="http://en.wikipedia.org/wiki/David_Brailer">entry</a>, Dr Brailer also came from the commercial health care IT industry, <blockquote class="tr_bq"> In 1992, Brailer left academia and founded a company spun out of his Ph.D. thesis, inventing ways to measure health-care quality. This became CareScience Inc., a Philadelphia software firm that helped hospitals improve efficiency and prevent errors. Under Brailer, CareScience established the nation's first health care Application Service Provider (ASP). Brailer led the company through several financings, strategic partnerships, an initial public offering in 2000, and sale to global software firm Quovadx in 2003.</blockquote> <a href="http://en.wikipedia.org/wiki/David_Brailer#cite_note-11"></a> Then, in 2004, <blockquote class="tr_bq">Brailer was appointed as the first National Health Information Technology Coordinator, pursuant to an executive order by President George W. Bush on April 27, 2004, which called for widespread deployment of health information technology within 10 years.</blockquote> According to his Health Evolution Partners <a href="http://www.healthevolutionpartners.com/david-j-brailer-md-phd/">biography</a>, Dr Brailer is also now a member of the boards of directors of American Optical Services, CenseoHealth, Optimal Radiology, and Walgreen Co. From Aide to Congressman Young to a Lobbying Firm with Health Care Clients Then to Congress According to the <a href="http://www.tampabay.com/news/politics/elections/david-jolly-elected-to-represent-pinellas-county-in-congress/2169727">Tampa Bay Times</a>, yesterday Republican David Jolly won a special election to a congressional seat for Florida.  The article noted that Mr Jolly was "once an obscure aide to the late Republican U.S. Rep. C.W. Bill Young and then a Washington lobbyist,..." His past work was described in more detail in a <a href="http://www.republicreport.org/2014/jolly/">post</a> on the Republic Report blog, <blockquote class="tr_bq">David Jolly, the Republican congressional candidate vying for the special election in Florida next week, has not only made a career out of lobbying. Records reviewed by Republic Report show that Jolly’s clients won millions of dollars in taxpayer earmarks from his old boss, the late Rep. C.W. 'Bill' Young (R-FL), an appropriator known for his lavish use of the earmarking process. </blockquote> Futhermore, <blockquote class="tr_bq">Two of the firms that hired Jolly as a lobbyist - BayCare Health Systems and Alakai Defense Systmes - won lucrative earmarks from Young while paying Jolly to influence the committee where Young was a senior member. In 2009, BayCare Health Sytems retained Jolly and another former Young staffer named Douglas Gregory.  Later that year, Young secured a $1 million earmark for BayCare Health Systems for 'facilities and improvements.'</blockquote> Summary Note that the revolving door does not seem to discriminate according to political party or ideology.  The cases above involved both Republicans and Democrats. But the revolving door does discriminate against the not well connected, because it seems to provided preferred posts in the upper echelons of government for industry insiders, and preferred posts in the upper echelons of industry for government insiders.  As we have said many times before, the constant interchange of health care insiders among government, large health care corporations, and the lobbying and legal firms which represent them certainly suggests that health care, like many other sectors, seems to be run by an amorphous group of insiders who owe allegiance neither to government nor industry. However, those who work in government are supposed to be working for the people, and those who work on health care within government are supposed to be working for patients' and the public health.  If they are constantly looking over their shoulders at potential private employers who might offer big checks, who indeed are they working for? <div itemprop="articleBody"></div>Attempts to turn government toward private gain and away from being of the people, by the people, and for the people have no doubt been going on since the beginning of government (and since the Constitution was signed, in the case of the US).  However, true health care reform  would require curtailing the severe sorts of conflicts of interest created by the revolving door. Real heath care reform would require  multiyear cooling off periods before someone who worked in the commercial world can get a job in a government whose work has direct effect on his or her previous employer or industry sector, and before someone who worked in government whose work had direct effect on a particular economic sector can accept a job for a company in that sector.

As the Door Turns - The Ongoing Interchange of Leaders Among Large Health Care Corporations, Those who Represent Them, and Government

The revolving door is the two-way conduit between leadership positions in government and industry that helps to enable health care, and mayb...

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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: <div class="gmail_extra"> <div style="margin-left: 40px;">Patient Safety and Health IT Usability Patient safety and usability continue to be a focus for ONC. Working with federal partners AHRQ and FDA, ONC will create the foundation for a patient safety program that will be launched in FY 2014called “The Patient Safety Plan”. The Plan seeks to ensure that health IT is safely designed and implemented, medical staff are properly informed and trained to use their health IT systems, and a surveillance system is established to monitor health IT related patient safety events and ensure that unsafe conditions are corrected.</div></div> 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 "Malpractice Claims Analysis Confirms Risks in EHRs" 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>). 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.  HHS along with its member branches FDA, AHRQ and ONC are executive departments of the US government  The legislation that governs the way such departments and agencies may propose and establish regulations is the Administrative Procedure Act of 1946 (<a href="http://en.wikipedia.org/wiki/Administrative_Procedure_Act">http://en.wikipedia.org/wiki/Administrative_Procedure_Act</a>). 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. 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/United_States_federal_executive_departments</a>. These are not entirely independent of presidential control: <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 serves at the disposal of the president and normally act as an advisory body to the presidency."</blockquote> In other words, the leaders serve at the pleasure of the President. 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/Independent_agencies_of_the_United_States_government</a>): <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, are independent of presidential control, usually because the president's power to dismiss the agency head or a member is limited.</blockquote> 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. It is clear to me that, in the current political environment, 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.   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 largely refrained from enforcing our regulatory requirements."  See my April 2011 post "FDA Decides Regulating Implantable Defibrillator Medical Devices a 'Political Hot Potato'; Demurs" 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. I believe it would be better to place the authority for health IT regulation under the aegis of a federal independent agency, whether an existing one or one created for that purpose, so that its leaders are more independent of executive branch control. ----- I predict that without meaningful regulation, this is where the health IT industry will find itself in a few years. <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/article/2014/03/11/us-autos-gm-recall-probe-idUSBREA2A1RZ20140311</a> Reuters - 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, according to a source familiar with the investigation. 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. .. 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. 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. Earlier on Tuesday, 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. 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. 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. GM has recommended that owners use only the ignition key with nothing else on the key ring. .. The House committee examining the GM issue, led by Michigan Republican Fred Upton, gave the company and NHTSA until March 25 to turn over information about their responses to consumers' complaints about the problem. The committee has asked GM officials to provide a briefing no later than March 18 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. 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. That law also makes it a crime to intentionally mislead the agency about defects that lead to serious accidents. ... The person familiar with the criminal probe declined to discuss whether prosecutors were considering liability under the TREAD Act.</blockquote>  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.   <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" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjAREJP0qSqoHqaCCq9y3x81HIJTzS6-HLSU3as_BIzCDOfNAHgX2WAaVEFDLHSYhUMaJFX_l6DHv-RxT00pyP3RJcFQfgbCqBsXJG_-xohfHQYOYO1jqYyqUUObqd3ro9ymPy1cI1ivlXh/s1600/dilbert.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"> <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> -- SS 3/12/14 Addendum: 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: <blockquote class="tr_bq">Did the Obama White House Protect GM? Liz Peek The Fiscal Times 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> 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? This is a tale of two car companies: GM, shining star in President Obama’s reelection galaxy, and Toyota, which became political fodder. 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.  [Because they were afraid to? - ed.]  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> Read the whole article. 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. -- SS <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>The Fiscal Times <div class="field field-name-field-release-date field-type-datetime field-label-hidden"><div class="field-items"><div class="field-item odd">March 12, 2014</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? This is a tale of two car companies: GM, shining star in President Obama’s reelection galaxy, and Toyota, which became political fodder. 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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Five Years Into Compelled National Adoption of Electronic Medical Records, Which Were Advertised As Capable Of Only Good, ONC Issues Safety "Suggestions"

