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

ECRI: Healthcare IT In Top Ten Health Technology Threats to Patient Safety

Number 5, that is.

The ECRI Institute is an independent, unbiased, evidence-based healthcare research, information, and advice provider. They have been in operation for more than 40 years and are one of only a handful of organizations designated as both a Collaborating Center of the World Health Organization and an Evidence-Based Practice Center by the U.S. Agency for Healthcare Research and Quality.

I've cited their code of ethics at HC Renewal as a model of commendable healthcare conduct before:

Conflict of Interest - The Integrity of Independence

Remaining unbiased is difficult, if not impossible, when conflicts of interest are present. That is why we strictly enforce our conflict-of-interest rules and have carefully developed an environment that maximizes objectivity, productivity, and integrity of process.

We accept no grants, gifts, finder’s fees, or consulting projects from, and our employees are not permitted to own stock shares in, medical device or pharmaceutical firms. To make sure that is the case, we examine each employee’s federal income tax return after it is filed.

And, we accept no advertising revenues from any source.

(Full disclosure: I was a contributor on health IT issues to their 2008 book "Physician Office Fundamentals in Risk Management and Patient Safety.")

ECRI's most recent report is "The Top Ten Health Technology Threats to Patient Safety" for 2011 available at this link. Their Dec. 7 press announcement is here.

I'd mentioned an earlier edition of the report at my Sept 2010 post "Health IT: Danger" as was spoken about by Dr. Ross Koppel at Univ. of PA, but will present more detail here now that the 2011 report is available to the public.

I am citing the WSJ health blog on this report, as ECRI requests linking to their registration and downloading page for the full report, rather than direct dissemination, posting, or republishing of this work, without prior written permission:

December 8, 2010, 6:15 PM ET
The Top Ten Health Technology Threats to Patient Safety
WSJ Health Blog

By Katherine Hobson

For the fourth year running, the nonprofit ECRI Institute has put together a list of what it judges to be the top ten health technology hazards on which health-care facilities should focus their efforts.

The list in descending order of importance, doesn’t necessarily reflect the devices or problems with the most reported errors. That’s a factor, but so is “the severity of the problem, whether or not there’s a way to fix or mitigate the problem, and the high-profile” nature of the problem, Jim Keller, vice president for health technology evaluation and safety at ECRI, tells the Health Blog.

Among risks such as radiation therapy overdose and other dosing errors (#1), alarm hazards (#2), cross-contamination from flexible endoscopes (#3), high radiation dose of CT scans (#4), and luer misconnections (#6, misconnections of various infusion tubes), there's this:

#5 Data loss, system incompatibilities and other health IT complications: Problems with electronic-health records and other health IT systems can lead to problems including lost data, the need for repeat testing and even patient injury or death.

Then another obvious concern is raised:

While Keller says both he and ECRI support the push for digitized systems, the rush for federal incentives raises “concern that some of the kind of problems we are describing will be overlooked.”

It's not a "concern" to me, it's a fact.

So, here we have it:

An independent, nonprofit organization that for more than 40 years has been dedicated to bringing the discipline of applied scientific research to discover which medical procedures, devices, drugs, and processes are best, with unique ability to marry practical experience and uncompromising independence with the thoroughness and objectivity of evidence-based research, reports:

"Problems with electronic-health records and other health IT systems can lead to problems including lost data, the need for repeat testing and even patient injury or death."

The degree of risk is unknown (cf.: Joint Commission 2009 Sentinel Event Alert on Health IT Safety, PDF):

"There is a dearth of data on the incidence of adverse events directly caused by HIT overall."

This does not seem the best environment for the ethical, rapid diffusion of this technology nationwide, under penalty of loss of income and loss of Board Certification and even licensure for non-adopters.

For those of different ethics than ECRI, health IT is a literal cornucopia.

Addendum:

I note this comment from a nurse at the WSJ health blog story's comment section:

8:50 am December 9, 2010

The list was predictable, emanating from my observations as a registered nurse. It has become impossible to give patients care that they need. Corners are cut. It is easier for doctors to order scans than it is to examine patients. I would rather examine patients but the hospital requires that I click everything in to the electronic record, and [t]hat takes a long time. The reference to the CPOE is true. It is a nightmare because of the mistakes it promotes and it intereferes with communication disrupting my team’s care of the patient.

This must be one of those "anecdotal" reports that constitute a growing corpus of irrelevant "anecdotes", to be safely ignored because they were not obtained as part of a scientific experiment.

-- SS

Addendum Dec. 10, 2010:

From an earlier post of mine (of which I was reminded via a viewing from IP 150.148.0.#, FDA.gov, on a Google search on "health IT safety" this morning), we don't need to worry about HIT risks. ONC chair David Blumenthal said so:

... [Blumenthal's] department is confident that its mission remains unchanged in trying to push all healthcare establishments to adopt EMRs as a standard practice. "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said.

-- SS

EHRevent.org CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error?

Additional detailed answers to the questions I raised here and here about a new site EHRevent.org, for reporting of healthcare IT-related medical errors, can now be found at a HIStalk interview entitled "HIStalk Interviews Edward Fotsch MD, CEO, PDR Network (EHR Event)" at this link.

It is an interesting interview. I certainly find the recognition of need for an EHR/clinical IT problems reporting service a major cultural advancement in healthcare.

