Monday, 2 February 2015

Former ONC Director David Blumenthal (Inadvertently?) Honest About EHRs in USA Today Story

Former ONC Director David Blumenthal (Inadvertently?) Honest About EHRs in USA Today Story

USA Today has published a story on health IT difficulties.  Read it in its entirety; it is fairly balanced, though mild, e.g., it omits mention of the ECRI Deep Dive study on patient harms (http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html) and other actual reports of patient harm.  (I was one of many who spoke to the reporters about this story.) 

Feds move into digital medicine, face doctor backlash
Laura Ungar and Jayne O'Donnell, USA TODAY
Feb. 1, 2015  
http://www.usatoday.com/story/news/nation/2015/02/01/backlash-against-electronic-medical-records/21693669/

I am only going to make one point about it, that being the candor (in a manner I'm reasonably certain was not intended) of former ONC Director Dr. David Blumenthal:

... David Blumenthal, national coordinator for health information technology for President Obama from 2009 to 2011, says, "the threat of penalties is the only incentive (doctors) have to make it [the adoption of healthcare IT] happen."

I don't think the candor was meant in the way I am about to interpret it, but I agree with his assessment.

The threat of Medicare penalties is indeed "the only incentive" (doctors) have to make "it" happen, because the technology is not helping them, and is making their work harder and more risk- and liability-prone.  But don't take that from just me:

... A group of 37 medical societies led by the American Medical Association sent a letter to Health and Human Services last month saying the certification program is headed in the wrong direction, and that today's electronic records systems are cumbersome, decrease efficiency and, most importantly, can present safety problems for patients. 

I covered that Jan. 21, 2015 letter at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html

(One can only imagine the level and duration of physician complaints it took for those 37 medical societies led by the American Medical Association to have crafted the letter to HHS/ONC, available at http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf.)

Also, as stated by the American Medical Association's president-elect to USA Today:

"Physicians passionately despise their electronic health records," says Lexington, Ky., emergency physician Steven Stack, the American Medical Association's president-elect. "We use technology quickly when it works … Electronic health records don't work right now."

"Passionately despise" is not exactly a ringing endorsement.

So, in effect,  the "stick" of financial penalties is indeed the "only incentive" doctors and nurses have right now for broad adoption, because the "carrot" is moldy and rotten - and despised with a passion.

A much better incentive - in fact, the only legitimate incentive for widespread adoption - is safe, sound, efficacious products, reasonably regulated, with defects and problems reasonably reported and acted upon ... in other words, with the products subject to the same scrutiny as IT in other mission and life-critical sectors.

Thanks for 'fessing up, Dr. Blumenthal.

-- SS
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Saturday, 31 January 2015

Time to "Look for the Union Label?" - "First US Doctors' Strike in Decades," at University of California Student Health

The First US Doctors' Strike in Decades

A few news media outlets in California have reported on what has been up to now a very rare event - a strike by physicians.  An initial summary was in an article in the San Diego Union - Tribune, whose title was

First U.S. Doctors' Strike in Decades

A handful of doctors providing medical services to students at UC San Diego — and their colleagues at nine other University of California campuses — went on strike Tuesday.

It's the first time in 25 years that fully licensed doctors are picketing a U.S. employer, according to the Union of American Physicians and Dentists, which represents the physicians at the UC schools.

The work stoppage began at 7:30 a.m. and is scheduled to last one day. It involves 150 health center doctors who manage the primary care and mental health needs of students.


A second article in the Union-Tribune suggested that the point of contention between the union and the University of California administration was not primarily wages,

Collective bargaining has not gone smoothly for UC student services doctors who voted to join the Union of American Physicians and Dentists in November 2013. The two sides have not been able to agree on a contract. Union members voted for the one-day strike after accusing the university system of refusing to provide key financial information that would aid their negotiations.


