Should health IT be immune from suits

Should health IT be immune from suits

Summary: Think health IT vendors should be subject to the full market discipline of civil courts, as doctors and (still) drug companies are? Or would that destroy the industry?


One important point about the 2008 Riegel vs. Medtronic decision is that it gave tech companies immunity from most state lawsuits, if their software is placed into a device.

But what if it isn't? Turns out it has immunity anyway.

The Journal of the American Medical Association, which has its own problems with criticism, has now published an editorial decrying the immunity, which is based on a doctrine called "learned intermediaries."

Present law assumes that faults lie with the user, writes Ross Koppel (right), a sociologist at the University of Pennsylvania.

"Health IT vendors claim that, because they cannot practice medicine, clinicians should be accountable for identifying errors resulting from faulty software or hardware," he said in a press release.

"But errors or lack of clarity in HIT software can create serious, even deadly, risks to patients that clinicians cannot foresee."

In his article, Koppel and David Kreda, a Philadelphia software designer, offer examples of software bugs causing mistakes in drug administration, and failures to carry over warnings about drug allergies to the clinicians using them.

All this hit like a thunderclap for Scot Silverstein of Drexel, the health IT skeptic profiled here last month, who blogs at Healthcare Renewal under the nom de blog MedinformaticsMD.

 Along with your patients you are nonconsented beta testers and experimental subjects of the health IT industry, and potential victims of the computer industry's arrogance and dysfunction.

Silverstein believes that legal threats are necessary to end the "mission hostile user experience" he finds so often.

So how about it? Think health IT vendors should be subject to the full market discipline of civil courts, as doctors and (still) drug companies are? Or would that destroy the industry?

Topics: Health, CXO, Enterprise Software, Software, IT Employment

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  • If they take the money they get the responsibility

    It's basically that simple. :)
    • Backwards....

      Think from the other direction -- who REALLY pays these costs? Excessive liability payments are passed on to ALL OF US. The lack of reasonable limits and the abundance of frivolous and even fraudulent lawsuits is one of the reasons healthcare is so expensive. So, say yes to some liability...but the extent of that needs some DRASTIC overhauling. Our legal system is out of control right now, and medical liability needs a complete overhaul.
  • RE: Should health IT be immune from suits

    "Think health IT vendors should be subject to the full market discipline of civil courts, as doctors and (still) drug companies are? Or would that destroy the industry?"

    What do you think is ALREADY destroying the industry??? The lack of reasonable liability limits on doctors and drug companies. The legal system in this country is OUT OF CONTROL, and it is one of the Big 3 reasons that health care is so d@mn expensive!! If you wanna exacerbate that, go ahead...add liability to yet another supplier of the industry....
  • The Great Olive Oil Scandal?

    Probably a century an auditing company got their
    testicles run through the ringer over what was
    canned the Great Olive Oil Scandal.

    That scandal was based on barrels of olive oil &
    water - with water making up the bulk of each
    barrel. The scandal broke when the warehouse
    certificates used to obtain cash were found to virtuously worthless.

    Result? The CPA firm paid out a lot of money, but
    more importantly the severity of the problem
    focused attention of significantly increasing the
    standards of verifying inventories. A major
    improvements in standards that has served us

    No transfer that to the field of medicine. While
    there are some dumb suits there are also valid
    ones. Basically look at what is charged and, more
    importantly, look at the witnesses.

    Where there is a honest cause for action I believe
    that the insurance companies are pretty quick to
    settle. I also believe that they should also be
    proactive - just like they may be with auto
    insurance companies.

    There are times, however, when the public is well
    served by a very public and painful trial for the
    insurance companies. The ability for you or me to
    get a bone marrow transplant if we need it is far
    greater because some juries have publicly kicked
    the insurance companies really hard. If this hadn't
    happened then insurance companies would still be
    calling bone marrow transplants as experimental at
    the turn of the NEXT century.

