The mHealth Alliance Welcomes FDA Draft Guidance on Mobile Medical Applications

Washington, DC (July 22, 2011) - The mHealth Alliance (mHA) welcomes the U.S. Food and Drug Administration's (FDA) Draft Guidance: Mobile Medical Applications as the first steps to creating guidance and regulatory framework for the use of mHealth applications. Policy frameworks such as this help curb potential uncertainty in the mHealth field that too often deter investors and stifle innovation.

The mHA focuses its attention on developing countries, where the FDA has no regulatory authority. At the same time, the mHA recognizes that many developing countries will look to the FDA to set the standard of guidance in the mobile medical field. The FDA therefore has an opportunity to influence how standards are set on this global issue.

"The applications that fall under the purview of the FDA's Draft Guidance are largely smartphone-specific and mobile applications that either connect to currently regulated medical devices or render the mobile phone into a medical device, while most mHealth initiatives in developing nations are SMS based and untethered to medical devices," said Jody Ranck, Director of Thought Leadership, Policy and Advocacy at the mHealth Alliance. "While sophisticated applications are not currently widely used in the areas that the mHealth Alliance focuses on, smartphone applications and peripherals that do perform medical functions will become more important in the next several years."

The mHA encourages and supports the development of policy frameworks, with a focus on frameworks that enable innovation and health system transformation while also protecting and empowering citizen-patients. In this emerging field, the mHA will work with its partners and networks to develop policy frameworks that can both foster innovation and protect the rights of patients.

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About the mHealth Alliance

The mHealth Alliance (mHA) mobilizes innovation to deliver quality health at the furthest reaches of wireless networks and mobile devices. Working with diverse partners, the mHA advances mHealth through research, advocacy, and support for the development of interoperable solutions and sustainable deployment models. The mHA sponsors innovation challenges and conferences, leads cross-sector mHealth initiatives, and hosts HUB (Health UnBound), a global online community for resource sharing and collaborative solution generation. Hosted by the United Nations Foundation, and founded by the UN, Rockefeller, and Vodafone Foundations, the mHA now also includes PEPFAR, HP, and the GSM Association among its founding partners. For more information, visit www.mhealthalliance.org.

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