An article in the East Bay Express clarified that, 

The central unfair labor practice complaint centers on the university's refusal to disclose basic financial data to doctors as part of the negotiations, according to Dr. Jeff Nelson, a UC Berkeley physician and a member of the bargaining team.

'We have asked UC for financial information as to where their funding sources are and what kind of finding they have, and they're not giving that, even though as a public institution, they're required to,' Nelson told me this morning at a rally outside the Tang Center where UC Berkeley students receive health services. Citing the $3.1 billion fundraising campaign UC Berkeley completed last year, he added: 'They have an awful lot of money.'

Without the financial statistics the union has requested, UAPD can't fairly negotiate and settle a contract, said Sue Wilson, a UAPD spokesperson. 'We have a right to certain information that we need in order to bargain a contract.' For example, she said, the union has sought information about the recently approved 20 percent salary increases for chancellors, but hasn't had any luck getting the details it requested. Wilson said the union has also filed an unfair labor practice charge regarding UC's recent decision to require UAPD doctors to contribute more money to their pensions, despite the fact that university officials originally said they would make those changes through the contract negotiations. 'It shows a lack of respect,' she said.

Apparently, the striking doctors want more money not for salaries, but to improve services to patients, as discussed in the second Union-Tribune article,


Dr. Amol Doshi, one of the staff physicians who didn’t report to work Tuesday, said his decision to join the union and to strike came down to disagreements with management over how student health services is run. 

He said only about 15 minutes is provided for each patient, regardless of whether that student has one or several medical issues that need to be addressed.

'We feel like our professional autonomy is being compromised in how we can take care of our patients. We feel that the number of patients that we’re asked to see, many of whom have mental health concerns, require more time and more staffing,' Doshi said.

The East Bay Express noted the UC administration's response did not deal with the substance of these issues,

Reached for comment today, a UC Berkeley spokesperson referred me to the UC Office of the President. Shelly Meron, a spokesperson for that office, dismissed the union's complaints in a phone interview this morning.'"They say this is about unfair labor practice charges. We believe this is simply a negotiation tool.'  Meron said the president's office does not comment on the specifics of unfair labor practice charges and declined to answer questions about the union's claims regarding financial disclosures and the pension policy.

Note that so far this story has been reported nationally only in one small item by Reuters.

Unions as One Method to Address the Plight of the Corporate Physician

So, to summarize, a small group of unionized physicians employed by the student health services of the University of California called a one day strike to protest infringements of their autonomy, particularly requirements that they see patients too quickly for what they believe to be the patients' good, and failure to provide budgetary information relevant to the university's financial capacity to provide better services.  The physicians suspect the university has sufficient money to do so, especially given generous raises given to university managers.

The issues these physicians seem to be facing are familiar aspects of the plight of the American corporate physician.  To recap the background, decades ago, most US physicians worked as solo entrepreneurs, or for small, physician owned groups.  Those few who were employed worked for small non-profits, like the local teaching hospital, or local or US government.  That has all changed.

Now increasing numbers of physicians are employed by increasingly large non-profits, such as hospital systems, or for-profit corporations. A 2013 Medscape article reported that the then current rate of employment was over 50%.

As such these physicians often report ultimately to managers, administrators, bureaucrats, and executives (MABEs).  Many of the people they report do may not be physicians or health care professionals.  Instead, they are likely to be generic managers, trained in business and management schools, with no direct experience in health care, and unclear commitment to its value.  (The 2013 Medscape article cited above included results of survey suggesting the top complaint of employed physicians was being "bossed around by less-educated admins.")

Worse, many generic managers have bought into the primacy of short-term revenue over all other considerations, including patients' and the public's health.  Examples of mission hostile management in health care thus now abound.

In parallel, most top corporate leaders have received increasingly generous compensation, far more generous than non-management employees, including health care professionals get, and that compensation seems to rise regardless of the quality of health care their organizations provide, or even their organizations' financial performance.  (For example, see this post.

