A War on Patients: Panel Says EHRs Should Not Be Vetted Before Marketing and Deployment

"First, do harm - it's a learning experience, and injured or dead patients are just a bump in the road, anyway" - the apparent creed of the healthcare computing hyperenthusiasts

Joe Conn and Modern Healthcare published the following article:

Work group says OK to some HIT safety regs (link), Joe Conn, Modern Healthcare, Aug. 7, 2013

What is important is what safety regs the Workgroup said "no" to.  It comes as no surprise:

A federally chartered special work group with representatives from three federal agencies has submitted its draft recommendations on establishing a regulatory framework for health information technology. Chief among those recommendations is that health IT should not be subjected to pre-market federal regulation, but there were a few exceptions.

The exceptions are narrow, and are likely already covered as Class III medical devices by FDA (see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/):

The exceptions under which there should be FDA regulation, according to the work group, include medical device accessories to be defined as such by the FDA; certain forms of “high risk” clinical decision support systems, such as “computer aided diagnostics,” also to be defined by the FDA; and some “higher risk software” use cases to be defined by the committee's own safety work group.

They did acknowledge the need for postmarket surveillance:

... The group also recommended: developing a federally supported, post-market surveillance system for health IT products “to ensure safety-related decision support is in place,” creating a process for gathering information on safety issues, aggregated at the federal level and establishing a public process for “customer rating of HIT to enhance transparency.”

Dr. David Bates [a professor at Harvard Medical School], chairman of the Food and Drug Administration Safety Innovation Act work group, presented the preliminary findings Wednesday at a meeting of HHS' Health Information Technology Policy Committee.

Let me translate this to plain English:  the health IT systems that go in (and their upgrades and patches) are recommended to be free from pre-marketing regulation and regulatory vetting.  Patients are to be the guinea pigs for testing of the software.  

If patients are harmed or killed, they get the honor of being named as "postmarket surveillance learning cases" who gave their all for the betterment of healthcare information technology.  

(Without their consent, but who needs consent to test experimental and unvetted devices on guinea pigs?)

Bates did express some liability concerns:

Asked during a question and answer period following his presentation whether the committee had considered the liability implications of its recommendations, Bates said, “It's not something we discussed at length, but it's something we can discuss over the next month.”

I, on the other hand, as a legal consultant on health IT-related medical errors and evidence tampering, am considering liability issues.

Unfortunately, patients would rather be whole than in lawsuits (or dead).  Also, sadly, it's physicians and nurses who will bear the brunt, if not all, of the liability for bad outcomes due to defective IT such as at these two recent posts, with vendor alerts regarding serious flaws of medication and other orders not being retained:

• Another Health IT "Glitch" - Can Digital Disappearing Ink Kill Patients? - Siemens Safety Advisory Notification #1

• Can Digital Disappearing Ink (An EHR "Glitch") Kill Patients? Part 2 - Siemens Safety Advisory Notification #2

• and the others posted at this blog at query link: http://hcrenewal.blogspot.com/search/label/glitch

A clarification for all those proletarians who lack Harvard educations, and for the Workgroup members as well. Allow me to point out that the above manufacturer safety alerts of life-threatening fundamental flaws (involving entered text that "disappears", apparently found in live-patient scenarios, and the other "glitches" that did cause life-threatening errors sometimes en masse involving thousands of patients such as another apparent Siemens debacle at http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html) would likely not have occurred if the systems had been vetted before being turned loose on patients.

Finally:  David and panel members, my mother and I thank you profusely. 

Oh wait...my mother can't thank you, she's dead from the toxic effects of un-premarket-vetted health IT on simple care processes at the very hospital where I performed my residency two decades ago.

She might have died a few times before she actually did thanks to other IT "glitches" that cropped up during her recovery from the first one, but I was able to (in one case, by sheer happenstance of showing up at  the right time) discover or provide staff with information to work around additional unvetted-health-IT flaws before those did her in.

It's taken more than a decade for critical-thinking, unconflicted writers and researchers ("iconoclasts") to force cybernetics-over-all hyperenthusasts (see here) like Bates and his panel members to own up the risks of health IT at all, e.g. via sites like this blog and this teaching site. These panel members IMO have their heads buried in sand.

Dr. Bates and his panel are, in my opinion, healthcare IT extremists, which is in part the apparent holding of the belief that computers have more rights than patients - and the other beliefs mentioned in this post:  "Another Health IT 'Glitch' - Can Digital Disappearing Ink Kill Patients?" at http://hcrenewal.blogspot.com/2013/08/another-health-it-glitch-can.html.

-- SS

Modern Healthcare: "Health IT Iconoclasts"

The healthcare executive-targeted journal "Modern Healthcare" has named Dr. Ross Koppel, Dr. Deborah Peel, Dr. Larry Weed, and yours truly as "healthcare IT iconoclasts."  Dr. William Bria corroborated the importance of iconoclasty in this domain.

(I would rather see the term "defender of patient's rights" rather then "iconoclast", but I'll settle for the latter if it gets the message out.)

Author Joe Conn writes:

... health IT has long had its critics, even among its pioneers and proponents, as these four prominent health IT iconoclasts will attest. All four consider themselves to be proponents of health IT, but they rail against a tide of health IT boosterism. Their targets: misplaced priorities, failing to promote EHR usability and interoperability, inadequate concern for patient safety and privacy, overemphasizing EHR adoption, understating IT costs and overestimating the return on public IT investments.

