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

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

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

The complaints are not just coming from me now.

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

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

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

Dear Dr. DeSalvo:

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

Of course, my attitude is that we need basic operability before the wickedly difficult to accomplish and far less useful (to patients) interoperability. 
 

... Most importantly, certified EHR technology (CEHRT) can present safety concerns for patients. We believe there is an urgent need to change the current certification program to better align end-to-end testing to focus on EHR usability, interoperability, and safety.

Let me state what they're saying more clearly:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

-- SS

1/28/2015  Addendum:

Per a colleague:

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

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

That is simply perverse.

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

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

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

It's the responsibility of the sellers.

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

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

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

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

-- SS

6:02 AM

A new "Better EHR" book and an observation re: health IT regulation, health IT amateurs, and user centered design (UCD) - "responding to user feature requests or complaints?"

A new book has appeared on improving usability of electronic health records.  The result of government-sponsored work, the book is available free for download.  It was announced via an AMIA (American Medical Informatics Association, http://www.amia.org/) listserv, among others:

From: Jiajie Zhang [support@lists.amia.org]
Sent: Tuesday, December 02, 2014 6:00 PM
To: implementation@lists.amia.org
Subject: [Implementation] - New Book on EHR Usability - "Better EHR: Usability, Workflow, and Cognitive Support in Electronic Health Records"

Dear Colleagues,

We are pleased to announce the availability of a free new book from the ONC supported SHARPC project: "Better EHR: Usability, Workflow, and Cognitive Support in Electronic Health Records".The electronic versions (both pdf and iBook) are freely available to the public at the following link:https://sbmi.uth.edu/nccd/better-ehr/

First, this book appears to be a very good resource at understanding issues related to EHR usability.  I particularly like the discussion of cognitive issues.

However, this book also holds messages about the state of the industry and the issue of regulation vs. no regulation, and impairment of innovation:

I think it axiomatic that user-centered design (UCD) is a key area for innovation, especially in life-critical software like clinical IT.  (I would opine that UCD is actually critical to safety and efficacy of these sophisticated information systems in a sociotechnically complex setting.)

I think it indisputable that the health IT industry has been largely unregulated for most of its existence, in the manner of other healthcare sectors such as pharma and traditional medical devices.

Yet, even in the absence of regulation, the book authors found this, per Section 5 - EHR Vendor Usability Practices:

a)  A research team of human factors, clinician/human factors, and clinician/informatics experts visited eleven EHR vendors and conducted semi-structured interviews about their UCD processes. "Process" was defined as any series of actions that iteratively incorporated user feedback throughout the design and development of an EHR system. Some vendors developed their own UCD processes while others followed published processes, such as ISO or NIST guidelines.

Vendor recruitment. Eleven vendors based on market position and type of knowledge that might be gained were recruited for a representative sample (Table 1). Vendors received no compensation and were ensured anonymity.

and

b)  RESULTS
Vendors generally fell into one of three UCD implementation categories:

Well-developed UCD: These vendors had a refined UCD process, including infrastructure and the expertise to study user requirements, an iterative design process, formative and summative testing. Importantly, these vendors developed efficient means of integrating design within the rigorous software development schedules common to the industry, such as maintaining a a network of test participants and remote testing capabilities. Vendors typically employed an extensive usability staff.

Basic UCD: These vendors understood the importance of UCD and were working toward developing and refining UCD processes to meet their needs. These vendors typically employed few usability experts and faced resource constraints making it difficult to develop a rigorous UCD process.

Misconceptions of UCD: These vendors did not have a UCD process in place and generally misunderstood the concept, in many cases believing that responding to user feature requests or complaints constituted UCD. These vendors generally did not have human factors/usability experts on staff. Leadership often held little appreciation for usability.

About a third of our vendor sample fell equally into each category.

In other words, a third of health IT sellers lacked the resources to do an adequate job of UCD and testing; and a third did not even understand the concept.

Let me reiterate:

In an unregulated life-critical industry, a third of these sampled sellers thought 'responding to user feature requests or complaints constituted UCD'.  And another third neglected UCD due to a 'lack of resources'.

I find that nothing short of remarkable.

I opine that this is only possible in healthcare in an unregulated healthcare sector.

Regulation, for example, that enforced good design practices and good manufacturing practices (GMP's) could, it follows, actually improve clinical IT innovation considering the observations found by these authors, through ensuring those without the resources either found them or removed themselves from the marketplace, and by making sure those sellers that did not understand such a fundamental concept either became experts it UCD, or also left the marketplace.

I can only wonder in what other fundamental(s) other sellers are lacking, hampering innovation, that could be improved through regulation.

As a final point, arguments that regulation hampers innovation seems to assume a fundamental level of competency and good practices to start with among those to be freed from regulation. In this case, that turns our to be an incorrect assumption. 

As a radio amateur, I often use the term "health IT amateurs" to describe persons and organizations who should not be in leadership roles in health IT, just as I, as a radio amateur, should not be (and would not want to be) in a leadership role in a mission-critical telecommunications project.

I think that, inadvertently, the writers of this book section gave real meaning to my term "health IT amateurs."  User centered design is not a post-accident or post-mortem activity.

