On Health Care Renewal, we have noted how the direct care of patients in the US is increasingly in the hands of large corporations, often for-profit. We have noted the plight of the corporate physicians who swore oaths to put patients first, and now report to managers who put revenue first.
Health Care Renewal was hardly the first to raise these issues. For years, the renowned editor emeritus of the New England Journal, Dr Arnold Relman, has been warning about the effects of the commercial practice of medicine, which once was illegal in most US states, and until 1980 was condemned by the American Medical Association (look here).
Yet in a world in which market fundamentalism (or economism, or neoliberalism) is increasingly dominant, there is little room for the view that turning health care into a business, and having the new health care businesses lead by people who are only interested in increasing short term revenue (financialization) and increasing their own compensation might be bad for patients' and the public's health.
However, close reading of a recent article suggests that many physicians "get" this problem, although may be reticent about protesting it.
Summary of the JAMA Article
Tilburt et al authored an article published in July, 2013 that focused on physicians views about "controlling health care costs."(1) They sent a survey to 3900 randomly chosen physicians less than 65 years old and in active practice. 2556 (65%) responded.
The survey included questions about who should be responsible for reducing health care costs, and about the physicians' enthusiasm for various means of cutting costs. The results that got the most publicity were that physicians thought others (trial lawyers, health insurance companies, pharmaceutical and device manufacturers, hospitals and health care systems, patients, and government) were more responsible for controlling costs than physicians.
Nonetheless, the physicians were relatively enthusiastic about potential cost control measures that would improve "quality and efficiency of care," for example, promoting 75% were very enthusiastic about continuity of care, 69% about promoting chronic disease care coordination, and 70% about "rooting out fraud and abuse." They were also relatively enthused about "improving conditions for evidence-based decisions," for example, 51% were very enthusiastic about "expanding access to quality and safety data," and and 50% about "promoting head-to-head trials of competing treatments" (also known as a type of comparative effectiveness research).
Strikingly, however, 63% of physicians were "very enthusiastic" about "limiting corporate influence on physician behavior." The article did not further explain that item.
An Almost Unnoticed Result
The article's results section noted "some or strong enthusiasm for improving conditions for evidence-based decisions," including "limiting corporate influence on physician behavior." It included no further comments on this issue.
The public discussion it generated largely ignored physicians' views on corporate influence..
An accompanying editorial by Dr Ezekiel Emanuel and Mr Andrew Steinmetz (2) called the survey's findings "discouraging" and chided physicians for not having an "all hands on deck" approach to controlling health care costs, stating they "must lead" on this issue, because they "captains of the ship." It ignored the notion that the physicians may have thought that their first responsibility was
to "individual patients best interests," and thus controlling costs
(especially costs that do not accrue directly to patients) should be a
secondary concern. It also belittled their enthusiasm about curbing "fraud and abuse," implying that it was "sufficiently vague" that it "may offer only modest improvements but certainly will not transform the health care system." Instead, Emanuel and Steinmetz wanted physicians to support six strategies for transforming health care delivery, without citing evidence in support of these strategies. The Emanuel and Steinmetz editorial ignored the physicians' views on corporate influence.
A post on the In My Humble Opinion blog by Dr Jordan Grumet in turn wondered why physicians should support "Ezekiel's fantasies about healthcare [which] are unsubstantiated." Dr Grumet decried how particularly primary care physicians have been marginalized, and suggested that if Emanuel and Steinmetz want physicians to act like the captains of the ship they perhaps should not dictate their navigation. But Dr Grumet apparently did not notice that physicians may realize that their captaincy has been challenged by corporate influence. .
Media coverage in, for example, the Los Angeles Times, Fox News, and the Pioneer Press focused on the question of whether physicians were denying a responsibility to control costs, and whether that responsibility was really theirs. It did not comment on the issue of corporate influence.
However, so far the striking result that a large, well conducted survey showed that the majority of physicians support limiting corporate influence on their behavior remains almost completely unnoticed.
Summary
We now have some reasonably good data suggesting that the majority of physicians are very troubled by "corporate influences" on them.
It could be that they are troubled by the most direct corporate influences, the practice of medicine by physicians who are employees of corporations, often large, and for-profit.
Dr Arnold Relman reminded us that physicians used to shun the commercial practice of medicine (look here). Yet now increasing numbers of physicians are employees of for-profit corporations. Physicians and other health professionals who sign on as full-time
employees of large corporate entities have to realize that they are now
beholden to managers and executives who may be hostile to their professional values, and who are subject to perverse incentives that support such hostility, including the potential for huge executive compensation. It is not clear why physicians seem to be willing to sign contracts that underline their new subservience to their corporate overlords, and likely trap them within confidentiality clauses that make blowing the whistle likely to lead to extreme unpleasantness.
It could also be that physicians are troubled by slightly less direct corporate influences. We have blogged about
- suppression and manipulation of clinical research by corporations
sponsoring such research to assess their own products and services
- deceptive corporate practices like stealth marketing of stealth lobbying
- financial arrangements among physicians (and other health professionals) and health care corporations (e.g., drug, biotechnology and device corporations) which often seem to deliberately produce conflicts of interest meant to help market products and services, particularly the use of paid "key opinion leaders" as marketers
- institutional conflicts of interest that involve academic institutions, disease advocacy organizations, and other non-profit groups in corporate marketing and public relations
Furthermore, stories about and criticisms of these issues remain
markedly muted in the media, and even more muted in medical and health
care scholarship and scholarly journals. We have attributed this anechoic effect
to individual and institutional conflicts of interest, fear of
offending conflicted friends, relatives, colleagues and supervisors, and
fear of offending the rich and powerful.
Despite the anechoic effect, the article by Tilburt et al suggests that
physicians want to reduce corporate influence in medicine. Yet this
evidence of physicians' discomfort with corporate influences itself has
been greatly muted by the anechoic effect.
While the survey results are reminiscent of opinions I have heard from many physicians, it is striking that there is no perceptible organized movement by physicians against excess corporate influence. At best, public expression of concerns about excess corporate influence has been muted and fragmented, often relegated to blogs and sometimes derided as coming from malcontents, dissidents, disgruntled employees, and other assorted trouble-makers. But again it looks like the majority of physicians may (often silently) agree with these "whiners and complainers."
Physicians need to realize that they mostly agree that to fulfill their oaths to put patients first, they have to reduce the influence of rich and powerful organizations, like health care corporations, with other agendas. Maybe once they realize this, they will be able to start doing something to reduce such influences. Maybe once they start, they will be able to rethink the notion that direct health care should ever be provided, or
that medicine ought to be practiced by for-profit corporations. I submit that we will not be able to
have good quality, accessible health care at an affordable price until
we restore physicians as independent, ethical health care professionals,
and until we restore small, independent, community responsible,
non-profit hospitals as the locus for inpatient care.
Roy M. Poses MD on Health Care Renewal
References
1. Tilburt JC, Wynia MK, Sheeler RD et al. Views of physicians about controlling health care costs. JAMA 2013: 310: 380-388. Link here.
2. Emanuel EJ, Steinmetz A. Will physicians lead on controlling health care costs? JAMA 2013; 310: 374-375. Link here.
Monday, August 12, 2013
Doctors now spend more time with computers than they do with patients
This bodes poorly for future physician quality:
I can assert this is not what the EMR pioneers intended. They intended health IT to reduce workloads and inefficiencies so clinicians could spend more time performing care. The tools they prototyped decades ago, unfortunately, are no longer in control of, or serving, the clinicians they intended the tools to serve. Instead they are largely serving a permanent and growing bureaucracy.
They are, in fact, mis-serving clinicians e.g., through production of reams of legible gibberish (http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html), clinically mission-hostile designs (http://www.tinyurl.com/hostileuserexper), outright defects (http://hcrenewal.blogspot.com/search/label/glitch) and marauding hyperenthusiast-extremists pushing the technology on ill-informed management (http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html).
I think the illustration was appropriate; see article link for the artwork.
Let me say this bluntly: most people lacking full medical training cannot grasp this concept. They do not know what they do not know. Worse, many non-clinicians I've encountered, especially in the health IT domain, seem to be unable or unwilling will to accept that simple truth (perhaps in part due to the Dunning-Kruger effect).
Perhaps decreasing patient satisfaction scores might change the current state of affairs?
Or, if unable to "exist in service to patient care" due to industry problems, it needs to cease to exist (i.e., be put on hold or put on ice) until it can perform to expectations.
-- SS
The doctor won't see you now
DANIELLE OFRI
Pittsburgh Post-Gazette
August 11, 2013 12:03 am
Like the mail carrier or the milkman of yore, the doctor makes rounds every day in the hospital. If it's an academic institution, a bevy of medical students, interns and residents accompany an attending physician from room to room, checking up on the patient, doing a daily physical exam, reviewing the latest test results and highlighting the relevant teaching points. That's been the mainstay of medical education, and that's how my colleagues and I were taught to train the next generation of doctors.
Alas, this image would be true today only if a computer terminal were plunked in the bed instead of a patient. A new study in the Journal of General Internal Medicine confirms what any physician or patient could tell you: Doctors spend more time with computers than they do with patients. In fact, computers handily beat out patients: Medical interns spent 40 percent of their day with a computer compared with 12 percent of their day with actual living, breathing patients. (Discussing cases with other health care professionals and educational activities were the other main activities of the day.)