He then profiles the four.

On Univ. of Pennsylvania professor and industry punching-bag Dr. Ross Koppel:

Researcher Ross Koppel started an uproar in 2005 when he and a colleague coauthored an article in the Journal of the American Medical Association that found a first-generation computerized physician order entry system (CPOE) at the Hospital of the University of Pennsylvania was simultaneously creating new errors even as it reduced others.

Koppel’s bombshell—he’s now an adjunct professor of sociology at the University of Pennsylvania— brought down the wrath of information technology boosters. The Healthcare Information and Management Systems Society, a health IT trade group, challenged the study’s “methodology and its subsequent outcomes,” and criticized its authors for their “limited view” and not “looking at the big picture.”

... In 2009, he revealed in another JAMA article that health IT vendors’ contracts included “hold harmless” clauses that shielded software developers from legal liability for medical errors their systems caused, even if the developers had been warned about the defects. “That got me major upheaval,” the worst of his career, Koppel recalls.

On privacy advocate, psychiatrist Dr. Deborah Peel (no relation to Emma Peel, although there are similarities in the "has guts" department):

“Let’s face it,” Peel says, “HHS is the agency that eliminated patient control over electronic medical records and has remained hostile to patients’ rights ever since.”

Days before the 2002 revision [HHS redraft of the privacy rule of the HIPAA Health Insurance Portability and Accountability Act] went into effect, a group of patients calling themselves Citizens for Health, and more than dozen other plaintiffs, including Peel, sued HHS Secretary Tommy Thompson in federal court, alleging the revisions violated patients’ constitutional rights to privacy. They lost at both the trial and appeals-court levels and were denied a hearing on appeal to the U.S. Supreme Court in 2006.

Peel launched the not-for-profit Patient Privacy Rights Foundation in 2003.

... “Where I’m coming from is, I’ve spent all this time in a profession with people being hurt,” Peel says. “Starting in the 1970s, when I first let out my shingle, people came to me and said, if I paid you in cash, would you keep my records private. Now, we’ve got a situation where you don’t even know where all your records are. We don’t have a chain of custody for our data, or have a data map” to track its location.

 On SOAP-note and Medical Informatics pioneer Dr. Larry Weed:

It’s a rotten system,” declares Dr. Lawrence Weed, who at age 89 is the dean of healthcare information technology iconoclasts.

Weed isn’t disparaging any particular brand of electronic health record system. A dismissive “they’re inadequate” would fairly well cover a Weed-guided tour of today’s EHR systems.

“People don’t get the general picture,” he says. “It’s broken. It’s basically an unsound system.” By that he means the entire healthcare system, but not because its providers are using faulty information technology, but because they’re using IT the wrong way, at least in part.

... In 1984, to help physicians cope [with the knowledge explosion], Weed developed a computer-based, diagnostic support system he called the problem-knowledge coupler. The software company he founded, but is no longer with, PKC, now part of Sharecare, still sells the system. Weed still proselytizes with fervor, calling for the use of computers to store, retrieve and apply medical knowledge.

On me:

The title of Dr. Scot Silverstein’s teaching website at Drexel University, “Contemporary Issues in Medical Informatics: Good Health IT, Bad Health IT, and Common Examples of Healthcare IT Difficulties,” [link] summarizes the veteran physician informaticist’s general outlook on the current state of affairs in health information technology.

It tells you nothing, however, of the passion with which Silverstein speaks or writes about the subject. Also a frequent contributor to the popular reformist “Healthcare Renewal” blog, Silverstein writes with the fire you might expect coming from a self-described computer geek who says he has witnessed a faulty electronic health-record system mysteriously drop a single medication from a patient’s medication list. That missing drug led to a medical error that resulted in a year of suffering and, eventually, that patient’s death, he says.

Silverstein’s passion is even more understandable when he tells you that patient was the doctor’s own mother.

... The health IT world, Silverstein says, parts neatly between “good IT” and “bad IT.” There are those who push hard for the good and complain about the bad, physicians and other clinicians he calls “pragmatic,” and for whom he has sympathy and respect. And then there are those who stay silent, ignoring or acquiescing to the bad, the “hyper-enthusiasts” for whom he holds only unmitigated scorn. “The doctors who don’t speak up about health IT, who work around it, which can cause its own bad results, those are traitors to the oath they took to first do no harm,” he says.

“Physicians are still being accused of being Luddites for not adopting this stuff,” Silverstein says. “Physicians are not Luddites. When it’s good IT, it’s used. I see the tension now between hyper-enthusiasts, who turn a blind eye to the negatives, and pragmatic physicians and nurses who have work to do.”

Finally, Dr. William Bria, longtime president of the Association of Medical Directors of Information Systems (AMDIS) sums up the article this way:

... When it comes to the criticism, “the one thing we can’t do with this information is to ignore it."

“Many, many technologies have come and gone in the history of medicine over the centuries, and it often has been a maverick physician that has called a timeout on ineffective medications or treatments.

“There is little question that, going forward, medicine will be using information tools,” Bria says. “However, I believe it’s becoming also very apparent that we need a modulation and a proper regulation of information technologies used in day-to-day care.”

Amen to that.

The article is available here.

-- SS