HITECH and Funding Cuts: The Battle Begins

At "US House of Representatives Proposes to Defund Largest Non-Consented Medical Experiment in U.S. History: HITECH" I predicted this:

... I have no financial conflicts of interest regarding HITECH or health IT to weep about. Others do, and it's not hard to predict their financial interests will push them to oppose repeal "by any means necessary."

The next few months should be an interesting time in the politics of healthcare IT.

A replacement HITECH act that's "HI" on research and caution, but not so "HIGH" on stealth, coercion and euphoria (i.e., as on mind altering substances) would be welcomed.

The battle's already begun. At "Meaningful Use incentives jeopardized by GOP bill", Jan. 28, 2011 by at Dan Bowman at FierceHealthIT.com, views exactly as I expected have begun being proffered by the industry:

... All of that [possibility of HITECH funding termination] has HIMSS Vice President for government relations Dave Roberts just a little on edge, reports Healthcare IT News.

"We're trying to tell people that this process is going on. This is only one body [of Congress]. Don't let this be a concern," he said. But "if this is a new way of thinking, that could be concerning. So I think that while this particular bill may not pass, it's something that has to be watched closely."

Patti Dodgren, CEO of Hielix--which helps to facilitate electronic health information exchanges across the U.S., shares Roberts' view. [Any possible conflicts of interest towards full-speed-ahead-damn-the-torpedoes health IT diffusion in that role, I ask? - ed.]

"Just the suggestion of repealing HITECH stimulus funds for physicians...is short-sighted at best, and threatens the very progress that is already beginning to be realized within the industry to move our healthcare system into the 20^th [yes, 20th] Century," Dodgren told FierceHealthIT. "All this bill serves to do is strengthen the cynics of health IT.

[Translation: "short sighted" and "cynic" = those more interested in taking the time to do health IT "right" and in patient rights and patient well being, than in personal gain - ed.]

We work with thousands of physicians and state government healthcare officials who have worked tirelessly over the past months to achieve the benefits that healthcare IT promises [no, Ms. Dodgren, they haven't, actually; you and they have merely encouraged a rushed, cavalier and reckless rollout (of a technology even HIMSS' former Chairman of the Board, a physician, admitted is not ready), damaging - not helping - health IT's prospects. See below - ed.], and this bill is a disservice to them and to the healthcare industry."

It may be a "disservice" to those who stand to profit from the health IT industry, but it's a great service to the healthcare industry and to the patients it serves.

I didn't really need to look, as experience at HC Renewal has proven time and again about the healthcare pundits, but the credentials of someone making such claims about health IT are not impressive IMO.

From an online bio, Ms. Dodgren holds the illustrious "CPHIMS" certification that I wrote about at my April 2008 post "Is the HIMSS Certified Professional in Healthcare Information and Management Systems stamp substantive, or just alphabet soup?". After 8 years as Director Budgeting & Financial Systems at (now-defunct) Digital Equipment Corp. (DEC) and 4 years as Senior Business Analyst at Dun & Bradstreet, she has been a "change management professional" for twenty years who "co-founded a management consulting practice which specializes in the application of change management principles to health information technology." I note no medical (or medical informatics) training or experience.

My reply to these people is as follows, as posted in a FierceHealthIT comment:

By S Silverstein MD | Posted 7:09pm | January 30, 2011

Patti Dodgren and Dave Roberts seem to favor continuation of a risky and even harmful national medical experiment that does not even have the fundamental decency to seek patient informed consent.

See http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html for examples of some of the risks.

The former Board Chair of HIMSS, Barry Chaiken, MD, MPH, FHIMSS said it best in July 2010:

http://histalk2.com/2010/07/19/histalk-interviews-barry-chaiken/

... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better.

Let the industry learn the responsible way, not on patients' and physicians' blood, sweat and tears through way-too-early national initiatives that will only add to the $14 trillion national debt (http://www.usdebtclock.org/), and throw some of the money into industry pockets.

Franky, as a physician with no financial conflict-of-interest axes to grind, I am increasingly disgusted with the cavalier, money-grubbing attitudes of the health IT industry and its pundits. Their attitudes and behaviors represent a poster study of healthcare industry at its worst.

This latter fact is not lost on me as I speak with government representatives seeking to improve medical drug/device watchdog legislation, and to attorneys looking to protect patients from harm or gain recompense for those already injured as a result of faulty IT.

-- SS

HITECH and Funding Cuts: The Battle Begins

At "US House of Representatives Proposes to Defund Largest Non-Consented Medical Experiment in U.S. History: HITECH" I predicted this:

... I have no financial conflicts of interest regarding HITECH or health IT to weep about. Others do, and it's not hard to predict their financial interests will push them to oppose repeal "by any means necessary."

The next few months should be an interesting time in the politics of healthcare IT.

A replacement HITECH act that's "HI" on research and caution, but not so "HIGH" on stealth, coercion and euphoria (i.e., as on mind altering substances) would be welcomed.

The battle's already begun. At "Meaningful Use incentives jeopardized by GOP bill", Jan. 28, 2011 by at Dan Bowman at FierceHealthIT.com, views exactly as I expected have begun being proffered by the industry:

... All of that [possibility of HITECH funding termination] has HIMSS Vice President for government relations Dave Roberts just a little on edge, reports Healthcare IT News.

"We're trying to tell people that this process is going on. This is only one body [of Congress]. Don't let this be a concern," he said. But "if this is a new way of thinking, that could be concerning. So I think that while this particular bill may not pass, it's something that has to be watched closely."

Patti Dodgren, CEO of Hielix--which helps to facilitate electronic health information exchanges across the U.S., shares Roberts' view. [Any possible conflicts of interest towards full-speed-ahead-damn-the-torpedoes health IT diffusion in that role, I ask? - ed.]

"Just the suggestion of repealing HITECH stimulus funds for physicians...is short-sighted at best, and threatens the very progress that is already beginning to be realized within the industry to move our healthcare system into the 20^th [yes, 20th] Century," Dodgren told FierceHealthIT. "All this bill serves to do is strengthen the cynics of health IT.

[Translation: "short sighted" and "cynic" = those more interested in taking the time to do health IT "right" and in patient rights and patient well being, than in personal gain - ed.]

We work with thousands of physicians and state government healthcare officials who have worked tirelessly over the past months to achieve the benefits that healthcare IT promises [no, Ms. Dodgren, they haven't, actually; you and they have merely encouraged a rushed, cavalier and reckless rollout (of a technology even HIMSS' former Chairman of the Board, a physician, admitted is not ready), damaging - not helping - health IT's prospects. See below - ed.], and this bill is a disservice to them and to the healthcare industry."

It may be a "disservice" to those who stand to profit from the health IT industry, but it's a great service to the healthcare industry and to the patients it serves.

I didn't really need to look, as experience at HC Renewal has proven time and again about the healthcare pundits, but the credentials of someone making such claims about health IT are not impressive IMO.

From an online bio, Ms. Dodgren holds the illustrious "CPHIMS" certification that I wrote about at my April 2008 post "Is the HIMSS Certified Professional in Healthcare Information and Management Systems stamp substantive, or just alphabet soup?". After 8 years as Director Budgeting & Financial Systems at (now-defunct) Digital Equipment Corp. (DEC) and 4 years as Senior Business Analyst at Dun & Bradstreet, she has been a "change management professional" for twenty years who "co-founded a management consulting practice which specializes in the application of change management principles to health information technology." I note no medical (or medical informatics) training or experience.