In the media, and even the medical and health care literature, the rise of the employed, corporate physician has been celebrated, or at least accepted as inevitable. For example, see this post on a Forbes blog by a non-physician pundit with the title, "Physicians want employment, not Marcus Welby MD," implying that choice was completely voluntary.   This attitude may be a product of the long domination of market fundamentalism in the US, in which markets are seen as the solution to all social problems, so neither the outcomes of the "free market" or corporate management are to be questioned. 

However, one would think that contemporary employed physicians are increasingly in a predicament, caught between their professional oaths to put individual patients first, and their generic manager bosses pushing to increase revenue no matter what.  Yet for the corporate physician, protest might jeopardize their livelihood, or worse.  Such physicians may feel captive of the restrictive clauses, such as confidentiality agreements and non-disparagement clauses, in the contracts they signed, possibly often under pressure and without adequate legal counsel.  For example, a 2013 Medscape article was entitled, "Can you speak out without getting fired or being labeled a troublemaker?"  The answer was at best, only sometimes. 

Even in the limited coverage of the California student health doctors' strike, there were references to some of these issues.  These included  what could be mission-hostile management (shrinking visit times regardless of patient needs), and excess compensation to top management (particularly, the Chancellors' pay raises.)   The anechoic nature of the strike, that is, the lack of media coverage so far, seems to reflect the now prevailing market fundamentalist dogma that is generally hostile to workers' rights and organization. 

Nonetheless, the doctors of the University of California student health services did organize, and now they have taken the unheard of step of calling a strike.  That this did not happen sooner is a testament to the enormous power, enforced by billions in public relations and marketing, of the dogma of market fundamentalism.  However, given that most physicians are now employees, and have not been having an easy time of it, this strike may be just the beginning.

In any case, organization of employed workers, collective bargaining, and even strikes, while being anathema to market fundamentalists, may be much better for society than even more radical responses to the ongoing plight of workers.  Remember, it was robber baron capitalism not much different from today's market fundamentalism, that inspired not only the rise of trade unions, but unfortunately, the rise of Marxism and ultimately Communism.

So maybe we should start looking for the "union label" more often in health care.



ADDENDUM (2 February, 2015) - See also post entitled, "Why Physicians Must Unionize" on the On Health Care Technology blog.

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Friday, 30 January 2015

CMS: Millions of patients across the nation are benefiting from the - um - potential - of Health IT?

I presume this is, in part, a response to the Jan. 21 letter from AMA and the other medical societies as I wrote about two days ago at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html:

CMS intends to modify requirements for Meaningful Use
http://blog.cms.gov/2015/01/29/cms-intends-to-modify-requirements-for-meaningful-use/

January 29
By Patrick Conway, MD

Today, we at the Centers for Medicare & Medicaid Services (CMS) are pleased to announce our intent to engage in rulemaking to update the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs beginning in 2015. These intended changes would help to reduce the reporting burden on providers, while supporting the long term goals of the program.

Read the document at the link above.

Note in particular this cheerful statement:

Since the first year of the EHR Incentive Programs in 2011, the United States has seen unprecedented growth in the adoption and meaningful use of EHRs. To date, more than 400,000 eligible providers have joined the ranks of hospitals and professionals that have adopted or are meaningfully using EHRs. This means that millions of patients across the nation are benefiting from the potential of better coordinated care among professionals, more accurate prescribing, and improved communication.

How does one, I ask, benefit from "potential of better care"?

How about the more factual "millions of patients are being put at risk and actually being harmed by the non-potential, but in fact actual, flaws in the technology?"

Until our leadership stops the mental cheerleading like this (or is it a form of subliminal messaging?), which blinds the uninformed to the reality ... the situation with healthcare IT will not improve, in my opinion.


