A virtual medical tool (i.e., a medical tool that happens to involve computers) that can impact the quality of care and outcomes either positively or adversely seems to me to be a very potent device. I also believe the regulatory definition of "medical device" needs updating; it may have become obsolete with the galloping advances in technology over the past decade or two.
Patients currently are subject to the effects upon their care of electronic medical devices known collectively as "clinical IT" (electronic health records, computerized physician order entry, clinical decision support, clinical data repositories, etc.), but are not informed of the nature of this IT nor its possible adverse effects on their care. The consent forms they do sign are, therefore, incomplete.
I am proposing a "Patient Rights Statement and Informed Consent on Use of Clinical IT Devices" be required at healthcare organizations using this technology. Here is a draft of such a consent. Note that this draft is a bit tongue in cheek, but not entirely so. There is nothing nonfactual about it:
Patient Rights Statement and Informed Consent on Use of Clinical IT Devices
I, ___________, consent to treatment at Acme General Hospital. I understand my rights to the very best care Acme General can provide, and understand that Acme General has taken every feasible step to assure my safety and comfort.
I understand that my treatment will be modulated and advised by my doctors' and nurses' interactions with clinical devices still under development in an exploratory fashion known as "electronic health records systems", "clinician order entry systems", "clinical decision support systems" and other computer systems, hereafter "clinical IT devices."
I understand that said clinical IT devices are not subject to federal or state evaluation, regulation or approval, as are the drugs I take and the "physical" medical devices that may be used in my care (such as catheters and defibrillators), and were designed by for profit IT companies whose primary leaders and developers lack clinical expertise.
I further understand that these clinical IT devices, while believed to be benign and helpful, have never been rigorously and scientifically proven to be safe and effective. I understand that the literature is conflicting on this point, and that patients have been documented to have been harmed or nearly harmed by design problems, defects and malfunctions in these clinical IT devices.
I understand the vendor of the clinical IT devices in use at Acme General has a contract with Acme General Hospital that forbids Acme General and its employees and representatives from sharing known defects about the clinical IT devices with other organizations.
I also understand that there are currently ____ clinical IT device defects known at Acme General as reported by its staff. Of these defects, ___% fall into the category of affecting revenue, ___ % fall into the category of affecting clinician work efficiency, and ___ % fall into the category of affecting patient safety and outcomes.
I understand that of these known defects, ___ % fall into Class 1, "likely to cause patient harm in short term if uncorrected", ___% fall into Class 2, "may cause in patient harm in medium or long term", and ___% fall into Class 3, "not likely to cause patient harm, but may affect operations."
I understand the vendor of the clinical IT devices in use at Acme General have granted Acme General 75,000 shares of their stock, and are using Acme General to refine these clinical IT devices for sale to other healthcare organizations and to other clinical IT initiatives in the U.S. and overseas.
I also understand the vendors of these clinical IT devices have promised Acme General these defects will be remediated by ______ (date).
Finally, I understand that use of these clinical IT devices may cause user fatigue and cognitive overload in clinical users after prolonged exposure, especially if not well designed, making the clinicians more liable to commit medical error.
I, however, also understand, since these clinical personnel are "learned intermediaries", that if I suffer injury or die as a result of a clinical IT device problem, the vendor of the clinical IT device is immune from liability. The liability will fall upon the doctors and nurses using it, and upon Acme General.
I understand that if I do not consent to use of these clinical IT devices by hospital clinicians during my care, I will be treated by clinicians using paper charts and forms to manage my information, which carries risk but is a proven technology in widespread use in medicine to record detailed clinical information over approximately the past century.
Signed,
________________ (patient name)
_________ (date)
-- SS