My reply to these people is as follows, as posted in a FierceHealthIT comment:

By S Silverstein MD | Posted 7:09pm | January 30, 2011

Patti Dodgren and Dave Roberts seem to favor continuation of a risky and even harmful national medical experiment that does not even have the fundamental decency to seek patient informed consent.

See http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html for examples of some of the risks.

The former Board Chair of HIMSS, Barry Chaiken, MD, MPH, FHIMSS said it best in July 2010:

http://histalk2.com/2010/07/19/histalk-interviews-barry-chaiken/

... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better.

Let the industry learn the responsible way, not on patients' and physicians' blood, sweat and tears through way-too-early national initiatives that will only add to the $14 trillion national debt (http://www.usdebtclock.org/), and throw some of the money into industry pockets.

Franky, as a physician with no financial conflict-of-interest axes to grind, I am increasingly disgusted with the cavalier, money-grubbing attitudes of the health IT industry and its pundits. Their attitudes and behaviors represent a poster study of healthcare industry at its worst.

This latter fact is not lost on me as I speak with government representatives seeking to improve medical drug/device watchdog legislation, and to attorneys looking to protect patients from harm or gain recompense for those already injured as a result of faulty IT.

-- SS

US House of Representatives Proposes to Defund Largest Non-Consented Medical Experiment in U.S. History: HITECH

In a new bill in the House of Representatives, the ‘‘Spending Reduction Act of 2011’’ (link - PDF), it is proposed to cut unobligated funds of, among others, division A of the "American Recovery and Reinvestment Act of 2009":

Spending Reduction Act of 2011

... TITLE III—RESCISSION OF UNOBLIGATED STIMULUS FUNDS AND REPEAL OF CERTAIN STIMULUS PROVISIONS

SEC. 301. RESCISSION OF UNOBLIGATED STIMULUS FUNDS.

Effective on the date of the enactment of this Act, there are rescinded all unobligated balances of the discretionary appropriations made available by division A of the American Recovery and Reinvestment Act of 2009 (Public Law 111–5).

SEC. 302. REPEAL OF CERTAIN STIMULUS PROVISIONS.

Effective on the date of the enactment of this Act, subtitles B and C of title II and titles III through VII of division B of the American Recovery and Reinvestment Act of 2009 (Public Law 111–5) are repealed, and the provisions of law amended or repealed by such provisions of division B are restored or revived as if such provisions of division B had not been enacted.

Division A of the ARRA Act of 2009 (link to PDF) includes this:

SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘American Recovery and Reinvestment Act of 2009’’.

SEC. 2. TABLE OF CONTENTS.

... The table of contents for this Act is as follows:

DIVISION A—APPROPRIATIONS PROVISIONS

... TITLE XIII—HEALTH INFORMATION TECHNOLOGY

Title XIII of the ARRA along with title IV of division B is better known as HITECH:

SEC. 13001. SHORT TITLE; TABLE OF CONTENTS OF TITLE.

(a) SHORT TITLE.—This title (and title IV of division B) may be cited as the ‘‘Health Information Technology for Economic and Clinical Health Act’’ or the ‘‘HITECH Act’’.

It looks like HITECH is one of a number of spending extravaganzas now on the proposed chopping block.

I can't be too sorry about this for these reasons:

• This country cannot afford HITECH at this time. We are broke, with some calling the economic crisis of 2008 worse than the crisis of 1929, and the national deficit ballooning far out of control. The money would be far better spent at this time on care of those who cannot afford it.
  

• HITECH appeared as if out of nowhere, with little to no input time from stakeholders. This suggests lobbying by those with conflicts of interest to push this bill onto the public, affecting their medical care without informed consent (see my March 2009 post "Draft Patient Rights Statement and Informed Consent on Use of HIT"). The bill includes persuasion along with economic coercion for non-adopting organizations and physicians. ("Adoption" = adherence to government-set standards of "meaningful use" of poorly usable technology.) I disapprove of the stealth process by which HITECH appeared. This is the U.S., not the old USSR.

• Mass social experiments involving major systemic changes to our healthcare delivery system, with exceptional claims being made about IT, need to be backed by exceptional evidence. That evidence is lacking. (March 2011 addendum: the evidence might actually be in the negative direction. See my post "An Updated Reading List on Health IT.")
  

• The technology is not ready. It is dangerous in unqualified hands, which most every medical center and physician office is in 2011 (i.e., an IT backwater). The field of health IT was somehow transformed from an experimental field into the 'savior of medicine' without the proof of value and safety that would ordinarily be required to move an experimental technology from lab to national rollout. Per the Washington Post, this process appears to have been a highly politicized one, favoring the corporate elites. The Washington Post’s 2009 article on the influential HIT vendor lobby “The Machinery Behind Healthcare Reform” is at this link.

While this House Bill is just the initial battle in the repeal of this and other mass expenditures, I would not weep for the HITECH act's passing. It would allow the restoration of health IT back to an unrushed and careful endeavor. It would also give time to work out the significant issues causing health IT difficulty (such as raised in 2009 by our National Research Council) before we embark on national diffusion.

In other words, its passing would reduce risk and help restore an essential level of sanity and due diligence to the healthcare IT sector, now afflicted by irrational exuberance bordering on delirium. We would avoid the largest non-consented medical experiment in US history, which as I have repeatedly written I feel would be disastrous with current levels of understanding of this technology and how to design, deploy and manage it. (My relative's 2010 HIT-related injuries only strengthened my convictions in this regard.)

Of course, I have no financial conflicts of interest regarding HITECH or health IT to weep about. Others do, and it's not hard to predict their financial interests will push them to oppose repeal "by any means necessary."

The next few months should be an interesting time in the politics of healthcare IT.

A replacement HITECH act that's "HI" on research and caution, but not so "HIGH" on stealth, coercion and euphoria (i.e., as on mind altering substances) would be welcomed.

-- SS

US House of Representatives Proposes to Defund Largest Non-Consented Medical Experiment in U.S. History: HITECH

In a new bill in the House of Representatives, the ‘‘Spending Reduction Act of 2011’’ (link - PDF), it is proposed to cut unobligated funds of, among others, division A of the "American Recovery and Reinvestment Act of 2009":

Spending Reduction Act of 2011

... TITLE III—RESCISSION OF UNOBLIGATED STIMULUS FUNDS AND REPEAL OF CERTAIN STIMULUS PROVISIONS

SEC. 301. RESCISSION OF UNOBLIGATED STIMULUS FUNDS.

Effective on the date of the enactment of this Act, there are rescinded all unobligated balances of the discretionary appropriations made available by division A of the American Recovery and Reinvestment Act of 2009 (Public Law 111–5).

SEC. 302. REPEAL OF CERTAIN STIMULUS PROVISIONS.

Effective on the date of the enactment of this Act, subtitles B and C of title II and titles III through VII of division B of the American Recovery and Reinvestment Act of 2009 (Public Law 111–5) are repealed, and the provisions of law amended or repealed by such provisions of division B are restored or revived as if such provisions of division B had not been enacted.

Division A of the ARRA Act of 2009 (link to PDF) includes this:

SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘American Recovery and Reinvestment Act of 2009’’.

SEC. 2. TABLE OF CONTENTS.

... The table of contents for this Act is as follows:

DIVISION A—APPROPRIATIONS PROVISIONS

... TITLE XIII—HEALTH INFORMATION TECHNOLOGY

Title XIII of the ARRA along with title IV of division B is better known as HITECH:

SEC. 13001. SHORT TITLE; TABLE OF CONTENTS OF TITLE.

