The Telecommunications Industry Association supports Food and Drug Administration intentions not to enforce some regulatory controls that apply to medical device data systems (MDDS), which the agency deems to be low risk to patients.
TIA makes the case in an Aug. 25 letter to the regulatory agency that FDAs proposed guidance on MDDS will facilitate greater innovation in the medical device industry and is consistent with the agencys stated goals of taking an appropriately-tailored approach to medical device innovation.
In late June, FDA issued draft guidance explaining that its regulatory oversight of health IT products is now focused on devices that pose higher risk to patients than MDDS, which collect and store data from a variety of other medical devices including glucose meters, blood pressure cuffs, and weight scales.
TIA notes in its letter that 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 patient-generated health data.
The value of this data is that it can be used remotely at home to track certain patient information or it can be stored for a doctor to review at a later time. MDDS can also be used in hospitals to collect information and data from other medical devices including bedside monitors and infusion pumps. This information can then be stored in a patients EHR for a more complete review of a patients total health.
The known benefits of remote patient monitoring services include improved care, reduced hospitalizations, avoidance of complications and improved satisfaction, particularly for the chronically ill, states the association. 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 percent of those savings.
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