-- SS

12/4/2014 Addendum:

I should add that in the terminology of IT, "we don't have enough resources" - a line I've heard numerous times in my CMIO and other IT-related leadership roles - often meant: we don't want to do extra work, to reduce our profits (or miss our budget targets), or hire someone who actually knows what they're doing because we don't really think that the expertise/tasks in question are really that important.

In other cases, the expertise is present. but when those experts opine an EHR product will kill people if released, they find the expert 'redundant', e.g., http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=lawsuit.

Put in more colloquial terms, this is a slovenly industry that has always made me uncomfortable, perhaps in part due to my experience having been a medical safety manager in public transit (SEPTA in Philadelphia), where lapses in basic safety processes could, and did, result in bloody train wrecks.

Perhaps some whose sole experience with indolence and incompetence-driven catastrophe has been in discussions over coffee in faculty lounges cannot appreciate that viewpoint.

Academic organizations like AMIA could do, and could have done, a whole lot more to help reform this industry, years ago.

-- SS

2:39 PM

JAMA letter: "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards"

My letter "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" was published in JAMA yesterday. A preview of the letter can be seen here, or a full version here if you subscribe to JAMA.

The letter was in response to Koppel and Kreda's groundbreaking March 2009 JAMA article "Health Care Information Technology Vendors' Hold Harmless Clause: Implications for Patients and Clinicians."

The JAMA letter covered some of the same points I addressed extensively at my Drexel HIT website essay "Hold Harmless and Keep Defects Secret Clauses", including the major point that hospital executives signing such contracts are in violation of Joint Commission standards for conduct related to safety, and in violation of their fiduciary responsibilities towards patient and employee safety and freedom from undue liability. In the Drexel website essay I also noted that:

... these stipulations [hold harmless and gag clauses in contracts] further instantiate my observation that health IT lacks the rigor of medical science itself, its major Achilles heel.

Koppel and Kreda note in their JAMA reply to my JAMA letter that:

Dr Silverstein's letter adds context to our Commentary on HIT vendors' self-protective "hold harmless" clauses while introducing an important discussion about hospitals' and vendors' possible violations of Joint Commission standards. We agree with Silverstein about the misapplication of the standard business software contracting model.

Of interest, the American Medical Informatics Association (AMIA) had authored a reply to Koppel and Kreda quite different than mine, which for a time appeared on their national website (www.jamia.org) but was later withdrawn apparently due to concerns that such a letter might be viewed as an official organizational position. It was entitled "Response to Commentary in JAMA -- Ross Koppel, David Kreda" and can be read in its entirety here.

The AMIA response piece concluded:

"While we support increased transparency around error disclosure, the belief that the best approach to increase the safety and effectiveness of EHR systems is by legal regulation of system vendors is misplaced. Such an approach would stifle innovation and not achieve the desired goals. At a minimum equal attention needs to be given to the role that provider organizations bring to configuration, management and oversight of the software and related processes."

In fact, Koppel and Kreda addressed the provider side issues extensively in their article.

Of interest, JAMA did not publish the AMIA response but instead published mine. Perhaps it's because JAMA felt I had something important to say, as opposed to simply making excuses for HIT vendors and valuing prevention of "stifling of innovation" over hospital leadership's safety and fiduciary obligations to patients and staff.

"The belief that the best approach to improving HIT safety is via regulation is misplaced?" (Misplaced how, exactly?) Tell that to the airline or public transit or pharma or the medical device industries. Or to the public whose care is increasingly dependent upon these HIT systems.

It is my firm opinion that "innovation" done recklessly, in secrecy, without accountability, and via exploitation is not innovation at all.

-- SS

July 23 addendum:

Dr. Koppel has forwarded to me a letter he and Mr. Kreda submitted to AMIA in response to AMIA's aforementioned critique of his March 2009 JAMA "Hold Harmless Clause" article. Koppel and Kreda's letter, "On the AMIA Response to Commentary in JAMA by Ross Koppel and David Kreda" can be read here (MS Word .doc format).

Highlights:

... Where the AMIA authors disagree with us is the emphasis placed on errors produced in the coupling. [The coupling of healthcare organization and software, i.e., alterations and customizations beyond the control of the software vendor - ed.] We say a vast number or errors are generated in the marriage. But they say we have essentially ignored how many errors are created by doctors and hospitals seeking to consummate their relationship with HIT systems in situ ...

... A brief recap of our JAMA commentary seems in order. We wrote about: (1) the HIT vendor “non-disclosure” clauses that prevent clinicians from sharing information about errors generated from faulty software; (2) the clauses that remove all vendor responsibility for errors in their systems – and place all responsibility on clinicians and hospitals (the “hold harmless/learned intermediary” clauses); (3) the need to protect vendors from responsibilities for errors introduced when hospitals implement HIT or when untrained or incompetent clinicians use the HIT; and (4) the need for more balanced contracts that are fair to clinicians and hospitals ...

... Given that we addressed the non-software issues we are said to have ignored, we are not sure why our JAMA commentary earned the response it received on official AMIA letterhead. We hope, therefore that this letter can further a longer conversation about the many ways to make clinical IT software and its implementation better. Nonetheless, we stand by our statement that the imbalance in incentives we described in our JAMA Commentary is a structural obstacle that on balance hurts improving the clinical part of clinical IT.

Read the whole thing at the link above. (I placed Koppel and Kreda's response to AMIA on my faculty server. The response, to the best of my knowledge, was not published by AMIA itself.)

-- SS

7:06 AM