(a) SHORT TITLE.—This title (and title IV of division B) may be cited as the ‘‘Health Information Technology for Economic and Clinical Health Act’’ or the ‘‘HITECH Act’’.

It looks like HITECH is one of a number of spending extravaganzas now on the proposed chopping block.

I can't be too sorry about this for these reasons:

• This country cannot afford HITECH at this time. We are broke, with some calling the economic crisis of 2008 worse than the crisis of 1929, and the national deficit ballooning far out of control. The money would be far better spent at this time on care of those who cannot afford it.
  

• HITECH appeared as if out of nowhere, with little to no input time from stakeholders. This suggests lobbying by those with conflicts of interest to push this bill onto the public, affecting their medical care without informed consent (see my March 2009 post "Draft Patient Rights Statement and Informed Consent on Use of HIT"). The bill includes persuasion along with economic coercion for non-adopting organizations and physicians. ("Adoption" = adherence to government-set standards of "meaningful use" of poorly usable technology.) I disapprove of the stealth process by which HITECH appeared. This is the U.S., not the old USSR.

• Mass social experiments involving major systemic changes to our healthcare delivery system, with exceptional claims being made about IT, need to be backed by exceptional evidence. That evidence is lacking. (March 2011 addendum: the evidence might actually be in the negative direction. See my post "An Updated Reading List on Health IT.")
  

• The technology is not ready. It is dangerous in unqualified hands, which most every medical center and physician office is in 2011 (i.e., an IT backwater). The field of health IT was somehow transformed from an experimental field into the 'savior of medicine' without the proof of value and safety that would ordinarily be required to move an experimental technology from lab to national rollout. Per the Washington Post, this process appears to have been a highly politicized one, favoring the corporate elites. The Washington Post’s 2009 article on the influential HIT vendor lobby “The Machinery Behind Healthcare Reform” is at this link.

While this House Bill is just the initial battle in the repeal of this and other mass expenditures, I would not weep for the HITECH act's passing. It would allow the restoration of health IT back to an unrushed and careful endeavor. It would also give time to work out the significant issues causing health IT difficulty (such as raised in 2009 by our National Research Council) before we embark on national diffusion.

In other words, its passing would reduce risk and help restore an essential level of sanity and due diligence to the healthcare IT sector, now afflicted by irrational exuberance bordering on delirium. We would avoid the largest non-consented medical experiment in US history, which as I have repeatedly written I feel would be disastrous with current levels of understanding of this technology and how to design, deploy and manage it. (My relative's 2010 HIT-related injuries only strengthened my convictions in this regard.)

Of course, I have no financial conflicts of interest regarding HITECH or health IT to weep about. Others do, and it's not hard to predict their financial interests will push them to oppose repeal "by any means necessary."

The next few months should be an interesting time in the politics of healthcare IT.

A replacement HITECH act that's "HI" on research and caution, but not so "HIGH" on stealth, coercion and euphoria (i.e., as on mind altering substances) would be welcomed.

-- SS

Professors at Harvard and Nottingham Medical School (UK): Are we repeating the UK's clinical IT failures in the US?

In the opinion piece "Don't Repeat the UK's Electronic Health Records Failure" (Huffington Post, Dec. 5, 2010), Dr. Stephen B. Soumerai, Professor of Population Medicine at Harvard Medical School and Dr. Anthony Avery, Professor of Primary Care at the University of Nottingham Medical School, UK share familiar themes on health IT.

These themes will be especially familiar to HC Renewal readers and to my students and other readers of my Medical Informatics teaching website.

The professors wrote:

Fueled by the economic stimulus passed by Congress in 2008 [The ARRA a.k.a. "American Recovery and Reinvestment Act" and the HITECH legislation it contained - ed.], the federal government has embarked on a controversial $30 billion program to induce doctors throughout the country to adopt electronic health records (EHRs) by 2014. The purpose is to create an interconnected system of electronic health records to improve safety and reduce medical costs.

But the United Kingdom has spent the last 6 years working on the same idea, and it's proven to be a colossal failure -- so much so that the government is drastically cutting its program. What happened to their plan? Should we be paying attention before rushing ahead with our own?

My response to that question is clear, such as at my Nov. 2008 post "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" and the followup Jan. 2009 post "I Ask Again: Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" where I wrote:

$50 billion a year is big money that might be better spent elsewhere - such as providing care for the poor and for disadvantaged children - until we know how to get HIT right.

I suggest it may be best not to go all-out for HIT under the current paradigm. It is my belief, in fact, based on the above issues [UK and US issues - ed.] plus a chronic influx of HIT difficulty and mismanagement stories I hear from colleagues, ex-colleagues, recruiters, etc., that healthcare organizations not contractually obligated should consider a postponement of plans to purchase clinical IT (i.e., systems for direct use by clinicians such as EHR's).

This postponement should last at least until the issues that lead to ineffective and counterproductive HIT can be better understood and corrections initiated in the industry.

The professors further write:

In 2005 the United Kingdom embarked on the largest investment ($18 billion) in health information technology in the world. Yet despite expectations that the system would increase efficiency and reduce medical errors, their efforts neither improved health nor saved money -- in fact in some cases, they may have led to patient harm.

Britain's government-run medical system is obviously different from our complex public-private insurance system. [I had written that a smaller, socialized healthcare system should be far easier to automate than our own in the US - ed.] However, its electronic health record project bears an uncanny resemblance to the program President Obama is starting.

They then delineated a number of problems:

Too large and ambitious: The UK project tried to accomplish too much, too fast, attempting to digitize health records for the whole population in a period of four years. This massive undertaking is years behind schedule and has delivered only a fraction of what it promised. Despite all the money poured into the system, the vast majority of hospitals in the UK still don't have integrated electronic health records.

Why? The reasons sound familiar:

... Because non-clinicians developed the system, the electronic forms they designed have little to do with how doctors treat patients -- making it unworkable for many physicians. As the Chair of the British House of Commons Public Accounts Committee recently stated, "This is the biggest IT [Information Technology] project in the world and it is turning into the biggest disaster."

The "biggest IT disaster in the world" is not an honor I wish to see repeated in the U.S.

On another familiar problem:

Too dependent on commercial, proprietary companies: Rather than create one system and beta-test it, the UK government depended on four companies to build the system, two of which quit or were fired for missing deadlines. So the health records were never developed in the south of England. The computer software was secret and proprietary. There was no accountability to the public, and the vendors did not provide enough technical support to clinicians having trouble using the records.

The resulting software errors and crashes caused missing or incorrect clinical information and sometimes threatened patient safety, for example by causing surgical delays and the cancellation of hundreds of operations.

The inquiring mind would want to know about actual patient injuries and deaths that likely resulted from such problems...

The professors observe:

If a country like Britain -- which already has a national health system and is a fraction of the size of the US -- had so many problems with electronic health records, imagine the problems America would face.

This sounds like my comments in a public comment letter of March 9, 2010 to HHS/ONC (Re: RIN 0991-AB59, "Proposed Establishment of Certification Programs for Health Information Technology") where I wrote, among many other things:

... We ignore the UK experience at our peril, an experience in a medical environment smaller and far more government-controlled than our own.

... I believe that a rushed National Program for HIT in the United States will suffer the same fate as the aforementioned National Programme for IT in the UK, and perhaps even a worse fate as the UK’s socialized medicine system is certainly a smaller, more homogeneous and more controllable testbed environment for experimenting with HIT.

