An Open Letter to David Bates, MD, Chair, ONC FDASIA Health IT Policy Committee on Recommendations Against Premarket Testing and Validation of Health IT

From http://www.healthit.gov/policy-researchers-implementers/federal-advisory-committees-facas/fdasia:

The Food and Drug Administration Safety Innovation Act (FDASIA) Health IT Policy Committee Workgroup is charged with providing expert input on issues and concepts identified by the Food and Drug Administration (FDA), Office of the National Coordinator for Health IT (ONC), and the Federal Communications Commission (FCC) to inform the development of a report on an appropriate, risk-based regulatory framework pertaining to health information technology including mobile medical applications that promotes innovation, protects patient safety, and avoids regulatory duplication.

My Open Letter to the Committee's chair speaks for itself:

From: Scot Silverstein
Date: Mon, Sep 16, 2013 at 9:39 AM
Subject: ONC FDASIA Health IT Policy Committee's recommendations on Premarket Surveillance
To: David Bates

Sept. 16, 2013

David Bates, Chair, ONC FDASIA Health IT Policy Committee
via email
   
Dear David,

I am disappointed (and in fact appalled) at the ONC FDASIA Health IT Policy Committee's recommendations that health IT including typical commercial EHR/CPOE systems not be subjected to a premarket testing and validation process.  I believe this recommendation is, quite frankly, negligent. [1]

As you know, my own mother was injured and then died as a result of EHR deficiencies, and nearly injured or killed again in the recuperation period from her initial injuries by more health IT problems in a second EHR used in her care.  In my legal consulting and from my colleagues, as well as from the literature, I hear about other injuries/deaths and many "near misses" as well.  That your recommendations came in the face of the recent ECRI Deep Dive study is even more appalling, with the latter's finding of 171 health IT-related incidents in 9 weeks from 36 member PSO hospitals, resulting in 8 injuries and 3 possible deaths, all reported voluntarily. [2]

It is my expert opinion the issues that cause these outcomes would never have made it into production systems, had a reasonable, competent, unbiased premarket testing and validation process been in place.

Consequently, I have shared the FDASIA HIT Policy Committee's recommendations with the Plaintiff's Bar, and will use its recommendations in my presentations to various chapters of the American Association for Justice (the trial lawyer's association) - as well as to interested Defense attorneys so they may advise their clients accordingly.

I am also making recommendations that in any torts, individual or class, regarding EHR problems that would likely have been averted with competent premarket testing and validation, that the FDASIA HIT Policy Committee members who agreed with the recommendation be considered possible defendants.

I am sorry it has come to this.

Please note I am also posting this message for public viewing at the Healthcare Renewal weblog of the Foundation for Integrity and Responsibility in Medicine (FIRM).

Sincerely,

Scot Silverstein, MD
Consultant/Independent Expert Witness in Healthcare Informatics
Adjunct Faculty, Drexel University, College of Computing and Informatics

Notes:


[1] FDA Law Blog, Recommendations of FDASIA Health IT Workgroup Accepted, September 11, 2013, available at http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/09/recommendations-of-fdasia-health-it-workgroup-accepted.html: "Of particular interest is the recommendation that health IT should generally not be subject to FDA premarket requirements, with a few exceptions:  medical device accessories, high-risk clinical decision support, and higher risk software use cases."

[2] "Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI 'Deep Dive' Study of Health IT Events" , Feb. 28. 2013, available at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html.

-----------------------------------------------

Note: the following are listed on the linked site above as members of the committee:

Member List

• David Bates, Chair, Brigham and Women’s Hospital
• Patricia Brennan, University of Wisconsin-Madison
• Geoff Clapp, Better
• Todd Cooper, Breakthrough Solutions Foundry, Inc.
• Meghan Dierks, Harvard Medical Faculty, Division of Clinical Informatics
• Esther Dyson, EDventure Holdings
• Richard Eaton, Medical Imaging & Technology Alliance
• Anura Fernando, Underwriters Laboratories
• Lauren Fifield, Practice Fusion, Inc.
• Michael Flis, Roche Diagnostics
• Elisabeth George, Philips Healthcare
• Julian Goldman, Massachusetts General Hospital/ Partners Healthcare
• T. Drew Hickerson, Happtique, Inc.
• Jeffrey Jacques, Aetna
• Robert Jarrin, Qualcomm Incorporated
• Mo Kaushal, Aberdare Ventures/National Venture Capital Association
• Keith Larsen, Intermountain Health
• Mary Anne Leach, Children’s Hospital Colorado
• Meg Marshall, Cerner Corporation
• Mary Mastenbrook, Consumer
• Jackie McCarthy, CTIA - The Wireless Association
• Anna McCollister-Slipp, Galileo Analytics
• Jonathan Potter, Application Developers Alliance
• Jared Quoyeser, Intel Corporation
• Martin Sepulveda, IBM
• Joseph Smith, West Health
• Paul Tang, Palo Alto Medical Foundation
• Bradley Thompson, Epstein Becker Green, P.C
• Michael Swiernik, MobileHealthRx, Inc.