    Another area of concern is called duty of care. My
    sister died as a direct result of her nurse refusing
    to let her husband put her on her cpap. Cause of
    death was lack of oxygen to the brain.

    I won't financially benefit from a lawsuit, but I
    want one filed and I want a jury to make it clear to
    the hospital industry that it is their duty to ensure
    proper use of cpaps or any other pap. And,
    techboy - it might just benefit you or someone in
    your family if there is ever a need for pap
    • thought at first you were talking about the new scandal

      Italian vendors with licenses watering down
      their olive oil with canola and food coloring to
      create licensed extra virgin.

      It's been in all the papers At least those I
      read. (They're in Italian.)
      • Like the Jack In The Box hop?

        The Australian Government some years back discovered that
        some meat packers were including some 'Roo meat in with the
        beef they were sending to the US for burgers at Jack In The Box.

        The politicians were so angry about it I thought they might bring
        back the death penalty.

        Aussie meat, by the way, is very lean as there is a lot of range fed
        beef there.
        • At least it was good kangaroo...

          A friend once smuggled a kangaroo doll (with
          fur) to give to my baby girl (now 21). She liked
          it, but our cat liked it more.
  • Who will write the software?

    We all know the moment even one tiny miniscule mistake is made by a doctor or hospital, [i]everyone[/i] is sued.

    Now, what happens if a doctor using the software makes a mistake in reading or using it: no bugs involved, just a misread in his haste?

    Why am I to be sued for writing the software?

    In any other company, the person is held responsable, and fired if it is warrented, not the person writing the software; let it be a medical related business, and the lawyers come running, all are fair game!

    Give me an incentive to write medical software without the risk of being drawn into the world of medical malpractices, a world with a life all of its own.

    • User error

      I was thinking the trials are going to be a
      bitch, as lawyers argue over operator error vs.
      programming error. y'know?
  • RE: Should health IT be immune from suits

    It also seems to me that hospital executives, boards and counsel have fiduciary responsibilities, as well as obligations under principles of due diligence, Joint Commission and other regulatory guidelines, etc. to protect patients from defective technologies and protect their staffs from unfair liabilities.

    Have hospital executives, boards and general counsel been violating such standards and expectations every time they've signed a healthcare IT "hold HIT vendors harmless" and "keep defects secret" contract?

    See "[b]Have Hospital Executives Violated Their Fiduciary Responsibilites by Signing Such Contracts?[/b]" at <a href="">this link</a>.

    By the way, Dana, I'm not a HIT skeptic, I'm a gadfly towards <b>irrational and dysfunctional HIT design and management practices</b>.

    I and other like-minded healthcare IT blogger "skeptics" have been described as "disruptive innovators" at sites such as <a href="">HealthMemes: Tracking Conversations About the Future of Health</a> that identifies latest trends in health care disruptive innovations (thought that goes way outside the box of convention).

    HIT can and does work, when designed with appropriate input and implemented with leadership by true domain experts (clinical, informatics, computer science, HCI etc.) and implemented with true best practices. Unfortunately, that environment is not common enough.

    Note that I did not include "MIS" where <a href="">I have observed traditional ridigities and needless formalisms</a> that can <a href="">place patients at risk</a> and are in opposition to the dynamism and flexibility needed to create and implement effective HIT.

    Clnical computing and business computing are different computing specialties, and clinical IT systems are not management information systems. Therefore I believe MIS leadership roles in HIT should be limited; MIS roles should be primarily <i>facilitative</i>.

    • Skeptics are not enemies

      I'm sorry if you felt calling you a skeptic
      implied you were opposed to health IT.

      Skeptics are good. Skeptics keep you honest.

      Thanks so much for your long and thoughtful
      post. I hope all our readers look at it closely
      and get something out of it.
      • Skeptics are good

        [i]I'm sorry if you felt calling you a skeptic
        implied you were opposed to health IT. Skeptics are good. Skeptics keep you honest.[/i]

        Some don't think that way, but I almost forgot: you are an exceptionally broad thinker yourself!

        -- SS