The professors relate:

Even our partial adaption of electronic health records is causing problems. Over the last couple of years, doctors and hospitals have reported to the FDA dozens of medical injuries -- including six deaths and preventable heart attacks -- caused by problems related to computerized health records such as software errors and unreadable computer screens. Some errors resulted in drug doses that were 10 times higher than intended. FDA officials called this the "tip of the iceberg."

I wrote about the FDA's findings here, and conducted a "thought experiment" regarding what those numbers might extrapolate out to in my April 2010 post "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers."

They continue:

... More than 50 medical organizations, including the AMA, have called on the Secretary of Health and Human Services to delay the program. In response, the administration delayed some of the required health IT functions, but kept the same 2014 deadline.

Indeed. They are courting disaster in my opinion, both clinically and financially, as I wrote in a Feb. 2009 Wall Street Journal letter to the editor entitled “Digitizing Medical Records May Help, but It's Complex”:

Dear WSJ,

You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.

I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.

For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors.

HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.

The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker.

I can only hope patients get something worthwhile for the $20 billion.

The professors then note:

How do we avoid the UK's failure? The administration or Congress should slow down the program and delete those parts of the legislation that fine doctors for not using this technology. There's no need to have this system in place by 2014. Instead, we should conduct rigorous studies of the cost-effectiveness of electronic health records systems before mandating their use. Rather than force doctors to choose from dozens of commercial software products developed in secret, we should take a hint from the non-commercial sector, such as the Veterans Administration, which uses "open-source" coding so people can work collaboratively to continuously improve the system.

Slowing down the program and performing rigorous studies of HIT before wide scale rollout are themes I raised, among other places, in my Dec. 2009 post "Tensions and Paradoxes in Electronic Patient Record Research: Critical Thinking on Health IT" where I wrote:

In conclusion, I believe this literature review supports the notion expressed in other studies and opinion pieces here and elsewhere that we really need to SLOW DOWN the current HIT stampede, largely promoted by the HIT industry lobby. We need to take the appropriate time to better understand how to "do HIT well" before plunging in as if we actually know what we're doing

as well as at my Oct. 2009 post "Washington Post Article: Electronic medical records not seen as a cure-all" where I wrote:

... The literature is indeed conflicting, and the need for rigorous scientific study has never been more essential considering the commitment of tens of billions of dollars towards health IT. The time for story telling, marketing based on opinion, name calling, leap-of-faith extrapolations of light year dimensions, and other forms of pseudoscience and non-science are over. The time for objective study is now.

The professors conclude:

The Obama administration wants government programs to be based on evidence of effectiveness. Simply following the lead of "IT believers" and salesmen without the requisite evidence will repeat the UK's failures. Now is the time to proceed carefully, consider existing research and the British experience, and chart a more rational course into the digital age of medicine.

I do not know if these two professors were familiar with my writings, but I am happy to see these themes (once treated as verboten and as grounds for marginalization by the HIT industry) increasingly going mainstream.

Patient well being - which includes you, dear readers - depends on that.

-- SS

Professors at Harvard and Nottingham Medical School (UK): Are we repeating the UK's clinical IT failures in the US?

In the opinion piece "Don't Repeat the UK's Electronic Health Records Failure" (Huffington Post, Dec. 5, 2010), Dr. Stephen B. Soumerai, Professor of Population Medicine at Harvard Medical School and Dr. Anthony Avery, Professor of Primary Care at the University of Nottingham Medical School, UK share familiar themes on health IT.

These themes will be especially familiar to HC Renewal readers and to my students and other readers of my Medical Informatics teaching website.

The professors wrote:

Fueled by the economic stimulus passed by Congress in 2008 [The ARRA a.k.a. "American Recovery and Reinvestment Act" and the HITECH legislation it contained - ed.], the federal government has embarked on a controversial $30 billion program to induce doctors throughout the country to adopt electronic health records (EHRs) by 2014. The purpose is to create an interconnected system of electronic health records to improve safety and reduce medical costs.

But the United Kingdom has spent the last 6 years working on the same idea, and it's proven to be a colossal failure -- so much so that the government is drastically cutting its program. What happened to their plan? Should we be paying attention before rushing ahead with our own?

My response to that question is clear, such as at my Nov. 2008 post "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" and the followup Jan. 2009 post "I Ask Again: Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" where I wrote:

$50 billion a year is big money that might be better spent elsewhere - such as providing care for the poor and for disadvantaged children - until we know how to get HIT right.

I suggest it may be best not to go all-out for HIT under the current paradigm. It is my belief, in fact, based on the above issues [UK and US issues - ed.] plus a chronic influx of HIT difficulty and mismanagement stories I hear from colleagues, ex-colleagues, recruiters, etc., that healthcare organizations not contractually obligated should consider a postponement of plans to purchase clinical IT (i.e., systems for direct use by clinicians such as EHR's).

This postponement should last at least until the issues that lead to ineffective and counterproductive HIT can be better understood and corrections initiated in the industry.

The professors further write:

In 2005 the United Kingdom embarked on the largest investment ($18 billion) in health information technology in the world. Yet despite expectations that the system would increase efficiency and reduce medical errors, their efforts neither improved health nor saved money -- in fact in some cases, they may have led to patient harm.

Britain's government-run medical system is obviously different from our complex public-private insurance system. [I had written that a smaller, socialized healthcare system should be far easier to automate than our own in the US - ed.] However, its electronic health record project bears an uncanny resemblance to the program President Obama is starting.

They then delineated a number of problems:

Too large and ambitious: The UK project tried to accomplish too much, too fast, attempting to digitize health records for the whole population in a period of four years. This massive undertaking is years behind schedule and has delivered only a fraction of what it promised. Despite all the money poured into the system, the vast majority of hospitals in the UK still don't have integrated electronic health records.

Why? The reasons sound familiar:

... Because non-clinicians developed the system, the electronic forms they designed have little to do with how doctors treat patients -- making it unworkable for many physicians. As the Chair of the British House of Commons Public Accounts Committee recently stated, "This is the biggest IT [Information Technology] project in the world and it is turning into the biggest disaster."

The "biggest IT disaster in the world" is not an honor I wish to see repeated in the U.S.

On another familiar problem:

Too dependent on commercial, proprietary companies: Rather than create one system and beta-test it, the UK government depended on four companies to build the system, two of which quit or were fired for missing deadlines. So the health records were never developed in the south of England. The computer software was secret and proprietary. There was no accountability to the public, and the vendors did not provide enough technical support to clinicians having trouble using the records.

The resulting software errors and crashes caused missing or incorrect clinical information and sometimes threatened patient safety, for example by causing surgical delays and the cancellation of hundreds of operations.

The inquiring mind would want to know about actual patient injuries and deaths that likely resulted from such problems...

The professors observe:

If a country like Britain -- which already has a national health system and is a fraction of the size of the US -- had so many problems with electronic health records, imagine the problems America would face.

This sounds like my comments in a public comment letter of March 9, 2010 to HHS/ONC (Re: RIN 0991-AB59, "Proposed Establishment of Certification Programs for Health Information Technology") where I wrote, among many other things:

... We ignore the UK experience at our peril, an experience in a medical environment smaller and far more government-controlled than our own.

... I believe that a rushed National Program for HIT in the United States will suffer the same fate as the aforementioned National Programme for IT in the UK, and perhaps even a worse fate as the UK’s socialized medicine system is certainly a smaller, more homogeneous and more controllable testbed environment for experimenting with HIT.

