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Semi-Retirement of a Salesman - Weldon to Retire as Johnson and Johnson CEO

The extremely well compensated CEO and Chairman of Johnson and Johnson, the huge and recently hugely troubled US based pharmaceutical and device company, is going to retire, at least as CEO.  Reporting on this event may shed a little more light on the sorts of leadership problems that now commonly afflict health care organizations. The Credo Johnson and Johnson was once one of the US' most respected companies.  Its <a href="http://www.jnj.com/wps/wcm/connect/c7933f004f5563df9e22be1bb31559c7/jnj_ourcredo_english_us_8.5x11_cmyk.pdf?MOD=AJPERES">credo</a>, written in 1943 by Robert Wood Johnson, bravely begins: <blockquote>We believe our first responsibility is to doctors, nurses and patients, to mothers and fathers, and all others who use our products and services. In meeting their needs, everything we do must be of high quality. </blockquote>Dishonoring the Credo Yet in the last few years the company has not honored this credo. It seems to have lost the ability to manufacture high quality products. It has had to make 30 separate product recalls since 2009. The latest was Liquid Infant Tylenol. (The current WSJ Health Blog list of recalls can be found <a href="http://blogs.wsj.com/health/2012/02/17/jj-recall-watch-mcneil-pulls-liquid-infant-tylenol-on-dosing-system-concerns">here</a>.) Johnson and Johnson also has an amazing recent record of ethical lapses and guilty pleas, including: - Convictions in two different states in 2010 for misleading marketing of Risperdal - A guilty plea for misbranding Topamax in 2010 - Guilty pleas to bribery in Europe in 2011 by J+J's DePuy subsidiary - A guilty plea for marketing Risperdal for unapproved uses in 2011 (see <a href="http://hcrenewal.blogspot.com/2011/08/why-cultivate-weldons-confidence-ceo.html">this link</a> for all of the above) - Accusations that the company, which makes smoking cessation products, participated along with tobacco companies in efforts to lobby state legislators (see post <a href="http://hcrenewal.blogspot.com/2011/09/smart-alecs-strange-bedfellows.html">here</a>) - A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post <a href="http://hcrenewal.blogspot.com/2011/09/johnson-and-johnson-pleads-guilty.html">here</a>) -  Most recently, in 2012, testimony in a trial of allegations of unethical marketing of the drug Respirdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers.  After these revelations, the company abruptly settled the case (see post <a href="http://hcrenewal.blogspot.com/2012/02/texas-tmap-trials-as-illustration-of.html">here</a>). Disconnect Between Leadership Performance and Rewards Nonetheless, until very recently, the top leadership of the company continued to collect outrageous compensation, and to be regarded as a font of health care wisdom, even by the current US administration. In 2010, the company gave CEO and Chairman William Weldon over $29 million in compensation, saying he "met expectations," (see <a href="http://hcrenewal.blogspot.com/2011/03/despite-recalls-legal-settlements.html">this post</a>). In 2011, just days after the company pleaded guilty in the Risperdal marketing case (above), CEO and Chairman Weldon was invited to the White House to discuss health care (see <a href="http://hcrenewal.blogspot.com/2011/08/why-cultivate-weldons-confidence-ceo.html">this post</a>.) Just after his resignation was announced a few days ago, the Wall Street Journal <a href="http://online.wsj.com/article/SB10001424052970203918304577243542528572590.html">reported</a> that Weldon would get an increased bonus for 2011 ($3.1 million, up from $1.98 million in 2010), and an increased base salary ($1.97 million up from $1.92 million.)  His total compensation for 2011 was not yet revealed.  Swapping One Salesman for Another A single New York Times <a href="http://www.nytimes.com/2012/02/24/business/alex-gorsky-of-jj-emerged-from-its-sales-culture.html">article</a> suggested one reason why Weldon's reign was ultimately so unsuccessful, and perhaps why his successor may not do better. <blockquote>Alex Gorsky, the newly named chief executive of Johnson & Johnson, shares a crucial biographical detail with William C. Weldon, the man he is succeeding. Both got their starts as pharmaceutical sales representatives, a notoriously grueling job that — because it demands stamina, charisma and a near devotion to making the sale — has become a crucible for future drug company executives in recent years.</blockquote> Indeed, Mr Weldon's <a href="http://www.investor.jnj.com/governance/biodetail.cfm?bioid=3197">official biography </a>indicates he "served in several sales, marketing and international management positions." The <a href="http://www.investor.jnj.com/governance/managementdetail.cfm?bioid=23627">official biography </a>of CEO-to-be, Alex Gorsky, stated he "began his Johnson & Johnson career as a sales representative with Janssen Pharmaceutica in 1988. Over the next 15 years, he advanced through positions of increasing responsibility in sales, marketing, and management." Previously, he earned "a Bachelor of Science degree from the U.S. Military Academy at West Point, N.Y., and spent six years in the U.S. Army, finishing his military career with the rank of Captain. Alex earned a Master of Business Administration degree from The Wharton School of the University of Pennsylvania in 1996." Apparently neither current nor nominated CEO had any direct experience in patient care, nor in biomedical or clinical science, nor in chemistry, engineering or manufacturing. So both are generic managers, that is, health care leaders without any direct experience in health care, or in the science and technology underlying it. "Making the Numbers" Versus the Credo Moreover, they are both a particular type of generic manager, salespeople. As the Times reported: <blockquote>Mr. Gorsky, who is 51, fits the mold of someone who once 'carried the bag' — industry slang for working as a sales representative. He is known as a polished speaker and an intense yet likable manager who is a quick study when it comes to learning new topics.</blockquote> However, while sales people may be personable, they often have goals that have nothing to do with responsibilities "to doctors, nurses and patients, to mothers and fathers,...." As the Times article also noted, <blockquote>But the ethos of the sales representative may not be what Johnson & Johnson needs right now, said Erik Gordon, who teaches business at the University of Michigan. 'That culture was very much the Weldon culture writ large — we will make our numbers for the analysts, period,' he said. 'And if that means we have to cut costs on things that affect quality, then by God, we’re going to make those numbers.'</blockquote> So while Johnson and Johnson for years prided itself as a company that put the needs of patients and health professionals first, it hired leaders from the culture of sales where the impetus is to "make the numbers," to fulfill short term revenue goals, no matter what. This illustrates how generic management given perverse incentives in an era that honors greed and puts short-term economic goals ahead of all others had hollowed out health care. We wish Mr Gorsky well, but worry that if he too focuses just on making the numbers, the result will be only mischief. The Moral of the Story Health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior. If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