And this after a formal letter of complaint about health IT disruptions to care, dangers, etc. from these organizations:

American Medical Association
AMDA – The Society for Post-Acute and Long-Term Care Medicine
American Academy of Allergy, Asthma and Immunology
American Academy of Dermatology Association
American Academy of Facial Plastic
American Academy of Family Physicians
American Academy of Home Care Medicine American Academy of Neurology
American Academy of Ophthalmology
American Academy of Otolaryngology—Head and Neck Surgery
American Academy of Physical Medicine and Rehabilitation
American Association of Clinical Endocrinologists
American Association of Neurological Surgeons
American Association of Orthopaedic Surgeons
American College of Allergy, Asthma and Immunology
American College of Emergency Physicians
American College of Osteopathic Surgeons
American College of Physicians
American College of Surgeons
American Congress of Obstetricians and Gynecologists
American Osteopathic Association
American Society for Radiology and Oncology
American Society of Anesthesiologists
American Society of Cataract and Refractive Surgery and Reconstructive Surgery
American Society of Clinical Oncology
American Society of Nephrology
College of Healthcare Information Management Executives
Congress of Neurological Surgeons
Heart Rhythm Society
Joint Council on Allergy, Asthma and Immunology
Medical Group Management Association
National Association of Spine Specialists
Renal Physicians Association
Society for Cardiovascular Angiography and Interventions
Society for Vascular Surgery


-- SS

Addendum 1/30/15:

Also see my April 26, 2014 post "Followup to CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives" at http://hcrenewal.blogspot.com/2014/04/followup-to-cms-does-not-have-any.html with its attached March 2014 lettert from CMS.  This document was obtained by the American Association of Physicians and Surgeons (AAPS) via FOIA on the "potential" benefits patients are realizing from the hundreds of billions of dollars spent on this technology to date:

CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But millions of patients are already benefiting from the potential!]  Click to enlarge.

-- SS
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Thursday, 29 January 2015

None Dare Call It Health Care Corruption

None Dare Call It Health Care Corruption

... even when allegedly a prominent academic physician's traded referrals of cancer patients to a law firm, resulting in referral fees to a prominent politician who worked for the firm, for government research grants to the physician's foundation and another foundation on whose board he sat, and a job for his son at yet another non-profit organization.
***

Health care corruption, remains a largely taboo topic, especially when it occurs in developed countries like the US.  Searching PubMed or major medical and health care journals at best will reveal a few articles on health care corruption, nearly all about corruption in less developed countries far away from where the authors live.  When the media may publish stories about issues related to health care corruption, they are almost never labelled as such.

For example, last year we discussed two widely reported cases of alleged political corruption.  One included allegations that a company producing a supposedly anti-inflammatory dietary supplement bribed Robert McDonnell, the former Governor of Virginia.  Mr McDonnell was later convicted and sentenced to two years in jail for public corruption (look here).  Another included allegations that Rick Perry, the former Governor of Texas abused his power by cutting funding of the state anti-corruption unit, which was investigating whether the Texas Cancer Research and Prevention Institute was awarding grants based on political influence rather than clinical and methodological merit. The reporting of both cases underplayed the health care aspects, and never mentioned health care corruption, or words to that effect.


Yet Transparency International's report on global health care corruption suggested health care corruption occurs in all countries.  A recent TI survey showed that 43% of US citizens believe the country has a health care corruption problem (look here).  Perhaps some US citizens have been reading between the lines, or have personal experiences with health care corruption. However, as long as we cannot talk about this problem openly, there is no chance it will be solved.

In January, 2015, a case of apparent political corruption made headlines.  It turns out to also be a case of apparent health care corruption.  

New York Assembly Speaker Sheldon Silver Charged with Fraud, Extortion, and Receiving Bribes


In late January, 2015, from early reporting  by the Capital New York,

The federal corruption case against Assembly Speaker Sheldon Silver rests in part on his alleged scheme with a doctor who referred asbestos cases to the Weitz & Luxenberg law firm where Silver is of counsel.