The professors relate:

Even our partial adaption of electronic health records is causing problems. Over the last couple of years, doctors and hospitals have reported to the FDA dozens of medical injuries -- including six deaths and preventable heart attacks -- caused by problems related to computerized health records such as software errors and unreadable computer screens. Some errors resulted in drug doses that were 10 times higher than intended. FDA officials called this the "tip of the iceberg."

I wrote about the FDA's findings here, and conducted a "thought experiment" regarding what those numbers might extrapolate out to in my April 2010 post "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers."

They continue:

... More than 50 medical organizations, including the AMA, have called on the Secretary of Health and Human Services to delay the program. In response, the administration delayed some of the required health IT functions, but kept the same 2014 deadline.

Indeed. They are courting disaster in my opinion, both clinically and financially, as I wrote in a Feb. 2009 Wall Street Journal letter to the editor entitled “Digitizing Medical Records May Help, but It's Complex”:

Dear WSJ,

You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.

I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.

For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors.

HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.

The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker.

I can only hope patients get something worthwhile for the $20 billion.

The professors then note:

How do we avoid the UK's failure? The administration or Congress should slow down the program and delete those parts of the legislation that fine doctors for not using this technology. There's no need to have this system in place by 2014. Instead, we should conduct rigorous studies of the cost-effectiveness of electronic health records systems before mandating their use. Rather than force doctors to choose from dozens of commercial software products developed in secret, we should take a hint from the non-commercial sector, such as the Veterans Administration, which uses "open-source" coding so people can work collaboratively to continuously improve the system.

Slowing down the program and performing rigorous studies of HIT before wide scale rollout are themes I raised, among other places, in my Dec. 2009 post "Tensions and Paradoxes in Electronic Patient Record Research: Critical Thinking on Health IT" where I wrote:

In conclusion, I believe this literature review supports the notion expressed in other studies and opinion pieces here and elsewhere that we really need to SLOW DOWN the current HIT stampede, largely promoted by the HIT industry lobby. We need to take the appropriate time to better understand how to "do HIT well" before plunging in as if we actually know what we're doing

as well as at my Oct. 2009 post "Washington Post Article: Electronic medical records not seen as a cure-all" where I wrote:

... The literature is indeed conflicting, and the need for rigorous scientific study has never been more essential considering the commitment of tens of billions of dollars towards health IT. The time for story telling, marketing based on opinion, name calling, leap-of-faith extrapolations of light year dimensions, and other forms of pseudoscience and non-science are over. The time for objective study is now.

The professors conclude:

The Obama administration wants government programs to be based on evidence of effectiveness. Simply following the lead of "IT believers" and salesmen without the requisite evidence will repeat the UK's failures. Now is the time to proceed carefully, consider existing research and the British experience, and chart a more rational course into the digital age of medicine.

I do not know if these two professors were familiar with my writings, but I am happy to see these themes (once treated as verboten and as grounds for marginalization by the HIT industry) increasingly going mainstream.

Patient well being - which includes you, dear readers - depends on that.

-- SS

Avatar fails. (No, not the Cameron movie, but yet another lousy EMR system implemented by amateurs.)

A story "Designed for Efficiency, New Computer Software at Health Dept. Misfires" by The Bay Citizen senior writer Katharine Mieszkowski appeared in the New York Times today regarding San Francisco's Dept. of Public Health.

"Misfires?"

That's a mild term indeed. In the realm of incendiary comments in the interest of patient care:

In this story, mental health and social workers, and the disadvantaged people suffering mental illness, drug addiction, etc. that these professionals attempt to raise up from misery one difficult step at a time, are being used as unconsenting experimental subjects and free software debuggers and beta testers:

This story follows a script very familiar to Medical Informatics professionals:

• Poorly designed and implemented healthcare IT causes clinical and other chaos;
• Vendor and implementation leaders claims "glitches" and "teething pains" and blame the users for inexperience and/or incompetence;
• Vendor promises relief in the "next version";
• These principals hope it all "goes away" until the system implodes on itself and needs replacement, starting the cycle anew, and/or-
• The principals hope newspapers stop paying attention to the chaos caused by the IT and the users simply surrender, and let the information systems control them, rather than the other way around.

Considering the patient population involved here, one might wonder if the project leaders have any more compassion than the machines they proffer:

New York Times
Designed for Efficiency, New Computer Software at Health Dept. Misfires
By KATHARINE MIESZKOWSKI
November 18, 2010 (from the Bay Citizen)

In July, the San Francisco Department of Public Health started using an $11.2 million electronic medical records system, Avatar, that was designed to streamline billing and improve care for tens of thousands of clients. Thus far, however, it has brought administrative chaos to the mental health and substance abuse services in the city.

Documents obtained by The Bay Citizen under a California Public Records Act request show that shortly after installing Avatar, providers struggled to use the new software, causing health officials to lose track of millions of dollars of services.

Officials are scrambling to fill in the missing data to meet deadlines to qualify for reimbursement from the state.

In addition to mere financial chaos:

... Problems related to the conversion to Avatar delayed for months the payment of about $450,000 to individual therapists, Anne Okubo, the health department’s deputy financial officer, told the San Francisco Health Commission on Tuesday night. The department was forced to use a third party to make the payments, which are still incomplete.

In addition, some therapists and social workers report that the demands of the new software have cut into the time they spend with patients, eroding the quality of care.

In an Aug. 19 e-mail headed “problems with Avatar,” Steven Schreibman, a social worker at Sunset Mental Health, a city-run clinic, wrote that the software required “excessive time charting and performing data entry” and had led to “shorter sessions with clients” and “delays in our capacity to accept new clients.” [This is not news to anyone familiar with poorly designed, mission hostile healthcare IT - ed.]

The customary excuses were presented. Growing pains, ignorant users:

Senior health department officials and Netsmart Technologies, Avatar’s developer, said the problems were glitches that were to be expected as the city made the transition to a more efficient record-keeping system.

“We knew it was going to be rough initially, because there is a learning curve,” said Jo Robinson, who heads the Community Health Behavioral Services division, where Avatar was introduced.

Kevin Scalia, a Netsmart Technologies executive vice president, said that he does not see this as a big problem. “From our point of view,” he said, “everything is going swimmingly.” [Translation - they're making good money - ed.]

Here's the key passage:

Department managers told the Health Commission that Avatar would lead to “improved client care” and had “positive fiscal impacts,” but they acknowledged there had been problems.

In September, the department compared the cost of mental health and substance services reported by the hospital, clinics and organizations in March, before the software was put into use, to those reported in July using the new system.

The data showed that the mental health services reported had plunged 55 percent. Substance abuse services reported fell 32 percent. The large discrepancies caused alarm because they indicated that providers were having problems using the software, according to documents and interviews. [I can also predict they've had problems _providing_ those services under the time duress added by the software - ed.]

As someone who was once a Medical Review Officer for drug testing in the public transit industry, and a colleague of the company's Employee Assistance Program liaison, I can assure readers that implementation of health IT will not effect a one-third reduction in drug abuse problems and recidivism.

After a month of use:

A month later, as more providers gained access and proficiency with the software, the picture improved, but significant discrepancies remained.

Some data modeling issues are apparent:

But some organizations worry that the services they are providing will not be fully reflected in the new system.

Here's a reverse twist on HIT vendor "Hold Harmless" clauses:

At the Health Commission meeting, Estela Garcia, executive director of the Instituto Familiar de la Raza, a community organization that provides mental health services, asked the commission to protect organizations like hers from any financial liability related to Avatar.

“I want a hold-harmless policy until the system is fully up and running,” Ms. Garcia said.

How long that will take is unclear. One mental health program director, who would not allow his name to be used because it could jeopardize his relationship with the department, said his staff had gone to repeated training sessions to try to get up to speed.