Ten years after creation of the ONC office, and almost five years into compelled national adoption of health IT under HITECH (financial penalties soon start to accrue for non-users or non-adopters of "certified" systems and in at least one state, denial of medical licensure), the HHS's Office of the National Coordinator for health IT released the cutely-named "SAFER" guides ("Safety Assurance Factors for EHR Resilience"). That's progress.  (A previous ONC leader, for instance, had opined that the FDA’s injury findings related to health IT that appeared in the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf">Internal FDA memorandum on HIT risks</a> were merely “anecdotal and fragmentary”;  see my April 2, 2011 post "Making a Stat Less Significant: Common Sense on 'Side Effects' Lacking in Healthcare IT Sector" at <a href="http://hcrenewal.blogspot.com/2011/04/common-sense-on-side-effects-lacking-in.html">http://hcrenewal.blogspot.com/2011/04/common-sense-on-side-effects-lacking-in.html</a>.) While these Guides are a welcome first step, I observe: These Guides are really an admission HHS and the pundits have been pushing a technology, at best, of an unknown safety profile onto medicine and onto the public.  (The harm profile is becoming better understood, e.g., see the ECRI Institute Deep Dive Study on health IT risk at <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>, a study not just remarkable for its results but also for its strange regulator and press invisibility).  I guess that's par for the course in today's world. I also opine these guides would not have appeared at all, if not for grass-roots efforts in exposing health IT dangers over the years. That said, more on the guides, and a link to them: <blockquote class="tr_bq"><a href="http://www.healthit.gov/policy-researchers-implementers/safer">http://www.healthit.gov/policy-researchers-implementers/safer</a> SAFER Guides The SAFER guides consist of nine guides organized into three broad groups. These guides enable healthcare organizations to address EHR safety in a variety of areas. Most organizations will want to start with the Foundational Guides, and proceed from there to address their areas of greatest interest or concern. The guides identify recommended practices to optimize the safety and safe use of EHRs. The content of the guides can be explored here, at the links below, or interactive PDF versions of the guides can be downloaded and completed locally for self-assessment of an organization’s degree of conformance to the Recommended Practices. The downloaded guides can be filled out, saved, and transmitted between team members.</blockquote> The overall purpose: <blockquote class="tr_bq">This guide is designed to help safely manage the individual and organizational responsibilities in a complex "sociotechnical" healthcare organization. </blockquote> (I note that "sociotechnical" is not really a decriptor of an organization; rather, it is a descriptor of inter-related issues in a healthcare organization.  More properly, a healthcare organization is an entity where implementation of health IT requires "consideration of many sociotechnical issues", or, "is an organization that is sociotechnically complex".  I also note a somewhat loose use of the scientific term "Informatics" in the guides, e.g., "Informatics-type department."  But, whatever.  When a word is used in healthcare today, it means, paraphrasing what a character in a Lewis Carroll book said to a woman named Alice, just what the healthcare leadership chooses it to mean - neither more nor less. (The irony is that Medical Informatics is a field that has as one of its major core competencies the defining of precise language and definitions.) Read the Guides at the above link, but these "guides" are really a set of "Health IT 101", Masters-of-the-Obvious rules of thumb, presented in a "sparse display" format. For instance: <ul><li>The highest-level decision makers (e.g., boards of directors or owners of physician practices) are committed to promoting a culture of safety that incorporates the safety and safe use of EHRs.</li></ul><ul><li>An effective decision-making structure exists for managing and optimizing the safety and safe use of the EHR.</li></ul><ul><li>Staff members are assigned responsibility for the management of clinical decision support (CDS) content.</li></ul><ul><li>Practicing clinicians are involved in all levels of EHR safety-related decision making that impact clinical use.</li></ul> I won't display them further. While this is not an unwelcome development, here are the caveats: 1.  Disclaimer on page 1 of "Organizational Responsibilities" document: <blockquote class="tr_bq">In some instances, Meaningful Use and/or HIPAA Security Rule requirements are identified in connection with recommended practices. The SAFER Guides are not intended to be used for legal compliance purposes, and implementation of a recommended practice does not guarantee compliance with Meaningful Use, HIPAA, or other laws. The SAFER Guides are for informational purposes only and are not intended to be an exhaustive or definitive source. They do not constitute legal advice or offer recommendations based on a healthcare provider’s specific circumstances. Users of the SAFER Guides are encouraged to consult with their own legal counsel with regard to compliance with Meaningful Use, HIPAA, and other laws.</blockquote> "For informational purposes only?" Wow.  I feel SAFER already ... (too late for my mother, though). <table cellpadding="0" class="Bs nH iY" role="presentation"><tbody><tr><td class="Bu">Who is going to evaluate whether hospitals are carrying out these recommendations properly?    Joint Commission?  FDA?  As it appears now, the answer is ... nobody.  </td></tr></tbody></table> In effect, these "guidelines" are issued for "self-assessment" in a regulatory vacuum, with no validation of compliance, no reporting requirements, no formal surveillance, etc.  Hiring the right people, doing all these things, and doing them effectively, is not cheap. Translation: these guidelines are safely ignored, to be put on a shelf somewhere. 2.  The focus of these documents seems to put the responsibility for health IT safety on the customer/user.  Problem is, the ability to compensate for the deficits of fundamentally poorly designed and bad health IT is limited, just as a "safe flying practices" manuals for pilots cannot compensate completely for faulty aircraft design.  Especially if the manuals are for "self assessment" and there is no FAA-mandated oversight, testing and operational surveillance ... 3.  Thus, these guides appear to be a "baby step" in the true sense of the word, and "tension management" in the political sense, a term used by my claimed-Communist sociology professor several decades ago to refer to government actions that made it appear, falsely, that the government was truly "doing something" for the people.  While I am certainly not a Communist, he had a point... <div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjWSGFFdv9UG9AMt1HpcQpSULolTX-pATxEc9hW4tQJiNySMgmh3P8MjLvCnvrqc2bXIClwbKrJs4_UHUN_mFdTJps6bwhtffM3I2Ftgl4xzfTyfFlIUNWR5o3uwlnTApItIDurTvsb3mJT/s1600/caspar.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjWSGFFdv9UG9AMt1HpcQpSULolTX-pATxEc9hW4tQJiNySMgmh3P8MjLvCnvrqc2bXIClwbKrJs4_UHUN_mFdTJps6bwhtffM3I2Ftgl4xzfTyfFlIUNWR5o3uwlnTApItIDurTvsb3mJT/s1600/caspar.jpg" width="145" /></a></div> In summary, while welcome, at best a "milk and toast" award needs to be given to HHS and its health IT arm, ONC for these guidelines. -- SS

