New York Times: Panel Set to Study Safety of Electronic Patient Data

New York Times author Milt Freudenheim has published an interesting article on health IT:

"Panel Set to Study Safety of Electronic Patient Data" (Dec. 13, 2010, link)

In the article Mr. Freudenheim presents various viewpoints on health IT safety and usability, and reports on an upcoming Institute of Medicine (IOM) Committee on Healthcare IT safety.

In general, the expressed viewpoints reported upon are consistent with the position in the Healthcare IT Ecosystem of those quoted. I wish to add some commentary to a number of those stated positions.

Mr. Freudenheim observes:

Taking a fresh look at such concerns, the Institute of Medicine created the Committee on Patient Safety and Health Information Technology to run a yearlong study and issue recommendations. The 16-member panel is meeting for the first time on Tuesday in Washington.

(This new IOM Committee is in addition to a 2009 study by the National Academies/National Research Council that concluded that "Current Approaches to U.S. Health Care Information Technology are Insufficient", which has largely been invisible. The IOM is the health arm of the National Academies.)

I would add that this Committee is at least a decade late. That it is occurring at all seems to be at the behest of a multitude of complaints and "blows of the whistle" from clinicians who increasingly depend (either voluntarily or by coercion) on this technology to provide safe care.

I would also add that it is my hope the IOM committee with not be overly politicized, considering the stated unconditional exuberance of the past two administrations towards health IT, and that a wide variety of stakeholders will be heard. (For instance, as a medical informatics specialist whose mother was injured as a result of HIT interference with clinician communications, will I be allowed to testify?)

Mr. Freudenheim then relates the points of view of stakeholders.

In February, the F.D.A. said it had received 260 reports of malfunctions related to health information technology “with the potential for patient harm,” including 44 reported injuries and six reported deaths in 2008 and 2009. The malfunctions were reported voluntarily to the agency, mainly by hospitals.

“Because these reports are purely voluntary, they may represent only the tip of the iceberg,” said Dr. Jeffrey Shuren, a senior F.D.A. policy and enforcement official.

I'd written about this at "FDA on Health IT Adverse Consequences: 44 Reported Injuries and 6 Deaths, Probably Just Tip of Iceberg" where I noted:

This is a technology almost universally touted as inherently beneficial, right up to our most senior elected leaders, who are now pushing this unproven technology under threat of penalty for non-adopters.

Healthcare IT irrational exuberance can perhaps be illustrated in statements such as this:

“We have the capacity to transform health with one thunderous click of a mouse after another,” said (former) HHS Secretary Michael Leavitt - 2005 HIMSS Summit

I also opined at "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers" that one could, as a type of thought experiment, extrapolate from these numbers to guesstimate the effects of universal health IT in the US. The results were startling, even if just an experiment:

[We might have] 880,000 injuries per year, 120,000 deaths when universal HIT use is achieved ... While this is a mere thought experiment, the result certainly suggests we need to know the actual rates of HIT-related patient harm, and act to understand and minimize these events.

In setting national healthcare policy, we should not rely on thought experiments - but even more importantly, we should not be relying on guesswork and wishful thinking as we are currently.

Unfortunately, national policy has been set up to now on wishful thinking. As I stated, the IOM meeting is coming none too soon.

The NYT article then reports on a statement made by ONC Chair David Blumenthal:

“All options for assuring safety are on the table,” said Dr. David Blumenthal, the Obama administration’s national coordinator for health information technology.

Yet Dr. Blumenthal is clearly an adherent to unbridled exuberance about health IT. At "Science or Politics? The New England Journal and the 'Meaningful Use' Regulation for Electronic Health Records" I wrote:

... In the NEJM article "The 'Meaningful Use' Regulation for Electronic Health Records", David Blumenthal, M.D., M.P.P. (ONC Chair) and Marilyn Tavenner, R.N., M.H.A. (10.1056/NEJMp1006114, July 13, 2010) available at this link, the opening statement is (emphases mine):

The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

I think it fair to say those are grandiose statements and predictions presented with a tone of utmost certainty in one of the world's most respected scientific medical journals.

Even though it is a "perspectives" article, I once long ago learned that in writing in esteemed scientific journals of worldwide impact, statements of certainty were at best avoided, or if made should be exceptionally well referenced.

I note the lack of footnotes showing the source(s) of these statements.

I also note the lack of mention of literature refuting or potentially refuting these statements of certainty. [Followed by a list of such literature just off the top of my head - ed.]

Dr. Blumenthal then appeals to authority:

Dr. Blumenthal said health information experts like Dr. Donald M. Berwick, the Medicare and Medicaid administrator, and Dr. Brent James, of Intermountain Healthcare, based in Salt Lake City, “agree that electronic health records will improve the safety of care.”

I am unaware of the expertise of Dr. Berwick and Dr. James in this domain, and the peer reviewed literature they've written that supports such a statement while soundly refuting literature written by other experts that indicates otherwise.

(Perhaps at Intermountain, custom systems that took decades to develop utilizing their Medical Informatics expertise do show safety gains, but such systems and the lessons learned building them are not easily portable to a country's worth of organizations and practitioners, especially under HITECH timeframes.)

Freudenheim then quotes Blumenthal as stating:

“At the same time, any time you change the world you create risks,” Dr. Blumenthal said in a telephone interview last weekend.

This sounds typical of utopian ideology. Yes, any time you change the world you create risks, but you should not attempt to change the world cavalierly and blindly to those risks. (That's the path the National Program for Health IT in the United States has been on, until the IOM meeting was called.) Idealists tend to believe the collateral damage that is caused by utopian experiments (e.g., communism) are a necessary sacrifice to achieve the utopia. Such values are both abhorrent and alien to medicine.

“We want to make sure that implementation is as safe as it can be and all safety benefits are realized.”

Blumenthal's been painted into a corner by tons of complaints on HIT safety; ONC must act, even if just putting on a show about safety considerations. If there were true concern for safety he'd recommend slowing down HITECH timelines until the industry gets its act together and our understanding of HIT usability, safety, and other issues is resolved; cf.: statements of HIMSS leaders on 'needing to be patient' for the industry to get healthcare IT right:

As I'd written about HIMSS admissions of health IT unsuitability to task at "NIST Provides Healthcare IT Industry with Remedial Undergraduate Computer Science Education":

... What have been their product design and development practices, such that leaders of their own trade group HIMSS (as I pointed out in other posts) opine we should be "patient" for them to figure it all out about how to do health IT better and they need more time, and that the technology does not support its users properly due to lack of efficiency and usability of EMRs currently available? (As at my July 2010 post "The National Program for Healthcare IT in the U.S., and the Elephant in the Living Room".)

Further, from the NYT article:

He [Blumenthal] said that if the Institute of Medicine “concludes that regulation is an important part of this fabric of assuring safety, we will want to balance regulation and innovation as we do in every marketplace.”

