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


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).


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


[1] FDA Law Blog, Recommendations of FDASIA Health IT Workgroup Accepted, September 11, 2013, available at "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


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
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