It's still unclear to me how -- and why -- this organization originated with little to no public knowledge and involvement, especially considering the organization types mentioned below that participated, and how it will function in interactions with myriad healthcare IT stakeholders.

Here's an explanation by Dr. Fotsch:

... We work with a not-for-profit board called the iHealth Alliance. They Alliance is made up of medical society executives, professional liability carriers, and liaison representatives from the FDA. They govern some of the networks that we run, and in exchange for that, help us recruit physicians. Professional liability carriers, for example, promote our services that send drug alerts to doctors because that’s good and protective from a liability standpoint.

In the course of our conversations with them roughly a year ago, when we were talking about adding some drug safety information into electronic health records, we came across the fact that there were concerns from the liability carriers that there was no central place for reporting adverse EHR events or near misses or potential problems or issues with electronic health records.

[Translation: the carriers saw their losses potentially increasing as a result of litigation arising from EHR-related lawsuits, and decided to do something proactive- ed.]

They were interested in creating a single place where they could promote to their insured physicians that they could report adverse EHR events. Then it turned out that medical societies had similar concerns.

[That must have been one of the best-kept secrets on Earth considering the promotion EHR's have received as a miracle-working technology, and the lack of expression of concerns from those societies - ed.]

Rather than have each of them create a system, the Alliance took on a role of orchestrating all of the interests, including some interest from the FDA and ONC in creating an electronic health record problem reporting system. That’s how it came into play.

Our role in it, in addition to having a seat on the iHealth Alliance board, was really in network operations — in running the servers, if you will, which didn’t seem like a very complicated task. Since business partners we rely on for our core business were interested in it, it was easy to say yes. It frankly turned out to be somewhat more complicated than we originally thought [I predict they haven't seen anything yet; wait until they get knee deep into real world EHR issues - ed.], but now it’s up and available.

While I find the recognition of need for an EHR/clinical IT reporting service a major advancement, I am nonetheless troubled by certain statements made by Dr. Fotsch. They seem at odds with the theoretic and empirical findings of medical informatics, social informatics, human-computer interaction and other fields relevant for health IT evaluation, and/or seem to demonstrate biases about HIT. My comments are in red italics:

Fotsch:

… Probably what we’re seeing more often than not, the real challenge with EHRs like any technology, turns out to be some form of user error.

[What about contributory or causative designer error? – ed.]

“I didn’t know it would do that"

[Why did the user not know? Lack of training, poor manuals, or overly complex information systems lacking informative messages and consistency of control-action relationships, as an example? -ed]

... or “I didn’t know that it pre-populated that"

[Why did it pre-populate? Was that inappropriate for the clinical context, such as in this example?]

... or “I didn’t know I shouldn’t cut and paste"

[Then why did the software designers enable cut and paste, without some informative message on overuse, such as length of text cut and pasted?– ed.]

... or “I wasn’t paying attention to this"

[Perhaps due to distractions from mission hostile user interfaces? -ed]

... or maybe the user interface was a little confusing

[What is "a little confusing?" (Is that like "A little pregnant?) And why was it confusing? User intellectual inadequacy, or software design issues leading to cognitive overload? - ed.]

Actual software errors appear to be the exception rather than the rule as it relates to EHR events.

["Actual software errors" are defined as, what, exactly--? Loss of database relational integrity as a result of a programming error, as apparently recently happened at Trinity Health, a large Catholic hospital chain as reported in HIStalk? Memory leaks from poor code? Buffer overflows? What?]

That’s at least as I understand it.

[Understand it from whom? Hopefully not from me or my extensive website on the issues, the site whose header sadly now appears as below - ed.]

A new, unfortunate header for my website on health IT failures. Click to enlarge the shaded area, or click here to go to the site.

In summary, a "blame the user" attitude seems apparent. There appears to be little acknowledgment of the concept of IT "errorgenicity" - the capacity of a badly designed or poorly implemented information system to facilitate error, and of the systemic nature of errors in complex organizations to which ill-done IT can contribute.

These are concepts understood long ago in mission critical settings, as in this mid 1980's piece from the Air Force cited in my previously-linked eight part series on mission hostile health IT:

From "GUIDELINES FOR DESIGNING USER INTERFACE SOFTWARE"
ESD-TR-86-278
August 1986
Sidney L. Smith and Jane N. Mosier
The MITRE Corporation
Prepared for Deputy Commander for Development Plans and Support Systems, Electronic Systems Division, AFSC, United States Air Force, Hanscom Air Force Base, Massachusetts.

... SIGNIFICANCE OF THE USER INTERFACE

The design of user interface software is not only expensive and time-consuming, but it is also critical for effective system performance. To be sure, users can sometimes compensate for poor design with extra effort. Probably no single user interface design flaw, in itself, will cause system failure. But there is a limit to how well users can adapt to a poorly designed interface. As one deficiency is added to another, the cumulative negative effects may eventually result in system failure, poor performance, and/or user complaints.

Outright system failure can be seen in systems that are underused, where use is optional, or are abandoned entirely. There may be retention of (or reversion to) manual data handling procedures, with little use of automated capabilities. When a system fails in this way, the result is disrupted operation, wasted time, effort and money, and failure to achieve the potential benefits of automated information handling.