A criminal complaint from U.S. Attorney Preet Bharara alleges that Silver obtained referrals of asbestos
cases from a doctor affiliated with a university in Manhattan, referred to as 'Doctor-1,' by using his position as speaker to quietly direct $500,000 in state funds to the doctor's research and give 'additional benefits' to the doctor and the doctor's family.

The Doctor-1 described in the criminal complaint appears to be Dr. Robert Taub of Columbia University, based on details outlined in the criminal complaint, and confirmed by a secretary at his office and separately by a knowledgeable source. Taub specializes in mesothelioma research, for which it is hard to find research funding.

Regarding the advantages gained by Mr Silver,

Silver allegedly received millions of dollars in referral fees from Weitz & Luxenberg, and was credited with referring more than 100 clients, many of whom were referred for asbestos cases, according to the complaint.

The firm paid Silver $3.2 million for referrals related to asbestos cases between 2003 and 2014, according to the complaint. Prosecutors claim that several of those asbestos clients said they had been referred to Doctor-1 for treatment, and said the doctor had also recommended they retain Weitz & Luxenberg as their counsel.

Regarding the benefits to Dr Taub,


The complaints say the scheme began when the doctor allegedly asked Silver if his firm would help fund mesothelioma research and Silver declined. But prosecutors claim the doctor became aware that Silver wanted him to refer asbestos patients to Silver and the law firm for counsel, in exchange for funding for his medical research.

Doctor-1 started referring patients to Silver, and Silver began directing state funding to the doctor's research, the complaint alleges.

In December 2003, Doctor-1 requested a $250,000 grant from Silver to establish a Mesothelioma center at a university, according to the complaint. The complaint also says that the request was granted, and Silver approved payment from a pool of discretionary funds paid for by health care-related assessments that was under Silver's sole control until the year 2007.

Silver later directed another grant from the same pool of funds, also worth $250,000, to the Mesothelioma Center.

In 2008, the speaker directed a further $25,000 discretionary member item grant to a not-for-profit where the doctor was a board member, according to the complaint.

In 2012, the complaint alleges that Doctor-1 asked Silver for help in finding a family member a job with a nonprofit organization that 'received millions of dollars in member items and capital funding from Silver.'

A New York Times article verified that "Doctor-1" was Dr Robert N Taub, a previously highly reputed academic.  

In the criminal complaint against Sheldon Silver, he is identified simply as “Doctor-1.”

But Dr. Robert N. Taub, who headed a Columbia University center dedicated to curing a rare form of cancer caused by asbestos, is no ordinary doctor.

Also,

In 2002, Dr. Taub created one of the nation’s few mesothelioma research hubs, the Columbia University Mesothelioma Center. He was also active in an organization that raised money for research, sitting on the scientific advisory board of one of the few nonprofits created to help victims, the Mesothelioma Applied Research Foundation. The foundation, which awards research grants, relies heavily on gifts from law firms.


Finally, the NY Times story identified Dr Taub's family member who got a job through Mr Silver's intervention,

 According to the complaint and people briefed on the investigation, Dr. Taub also asked Mr. Silver in 2012 to help his son, Jonathan, find a job. The speaker arranged for an interview at OHEL Children’s Home and Family Services, a social services organization based in Brooklyn that had received millions of dollars in state funds from Mr. Silver.
After the allegations were made public, the NY Times also reported that Dr Taub "is leaving his position as head of a Columbia University cancer center, and the center is being disbanded," and the New York Post reported that Mr Silver is stepping down from his position as Speaker of the NY Assembly.

Political Corruption Highlighted, Health Care Corruption Ignored 


Corruption as defined by Transparency International is abuse of entrusted power for private gain.  Thus TI does not limit the term to cases involving politicians or government. Clearly, the allegations above were for corruption in this sense, and that corruption involved health care.