“Avatar turns out to be a total disaster,” the program director said. “What is going to happen to contracted agencies if their billing is short at the end of the fiscal year as compared to the terms of their contract, because they can’t master Avatar?”

As in typical in health IT, system users are afraid to speak candidly:

A psychologist who works with a community organization under contract to the city, who spoke on the condition of anonymity because he was afraid of losing his job, said he used to do all his charting and billing on paper and was told that the new system would be more efficient. So far, that has not proved to be the case, he said.

“We are seeing the same number of patients,” he said, “but we are providing substantially less service to them, because the time we are now spending just to do the billing alone, not to mention the record keeping, it’s become the majority of our time.”

Labor unions are taking a look:

Greg Cross, a field representative for Service Employees International Union Local 1021, which represents hundreds of social workers, psychologists and counselors who work for the city, said he had met with officials to discuss Avatar’s impact on workload as well as performance expectations.

I invite SEIU Local 1021 and national SEIU leaders to read this blog, and review my academic site on HIT failure here, to better understand why these debacles repeatedly occur.

At the Health Commission meeting, Fred McGregor, the health department’s senior information technology manager for community programs, said that the department was aware that providers find the demands of Avatar “a little onerous” and that it was working on a redesign to make clinical assessment more efficient.

A "little onerous"?

"Working on a redesign to make clinical assessment more efficient"?

What about getting it right the first time, based on the significant amount of literature that exists on proper IT design?

I, for one, am tired of hearing this corporate mumbo-jumbo every time another health IT system impairs users.

What is needed here is a full scale investigation and evaluation of the competence and expertise of the project leaders, designers, and implementers to be experimenting in the complex field of healthcare information technology.

Mr. Schreibman, the social worker, made it clear in his August e-mail that change was needed quickly.

“The kind and amount of work skill involved using this software represents a change in our job description,” he wrote. “This is not the job we accepted when we chose to do clinical work for the city.”

In other words, they did not accept a job as data entry clerks and directors of workarounds to the mission hostile user experience presented by poorly designed healthcare information systems.

I note that missing in this story are the human tragedies (such as pain & suffering, injury, death) these IT "glitches" may have caused.

Until the memes of complete health IT beneficence and "anyone can do it" are soundly pounded into the ground and out of the heads of hapless politicians, healthcare leaders, and IT personnel, this type of mishap will continue.

Sadly, health IT mishaps are likely to be occurring on a national scale, soon, in a neighborhood near you, thanks to the timelines and penalties expounded in the HITECH act. HITECH was an integral part of the legislation known as the ARRA (American Recovery and Reinvestment Act of 2009).

-- SS

Avatar fails. (No, not the Cameron movie, but yet another lousy EMR system implemented by amateurs.)

A story "Designed for Efficiency, New Computer Software at Health Dept. Misfires" by The Bay Citizen senior writer Katharine Mieszkowski appeared in the New York Times today regarding San Francisco's Dept. of Public Health.

"Misfires?"

That's a mild term indeed. In the realm of incendiary comments in the interest of patient care:

In this story, mental health and social workers, and the disadvantaged people suffering mental illness, drug addiction, etc. that these professionals attempt to raise up from misery one difficult step at a time, are being used as unconsenting experimental subjects and free software debuggers and beta testers:

This story follows a script very familiar to Medical Informatics professionals:

• Poorly designed and implemented healthcare IT causes clinical and other chaos;
• Vendor and implementation leaders claims "glitches" and "teething pains" and blame the users for inexperience and/or incompetence;
• Vendor promises relief in the "next version";
• These principals hope it all "goes away" until the system implodes on itself and needs replacement, starting the cycle anew, and/or-
• The principals hope newspapers stop paying attention to the chaos caused by the IT and the users simply surrender, and let the information systems control them, rather than the other way around.

Considering the patient population involved here, one might wonder if the project leaders have any more compassion than the machines they proffer:

New York Times
Designed for Efficiency, New Computer Software at Health Dept. Misfires
By KATHARINE MIESZKOWSKI
November 18, 2010 (from the Bay Citizen)

In July, the San Francisco Department of Public Health started using an $11.2 million electronic medical records system, Avatar, that was designed to streamline billing and improve care for tens of thousands of clients. Thus far, however, it has brought administrative chaos to the mental health and substance abuse services in the city.

Documents obtained by The Bay Citizen under a California Public Records Act request show that shortly after installing Avatar, providers struggled to use the new software, causing health officials to lose track of millions of dollars of services.

Officials are scrambling to fill in the missing data to meet deadlines to qualify for reimbursement from the state.

In addition to mere financial chaos:

... Problems related to the conversion to Avatar delayed for months the payment of about $450,000 to individual therapists, Anne Okubo, the health department’s deputy financial officer, told the San Francisco Health Commission on Tuesday night. The department was forced to use a third party to make the payments, which are still incomplete.

In addition, some therapists and social workers report that the demands of the new software have cut into the time they spend with patients, eroding the quality of care.

In an Aug. 19 e-mail headed “problems with Avatar,” Steven Schreibman, a social worker at Sunset Mental Health, a city-run clinic, wrote that the software required “excessive time charting and performing data entry” and had led to “shorter sessions with clients” and “delays in our capacity to accept new clients.” [This is not news to anyone familiar with poorly designed, mission hostile healthcare IT - ed.]

The customary excuses were presented. Growing pains, ignorant users:

Senior health department officials and Netsmart Technologies, Avatar’s developer, said the problems were glitches that were to be expected as the city made the transition to a more efficient record-keeping system.

“We knew it was going to be rough initially, because there is a learning curve,” said Jo Robinson, who heads the Community Health Behavioral Services division, where Avatar was introduced.

Kevin Scalia, a Netsmart Technologies executive vice president, said that he does not see this as a big problem. “From our point of view,” he said, “everything is going swimmingly.” [Translation - they're making good money - ed.]

Here's the key passage:

Department managers told the Health Commission that Avatar would lead to “improved client care” and had “positive fiscal impacts,” but they acknowledged there had been problems.

In September, the department compared the cost of mental health and substance services reported by the hospital, clinics and organizations in March, before the software was put into use, to those reported in July using the new system.

The data showed that the mental health services reported had plunged 55 percent. Substance abuse services reported fell 32 percent. The large discrepancies caused alarm because they indicated that providers were having problems using the software, according to documents and interviews. [I can also predict they've had problems _providing_ those services under the time duress added by the software - ed.]

As someone who was once a Medical Review Officer for drug testing in the public transit industry, and a colleague of the company's Employee Assistance Program liaison, I can assure readers that implementation of health IT will not effect a one-third reduction in drug abuse problems and recidivism.

After a month of use:

A month later, as more providers gained access and proficiency with the software, the picture improved, but significant discrepancies remained.

Some data modeling issues are apparent:

But some organizations worry that the services they are providing will not be fully reflected in the new system.

Here's a reverse twist on HIT vendor "Hold Harmless" clauses:

At the Health Commission meeting, Estela Garcia, executive director of the Instituto Familiar de la Raza, a community organization that provides mental health services, asked the commission to protect organizations like hers from any financial liability related to Avatar.

“I want a hold-harmless policy until the system is fully up and running,” Ms. Garcia said.

How long that will take is unclear. One mental health program director, who would not allow his name to be used because it could jeopardize his relationship with the department, said his staff had gone to repeated training sessions to try to get up to speed.