In a constrained environment, such as that of many military and commercial information systems, users may have little choice but to make do with whatever interface design is provided. There the symptoms of poor user interface design may appear in degraded performance. Frequent and/or serious errors in data handling may result from confusing user interface design [in medicine, this often translates to reduced safety and reduced care quality - ed.] Tedious user procedures may slow data processing, resulting in longer queues at the checkout counter, the teller's window, the visa office, the truck dock, [the hospital floor or doctor's office - ed.] or any other workplace where the potential benefits of computer support are outweighed by an unintended increase in human effort.

In situations where degradation in system performance is not so easily measured, symptoms of poor user interface design may appear as user complaints. The system may be described as hard to learn, or clumsy, tiring and slow to use [often heard in medicine, but too often blamed on "physician resistance" - ed.] The users' view of a system is conditioned chiefly by experience with its interface. If the user interface is unsatisfactory, the users' view of the system will be negative regardless of any niceties of internal computer processing.

I am not entirely happy when the CEO of an organization taking on the responsibility of being a central focus for EHR error reporting makes statements that are consistent with unfamiliarity with important HIT-relevant domains, as well as a possible pro-IT, anti-user biases.

For that reason as well as the other questions raised at my prior posts (such as the onerous legal contract and apparent lack of ability of the public to easily view the actual report texts themselves), I cannot recommend use of their site for EHR problems reporting.

I recommend the continued use of the FDA facilities until such time as a compelling argument exists to do otherwise.

-- SS

Addendum 11/28/10:

This passage ends the main essay at my site "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" and is quite relevant here:

... An article worth reviewing is "Human error: models and management", James Reason (a fitting name!), BMJ 2000;320:768-770 (18 March), http://www.bmj.com/cgi/content/full/320/7237/768:

Summary points:

• Two approaches to the problem of human fallibility exist: the person and the system approaches
  

• The person approach focuses on the errors of individuals, blaming them for forgetfulness, inattention, or moral weakness

• The system approach concentrates on the conditions under which individuals work and tries to build defenses to avert errors or mitigate their effects

• High reliability organizations---which have less than their fair share of accidents---recognize that human variability is a force to harness in averting errors, but they work hard to focus that variability and are constantly preoccupied with the possibility of failure.

-- SS

NEJM: Medical Malpractice Liability in the Age of Electronic Health Records

As I wrote on Nov. 11 at Report of an AMIA special task force on challenges in ethics, safety, best practices, and oversight regarding HIT :

This report may be part of a trend ... It appears that the views on healthcare IT safety, ethics, management practices, etc. appearing on the Healthcare Renewal blog and on my once-controversial academic health IT website "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" (started in 1999) are now becoming mainstream.

Notable "events" continue to occur rapidly in the literature on clinical IT. Another example of the trend I noted appeared today, this time in the New England Journal of Medicine:

Medical Malpractice Liability in the Age of Electronic Health Records
Sandeep S. Mangalmurti, M.D., J.D., Lindsey Murtagh, J.D., M.P.H., and Michelle M. Mello, J.D., Ph.D.
N Engl J Med 2010; 363:2060-2067 (Nov. 18, 2010)

From the Department of Medicine, New York University Medical Center, New York (S.S.M.); and the Department of Health Policy and Management, Harvard School of Public Health, Boston (L.M., M.M.M.).

The above hyperlink takes you, as of this writing, to full text and an available PDF.

My comments on this article are that:

I am happy to see it appear -- as it shows that critical thinking about HIT has reached the top echelons of the medical literature.

However, the new paper itself appears to wander a bit, and seems to add little to the much more comprehensive article:

"E-Health Hazards: Provider Liability and Electronic Health Record Systems." Sharona Hoffman and Andy Podgurski. Berkeley Technology Law Journal (2010).
Available at: http://www.btlj.org/data/articles/24_4/1523_Hoffman.pdf

(Sharona Hoffman JD is Professor of Law and Bioethics, Co-Director of Law-Medicine Center, Case Western Reserve University School of Law, and Andy Podgurski PhD is Professor of Electrical Engineering and Computer Science, Case Western Reserve University.)

The new article does reference the Hoffman/Posgurski article once at [32].

The new NEJM article also seems to display biases. For instance, it states:

EHR users overwhelmingly report improvement in the quality of care they provide. [29]

Reference [29] is this article:

29. DesRoches CM, Campbell EG, Rao SR, et al. Electronic health records in ambulatory care — a national survey of physicians. N Engl J Med 2008;359:50-60.

From that article:

In late 2007 and early 2008, we conducted a national survey of 2758 [ambulatory care] physicians, which represented a response rate of 62%. Using a definition for electronic health records that was based on expert consensus, we determined the proportion of physicians who were using such records in an office setting and the relationship between adoption and the characteristics of individual physicians and their practices.

... Four percent of physicians reported having an extensive, fully functional electronic records system, and 13% reported having a basic system ... Physicians reported positive effects of these systems on several dimensions of quality of care and high levels of satisfaction ... Physicians who use electronic health records believe such systems improve the quality of care and are generally satisfied with the systems. However, as of early 2008, electronic systems had been adopted by only a small minority of U.S. physicians, who may differ from later adopters of these systems.

I would therefore relate that the blanket statement that "EHR users overwhelmingly report improvement in the quality of care they provide" is overstated.

It might have been more appropriate to write that:

"In one study of ambulatory care physicians, a minority of which at present were using EMR's at various levels of sophistication, users reported improved care."