Five Years Into Compelled National Adoption of Electronic Medical Records, Which Were Advertised As Capable Of Only Good, ONC Issues Safety "Suggestions"

Ten years after creation of the ONC office, and almost five years into compelled national adoption of health IT under HITECH (financial pena...

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EHR cut-and-paste problem is only one of the several mechanisms to clone documentation - and facilitate fraud

In my Dec. 10, 2013 post "44% of hospitals reported to HHS that they can delete the contents of their EHR audit logs whenever they'd like" (<a href="http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html">http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html</a>) I observed that the "money quote" of the Modern Healthcare article that prompted the post, "Feds eye crackdown on cut-and-paste EHR fraud" by <a href="mailto:jcarlson@modernhealthcare.com" target="_blank">Joe Carlson</a> was not the issue of EHR cut-and-paste features and billing fraud, but EHRs and audit trail alteration. Dr. Stephen R. Levinson, an E/M compliance and healthcare quality expert among other areas of expertise (see <a href="http://www.linkedin.com/in/stephenlevinson">http://www.linkedin.com/in/stephenlevinson</a>), wrote me with the following regarding the issue I glossed over in favor of the audit trail concerns, namely, EHR cloning. Reproduced with Dr. Levinson's permission: <blockquote class="tr_bq">This long-recognized and high-profile problem [EHR cut and paste, copy forward, etc. - ed.] covers only one of the several mechanisms EHRs provide to create CLONED Documentation. Other non-compliant short-cuts include documentation by exception (auto-entry of extensive negative history reviews and normal comprehensive examinations), use of restricted pick list words and phrases, and "translation." Translation is my own terminology for taking actively entered "yes" or "no" responses in medical history (and "normal" or "abnormal" findings in physical exam) and using pre-loaded software to convert (i.e., translate) the response to a long pseudo dictation paragraph. For example, check a box for lungs being "normal" may automatically appear in a paragraph as "lungs clear to percussion and auscultation; respiratory effort is normal on inspiration and expiration with normal excursions of the diaphragm; there are no rales or rhonchi, and no wheezes are present." This extended statement will appear identically in patient after patient and visit after visit, regardless of whether this level exam was performed. Further, the likelihood of every patient having completely normal lungs is non-existent.  [This is one mechanism by which reams of "legible gibberish" are produced even with modest hospital stays, e.g., see my Feb. 27, 2011 post "Two Weeks, Two Reams" at <a href="http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html">http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html</a> - ed.] Finally, although cloned documentation is egregious, there are four other equally egregious non-compliant documentation and coding features, common to most EHRs, that are being totally ignored by OIG. These 4 features are: 1) non-compliant coding engines (including failure to consider medical necessity of the level of care) 2) Replacing narrative documentation of differential diagnoses with billing codes (ICD-9) and billing semantics 3) Failure to document the qualitative components of E/M coding, while addressing only quantitative components (e.g., when patient has a positive response to review of systems question on chest pain, compliance (and quality care) requires further investigation and documentation of further details; most current systems either lack ability to document these details or fail to guide and require physicians to document them) 4) Failure to incorporate consideration of "medical necessity" (indicated in E/M coding as the "nature of the presenting problems") into care, documentation, and coding</blockquote> As evidenced by these explanations, common commercial EHRs in use today were either designed by amateurs or by crooks, with the gatekeepers turning a blind eye towards abuses since at least 2007 (per commenter and EHR compliance expert Dr. Reed Gelzer who, at <a href="http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html">http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html</a>, indicated ONC and OIG knew of these issues since a 2007 report he contributed to). The gatekeepers have turned a blind eye, that is, until now when they've finally opened one eye very slightly, like a ten-day-old puppy, as the abuses become more widely known. <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/AVvXsEhdGG663K2XijBFNigZfHwVmLpFLgpCBrFX0e5PhiNJncsHPqiOqeB4XYVVBnDx17jKEBObsuCBriTk4wzIYibrxTW8zOoHH84Rizg0YHVbEn59H-wqeC_O9ozMcYdy99UrcXKebsr1GoFC/s1600/week2-puppy2eyes.gif" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="151" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhdGG663K2XijBFNigZfHwVmLpFLgpCBrFX0e5PhiNJncsHPqiOqeB4XYVVBnDx17jKEBObsuCBriTk4wzIYibrxTW8zOoHH84Rizg0YHVbEn59H-wqeC_O9ozMcYdy99UrcXKebsr1GoFC/s200/week2-puppy2eyes.gif" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Young puppy begins to open its eyes.</td></tr></tbody></table> -- SS

EHR cut-and-paste problem is only one of the several mechanisms to clone documentation - and facilitate fraud

In my Dec. 10, 2013 post " 44% of hospitals reported to HHS that they can delete the contents of their EHR audit logs whenever they'...

