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TIA Commends New FDA Approach to Medical Device Data Systems

E-Health | In Compliance Magazine

The Telecommunications Industry Association (TIA) submitted comments to the Food and Drug Administration (FDA) in support of its new approach to medical device data systems (MDDS) devices, medical image storing devices, and medical image communication devices.

In its comments, TIA described how remote patient monitoring of patient-generated health data (PGHD) must be utilized for any health care system to realize its full potential to deliver care. The known benefits of remote patient monitoring services include improved care, reduced hospitalizations, avoidance of complications and improved satisfaction, particularly for the chronically ill. There are also significant potential cost savings, with a recent study predicting that remote monitoring will result in saving $36 billion globally by 2018, with North America accounting for 75% of those savings.

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TIA described how, by providing the means to transmit, store, and convert important medical device data, MDDS are the cornerstone for an interoperable 21st century healthcare system that fully utilizes remote patient monitoring technologies to fully leverage PGHD. Accordingly, TIA supports FDA’s proposed approach towards MDDS. This approach will facilitate greater innovation in the medical device industry and consistent with the FDA’s stated goals of taking an appropriately-tailored approach to medical device innovation.

To read TIA’s comments in their entirety, click here.

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