That he even needs to make such a statement is likely revealing of biases on regulation, which seem aligned to the industry. To wit:

“The policing of design by a third party or agency, however well intended, will likely stifle innovation and inhibit the growth and development of electronic health records in the future,” said Carl Dvorak, executive vice president of Epic Systems, which has built electronic records systems for Kaiser Permanente and other large health care and hospital groups.

There is a lack of evidence supporting such a statement (e.g., pharma has been regulated for decades, as is its clinical IT). The fact that NIST has just delivered Computer Science 101-level usability guidelines to the HIT industry in its recent report “NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records” to help solve the HIT unusability crisis also suggests that 30+ years of un-regulation did not facilitate ‘innovation.’

In fact 'unregulation' appears to have led to prima facie innovation failure and paralysis as far as usability is concerned.

Unusable health IT might as well not exist as far as clinicians are concerned. It is a menace to the safe practice of medicine. This is a first principle.

Per the NYT, the industry trade group HIMSS has gone mum:

The industry has recently avoided speaking out on a role for the F.D.A. In a statement for this article, the Healthcare Information and Management Systems Society, a Washington-based industry group, said only that it “supports the administration’s decision to ask the Institute of Medicine to study this complex issue and report back over the next 12 months.”

They are certainly not taking a leadership role on this issue. In my humble opinion they will allow regulation, only kicking and screaming and being dragged into it by force. Patients come second to profits - the only factor that will be "stifled" as vendors are coerced to make better products.

The NYT article goes on:

Last month, in protest of one common industry practice, the American Medical Informatics Association said “hold harmless” clauses in many purchasing contracts were unethical. The clauses typically absolve manufacturers of responsibility for any errors or misuse.

“We said we value innovation, but we don’t value it more than safety,” said Kenneth W. Goodman, a University of Miami bioethicist who headed an association advisory group on patient safety.

It took a lot of writing and politicking to get AMIA to this point as well, at least to express it openly (cf.: my efforts here).

Finally, with regard to the IOM meetings on HIT safety, there will be industry stakeholders in attendance such as CCHIT and EPIC.

I believe they should be held to scientific standards of delivery. If they deliver marketing-based spin, they should be called to present scientific evidence for their stance – and not just “positive” evidence. They should be made to refute “negative” evidence as well, not ignore it.

In summary, I welcome the New York Times bringing these issues to the public.

I also welcome IOM's entry into studying HIT safety. While a "Committee on Patient Safety and Health Information Technology" should have been convened years ago, it's better late than never. (Except for patients already injured or killed, of course.)

The results may remain as invisible as the aforementioned National Research Council study. I also doubt the Committee's findings will change hearts and minds. Idealism, profit motive, and irrational exuberance are hard to rectify.

But their effects on people's behaviors can - and should - be regulated.

-- SS

Addendum Dec. 17:

Healthcare Renewal blog to IOM: I have the information of the type you apparently seek on HIT-related injury. My Drexel Univ. site on HIT failures that's been around since 1999 comes up in the first few hits of Google searches on that subject, and has a banner at the top about my mother:

(click to enlarge, or go to site)

Anyone at IOM listening?

-- SS

New York Times: Panel Set to Study Safety of Electronic Patient Data

New York Times author Milt Freudenheim has published an interesting article on health IT:

"Panel Set to Study Safety of Electronic Patient Data" (Dec. 13, 2010, link)

In the article Mr. Freudenheim presents various viewpoints on health IT safety and usability, and reports on an upcoming Institute of Medicine (IOM) Committee on Healthcare IT safety.

In general, the expressed viewpoints reported upon are consistent with the position in the Healthcare IT Ecosystem of those quoted. I wish to add some commentary to a number of those stated positions.

Mr. Freudenheim observes:

Taking a fresh look at such concerns, the Institute of Medicine created the Committee on Patient Safety and Health Information Technology to run a yearlong study and issue recommendations. The 16-member panel is meeting for the first time on Tuesday in Washington.

(This new IOM Committee is in addition to a 2009 study by the National Academies/National Research Council that concluded that "Current Approaches to U.S. Health Care Information Technology are Insufficient", which has largely been invisible. The IOM is the health arm of the National Academies.)

I would add that this Committee is at least a decade late. That it is occurring at all seems to be at the behest of a multitude of complaints and "blows of the whistle" from clinicians who increasingly depend (either voluntarily or by coercion) on this technology to provide safe care.

I would also add that it is my hope the IOM committee with not be overly politicized, considering the stated unconditional exuberance of the past two administrations towards health IT, and that a wide variety of stakeholders will be heard. (For instance, as a medical informatics specialist whose mother was injured as a result of HIT interference with clinician communications, will I be allowed to testify?)

Mr. Freudenheim then relates the points of view of stakeholders.

In February, the F.D.A. said it had received 260 reports of malfunctions related to health information technology “with the potential for patient harm,” including 44 reported injuries and six reported deaths in 2008 and 2009. The malfunctions were reported voluntarily to the agency, mainly by hospitals.

“Because these reports are purely voluntary, they may represent only the tip of the iceberg,” said Dr. Jeffrey Shuren, a senior F.D.A. policy and enforcement official.

I'd written about this at "FDA on Health IT Adverse Consequences: 44 Reported Injuries and 6 Deaths, Probably Just Tip of Iceberg" where I noted:

This is a technology almost universally touted as inherently beneficial, right up to our most senior elected leaders, who are now pushing this unproven technology under threat of penalty for non-adopters.

Healthcare IT irrational exuberance can perhaps be illustrated in statements such as this:

“We have the capacity to transform health with one thunderous click of a mouse after another,” said (former) HHS Secretary Michael Leavitt - 2005 HIMSS Summit

I also opined at "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers" that one could, as a type of thought experiment, extrapolate from these numbers to guesstimate the effects of universal health IT in the US. The results were startling, even if just an experiment:

[We might have] 880,000 injuries per year, 120,000 deaths when universal HIT use is achieved ... While this is a mere thought experiment, the result certainly suggests we need to know the actual rates of HIT-related patient harm, and act to understand and minimize these events.

In setting national healthcare policy, we should not rely on thought experiments - but even more importantly, we should not be relying on guesswork and wishful thinking as we are currently.

Unfortunately, national policy has been set up to now on wishful thinking. As I stated, the IOM meeting is coming none too soon.

The NYT article then reports on a statement made by ONC Chair David Blumenthal:

“All options for assuring safety are on the table,” said Dr. David Blumenthal, the Obama administration’s national coordinator for health information technology.