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An Open Letter to David Bates, MD, Chair, ONC FDASIA Health IT Policy Committee on Recommendations Against Premarket Testing and Validation of Health IT

From <a href="http://www.healthit.gov/policy-researchers-implementers/federal-advisory-committees-facas/fdasia">http://www.healthit.gov/policy-researchers-implementers/federal-advisory-committees-facas/fdasia</a>: <blockquote class="tr_bq">The Food and Drug Administration Safety Innovation Act (FDASIA) Health IT Policy Committee Workgroup is charged with providing expert input on issues and concepts identified by the Food and Drug Administration (FDA), Office of the National Coordinator for Health IT (ONC), and the Federal Communications Commission (FCC) to inform the development of a report on an appropriate, risk-based regulatory framework pertaining to health information technology including mobile medical applications that promotes innovation, protects patient safety, and avoids regulatory duplication.</blockquote> My Open Letter to the Committee's chair speaks for itself: <blockquote class="tr_bq">From: Scot Silverstein Date: Mon, Sep 16, 2013 at 9:39 AM Subject: ONC FDASIA Health IT Policy Committee's recommendations on Premarket Surveillance To: David Bates Sept. 16, 2013 David Bates, Chair, ONC FDASIA Health IT Policy Committee via email     Dear David, I am disappointed (and in fact appalled) at the ONC FDASIA Health IT Policy Committee's recommendations that health IT including typical commercial EHR/CPOE systems not be subjected to a premarket testing and validation process.  I believe this recommendation is, quite frankly, negligent. [1] As you know, my own mother was injured and then died as a result of EHR deficiencies, and nearly injured or killed again in the recuperation period from her initial injuries by more health IT problems in a second EHR used in her care.  In my legal consulting and from my colleagues, as well as from the literature, I hear about other injuries/deaths and many "near misses" as well.  That your recommendations came in the face of the recent ECRI Deep Dive study is even more appalling, with the latter's finding of 171 health IT-related incidents in 9 weeks from 36 member PSO hospitals, resulting in 8 injuries and 3 possible deaths, all reported voluntarily. [2] It is my expert opinion the issues that cause these outcomes would never have made it into production systems, had a reasonable, competent, unbiased premarket testing and validation process been in place. Consequently, I have shared the FDASIA HIT Policy Committee's recommendations with the Plaintiff's Bar, and will use its recommendations in my presentations to various chapters of the American Association for Justice (the trial lawyer's association) - as well as to interested Defense attorneys so they may advise their clients accordingly. I am also making recommendations that in any torts, individual or class, regarding EHR problems that would likely have been averted with competent premarket testing and validation, that the FDASIA HIT Policy Committee members who agreed with the recommendation be considered possible defendants. I am sorry it has come to this. Please note I am also posting this message for public viewing at the Healthcare Renewal weblog of the Foundation for Integrity and Responsibility in Medicine (FIRM). Sincerely, Scot Silverstein, MD Consultant/Independent Expert Witness in Healthcare Informatics Adjunct Faculty, Drexel University, College of Computing and Informatics Notes: [1] FDA Law Blog, Recommendations of FDASIA Health IT Workgroup Accepted, September 11, 2013, available at <a href="http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/09/recommendations-of-fdasia-health-it-workgroup-accepted.html">http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/09/recommendations-of-fdasia-health-it-workgroup-accepted.html</a>: "Of particular interest is the recommendation that health IT should generally not be subject to FDA premarket requirements, with a few exceptions:  medical device accessories, high-risk clinical decision support, and higher risk software use cases." [2] "Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI 'Deep Dive' Study of Health IT Events" , Feb. 28. 2013, available at <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>.</blockquote> ----------------------------------------------- Note: the following are listed on the linked site above as members of the committee: <div>Member List</div><ul><li>David Bates, Chair, Brigham and Women’s Hospital</li><li>Patricia Brennan, University of Wisconsin-Madison</li><li>Geoff Clapp, Better</li><li>Todd Cooper, Breakthrough Solutions Foundry, Inc.</li><li>Meghan Dierks, Harvard Medical Faculty, Division of Clinical Informatics</li><li>Esther Dyson, EDventure Holdings</li><li>Richard Eaton, Medical Imaging & Technology Alliance</li><li>Anura Fernando, Underwriters Laboratories</li><li>Lauren Fifield, Practice Fusion, Inc.</li><li>Michael Flis, Roche Diagnostics</li><li>Elisabeth George, Philips Healthcare</li><li>Julian Goldman, Massachusetts General Hospital/ Partners Healthcare</li><li>T. Drew Hickerson, Happtique, Inc.</li><li>Jeffrey Jacques, Aetna</li><li>Robert Jarrin, Qualcomm Incorporated</li><li>Mo Kaushal, Aberdare Ventures/National Venture Capital Association</li><li>Keith Larsen, Intermountain Health</li><li>Mary Anne Leach, Children’s Hospital Colorado</li><li>Meg Marshall, Cerner Corporation</li><li>Mary Mastenbrook, Consumer</li><li>Jackie McCarthy, CTIA - The Wireless Association</li><li>Anna McCollister-Slipp, Galileo Analytics</li><li>Jonathan Potter, Application Developers Alliance</li><li>Jared Quoyeser, Intel Corporation</li><li>Martin Sepulveda, IBM</li><li>Joseph Smith, West Health</li><li>Paul Tang, Palo Alto Medical Foundation</li><li>Bradley Thompson, Epstein Becker Green, P.C</li><li>Michael Swiernik, MobileHealthRx, Inc.</li></ul>Federal Ex Officios <ul><li>Jodi Daniel, ONC</li><li>Bakul Patel, FDA</li><li>Matthew Quinn, FCC</li></ul>  -- SS

An Open Letter to David Bates, MD, Chair, ONC FDASIA Health IT Policy Committee on Recommendations Against Premarket Testing and Validation of Health IT

From http://www.healthit.gov/policy-researchers-implementers/federal-advisory-committees-facas/fdasia : The Food and Drug Administration Saf...

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Is ONC's definition of "Significant EHR Risk" when body bags start to accumulate on the steps of the Capitol?