Semi-Retirement of a Salesman - Weldon to Retire as Johnson and Johnson CEO

The extremely well compensated CEO and Chairman of Johnson and Johnson, the huge and recently hugely troubled US based pharmaceutical and de...

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BLOGSCAN - Keeping the Echoes Alive

We frequently discuss the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, how many of the cases and issues of interest to <a href="http://hcrenewal.blogspot.com/">Health Care Renewal,</a> which conversely may be troubling to the powers that be in health care, often fail to inspire as much discussion, or the echoes that they deserve, either in the "main-stream media," or in the medical and health care literature.  A <a href="http://1boringoldman.com/index.php/2012/02/27/more-on-echo-echo-echo-echo-echo-echo-echo">new post</a> on the 1BoringOldMan blog likened the anechoic effect to the "flooding" phenomenon seen in psychotherapy, basically how patients seek to change the subject when a particularly troubling issue comes up.  Furthermore, the semi-anonymous blogger, "Mickey," is hopping on our tiny bandwagon for those dedicated to keep these troubling topics from completely fading from public view.

BLOGSCAN - Keeping the Echoes Alive

We frequently discuss the anechoic effect , how many of the cases and issues of interest to Health Care Renewal, which conversely may be tr...

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True or Not? Death By Deletion, Adventist Health System IT Whistleblower Patricia Moleski Speaks Out

Not sure what to make of this yet: <div style="text-align: center;"><a href="http://workmancompensationlawyers.net/12/23/death-by-deletion-adventist-health-system-it-whistleblower-patricia-moleski-speaks-out/"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5714029864071150194" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjlHdzwxZwvVcxZUB0fkLhI1MY8nXfdxFdIjjuBc56E72oN5YBlT5GoMyAubm_fK9QYC-tWvL1LaEu6HTSGjLZEw-grfGGaprfwkdHRgGgJOtFluHvWylSud8uEHR8EQiig-vsqw1HY3Bz5/s320/moleski.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 311px; height: 258px;" /></a>Whistleblower Patricia Moleski speaks out about health IT abuses - play at <a href="http://workmancompensationlawyers.net/12/23/death-by-deletion-adventist-health-system-it-whistleblower-patricia-moleski-speaks-out/">http://workmancompensationlawyers.net/12/23/death-by-deletion-adventist-health-system-it-whistleblower-patricia-moleski-speaks-out/</a> </div> A former hospital IT worker claims very deliberate mass spoliation (e.g., deletion) of electronic medical record evidence to limit her (ex)-employer's liability for EHR-related medical malpractice on patients and injured workers who were entitled to workers compensation, as well as EHR defects. She alleges that IT personnel are used as naïve accomplices to perform the spoliation acts. She grew suspicious when she was asked to delete nursing information about a patient who committed suicide by jumping out a hospital window after an EHR-related drug overdose. The video is over an hour long and is worth listening to. She made these claims to the FBI and alleged to have suffered retaliation including firing, and possible terroristic activities directed against her. <a href="http://www.barbclark.org/e_mail_to_governor_christ.pdf">A Feb. 2010 letter to Gov. Crist, Sen. Grassley</a> and many other government officials, a <a href="http://www.barbclark.org/counter_claim_petition_against_adventist_health_system_sunbelt_healthcare_corporation.pdf">9th Judicial Circuit court document</a> for Orange County, FL (PDF), and other details - some scary - can be found via a google search on this person's name: <a href="https://www.google.com/search?q=Patricia%20Moleski">https://www.google.com/search?q=Patricia%20Moleski</a> . <div style="text-align: center;"><a href="http://www.barbclark.org/e_mail_to_governor_christ.pdf"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5714192301488956402" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh3r5LNUCzUdeRm_RB7sSNhCtI1DOljSSvPRHqzXTI4QQD4SHy3BHvRLtzutycP2ewk0HYO5UoQ0cggetV0XsV4u5ckhXdWgOmJYTJR-G0wmIg4UjxAb2x6e3_eXqQi0mHHiUHN8n4WIgko/s320/moleski_letter.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 324px; height: 392px;" /></a>A Feb. 2010 letter to Sen. Grassley, former Fla. Governor Crist, various other senators, news media, etc. alleging serious, systematic, purposeful HIT evidence tampering and erasure. Click to bring up full letter. </div> This could be the "Libby Zion" (or Bernard Madoff?) case of the health IT world if these allegations are true. -- SS