Also, other literature refuting the premise that physicians report improved care could (should) have been considered, such as (in just one example) the 2008 survey reported upon by the American Association of Physicians and Surgeons (AAPS):

PHYSICIAN ATTITUDES & ADOPTION OF HEALTH INFORMATION TECHNOLOGY (PDF)

I wrote about that survey at this link. (I note that the AAPS is a conservative group; NYU and Harvard tend strongly towards the left; one wonders if the NEJM authors would have considered mentioning the AAPS survey, even if they did know of it.)

More potential biases appear in the conclusion of the new NEJM paper:

... In evaluating whether to invest in EHR technologies, provider organizations must weigh the substantial up-front cost and possible risks against the potentially sizeable, but uncertain, long-run benefits.[55]

[55] DesRoches CM, Campbell EG, Vogeli C, et al. "Electronic health records’ limited successes suggest more targeted uses." Health Aff (Millwood) 2010;29:639-46.

From [55]:

... We examined electronic health record adoption in U.S. hospitals and the relationship to quality and efficiency. Across a large number of metrics examined, the relationships were modest at best and generally lacked statistical or clinical significance. However, the presence of clinical decision support was associated with small quality gains. Our findings suggest that to drive substantial gains in quality and efficiency, simply adopting electronic health records is likely to be insufficient. Instead, policies are needed that encourage the use of electronic health records in ways that will lead to improvements in care.

Using [55] as an example of "potentially sizable but uncertain long-run benefits" is not how I would have interpreted the Health Affairs Millwood article.

The NEJM paper authors then write in their conclusion:

... The malpractice implications of EHRs should be included in future discussions of risks and benefits. [Agreed - ed.] Although there is currently little research quantifying the risks and benefits with respect to liability, we are optimistic that they will ultimately weigh in favor of the implementation of EHRs.

They do not state how or why they are optimistic, nor provide corroborating references for that opinion.

Is it revealing of bias and probably not a good practice, as far as I am concerned, to put what appears as wishful thinking -- especially where one states that there is little research supporting the optimism -- in the conclusion of a scientific paper.

In summary, while I feel the paper has a number of flaws, I am glad to see the topic of potential healthcare IT malpractice liability addressed in one of the top journals in medicine.

-- SS

Some answers about new site "EHRevent.org" for health IT and drug adverse event reporting - and a note on incendiaries

Some answers to the questions I raised here and here about a new site EHRevent.org, for reporting of healthcare IT and drug problems, can be found in a blog post at the site of Occam Practice Management at this link: http://www.occampm.com/blog/general/ehr-event-reporting/.

Its author, Michelle R. Wood, had noted this HC Renewal post. She researched some of the questions and wrote up her findings.

It is well worth a read.

I do have a small bone to pick with her post at Occam. She wrote:

"While HC Renewal occasionally borders on the incendiary side of things, Dr Silverstein posed some valid questions about a website that seem to have caught everyone by surprise..."

I maintain that the true incendiaries are fired by those we write about, those whose pronouncements and acts are "threats to health care's core values, especially those stemming from concentration and abuse of power."

Those 'incendiary' pronouncements and acts can indeed maim and kill (for example, as my own mother is now experiencing thanks to an ill done commercial EMR).

I may be more accurate to say we don't restrict ourselves to the confines of 'political correctness', that is, stunted discourse conventions that generally favor maintenance of the status quo.

As I wrote on that issue last year here in my series on mission hostile healthcare IT:

... Some have complained I am being "politically incorrect." At a time when our banks, major industries, investments, lifestyle and retirements have been seriously eroded by a combination of secrecy, incompetence, and criminal behavior on an unprecedented scale, I think such people need to get their priorities in order.

In his mantra "Critical thinking always, or your patient's dead", cardiothoracic surgeon Victor P. Satinsky, mentioned in earlier posts as my earliest medical mentor, did not include "but be polite about it" as part of the lesson.

On those pesky EMR curmudegons ... (click to enlarge)

-- SS

Addendum 11/17/10:

At the above Occam link Ms. Wood published my brief comment on this issue, and a thoughtful response. See the comment thread of her EHRevent essay.

-- SS

EHRevent: survey amateurism, bias, or something else?

At my post EHRevent.org: Web Site to Collect EHR Safety Reports, I wrote of my questions about a new organization, EHRevent.com, that seems to supercede or compete with the FDA's MAUDE and Medwatch medical device and medication adverse events reporting and analysis services.

Reviewing the EHRevent report form on this day (archived here, PDF), I note the following multiple choice question on page 7 (emphasis mine):

Notwithstanding the event you are reporting, has the adoption and use of an EHR by your practice added to patient safety, improved care or improved documentation? Select one option.

o Yes, definitely

o Likely

o Not sure

o No impact

A bias and/or survey amateurism is clearly evident in this question. And perhaps something more?

Missing is this option:

o None of the above; EHR adoption did not "add to"; rather, it subtracted, as worsening occurred

A fundamental rule of surveys is that the choices should not artificially limit the survey taker's ability to provide critical or relevant information.

As Ross Koppel, PhD, a sociologist studying healthcare IT at the University of Pennsylvania stated at the Feb. 25, 2010 HHS Certification/Adoption Workgroup Meeting on Health IT Safety (minutes of that meeting are archived at this link, PDF):

... Like everyone else, I want HIT to increase patient safety, care efficiency, treatment quality, savings, and drug ordering guidance. I want HIT to provide coherent structures for test results and other data, and I wanted to provide better visualization of complex clinical data.