In a June 25, 2013 Bloomberg News article "<a href="http://www.bloomberg.com/news/2013-06-25/digital-health-records-risks-emerge-as-deaths-blamed-on-systems.html">Digital Health Records’ Risks Emerge as Deaths Blamed on Systems</a>" by technology reporter Jordan Robertson (<a href="http://go.bloomberg.com/tech-blog/author/jrobertson40/">http://go.bloomberg.com/tech-blog/author/jrobertson40/</a>), an EHR-harms case in which I am (unfortunately) intimately involved as substitute plaintiff is mentioned: <blockquote class="tr_bq">When Scot Silverstein’s 84-year-old mother, Betty, starting mixing up her words, he worried she was having a stroke. So he rushed her to Abington Memorial Hospital in Pennsylvania. After she was admitted, Silverstein, who is a doctor, looked at his mother’s electronic health records, which are designed to make medical care safer by providing more information on patients than paper files do. He saw that Sotalol, which controls rapid heartbeats, was correctly listed as one of her medications. Days later, when her heart condition flared up, he re-examined her records and was stunned to see that the drug was no longer listed, he said. His mom later suffered clotting, hemorrhaged and required emergency brain surgery. She died in 2011. Silverstein blames her death on problems with the hospital’s electronic medical records. “I had the indignity of watching them put her in a body bag and put her in a hearse in my driveway,” said Silverstein, who has filed a wrongful-death lawsuit. “If paper records had been in place, unless someone had been using disappearing ink, this would not have happened.”</blockquote> How can I say that?  Because I trained in this hospital and worked as resident Admitting Officer in that very ED pre-computer.  The many personnel in 2010 who were given the meds history by my mother and myself directed it not to paper for others to see, but to /dev/null. Why can I say that?  Because the hospital's Motion for Prior Restraint (censorship) against me was denied outright by the presiding judge just days before the Bloomberg article was published (<a href="http://en.wikipedia.org/wiki/Prior_restraint">http://en.wikipedia.org/wiki/Prior_restraint</a>): <blockquote class="tr_bq">Prior restraint (also referred to as prior censorship or pre-publication censorship) is <a href="http://en.wikipedia.org/wiki/Censorship" title="Censorship">censorship</a> imposed, usually by a government, on expression before the expression actually takes place. An alternative to prior restraint is to allow the expression to take place and to take appropriate action afterward, if the expression is found to violate the law, regulations, or other rules. Prior restraint prevents the censored material from being heard or distributed at all; other measures provide sanctions only after the offending material has been communicated, such as suits for <a class="mw-redirect" href="http://en.wikipedia.org/wiki/Slander" title="Slander">slander</a> or <a class="mw-redirect" href="http://en.wikipedia.org/wiki/Libel" title="Libel">libel</a>. In some countries (e.g., <a href="http://en.wikipedia.org/wiki/Law_of_the_United_States" title="Law of the United States">United States</a>, <a href="http://en.wikipedia.org/wiki/Constitution_of_Argentina" title="Constitution of Argentina">Argentina</a>) prior restraint by the government is forbidden, subject to certain exceptions, by a <a href="http://en.wikipedia.org/wiki/Constitution" title="Constitution">constitution</a>. Prior restraint is often considered a particularly oppressive form of <a href="http://en.wikipedia.org/wiki/Censorship" title="Censorship">censorship</a> in Anglo-American jurisprudence because it prevents the restricted material from being heard or distributed at all. Other forms of restrictions on expression (such as actions for <a class="mw-redirect" href="http://en.wikipedia.org/wiki/Libel" title="Libel">libel</a> or <a class="mw-redirect" href="http://en.wikipedia.org/wiki/Slander_and_libel#Criminal_libel" title="Slander and libel">criminal libel</a>, <a class="mw-redirect" href="http://en.wikipedia.org/wiki/Slander" title="Slander">slander</a>, <a href="http://en.wikipedia.org/wiki/Defamation" title="Defamation">defamation</a>, and <a href="http://en.wikipedia.org/wiki/Contempt_of_court" title="Contempt of court">contempt of court</a>) implement criminal or civil sanctions only after the offending material has been published. While such sanctions might lead to a <a class="mw-redirect" href="http://en.wikipedia.org/wiki/Chilling_effect_%28term%29" title="Chilling effect (term)">chilling effect</a>, legal commentators argue that at least such actions do not directly impoverish the <a href="http://en.wikipedia.org/wiki/Marketplace_of_ideas" title="Marketplace of ideas">marketplace of ideas</a>. Prior restraint, on the other hand, takes an idea or material completely out of the marketplace. Thus it is often considered to be the most extreme form of censorship.</blockquote> The First Amendment lives. (I wonder if it irks the hospital that they cannot perform <a href="http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/">sham peer review</a> upon me now that the censorship motion is denied.  Sham peer review is a common reaction by hospital executives to "disruptive" physicians, but I have not worked there since 1987 and I no longer practice medicine.) In the Bloomberg story Mr. Robertson wrote: <div style="margin-left: 40px;">... “So far, the evidence we have doesn’t suggest that health information technology is a significant factor in safety events,” said Jodi Daniel (<a href="http://www.healthit.gov/newsroom/jodi-daniel-jd-mph">http://www.healthit.gov/newsroom/jodi-daniel-jd-mph</a>), director of ONC’s office of policy and planning. “That said, we’re very interested in understanding where there may be a correlation and how to mitigate risks that do occur.”</div> In my opinion this statement represents gross negligence by a government official.  Ms. Daniel is unarguably working for a government agency pushing this technology.   She makes the claim that "so far the evidence we have doesn't suggest significant risk" while surely being aware (or having the fiduciary responsibility to be aware) of the impediments to having such evidence. From my March 2012 post "Doctors and EHRs: Reframing the 'Modernists v. Luddites' Canard to The Accurate 'Ardent Technophiles vs. Pragmatists' Reality" at <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html">http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html </a> (yes, this was more than a year ago): <blockquote class="tr_bq">... The Institute of Medicine of the National Academies noted this in their <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">late 2011 study on EHR safety</a>: <blockquote>... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk. Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.[IOM (Institute of Medicine). 2012. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">Health IT and Patient Safety: Building Safer Systems for Better Care</a> (PDF). Washington, DC: The National Academies Press, pg. S-2.] </blockquote> Also in the IOM report: <blockquote class="tr_bq">… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect. More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”</blockquote></blockquote> I also noted that the 'impediments to generating evidence' effectively rise to the level of legalized censorship, as observed by Koppel and Kreda regarding gag and hold-harmless clauses in their JAMA article "<a href="http://jama.ama-assn.org/content/301/12/1276.extract">Health Care Information Technology Vendors' Hold Harmless Clause: Implications for Patients and Clinicians</a>", JAMA 2009;301(12):1276-1278. doi: 10.1001/jama.2009.398. FDA had similar findings about impediments to knowledge of health IT risks, see my Aug. 2010 post "Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun?" at <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a>. I also note this from amednews.com's coverage of the ECRI Deep Dive Study (<a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html" target="_blank">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>): <div style="margin-left: 40px;">... In spring 2012, a surgeon tried to electronically access a patient’s radiology study in the operating room but the computer would show only a blue screen. The patient’s time under anesthesia was extended while OR staff struggled to get the display to function properly. That is just one example of 171 health information technology-related problems reported [voluntarily] during a nine-week period [from 36 hospitals] to the ECRI Institute PSO, a patient safety organization in Plymouth Meeting, Pa., that works with health systems and hospital associations in Kentucky, Michigan, Ohio, Tennessee and elsewhere to analyze and prevent adverse events. Eight of the incidents reported involved patient harm, and three may have contributed to patient deaths, said the institute’s 48-page report, first made privately available to the PSO’s members and partners in December 2012. The report, shared with American Medical News in February, highlights how the health IT systems meant to make care safer and more efficient can sometimes expose patients to harm.</div> One wonders if Ms. Daniels' definition of "significant" is when body bags start to accumulate on the steps of the Capitol. I also note she is not a clinician but a JD/MPH. I am increasingly of the opinion that non-clinicians need to be removed from positions of health IT leadership at regional and national levels. In large part many just don't seem to have the experience, insights and perhaps ethics necessary to understand the implications of their decisions. At the very least, such people who never made it to medical school or nursing school need to be kept on a very short leash by those who did. -- SS