Federal Ex Officios

• Jodi Daniel, ONC
• Bakul Patel, FDA
• Matthew Quinn, FCC

 -- SS

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

Forbes: Obamacare Billionaire: What One Entrepreneur's Rise Says About The Future Of Medicine

An article in Forbes appeared today (4/18/12) entitled "Obamacare Billionaire: What One Entrepreneur's Rise Says About The Future Of Medicine" by Matthew Herper.

The article is largely a hagiography of Cerner founder Neal Patterson:

North Kansas City is an unlikely place to launch a revolution in American health care. Yet here, amid the dilapidated grain elevators, fast food joints and vast green plains, the dream of using computers to keep you alive at a reasonable cost is battling onward. In a bunkerlike building built to withstand a direct hit by a category five tornado, 22,000 servers handle 150 million health care transactions a day, roughly one-third of the patient data for the entire U.S. Records of your blood pressure, cholesterol, lab test results, that gallbladder surgery last year—and how much you paid for it—may sit there right now. Armed guards stand watch.

This is a data center at the headquarters of Cerner, the world’s largest stand-alone maker of health IT systems—and company number 1,621 on FORBES’ Global 2000 list—where the blood-and-guts realities of medicine meet the ­sterile speed and exactitude of the computer revolution.

Omitted are some pertinent negative accounts, such as Cerner's role in the failed £12.7bn ($20bn U.S.) National Programme for IT in the NHS (NPfIT), as described here and here.

Patterson is quoted with the standard industry bellicose grandiosity and hysterics about computers "revolutionizing" (as opposed to facilitating) medicine:

... In 1999 a report from the prestigious Institute of Medicine gave Patterson hope that the rest of medicine was ready to follow in Mayo’s footsteps. Titled “To Err Is Human,” the report detailed how between 44,000 and 98,000 people die every year in hospitals from preventable mistakes, like getting the wrong medicine or the wrong dose of the right one. The ­report specifically prescribed better computer systems as a way to prevent these deadly mistakes. Patterson cites that study as the moment when health IT entered the mainstream. But it was still slow going, and that drove him nuts. His customers at that time were more worried about the Y2K bug than they were about revolutionizing health care.

I first heard him and other HIT CEO's uttering the "revolution" line at a Microsoft Healthcare Users Group meeting ca. 1997 and attended largely by IT technicians. I was probably the only Medical Informatics-trained professional in attendance, and perhaps the only physician there.

When I then asked those in the room how many had healthcare experience or had even read the Merck Manual, few hands went up. The CEO's could not then satisfactorily explain how medicine would be "revolutionized" by such a crowd. (One of those CEO's, of erstwhile HIT vendor HBOC, was later found to be seriously cooking the books after acquisition by McKesson. See "Former McKesson HBOC Chairman Convicted of Securities Fraud; Defrauded Investors Lost in Excess of $8 Billion" at FBI.gov. Some revolution...)

Unfortunately, most medical errors have little to do with documentation, either paper or electronic, as I wrote in Dec. 2010 at "Is Healthcare IT a Solution to the Wrong Problem?". The latter, however, has introduced many new errors modes and other social-technical problems, permitted massive security breaches (it's very hard to haul away 10,000 paper charts without being noticed) and opportunities for medical records evidence spoliation simply not possible with paper.

There are a few Ddulite-ish quotes from Eric Topol and David Bates in an article with a clear tone of exalting health IT.

I am quoted in the Forbes article in about the only comment critical of health IT, and the only comment concerning the ethics of human subjects experimentation conducted with this technology, as it exists in 2012:

... the Hippocratic oath says nothing about breaking eggs to make omelets. “We’re kind of headed in the wrong direction,” says Scot Silverstein, a health IT expert at Drexel University who believes that the current systems are too prone to randomly losing data [I had cited this study - ed.] and complicating doctors’ lives.

While the "breaking eggs to make omelets" metaphor was not mine, it reminded me that I just carried out my final earthly duty for my mother, injured in mid 2010 by a health IT-related error and deceased since June 2011. I filed her final IRS tax return yesterday, the due date.

I just hope my mother is enjoying her omelet in the Pearly Gates Diner. Scrambled eggs were about all she could eat well after the health IT accident.

As a result of that experience, my new business card (phone # redacted):

(Click to enlarge)

I no longer merely write about health IT risks. I find past involvement with attorneys early in my medical career, as Manager of Medical Programs and Medical Review Officer (drug testing officer) for one of the largest public transit authorities in the United States, quite helpful in this new role.

The "eggs that get broken", as in a well known old nursery rhyme from the early 1800's, cannot be reassembled. Those injured or killed in the unregulated, thoughtless, cavalier journey to some mystical medical cybernetic utopia deserve justice, and the eggheads responsible for their harms have earned the privilege of explaining themselves in the courtroom and being properly penalized where appropriate.

The future of medicine - if it is to not become a nightmare ignoring the lessons of history, repeating the mistakes of the past - belongs to those willing to take an ethical stand in defense of medicine's core values, and in defense of patients.

-- SS