Unlike many of my colleagues here who are HIT scholars and advocates, however, because of my training perhaps, I‘ve studied the surveys that have been used to guide and explain the current HIT strategy.

These surveys explored why doctors and hospitals have not embraced HIT‘s benefits. The findings pointed to the cost of HIT, to the physicians‘ resistance. They called them technophobic, hide bound, and perhaps most gruesome, too old. It also talked about overwhelmed hospital IT staff and other user pathologies or user inadequacies.

Now the years of research on HIT suggested that those answers could not be complete. They weren‘t right. The reasons the surveys found this, I‘ve been investigated, was I looked at the questions that were asked of the doctors and hospitals. And the only answer options dealt with the problems of hospitals and doctors. In other words, they found only the questions that they asked about physician difficulties, doctor difficulties. They didn‘t look for any other options, and they didn‘t even give other option answers to talk about the following issues.

So they could have asked, does HIT slow or speed your clinical work? Are EHR data presented in helpful ways, or do they generate unnecessary cognitive burdens because, for example, the data that should be contiguous are in five separate screens, where you‘re scrolling across vast wastelands of rows and columns looking for the needed information. How many information displays are understandable or are disarticulated, confusing, or missing key data? Does HIT distract from your patient care or improve it? And the last one I‘ll ask, although I have about 50 others, how responsive are HIT vendors to acknowledging and repairing defects? How quickly are these defects repaired?

The absence of the relevant questions divert us from understanding the actual HIT needs of clinicians and patients. Now I‘m certain that the people who asked these questions, designed these surveys, were not intentionally deceptive. Well, I‘m certain most were not intentionally deceptive. But the restricted options reflects a series of assumptions or … that says HIT is intrinsically beneficial. Anything that encourages HIT is good for patient safety. Anything that discourages it or retards it is bad by definition.

The creators of the EHRevent survey apparently were not present, or not listening, during Dr. Koppel's presentation.

I have not yet reviewed in depth the other survey questions for similar issues, but this one stood out like a sore thumb.



I cannot imagine an objective, competent scientist committing such an error.

-- SS

EHRevent.org: Web Site to Collect EHR Safety Reports

At "Cart before the horse, again" I observed the irrationality of creating "meaningful use" rules for health IT before usability issues (i.e., poor usability) had been robustly addressed, and the further irrationality of the IOM studying HIT safety after HIT became slated for national rollout in the next few years.

The horse seems to be starting to catch up to the cart (or is it the other way around?):

HDM Breaking News, November 15, 2010

The iHealth Alliance, a coalition of industry stakeholders, has launched an electronic health record safety reporting Web site, called EHRevent.org.

The site is designed to be a national system where providers can report safety issues related to the use of EHRs. Reported events will be confidential but used as the basis to generate other reports that medical societies, malpractice insurers and government agencies can use "to help educate providers on the potential challenges that EHR systems may bring," according to the alliance. The Food and Drug Administration will use data collected on the site to assist in evaluating safety issues that may arise during the forthcoming widespread implementation of EHRs.

Initial supporters of EHRevent.org include the American Medical Association and some state medical societies, American Cancer Society, National Patient Safety Foundation, American Pharmacists Association, CentrEast Regional Extension Center in Texas, and EHR vendor eMDs Inc.The PDR Network, which distributes drug labeling information, FDA-issued product safety alerts and other services such as the Physicians' Desk Reference, will operate the network. Participating insurers, medical societies, EHR vendors and other entities will have links to EHRevent.org on their own Web sites. A similar site to report adverse medication events, RxEvent.org, will launch in 30 to 60 days. [Is the FDA outsourcing MedWatch? - ed.]

Federal agency supporters include the Agency for Healthcare Research and Quality, and the Food and Drug Administration. Malpractice carrier supporters include COPIC Insurance Company and The Doctors Company.

From the homepage at http://www.ehrevent.org/:

The EHR Safety Event Reporting Service is a service of PDR Secure™, a Patient Safety Organization (“PSO”).

I have several concerns with this development:

• The site page on Privacy and Security states that "PDR Secure™, a certified Patient Safety Organization, receives oversight and governance from the iHealth Alliance, a not-for-profit organization whose mission is to protect the interests of patients and providers, as healthcare increasingly moves online." However, who's paying for the EHR Safety Event Reporting Service and the salaries of the people involved?
  

• How is it that these watchdog organizations seem to spring out of nowhere, with no opportunity for public comment or involvement before they "hatch?"

• Did Congress or other elected representatives have a role in this development?
  

• Will competitors also "hatch?"
  

• Why doesn't the FDA take on this role instead of simply "using data collected on the site to assist in evaluating safety issues that may arise during the forthcoming widespread implementation of EHRs?" They have the infrastructure and experience (e.g., the Medwatch and MAUDE reporting facilities).

• Will actual reports, de-identified as the the reporter, be available to the public in a searchable database as they are in, say, FDA's MAUDE database? (See posts on MAUDE here and here.) From the EHRevent site:
  

The Privacy and Security page states that "PDR Secure™ ... will collect, analyze and report back to healthcare providers and others on trends, recent new developments, and other information designed to reduce the risk of harm in the delivery of health care." The FAQ page states "PDR Secure will ... analyze and make available reports on the type of events, frequency of events, and other statistics as well as recommendations and best practices for using EHR systems. "

Will the actual report text itself be unavailable to the public?

