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EXTENSION, INC. Joins the mHealth Regulatory CoalitionFORT WAYNE, Ind. --(Business Wire)-- EXTENSION, INC. announced that it has joined the mHealth Regulatory Coalition (MRC) to assist with the development of a guidance document, which will outline industry-wide concerns and propose solutions to the FDA relating to the regulatory oversight of mHealth products. The MRC was organized to gather industry stakeholders and determine the quality and safety issues that are created when these technologies combine to create a network of products and services, which can be ill-defined within the purview of current FDA guidance. "As the developer of an advanced middleware appliance, EXTENSION integrates with a number of clinical information systems, medical devices, and end-points, which can each have different levels of regulatory oversight," said Jenny Kakasuleff, Government Liaison with EXTENSION. "Therefore, determining where EXTENSION exists on the continuum of regulated to unregulted products is necessary, particularly with respect to solutions like EXTENSION® HealthAlert™ that deliver critical, time-sensitive data to clinicians, and which could directly drive a medical decision, diagnosis, and/or treatment." mHealth is a relatively new concept that will continue to be clarified as market demands shape its meaning, but MRC participants have little doubt that it will do great things for population health; particularly rural populations, which have the most difficulty accessing affordable healthcare. Industrialized nations stand to gain significantly by encouraging patients to take a greater role in their health care. As part of the mHealth network, EXTENSION offers clinicians a tool that enables them to know immediately when a critical event occurs, details of the event, and a means for taking action. EXTENSION has embraced the transition from a static healthcare model to one in which information flows freely between patients and providers, which empowers providers to access and share information on their patients quickly and easily. EXTENSION recently launched its integration with the Apple iPhone (News - Alert) during a trial implementation at Stanford Hospital and Clinics and demonstrated its Google Android (News - Alert) integration at the mHealth Summit in Washington, D.C. in November 2010. As an enterprise solution, EXTENSION is end-point agnostic and can deliver alerts to any SMS text message and/or web-enabled mobile device.
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