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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Insight Brief
Expanding Access to Home-Use Medical Technologies
IQVIA Regulatory Science Series
May 07, 2024
Expanding access to home-use technologies can help bridge the healthcare gap and advance health equity. However, there are challenges and opportunities associated with developing, evaluating, and monitoring home-use technologies, such as ensuring usability, reliability, connectivity, security, privacy, and patient safety. The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) released a request for public comments titled, Increasing Patient Access to At-Home Use of Medical Technologies, consistent with its efforts to advance health equity.
IQVIA is actively involved is designing and conducting clinical studies and patient adherence programs that utilize at-home and remote medical devices, encompassing both the pre-market and post-market activities. Given our experience in this area and passion for advancing health equity, a group of IQVIA data scientists and subject matter experts discussed the Agency's concerns and prepared a written response. This document conveys our general thinking and answers to the FDA's eight specific questions.