Is ONC's definition of "Significant EHR Risk" when body bags start to accumulate on the steps of the Capitol?

In a June 25, 2013 Bloomberg News article " Digital Health Records’ Risks Emerge as Deaths Blamed on Systems " by technology repor...

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Marin General Hospital's Nurses are Afraid a Defective EMR Implementation Will Harm or Kill Patients .. CEO Cites Defective HHS Paper and Red Herrings As Excuse Why He Knowingly Allows This To Continue

<div style="text-align: center;">- Posted at the Healthcare Renewal Blog on May 30, 2013 - </div> The following appeared in the Marin County Independent Journal about an EHR system so bad the nurses at Marin General Hospital were publicly complaining, putting their careers at risk (see my May 17, 2013 post "<a href="http://hcrenewal.blogspot.com/2013/05/marin-general-hospital-nurses-warn-that.html">Marin General Hospital nurses warn that new computer system is causing errors, call for time out</a>"): <blockquote class="tr_bq">National critic of health care information technology says Marin General should heed nurses' advice <div class="articleByline" id="articleByline"><a class="articleByline" href="mailto:rhalstead@marinij.com?subject=Marin%20Independent%20Journal:"></a> <div class="Byline"><a class="articleByline" href="mailto:rhalstead@marinij.com?subject=Marin%20Independent%20Journal:">By Richard Halstead Marin Independent Journal</a></div></div><div class="articleDate" id="articleDate">Posted:   05/27/2013 04:03:00 PM PDT</div></blockquote> The critic is me.   I spoke to the reporter but did not know he would publish: <blockquote class="tr_bq"> <div class="bodytext">A nationally known critic of electronic health records has harshly criticized managers at Marin General Hospital for their response to a plea by nurses to hold off on a new computer system to prevent potentially dangerous errors.</div> "The executives at the hospital should be taking out extra insurance policies because they're setting themselves up for a massive corporate negligence lawsuit," said Dr. Scot Silverstein, an adjunct professor of health care informatics at Drexel University in Philadelphia. Silverstein, who contacted the Independent Journal after reading about the Marin General situation, doesn't dispute the potential of digital records; but he believes implementation has been rushed. He thinks electronic health records should be regulated by the federal Food and Drug Administration, much like medical hardware or pharmaceuticals. </blockquote> Or regulated by someone with experience in similar mission critical software, and with regulatory teeth.  Paper tigers and bad health IT are a very poor mix where patients' rights are concerned IMO. <blockquote class="tr_bq"> At issue is a new computerized physician order entry system, known as CPOE; doctors place medication orders for patients directly into the system. At a meeting of the Marin Healthcare District board on May 14, a group of Marin General nurses told the board problems with the new computer system were diverting them from their patients and causing errors, such as sending orders to the wrong patients. One nurse reported that a patient had received a medication to which he was allergic. </blockquote> That is a very direct calling out of the potential for harm and death by front line clinical personnel.  To ignore it is grossly if not criminally negligent. <table border="0" cellpadding="0" cellspacing="0" style="width: 100%px;"><tbody><tr><td class="articleBox" style="width: 100%;"><a href="https://www.blogger.com/null" name="top"></a></td></tr></tbody></table><blockquote class="tr_bq">Lee Domanico, who serves as the CEO of both Marin General and the Marin Healthcare District, assured the board that the hospital was safe, despite "glitches" in the new system. Domanico said he was working to fix the problem.</blockquote> Glitches = safe?  The Board must be highly gullible if they believe this  See <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a> for more on "safe" glitches. <blockquote class="tr_bq">Silverstein said, "Glitches are a euphemism for life-threatening electronic health record malfunctions and defects." "What they need to do is exactly what the nurses are asking for," Silverstein said. "They need to turn the system off and put it through rigorous testing and confirm the thing is going to work properly with no glitches before they use it on patients."</blockquote> That's not rocket science - its common sense - unless they think their own nurses are lying. Of course, as computers have more rights than patients, and bonuses might be affected, the system will likely continue in full operation, with patients as guinea pigs, and the nurses punished for informing the public that perhaps they should consider other hospitals while the "glitches" in this enterprise clinician command-and-control system are worked out. <blockquote class="tr_bq"> Two days after the Marin Healthcare District meeting, Domanico issued a press release stating, "We have not received any medication error incident reports resulting from the implementation of computerized physician order entry." On Friday, however, Barbara Ryan, a Marin General registered nurse who serves as the California Nurses Association/National Nurses United representative, said, "I can't understand why that statement was made." Ryan said nurses have told her of errors, and information about errors appears in "Assignment Despite Objection" forms that nurses have filed since implementation of the computerized order system began on May 7. Nurses file the forms to document formal objections to an unsafe, or potentially unsafe, patient care assignment. </blockquote> The statement's reason and purpose seems fairly obvious.  <blockquote class="tr_bq">Ryan said Marin General nurses have filed close to 50 such forms so far this month; she said typically 10 to 20 such forms are filed per month at the hospital. "There are still problems with the system," she said. "There are still mistakes being made." Ryan said the hospital needs to boost nurse staffing ratios during the implementation.</blockquote> That would increase costs (and probably decrease the pool of money for bonuses). <blockquote class="tr_bq">Jon Friedenberg, Marin General's chief fund and business development officer, said the hospital is in the process of upgrading computer servers and adding memory to work stations to increase the speed of the new computerized order system. "We completed an upgrade of memory to 200 of the work stations, and 120 of the work stations have been replaced," Friedenberg said.</blockquote> This reminds me of a similar IT fiasco I faced some years ago, when the brilliance of IT personnel really shone through regarding an ICU monitoring system that crashed regularly.  Their solution?  Add more RAM.  (See "Serious clinical computing problems in the worst of places: an ICU" at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU</a>). <blockquote class="tr_bq">... Silverstein earned a medical degree from Boston University and subsequently completed a two-year fellowship in medical informatics at Yale University School of Medicine. He served as Merck Research Laboratories' director of scientific information in the early 2000s before serving for a time as a full-time professor at Drexel University. Today, in addition to teaching part-time, Silverstein works on [EHR-related - ed.] medical liability cases for plaintiff attorneys. [And the defense too, when asked; I'd rather advise on how to prevent mistakes, in fact, than get involved after the fact when someone's been injured or killed - ed.] </blockquote> What was not mentioned was that I was a CMIO in a major hospital in the mid to late 1990s. But of course, I - and similarly trained Medical Informatics experts - "don't have enough experience" to lead (as opposed to being an 'internal consultant') health IT projects, a refrain I've often heard from hospital executives. <blockquote class="tr_bq">Silverstein said he started assisting on the liability cases after his mother died as the result of an electronic health care record error that resulted in her not being given the proper heart medicine. Silverstein said his mother's case was not an anomaly. </blockquote><blockquote>For example, he pointed to the results of a recent Emergency Care Research Institute study of 36 hospitals conducted over a nine-week period. Asked to report electronic record problems on a volunteer basis, Silverstein said the hospitals reported 170 malfunctions, including eight incidents that resulted in patient harm, three of which may have contributed to patients' deaths.  Although the federal Food and Drug Administration does not regulate health care information technology, some manufacturers have voluntarily supplied data to the FDA. In February 2010, the FDA reported it had been notified of 260 problem events involving health care information technology in the previous two years that were linked with 44 injuries and six deaths. </blockquote> See my Feb. 28, 2013 post "Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI Deep Dive Study of Health IT Events" at <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>.  Also see my Aug. 5, 2010 post "Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun? I report, you decide" at <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a>. I merely report what ECRI, AMA and FDA have reported. Finally: <blockquote class="tr_bq">In his press release, however, [CEO] Domanico stated that "more than 150 studies conducted since 2007 have confirmed that organizations using health information technology, like CPOE, have seen positive outcomes." </blockquote> I believe he's referring to a highly biased and scientifically defective ONC paper of 154 selected studies: "The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results." What an unbelievably cavalier attitude. My colleagues and I refuted (dare I say trashed) that paper pretty thoroughly here: <a href="http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html" rel="nofollow nofollow" target="_blank">http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html.</a> Even worse, the mention of that paper, or EHR benefits in general, is a diversion, an in-your-face red herring (at best; an inability to reason logically at worst), steering away from the real issue:  an EHR implementation about which nurses are complaining ... in the now. <blockquote class="tr_bq"><a href="http://www.nizkor.org/features/fallacies/red-herring.html">http://www.nizkor.org/features/fallacies/red-herring.html</a>:  A Red Herring is a fallacy in which an irrelevant topic is presented in order to divert attention from the original issue. </blockquote> That a CEO of a major hospital relies on one defective paper - one that he most likely lacks the experience and expertise to understand, let alone critically evaluate - and red herrings is a poster example of why medical and medical informatics amateurs should not be running hospitals or clinical IT projects. -- SS