... Nurses are practically chained to their computers these days. A typical outpatient office visit today consists of a doctor focused directly at a screen, and a patient waiting, ahem, patiently, while the doctor thrashes it out with the computer, furiously typing notes, orders and prescriptions, occasionally whacking the side of the computer in frustration.
I can assert this is not what the EMR pioneers intended. They intended health IT to reduce workloads and inefficiencies so clinicians could spend more time performing care. The tools they prototyped decades ago, unfortunately, are no longer in control of, or serving, the clinicians they intended the tools to serve. Instead they are largely serving a permanent and growing bureaucracy.
They are, in fact, mis-serving clinicians e.g., through production of reams of legible gibberish (http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html), clinically mission-hostile designs (http://www.tinyurl.com/hostileuserexper), outright defects (http://hcrenewal.blogspot.com/search/label/glitch) and marauding hyperenthusiast-extremists pushing the technology on ill-informed management (http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html).
I think the illustration was appropriate; see article link for the artwork.
... For many doctors, nurses and patients, the experience of technology today--particularly the electronic medical record -- makes it feel as though technology is front and center while actual medical care is secondary. The expansion of the EMR has taken us to the point that caregivers hardly need to see a patient at all; the practice of medicine can be entirely virtual.
It can be "virtual" if one wants low quality, that is. Here's why:
... It was a brazen revolution in the 1890s when Sir William Osler pulled medical students out of the lecture hall and into the ward, with the startling idea that students needed to learn medicine with actual patients. But our technological march has steadily sapped this Oslerian ideal, and our trainees today are missing out on many of the finer points of medicine. Despite the impressive leaps forward in simulation technology, you simply cannot learn the subtleties of assessing a wound, palpating a spleen, asking the right questions, navigating a patient's fears, engendering trust, without actually being with patients.
Let me say this bluntly: most people lacking full medical training cannot grasp this concept. They do not know what they do not know. Worse, many non-clinicians I've encountered, especially in the health IT domain, seem to be unable or unwilling will to accept that simple truth (perhaps in part due to the Dunning-Kruger effect).
... And for patients, medical care has become an increasingly isolating experience, as their caregivers seem more beholden to technologies than to their illnesses, which are most certainly not virtual.
Perhaps decreasing patient satisfaction scores might change the current state of affairs?
... We need to rethink the role of technology in medicine, especially the electronic medical record. The new mantra of "patient-centered care" needs to apply equally to our computerized systems. With each new iteration of the EMR, we need to ask ourselves how patients are benefiting, as opposed to whether we are merely satisfying administrative documentation mandates. The EMR needs to exist in service to patient care, not simply as an end in itself.
Or, if unable to "exist in service to patient care" due to industry problems, it needs to cease to exist (i.e., be put on hold or put on ice) until it can perform to expectations.
Friday, August 09, 2013
A War on Patients: Panel Says EHRs Should Not Be Vetted Before Marketing and Deployment
"First, do harm - it's a learning experience, and injured or dead patients are just a bump in the road, anyway" - the apparent creed of the healthcare computing hyperenthusiasts
Joe Conn and Modern Healthcare published the following article:
Work group says OK to some HIT safety regs (link), Joe Conn, Modern Healthcare, Aug. 7, 2013
Wednesday, August 07, 2013
Health Care Revolving Door Roundup
Increasingly, the regulatory and law enforcement functions of the US government in the health care sphere seem to be blending with the management of large health care organizations. One mechanism for this is the "revolving door," the constant interchange of personnel between government agencies and corporate management.
Here is a list of some of this year's interesting cases of people transiting the revolving door between US government agencies that are supposed to regulate health care organizations or enforce the relevant laws and the organizations subject to these regulations and laws. Note that this list may not be complete. It is difficult to keep track of these transitions.
Leader of Health Care Fraud Section of Philadelphia US Attorney's Office to Teva Pharmaceuticals
Via MainJustice.org in March, 2013,
Leader of US Department of Justice Fraud Section in Charge of Health Care Issues to Law Firm as Defender of Companies and Senior Executives
The initial notice again was via MainJustice.org in March, 2013
Mr Sheldon's new job was made clear on the firm's website,
FDA Deputy Commissioner for Global Regulatory Operations and Policy to Mylan
This story, in April, actually made it (briefly) to Reuters,
Leader of Health Care Fraud Enforcement of Philadelphia US Attorney's Office to Law Firm as Industry Defender
From Bloomberg, in August, 2013,
The law firm's website states,
Summary
In each of these cases, a person with responsibility for regulation of and/or law enforcement for health care organizations went through the revolving door to either work for health care corporations subject to such regulation and/or law enforcement, or work for legal firms that specialize in defending such corporations and their leaders in regulatory and law enforcement actions.
As far as I know, none of these instances was the least bit illegal. However, like previous examples of the revolving door, they raise the concern that people in government regulation or law enforcement who think that they may have future lucrative job prospects helping health care organizations attenuate regulation and law enforcement may not be the most enthusiastic, aggressive, or persistent regulators or law enforcers. Why would one want to upset one's future employer?
While these cases of the revolving door are legal, they are clearly conflicts of interest in the sense that the prospect of such future employment likely may increase the risk of compromising a government official's devotion to serving the public and enforcing the law, if not in the legal sense. In some particular case, the revolving door may actually lead to corruption according to the Transparency International definition, abuse of entrusted power for private gain, if not according to the legal definition. Thus the continuing occurrence of government officials blithely transiting the revolving door no doubt was a reason that more than 40% of the public consider the US health care sector to be corrupt (see this post.)
True health care reform would require curtailing the severe sorts of conflicts of interest created by the revolving door. This might require both improving pay and working conditions for government regulators and law enforcers, and specific laws to prevent immediate transitions from being a regulator/ law enforcer to handling corporate responses to or defenses of such regulation and enforcement.
Of course, I can already hear the protests of those people who decry paying more for government or increasing government regulation. I can at least hope that the protests are not from those who personally profit from the current seemingly corrupt system.
Here is a list of some of this year's interesting cases of people transiting the revolving door between US government agencies that are supposed to regulate health care organizations or enforce the relevant laws and the organizations subject to these regulations and laws. Note that this list may not be complete. It is difficult to keep track of these transitions.
Leader of Health Care Fraud Section of Philadelphia US Attorney's Office to Teva Pharmaceuticals
Via MainJustice.org in March, 2013,
John Pease, who led the government and health care fraud section in the U.S. Attorney's Office in Philadelphia, has left the Justice Department for a job with a pharmaceutical company.
Pease, 45, is a new senior counsel at Teva Pharmaceuticals, where he oversees government investigations of the company for the Americas. 'I was just ready to try something different,' Pease said in an interview.
Leader of US Department of Justice Fraud Section in Charge of Health Care Issues to Law Firm as Defender of Companies and Senior Executives
The initial notice again was via MainJustice.org in March, 2013
Sam Sheldon, the deputy chief in the Criminal Division's Fraud Section who oversaw health care fraud prosecutions, is leaving the Justice Department to join Quinn Emanuel Urquhart & Sullivan LLP.
Mr Sheldon's new job was made clear on the firm's website,
Sam Sheldon is head of the firm’s Health Care Practice Group. He is a trial lawyer who represents companies and senior executives in litigation before the United States federal government including Department of Justice and Department of Health and Human Services, and other law enforcement and regulatory agencies.
FDA Deputy Commissioner for Global Regulatory Operations and Policy to Mylan
This story, in April, actually made it (briefly) to Reuters,
Generic drugmaker Mylan Inc said on Tuesday it hired Deborah Autor, deputy commissioner for global regulatory operations and policy at the U.S. Food and Drug Administration, to help oversee its global regulatory strategy.
Leader of Health Care Fraud Enforcement of Philadelphia US Attorney's Office to Law Firm as Industry Defender
From Bloomberg, in August, 2013,
Marilyn May, a False Claims Act litigator at the U.S. Justice Department, joined Arnold & Porter LLP’s Washington office as litigation counsel with a focus on healthcare, pharmaceutical and medical device industry defense work.
May was the head of healthcare fraud enforcement in the U.S. Attorney’s Office in the Eastern District of Pennsylvania. She coordinated healthcare fraud cases and investigations as well as handled False Claims Act cases involving pharmaceutical and medical device companies, hospitals, nursing homes and other healthcare providers, the firm said.
The law firm's website states,
Her litigation practice focuses on pharmaceutical, medical device and healthcare defense matters.
Summary
In each of these cases, a person with responsibility for regulation of and/or law enforcement for health care organizations went through the revolving door to either work for health care corporations subject to such regulation and/or law enforcement, or work for legal firms that specialize in defending such corporations and their leaders in regulatory and law enforcement actions.
As far as I know, none of these instances was the least bit illegal. However, like previous examples of the revolving door, they raise the concern that people in government regulation or law enforcement who think that they may have future lucrative job prospects helping health care organizations attenuate regulation and law enforcement may not be the most enthusiastic, aggressive, or persistent regulators or law enforcers. Why would one want to upset one's future employer?