Yet Dr. Blumenthal is clearly an adherent to unbridled exuberance about health IT. At "Science or Politics? The New England Journal and the 'Meaningful Use' Regulation for Electronic Health Records" I wrote:

... In the NEJM article "The 'Meaningful Use' Regulation for Electronic Health Records", David Blumenthal, M.D., M.P.P. (ONC Chair) and Marilyn Tavenner, R.N., M.H.A. (10.1056/NEJMp1006114, July 13, 2010) available at this link, the opening statement is (emphases mine):

The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

I think it fair to say those are grandiose statements and predictions presented with a tone of utmost certainty in one of the world's most respected scientific medical journals.

Even though it is a "perspectives" article, I once long ago learned that in writing in esteemed scientific journals of worldwide impact, statements of certainty were at best avoided, or if made should be exceptionally well referenced.

I note the lack of footnotes showing the source(s) of these statements.

I also note the lack of mention of literature refuting or potentially refuting these statements of certainty. [Followed by a list of such literature just off the top of my head - ed.]

Dr. Blumenthal then appeals to authority:

Dr. Blumenthal said health information experts like Dr. Donald M. Berwick, the Medicare and Medicaid administrator, and Dr. Brent James, of Intermountain Healthcare, based in Salt Lake City, “agree that electronic health records will improve the safety of care.”

I am unaware of the expertise of Dr. Berwick and Dr. James in this domain, and the peer reviewed literature they've written that supports such a statement while soundly refuting literature written by other experts that indicates otherwise.

(Perhaps at Intermountain, custom systems that took decades to develop utilizing their Medical Informatics expertise do show safety gains, but such systems and the lessons learned building them are not easily portable to a country's worth of organizations and practitioners, especially under HITECH timeframes.)

Freudenheim then quotes Blumenthal as stating:

“At the same time, any time you change the world you create risks,” Dr. Blumenthal said in a telephone interview last weekend.

This sounds typical of utopian ideology. Yes, any time you change the world you create risks, but you should not attempt to change the world cavalierly and blindly to those risks. (That's the path the National Program for Health IT in the United States has been on, until the IOM meeting was called.) Idealists tend to believe the collateral damage that is caused by utopian experiments (e.g., communism) are a necessary sacrifice to achieve the utopia. Such values are both abhorrent and alien to medicine.

“We want to make sure that implementation is as safe as it can be and all safety benefits are realized.”

Blumenthal's been painted into a corner by tons of complaints on HIT safety; ONC must act, even if just putting on a show about safety considerations. If there were true concern for safety he'd recommend slowing down HITECH timelines until the industry gets its act together and our understanding of HIT usability, safety, and other issues is resolved; cf.: statements of HIMSS leaders on 'needing to be patient' for the industry to get healthcare IT right:

As I'd written about HIMSS admissions of health IT unsuitability to task at "NIST Provides Healthcare IT Industry with Remedial Undergraduate Computer Science Education":

... What have been their product design and development practices, such that leaders of their own trade group HIMSS (as I pointed out in other posts) opine we should be "patient" for them to figure it all out about how to do health IT better and they need more time, and that the technology does not support its users properly due to lack of efficiency and usability of EMRs currently available? (As at my July 2010 post "The National Program for Healthcare IT in the U.S., and the Elephant in the Living Room".)

Further, from the NYT article:

He [Blumenthal] said that if the Institute of Medicine “concludes that regulation is an important part of this fabric of assuring safety, we will want to balance regulation and innovation as we do in every marketplace.”

That he even needs to make such a statement is likely revealing of biases on regulation, which seem aligned to the industry. To wit:

“The policing of design by a third party or agency, however well intended, will likely stifle innovation and inhibit the growth and development of electronic health records in the future,” said Carl Dvorak, executive vice president of Epic Systems, which has built electronic records systems for Kaiser Permanente and other large health care and hospital groups.

There is a lack of evidence supporting such a statement (e.g., pharma has been regulated for decades, as is its clinical IT). The fact that NIST has just delivered Computer Science 101-level usability guidelines to the HIT industry in its recent report “NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records” to help solve the HIT unusability crisis also suggests that 30+ years of un-regulation did not facilitate ‘innovation.’

In fact 'unregulation' appears to have led to prima facie innovation failure and paralysis as far as usability is concerned.

Unusable health IT might as well not exist as far as clinicians are concerned. It is a menace to the safe practice of medicine. This is a first principle.

Per the NYT, the industry trade group HIMSS has gone mum:

The industry has recently avoided speaking out on a role for the F.D.A. In a statement for this article, the Healthcare Information and Management Systems Society, a Washington-based industry group, said only that it “supports the administration’s decision to ask the Institute of Medicine to study this complex issue and report back over the next 12 months.”

They are certainly not taking a leadership role on this issue. In my humble opinion they will allow regulation, only kicking and screaming and being dragged into it by force. Patients come second to profits - the only factor that will be "stifled" as vendors are coerced to make better products.

The NYT article goes on:

Last month, in protest of one common industry practice, the American Medical Informatics Association said “hold harmless” clauses in many purchasing contracts were unethical. The clauses typically absolve manufacturers of responsibility for any errors or misuse.

“We said we value innovation, but we don’t value it more than safety,” said Kenneth W. Goodman, a University of Miami bioethicist who headed an association advisory group on patient safety.

It took a lot of writing and politicking to get AMIA to this point as well, at least to express it openly (cf.: my efforts here).

Finally, with regard to the IOM meetings on HIT safety, there will be industry stakeholders in attendance such as CCHIT and EPIC.

I believe they should be held to scientific standards of delivery. If they deliver marketing-based spin, they should be called to present scientific evidence for their stance – and not just “positive” evidence. They should be made to refute “negative” evidence as well, not ignore it.

In summary, I welcome the New York Times bringing these issues to the public.

I also welcome IOM's entry into studying HIT safety. While a "Committee on Patient Safety and Health Information Technology" should have been convened years ago, it's better late than never. (Except for patients already injured or killed, of course.)

The results may remain as invisible as the aforementioned National Research Council study. I also doubt the Committee's findings will change hearts and minds. Idealism, profit motive, and irrational exuberance are hard to rectify.

But their effects on people's behaviors can - and should - be regulated.

-- SS

Addendum Dec. 17:

Healthcare Renewal blog to IOM: I have the information of the type you apparently seek on HIT-related injury. My Drexel Univ. site on HIT failures that's been around since 1999 comes up in the first few hits of Google searches on that subject, and has a banner at the top about my mother:

(click to enlarge, or go to site)

Anyone at IOM listening?

-- SS

NIST Provides Healthcare IT Industry with Remedial Undergraduate Computer Science Education

The National Institute of Standards & Technology (NIST) has published a guide entitled:

NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records

It is available free at this link in PDF: http://www.nist.gov/itl/hit/upload/Guide_Final_Publication_Version.pdf (hat tip to an AMIA colleague for posting the URL on an AMIA mailing list.)

The NIST was commissioned by HHS/ONC to study Health IT issues such as usability and report on them.