True or Not? Death By Deletion, Adventist Health System IT Whistleblower Patricia Moleski Speaks Out

Not sure what to make of this yet: Whistleblower Patricia Moleski speaks out about health IT abuses - play at http://workmancompensationlawy...

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Health IT Culture: Severe Overconfidence (Arrogance?) Shows In The Industry's Very Terminology For Their Deliverables

Health IT commentator Neil Versel notes in his piece "<a href="http://www.meaningfulhitnews.com/2012/02/24/himss12-notes/">HIMSS12 notes</a>" at his site Meaningful Health IT News that: <blockquote>I am in 100 percent agreement with something Dr. Wendy Sue Swanson, a.k.a. <a href="http://seattlemamadoc.seattlechildrens.org/" target="_blank">Seattle Mama Doc</a>, said during an engaging presentation Monday at the HIMSS/CHIME CIO Forum. She made the astute observation that there needs to be better distinction between expertise and merely experience when it comes to celebrities being held up as “experts” in healthcare and medicine. Let’s just say that Swanson, as a pediatrician, is no fan of some of the things Jenny McCarthy and Dr. Mehmet Oz have told wide audiences.</blockquote> He posted a link to his piece in a social networking site we both visit. I commented: <blockquote>To that, I add "healthcare IT" where it seems anyone who's done anything with a computer in some medical setting can get away with calling themselves a "medical informatics expert" or "health IT expert." As in ham radio levels of just a few years ago, we need distinctions between novice class, technician class, general class, advanced class, and extra class.</blockquote> In his piece Neil also linked to what he correctly termed "scathing critique" of the venue for HIMSS 2012 at my HC Renewal post "<a href="http://hcrenewal.blogspot.com/2012/02/himss-annual-meeting-in-las-vegas.html">H</a><a href="http://hcrenewal.blogspot.com/2012/02/himss-annual-meeting-in-las-vegas.html">IMSS Annual Meeting in Las Vegas - Fitting for People Who Gamble With People's Lives to Make a Buck?</a>" I replied to him via the social networking site that: <blockquote> "I like to point out ironies that seem to escape others, although I have heard from other colleagues that I was not alone in finding Las Vegas a somewhat peculiar place for a medical meeting about improving health! However, others' mileage may vary."</blockquote> Neil noted that he likes pointing out ironies, too, and gave as an example as the meetings held at the Loews Hotel near Vanderbilt University Medical Center, being that Loews Hotels is a corporate cousin of Lorrilard Tobacco. Finally, Neil comments: <blockquote>Popular topics this year were the expected meaningful use and ICD-10, plus the buzzwords of the moment, business analytics and big data. I’d be happy I never hear the word “solution” as a synonym for “product” or “service” again. To me, that represents lazy marketing. Get yourself a thesaurus.</blockquote> I agreed, and replied that: <blockquote> "Solution", the common term in IT for anything an IT department or company provides, is a one-word example of a language usage akin to 'begging the question.'</blockquote> This term, in one mere word, reflects a stunning arrogance within the IT culture. I also noted that: <blockquote>... there needs to be terminological consistency. If the IT vendors can call their wares "solutions", then doctors should call their treatments and drugs "cures." Come to my office for your cure; I am a curer; I write cures, not prescriptions. </blockquote> I also noted that the term "meaningful use" phrase selected by the U.S. government/HHS for EHR adoption according to printed guidelines is another example of terminology that, ante hoc, assumes its semantics are correct. How do we know the use is "meaningful" until such use is studied rigorously and outcomes, costs. etc. assessed? Answer: we don't. And this administration criticized the previous one for politicizing science ... George Orwell could not have selected better terms than "meaningful use", "<a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html">certified EHR</a>", and "solution" as examples of "<a href="http://en.wikipedia.org/wiki/Newspeak">Newspeak</a>" in 1984. -- SS <div class="commentContent UIImageBlock_Content UIImageBlock_SMALL_Content" ft="{"type":33}"> </div>