While these cases of the revolving door are legal, they are clearly conflicts of interest in the sense that the prospect of such future employment likely may increase the risk of compromising a government official's devotion to serving the public and enforcing the law, if not in the legal sense. In some particular case, the revolving door may actually lead to corruption according to the Transparency International definition, abuse of entrusted power for private gain, if not according to the legal definition. Thus the continuing occurrence of government officials blithely transiting the revolving door no doubt was a reason that more than 40% of the public consider the US health care sector to be corrupt (see this post.)
True health care reform would require curtailing the severe sorts of conflicts of interest created by the revolving door. This might require both improving pay and working conditions for government regulators and law enforcers, and specific laws to prevent immediate transitions from being a regulator/ law enforcer to handling corporate responses to or defenses of such regulation and enforcement.
Of course, I can already hear the protests of those people who decry paying more for government or increasing government regulation. I can at least hope that the protests are not from those who personally profit from the current seemingly corrupt system.
Today's Bad Health IT Systems: More Dangerous Than Paper?
I believe in 2013 that they are.
(Definition of bad health IT is here: http://www.ischool.drexel.edu/faculty/ssilverstein/cases/)
I recently posted about two "glitches" in a major EHR seller's clinical systems, Siemens Healthcare, affecting safety-critical functions of medication reconciliation and medication ordering.
Considering these, plus the many "glitches" reported by the only EHR seller who does so via FDA's MAUDE database (see here: http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html), and the others posted at this blog at query link: http://hcrenewal.blogspot.com/search/label/glitch, the following issue needs serious consideration by policymakers.
Namely, the issue that enterprise electronic medical command-and-control systems, which today's "EHRs" in reality are, are on their face more risk-prone than the paper systems they are replacing.
The "glitches" reported above are clearly the tip of the iceberg due to industry norms of secrecy, the absence of most of the industry in reporting to FDA MAUDE or anywhere, and my limited sources of information. It is likely the true level of "glitches" in live EHR/clinical IT installations is far, far higher - conservatively, I believe, at least two orders of magnitude.
Workarounds to IT "glitches" such as recommended in the Siemens bulletins at the aforementioned posts cause hospital officials to have to reliably get the notices to all users of the systems, including medical students, nurses, physicians and allied health professionals.
The workarounds also cause users to:
1) have to deviate from habits of use acquired in training and active use of the systems in question;
2) remember, without fail, to deviate from habits of use acquired in training and active use of the systems in question, in effect giving them the responsibility of caring for sick patients and for "sick" information technology;
3) keep in mind any other extant workarounds that exist waiting for "fixes"; and
4) be constantly on guard for information storage failures.
In fact, the recent Siemens "glitches" and workarounds represent a clear danger to patient safety. If these were more conventional medical devices, they'd be recalled.
See my Dec. 14, 2011 post "FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death" (http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html) and July 23, 2012 post "Health IT FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems"(http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html) for examples where health IT defects similar to the Siemens issues were, in fact, recalled.
Further, with paper records or tangible images, a page or image can be lost, or it can be illegible. In the case of lost, in any quality paper record keeping system the information stewards or others using the paper (e.g., office staff or ward clerks) will generally note the absence and act accordingly. Further, illegible notes or orders will most often be recognized as illegible and result in attempted clarification or other corrective actions.
On the other hand, when electronic systems:
1) lose modified information en masse as in the Siemens examples but keep the old, or
2) when outright errors such as en masse truncation occur (as in the thousands of prescriptions whose long-acting suffixes were cut off at Lifespan in Rhode Island, see "Yet another health IT "glitch" affecting thousands" here: http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html), or
3) images are lost (see "Potential Image Loss in GE Centricity PACS" here: http://hcrenewal.blogspot.com/2012/11/potential-image-loss-in-ge-centricity.html) without warning-
- There are no "flags" that the obsolete, truncated or missing information is erroneous.
What remains is perfectly legible, perfectly convincing and perfectly deceiving.
Electronic healthcare information systems on their face create more risk than paper record systems. Further, the problem with "bugs" and "glitches" will not go away with today's industry models of "hiring down" and lack of regulation. Every new upgrade or patch is suspect for introducing new bugs.
Paper does not suffer these issues, unless disappearing ink is used to cross out the old and add new information ...
Not that I am advocating for a return to 100% paper, but certain critical functions probably are best left to paper. Further, hundreds of billions of dollars can certainly buy:
1) a lot of Health Information Management professionals to perform continuous QA of paper,
2) a lot of document imaging systems to make the paper records available anywhere, anytime they are needed, and
3) a lot of data entry personnel to relieve clinicians of clerical burdens so they may use their valuable experience more productively, as guest poster Howard Brody points out at http://hcrenewal.blogspot.com/2013/07/guest-post-incompetent-management.html.
4) a lot of sensible regulation of this industry's product quality.
-- SS
(Definition of bad health IT is here: http://www.ischool.drexel.edu/faculty/ssilverstein/cases/)
I recently posted about two "glitches" in a major EHR seller's clinical systems, Siemens Healthcare, affecting safety-critical functions of medication reconciliation and medication ordering.
Considering these, plus the many "glitches" reported by the only EHR seller who does so via FDA's MAUDE database (see here: http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html), and the others posted at this blog at query link: http://hcrenewal.blogspot.com/search/label/glitch, the following issue needs serious consideration by policymakers.
Namely, the issue that enterprise electronic medical command-and-control systems, which today's "EHRs" in reality are, are on their face more risk-prone than the paper systems they are replacing.
The "glitches" reported above are clearly the tip of the iceberg due to industry norms of secrecy, the absence of most of the industry in reporting to FDA MAUDE or anywhere, and my limited sources of information. It is likely the true level of "glitches" in live EHR/clinical IT installations is far, far higher - conservatively, I believe, at least two orders of magnitude.
Workarounds to IT "glitches" such as recommended in the Siemens bulletins at the aforementioned posts cause hospital officials to have to reliably get the notices to all users of the systems, including medical students, nurses, physicians and allied health professionals.
The workarounds also cause users to:
1) have to deviate from habits of use acquired in training and active use of the systems in question;
2) remember, without fail, to deviate from habits of use acquired in training and active use of the systems in question, in effect giving them the responsibility of caring for sick patients and for "sick" information technology;
3) keep in mind any other extant workarounds that exist waiting for "fixes"; and
4) be constantly on guard for information storage failures.
In fact, the recent Siemens "glitches" and workarounds represent a clear danger to patient safety. If these were more conventional medical devices, they'd be recalled.
See my Dec. 14, 2011 post "FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death" (http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html) and July 23, 2012 post "Health IT FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems"(http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html) for examples where health IT defects similar to the Siemens issues were, in fact, recalled.
Further, with paper records or tangible images, a page or image can be lost, or it can be illegible. In the case of lost, in any quality paper record keeping system the information stewards or others using the paper (e.g., office staff or ward clerks) will generally note the absence and act accordingly. Further, illegible notes or orders will most often be recognized as illegible and result in attempted clarification or other corrective actions.
On the other hand, when electronic systems:
1) lose modified information en masse as in the Siemens examples but keep the old, or
2) when outright errors such as en masse truncation occur (as in the thousands of prescriptions whose long-acting suffixes were cut off at Lifespan in Rhode Island, see "Yet another health IT "glitch" affecting thousands" here: http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html), or
3) images are lost (see "Potential Image Loss in GE Centricity PACS" here: http://hcrenewal.blogspot.com/2012/11/potential-image-loss-in-ge-centricity.html) without warning-
- There are no "flags" that the obsolete, truncated or missing information is erroneous.
What remains is perfectly legible, perfectly convincing and perfectly deceiving.
Electronic healthcare information systems on their face create more risk than paper record systems. Further, the problem with "bugs" and "glitches" will not go away with today's industry models of "hiring down" and lack of regulation. Every new upgrade or patch is suspect for introducing new bugs.
Paper does not suffer these issues, unless disappearing ink is used to cross out the old and add new information ...
Not that I am advocating for a return to 100% paper, but certain critical functions probably are best left to paper. Further, hundreds of billions of dollars can certainly buy:
1) a lot of Health Information Management professionals to perform continuous QA of paper,
2) a lot of document imaging systems to make the paper records available anywhere, anytime they are needed, and
3) a lot of data entry personnel to relieve clinicians of clerical burdens so they may use their valuable experience more productively, as guest poster Howard Brody points out at http://hcrenewal.blogspot.com/2013/07/guest-post-incompetent-management.html.
4) a lot of sensible regulation of this industry's product quality.
-- SS
Tuesday, August 06, 2013
Can Digital Disappearing Ink (An EHR "Glitch") Kill Patients? Part 2
At "Another Health IT "Glitch" - Can Digital Disappearing Ink Kill Patients?" just yesterday, on August 5, 2013, I wrote about a Siemens EHR "glitch" worse than any paper records system problem. Typed order changes in the medication reconciliation process on patient discharge are disappearing into thin air, unknown to the clinicians typing the orders. This is likely due to an issue such as some programmer forgetting to put in a statement to write the text to disk, complicated by software testing problems that missed the defect.
I noted:
Paper records may have illegible writing that would generally cause the reader to make a phone call or otherwise contact the writer, but those events are one-offs. EHR defects potentially affect hundreds of installations and thousands of patients, en masse. (If patients are not dying en masse from such errors, then the whole argument against paper and for IT on the issue of vastly improved safety goes out the windows, but that's an argument for another time.)
