Scott Silverstein, MD has come up with a Informed Consent on Use of HIT: “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:”
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 experimental clinical devices
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 regulation or approval, as are the drugs I take and the “physical” medical devices that may be used on 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 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 is likely to cause user fatigue and cognitive overload in clinical users after prolonged exposure, making them more liable to commit medical error. I understand that since these clinical personnel are “learned intermediaries”, however, the vendor of the clinical IT devices is completely immune from liability, which will fall on 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, which carries risk but is a proven technology in widespread use over
approximately the past century.
________________ (patient name)
Scot M. Silverstein, MD
Consultant in Medical Informatics
Teaching faculty in Healthcare Informatics and IT (Sept. 2007-)
Director, Institute for Healthcare Informatics (2005-7)
College of Information Science and Technology
3141 Chestnut St.
Philadelphia, PA 19104-2875