Health IT Culture: Severe Overconfidence (Arrogance?) Shows In The Industry's Very Terminology For Their Deliverables

Health IT commentator Neil Versel notes in his piece " HIMSS12 notes " at his site Meaningful Health IT News that: I am in 100 pe...

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Three Facets of One Hospital: Coddling the Rich, Hounding the Poor, and Crooked Executives

Juxtaposing three news stories from the past few months raises disturbing questions about the priorities of the leaders of one of the US' more prestigious hospitals. "Chefs, Butlers, Marble Baths: Hospitals Vie for the Affluent"  This 21 January, 2012 <a href="http://www.nytimes.com/2012/01/22/nyregion/chefs-butlers-and-marble-baths-not-your-average-hospital-room.html">article </a>from the New York Times focused on the ritzy comforts now provided for wealthy (but perhaps not very sick) patients at the renowned New York Presbyterian/ Weill Cornell Hospital.  It opened, <blockquote>The feverish patient had spent hours in a crowded emergency room. When she opened her eyes in her Manhattan hospital room last winter, she recalled later, she wondered if she could be hallucinating: 'This is like the Four Seasons — where am I?' The bed linens were by Frette, Italian purveyors of high-thread-count sheets to popes and princes. The bathroom gleamed with polished marble. Huge windows displayed panoramic East River views. And in the hush of her $2,400 suite, a man in a black vest and tie proffered an elaborate menu and told her, 'I’ll be your butler.' It was Greenberg 14 South, the elite wing on the new penthouse floor of NewYork-Presbyterian/Weill Cornell hospital. Pampering and décor to rival a grand hotel, if not a Downton Abbey, have long been the hallmark of such 'amenities units,' often hidden behind closed doors at New York’s premier hospitals. But the phenomenon is escalating here and around the country, health care design specialists say, part of an international competition for wealthy patients willing to pay extra, even as the federal government cuts back hospital reimbursement in pursuit of a more universal and affordable American medical system. </blockquote> Additional amenities include: <blockquote>A waterfall, a grand piano and the image of a giant orchid grace the soaring ninth floor atrium....</blockquote> Also, <blockquote>the visitors’ lounge seems to hang over the East River in a glass prow and Ciao Bella gelato is available on demand....</blockquote> An architect who specializes in designing such luxury facilities for hospitals noted: <blockquote>'These kinds of patients, they’re paying cash — they’re the best kind of patient to have,' she added. 'Theoretically, it trickles down.' </blockquote> Note that the article also mentioned other hospitals which offered similar luxuries, including Johns Hopkins Hospital in Baltimore, Cedars-Sinai Medical Center in Los Angeles, and Mount Sinai Medical Center in New York. On the other hand,.... Hounding the Poor for Payment While Getting Government Money for Indigent Care On 12 February, the New York Times published an <a href="http://www.nytimes.com/2012/02/13/nyregion/study-finds-new-york-hospitals-flout-charity-rules.html">article</a> about how New York Presbyterian/ Weill Cornell deals with patients with fewer resources than those discussed above: <blockquote>For most of her life, Hope Rubel was a healthy woman with good medical insurance, an unblemished credit history and a solid career in graphic design. But on the day an ambulance rushed her to a Manhattan hospital emergency room shortly after her 48th birthday, she was jobless, uninsured and having a stroke. Ms. Rubel’s medical problem was rare, a result of a benign tumor on her adrenal gland, but the financial consequences were not unusual. She depleted her savings to pay $17,000 for surgery to remove the tumor, and then watched, 'emotionally paralyzed,' she said, as $88,000 in additional hospital bills poured in. Eventually the hospital sued her for the money. Yet that year the hospital, NewYork-Presbyterian/Weill Cornell, had already collected $50.2 million from the state’s so-called Indigent Care Pool to help care for people like Ms. Rubel who have no insurance and cannot pay their bills. </blockquote> Note that the article also included other New York hospitals that allegedly used aggressive collection tactics on poor patients even though they too collected government money for indigent care. These included NYU Langone Medical Center and State University of New York Downstate Medical Center. And one more... Kickbacks for Hospital Executives For some reason, the only media coverage of this story was not in New York, but <a href="http://articles.philly.com/2012-02-13/news/31054958_1_kickbacks-philadelphia-developer-hospital-employees">by the Philadelphia Inquirer </a>on 13 February, 2012. <blockquote>The FBI said that ... [Michael Yaron] he received asbestos-removal and construction contracts at New York Presbyterian Hospital for two of his companies, Cambridge Environmental & Construction Corp. and Oxford Construction & Development Corp., because he paid about $2.3 million in kickbacks starting in 2000. Neither Yaron, a resident of Meadowbrook, Montgomery County, nor his attorneys could be reached for comment yesterday. No one answered at Yaron Properties, his offices on Arch Street in Old City. Bucks County native Moshe Buchnik, a president of two asbestos-abatement companies, was also convicted after the four-week trial. Santo Saglimbeni, a former vice president of facilities operations at the hospital, and Emilio 'Tony' Figueroa, a former director of facilities operations at the hospital, were also convicted. The FBI said the two former hospital employees steered contracts to Yaron and Buchnik in exchange for the kickbacks.