Siemens has just released another "glitch" announcement, this time with CPOE (computerized order entry):
Text is as follows:
I note that "glitches" are not uncommon after software patches and upgrades. See examples at the query link http://hcrenewal.blogspot.com/search/label/glitch. This reflects inadequate vetting of the patches.
I also note that "medication orders not operating properly" is a very, very serious matter.
"May only affect some customers?" (I suspect from this double-indefinite that who is affected is not rigorously known). "Taking a conservative approach?" I ask: what would a non-conservative approach entail?
Again, they mean "yet."
When does this issue occur and what are the potential risks?
This problem - manually changed data apparently not written to disk - seems similar to the "digital disappearing ink" med reconciliation bug in the aforementioned Aug. 5, 2013 post.
Immediate steps you should take to avoid the potential risk of this issue:
Again, a workaround. How many times will this workaround be forgotten, compared to issues of illegibility in a paper record resulting in a phone call to the writer?
Perhaps they should have been working more diligently to detect the "glitch" before it went live.
Also, perhaps the touted power of EHRs to reduce medical errors needs to be re-examined. Considering bugs like these - creating en-masse problems far worse than possible with paper (another en-masse example at http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html) - then, if the EHRs are so essential to safety, one would expect significant morbidity and mortality from these defects.
If one is to believe patients are not being injured by "glitches", then the expenditure of hundreds of billions of dollars for these systems on the basis of "error reduction" compared to paper is likely a waste of money and resources.
-- SS
I noted:
... "Glitch" is a banal term used by health IT extremists (those who have abandoned a rigorous scientific approach to these medical devices as well as basic patient protections, in favor of unwarranted and inappropriate overconfidence and hyper-enthusiasm). The term is used to represent potentially injurious and lethal problems with health IT, usually related to inadequate software vetting and perhaps even "sweatshop floor in foreign country directly to production for U.S. hospital floors" development processes (this industry is entirely unregulated).
Paper records may have illegible writing that would generally cause the reader to make a phone call or otherwise contact the writer, but those events are one-offs. EHR defects potentially affect hundreds of installations and thousands of patients, en masse. (If patients are not dying en masse from such errors, then the whole argument against paper and for IT on the issue of vastly improved safety goes out the windows, but that's an argument for another time.)
Siemens has just released another "glitch" announcement, this time with CPOE (computerized order entry):
 |
| (Medication orders "glictch" safety complaint. Click to enlarge, text below) |
Text is as follows:
August 2, 2013
Safety Advisory Notification
Soarian® Clinicals Medication Orders, Safety Complaint ID# EV06643783
Dear Customer:
This notification is to inform you that the Soarian Clinicals Medication Orders may not be operating properly in some cases in Soarian Clinicals 3.3 Service Pack 6 and above.
I note that "glitches" are not uncommon after software patches and upgrades. See examples at the query link http://hcrenewal.blogspot.com/search/label/glitch. This reflects inadequate vetting of the patches.
I also note that "medication orders not operating properly" is a very, very serious matter.
Although this may affect only some customers, we are taking a conservative approach and are alerting you to this potential problem. As such, please forward this notification to appropriate personnel as soon as possible.
"May only affect some customers?" (I suspect from this double-indefinite that who is affected is not rigorously known). "Taking a conservative approach?" I ask: what would a non-conservative approach entail?
This letter is being sent as a precautionary measure as there have been no adverse events reported from customers.
Again, they mean "yet."
When does this issue occur and what are the potential risks?
The issue occurs while placing medication orders. In certain cases, when users select orders from predefines or personal favorites and make changes on the order detail forms, the changes are correctly saved and displayed on the forms but the Order As Written (OAW) is not refreshed to reflect the changes. The incorrect OAW is displayed in Siemens Pharmacy in the Order As Written window but the discrete order details are correct. As a result dispensing or administering relying solely on the OAW prior to pharmacy validation may result in error. [Putting patients directly in harm's way, patients who never consented to the use of these experimental and unvetted medical devices - ed.] Once the order is validated the OAW in Soarian is updated correctly.
This problem - manually changed data apparently not written to disk - seems similar to the "digital disappearing ink" med reconciliation bug in the aforementioned Aug. 5, 2013 post.
Immediate steps you should take to avoid the potential risk of this issue:
To prevent this issue from occurring at your facility, dispensing or administering of unvalidated order should rely on the order details displayed. Secondly, any deviations from the predefined or personal favorites should be phoned in to pharmacy as a verbal order. During validation, if the pharmacist sees a discrepancy between the order detail and the OAW, verbal follow up with the ordering physician is required.
Again, a workaround. How many times will this workaround be forgotten, compared to issues of illegibility in a paper record resulting in a phone call to the writer?
Steps that Siemens is taking to correct this complaint:
We are diligently working to develop a correction and will test and deliver it as soon as possible.
Perhaps they should have been working more diligently to detect the "glitch" before it went live.
Also, perhaps the touted power of EHRs to reduce medical errors needs to be re-examined. Considering bugs like these - creating en-masse problems far worse than possible with paper (another en-masse example at http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html) - then, if the EHRs are so essential to safety, one would expect significant morbidity and mortality from these defects.
If one is to believe patients are not being injured by "glitches", then the expenditure of hundreds of billions of dollars for these systems on the basis of "error reduction" compared to paper is likely a waste of money and resources.
-- SS
Monday, August 05, 2013
The Mystery of the Northwestern Settlement
Watson, quick, the game's afoot. We have discussed a large number of legal settlements by large health care organizations that serve as markers of misbehavior and often lack of leaderships' responsibility for same. These settlements often follow a common pattern. Yet this week a settlement appeared that was quite different, and hence raised some important questions.
The Basics of the Settlement
I will summarize the settlement as described by the Wall Street Journal. The basic points were:
The settlement seemed to be more about the researcher, Dr Charles L Bennett, than Northwestern,
Meanwhile,
The settlement was the result of the actions of a purported whistle-blower,
The settlement resulted from the efforts of multiple federal agencies,
Curious Aspects and the Questions They Raise
So here is yet another settlement by a large health care organization, in this case, the prestigious academic medical center of a well known university. This one, however, does not follow the usual pattern, and includes some quite curious aspects.
Media Attention vs Severity
The settlement so far has generated articles in the WSJ (above), the Chicago Tribune, the Chicago Sun-Times, Crains Chicago Business, Medscape, Modern Healthcare, UPI, Bloomberg, other local Chicago and university publications, and local outlets in South Carolina, the state in which Dr Bennett currently works.
The amount of the grants that Dr Bennett allegedly misused was $8 million, according to the University Herald.
There are no allegations that any activities of Dr Bennett or the university affected the quality of clinical research, clinical teaching, or patient care.
Contrast that substantial media attention to that generated by another recent settlement we just discussed, that of Pfizer misbranding of Rapamune (look here.) This involved the excess promotion of a relatively dangerous drug that likely resulted in harm to many patients. The over-promotion may have caused up to 90% of the drug's $200 million yearly sales. The settlement itself was for $491 million. Yet while it got more coverage, mainly from local media outlets which covered it because the settlement will result in payments to individual states, only four big national outlets have covered it so far, again the Wall Street Journal, and the New York Times, Reuters and Businessweek.
Why did a relatively small settlement of alleged financial misbehavior without clinical implications get nearly as much attention as a settlement fifty times bigger that involved actions that likely harmed patients?
Intensity of the Government Response
Dr Bennett's alleged misuse of grant funds required investigation by four different federal agencies, including the FBI. Pfizer's misbranding of a dangerous drug seemingly was handled only by one, and the FBI was not obviously involved. In fact, the FBI rarely has rarely been mentioned in the media coverage of most of the legal settlements we have discussed.
Why did again a case of relatively small alleged financial misbehavior require such massive federal resources when much bigger cases which had implications for clinical care, policy, or research seemed to command lesser resources?
Naming and Shaming
The settlement did not involve any admission of any wrongdoing by Northwestern.
In contrast, nearly all the news coverage of this settlement emphasized the role of Dr Charles L Bennett. The coverage seemed to be following the lead of the Department of Justice press release, which included,
Yet Dr Bennett appeared not to be a party in this settlement, and it was unclear whether he had a direct opportunity to respond to it. The Wall Street Journal did note that after it was announced,
We have discussed numerous legal settlements by large health care organizations, often involving hundreds of millions or even billions of dollars, sometimes involving guilty pleas by the companies involved or their subsidiaries. Almost never do these settlements name or involve in any way persons who authorized, directed, or implemented the misbehavior. In fact, we have commented again and again about the impunity of health care organizational managers and executives. For example, the recent $491 million Pfizer settlement did not name or punish any individuals. Furthermore, Pfizer's $2.3 billion settlement for deceptive marketing of a drug later pulled from the market (Bextra) did not name much less penalize any responsible individuals (look here.) Also, GlaxoSmithKline's $3 billion settlement of numerous unethical practices did not name much less penalize any responsible individuals (look here).
So why was naming and shaming Dr Charles L Bennett such an important part of the relatively small Northwestern settlement, when much larger settlements, many involving unethical behavior that could have harmed patients or distorted medical research, and some of which involved corporate guilty pleas to criminal charges did not involve naming and shaming any responsible person?
How Accountable was Dr Bennett?