I find the publication both welcome, and pitiable.

As I started to read ch. 6, for example, I observed material that is suitable for undergraduate computer science instruction:

6. User-Centered Design Process in EHRs

User-centered design is a bedrock principle for creating usable systems and devices. [You don't say? - ed.] One of the most common reasons why systems are poorly designed is that designers and developers fail to engage users in appropriate ways at appropriate times. [Hear that, my young Paduan learners? - ed.] At its core UCD is a process that relies on systematic understanding of users and their environments, and iterative design and testing based on user performance objectives. (Details on usability testing are provided in Section 9.)

UCD has been shown to be effective in many fields. In aviation, for example, this method has been used to develop cockpit navigation displays for low-visibility surface operations. [22] By taking the limitations and capabilities of the flight crew into account, navigation errors have decreased by almost 100%. The adoption of UCD has also been shown to be effective in the design of personal computers. When working on a redesign of the laptop computer, a UCD process was employed. Users were asked to offer feedback about the current model and to offer input about ways to improve the current design. User-centered design was successful in increasing market share, brand equity, and customer satisfaction. [23] In fact, user-centered design has been elevated to an ISO standard. [24] UCD serves to engineer improved human performance into a system or device, and has been crystallizing for several decades as a design philosophy. [25]

While there is no singular model of UCD, the instantiations embody the following principles:

• Understand user needs, workflows and work environments
• Engage users early and often
  
• Set user performance objectives
• Design the user interface from known human behavior principles and familiar user interface models
• Conduct usability tests to measure how well the interface meets user needs
• Adapt the design and iteratively test with users until performance objectives are met

[HHS needs ONC to commission NIST to provide schooling for the HIT industry on these bons mots? - ed.]

As an iterative process, UCD is a cycle that serves to continually improve the application. For each iteration, critical points and issues are uncovered which can be improved upon and implemented in subsequent releases. An illustration of the UCD process is included in Figure 1.

"User centered design process in EHR's." Undergraduate-level computer science 101 instruction from NIST for the healthcare IT industry? (click to enlarge)

Here is Figure 1:

User centered design 101 (click to enlarge)

I might even have used this in teaching high school students about computer programming.

Readers can download the entire report at the above URL.

I find this publication, or, rather, the need for it to exist at all in 2010, remarkable. Absurd and an embarrassment, in fact. Master of the Obvious [1] material that apparently was not so obvious to this industry.

This is after all a multi-billion dollar industry making claims its products will "revolutionize medicine" and other exceptional claims (but without exceptional evidence). These claims have been pushed so hard that many tens of billions of dollars (with penalties) have been earmarked to either entice -- or coerce -- physicians and hospitals to use these products.

What has this industry, including vendors and highly paid management consultants and contractors, been doing, exactly, for the past thirty+ years?

What have been their product design and development practices, such that leaders of their own trade group HIMSS (as I pointed out in other posts) opine we should be "patient" for them to figure it all out about how to do health IT better and they need more time, and that the technology does not support its users properly due to lack of efficiency and usability of EMRs currently available? (As at my July 2010 post "The National Program for Healthcare IT in the U.S., and the Elephant in the Living Room".)

That HHS needs NIST to provide undergraduate level remedial teaching to the multibillion dollar health IT industry is a very poignant commentary indeed on the priorities of that industry regarding engineering rigor, talent management, attention to safety, and other factors affecting human lives.

These observations speak strongly to the need for regulation for this industry, for a talent management and trade association shakeup of major proportions, and most especially for an awakening of our government servants to exactly what the real situation is with respect to HIT on the ground.

12/14/10 addendum: it struck me that the Guide might need another chapter. I suggest a chapter entitled:

"Listening to informatics experts when they say your product will kill people, instead of firing them."

-- SS

[1] This was another pithy line from my early medical mentor, pioneering cardiothoracic surgeon Victor Satinsky, MD at Hahnemann Medical College.

NIST Provides Healthcare IT Industry with Remedial Undergraduate Computer Science Education

The National Institute of Standards & Technology (NIST) has published a guide entitled:

NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records

It is available free at this link in PDF: http://www.nist.gov/itl/hit/upload/Guide_Final_Publication_Version.pdf (hat tip to an AMIA colleague for posting the URL on an AMIA mailing list.)

The NIST was commissioned by HHS/ONC to study Health IT issues such as usability and report on them.

I find the publication both welcome, and pitiable.

As I started to read ch. 6, for example, I observed material that is suitable for undergraduate computer science instruction:

6. User-Centered Design Process in EHRs

User-centered design is a bedrock principle for creating usable systems and devices. [You don't say? - ed.] One of the most common reasons why systems are poorly designed is that designers and developers fail to engage users in appropriate ways at appropriate times. [Hear that, my young Paduan learners? - ed.] At its core UCD is a process that relies on systematic understanding of users and their environments, and iterative design and testing based on user performance objectives. (Details on usability testing are provided in Section 9.)

UCD has been shown to be effective in many fields. In aviation, for example, this method has been used to develop cockpit navigation displays for low-visibility surface operations. [22] By taking the limitations and capabilities of the flight crew into account, navigation errors have decreased by almost 100%. The adoption of UCD has also been shown to be effective in the design of personal computers. When working on a redesign of the laptop computer, a UCD process was employed. Users were asked to offer feedback about the current model and to offer input about ways to improve the current design. User-centered design was successful in increasing market share, brand equity, and customer satisfaction. [23] In fact, user-centered design has been elevated to an ISO standard. [24] UCD serves to engineer improved human performance into a system or device, and has been crystallizing for several decades as a design philosophy. [25]

While there is no singular model of UCD, the instantiations embody the following principles:

• Understand user needs, workflows and work environments
• Engage users early and often
  
• Set user performance objectives
• Design the user interface from known human behavior principles and familiar user interface models
• Conduct usability tests to measure how well the interface meets user needs
• Adapt the design and iteratively test with users until performance objectives are met

[HHS needs ONC to commission NIST to provide schooling for the HIT industry on these bons mots? - ed.]

As an iterative process, UCD is a cycle that serves to continually improve the application. For each iteration, critical points and issues are uncovered which can be improved upon and implemented in subsequent releases. An illustration of the UCD process is included in Figure 1.

"User centered design process in EHR's." Undergraduate-level computer science 101 instruction from NIST for the healthcare IT industry? (click to enlarge)

Here is Figure 1:

User centered design 101 (click to enlarge)

I might even have used this in teaching high school students about computer programming.

Readers can download the entire report at the above URL.

I find this publication, or, rather, the need for it to exist at all in 2010, remarkable. Absurd and an embarrassment, in fact. Master of the Obvious [1] material that apparently was not so obvious to this industry.