</blockquote> The Inquirer apparently covered the story because Yaron lives in Philadelphia. Thus it treated the convictions of a former vice president and former director of facilities operations at New York Presbyterian/ Weill Cornell Hospital as afterthoughts. Summary Thus, in the last six weeks, we have been treated to stories that showed how New York Presbyterian/ Weill Cornell Hospital has devoted substantial resources to create luxury suites for rich patients, presumably because they may pay cash; while simultaneously hounding poor patients who could not pay their large medical bills, even though the hospital was receiving government funds for indigent care; and until recently was employing some executives now shown to have abused their authority. The themes of the three individual stories should be familiar. The first story was a reminder that the very rich are different from you and me in how they interact with the health care system. In many ways, the rich and powerful - some might call them the one percent - are personally protected from various aspects of health care dysfunction. For example, <a href="http://hcrenewal.blogspot.com/search/label/executive%20health%20plans">here</a> we have discussed how wealthy executives seem to be able to obtain health insurance with benefits unheard of by the more common folk, and <a href="http://hcrenewal.blogspot.com/2011/10/how-rich-and-influential-get-health.html">here</a> we discussed how the wealthy and influential may get preferential hospital treatment. Thus, even one percenters who are not otherwise involved in health care may not be inclined to lend their support to any efforts to really reform the system. Aggressive bill collection practices by hospitals which are supposed to serve the poor are also old news. We first <a href="http://hcrenewal.blogspot.com/2004/12/money-trumps-mission.html">discussed</a> such practices occurring in New York City in 2004 - yes, this blog is that old. We also <a href="http://hcrenewal.blogspot.com/2008/12/suing-poor-patients-in-maryland.html">discussed</a> such practices in Baltimore in 2008. Such practices are an example of <a href="http://hcrenewal.blogspot.com/search/label/mission-hostile%20management">mission-hostile management</a>. Finally, we have commented many times about misbehavior by health care executives, and discussed examples of <a href="http://hcrenewal.blogspot.com/search/label/fraud">fraud</a>, <a href="http://hcrenewal.blogspot.com/search/label/kickbacks">kickbacks</a>, and <a href="http://hcrenewal.blogspot.com/search/label/health%20care%20corruption">health care corruption</a>. It has been unusual, however, for individual executives to actually suffer negative consequences when they induce systemic misbehavior in their organizations. Instead, the results are often <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> that only lead to financial penalties on the organizations that are no more than costs of doing business. However, the juxtaposition of stories that a hospital has been coddling the rich, and simultaneously hounding the poor while it was lead by at least a few criminal executives is unusual. One would think that they should lead to an in-depth look at the leadership and governance of the institution in question, perhaps even to some reform of same. (By the way, one area of interest to such an investigation should be the presence of several former and current leaders of some of the failed financial firms that lead us into the global financial crisis or great recession on the board of that hospital, as we discussed <a href="http://hcrenewal.blogspot.com/2012/01/new-york-presbyterian-hospital-trustee.html">here</a> and <a href="http://hcrenewal.blogspot.com/2009/12/with-leaders-like-these.html">here</a>.) However, so far I seem to be only one to note the inter-relationships of these stories, and their implications, while obvious, therefore remain anechoic. So I get to repeat.... Health care organizations need leadership that understands, and knowledgeably upholds the organizations' missions and patients and the public's health. The leaders should be subject to incentives that align with these responsibilities, and should not be given opportunities to personally profit from activities hostile to the mission.

Three Facets of One Hospital: Coddling the Rich, Hounding the Poor, and Crooked Executives

Juxtaposing three news stories from the past few months raises disturbing questions about the priorities of the leaders of one of the US'...