As in the Wall Street Journal version, the settlement implies that Dr Bennett was the person most responsible. The Chicago Sun-Times put it this way,
Here I will have to interject a bit of information about how federal grants work. As I learned when I was a young faculty member, and as I confirmed with several other experienced researchers who have run and reviewed federal grants, these grants are made to institutions. In the current case, the grant apparently went to Northwestern University. The institution that receives the grant is responsible for making all payments and disbursements related to that grant. The grant's Principal Investigator is responsible for the scientific conduct of the grant, but NOT payments, disbursements, business management or accounting. The Principal Investigator can request that payments be made for various things, including travel expenses and consulting work. But the Principal Investigator cannot directly authorize or make these payments. They are authorized, signed, and made by institutional administrators, usually in grants and contracts offices or the equivalent, and usually only after copious paperwork to justify the payments.
So Dr Bennett may have requested reimbursement for travel expenses, or requested the university to hire a consultant. But university managers must have made those payments, unless the university's grants administration mechanism had completely broken down. Note that given the usual ways grants are administered, it would appear that Ms Theis, the ostensible whistle-blower, who will receive nearly one half of a million dollars from this settlement, actually may have had more direct responsibility for making the payments in question than did Dr Bennett.
Presumably, that is why the settlement was made by Northwestern.
Why then did the settlement, the DOJ press release, and the media coverage so emphasize Dr Bennett's responsibility, and so minimize the role of the university?
Was Anyone Else Accountable?
The DOJ press release, and all the media articles on the case, save one, mention only Dr Bennett as the person at fault. Crain's Chicago Healthcare Daily, however, suggested someone else was responsible,
As I noted above, the way federal grants work, it was the university, and its managers and leaders, who were responsible for making all payments on this and other federal grants.
Why did the government press release and the media coverage emphasize Dr Bennett's alleged role, while ignoring any possible responsibility of anyone else, especially his supervisor?
Backgrounds of the Principles
Dr Bennett and Dr Rosen, who seemingly were treated so differently in this settlement, travel in very different circles.
Most media articles described Dr Bennett as a prolific researcher and medical academic. Although some described his areas of interest in hematology and oncology, only Medscape described one particular project of his.
In fact, as we discussed here, Dr Bennett was the first author of a meta-analysis that was the first to show that epoetins increased the rates of adverse effects and death for cancer patients. This evidence lead to reduced use of some very expensive drugs made by Johnson and Johnson and Amgen, and hence reduced revenues for both companies.
The JAMA article noted that at the time he wrote it, Dr Bennett had financial relationships with Amgen. He and a coauthor "reported serving as consultants to AMGEN and Dr Bennett reported he has received grant support from AMGEN previously."
Note that Amgen pleaded guilty to misbranding its epoetin, Aranesp, and therefore paid fine and a civil settlement totaling $762 million. Given the data on this drug class' adverse events, as shown by Dr Bennett and others, it is likely that the misbranding lead to patients being harmed by the drug without receiving any benefits (look here.)
After writing that article, Dr Bennett became known as a strong skeptic of the pharmaceutical industry. Just before the JAMA article was published, he coauthored an editorial which wondered if conflicts of interest would ever prove to be acceptable once sufficient research was done.(2) In that article, he disclosed consulting for, and receiving honoraria and research grants from Amgen. In 2010, he published research showing the effects of conflicts of interest on reporting of possible adverse effects based on basic science research about epoetins.(3) By then he apparently no longer had financial relationships with Amgen. In 2011, he reported a survey of major cases of pharmaceutical fraud resulting in legal actions.(4)
Dr Bennett became known for skepticism about the practices of pharmaceutical companies, and for publishing about the harms of specific drugs, despite his previous financial relationships with Amgen.
However, Dr Rosen apparently has continued to work closely with industry. His faculty disclosure page revealed the following industry relationships
Did Dr Bennett's break with a powerful industry make it easier to set him up as the villain in this story?
Summary
The settlement by Northwestern University, which was mainly about allegations made against Dr Charles L Bennett, who was not a party to the settlement, was very different that the vast majority of the march of legal settlements whose continuation we have frequently discussed.
The settlement and its media coverage raised important questions whose answers would be important to the assessment of our current regulatory and legal response to misbehavior by and within large health care organizations. Health Care Renewal is about raising such issues by commenting on public information, media reports, and research. I hope those with capacity to investigate will consider these questions. Inquiring minds want to know.
Roy M. Poses MD in Health Care Renewal
References
1. Bennett CI, Silver SM, Djulbegovic B et al. Venous thromboembolism and mortality associated with recombinant erythropoietin and darbepoetin adminstration for the treatment of cancer-associated anemia. JAMA 2008; 299: 914-924.
2. Djulbegovic B, Angolotta C, Knox KE, Bennett CI. The sound and the fury: financial conflicts of interest in oncology. J Clin Oncol 2007; 25:3567-3568. Link here
3. Bennett CI, Lai SY, Henke M et al. Association between pharmaceutical support and basic science research on erythropoiesis-stimulating agents. Arch Intern Med 2010; 170: 1490-1498. Link here.
4. Qureshi Z, Sartor O, Xirasagar S, Liu Y, Bennett CI. Pharmaceutical fraud and abuse in the United States, 1996-2010. Arch Intern Med 2011; 171: 1503-1506. Link here.
The Basics of the Settlement
I will summarize the settlement as described by the Wall Street Journal. The basic points were:
Northwestern University agreed to pay nearly $3 million to settle claims that a former cancer researcher fraudulently used federal grant money for personal expenses, including food, hotels and airfare for family trips between 2003 and 2010.
The settlement in the civil suit was unsealed Tuesday by the U.S. Attorney for the Northern District of Illinois, which investigated claims brought by a whistle blower under the False Claims Act.
The settlement seemed to be more about the researcher, Dr Charles L Bennett, than Northwestern,
At the time of the alleged fraud, Dr. Bennett was the principal investigator on research funded by the National Institutes of Health, studying adverse drug events, multiple myeloma, a blood disorder known as thrombotic thrombocytopenic purpura, and quality of care for cancer patients.
According to the settlement agreement, he allegedly billed federal grants for family trips, meals and hotels for himself and friends, and for 'consulting fees' for unqualified friends and family. Northwestern also allegedly improperly subcontracted, at Dr. Bennett's request, with various universities for services that were paid for by the NIH grants.
'Allowing researchers to use federal grant money to pay for personal travel, hotels, and meals and to hire unqualified friends and relatives as 'consultants' violates the public trust and federal law,' U.S. Attorney Gary S. Shapiro said in a statement.
Meanwhile,
Northwestern, which is in Evanston, Ill., cooperated with the investigators and didn't admit to any wrongdoing, according to a statement by the university.
The settlement was the result of the actions of a purported whistle-blower,
The whistleblower, Melissa Theis, worked as a purchasing coordinator in the Feinberg school's department of hematology and oncology, processing invoices when she 'noticed some red flags,' according to her attorney, Linda Wyetzner, of the Evanston firm Behn & Wyetzner Chartered.
The federal False Claims Act allows private citizens who allege government programs are being defrauded to file actions on behalf of the government and receive a portion, usually 15% to 30%, of any recovered damages. Ms. Theis will get $498,100 in settlement proceeds, according to the agreement.
The settlement resulted from the efforts of multiple federal agencies,
The allegations were investigated by the NIH, Federal Bureau of Investigation, U.S. Department of Health and Human Services Office of Inspector General and the U.S. attorney's office.
Curious Aspects and the Questions They Raise
So here is yet another settlement by a large health care organization, in this case, the prestigious academic medical center of a well known university. This one, however, does not follow the usual pattern, and includes some quite curious aspects.
Media Attention vs Severity
The settlement so far has generated articles in the WSJ (above), the Chicago Tribune, the Chicago Sun-Times, Crains Chicago Business, Medscape, Modern Healthcare, UPI, Bloomberg, other local Chicago and university publications, and local outlets in South Carolina, the state in which Dr Bennett currently works.
The amount of the grants that Dr Bennett allegedly misused was $8 million, according to the University Herald.
There are no allegations that any activities of Dr Bennett or the university affected the quality of clinical research, clinical teaching, or patient care.
Contrast that substantial media attention to that generated by another recent settlement we just discussed, that of Pfizer misbranding of Rapamune (look here.) This involved the excess promotion of a relatively dangerous drug that likely resulted in harm to many patients. The over-promotion may have caused up to 90% of the drug's $200 million yearly sales. The settlement itself was for $491 million. Yet while it got more coverage, mainly from local media outlets which covered it because the settlement will result in payments to individual states, only four big national outlets have covered it so far, again the Wall Street Journal, and the New York Times, Reuters and Businessweek.
Why did a relatively small settlement of alleged financial misbehavior without clinical implications get nearly as much attention as a settlement fifty times bigger that involved actions that likely harmed patients?
Intensity of the Government Response
Dr Bennett's alleged misuse of grant funds required investigation by four different federal agencies, including the FBI. Pfizer's misbranding of a dangerous drug seemingly was handled only by one, and the FBI was not obviously involved. In fact, the FBI rarely has rarely been mentioned in the media coverage of most of the legal settlements we have discussed.
Why did again a case of relatively small alleged financial misbehavior require such massive federal resources when much bigger cases which had implications for clinical care, policy, or research seemed to command lesser resources?