This is after all a multi-billion dollar industry making claims its products will "revolutionize medicine" and other exceptional claims (but without exceptional evidence). These claims have been pushed so hard that many tens of billions of dollars (with penalties) have been earmarked to either entice -- or coerce -- physicians and hospitals to use these products.

What has this industry, including vendors and highly paid management consultants and contractors, been doing, exactly, for the past thirty+ years?

What have been their product design and development practices, such that leaders of their own trade group HIMSS (as I pointed out in other posts) opine we should be "patient" for them to figure it all out about how to do health IT better and they need more time, and that the technology does not support its users properly due to lack of efficiency and usability of EMRs currently available? (As at my July 2010 post "The National Program for Healthcare IT in the U.S., and the Elephant in the Living Room".)

That HHS needs NIST to provide undergraduate level remedial teaching to the multibillion dollar health IT industry is a very poignant commentary indeed on the priorities of that industry regarding engineering rigor, talent management, attention to safety, and other factors affecting human lives.

These observations speak strongly to the need for regulation for this industry, for a talent management and trade association shakeup of major proportions, and most especially for an awakening of our government servants to exactly what the real situation is with respect to HIT on the ground.

12/14/10 addendum: it struck me that the Guide might need another chapter. I suggest a chapter entitled:

"Listening to informatics experts when they say your product will kill people, instead of firing them."

-- SS

[1] This was another pithy line from my early medical mentor, pioneering cardiothoracic surgeon Victor Satinsky, MD at Hahnemann Medical College.

Health IT: "Danger"

In an article simply entitled "Danger", Health Data Management author Elizabeth Gardner spells out some "inconvenient truths" about health IT.

Many of the contributors have opined on the risks associated with health IT; several are newly contrite about this issue:

Danger
By Elizabeth Gardner
Health Data Management Magazine, 08/01/2010

Even to Ross Koppel, electronic health records are better than paper ones, "or cuneiform tablets, smoke signals, or carrier pigeons," he adds. He prefers to use hospitals and doctors that have EHRs.

But the University of Pennsylvania sociologist specializes in analyzing interactions between medical computer systems and the people who use them, and he's found enough problems to turn him into an industry gadfly on the potential dangers of EHRs.

"A resident will get an alert at 50 [milligrams of a certain drug] at one hospital, 60 at a second hospital, and no alert at a third hospital because they turned it off," Koppel says. "So he thinks the 70 milligrams he's ordered there are safe. The residents don't know whether the alerts are on or off. They're not familiar with many medications and they start a new rotation every thirty days. They use these alerts as safety bumpers and that's not safe."

... Koppel has found plenty of other glitches, from outright programming errors to user interfaces that make life difficult for clinicians. Numerical values appear in an order that makes sense to the computer but looks random to a human; positive test results aren't always flagged for review; weights aren't consistently labeled as pounds or kilograms (which can lead to babies, for example, being given twice, or half, the medication they need).

"Everyone focuses on why physicians are resistant to computers, but I would rather focus on how difficult the systems are to use," Koppel says. "Most physicians are the smartest guys in the room. Their resistance to technology as such is zero, but they resist software that has a clunky structure."

Dr. Koppel, a sociologist, is a well recognized name in health IT critical thinking circles. He will not win any favors from the health IT vendors and CIO's for that comment about physicians and smartness, but he is quite correct. Physicians are not Luddites. They readily adapt new technology proven as good for patients.

In fact, in my observations IT personnel are the true Luddites, clinging to inappropriate, rigid business-IT views on the healthcare IT development and implementation process (vs. more appropriate and modern agile methodologies), holding unshakable, stereotypical views about physicians, and remaining unreasonably obstinate on clinician complaints about "clunky" health IT user experiences.

Every year the ECRI Institute, Plymouth Meeting, Pa., a not-for-profit organization that evaluates health technology, issues a top 10 list of technology hazards in medical care. "Problems with computerized equipment and systems" ranked seventh this year, right behind "needlesticks and other sharps injuries" and ahead of "surgical stapler hazards." Most of the incidents reported to ECRI by its 5,000 members (hospitals, health systems, payers, and other interested parties) were due to convergence of computers and medical devices in areas like medication management and the routing of device alarms to clinicians' cell phones and pagers. (ECRI Institute points out that such problems are "most certainly underreported.")

Under-reporting of health IT hazards is a familiar theme to this author, as in a 2009 paper entitled "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT" that was not published due to first-round reviews. Some of those reviews were legitimate and constructive regarding revision, but others appeared to suggest the topic was verboten (for example, "nothing is in this paper that could not be read in any big city newspaper", rather the oxymoron considering the paper's topic). I did not bother with a revision, simply making the paper public and bypassing the peer review censorship I saw coming.

But EHRs can easily cause errors, too. Plenty of experts believe that too many systems are being installed too fast into environments too complex to be easily computerized. In the frenzy to be eligible for federal EHR meaningful use incentive payments, and avoid reimbursement penalties starting in 2015, institutions may be setting themselves up for disastrous computer-induced medical errors.

The theme of "too fast" has been present in my writings for awhile now; see for example my 2008 posts "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" and "Open Letter to President Barack Obama on Healthcare Information Technology".

"I'm one of the biggest believers [in EHRs], but there's tremendous pressure to implement these systems so fast," says medical informaticist Dean Sittig, associate professor at the University of Texas Health Science Center at Houston and a leading researcher on successes and failures of EHR implementations. "It worries me that people won't have adequate time to come to grips with what they're doing and test their systems properly."

Dr. Sittig did write some excellent, pioneering articles on the indispensibility of the CMIO role ("information architect" - PDF) back in the mid-1990's that I use in my teaching. However, a few years ago he told a former student of mine (he was unaware of that relationship) who listed me as a reference on her CV to not do so, as I was not a "real medical informaticist" or words to that effect. Seems at the time he may have taken issue with my realist views on the problems with health IT.

The medical environment is more complex than other fields like aircraft navigation, which is already hard enough to computerize, notes Nancy Leveson, professor of aeronautics and astronautics at the Massachusetts Institute of Technology. She's a pioneer in software safety ... "We're talking about a professional environment of doctors, and changing the way they do business," Leveson says. "Most other kinds of automation aren't doing that.

This issue is critical and at the root of health IT dysfunction. No other profession is being asked to use IT in the manner in which clinicians have been asked. No other profession may have an information model as complex that they're asked to record in painstaking, granular detail, either.

Because software engineers aren't taught about usability and the impact of their systems on the world, they think they'll just automate it the way they want and make people do it their way. There's a lot of stuff out there [in health care] that's very difficult to use. The industry is naive about introducing software and the change it requires and the potential hazards it introduces, and they think it's going to be all right."

I would replace the word "naive" with "willfully ignorant, complacent and negligent." There are simply no acceptable excuses for a field that has been in existence for decades to be as toddlers on the impact of their work.