“Avatar turns out to be a total disaster,” the program director said. “What is going to happen to contracted agencies if their billing is short at the end of the fiscal year as compared to the terms of their contract, because they can’t master Avatar?”

As in typical in health IT, system users are afraid to speak candidly:

A psychologist who works with a community organization under contract to the city, who spoke on the condition of anonymity because he was afraid of losing his job, said he used to do all his charting and billing on paper and was told that the new system would be more efficient. So far, that has not proved to be the case, he said.

“We are seeing the same number of patients,” he said, “but we are providing substantially less service to them, because the time we are now spending just to do the billing alone, not to mention the record keeping, it’s become the majority of our time.”

Labor unions are taking a look:

Greg Cross, a field representative for Service Employees International Union Local 1021, which represents hundreds of social workers, psychologists and counselors who work for the city, said he had met with officials to discuss Avatar’s impact on workload as well as performance expectations.

I invite SEIU Local 1021 and national SEIU leaders to read this blog, and review my academic site on HIT failure here, to better understand why these debacles repeatedly occur.

At the Health Commission meeting, Fred McGregor, the health department’s senior information technology manager for community programs, said that the department was aware that providers find the demands of Avatar “a little onerous” and that it was working on a redesign to make clinical assessment more efficient.

A "little onerous"?

"Working on a redesign to make clinical assessment more efficient"?

What about getting it right the first time, based on the significant amount of literature that exists on proper IT design?

I, for one, am tired of hearing this corporate mumbo-jumbo every time another health IT system impairs users.

What is needed here is a full scale investigation and evaluation of the competence and expertise of the project leaders, designers, and implementers to be experimenting in the complex field of healthcare information technology.

Mr. Schreibman, the social worker, made it clear in his August e-mail that change was needed quickly.

“The kind and amount of work skill involved using this software represents a change in our job description,” he wrote. “This is not the job we accepted when we chose to do clinical work for the city.”

In other words, they did not accept a job as data entry clerks and directors of workarounds to the mission hostile user experience presented by poorly designed healthcare information systems.

I note that missing in this story are the human tragedies (such as pain & suffering, injury, death) these IT "glitches" may have caused.

Until the memes of complete health IT beneficence and "anyone can do it" are soundly pounded into the ground and out of the heads of hapless politicians, healthcare leaders, and IT personnel, this type of mishap will continue.

Sadly, health IT mishaps are likely to be occurring on a national scale, soon, in a neighborhood near you, thanks to the timelines and penalties expounded in the HITECH act. HITECH was an integral part of the legislation known as the ARRA (American Recovery and Reinvestment Act of 2009).

-- SS

Hoffman and Podgurski: A relatively lawless industry and "meaningful use" of health IT, with safety as an afterthought

In their article "Meaningful Use and Certification of Health Information Technology: What About Safety?" (free PDF here), Sharona Hoffman (Professor of Law and Bioethics and Co‐Director of the Law‐Medicine Center, Case Western Reserve University School of Law) and Andy Podgurski (Professor of Electrical Engineering and Computer Science, Case Western Reserve) make an important case for what I've previously described as "putting the cart before the horse."

At my Oct. 1, 2010 post "Cart before the horse, again: IOM to study HIT patient safety for ONC" I argued that the IOM was only called in to study HIT safety after plans for national rollout were put into law, and a "stimulus to adoption" (with penalties for refusniks) financed at the cost of tens of billions of dollars.

I found this approach to HIT and the sequencing of events - the development of "meaningful use" criteria before usability and safety criteria - quite cavalier.

Hoffman and Podgurski go a step further.

They begin:

In the summer of 2010, the Department of Health and Human Services (HHS) published three sets of regulations to implement ARRA. This article briefly describes and critiques the regulations, arguing that (1) they fail to appropriately address HIT safety and (2) further steps must be taken to protect patients and serve public health needs in the new digital era.

After a brief review of the Meaningful Use and "Certification" (a.k.a. features qualification) regulations and programs, they go on to critique those regulations and programs as a "step towards comprehensive oversight", but a very deficient step considering the ambitions and timelines of the HITECH act and the federal government.

They aptly note (along with with footnotes):

... While advocates argue that computerization will reduce errors, numerous recent reports have demonstrated that the opposite can be true. Hospitals have experienced incidents in which doctors’ orders were posted to the wrong patient charts and electronic drug orders were not delivered to nurses who needed to dispense them to patients. A published 2009 review of almost 56,000 CPOE prescriptions found that approximately 1% of them contained errors. Patients who do not receive needed medication or whose treatment is otherwise mismanaged because of software or usability problems can suffer catastrophic consequences [my own mother is sadly familiar with this latter problem - ed.]

General system safety is a property that is attainable only through rigorous processes for development and evaluation. [Evaluations of the kind the healthcare IT industry seems to have steadfastly circumvented and avoided - ed.]

However, the regulations do not address certification of EHR vendors’ software development processes or even require vendors to analyze and mitigate potential safety hazards. [In other words, they are essentially meaningless in terms of HIT safety - ed.]

Furthermore, ATCBs [ONC 'Authorized Testing and Certification Bodies'] will use testing requirements developed by the National Institute of Standards and Technology (NIST) that are apparently intended only to determine whether systems include certain features. Passing such tests is not sufficient to ensure that those features function properly in the long term and under varied operating conditions. [In other words, a preflight checklist will be conducted of aircraft that have rarely or never actually flown, to declare them flight ready for the amateur pilot - ed.]

They note the obvious:

Meticulous testing of EHR products is critical to their safety. Because of the government’s lucrative incentive payments, many new vendors may attempt to enter the market and to quickly produce EHR systems whose quality is unproven and perhaps dubious.

A key passage in this article is this:

Admittedly, clinical evaluation of new products poses challenges for vendors who would need to find facilities willing to accept the administrative burdens of assessing systems that may ultimately fail. [In other words, it will cost them to improve the safety of their products, a core competency they should have developed decades ago - ed.]

Such facilities would also experience delays in receiving incentive payments because they would use uncertified systems during the evaluation period. However, certification of HIT that has not been thoroughly evaluated is no more responsible than approval of medications or devices that have not been carefully scrutinized by the FDA

"No more responsible than approval of medications not scrutinized by FDA" is quite on target. I personally would use a stronger term than deficient responsibility, however: deliberate reckless indifference to health IT safety seems more descriptive.

The authors do note that:

The delegation of EHR approval responsibilities to ATCBs will ease HHS’s regulatory burdens and likely supply an adequate pool of experts for HIT testing. HHS is authorized to monitor ATCBs through on‐site visits, reports, and review of documentation. It remains to be seen if these measures will ensure that ATCB members are qualified, competent, and free of conflict of interest. These issues will become more critical if HHS eventually requires rigorous clinical testing of EHR systems as described above.

Considering the track record of the pharma and medical device industries as presented in many case examples at this blog, "qualified, competent, and free of conflict of interest" is a tall order indeed for the health IT industry and its "certifiers."

The authors again state the obvious (albeit an "inconvenient truth"):

... it is naive to assume that any use of HIT is better than no use of HIT. [This warning echoes the "use equals success" fallacy as described by Karsh et al. in their recent JAMIA article described here - ed.]

EHR systems constitute complex technology that can introduce errors as well as prevent them. Medical errors can occur because of computer bugs, computer shut‐downs, or user mistakes that may be attributable to a flawed user interface. Through communication tools, electronic ordering, decision support features, and data management, EHR systems will guide many aspects of patient care. Treatment success will often depend on their proper functioning.