Furthermore, the alleged facts in the case implied,
-  Dr Taub abused his patients' trust in him by directing them to Mr Silver's firm, whether or not that was the best choice for these patients
-  Dr Taub abused the trust he inspired as a medical researcher by trading referral of his patients for government research grants
-  Dr Taub personally profited from these arrangements by obtaining a job for his family member, and a grant for another (non medical research) foundation on whose board he sat.
-  By directing grants to Dr Taub's research foundation, and the foundation on whose board Dr Taub sat, Mr Silver allocated scarce research funding for private gain, rather than for clinical, public health, or scientific reasons.


However, the coverage of the charges against Mr Silver, and particularly those relating to Dr Taub, was solely in terms of political corruption.  While the media reported the facts related to health care, there was no mention of health care corruption.

Even the pithy op-ed on the case by Prof Zephyr Teachout, now widely known for her expertise in corruption, and for increasing awareness of the importance of corruption in modern US society, did not mention health care corruption.  Her op-ed did note the earlier case of former Virginia Governor McDonnell,

As with the recent conviction of the former Virginia governor Bob McDonnell for receiving improper gifts and loans, a fixation on plain graft misses the more pernicious poison that has entered our system.

However, Professor Teachout did not note that these gifts and loans resulted from Governor McDonnell using his influence to market a supposed anti-inflammatory nutritional supplement.

Summary

Professor Teachout has decried how the definition of corruption has narrowed.

A fixation on plain graft misses the more pernicious poison that has entered our system.

However, our system is poisoned not only by political, but by health care corruption.  

However, when health care corruption is clearly the issue, the news media will not use that term.  Only when the corruption is occurring far away, usually in a supposedly benighted less developed country, will the news media or the scholarly medical, health care, and health policy literature discuss it as such.  So the anechoic nature of health care corruption has not changed since my post of August, 2014.

If we are not willing to even talk about health care corruption, how will we ever challenge it? 

So to repeat an ending to one of my previous posts on health care corruption....  if we really want to reform health care, in the little time we may have before our health care bubble bursts, we will need to take strong action against health care corruption.  Such action will really disturb the insiders within large health care organizations who have gotten rich from their organizations' misbehavior, and thus taking such action will require some courage.  Yet such action cannot begin until we acknowledge and freely discuss the problem.  The first step against health care corruption is to be able to say or write the words, health care corruption.

ADDENDUM (29 January, 2015) - This post was reposted on Naked Capitalism.  
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Wednesday, 28 January 2015

"Meaningful Use" not so meaningful: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing

The "Meaningful Use" program for EHRs is a mismanaged boondoggle causing critical issues of patient safety, EHR usability, etc. to be sidestepped.

This is on top of the unregulated U.S. boondoggle which should probably be called "the National Programme for IT in the HHS" - in recognition of the now-defunct multi-billion-pound debacle known as the National Programme for IT in the NHS (NPfIT), see my Sept. 2011 post "NPfIT Programme goes PfffT" at http://hcrenewal.blogspot.com/2011/09/npfit-programme-going-pffft.html.

The complaints are not just coming from me now.

As of January 21, 2015 in a letter to HHS at: http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf, they are now coming from the:

American Medical Association
AMDA – The Society for Post-Acute and Long-Term Care Medicine
American Academy of Allergy, Asthma and Immunology
American Academy of Dermatology Association
American Academy of Facial Plastic
American Academy of Family Physicians
American Academy of Home Care Medicine American Academy of Neurology
American Academy of Ophthalmology
American Academy of Otolaryngology—Head and Neck Surgery
American Academy of Physical Medicine and Rehabilitation
American Association of Clinical Endocrinologists
American Association of Neurological Surgeons
American Association of Orthopaedic Surgeons
American College of Allergy, Asthma and Immunology
American College of Emergency Physicians
American College of Osteopathic Surgeons
American College of Physicians
American College of Surgeons
American Congress of Obstetricians and Gynecologists
American Osteopathic Association
American Society for Radiology and Oncology
American Society of Anesthesiologists
American Society of Cataract and Refractive Surgery and Reconstructive Surgery
American Society of Clinical Oncology
American Society of Nephrology
College of Healthcare Information Management Executives
Congress of Neurological Surgeons
Heart Rhythm Society
Joint Council on Allergy, Asthma and Immunology
Medical Group Management Association
National Association of Spine Specialists
Renal Physicians Association
Society for Cardiovascular Angiography and Interventions
Society for Vascular Surgery