... Clinicians who already have extensive experience with EHRs are under no illusions that everything works smoothly. "It's inevitable that some new errors will be introduced [with EHRs]," says David Bates, M.D., chief of general medicine at Brigham and Women's Hospital, Boston, a patient safety expert, and a member of the information technology executive committee of Partners HealthCare, Brigham's parent.

Considering the ice-cold reception by most of those clinician experts (e.g., in the medical informatics community) to my writings on HIT problems that began in 1999 and now reside at my Drexel site here, and to the similar writings of others, I disagree with Bates' assessment. I think the experts have now painted themselves into a corner and have been forced by reality and their own willful blindness into admitting the truth about this experimental technology. (A PubMed search on "Bates DW" is not generally revealing of papers on health IT risks until relatively recently.)

"The key thing is to devote enough resources and attention to fixing them [errors] after they happen. Your EHR may prevent 10 errors for every new one it causes [not sure where these figures come from or if they're generalizable at all - ed.], but you have to have an approach for dealing with the new ones."

Again, I would differ. The key thing is to prevent them from happening as much as possible. The pharma and medical device industries do this through RCT's, post market studies, and strong regulatory requirements for their products' manufacture and use.

Bates is not an advocate of regulation of health IT. As in my post "JAMA letter: Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards", in 2009 Bates signed on to an unpublished letter to JAMA (archived here) in response to Koppel and Kreda's article on "hold harmless" clauses that stated "... the belief that the best approach to increase the safety and effectiveness of EHR systems is by legal regulation of system vendors is misplaced." (Incidentally, the letter that JAMA did publish was mine.)

... Partners has been developing its own in-house EHR for several decades, and still encounters things that need fixing. For example, when physician order entry was introduced, the system made it possible to order fatally large doses of intravenous potassium, because the initial order choices hadn't been properly vetted by the internal team responsible. The nurses who executed the orders knew enough to catch the error before it harmed a patient, but Bates says it took a year and a half to get the screen corrected in the order entry system.

I can add that taking a year and a half to correct a potential fatality-causing screen in a home-built clinical IT application is not just a technological issue, but also an organizational, political and leadership issue.

... "Emergency care is by definition nonlinear and unpredictable, and information technology tends to enforce a certain amount of linearity: you can't do step 5 until you've done steps 1 through 4," says Wears. Emergency room personnel often care for multiple patients simultaneously and have to do things "out of order" so they can be more efficient. If an EHR enforces a linear pattern, it will just get in their way, and they'll compensate by running a parallel system on paper and putting information into the EHR later. "That subverts one of the fundamental things you wanted the system to do-give you real-time feedback on good and bad ideas," Wears says.

The realities of the ED cannot be neatly dealt with as if a calm, solitary office environment .

There's plenty of blame to go around. Koppel and Leveson say software design, or lack of it, is a common culprit, and they take vendors to task for not focusing on usability.

Again, there is no reasonable excuse for IT intractability in a mission critical sector.

Leveson says part of the problem is a lack of regulatory standards. "The FDA doesn't want to oversee anything and that's a mistake," she says. "So it's become this free-for-all in the industry."

I've used that same language. In my 2009 post E-Health Hazards: Provider Liability and Electronic Health Record Systems I wrote "the unregulated free-for-all that has been the health IT marketplace, with dangerous and even outrageous practices I noted starting a decade ago, must come to an end as the market matures and as diffusion of this technology massively increases per the government mandates now in effect."

Though experts say EHRs clearly fall under the category of medical devices, the FDA has steered clear of directly regulating them. Its ill-starred policy of requiring pre-market approval for blood-bank software, begun back in the 1990s, resulted in major vendors pulling out of the market altogether and stifling innovation ... "That kind of regulation provides a huge economic disincentive and there hasn't been any substantial improvement in blood bank software in 10 years," says Geisinger's Walker. "If the FDA required it for EHRs, it would harm patients more than help."

I disagree with Walker and especially disagree with the latter statement, based on one anecdotal case of IT regulation (ironically, it's HIT proponents who most often claim that 'anecdotes' of patient harm don't make data).

Further, the FDA was called in initially because of IT dangers in existing blood banking software. Also, the "innovation" referred to could more accurately be referred to as "lifecycle adaptation and enhancement", not true innovation. In other words, there was not enough profit to be made in maintaining mature software under regulation. The effect might be to push the quick-buck profiteers out of the industry, and thus improve quality and innovation.

The Swedish Medical Products Agency is leading the way for consideration of HIT in the EU as a medical device to be regulated as in my post "Improving Patient Safety In The EU: HIT Should Be Classified As Medical Devices". Yet, that didn't seem to impact Swedish innovation; in the UK, Wrightington, Wigan and Leigh NHS Foundation Trust has recently awarded its hospital information system contract to Swedish healthcare systems provider, Cambio (link).

Albeit in another anecdote, FDA's regulation did not harm pharma IT as far as I could tell, while a Group Director in Merck Research Labs' Research Information Systems Division.

Truth is, there is no good data one way or the other regarding regulation, but after thirty or more years of an unfettered HIT industry, I believe it reasonable to say that the presence of harmful HIT speaks more for regulation than for a continued industry "free-for-all."

The Agency for Healthcare Research and Quality is currently working with the FDA, VA and other federal agencies to develop a common format for reporting I.T.-related patient safety events and unsafe conditions.

"What took so long" is my question.

Read the whole article. The myth of health IT beneficence continues to be eroded. One can only hope the tens of billions earmarked for the technology in the recent economic "recovery" legislation will become similarly eroded in years to come, to allow the technology to be safely improved - that is, in vitro, not in vivo.

-- SS

Health IT: "Danger"

In an article simply entitled "Danger", Health Data Management author Elizabeth Gardner spells out some "inconvenient truths" about health IT.

Many of the contributors have opined on the risks associated with health IT; several are newly contrite about this issue:

Danger
By Elizabeth Gardner
Health Data Management Magazine, 08/01/2010

Even to Ross Koppel, electronic health records are better than paper ones, "or cuneiform tablets, smoke signals, or carrier pigeons," he adds. He prefers to use hospitals and doctors that have EHRs.

But the University of Pennsylvania sociologist specializes in analyzing interactions between medical computer systems and the people who use them, and he's found enough problems to turn him into an industry gadfly on the potential dangers of EHRs.

"A resident will get an alert at 50 [milligrams of a certain drug] at one hospital, 60 at a second hospital, and no alert at a third hospital because they turned it off," Koppel says. "So he thinks the 70 milligrams he's ordered there are safe. The residents don't know whether the alerts are on or off. They're not familiar with many medications and they start a new rotation every thirty days. They use these alerts as safety bumpers and that's not safe."