Naming and Shaming
The settlement did not involve any admission of any wrongdoing by Northwestern.
In contrast, nearly all the news coverage of this settlement emphasized the role of Dr Charles L Bennett. The coverage seemed to be following the lead of the Department of Justice press release, which included,
Northwestern allegedly allowed one of its researchers, Dr. Charles L. Bennett, to submit false claims under research grants from the National Institutes of Health. The settlement covers improper claims that Dr. Bennett submitted for reimbursement from the federal grants for professional and consulting services, subcontracts, food, hotels, travel and other expenses that benefited Dr. Bennett, his friends, and family from Jan. 1, 2003, through Aug. 31, 2010.
Yet Dr Bennett appeared not to be a party in this settlement, and it was unclear whether he had a direct opportunity to respond to it. The Wall Street Journal did note that after it was announced,
James M. Becker, an attorney for Dr. Bennett, said, 'We deny the allegations.…We are actively engaged in discussions to resolve the allegations.'
We have discussed numerous legal settlements by large health care organizations, often involving hundreds of millions or even billions of dollars, sometimes involving guilty pleas by the companies involved or their subsidiaries. Almost never do these settlements name or involve in any way persons who authorized, directed, or implemented the misbehavior. In fact, we have commented again and again about the impunity of health care organizational managers and executives. For example, the recent $491 million Pfizer settlement did not name or punish any individuals. Furthermore, Pfizer's $2.3 billion settlement for deceptive marketing of a drug later pulled from the market (Bextra) did not name much less penalize any responsible individuals (look here.) Also, GlaxoSmithKline's $3 billion settlement of numerous unethical practices did not name much less penalize any responsible individuals (look here).
So why was naming and shaming Dr Charles L Bennett such an important part of the relatively small Northwestern settlement, when much larger settlements, many involving unethical behavior that could have harmed patients or distorted medical research, and some of which involved corporate guilty pleas to criminal charges did not involve naming and shaming any responsible person?
How Accountable was Dr Bennett?
As in the Wall Street Journal version, the settlement implies that Dr Bennett was the person most responsible. The Chicago Sun-Times put it this way,
Dr. Charles L. Bennett allegedly took his wife on personal trips, then illegally billed the flights, hotels and meals to the National Institutes of Health, claiming it was part of his cancer-fighting work. And he allegedly submitted phony bills for his work over a seven-year period beginning in 2003.
Here I will have to interject a bit of information about how federal grants work. As I learned when I was a young faculty member, and as I confirmed with several other experienced researchers who have run and reviewed federal grants, these grants are made to institutions. In the current case, the grant apparently went to Northwestern University. The institution that receives the grant is responsible for making all payments and disbursements related to that grant. The grant's Principal Investigator is responsible for the scientific conduct of the grant, but NOT payments, disbursements, business management or accounting. The Principal Investigator can request that payments be made for various things, including travel expenses and consulting work. But the Principal Investigator cannot directly authorize or make these payments. They are authorized, signed, and made by institutional administrators, usually in grants and contracts offices or the equivalent, and usually only after copious paperwork to justify the payments.
So Dr Bennett may have requested reimbursement for travel expenses, or requested the university to hire a consultant. But university managers must have made those payments, unless the university's grants administration mechanism had completely broken down. Note that given the usual ways grants are administered, it would appear that Ms Theis, the ostensible whistle-blower, who will receive nearly one half of a million dollars from this settlement, actually may have had more direct responsibility for making the payments in question than did Dr Bennett.
Presumably, that is why the settlement was made by Northwestern.
Why then did the settlement, the DOJ press release, and the media coverage so emphasize Dr Bennett's responsibility, and so minimize the role of the university?
Was Anyone Else Accountable?
The DOJ press release, and all the media articles on the case, save one, mention only Dr Bennett as the person at fault. Crain's Chicago Healthcare Daily, however, suggested someone else was responsible,
Northwestern University's nearly $3 million settlement of fraud claims by the federal government protects the director of the school's cancer center, who allegedly failed to supervise a researcher who used grant money to cover personal expenses over a seven-year period.
Dr. Steven Rosen, director of the Robert H. Lurie Comprehensive Center for Cancer, and Dr. Charles L. Bennett, a researcher who is no longer with the center, were both named in a whistleblower complaint unsealed on Tuesday, when the settlement was announced.
Dr. Bennett used federal grant money for family trips and fraudulent consulting fees for his brother and cousin from 2003-10, the government alleges.
Dr. Rosen 'failed to exercise appropriate responsibility,' Randall Samborn, a spokesman for the U.S. Attorney's office said. 'It was a supervisory function that he didn't adequately fulfill.'
When the settlement was announced, Mr. Samborn said the agreement did not cover either doctor. On Wednesday, he corrected himself, saying that settlement covered Dr. Rosen, but not Dr. Bennett.
As I noted above, the way federal grants work, it was the university, and its managers and leaders, who were responsible for making all payments on this and other federal grants.
Why did the government press release and the media coverage emphasize Dr Bennett's alleged role, while ignoring any possible responsibility of anyone else, especially his supervisor?
Backgrounds of the Principles
Dr Bennett and Dr Rosen, who seemingly were treated so differently in this settlement, travel in very different circles.
Most media articles described Dr Bennett as a prolific researcher and medical academic. Although some described his areas of interest in hematology and oncology, only Medscape described one particular project of his.
Dr. Bennett's research efforts included a 2008 study on which he was the first author (JAMA. 2008;299:914-924). The study was the first meta-analysis to identify an increased mortality risk in cancer patients associated with erythropoiesis-stimulating agents.(1)
In fact, as we discussed here, Dr Bennett was the first author of a meta-analysis that was the first to show that epoetins increased the rates of adverse effects and death for cancer patients. This evidence lead to reduced use of some very expensive drugs made by Johnson and Johnson and Amgen, and hence reduced revenues for both companies.
The JAMA article noted that at the time he wrote it, Dr Bennett had financial relationships with Amgen. He and a coauthor "reported serving as consultants to AMGEN and Dr Bennett reported he has received grant support from AMGEN previously."
Note that Amgen pleaded guilty to misbranding its epoetin, Aranesp, and therefore paid fine and a civil settlement totaling $762 million. Given the data on this drug class' adverse events, as shown by Dr Bennett and others, it is likely that the misbranding lead to patients being harmed by the drug without receiving any benefits (look here.)
After writing that article, Dr Bennett became known as a strong skeptic of the pharmaceutical industry. Just before the JAMA article was published, he coauthored an editorial which wondered if conflicts of interest would ever prove to be acceptable once sufficient research was done.(2) In that article, he disclosed consulting for, and receiving honoraria and research grants from Amgen. In 2010, he published research showing the effects of conflicts of interest on reporting of possible adverse effects based on basic science research about epoetins.(3) By then he apparently no longer had financial relationships with Amgen. In 2011, he reported a survey of major cases of pharmaceutical fraud resulting in legal actions.(4)
Dr Bennett became known for skepticism about the practices of pharmaceutical companies, and for publishing about the harms of specific drugs, despite his previous financial relationships with Amgen.
However, Dr Rosen apparently has continued to work closely with industry. His faculty disclosure page revealed the following industry relationships
Consulting / Related Activities
Faculty member engaged in activities such as speaking, advising, consulting, or providing educational programs for the following companies or other for-profit entities:
In addition, faculty member received compensation for medical record consultation and/or expert witness testimony.
- Allos Therapeutics, Inc.
- Carden Jennings Publishing Co., Ltd.
- Cerner Corporation
- Dava Oncology, LP
- Elorac, Inc.
- Envision Communications
- Health Practices Consulting - unverified entity
- Plexus Communications
- Prostrakan, Inc.
- Seattle Genetics, Inc.
- Studio ER Congressi (Triumph Group, Inc.)
- The Medal Group Corp.
Ownership or Investment Interests
Faculty member had an ownership or investment interest in the following companies:
Royalty Payments and Inventor Share
- AuraSense, LLC
- Nanosphere, Inc.
Faculty member has the right to receive payments or may receive future financial benefits for inventions or discoveries related to the following companies or other entities:
Nanosphere, Inc.
Did Dr Bennett's break with a powerful industry make it easier to set him up as the villain in this story?
Summary
The settlement by Northwestern University, which was mainly about allegations made against Dr Charles L Bennett, who was not a party to the settlement, was very different that the vast majority of the march of legal settlements whose continuation we have frequently discussed.
The settlement and its media coverage raised important questions whose answers would be important to the assessment of our current regulatory and legal response to misbehavior by and within large health care organizations. Health Care Renewal is about raising such issues by commenting on public information, media reports, and research. I hope those with capacity to investigate will consider these questions. Inquiring minds want to know.
Roy M. Poses MD in Health Care Renewal
References
1. Bennett CI, Silver SM, Djulbegovic B et al. Venous thromboembolism and mortality associated with recombinant erythropoietin and darbepoetin adminstration for the treatment of cancer-associated anemia. JAMA 2008; 299: 914-924.
2. Djulbegovic B, Angolotta C, Knox KE, Bennett CI. The sound and the fury: financial conflicts of interest in oncology. J Clin Oncol 2007; 25:3567-3568. Link here
3. Bennett CI, Lai SY, Henke M et al. Association between pharmaceutical support and basic science research on erythropoiesis-stimulating agents. Arch Intern Med 2010; 170: 1490-1498. Link here.