• Re: "A similar site to report adverse medication events, RxEvent.org, will launch in 30 to 60 days." Is FDA abandoning its role in collecting drug AE reports?

Further, from the site's own language:

• What, exactly, will be done with the information? They state: "Reporting EHR events can help improve EHRs, support patient safety, reduce professional liability and help liability carriers and others properly educate physicians on safe use of EHRs." How?

• Is the reporting process really protected? Again, from the site itself:

How broad is the legal protection in this PSO?

Patient Safety Work Product - the information you provide in the reporting form, once it becomes part of the PSO environment - is entitled to greater protection from disclosure in legal matters as part of a new statutory and regulatory framework. PDR Secure™, as a certified and listed Patient Safety Organization under Federal law/regulations, has been designed to afford a reporter with the protections under this law. However, it is important to know that PSOs are relatively new entities that have not been tested in the courts of every jurisdiction. Each person or entity who submits information to PDR Secure™ should make their own independent evaluation as to the risks involved in submitting information and what particular information to submit.

Can I submit a report without identifying myself?

You need to provide your identity, which will become part of the PSO database. You can select whether your identity can be shared or is to be kept confidential under the regulations governing the PSO, and PDR Secure’s policies and procedures.

• Will the "contract" one has to agree with, a 16-page document studded with legalese (download here, .doc format), inhibit voluntary EMR-related problem reporting?
  

Even with those questions in mind, I think this may be a net positive development. It would at the very least seem to lay to rest the deterministic notion (and/or marketing message) that this technology is harmless and entirely beneficent.

Will it be an effective way to help reform the health IT industry? Time will tell.

-- SS

Addendum 11/16/10:
See my initial concerns with the EMRevent report form at my followup post here.

Addendum 11/17/10:
Some answers to these questions can be found in a blog post at the site of Occam Practice Management at this link: http://www.occampm.com/blog/general/ehr-event-reporting/, whose author noted this HC Renewal post. My comments are at a post here.

Report of an AMIA special task force on challenges in ethics, safety, best practices, and oversight regarding HIT

I am both surprised and pleased to read the new report of an American Medical Informatics Association (AMIA) task force, in the form of an AMIA Board Position Paper released today entitled:

"Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force." Goodman, Berner, Dente, Kaplan, Koppel et al. for the AMIA Board of Directors. J Am Med Inform Assoc (2010). doi:10.1136/jamia.2010.008946.

A free PDF is available at this link.

This report may be part of a trend. As I wrote recently at this link:

I was somewhat taken aback by the appearance of the article by Karsh et al. entitled "Health information technology: fallacies and sober realities" (covered at Healthcare Renewal here) in the Oct. 2010 Journal of the American Medical Informatics Association (JAMIA).

I was taken aback since the article rains heavily on the academic memes of healthcare IT as a benign and deterministic solution to healthcare's ills, and of health IT-related adverse outcomes being mere "anecdotes."

It appears that the views on healthcare IT safety, ethics, management practices, etc. appearing on the Healthcare Renewal blog and on my once-controversial academic health IT website "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" (started in 1999) are now becoming mainstream.

Most of the issues in this new AMIA Position Paper have been written about at this blog since 2004, and at my aforementioned academic HIT website since 1999. I will reproduce the abstract of the paper below, but download and read the entire paper (emphases mine):

ABSTRACT
The current commercial health information technology (HIT) arena encompasses a number of competing firms that provide electronic health applications to hospitals, clinical practices, and other healthcare-related entities. Such applications collect, store, and analyze patient information. Some vendors incorporate contract language whereby purchasers of HIT systems, such as hospitals and clinics, must indemnify vendors for malpractice or personal injury claims, even if those events are not caused or fostered by the purchasers. Some vendors require contract clauses that force HIT system purchasers to adopt vendor-defined policies that prevent the disclosure of errors, bugs, design flaws, and other HIT-software-related hazards. [The "gag clauses." These are exceptionally unethical, in my view, regarding the use of an experimental technology, healthcare IT, on unsuspecting, unconsented patients unaware of health IT risks - ed.] To address this issue, the AMIA Board of Directors appointed a Task Force to provide an analysis and insights. Task Force findings and recommendations include: patient safety should trump all other values [I've been writing and saying this for many years now - ed.]; corporate concerns about liability and intellectual property ownership may be valid but should not over-ride all other considerations; transparency and a commitment to patient safety should govern vendor contracts; institutions are duty-bound to provide ethics education to purchasers and users, and should commit publicly to standards of corporate conduct; and vendors, system purchasers, and users should encourage and assist in each others’ efforts to adopt best practices. Finally, the HIT community should re-examine whether and how regulation of electronic health applications could foster improved care, public health, and patient safety. [Regulation has been another issue I have focused upon, especially after holding a management role in Big Pharma - ed.]

Also notable was this proclamation:

... “Hold harmless” clauses in contracts between Electronic Health Application vendors and purchasers or clinical users, if and when they absolve the vendors of responsibility for errors or defects in their software, are unethical. [I note that, somewhat remarkably, this is not the more typical hedged academic "may be unethical" statement- ed.] Some of these clauses have stated in the past that HIT vendors are not responsible for errors or defects, even after vendors have been informed of problems.