... Koppel has found plenty of other glitches, from outright programming errors to user interfaces that make life difficult for clinicians. Numerical values appear in an order that makes sense to the computer but looks random to a human; positive test results aren't always flagged for review; weights aren't consistently labeled as pounds or kilograms (which can lead to babies, for example, being given twice, or half, the medication they need).

"Everyone focuses on why physicians are resistant to computers, but I would rather focus on how difficult the systems are to use," Koppel says. "Most physicians are the smartest guys in the room. Their resistance to technology as such is zero, but they resist software that has a clunky structure."

Dr. Koppel, a sociologist, is a well recognized name in health IT critical thinking circles. He will not win any favors from the health IT vendors and CIO's for that comment about physicians and smartness, but he is quite correct. Physicians are not Luddites. They readily adapt new technology proven as good for patients.

In fact, in my observations IT personnel are the true Luddites, clinging to inappropriate, rigid business-IT views on the healthcare IT development and implementation process (vs. more appropriate and modern agile methodologies), holding unshakable, stereotypical views about physicians, and remaining unreasonably obstinate on clinician complaints about "clunky" health IT user experiences.

Every year the ECRI Institute, Plymouth Meeting, Pa., a not-for-profit organization that evaluates health technology, issues a top 10 list of technology hazards in medical care. "Problems with computerized equipment and systems" ranked seventh this year, right behind "needlesticks and other sharps injuries" and ahead of "surgical stapler hazards." Most of the incidents reported to ECRI by its 5,000 members (hospitals, health systems, payers, and other interested parties) were due to convergence of computers and medical devices in areas like medication management and the routing of device alarms to clinicians' cell phones and pagers. (ECRI Institute points out that such problems are "most certainly underreported.")

Under-reporting of health IT hazards is a familiar theme to this author, as in a 2009 paper entitled "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT" that was not published due to first-round reviews. Some of those reviews were legitimate and constructive regarding revision, but others appeared to suggest the topic was verboten (for example, "nothing is in this paper that could not be read in any big city newspaper", rather the oxymoron considering the paper's topic). I did not bother with a revision, simply making the paper public and bypassing the peer review censorship I saw coming.

But EHRs can easily cause errors, too. Plenty of experts believe that too many systems are being installed too fast into environments too complex to be easily computerized. In the frenzy to be eligible for federal EHR meaningful use incentive payments, and avoid reimbursement penalties starting in 2015, institutions may be setting themselves up for disastrous computer-induced medical errors.

The theme of "too fast" has been present in my writings for awhile now; see for example my 2008 posts "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" and "Open Letter to President Barack Obama on Healthcare Information Technology".

"I'm one of the biggest believers [in EHRs], but there's tremendous pressure to implement these systems so fast," says medical informaticist Dean Sittig, associate professor at the University of Texas Health Science Center at Houston and a leading researcher on successes and failures of EHR implementations. "It worries me that people won't have adequate time to come to grips with what they're doing and test their systems properly."

Dr. Sittig did write some excellent, pioneering articles on the indispensibility of the CMIO role ("information architect" - PDF) back in the mid-1990's that I use in my teaching. However, a few years ago he told a former student of mine (he was unaware of that relationship) who listed me as a reference on her CV to not do so, as I was not a "real medical informaticist" or words to that effect. Seems at the time he may have taken issue with my realist views on the problems with health IT.

The medical environment is more complex than other fields like aircraft navigation, which is already hard enough to computerize, notes Nancy Leveson, professor of aeronautics and astronautics at the Massachusetts Institute of Technology. She's a pioneer in software safety ... "We're talking about a professional environment of doctors, and changing the way they do business," Leveson says. "Most other kinds of automation aren't doing that.

This issue is critical and at the root of health IT dysfunction. No other profession is being asked to use IT in the manner in which clinicians have been asked. No other profession may have an information model as complex that they're asked to record in painstaking, granular detail, either.

Because software engineers aren't taught about usability and the impact of their systems on the world, they think they'll just automate it the way they want and make people do it their way. There's a lot of stuff out there [in health care] that's very difficult to use. The industry is naive about introducing software and the change it requires and the potential hazards it introduces, and they think it's going to be all right."

I would replace the word "naive" with "willfully ignorant, complacent and negligent." There are simply no acceptable excuses for a field that has been in existence for decades to be as toddlers on the impact of their work.

... Clinicians who already have extensive experience with EHRs are under no illusions that everything works smoothly. "It's inevitable that some new errors will be introduced [with EHRs]," says David Bates, M.D., chief of general medicine at Brigham and Women's Hospital, Boston, a patient safety expert, and a member of the information technology executive committee of Partners HealthCare, Brigham's parent.

Considering the ice-cold reception by most of those clinician experts (e.g., in the medical informatics community) to my writings on HIT problems that began in 1999 and now reside at my Drexel site here, and to the similar writings of others, I disagree with Bates' assessment. I think the experts have now painted themselves into a corner and have been forced by reality and their own willful blindness into admitting the truth about this experimental technology. (A PubMed search on "Bates DW" is not generally revealing of papers on health IT risks until relatively recently.)

"The key thing is to devote enough resources and attention to fixing them [errors] after they happen. Your EHR may prevent 10 errors for every new one it causes [not sure where these figures come from or if they're generalizable at all - ed.], but you have to have an approach for dealing with the new ones."

Again, I would differ. The key thing is to prevent them from happening as much as possible. The pharma and medical device industries do this through RCT's, post market studies, and strong regulatory requirements for their products' manufacture and use.

Bates is not an advocate of regulation of health IT. As in my post "JAMA letter: Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards", in 2009 Bates signed on to an unpublished letter to JAMA (archived here) in response to Koppel and Kreda's article on "hold harmless" clauses that stated "... the belief that the best approach to increase the safety and effectiveness of EHR systems is by legal regulation of system vendors is misplaced." (Incidentally, the letter that JAMA did publish was mine.)

... Partners has been developing its own in-house EHR for several decades, and still encounters things that need fixing. For example, when physician order entry was introduced, the system made it possible to order fatally large doses of intravenous potassium, because the initial order choices hadn't been properly vetted by the internal team responsible. The nurses who executed the orders knew enough to catch the error before it harmed a patient, but Bates says it took a year and a half to get the screen corrected in the order entry system.

I can add that taking a year and a half to correct a potential fatality-causing screen in a home-built clinical IT application is not just a technological issue, but also an organizational, political and leadership issue.

... "Emergency care is by definition nonlinear and unpredictable, and information technology tends to enforce a certain amount of linearity: you can't do step 5 until you've done steps 1 through 4," says Wears. Emergency room personnel often care for multiple patients simultaneously and have to do things "out of order" so they can be more efficient. If an EHR enforces a linear pattern, it will just get in their way, and they'll compensate by running a parallel system on paper and putting information into the EHR later. "That subverts one of the fundamental things you wanted the system to do-give you real-time feedback on good and bad ideas," Wears says.

