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The MedApps 2.0 - Remote Patient Monitoring System consists of a patient device, MedApps HealthPAL, a mobile over-the-counter wireless communication hub, or MedApps HealthAIR, a portable over-the-counter wireless communication hub, which connects to commercially available glucose meters, scales, blood pressure monitors and pulse oximeters and HealthCOM, MedApps' secure host server system. MedApps Remote Patient Monitoring devices receive and store measurements collected from the described monitors, either wirelessly (HealthPAL) or tethered (HealthPAL or HealthAIR). MedApps devices do not alter the indicated use of the peripheral monitors that they integrate with. MedApps devices indicate successful or failed reception and transmission of data with visual and audio cues (HealthPAL via OLED display screen, verbal message and audio tones; HealthAIR via LED lights and audio tones). MedApps devices store collected data and transmit to HealthCOM using commercially available, FCC compliant, wireless telecommunication protocols (including but not limited to cellular GSM, CDMA and WiMax), Healthcare professionals can review the transmitted information within the MedApps HealthCOM system, set thresholds to flag readings based on specific thresholds being exceeded. In addition, the MedApps Interactive Voice Response (IVR) has the ability to contact the patient remotely and use pre-approved ("canned") educational or reminder messages. ("Your nurse would like to talk to you, can I connect you now", "We haven"t received a reading from you today, please send us your readings"). The MedApps 2.0 - Remote Patient Monitoring System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

The MedApps 2.0 - Remote Patient Monitoring System consists of: (1) MedApps HealthPAL hardware: The physical component of the MedApps HealthPAL is an electronic device contained in a plastic enclosure with an OLED screen, built-in M2M cellular chip, speaker, smart cable connection, smart cables, wireless module, LED lights to indicate activity, timer button to assist patients with their reading schedule (i.e. remind them to take their reading in X minutes), last reading button, volume up and down buttons. (2) MedApps HealthPAL firmware / software: The firmware captures data from commercially available health monitors, and stores and transmits the information to the MedApps HealthCOM server, via the embedded communication chip / platform. The firmware allows HealthPAL to receive information via wire or via embedded wireless module from accessory medical devices that are compatibly wireless enabled, which have been paired to the MedApps HealthPAL. The firmware has many additional functions including: Download of user profiles from the server to configure HealthPAL remotely. HealthPAL has audio capability to deliver verbal announcement of readings and acknowledgment of data transmission from all connected accessory medical devices, time settings, volume control, educational content and reminders, in any language that is loaded to the device. Timer capability, activated by the user to provide assistance with adhering to a reading schedule (reminders to take readings within a set timeframe). OLED screen displays information regarding the HealthPAL's status including battery level, volume level, data transmission status, transmission pending indicator, activity icons / messages and other information to provide ease of use and promote patient adherence; as well as information received from accessory medical devices, such as the type of device, measurement, date and time of the last reading collected. Battery charging, isolation circuits, and interfaces to individual accessory medical devices / protocols via the smart cable. (3) MedApps HealthAIR hardware / software: MA020 HealthAIR is a modified MA105 HealthPAL device. The physical component of the MedApps HealthAIR is an electronic device contained in a plastic enclosure with built-in M2M cellular chip, speaker, standard USB cable and USB Smart Cable connection, and LED lights to indicate activity regarding the receiving and transmitting of collected data. Like the HealthPAL, HealthAIR's firmware / software captures, data from commercially available retail health monitors, and stores and transmits information to the MedApps HealthCOM server, via the embedded communication chip / platform. The firmware allows HealthAIR to receive information via wire, either standard USB or with a MedApps USB Smart Cable, from accessory medical devices. The firmware has many additional functions including: Download of user profiles from the server to configure HealthAIR remotely. HealthAIR's Audio feature uses audio tones to indicate acknowledgment of collected readings from all connected accessory medical devices as well as reading transmission via the cellular network. HealthAIR's visual user interface utilizes LED lights of collected readings from all attached medical devices as well as reading transmission acknowledgements (via). (5) MedApps HealthCOM software application: The HealthCOM software application allows caregivers access to review patient data collected from accessory medical devices using MedApps hardware on the secure HealthCOM website. HealthCOM software allows professional caregivers to set patient readings. HealthCOM software also allows the patient to establish an account and to direct / authorize their data to be directed to an outside, validated Personal Health Record (PHR), Electronic Health Record or Medical Record (EHR or EMR). (6) MedApps IVR software application: The IVR (Interactive Voice Response) software application provides the ability to contact the patient remotely, by phone (designated in the user profile), and executes an pre-approved ("canned") scripts to deliver preapproved ("canned") reminder messages ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings"), educational content and gather survey information. In addition, the MedApps IVR application will send out Email, SMS / Text Messages, Paging, IM and other forms of communications in order to contact patients or caregivers. This will include reminders and alerts, based on clinically defined parameters / thresholds established in HealthCOM by the professional care provider.