Unethical, indeed, as per my JAMA letter of July 22, 2009 on that issue entitled "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" (link) and per my more detailed essay at my Drexel HIT website (link).

Also remarkable were these statements:

... For-profit manufacturers of healthcare products are bound by values which may at times conflict. For instance, as entities in a marketplace, they are duty-bound to provide a financial return to those investors who have contributed resources in anticipation of their success. Yet, as developers and manufacturers of products that affect the health of people, they are no less obligated to ensure, to the extent possible, that their products are safe and effective, and beneficially support patients [that goes without saying - ed.] and those who treat and care for them. [That is, clinicians, who through their unpaid hard work using oft ill-designed HIT systems are currently used as beta testers and, through 'hold harmless' clauses, as an insurance company and, quite frankly, as cannon fodder - ed.]

... Contracts should require that system defects, software deficiencies, and implementation practices that threaten patient safety should be reported, and information about them be made available to others, as appropriate. Vendors and their customers, including users, should report and make available salient information about threats to patient safety [I've also been writing this for years; it's common sense - ed.] resulting from software deficiencies, implementation errors, and other causes. This should be done in a way easily accessible to customers and to potential customers. This information, when provided to customers, should be coupled with applicable suggested fixes, and should not be used to penalize those making the information available. [There should be as little fear of reporting HIT problems as in reporting medication problems - ed.]

... If appropriate for their size and mission, vendors and client institutions contribute to the growth of biomedical knowledge by conducting HIT research [including research on how to remediate the HIT itself and the IT industry creeds, customs and traditions that cause suboptimal design and implementation in the first place - ed.] … authors of scientific reports should not be prevented from identifying devices, tools, and systems by name in publications.

… There are situations in which HIT vendors pursue joint marketing agreements with institutions that adopt vendors’ products and by which these institutions become a part of the vendors’ marketing program [I believe that hospitals should never allow themselves to become IT marketing and promotion operations - ed.], often in exchange for discounts, payments, stock options, or favorable treatment by the vendor. In at least some cases, these agreements include provisions whereby healthcare institutions that serve as demonstration sites for particular products receive compensation when other institutions adopt products from the same vendor. The Task Force notes that such agreements might place the “referring” institutions in a conflict of interest [a common topic on this blog -ed.], and therefore recommends that:

• Any such conflicts should be eliminated or managed, including disclosure, according to current standards.

• Where such agreements are made, they should include a provision whereby any payment or other compensation contingent on the sale of a system to another party must be disclosed to that other party.

• Payments or gifts to individuals and institutions, including institutional officials, clinicians, etc, should be disclosed. Alternatively, they should be addressed by entities’ internal mechanisms for managing conflicts of interest and commitment, perhaps along the lines of the “rebuttable presumption” standard endorsed by the Association of American Medical Colleges. The goal of the standard is “to ensure that institutions systematically review any financial interest that might give rise to the perception of a conflict of interest, and further, that they limit the conduct of human subjects research by financially interested individuals to those situations in which the circumstances are compelling.

The new AMIA Position Paper and the aforementioned paper on HIT fallacies and realities seem to reflect a welcome transformation or even about-face for AMIA. I am likely considered "radioactive" by some in that organization for espousing similar views dating back to the late 1990's, when expression of such views was uncommon and even frowned upon. Academia has not been highly tolerant of heterodoxy in many domains for quite some time.

One wonders if that stigma will "stick" in view of the increasing realization that such views were not heretical, but forward-thinking along the lines of my early medical mentor, the late Victor P. Satinsky, MD of Hahnemann Medical College and Hospital:

From http://www.upenn.edu/gazette/0298/0298obits.html: Dr. Victor P. Satinsky, C'34, Philadelphia, a cardiovascular surgeon at the old Hahnemann Hospital who helped develop coronary-bypass surgery; September 7 [1997]. He is also credited with 30 major medical innovations and the invention of the Satinsky clamp, now a standard instrument in cardiovascular surgery. He joined Hahnemann (now part of the Allegheny health system [as of 2010 now Drexel College of Medicine - ed.]) in 1946 to do thoracic-surgical research, and from 1961 till his retirement in 1977 he was the research director of its cardiovascular institute. Dr. Satinsky liked to refer to himself on promotional materials as 'the Renaissance Doctor', as he was also a poet, a playwright (some of his plays were produced in London), a painter, a clarinetist, and a fencer; he was known at Hahnemann for practicing his swordsmanship in the halls and classrooms of the hospital. And at the age of 80, he earned a black belt in aikido, and subsequently taught it. Although he had no religious training, during the Second World War he once filled in as a rabbi on a troopship going to Europe when he learned it had chaplains, but no rabbi. He also had taught himself psychiatry and while at Hahnemann developed educational programs for young people; the first, for gifted high-school students, began in 1961. He later added programs for disadvantaged youth, for young people with emotional problems, and one for college dropouts. On retiring, he set up the Satinsky Institute for Human Resource Development to continue this work, which he ran until his death at 84 years.

Dr. Satinsky's short, simple and unyielding credo was:

"Critical thinking always, or your patient's dead."