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Proposed new Consumer Privacy Bill of Rights: Is It Too Late For Healthcare?

From the White House: <blockquote><a href="http://www.whitehouse.gov/the-press-office/2012/02/23/fact-sheet-plan-protect-privacy-internet-age-adopting-consumer-privacy-b">http://www.whitehouse.gov/the-press-office/2012/02/23/fact-sheet-plan-protect-privacy-internet-age-adopting-consumer-privacy-b</a> The White House Office of the Press Secretary For Immediate Release February 23, 2012 Plan to Protect Privacy in the Internet Age by Adopting a Consumer Privacy Bill of Rights CONSUMER PRIVACY BILL OF RIGHTS The Consumer Privacy Bill of Rights applies to personal data, which means any data, including aggregations of data, that is linkable to a specific individual. Personal data may include data that is linked to a specific computer or other device. The Administration supports Federal legislation that adopts the principles of the Consumer Privacy Bill of Rights. Even without legislation, the Administration will convene multi-stakeholder processes that use these rights as a template for codes of conduct that are enforceable by the Federal Trade Commission. These elements—the Consumer Privacy Bill of Rights, codes of conduct, and strong enforcement—will increase interoperability between the U.S. consumer data privacy framework and those of our international partners. <ol><li>INDIVIDUAL CONTROL: Consumers have a right to exercise control over what personal data companies collect from them and how they use it. Companies should provide consumers appropriate control over the personal data that consumers share with others and over how companies collect, use, or disclose personal data. Companies should enable these choices by providing consumers with easily used and accessible mechanisms that reflect the scale, scope, and sensitivity of the personal data that they collect, use, or disclose, as well as the sensitivity of the uses they make of personal data. Companies should offer consumers clear and simple choices, presented at times and in ways that enable consumers to make meaningful decisions about personal data collection, use, and disclosure. Companies should offer consumers means to withdraw or limit consent that are as accessible and easily used as the methods for granting consent in the first place.</li><li>TRANSPARENCY: Consumers have a right to easily understandable and accessible information about privacy and security practices. At times and in places that are most useful to enabling consumers to gain a meaningful understanding of privacy risks and the ability to exercise Individual Control, companies should provide clear descriptions of what personal data they collect, why they need the data, how they will use it, when they will delete the data or de-identify it from consumers, and whether and for what purposes they may share personal data with third parties. </li><li>RESPECT FOR CONTEXT: Consumers have a right to expect that companies will collect, use, and disclose personal data in ways that are consistent with the context in which consumers provide the data. Companies should limit their use and disclosure of personal data to those purposes that are consistent with both the relationship that they have with consumers and the context in which consumers originally disclosed the data, unless required by law to do otherwise. If companies will use or disclose personal data for other purposes, they should provide heightened Transparency and Individual Control by disclosing these other purposes in a manner that is prominent and easily actionable by consumers at the time of data collection. If, subsequent to collection, companies decide to use or disclose personal data for purposes that are inconsistent with the context in which the data was disclosed, they must provide heightened measures of Transparency and Individual Choice. Finally, the age and familiarity with technology of consumers who engage with a company are important elements of context. Companies should fulfill the obligations under this principle in ways that are appropriate for the age and sophistication of consumers. In particular, the principles in the Consumer Privacy Bill of Rights may require greater protections for personal data obtained from children and teenagers than for adults.</li><li>SECURITY: Consumers have a right to secure and responsible handling of personal data. Companies should assess the privacy and security risks associated with their personal data practices and maintain reasonable safeguards to control risks such as loss; unauthorized access, use, destruction, or modification; and improper disclosure. </li><li>ACCESS AND ACCURACY: Consumers have a right to access and correct personal data in usable formats, in a manner that is appropriate to the sensitivity of the data and the risk of adverse consequences to consumers if the data is inaccurate. Companies should use reasonable measures to ensure they maintain accurate personal data. Companies also should provide consumers with reasonable access to personal data that they collect or maintain about them, as well as the appropriate means and opportunity to correct inaccurate data or request its deletion or use limitation. Companies that handle personal data should construe this principle in a manner consistent with freedom of expression and freedom of the press. In determining what measures they may use to maintain accuracy and to provide access, correction, deletion, or suppression capabilities to consumers, companies may also consider the scale, scope, and sensitivity of the personal data that they collect or maintain and the likelihood that its use may expose consumers to financial, physical, or other material harm.</li><li>FOCUSED COLLECTION: Consumers have a right to reasonable limits on the personal data that companies collect and retain. Companies should collect only as much personal data as they need to accomplish purposes specified under the Respect for Context principle. Companies should securely dispose of or de-identify personal data once they no longer need it, unless they are under a legal obligation to do otherwise.</li><li>ACCOUNTABILITY: Consumers have a right to have personal data handled by companies with appropriate measures in place to assure they adhere to the Consumer Privacy Bill of Rights. Companies should be accountable to enforcement authorities and consumers for adhering to these principles. Companies also should hold employees responsible for adhering to these principles. To achieve this end, companies should train their employees as appropriate to handle personal data consistently with these principles and regularly evaluate their performance in this regard. Where appropriate, companies should conduct full audits. Companies that disclose personal data to third parties should at a minimum ensure that the recipients are under enforceable contractual obligations to adhere to these principles, unless they are required by law to do otherwise.</li></ol></blockquote> For an example of some of the major problems with healthcare data, see my Oct. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/10/health-it-vendors-trafficking-in.html">Health IT Vendors Trafficking in Patient Data?</a>" I like the proposals. The question is, regarding electronic health data: are these Federal proposals too little, too late? Complex systems such as massive computer networks (with myriad stakeholders seeking to 'game' the system, skirt the boundaries of the law, and make handsome profits) can become uncontrollable. -- SS