The MedApps 2.0 - Remote Patient Monitoring System consists of a patient device, MedApps HealthPAL, which is a mobile Over-The-Counter wireless communication hub that connects to commercially available wireless and tethered Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters. The HealthPAL stores and displays the information on the OLED screen, and transmits the information to the MedApps secure host server called "HealthCOM" using off the shelf FCC approved wireless / cellular connectivity (including, but not limited to GSM, CDMA and WiMax). Healthcare professionals can review the transmitted information within the MedApps HealthCOM system, set thresholds to flag readings based on specific thresholds being exceeded. In addition, the MedApps Interactive Voice Response (IVR) has the ability to contact the patient remotely and use pre-approved ("canned") educational or reminder messages. ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings"). The MedApps 2.0 - Remote Patient Monitoring System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

The MedApps 2.0 - Remote Patient Monitoring System consists of a patient device, MedApps HealthPAL, which is a mobile Over-The-Counter wireless communication hub that connects to commercially available wireless and tethered Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters. The HealthPAL stores and displays the information on the OLED screen, and transmits the information to the MedApps secure host server called "HealthCOM" using off the shelf FCC approved wireless / cellular connectivity (including, but not limited to GSM, CDMA and WiMax). Healthcare professionals can review the transmitted information within the MedApps HealthCOM system, set thresholds to flag readings based on specific thresholds being exceeded. In addition, the MedApps Interactive Voice Response (IVR) has the ability to contact the patient remotely and use pre-approved ("canned") educational or reminder messages. ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings"). The MedApps 2.0 - Remote Patient Monitoring System uses MedApps Accessories that help the patient in usability of the product, including HealthLINK which docks the HealthPAL, and HealthPOD which connects to off the shelf medical devices via their data port to transmit data via wireless or RF technology (including, but not limited to bluetooth, zigbee, ANT, ULP, etc.). The MedApps 2.0 - Remote Patient Monitoring System consists of: (1) MedApps HealthPAL hardware: The physical component of the MedApps HealthPAL is an electronic device contained in a plastic enclosure with an OLED screen, built-in M2M cellular chip, speaker, smart cable connection, smart cables, wireless, LED Lights to indicate activity, timer button to remind the patient to take their reading in X minutes, last reading button, volume up and down buttons. (2) MedApps HealthPAL software application: The software application captures, stores and transmits information to the MedApps HealthCOM server, via the embedded communication chip / platform. The software application takes in additional information via the embedded wireless module from other medical devices that are wireless enabled, and that have been paired to the MedApps HealthPAL. The software application has many additional functions including: - Download of the users profile from the server to configure the HealthPAL remotely. - Ability to "talk" to the patient with verbal acknowledgments of readings from all attached medical devices, time settings, volume control, educational content and reminders, in any language that is loaded to the device. - Timer set that was activated by the user at a set timeframe to do whatever they wanted to be reminded to do. - Control the OLED screen to show certain information including, battery status, volume level, transmission status, message waiting indicator, medical device last reading, activity icons / messages and more as it pertains to provide ease of use and easier adoption for the patient. - Battery charging, isolation circuits, and interfaces to individual medical devices / protocols via the smart cables. (3) MedApps HealthLINK hardware / software: The HealthLINK hardware / software plugs into off the shelf Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters, and transmit the data via wireless to a receiver that it is already paired with. (4) MedApps HealthPOD hardware / software: The HealthPOD hardware / software is an extension of the HealthPAL functionality that is outlined in this submission. HealthPOD acts as a "docking" station for the HealthPAL in order to recharge batteries, take in additional connections to off the shelf Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters, via smart cables (per validated in HealthPAL software), add a backup communication method via phone line (POTS line), and communicate via wireless to HealthPAL or additional HealthPODs. (5) MedApps HealthCOM software application: The software application allows caregivers to set thresholds and review patient data on the secure HealthCOM website. The HealthCOM software also allows the patient to establish an account and to direct / authorize their data to be directed to an outside, validated Personal Health Record (PHR), Electronic Health Record (EHR or EMR). (6) MedApps IVR software application: The software application calls the patient on any phone that is designated in their user profile, and executes an approved ("canned") script to gather information. ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings"). In addition, the MedApps IVR application will send out Email, SMS / Text Messages, Paging, IM and many other forms of communications in order to contact patients or caregivers. This will include reminders and alerts, based on parameters / thresholds set in the HealthCOM system.

The MedApps Wellness System is intended for use in non-clinical settings to collect and transmit historical data to healthcare professionals to help support effective management of patients. The System is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment. All patient medical diagnosis and treatment are performed under the supervision and oversight of an appropriate healthcare professional. The MedApps Wellness System model D-PAL acts as an accessory to FDA cleared devices, which collects and transmits stored patient data via wireless connections from medical devices to a cellular phone (Hub) and forwards to a central server for review of historical data about a patient over time to benefit the Healthcare Practitioner. The following medical devices and measuring systems are fully validated for this intended use at this time: - . LifeScan OneTouch ® Ultra® Blood Glucose Monitoring System (K024194 / K043197) - . Polytel PWR-08-03 Remote Module (K070559 pending clearance) The MedApps Wellness System is not intended to provide automated treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional. The MedApps Wellness System is not intended for emergency calls, and may not be used for transmission or indication of any real-time alarms or time-critical data. Clinical judgment and experience are required to check and interpret the measurements collected and transmitted. This device is not for use in systems which substitute for medical care. This device is not intended for patients requiring direct medical supervision or emergency intervention.

The MedApps Wellness System ("System") is designed to be used by patients to send their data from the LifeScan OneTouch Ultra glucometer to a central server for subsequent storage and display. The System is comprised of a "Hub" (cell phone software) and the MedApps Engine, which runs on a central server. The Hub is a software program that runs on a cell phone and takes in data from the OneTouch Ultra and then transmits it to the central server for storage and processing. The MedApps Engine is a software program that runs on a common Web / Internet secure server platform. The MedApps Engine picks up the stored data sent to it by the Hub and through a set of business rules set by the healthcare providers, determines if a follow-up Interactive Voice Response (IVR) call is required to be made to the patient to collect additional Behavioral information from the patient. Once all the data is collected, then it is stored in a repository for access by the healthcare provider, The Hub will utilize the OneTouch Ultra integrated Short-range low power wireless transmission (Bluetooth V1.2) or a FDA approved accessory to the medical devices that to transmits the medical device data via Bluetooth to a compatible cellular telephone, such as the Nokia 6620, or other /compatible cellular phones.