Common use of CLINICAL USE Clause in Contracts

CLINICAL USE. The Clinical Use of the Licensed Program by the End Users must comply with applicable United States laws and regulations, as well as the laws and regulations in the countries in which the Licensed Program will be used, governing medical devices intended for human use, including but not limited to 21 C.F.R. Part 812 and laws and regulations concerning registration and results reporting for clinical trials of medical devices promulgated under the Food and Drug Administration Amendments Act of 2007. The End User must obtain informed consent from their patients before using the Licensed Program. The informed consent must contain language specific to the use of virtual reality for exposure thereby, such as: “I understand that this treatment is a relatively new method for conducting exposure therapy. Using virtual reality environments might involve wearing a head-mounted display, which is like a helmet with mini-television screens in front of my eyes. The purpose of the virtual environment is to help me feel as if I am really in the situation of which I am afraid or learning to cope with. Thus, virtual environments may elicit anxiety or other physical/emotional responses, which are consistent with the treatment I wish to receive and designed to help me overcome my fears or other identified problem areas. I understand that it is possible to experience transient adverse side effects from virtual environments, including motion sickness, disorientation, and dizziness. I agree to inform my psychologist if I experience such side effects and wait until I am no longer experiencing any such effects before beginning other activities, such as operating a motor vehicle. A very small portion of the population may experience epileptic seizures when viewing certain kinds of flashing lights or patterns that are commonly present in daily activities. Such people also may experience seizures while using the head-mounted display. I agree to inform my psychologist of any past epileptic activity, as this may affect their professional judgment about utilizing the virtual environments as part of my child’s planned treatment.”