scope:

The present document covers various individual devices which when operating together form a system operating as a Medical Data Service (MEDS) that provides medical practitioners with therapeutic and/or diagnostic information used to provide improved medical treatment of a patient and/or to provide an interactive system for patient control of therapeutic devices.. MEDS is intended only for transmission of non-time critical data, the loss of which will not compromise the health and/or safety of the patient. Devices covered by the present document are an evolving new technology to be made available worldwide by the medical equipment industry that will provide high speed communications capability between devices associated with an individual patient that are part of a complete MEDS system as defined in clause 3.1. Examples of MEDS devices falling under the scope of the present document are portable body worn physiological sensors that allow ambulatory monitoring, implanted devices and external system devices used to transfer data collected by a MEDS system to medical practitioners that will use the data to diagnose and treat a patient. These devices utilize ultra low power radio transmitters in combination with medical devices, the medical portion of which is regulated by the Medical Device Directive [4] (MDD) or the Active Implantable Medical Device Directive (AIMD [7]). The radio part of medical devices regulated by the MDD is hereafter referred to as ULP-AMD, ULP-AMD-P for peripheral devices, and ULP-BWD for body worn devices. ULP-BWD are devices, such as a physiological parameter sensor or handheld devices that are intended to operate in very close proximity to the human body, including touching the body, whose radio antenna is external to the body and is used to communicate with a device that is part of a MEDS system. The radio part of medical devices regulated under the AIMD is hereafter referred to as Ultra Low Power-Active Medical Implants (ULP-AMI) and peripherals (ULP-AMI-P) used in a Medical Data Service (MEDS).