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FCC, FDA to work on effective mHealth regulation |
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Written by Akiba
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Wednesday, 17 March 2010 |
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Within the healthcare chapter of the FCC’s National Broadband Plan, which the agency published this morning, the FCC recommended that it work together with the FDA to clarify regulatory requirements and the approval processes for converged communications and health care devices. The FCC specifically pointed to mobile health apps, smartphone remote monitoring apps, point of care diagnostic smartphone apps and wearable, wireless biometric sensors as examples of the products in need of regulatory clarification. The FCC noted that while it has solely regulated general purpose devices like smartphones, videoconferencing equipment and wireless routers, the FDA has had sole regulation over life-critical wireless devices like remotely controlled drug release mechanisms. The FCC wrote that the two agencies should work together because emerging connected health devices pose a challenge to the legacy regulatory structure. Link
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