They conclude:

HHS’ new regulations constitute positive first steps and a laudable reversal of a relatively lawless approach to EHR system design and deployment. Previously, the only certification program was offered by the Certification Commission for Health Information Technology, a private industry group that was not subject to regulation.

I used terms such as "wild west", "out of control" and "pre-Flexnerian" to describe the HIT industry. That an attorney would use the term "lawless" seems quite fitting to describe similar observations.

Finally, they state:

Still, much more work must be done to protect public health in the digital era. We urge that future meaningful use and certification criteria and the post‐2011 permanent certification program be more attentive to safety issues.

EHR system approval should be no less rigorous than the FDA’s process for drug and device approval because HIT is as safety‐critical for patients. A prime criterion for certification should be a documented history of safe operations in a number of clinical environments.

The federal government would be wise to focus less on the speed of EHR adoption and more on product quality. Only through sufficient safeguards for EHR system safety can this technology fulfill its promise to dramatically improve individual and public health outcomes.

In my opinion, the HITECH timelines are far too ambitious (I sense a similar sentiment "between the lines" in the above passage). Perhaps it's time for those timelines to be revisited.

A new Congress should take that on, or defund HITECH and rewrite it to prevent patient harm and AHLTA and UK NPfIT-like debacles, to save billions of taxpayer dollars we really don't have to spare at the moment.

-- SS

Hoffman and Podgurski: A relatively lawless industry and "meaningful use" of health IT, with safety as an afterthought

In their article "Meaningful Use and Certification of Health Information Technology: What About Safety?" (free PDF here), Sharona Hoffman (Professor of Law and Bioethics and Co‐Director of the Law‐Medicine Center, Case Western Reserve University School of Law) and Andy Podgurski (Professor of Electrical Engineering and Computer Science, Case Western Reserve) make an important case for what I've previously described as "putting the cart before the horse."

At my Oct. 1, 2010 post "Cart before the horse, again: IOM to study HIT patient safety for ONC" I argued that the IOM was only called in to study HIT safety after plans for national rollout were put into law, and a "stimulus to adoption" (with penalties for refusniks) financed at the cost of tens of billions of dollars.

I found this approach to HIT and the sequencing of events - the development of "meaningful use" criteria before usability and safety criteria - quite cavalier.

Hoffman and Podgurski go a step further.

They begin:

In the summer of 2010, the Department of Health and Human Services (HHS) published three sets of regulations to implement ARRA. This article briefly describes and critiques the regulations, arguing that (1) they fail to appropriately address HIT safety and (2) further steps must be taken to protect patients and serve public health needs in the new digital era.

After a brief review of the Meaningful Use and "Certification" (a.k.a. features qualification) regulations and programs, they go on to critique those regulations and programs as a "step towards comprehensive oversight", but a very deficient step considering the ambitions and timelines of the HITECH act and the federal government.

They aptly note (along with with footnotes):

... While advocates argue that computerization will reduce errors, numerous recent reports have demonstrated that the opposite can be true. Hospitals have experienced incidents in which doctors’ orders were posted to the wrong patient charts and electronic drug orders were not delivered to nurses who needed to dispense them to patients. A published 2009 review of almost 56,000 CPOE prescriptions found that approximately 1% of them contained errors. Patients who do not receive needed medication or whose treatment is otherwise mismanaged because of software or usability problems can suffer catastrophic consequences [my own mother is sadly familiar with this latter problem - ed.]

General system safety is a property that is attainable only through rigorous processes for development and evaluation. [Evaluations of the kind the healthcare IT industry seems to have steadfastly circumvented and avoided - ed.]

However, the regulations do not address certification of EHR vendors’ software development processes or even require vendors to analyze and mitigate potential safety hazards. [In other words, they are essentially meaningless in terms of HIT safety - ed.]

Furthermore, ATCBs [ONC 'Authorized Testing and Certification Bodies'] will use testing requirements developed by the National Institute of Standards and Technology (NIST) that are apparently intended only to determine whether systems include certain features. Passing such tests is not sufficient to ensure that those features function properly in the long term and under varied operating conditions. [In other words, a preflight checklist will be conducted of aircraft that have rarely or never actually flown, to declare them flight ready for the amateur pilot - ed.]

They note the obvious:

Meticulous testing of EHR products is critical to their safety. Because of the government’s lucrative incentive payments, many new vendors may attempt to enter the market and to quickly produce EHR systems whose quality is unproven and perhaps dubious.

A key passage in this article is this:

Admittedly, clinical evaluation of new products poses challenges for vendors who would need to find facilities willing to accept the administrative burdens of assessing systems that may ultimately fail. [In other words, it will cost them to improve the safety of their products, a core competency they should have developed decades ago - ed.]

Such facilities would also experience delays in receiving incentive payments because they would use uncertified systems during the evaluation period. However, certification of HIT that has not been thoroughly evaluated is no more responsible than approval of medications or devices that have not been carefully scrutinized by the FDA

"No more responsible than approval of medications not scrutinized by FDA" is quite on target. I personally would use a stronger term than deficient responsibility, however: deliberate reckless indifference to health IT safety seems more descriptive.

The authors do note that:

The delegation of EHR approval responsibilities to ATCBs will ease HHS’s regulatory burdens and likely supply an adequate pool of experts for HIT testing. HHS is authorized to monitor ATCBs through on‐site visits, reports, and review of documentation. It remains to be seen if these measures will ensure that ATCB members are qualified, competent, and free of conflict of interest. These issues will become more critical if HHS eventually requires rigorous clinical testing of EHR systems as described above.

Considering the track record of the pharma and medical device industries as presented in many case examples at this blog, "qualified, competent, and free of conflict of interest" is a tall order indeed for the health IT industry and its "certifiers."

The authors again state the obvious (albeit an "inconvenient truth"):

... it is naive to assume that any use of HIT is better than no use of HIT. [This warning echoes the "use equals success" fallacy as described by Karsh et al. in their recent JAMIA article described here - ed.]

EHR systems constitute complex technology that can introduce errors as well as prevent them. Medical errors can occur because of computer bugs, computer shut‐downs, or user mistakes that may be attributable to a flawed user interface. Through communication tools, electronic ordering, decision support features, and data management, EHR systems will guide many aspects of patient care. Treatment success will often depend on their proper functioning.

They conclude:

HHS’ new regulations constitute positive first steps and a laudable reversal of a relatively lawless approach to EHR system design and deployment. Previously, the only certification program was offered by the Certification Commission for Health Information Technology, a private industry group that was not subject to regulation.

I used terms such as "wild west", "out of control" and "pre-Flexnerian" to describe the HIT industry. That an attorney would use the term "lawless" seems quite fitting to describe similar observations.

Finally, they state:

Still, much more work must be done to protect public health in the digital era. We urge that future meaningful use and certification criteria and the post‐2011 permanent certification program be more attentive to safety issues.

EHR system approval should be no less rigorous than the FDA’s process for drug and device approval because HIT is as safety‐critical for patients. A prime criterion for certification should be a documented history of safe operations in a number of clinical environments.

The federal government would be wise to focus less on the speed of EHR adoption and more on product quality. Only through sufficient safeguards for EHR system safety can this technology fulfill its promise to dramatically improve individual and public health outcomes.

In my opinion, the HITECH timelines are far too ambitious (I sense a similar sentiment "between the lines" in the above passage). Perhaps it's time for those timelines to be revisited.

A new Congress should take that on, or defund HITECH and rewrite it to prevent patient harm and AHLTA and UK NPfIT-like debacles, to save billions of taxpayer dollars we really don't have to spare at the moment.

-- SS