In the letter to Karen B. DeSalvo, National Coordinator for Health Information Technology at HHS, these organizations observe:

Dear Dr. DeSalvo:

The undersigned organizations are writing to elevate our concern about the current trajectory of the certification of electronic health records (EHRs). Among physicians there are documented challenges and growing frustration with the way EHRs are performing. Many physicians find these systems cumbersome, do not meet their workflow needs, decrease efficiency, and have limited, if any, interoperability.

Of course, my attitude is that we need basic operability before the wickedly difficult to accomplish and far less useful (to patients) interoperability. 
 
... Most importantly, certified EHR technology (CEHRT) can present safety concerns for patients. We believe there is an urgent need to change the current certification program to better align end-to-end testing to focus on EHR usability, interoperability, and safety.

Let me state what they're saying more clearly:

"This technology in its present state is putting patients at risk, harming them, and even killing them, is making practice of medicine more difficult, is putting clinicians at liability risk, and the 'certification' program is a joke."

... We understand from discussions with the Office of the National Coordinator for Health Information Technology (ONC) that there is an interest in improving the current certification program. For the reasons outlined in detail below, we strongly recommend the following changes to EHR certification:

1. Decouple EHR certification from the Meaningful Use program;
2. Re-consider alternative software testing methods;
3. Establish greater transparency and uniformity on UCD testing and process results;
4. Incorporate exception handling into EHR certification;
5. Develop C-CDA guidance and tests to support exchange;
6. Seek further stakeholder feedback; and
7. Increase education on EHR implementation.

Patient Safety
Ensuring patient safety is a joint responsibility between the physician and technology vendor and requires appropriate safety measures at each stage of development and implementation.

I would argue that it's the technologists who have butted into clinical affairs with aid from their government friends, thus the brunt of the ill effects of bad health IT should fall on them.  However, when technology-related medical misadventures occur, it's the physicians who get sued.

... While training is a key factor, the safe use of any tool originates from its inherent design and the iterative testing processes used to identify issues and safety concerns. Ultimately, physicians must have confidence in the devices used in their practices to manage patient care. Developers must also have the resources and necessary time to focus on developing safe, functional, and useable systems.

Right now, those design and testing processes compare to those in other mission-critical sectors employing IT quite poorly.

Considering fundamental stunningly-poor software quality that I've observed personally, such as lack of appropriate confirmation dialogs and notification messages supporting teamwork, lack of date constraint checking (see my report to FDA MAUDE at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1729552 and many others at http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html), and other fundamentals, I would say grade schoolers could probably have done a better job of safety testing than the vendors and IT amateur-implementers of the major systems I observed did. 

... Unfortunately, we believe the Meaningful Use (MU) certification requirements are contributing to EHR system problems, and we are worried about the downstream effects on patient safety.

In other words, computers and the government thirst for data do not have more rights than patients.  In the current state of affairs, as I have observed prior, computers do seem to have more rights than patients and the clinicians who must increasingly use them.

... Physician informaticists and vendors have reported to us that MU certification has become the priority in health information technology (health IT) design at the expense of meeting physician customers’ needs, patient safety, and product innovation. We are also concerned with the lack of oversight ONC places on authorized testing and certification bodies (ATCB) for ensuring testing procedures and standards are adequate to secure and protect electronic patient information contained in EHRs.