-- SS

On AMIA's Jan. 2009 Letter to The Office of President Elect Barack Obama: Something is Missing

------------------------------------------
Nov. 11, 2010 note: see the new post on an AMIA Board Position Paper released this day (Nov. 11) entitled "Report of an AMIA special task force on challenges in ethics, safety, best practices, and oversight regarding HIT" at this link.
------------------------------------------

I was somewhat taken aback by the appearance of the article by Karsh et al. entitled "Health information technology: fallacies and sober realities" (covered at Healthcare Renewal here) in the Oct. 2010 Journal of the American Medical Informatics Association (JAMIA).

I was taken aback since the article rains heavily on the academic memes of healthcare IT as a benign and deterministic solution to healthcare's ills, and of health IT-related adverse outcomes being mere "anecdotes."

(It is ironic that my own mother recently fell victim to healthcare IT's supposed beneficence. It is accurate to say she was nearly killed via health IT-related cognitive disruptions and the resultant utter failure of medication reconciliation, and remains severely impaired nearly six months later.)

My blog posting on that Karsh article brought a letter to my attention, authored by AMIA's leadership and sent on Jan. 7, 2009 to the Office of President Elect Barack Obama. The full PDF of the letter is here.

Here are relevant excerpts about which I will make only a single comment:

January 7, 2009

Dear Mr. President-Elect,

On behalf of the more than 4,000 physicians, nurses and other members of the American Medical Informatics Association (AMIA) who use health information and communications technology (HIT) to improve the quality, efficiency and safety of healthcare, I am writing to applaud and encourage your commitment to investing in a genuine transformation of our nation’s healthcare system. Properly deployed and supported, HIT can be part of broad health care reform and, importantly in this time of economic challenge, a significant economic multiplier that will encourage the creation of new jobs and real improvements in patient care, public health and life sciences research.

... If we are to develop a national infrastructure for the use of health information to benefit individuals and our entire population, the United States must –

• Develop mechanisms, including grants, loans and financial incentives for physicians, nurses, and healthcare organizations to deploy, implement successfully, and widely disseminate electronic health records (EHRs);
• Develop and support local, regional and national health information exchange to ensure that accurate, secure health information is available whenever and wherever needed by those authorized to access such information;
• Develop and support programs to address the need for a prepared health information technology workforce, with training and continuing education of physicians, nurses, health information managers and others;
• Develop more effective ways to address the health needs of underserved populations, including providing equitable access to health information and communications technology;
• Develop and assure compliance with standards, policies and practices that support effective sharing of health information, while fostering security, confidentiality and transparency, and building trust with the public;
• Develop and maintain health terminologies and classifications that will allow health data to be not only useful, but uniform and consistent, and enable interoperability across myriad information systems;
• Develop proper means to link information related to individuals in order to ensure the validity and integrity of health data used to inform care and research;
• Develop proper means for authentication of the identity of individuals and caregivers and any others authorized to access identifiable health information;
• Support the development of decision-making and other knowledge-management tools in order to permit the delivery of individualized, evidence-based care;
• Develop and support secure web-portals to link individuals to their caregivers and ensure genuinely patient-centered care;
• Develop appropriate and secure linkages between EHRs and the public health system to ensure safety from bioterrorism, rapidly spreading infectious diseases, and other threats;
• And provide appropriate funding for the development of a robust national health information strategy, with support for continued HIT and informatics research and innovation.

During the Presidential campaign, you demonstrated your boldness and vision by pledging to allocate $10 billion annually for five years to promote the adoption and use of health IT. Such an investment will pay dividends not only in improving health care, but in creating jobs...

These are all laudable and interesting goals for an experimental technology, as tacitly admitted in the above goals (although it would have been more ethical, I believe, to have waited for the technology to have "needed" fewer of these goals as a result of research in constrained settings before boldly promoting expensive national rollouts on live patients).

In any case, however, something very, very important is missing...

There is no mention of healthcare IT safety.

At $10 billion annually, surely the AMIA leadership could have specifically and explicitly recommended that some fraction, even a token % (even a small percentage of $10,000,000,000 is not chicken feed), should have been dedicated to help ensure the disruptions and unintended consequences caused by any new/developing/expanding information and communications technology (ICT) didn't kill or maim patients such as my mother.

Perhaps through the publication of the aforementioned Karsh study on HIT fallacies and sober realities, the AMIA leadership is subconsciously seeking absolution.

-- SS

Addendum: my own Dec. 7, 2008 "Open letter to President Obama" on healthcare IT took a decidedly different approach, namely, I attempted to make the President-elect aware of numerous HIT "fallacies and sober realities":

... our government has been seduced by the promise, the potential, the Siren Song if you will of HIT, and shielded from information on its true challenges, difficulties, downsides and failures. An "irrational exuberance", a Syndrome of Inappropriate and Uninformed Overconfidence in Computers prevails in healthcare.

... [If HIT itself is not reformed,] billions of precious healthcare dollars that might be spent on “IT misadventure” in a time of unprecedented national financial challenges and hardships might simply be better spent on delivery of needed medical services, health insurance and other "safety net" interventions.

... healthcare’s defects cannot be effectively changed or reformed via healthcare IT, if that healthcare IT itself is defective.

AMIA leadership and I also differed on the issue of health IT regulation, as I posted in July 2009 at "JAMA letter: Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards." On that issue, JAMA published my commentary, not theirs.

-- 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