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The MedApps /Alere Connect 2.0 Remote Patient Monitoring System is not intended for diagnosis or as a substitute for medical care, nor is it intended to provide real-time / time-critical data. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

The MedApps 2.0 - Remote Patient Monitoring System consists of: - HealthPAL hardware: (1) The physical component of the 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. The HealthPAL Model 105 contains a GSM cellular module while the HealthPAL Model 106 contains a CDMA cellular module. - HealthHUB hardware / software: (2) The HealthHUB hardware is an extension of the HealthPAL functionality. HealthHUB acts as a "docking" station for the HealthPAL in order to act as a conduit for the AC power adaptor connecting the electrical wall outlet to the HealthPAL providing power and battery charging capability. The Hubs also provide additional connections to off the shelf Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters, via smart cables (per validated in HealthPAL software). The HealthHUB model MA200 allows for multiple wired connections for accessory devices. HealthHUB Model 205 is specific for the HealthPAL MA105, and the HealthHUB 206 is specific for the HealthPAL MA 106 with both Hubs having one wired connector. - HealthPAL firmware / software: (3) The firmware captures data from commercially available health monitors, and stores and transmits the information to the 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. - MobileLink hardware / software: (4) AC020 MobileLink is a modified MA105 HealthPAL device. The physical component of the MobileLink is an electronic device contained in a plastic enclosure with built-in M2M cellular chip, speaker, standard USB cable and USB Smart Cable connection, OLED screen to review the reading, and LED lights to indicate activity regarding the receiving and transmitting of collected data. Like the HealthPAL, MobileLink's firmware / software captures, data from commercially available retail health monitors, and transmits information. to the HealthCOM server, via the embedded communication chip / platform. The firmware allows MobileLink to receive information via wire, either standard USB or with a customized USB Smart Cable, from accessory medical devices. The firmware has many additional functions including: Download of user profiles from the server to configure MobileLink remotely. MobileLink'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. MobileLink's visual user interface utilizes an OLED display to display collected readings from attached accessory medical devices as well as reading transmission acknowledgements. MobileLink's visual interface also contains a LED light to show power and provide reading request indication capability. - HomeLink hardware / software: (5) AC200 HomeLink is a modified MA105 HealthPAL device. The physical component of the HomeLink is an electronic device contained in a plastic enclosure with built-in M2M cellular chip, speaker, standard USB cable and USB Smart Cable connection, touch screen to review the reading and allow patients with ability to have "IVR" (questions and answers) functionality that was formally part of the HealthCOM IVR section, and wireless module. Like the HealthPAL or MobileLink, HomeLink's firmware / software captures biometric data from FDA cleared commercially available accessory devices, and stores and transmits information to the HealthCOM server, via the embedded communication chip / piatform. The firmware allows HomeLink 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 HomeLink device. The firmware has many additional functions including: Download of user profiles from the server to configure HomeLink remotely. HomeLink's has audio capability to deliver verbal announcement of readings and acknowledgment of data transmission from all connected accessory medical devices, volume control, user feedback, in any language that is loaded to the device. HomeLink's visual user interface utilizes a touch screen display to display collected readings from attached accessory medical devices as well as other user interactions. One such patient HomeLink user interface includes the MedApps 2.0 System IVR functionality, which originally was executed from the HealthCOM webportal by professionals to patient's phones. The updated version allows end users (patients) to provide answers on the HomeLink device based on professional predefined questions that are reviewed in HealthCOM. This allows an improved user interaction of the previous IVR procedure. HomeLink screen also displays information regarding the device's status including volume level, data transmission status, preferred language, 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. - MedApps HealthCOM software application: (6) 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), - MedApps IVR software application from HealthCOM: (7) 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 pre-approved ("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 original IVR system has moved to the HomeLink device for easier interaction with the patient compared to the need for the patient to receive an IVR phone call on their personal phone, which includes professionally defined questions that the patient can answer and both the questions and answers will be recorded in the HealthCOM system for professional review. - Accessory Device Descriptions: (8)