Marin General Hospital's Nurses are Afraid a Defective EMR Implementation Will Harm or Kill Patients .. CEO Cites Defective HHS Paper and Red Herrings As Excuse Why He Knowingly Allows This To Continue

- Posted at the Healthcare Renewal Blog on May 30, 2013 - The following appeared in the Marin County Independent Journal about an EHR system...

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Bad Science (and Perhaps Conflict of Interest) At ONC / HHS

This article recently appeared, quoting <a href="http://www.healthit.gov/newsroom/jacob-reider-md" target="_blank">Jacob Reider, M.D.</a>, chief medical officer at ONC on an upcoming Health IT Safety Plan: <blockquote class="tr_bq">Health Data Management <a href="http://www.healthdatamanagement.com/news/HIMSS13-ONC-HIT-safety-plan-45809-1.html" target="_blank">http://www.healthdatamanagement.com/news/HIMSS13-ONC-HIT-safety-plan-45809-1.html</a>  ONC Sets Early Summer for Release of HIT Safety Plan The Office of the National Coordinator for Health Information Technology anticipates releasing a final health information technology safety plan by early summer, officials announced on March 5 at HIMSS13 in New Orleans. ONC released a draft plan in December and accepted public comment until February 4. The draft followed an Institute of Medicine report that ONC commissioned that highlighted the need for better understanding of the HIT impacts on safety, as well as shared responsibilities among all stakeholders to improve safety, Jodi Daniel, director of the ONC office of policy and planning, said during an educational session. There is little doubt that use of I.T. results in fewer medical errors, particularly medication-related because of electronic prescriptions and clinical decision support, noted Jacob Reider, M.D., chief medical officer at ONC. “It’s obvious that in many areas there will be fewer errors, but at the same time, in other areas there will be more errors.” Consequently, a priority of the plan will be implementing a framework to help the industry better understand what the trouble areas will be as I.T. use increases. Less than 1 percent of patient safety events are related to HIT, Reider contended, but the industry needs more data to better understand the level of harm from such events and how to improve the technology. HIT-related errors, he reminded the audience, are not always the fault of vendors; providers can introduce risk when customizing their systems. </blockquote> The upcoming safety plan release is fine and good, but I, for one, wonder if it can be trusted. The level of bias and lack of knowledge of the domain, evidence of incomplete research, and/or poor scientific judgement inherent in the statements I bolded above are disturbing.  They are also  reminiscent of the problems in the ONC-authored paper discussed <a href="http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html" target="_blank">at this link</a>. First: <ul><li>There is little doubt that use of I.T. results in fewer medical errors</li></ul> On the contrary, there is significant well-researched doubt in that the evidence is quite contradictory.  Let's cite the IOM's 2012 report on health IT risk: <blockquote class="tr_bq">… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect.   </blockquote><blockquote> IOM (Institute of Medicine) 2012. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">Health IT and Patient Safety: Building Safer Systems for Better Care</a> (PDF). Washington, DC: The National Academies Press.</blockquote> Let's quote one of the IOM study panel members, an international authority on safety, <a href="http://hcrenewal.blogspot.com/2013/03/dr-richard-cook-on-health-it-sectors.html" target="_blank">Dr. Richard Cook</a>: <blockquote class="tr_bq">... HIT's cornucopia has been promised repeatedly since the 1960's. Nothing like the promises has materialized.  Indeed, the IOM committee that was commissioned to evaluate the best evidence on this subject found no persuasive evidence that HIT improved patient safety. I know because I was there.  </blockquote> The body of literature <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist" target="_blank">here</a> also contains relevant studies contradicting Dr. Reider's quoted, dispositive statement. Next: <ul><li>It’s obvious that in many areas there will be fewer errors</li></ul> This statement requires no response, but I'll respond anyway.   In science, stating something is "obvious" (i.e., what is referred to at the site "<a href="http://www.themathlab.com/geometry/funnyproofs.htm" target="_blank">36 Humorous Methods of Proof</a>" as "Proof by obviousness") is, on its face, bad science. Next: <ul><li>Less than 1 percent of patient safety events are related to HIT</li></ul> The aforementioned IOM report was quite clear on the following: <blockquote class="tr_bq">... Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety. ... The magnitude of the risk associated with health IT is not known.</blockquote> Likewise, FDA has concluded that what they know on HIT-related patient safety events is likely "<a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html" target="_blank">t</a><a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html" target="_blank">he tip of the iceberg</a>"  due to systematic impediments to knowing, as has the ECRI Institute who has only now begun to study the issue with any degree of rigor.  (The results are of great concern to anyone who should know, or should have made it their business to know, as <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html" target="_blank">at this lin</a><a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html" target="_blank">k</a>.) Perhaps Dr. Reider needs a lesson on basic <a href="http://plato.stanford.edu/entries/epistemology/" target="_blank">epistemology</a>:  "We simply don't know what we don't know." Finally: <ul><li>HIT-related errors, he reminded the audience, are not always the fault of vendors; providers can introduce risk when customizing their systems. </li></ul> I find it remarkable that a government official uses a public/industry platform HIMSS to defend an industry, while at the same time stating more study is needed to understand the causative factors of harm from the industry's products. This raises the question of conflict of interest, and the possibility this official is not impartial or trying to be "fair" but aiming towards protecting an industry he once worked for - and to where he's likely to return at some point.  (See Roy Poses' posts on "<a href="http://hcrenewal.blogspot.com/search/label/revolving%20doors" target="_blank">revolving doors</a>" for examples of that.) From his government biography <a href="http://www.healthit.gov/newsroom/jacob-reider-md" target="_blank">her</a><a href="http://www.healthit.gov/newsroom/jacob-reider-md" target="_blank">e</a>: <blockquote class="tr_bq">Dr. Jacob Reider Director, Office of the Chief Medical Officer Jacob Reider, MD is a family physician with 20 years of experience in health information technology and special interest in clinical innovation, user experience, and clinical decision support. His background includes leadership roles in nearly all facets of the health IT domain – from small start-up companies to academic facilities, primary care medical groups, and large health IT development organizations. Dr. Reider has served as a member of the Board of Trustees of the American Medical Students Association, the Society of Teachers of Family Medicine, and has served in directorial positions on boards of several innovative health IT companies. </blockquote>   I note I do not find evidence of formal medical informatics education, which selfsame ONC recommends for leadership roles in health IT (see my Dec. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html" target="_blank">ONC Defines a Taxonomy of Robust Healthcare IT Leadership</a>"), but I do find roles <a href="http://www.linkedin.com/in/jacobr" target="_blank">such as</a>: <blockquote class="tr_bq">Chief Medical Informatics Officer <a href="http://www.allscripts.com/" target="_blank">Allscripts</a> June 2009 – January 2011 (1 year 8 months) Medical Director <a href="http://www.allscripts.com/" target="_blank">Allscripts</a> March 2007 – June 2009 (2 years 4 months) Chief Medical Officer MedRemote (Now <a href="http://www.nuance.com/healthcare/services/dragon-CertifiedEHRs/dragon-works.asp" target="_blank">Nuance</a>) November 1999 – December 2002 (3 years 2 months) </blockquote> One might reasonably wonder what personal gains might accrue to Dr. Reider from the promotion of health IT - which includes downplaying its current risks - from an influential government perch.  (I for example held many Merck stock options after my late 2003 departure.  They remained underwater until expiration, but even a a $10 or $20 increase in stock price could have bought me, say, a new sports car or even house.) I also note that the former CEO of Allscripts, Glen Tullman was, in fact, a close confidant of our current President and <a href="http://www.allscripts.com/en/company/about-us/leadership/bio-tullman.html" target="_blank">advisor on health IT</a> during his first campaign: <blockquote class="tr_bq">A tireless advocate of technology in medicine, Tullman has been featured in virtually every major news outlet. An early supporter of fellow Chicagoan Barack Obama, Tullman introduced him to the Electronic Health Record (EHR) and served on his finance and healthcare committees during the 2008 presidential campaign. </blockquote> Is it any wonder, then, that my expectation is that the forthcoming ONC HIT safety plan will be biased towards industry, reflect poor science and incomplete/selective research, and overall be a <a href="http://en.wikipedia.org/wiki/Whitewash_%28censorship%29" target="_blank">whitewash</a>? I'll be presenting on issues such as this to the Plaintiff's Bar.  They seem to be the last protectors of people's/patient's rights where clinical IT is concerned - a role they seem most familiar with in other sectors. I emailed Dr. Reider a link to this post with a request that if he has robust evidence to support his assertions that is not publicly available, to please release it. -- SS Mar. 16, 2012 Addendum:  A correspondent asked me the following that I thought deserved mention beyond the comments section: <blockquote class="tr_bq">"How would he know, exactly, when we know, that they never tallied the thousands of e-Rx errors from a national Siemens defect that was disclosed only at the Brown Medical Center Hospitals (Lifespan) but was a systemwide defect; nor from the Cerner convert to e-Rx defect that was evident at the Trinity Health System; and millions of other errors from when the e-Rx system was unavailable. Or, do they simply do not count those?"</blockquote> My response?  No, they probably consider those "anecdotal."  -- SS

Bad Science (and Perhaps Conflict of Interest) At ONC / HHS

This article recently appeared, quoting Jacob Reider, M.D. , chief medical officer at ONC on an upcoming Health IT Safety Plan : Heal th Da...

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