TIA Supports FDA's Proposed Deregulatory Approach to Medical Device Data Systems
The ICT manufacturer community believes that medical device data systems (MDDS) – off-the-shelf or custom hardware or software products that transfer, store, convert format and display medical device data without modifying it – are the cornerstone for an interoperable 21st century healthcare system that fully utilizes remote patient monitoring technologies to fully leverage patient-generated health data (PGHD).
That is why on August 25, 2014, 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, where it has proposed a new deregulatory approach towards MDDS.
Less resources spent getting to market
Specifically, the FDA proposed a compliance policy under which medical device data systems will see a reduction in resources spent getting innovative products into the marketplace. This proposal is also consistent with the recently released joint agency Health IT Framework that urges for health IT products to be appropriately regulated according to their risk to patients.
TIA believes this proposed approach will facilitate greater innovation in the medical device industry and is consistent with the FDA's (as well as the ONC's and the FCC's) stated goals of taking an appropriately-tailored approach to medical device innovation. In our comments, we describe how remote patient monitoring of PGHD must be utilized for any health care system to realize its full potential to deliver care.
Benefits of remote monitoring
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.
TIA believes that the FDA's proposed approach, if finalized, will not only create certainty in the expectations and investments of medical device innovators, but will also help continue to reinforce the FDA as a global leader in regulatory approaches which are pro-innovation and pro-consumer. The industry stands ready to work with the FDA and all other stakeholders to continue to apply these approaches throughout the medical device industry.