4. Qureshi Z, Sartor O, Xirasagar S, Liu Y, Bennett CI. Pharmaceutical fraud and abuse in the United States, 1996-2010. Arch Intern Med 2011; 171: 1503-1506. Link here.
Another Health IT "Glitch" - Can Digital Disappearing Ink Kill Patients?
Yes, it can.
There's been yet another "glitch" in the world of health IT (see http://hcrenewal.blogspot.com/search/label/glitch for more examples).
"Glitch" is a banal term used by health IT extremists (those who have abandoned a rigorous scientific approach to these medical devices as well as basic patient protections, in favor of unwarranted and inappropriate overconfidence and hyper-enthusiasm). The term is used to represent potentially injurious and lethal problems with health IT, usually related to inadequate software vetting and perhaps even "sweatshop floor in foreign country directly to production for U.S. hospital floors" development processes (this industry is entirely unregulated).
This from Siemens Healthcare:
Text of this "Safety Advisory Notification":
They mean "no adverse events reported - yet." And if such events had been reported, Siemens would most certainly not make them public. (Why should they, when there are no regulations?)
The health IT extremists would invoke the "Leaned Intermediary" doctrine that lays all blame for errors on the user. It seems the only way to avoid such liability would be after every "enter" or "save" action (or perhaps every keystroke?), users then verify what was saved or entered...
The "fix" to this "glitch" is not too far off from that:
This is known as a "workaround." Anyone who believes this edict can and will be 100% reliably followed in often chaotic medical environments, by users from medical students to nurses to physicians, is truly cavalier.
Perhaps FDA and Joint Commission need to inquire about exactly what testing and QC was done on the current code, testing that (if actually performed) did not detect this glaring and Siemens-admitted safety-risk "glitch."
-- SS
There's been yet another "glitch" in the world of health IT (see http://hcrenewal.blogspot.com/search/label/glitch for more examples).
"Glitch" is a banal term used by health IT extremists (those who have abandoned a rigorous scientific approach to these medical devices as well as basic patient protections, in favor of unwarranted and inappropriate overconfidence and hyper-enthusiasm). The term is used to represent potentially injurious and lethal problems with health IT, usually related to inadequate software vetting and perhaps even "sweatshop floor in foreign country directly to production for U.S. hospital floors" development processes (this industry is entirely unregulated).
This from Siemens Healthcare:
 |
| Click to enlarge. Text below. |
Text of this "Safety Advisory Notification":
August 1, 2013
Safety Advisory Notification
Soarian® Clinicals Medication Reconciliation EV06736602
Dear Customer:
This notification is to inform you that Soarian Clinicals Medication Reconciliation 3.3 may not be operating properly in some cases.
Although this may affect only some customers, we are taking a conservative approach and are alerting you to this potential problem. As such, please forward this notification to appropriate personnel as soon as possible.
This letter is being sent as a precautionary measure as there have been no adverse events reported from customers.
They mean "no adverse events reported - yet." And if such events had been reported, Siemens would most certainly not make them public. (Why should they, when there are no regulations?)
When does this issue occur and what are the potential risks?
This issue occurs when a user moves a free text in-house order from the current and home medications side (left side) to the discharge medication side (right side), and then modifies the continued free text in-house order in discharge reconciliation prior to saving the discharge reconciliation list. After the modification of the continued free text medication order, the changes to the free text medication order are not recorded in the saved discharge medication list. [In other words, the changes to medication orders the user just typed disappear into thin air. I note that medication reconciliation failures are among the most common causes of medical error - ed.]
The health IT extremists would invoke the "Leaned Intermediary" doctrine that lays all blame for errors on the user. It seems the only way to avoid such liability would be after every "enter" or "save" action (or perhaps every keystroke?), users then verify what was saved or entered...
The "fix" to this "glitch" is not too far off from that:
Immediate steps you should take to avoid the potential risk of this issue:
To prevent this issue from occurring at your facility, instruct users not to modify continued free text in-house orders on the discharge medication list. Users may be instructed to enter free text in-house orders manually by selecting the add prescription action button and entering the order.
This is known as a "workaround." Anyone who believes this edict can and will be 100% reliably followed in often chaotic medical environments, by users from medical students to nurses to physicians, is truly cavalier.
Steps that Siemens is taking to correct this complaint:
We are diligently working to develop a correction and will test and deliver it as soon as possible.
Perhaps FDA and Joint Commission need to inquire about exactly what testing and QC was done on the current code, testing that (if actually performed) did not detect this glaring and Siemens-admitted safety-risk "glitch."
-- SS
Wednesday, July 31, 2013
Pfizer's Umpteenth Settlement (for $491 Million Plus a Guilty Plea), but No Person Held Responsible
The world's largest research based pharmaceutical company was in court again, as reported by the New York Times,
In particular,
The drug maker Pfizer agreed to pay $491 million to settle criminal and civil charges over the illegal marketing of the kidney-transplant drug Rapamune, the Justice Department announced on Tuesday.
In particular,
The recent case centers on the practices of Wyeth Pharmaceuticals, which Pfizer acquired in 2009.
Rapamune, which prevents the body’s immune system from rejecting a transplanted organ, was approved by the Food and Drug Administration in 1999 for use in patients receiving a kidney transplant. However, federal officials said Wyeth aggressively promoted the drug for use in patients receiving other organ transplants, even offering financial incentives to its sales force to do so.Accusations of Wyeth’s practices became public in 2010 after a whistle-blower lawsuit filed by two former employees was unsealed.After lawmakers announced a Congressional inquiry, the Justice Department opted to join the lawsuit. The settlement announced Tuesday, which also resolves a second, similar whistle-blower suit, includes a criminal fine and forfeiture of $233.5 million, and a civil settlement of $257.4 million with the federal government, all 50 states and the District of Columbia.
The case did not get much media coverage. So far, the only other somewhat detailed article on it was put out by Bloomberg. In fact, the lawyer for two of the whistle-blowers who alerted federal authorities to what Wyeth was doing had to say
the spate of pharmaceutical settlements in recent years had blunted reaction to what he said were shameful practices. 'Everybody’s been asking me why this case is different than any other,' he said. 'We used to trust these companies. You can’t trust these companies anymore.'
However, we should not be too blase. This case was not only about money. The over-promotion of a potentially dangerous drug likely lead to patients being harmed in the absence of any benefits. Rapamune suppresses the immune system and increases risks of serious infections and malignancy. Specific serious adverse events have been reported when it is used in transplants of organs other than the kidney (e.g., lung and liver transplants). (See full prescribing information here.) Bloomberg reported that 90% of Wyeth's revenues from Rapamune came from off-label uses, suggesting that quite a few people may have been adversely affected by its excess use.
As in most other members of the march of legal settlements by big health care organizations, this case involved no negative consequences for anybody who authorized, directed, or implemented the improper marketing practices. While such people must have existed, they were not even named in the press coverage. At least this settlement involved a guilty plea to a crime, albeit a misdemeanor (misbranding as reported by Bloomberg), so the company did have to admit some wrongdoing.
A Pfizer manager, however, tried to disavow responsibility, as noted by Bloomberg,
'Pfizer was not a subject or target of this matter, and cooperated fully with the government from the time it learned of this investigation in October 2009,' Chris Loder, a Pfizer spokesman,...
But Pfizer had purchased Wyeth, and in doing so got not only assets and profits, but responsibility for actions.
Also, neither the settlement nor the criminal plea seemed to take into account Pfizer's amazingly sorry recent track record. I am losing count of all of Pfizer's settlements and/or guilty plea or convictions since 2000. (The updated list of previous legal results is in the Appendix.)
People found guilty of small-time Medicaid or Medicare fraud often forfeit all their assets and go to jail. Yet actions by large pharmaceutical companies that may harm patients and cost many millions of dollars almost never result in any individual facing any negative consequences, or even being named and shamed. Meanwhile, the managers of these companies may make gargantuan amounts of money partially rationalized by the revenues produced by such recurrent misbehavior. In 2012, according to the company's 2013 proxy filing, Pfizer CEO Ian Reed's total compensation was $25,634,136, and the four next most highly paid executives all made more than $5,000,000.
So the Kabuki play that is regulation of and law enforcement for large health care organizations goes on. As our society is being increasingly divided into a huge majority in increasingly difficult economic circumstances and a small and increasingly rich minority, it also seems to be increasingly divided into little people who may be ruined by lawsuits, and imprisoned for even minor infractions, and big people who have impunity.
True health care reform would need to start by making leaders of big health care organizations accountable for their organizations' misbehavior.
APPENDIX - Pfizer's Settlements
Patients as lab rats for beta software: have sancrosanct patient's rights been trivialized, while poor software of non-trivial risk been sanctified?
I have noted a class action lawsuit vs. Allscripts and Eclipsys, EHR producers, regarding a merger:
The Lead Plaintiffs' Amended Complaint is available here in PDF: http://securities.stanford.edu/1048/MDRX00_01/2013515_r02c_12CV03297.pdf. It is worth reading, if just to understand the inner workings of an unregulated healthcare device industry on which your well-being and that of your family increasingly depends.
The lawsuit is primarily about alleged misrepresentations made to investors by Allscripts and Eclipsys in a merger regarding inability to integrate products, leadership chaos, and materially false and misleading statements and omissions made during the Class period by these companies about their progress.