Proposed new Consumer Privacy Bill of Rights: Is It Too Late For Healthcare?

From the White House: http://www.whitehouse.gov/the-press-office/2012/02/23/fact-sheet-plan-protect-privacy-internet-age-adopting-consumer-p...

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It's Remarkable That EHRs Can't Do What Med Students Are Taught in PGY3-4 ... And Remarkable That Academics Don't Push This Information to the Public

The following article's full text from the journal <a href="http://aci.schattauer.de/">Applied Clinical Informatics</a> (ACI) is not freely available, but the abstract says all that needs to be said: <a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=4257f2c99a56463ab08a659cf649047d&URL=http%3a%2f%2faci.schattauer.de%2fen%2fhome%2fissue%2fspecial%2fmanuscript%2f17336%2fshow.html"></a><blockquote><a href="http://aci.schattauer.de/de/contents/current-issue/issue/special/manuscript/17336/show.html">Clinical Summarization Capabilities of Commercially-available and Internally-developed Electronic Health Records</a> (Vol. 3: Issue 1 2012) A. Laxmisan (1), A. B. McCoy (2), A. Wright (3), D. F. Sittig (2) (1) Houston VA Health Services Research and Development Center of Excellence, Michael E. DeBakey Veterans Affairs Medical Center and Section of Health Services Research, Department of Medicine, Baylor College of Medicine, Houston, TX; (2) School of Biomedical Informatics, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX; (3) Brigham and Women’s Hospital, Harvard Medical School, Boston, MA Summary Objective: Clinical summarization, the process by which relevant patient information is electronically summarized and presented at the point of care, is of increasing importance given the increasing volume of clinical data in electronic health record systems (EHRs). There is a paucity of research on electronic clinical summarization, including the capabilities of currently available EHR systems. Methods: We compared different aspects of general clinical summary screens used in twelve different EHR systems using a previously described conceptual model: AORTIS (Aggregation, Organization, Reduction, Interpretation and Synthesis). Results: We found a wide variation in the EHRs’ summarization capabilities: all systems were capable of simple aggregation and organization of limited clinical content, but only one demonstrated an ability to synthesize information from the data. Conclusion: Improvement of the clinical summary screen functionality for currently available EHRs is necessary. Further research should identify strategies and methods for creating easy to use, well-designed clinical summary screens that aggregate, organize and reduce all pertinent patient information as well as provide clinical interpretations and synthesis as required. </blockquote>Put more directly, EHRs were poor at presenting relevant clinical information in summary form at the point of care. (They're even worse after care is finished; see my Feb. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html">Electronic Medical Records: Two Weeks, Two Reams</a>" on the piles of 'legible gibberish' put out as official medical records of entire hospital admissions.) The implications are that these systems cause physicians to waste time, weed through inordinate amounts of data in seeking what's important to help patients - and prevent errors. Thus, they are highly likely to increase clinician cognitive burdens and quite possibly reduce the quality of care. But don't just take my word for that. The 2009 National Research Council report made similar observations about EHRs in research overseen by two of HIT's preeminent pioneers, Drs. Octo Barnett and William Stead. See "Current Approaches to Healthcare Information Technology are Insufficient" and the accompanying full NRC report <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">here</a> that states: <blockquote> "Current efforts aimed at the nationwide deployment of health care information technology (IT) will not be sufficient to achieve medical leaders' vision of health care in the 21st century and may even set back the cause ... The report describes difficulties with data sharing and integration, deployment of new IT capabilities, and large-scale data management. Most importantly, current health care IT systems offer little cognitive support; clinicians spend a great deal of time sifting through large amounts of raw data (such as lab and other test results) and integrating it with their medical knowledge to form a whole picture of the patient. Many care providers told the committee that data entered into their IT systems was used mainly to comply with regulations or to defend against lawsuits, rather than to improve care. As a result, valuable time and energy is spent managing data as opposed to understanding the patient." </blockquote>I find several aspects of the new ACI study and its findings remarkable: First: Clinical summarization is an essential skill for patient pickups (e.g., taking over the care of a hospitalized patient or performing a consult on them), patient handoffs (such as when put in care of a covering physician), and other related informational reasons. It is a skill taught (at least when I attended medical school) in the third and fourth years, also known as PGY3 and PGY4 (postgraduate years 3 and 4). I was tested on my ability to perform this task adequately, and