The MedApps (Alere Connect) 2.0 - Remote Patient Monitoring System consists of 1) a cellular communication hub (MedApps' HealthPAL or MobileLink) an over-the-counter device that resides with the end-user (patient), which connects to commercially available FDA cleared accessory devices, specifically glucose meters, scales, blood pressure monitors, pulse oximeters, and PT/INR monitors and 2) web-based health data management application (MedApps' HealthCOM), that provides access to collected data stored on a secure host server system. MedApps Inc., DBA Alere Connect Remote Patient Monitoring devices receive and store measurements collected from the described accessory devices, either wirelessly using short-range radio protocols (e.g. Bluetooth, Zigbee, WiFi, Bluetooth Low Energy (BLE), Fitlinxx Radios) or tethered via cable (e.g. USB, serial, etc). Regardless of connectivity mode, the MedApps / Alere Connect monitoring devices do not alter the indications for use of the described peripheral accessory health devices. MedApps / Alere Connect devices indicate successful or failed data reception and transmission with visual and audio feedback using a combination of any of the following: OLED Display, LED Lights, verbal messages, and / or audio tones / chimes. MedApps / Alere Connect devices store collected data and forward / transmit to server for access in HealthCOM via commercially available, FCC compliant, wireless telecommunication protocols (including but not limited to cellular GSM, CDMA and WiMax). Healthcare professionals, clinicians and other authorized personnel can review the transmitted information within the MedApps HealthCOM system, where they can review collected readings, establish parameters to Indicate readings exceptions to set thresholds, or trigger Interactive Voice Response (IVR) messages to the patient remotely to issue Information such as reminders (e.g. "We haven't received readings from you today, please take and send your readings") or possibly educational information for conditions such as diabetes, hypertension, CHF, etc. Additionally, HealthCOM can port collected data to the healthcare providers' clinical back-end system(s) of choice. The MedApps 2.0 (Alere Connect) - Remote Patient Monitoring System is not intended for diagnosis or as a substitute for medical care, nor is it intended to provide real-time / time-critical data. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

The MedApps 2.0 - Remote Patient Monitoring System consists of: - (1) HealthPAL hardware: The physical component of the 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. The HealthPAL Model 105 contains a GSM cellular module while the HealthPAL Model 106 contains a CDMA cellular module. - (2) HealthHUB hardware / software: The HealthHUB hardware is an extension of the HealthPAL functionality. HealthHUB acts as a "docking" station for the HealthPAL in order to act as a conduit for the AC power adaptor connecting the electrical wall outlet to the HealthPAL providing power and battery charging capability. The Hubs also provide additional connections to off the shelf Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters, via smart cables (per validated in HealthPAL software). The HealthHUB model MA200 allows for multiple wired connections for accessory devices. HealthHUB Model 205 is specific for the HealthPAL MA105, and the HealthHUB 206 is specific for the HealthPAL MA 106 with both Hubs having one wired connector. - (3) HealthPAL firmware / software: The firmware captures data from commercially available health monitors, and stores and transmits the information to the 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, Audio capability to deliver verbal announcement of readings and acknowledgment of data transmission, Timer capability, OLED screen displays information regarding the HealthPAL's status, Battery charging, isolation circuits, and interfaces to individual accessory medical devices / protocols via the smart cable. - (4) MobileLink (formally HealthAIR) hardware / software: AC020 MobileLink is a modified MA105 HealthPAL device. The physical component of the MobileLink is an electronic device contained in a plastic enclosure with built-in M2M cellular chip, speaker, standard USB cable and USB Smart Cable connection, OLED screen to review the reading, and LED lights to indicate activity regarding the receiving and transmitting of collected data. Like the HealthPAL, MobileLink's firmware / software captures, data from commercially available retail health monitors, and stores and transmits information to the HealthCOM server, via the embedded communication chip / platform. The firmware allows MobileLink to receive information via wire, either standard USB or with a customized USB Smart Cable, from accessory medical devices. The firmware has many additional functions including: Download of user profiles from the server to configure MobileLink remotely, MobileLink's Audio feature uses audio tones to indicate acknowledgment of collected readings, MobileLink's visual user interface utilizes an OLED display to display collected readings. - (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, 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.