Monday, September 16, 2013

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

7 comments:

Anonymous said...

Trial lawyers just received one hell of a gift from David Bates and the ONC FDASIA Health IT Policy Committee. Sick sick sick.

InformaticsMD said...

Anonymous September 17, 2013 at 6:25:00 AM EDT writes:

Trial lawyers just received one hell of a gift from David Bates and the ONC FDASIA Health IT Policy Committee.

In my view, the Committee should be proud of their decisions and fully willing to defend them in front of juries in cases of EHR-related patient harm.

If not, they should have either decided differently, or not served on the Committee.

-- SS

Anonymous said...

The FDASIA Work Group is an example of what it means to have the fox guard the hen house.

Its recommendation was predictable.

The process was a sham.

Bates and his Work Group should be named in future lawsuits for participating in and guiding the scheme to put patients' lives at risk by recommending that medical devices be sold and used in violation of the Federal Food Drug and Cosmetic Act.

I too will adress this with the attorneys calling on me for expert opinion in deaths caused by toxic HIT.

Thanks for publishing this.

Michael said...

David Bates...or Norman Bates?

Anonymous said...

Before writing this letter, it probably would have been a good idea to read the recommendations. The working group recommended "FDA premarket requirements" should be reserved for several categories of higher risk HIT. The working group in no way said, as you accuse in your letter, that "health IT including typical commercial EHR/CPOE systems not be subjected to a premarket testing and validation process." You should have read the report more carefully.

The working group did not feel that low risk HIT (and you would need to read the report to see what the working group put in that category) should need to seek FDA premarket clearance before marketing.

But of course vendors of even lower risk HIT should subject their products to premarket testing and validation, just as anyone who makes a product where reliability is important. Basic tort law requires such diligence and the working group in no way suggested otherwise.

Please read the report and listen to the audio before you start making accusations.

InformaticsMD said...

Anonymous September 23, 2013 at 10:54:00 AM EDT wrote:

First, I note that you are posting anonymously. Why?

The working group did not feel that low risk HIT (and you would need to read the report to see what the working group put in that category) should need to seek FDA premarket clearance before marketing).

Perhaps you should read that report yourself. "Low risk" is quite a relative term subject to a lot of politicking, and considering the known risks of clinical IT (e.g., per the AHRQ Health IT Hazard Manager data at http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf and its HIT hazards ontology at http://healthit.ahrq.gov/sites/default/files/docs/citation/AppendixB_HIT_Hazard_Manager_Beta_Test.pdf), I'm not sure what "low risk" is.

A blanket recommendation against premarket testing and validation of "low risk" clinical IT is potentially quite industry-friendly.

Why does Pharma not receive a similar regulatory accommodation? Many of the products they produce are of (proven) very low risk. Or perhaps you think they should receive the extraordinary regulatory accommodations of the HIT sector.

But of course vendors of even lower risk HIT should subject their products to premarket testing and validation, just as anyone who makes a product where reliability is important. Basic tort law requires such diligence and the working group in no way suggested otherwise.

Well, yes, but many of the problems that have resulted such as aggregated in this blog in many, many reports from the wider press demonstrate that the industry is not doing do, or at best not doing very well at it. I note that it's costly to thoroughly test and validate software and reduces margins (but that's certainly not the ultimate customer's, a.k.a. patient's problem).

That you make such a statement in a tone of sincerity, that implies in effect the industry should be self-policing regarding "low risk" health IT software, shows you need to read this blog a bit more carefully, and not just regarding health IT risk, health IT dangers or other index terms.

Finally, you've in my view pregnantly ignored footnote [2]. the ECRI Deep Dive study of health IT risk, finding in a 9 week volunteer-reporting study of 36 ECRI PSO member hospitals, there were 171 health IT mishaps, 8 of which were reported to have caused harm, and 3 possibly contributing to patient death.

I'm personally aware of cases where mundane EHR systems for storing patient histories, medications, allergies and other routine data (here), or even simple PACS systems issues (here), led to patient death.

I do not find it credible that the Committee members do not have access to the same information, in far larger quantities than I as a sole citizen do.

ECRI is a world-renowned medical technology testing company (with which I have no connections) that for the past several years has listed health IT among the "Top Ten Hospital Technology Hazards", an annual report it authors.

ECRI as I understand is working on a larger study, but I believe you ignore the ECRI Deep Dive results because it is quite industry-unfriendly.

No matter. I am just a reporter on these issues, and educate attorneys on these issues and provide expert opinions to them. Ultimately, your arguments vs. mine will be decided - unfortunately - in a courtroom after someone's been maimed, or died.

-- SS

InformaticsMD said...

I note my post on health IT hyperenthusiasm is also worth a read in helping understand opinions such as that of Anonymous September 23, 2013 at 10:54:00 AM EDT:

It's at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html.

-- SS