TIA Backs FDA’s Plan Not To Regulate Medical Device Data Systems

August 27, 2014 in News

This week, the Telecommunications Industry Association sent a letter to FDA, saying it supports the agency’s decision not to enforce some regulatory standards that apply to medical device data systems, Health Data Management reports (Slabodkin, Health Data Management, 8/26).

Background on FDA’s Draft Guidance

In June, FDA issued draft guidance saying that it considers medical device data systems to be safe and does not intend to regulate such tools. The draft guidance marks a shift in FDA policy, as the agency as recently as January 2011 had said that MDDS are among the highest-risk technologies in health care.

In a blog post accompanying the draft guidance, Bakul Patel, senior policy adviser for FDA’s Center for Devices and Radiological Health, wrote that the change in policy comes in response to “additional experience” the agency gained through its efforts to ease regulatory burdens on the devices. 

According to the draft guidance, medical device data systems do not aim to control or “alter the functions … of any connected medical devices,” but rather are intended to:

  • Facilitate electronic transfer or exchange of medical device data;
  • Store and retrieve medical device information, such as blood pressure data;
  • Convert medical device data from one format to another; and
  • Display medical device information.

As a result of FDA’s draft guidance, medical device data systems — such as software that collects data from a glucometer or a weight scale — no longer will have to comply with FDA rules (iHealthBeat, 6/23).

TIA Letter Details

In its letter, TIA wrote that the draft guidance will “facilitate greater innovation in the medical device industry” and is in line with the agency’s goal to take an “appropriately-tailored approach to medical device innovation” (Health Data Management, 8/26).

TIA added, “By providing the means to transmit, store and convert important medical device data, [the tools] are the cornerstone for an interoperable 21st century health care system that fully utilizes remote patient monitoring technologies to fully leverage” patient-generated health data (TIA letter, 8/25). Further, TIA noted that information from medical device data systems can help:

  • Boost patient satisfaction;
  • Improve care;
  • Prevent medical complications;
  • Reduce health care costs; and
  • Reduce hospitalizations (Health Data Management, 8/26).
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