I note that in a chaotic environment such as alleged, product safety is not likely a big concern.
However, even more ominous are the allegations of deliberate use of beta software on patients without informed consent or any knowledge by patients whatsoever of its use, which apparently did not work out well. Not indicated is if patient harm occurred. If the allegations are true, considering the ECRI Deep Dive health IT risk study results of nearly 200 health IT "incidents" in 36 hospitals over 9 weeks voluntarily reported, including 8 harm incidents and 3 possible deaths - see http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html it would not be surprising.
From the Complaint, allegations on software beta testing are as follows. Emphases mine:
Again, I find the allegations of great concern - that experimental software was being beta tested on live patients and was stopped because it did not "perform to expectations." If true, what of the unconsenting meatbags a.k.a. patients? They would not have counted for much.
More from the Complaint in Count 50:
If the allegations are true, New York Presbyterian Hospitals in the fall of 2011 were performing beta testing of software so bad it was deemed unacceptable for LIJ Community Hospital. Again, if true, what about the risks patients were subjected to, and ... were any harmed?
Still more in Count 76:
In effect, if the allegations are true, sancrosanct patient's rights have been trivialized, while poor software of non-trivial risk has been sanctified.
This would be, needless to say, deranged. Software can be debugged in test environments without putting patients at risk - if one is willing to invest the resources to do so.
The Class Action lawsuit Plaintiffs should perhaps seek to discover if there were patient harms or deaths as a result of the alleged software beta testing - assuming that information was not thoroughly "cleansed" by now.
I also note that even small NIH SBIR/STTR grant proposals involving use of new or modified IT on patients, on whose study sections I am an invited reviewer in the domain of Medical Informatics, are subject to human subjects protection evaluation:
In health IT tests in hospital settings, which is most certainly experimentation, there are simply no human subjects protections whatsoever. Hospital IT deserves no special accommodation regarding Protections for Human Subjects. There are no justifiable reasons I can think of.
-- SS
Addendum: Perhaps I'm wrong about people's generosity and altruism. I would like to hear from people who would gladly submit, say, their newborns as test subjects for the beta testing of experimental health IT software.
UNITED STATES DISTRICT COURT, NORTHERN DISTRICT OF ILLINOIS, EASTERN DIVISION; BRISTOL COUNTY RETIREMENT SYSTEM, Individually and on Behalf of All Others Similarly Situated, Plaintiff, vs. ALLSCRIPTS HEALTHCARE SOLUTIONS, INC., GLEN E. TULLMAN, WILLIAM J. DAVIS AND LEE SHAPIRO, Defendants.
The Lead Plaintiffs' Amended Complaint is available here in PDF: http://securities.stanford.edu/1048/MDRX00_01/2013515_r02c_12CV03297.pdf. It is worth reading, if just to understand the inner workings of an unregulated healthcare device industry on which your well-being and that of your family increasingly depends.
 |
| Lead Plaintiffs' Amended Complaint, available here in PDF: http://securities.stanford.edu/1048/MDRX00_01/2013515_r02c_12CV03297.pdf |
The lawsuit is primarily about alleged misrepresentations made to investors by Allscripts and Eclipsys in a merger regarding inability to integrate products, leadership chaos, and materially false and misleading statements and omissions made during the Class period by these companies about their progress.
I note that in a chaotic environment such as alleged, product safety is not likely a big concern.
However, even more ominous are the allegations of deliberate use of beta software on patients without informed consent or any knowledge by patients whatsoever of its use, which apparently did not work out well. Not indicated is if patient harm occurred. If the allegations are true, considering the ECRI Deep Dive health IT risk study results of nearly 200 health IT "incidents" in 36 hospitals over 9 weeks voluntarily reported, including 8 harm incidents and 3 possible deaths - see http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html it would not be surprising.
From the Complaint, allegations on software beta testing are as follows. Emphases mine:
41. CW1 [coded person's name - ed.] explained the different interface integration systems as native integration, disparate integration, and High Level 7 “HL7” interface. The goal of native integration was to have the ability to update patient information throughout the Allscripts’ software offerings. This would allow Allscripts’ Sunrise products to seamlessly integrate with Allscripts’ Enterprise, Professional and MyWay products and allow the products to update patient health records without the use of industry standardized codes. Allscripts branded its native software as ADX. [see Complaint footnote 2.] CW1 described disparate integration as allowing Allscripts software to interface with non-Allscripts software which he described as a Health Information Exchange (“HIE”) software that allowed data to be read and
updated from different software vendors.
42. CW1 said ADX 1.0 was designed to pull and update patient electronic health records automatically and was Allscripts’ native integration software. In approximately July 2011, he learned that Allscripts began a complete reworking of ADX 1.0 because customers were complaining about the lack of functionality and integration, and that it did not allow the user to review and approve changes made in other healthcare settings before being accepted by the hospital or physician practice systems. [If the allegations are true, these problems would be creating on its face significant risk of oversights, confusion and medical errors - ed.] The upgrade was going to be known as ADX 1.5, but the method and interface for data integration changed. In particular, the interface was changed to allow clinicians to approve changes before they were entered into the system. He also learned from other Allscripts employees that ADX 1.0 was being beta tested [see Complaint footnote 3] at Blessing Hospital in Quincy, Illinois and another place he could not recall, but it was suspended in approximately the middle of 2011 because it failed to perform to expectations. [see Complaint footnote 4] [Remarkable - if the allegations are true, experimental software was being beta tested on live patients and was stopped because it did not "perform to expectations" - and what of the unconsenting meatbags a.k.a. patients it was purportedly tested on? - ed.]
Complaint footnotes:
[2] CW1 described the HL7 interface as using industry standardized codes or language to allow users of disparate software systems to update patients electronic health records.
[3] In software development, “beta testing” generally refers to a testing phase in which a subset of the intended user population tries the product out, in order to see how the product works in real-world conditions. [What sane patient would consent to such testing of medical IT involved in their care, to 'see how it works in real-world conditions'? - ed.]
[4] See also ¶158 (Defendant Davis’ May 8, 2012 statement “our initial release of our integrated capability...was launched in the middle of last year”); ¶189; cf. ¶76 (CW11’s statement that beta testing at Blessing occurred in late 2011 and was halted in Spring 2012);
Again, I find the allegations of great concern - that experimental software was being beta tested on live patients and was stopped because it did not "perform to expectations." If true, what of the unconsenting meatbags a.k.a. patients? They would not have counted for much.
More from the Complaint in Count 50:
50. Consistent with CW2, CW3 said the Helios system was never taken to production while he worked at Allscripts. After he left to join Medicity he had heard that Allscripts delivered a Helios type product for beta testing in the fall of 2011 at the New York Presbyterian Hospitals and it did not go well and that the beta testing of the Helios product at the North Shore Long Island Jewish Community Hospital was scratched prior to implementation.
If the allegations are true, New York Presbyterian Hospitals in the fall of 2011 were performing beta testing of software so bad it was deemed unacceptable for LIJ Community Hospital. Again, if true, what about the risks patients were subjected to, and ... were any harmed?
Still more in Count 76:
76. CW11 said that Blessing Hospital in Quincy, Illinois was beta testing ADX 1.0 sometime in late 2011, but could not recall specifically when it began. CW11 said he was told that the testing was stopped in early 2012 because the product was not working properly and Allscripts deployed a product development team to Blessing Hospital to develop a workflow which lead to ADX 1.5. As far as CW11 knew, no one went live on ADX 1.0. Blessing Hospital began testing ADX 1.5 in late Spring 2012, and was the first to go live using ADX 1.5 in July 2012 which allowed the integration of patient information seamlessly between Sunrise and Enterprise applications. Components of Helios went into ADX 1.5. ADX 1.5 allowed for integration of patient data relating to PAMI (problems, allergies, medications, and immunizations) but some competitor products allow for significantly more types of data to be seamlessly exchanged and Allscripts was working to increase the types of data that could be seamlessly exchanged between acute care and ambulatory applications.
In effect, if the allegations are true, sancrosanct patient's rights have been trivialized, while poor software of non-trivial risk has been sanctified.
This would be, needless to say, deranged. Software can be debugged in test environments without putting patients at risk - if one is willing to invest the resources to do so.
The Class Action lawsuit Plaintiffs should perhaps seek to discover if there were patient harms or deaths as a result of the alleged software beta testing - assuming that information was not thoroughly "cleansed" by now.
I also note that even small NIH SBIR/STTR grant proposals involving use of new or modified IT on patients, on whose study sections I am an invited reviewer in the domain of Medical Informatics, are subject to human subjects protection evaluation:
http://grants.nih.gov/grants/peer/critiques/sbir-sttr.htm
... Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46 [see http://www.research.uci.edu/ora/forms/hrpp/categories_of_exempt_human_subjects_research.pdf - ed.], the [grant review] committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
In health IT tests in hospital settings, which is most certainly experimentation, there are simply no human subjects protections whatsoever. Hospital IT deserves no special accommodation regarding Protections for Human Subjects. There are no justifiable reasons I can think of.
-- SS
Addendum: Perhaps I'm wrong about people's generosity and altruism. I would like to hear from people who would gladly submit, say, their newborns as test subjects for the beta testing of experimental health IT software.
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