the quality of my clinical summaries were also evaluated during internship and residency training as one of many criteria for successful completion. The author's results, therefore, indicate that EHR designers and implementers cannot, or will not, incorporate the skills of clinical summarization required of PGY3-4 medical students and interns into their products, even after several decades of product manufacturing. I find this astonishing. Second: While I applaud the authors of the new ACI study for performing such work, which in the current environment of <a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-irrational.html">hyper-enthusiastic cybernetic technophilia in medicine</a> might cause negative industry pushback, I find another aspect of their work astonishing (perhaps 'disappointing' is a better term): They only published their findings in ACI. ACI is an excellent new journal, but as it is a relatively specialized journal in a specialized domain, its content will reach probably on the order of thousands of people in a substantive way. This very blog has surpassed one million "hits", we estimate; my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">Drexel University site on HIT difficulties</a> (including its predecessors) has probably surpassed the quarter million mark. My point is that, at a time when the Institute of Medicine, NIST and others have advised further study of health IT to decide if HIT is safe and efficacious (because they don't really know) in order to decide if FDA or other governmental regulation is needed, research findings such as that of Archana Laxmisan, M.D, Dean Sittig PhD, and Adam Wright PhD, deserve far wider dissemination than in a highly specialized, relatively new informatics journal. Let me further go on to say that physicians, by the nature of their MD degree, and non-physician informaticists such as Sittig and Wright, should feel ethically compelled to actively diffuse this type of finding about an experimental, suboptimal and potentially dangerous medical device (as per <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">FDA CDRH's designation as such</a>) more widely. They should not leave it to bloggers such as myself to do that work for them. This is not to single out these authors, this journal or this article; the phenomenon is common. Health IT research findings of potential great import sit in scientific journals that rarely if ever get seen by the lay citizenry, despite the importance to their being informed about the technology's actual and potential downsides. How about the New York Times or Wall Street Journal? Even YouTube? These observations are not at all to impugn publication in ACI in any way, whose editor in chief I deeply respect for publishing articles that could be viewed as "negative" about HIT. Wider diffusion in non-academic print media and/or "New Media", however, would get messages such as in the clinical summarization deficiency study out in a way that would have far more social impact - and help protect patients. In other words, the authors of informatics studies need to actively "get out more." After all, the industry and government spare no effort in positive publicity, even making unabashed marketing claims not backed by the scientific literature, such as in the Feb. 24, 2012 HHS press release at <a href="http://www.hhs.gov/news/press/2012pres/02/20120224a.html">this link</a>: <blockquote> “We know that broader adoption of electronic health records can save our health care system money, save time for doctors and hospitals, and save lives,” said [HHS] Secretary Sebelius."</blockquote> Unlike the relationships between, say, hydrochlorothiazide diuretics and reductions in blood pressure, or sterile techniques in surgery lessening infection, I don't think that in 2012 we "know" that at all (<a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">link</a>). -- SS Feb. 26, 2012 addendum: Regarding my final point about the HHS statement, a reader who wishes to remain unnamed, familiar with efforts outside the US, offers the following interesting observations: <blockquote>"This [HHS statement from Sebelius] is political spin to try to keep some momentum in a project that is obviously failing. What is more they KNOW it is failing and can read the IOM report and the negative US and UK reports on EHR's. The White House is clearly desperate to calm voter and healthcare professional opinion and this is another naked attempt to project the inevitable crisis to beyond the end of this year...well at least early November. I know that this is true because Sebelius' language is exactly the same as that used by the UK Dept. of Health just before NPfIT completely folded... Also, implementation rates of HIT projects must also be carefully scrutinized as they reflect the percentage of hospitals where something, usually anything has been switched on rather than the proportion where a full EHR, PACS, CPOE etc. has been achieved. A good question to ask is how many units are now paperless?"</blockquote> -- SS

It's Remarkable That EHRs Can't Do What Med Students Are Taught in PGY3-4 ... And Remarkable That Academics Don't Push This Information to the Public

The following article's full text from the journal Applied Clinical Informatics (ACI) is not freely available, but the abstract says al...

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