The realities of the ED cannot be neatly dealt with as if a calm, solitary office environment .

There's plenty of blame to go around. Koppel and Leveson say software design, or lack of it, is a common culprit, and they take vendors to task for not focusing on usability.

Again, there is no reasonable excuse for IT intractability in a mission critical sector.

Leveson says part of the problem is a lack of regulatory standards. "The FDA doesn't want to oversee anything and that's a mistake," she says. "So it's become this free-for-all in the industry."

I've used that same language. In my 2009 post E-Health Hazards: Provider Liability and Electronic Health Record Systems I wrote "the unregulated free-for-all that has been the health IT marketplace, with dangerous and even outrageous practices I noted starting a decade ago, must come to an end as the market matures and as diffusion of this technology massively increases per the government mandates now in effect."

Though experts say EHRs clearly fall under the category of medical devices, the FDA has steered clear of directly regulating them. Its ill-starred policy of requiring pre-market approval for blood-bank software, begun back in the 1990s, resulted in major vendors pulling out of the market altogether and stifling innovation ... "That kind of regulation provides a huge economic disincentive and there hasn't been any substantial improvement in blood bank software in 10 years," says Geisinger's Walker. "If the FDA required it for EHRs, it would harm patients more than help."

I disagree with Walker and especially disagree with the latter statement, based on one anecdotal case of IT regulation (ironically, it's HIT proponents who most often claim that 'anecdotes' of patient harm don't make data).

Further, the FDA was called in initially because of IT dangers in existing blood banking software. Also, the "innovation" referred to could more accurately be referred to as "lifecycle adaptation and enhancement", not true innovation. In other words, there was not enough profit to be made in maintaining mature software under regulation. The effect might be to push the quick-buck profiteers out of the industry, and thus improve quality and innovation.

The Swedish Medical Products Agency is leading the way for consideration of HIT in the EU as a medical device to be regulated as in my post "Improving Patient Safety In The EU: HIT Should Be Classified As Medical Devices". Yet, that didn't seem to impact Swedish innovation; in the UK, Wrightington, Wigan and Leigh NHS Foundation Trust has recently awarded its hospital information system contract to Swedish healthcare systems provider, Cambio (link).

Albeit in another anecdote, FDA's regulation did not harm pharma IT as far as I could tell, while a Group Director in Merck Research Labs' Research Information Systems Division.

Truth is, there is no good data one way or the other regarding regulation, but after thirty or more years of an unfettered HIT industry, I believe it reasonable to say that the presence of harmful HIT speaks more for regulation than for a continued industry "free-for-all."

The Agency for Healthcare Research and Quality is currently working with the FDA, VA and other federal agencies to develop a common format for reporting I.T.-related patient safety events and unsafe conditions.

"What took so long" is my question.

Read the whole article. The myth of health IT beneficence continues to be eroded. One can only hope the tens of billions earmarked for the technology in the recent economic "recovery" legislation will become similarly eroded in years to come, to allow the technology to be safely improved - that is, in vitro, not in vivo.

-- SS

Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun? I report, you decide.

From the aforementioned Huffington Post Investigative Fund article "FDA, Obama Digital Medical Records Team at Odds over Safety Oversight" and timeline of industry resistance to government oversight of health IT (link), one document stands out in my mind.

The internal FDA memorandum of Feb. 23, 2010 ("not intended for public use") to Jeffrey Shuren on HIT risks. which I have now re-hosted at this link (PDF) is quite fascinating.

Internal FDA Memo ("not intended for public use") on potential dangers of health IT. Download the PDF here.

The memo begins:

This report serves to characterize medical device reports (MDRs) in the Manufacturer and User Facility Experience (MAUDE) database, inclusive of MedSun reports, pertaining to Health Information Technology (H-IT) safety issues as requested by the Office of the Center Director, Center for Devices and Radiological Health (CDRH), in contrast to the previously submitted MedSun and Office of Compliance information.

(I've mentioned MAUDE here and here, including a report of an HIT-related patient death at the latter link.)

To those "anecdotalists" in the healthcare information technology community who believe reports of HIT-related harm are "anecdotal, and anecdotes don't make data" (as opposed to the "Markopolists"):

When an internal FDA review of their own data concludes the following, I invite you to think about the point of view that maintains that reports of HIT-related patient injury and death are so 'fragmentary' as to not merit (actually, demand) significant resources be diverted to rigorously addressing the issue of HIT risk:

In summary, the results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs and impedes a more comprehensive understanding of the actual problems and implications.

This is especially true considering the FDA's own noted limitations of their information sources:

Limitations of the MAUDE search and final subset of MDRs include the following:

1. Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including

... (a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues;
... (b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue;
... (c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports.
2. Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events.
3. Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device.
Memo: H-IT Safety Issues
4 Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports.
5 The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting.

If HIT were VIOXX or Phen-Fen, the class action lawsuits would likely be starting already.

(Note: for more on why there is a scarcity of data on HIT related adverse events, see my paper "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT" at this Scribd link. This paper was not accepted on first draft by the medical informatics peer review process. I received anonymous review comments such as one that paradoxically stated that the paper "did not contain anything that could not be read in any big city newspaper", an odd comment indeed considering the topic. On that basis I decided not to attempt a revision but to post the paper publicly. -- SS)

One has to ask why this internal FDA report has not been made public until the Huffington Post article, nor been acted upon vigorously. The term of art is "double standard" compared to pharmaceuticals and other medical devices.

When the NEJM starts publishing unreferenced statements of absolute certainty like this from ONC Chair Blumenthal:

The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

and the HuffPo Investigative Fund quotes him as follows:

“We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system,” Blumenthal said when unveiling new regulations in Washington on July 13.

... a statement easily demonstrable to be without merit, in fact, then one has to wonder where science has gone.

One also has to wonder if someone is short-circuiting the FDA's role in regulating this technology.

Could Blumenthal (in essence a family doctor), Sibelius (a trial lawyer), DeParle, or others, or the White House itself be telling FDA how to conduct its business? Are they impeding FDA's regulatory role in the irrationally exuberant multi-billion $$$ race to HIT utopia?

Finally, it is my belief that numerous health IT/medical informatics academics and talking heads who've steadfastly avoided the issue of health IT-related patient harm, or scoffed at it in legally-discoverable forums, might find themselves as defendants in upcoming plaintiff lawsuits. "Knew, or should have known" is the phrase that might apply.

As I learned from my pre-informatics Transit Authority medical management experience, juries will likely not take kindly to academic and marketing arguments akin to Scott Adam's sarcastic example of the logical fallacy of "ignoring all anecdotal evidence":

"I always get hives immediately after eating strawberries. But without a scientifically controlled experiment, it's not reliable data. So I continue to eat strawberries every day, since I can't tell if they cause hives."

-- SS