Not just security, but patient safety also.  See for example my Feb. 2012 post "Hospitals and Doctors Use Health IT at Their Own Risk - Even if 'Certified'" at http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html.

Read the entire letter at http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf.

Sadly, while on the right track regarding the problems of bad health IT, the societies take a Milquetoast approach to correction:

... In May 2014, stakeholders representing accredited certification bodies and testing laboratories (ACB & ATL), EHR vendors, physicians, and health care organizations provided feedback to ONC on the complexities of the current certification system. Two main takeaways from these comments were for ONC to host a multi-stakeholder Kaizen event and to prioritize security, quality measures, and interoperability in the EHR certification criteria. We strongly support both of these ideas...

A multi-stakeholder "Kaizen event'?  (http://en.wikipedia.org/wiki/Kaizen)

That's one recommendation I find disappointing.  The industry plays hard politics, and organized medicine wants to play touchy-feely "good change" management mysticism with that industry and their government apparatchiks.  That's how organized medicine wants patients and the integrity of the medical profession to be protected from the dysfunctional health IT ecosystem (see http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=ecosystem)?  

When I originally created my old website called "Medical informatics and leadership of clinical computing" back in 1998, Kaizen events were not exactly what I had in mind.

Finally, the American Medical Informatics Association (http://www.amia.org) was apparently not informed of this letter, nor did it participate in its drafting.  While this is regrettable, as the organization is the best reservoir of true Healthcare Informatics expertise, I opined to that group that this may have been due to the organization's tepid response to bad health IT and to industry control of the narrative, and the problems these issues have caused for physicians and other clinicians. The lack of AMIA leadership regarding bad health IT is an issue I've been pointing out since the late 1990s. AMIA has been largely a non-critical HIT promoter.  That stance has contributed to the need for this multiple-medical specialty society letter in the first place.

Parenthetically, and for a touch of humor about an otherwise drab topic: Here's an example of how management mysticism plays out in pharma.

It's meant to be satirical, but captures reality all too well, in fact scarily so at times:


Management mysticism and muddled thinking.  See https://www.youtube.com/watch?v=kwVjftMMCIE

In pharma, as well as in hospital IT in my days as CMIO, gibberish like this was real.  I imagine it's no different in many hospital management suites these days.

-- SS

1/28/2015  Addendum:

Per a colleague:

FierceHealthIT (1/28) reports, “It’s time for the American Medical Association and more than 30 other organizations urging change in the electronic health record certification process to be part of the solution, former Deputy National Coordinator for Health IT Jacob Reider said in a blog post.” Reider said, “So far, I don’t see much [any?] engagement from the AMA or the others who signed the letter. It’s relatively easy to write a letter saying someone else is responsible for solving problems. Time to step up to the plate and participate in the solutions, folks!"

Regarding the victims of compelled use of bad health IT, this erstwhile health IT leader opines "It's relatively easy to write a letter saying someone else is responsible for solving problems?"

That is simply perverse.

I ask: why are we in the midst of a now-compelled national rollout with Medicare penalties for non-adopters when a former government official once responsible for the technology remarks that it's apparently not the makers' problem and that it's "time to step up to the plate and participate in the solutions, folks [a.k.a. end users]!"

(One wonders if Reider believes those who step up to the plate are entitled to fair compensation for their aid to an industry not exactly known for giving its products away, free.)

It seems to me it's not up to (forced) customers to find solutions to vendor product problems, some deadly.

It's the responsibility of the sellers.

Put more bluntly, Reider's statement is risible and insulting.

I've already opined the following to the AMA contact at the bottom of the letter:

... Relatively milquetoast approaches such as multi-stakeholder Kaizens are not what I had in mind ... A more powerful stance would be to advise society members to begin to avoid conversion, report on bad health IT, and even boycott bad health IT until substantive changes are realized in this industry.

That's "stepping up to the plate" to protect patients, in a very powerful way.

-- SS
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