Medical knowledge and advice can change rapidly, as we have seen during the Covid-19 pandemic, and applications require frequent updates. However, the FDA does regulate and approve devices as end products. The FDCA regulates the safety and effectiveness of medical devices, including certain mobile medical applications. In technology-driven digital health collaborations, parties are interested in obtaining technology from each other or sharing their collective technologies to develop digital health solutions.
The prevalence of smartphones today, together with the increasing precision and therapeutic potential of digital capabilities, offer an unprecedented opportunity in the field of digital medicine. In data-based digital health collaborations, parties are interested in granting, acquiring or sharing access to data that is used to drive digital health solutions forward. The Food and Drug Administration (headquartered at the Center for Devices and Radiological Health) aligns and coordinates digital health work throughout the FDA, providing regulatory advice and support to the FDA to assist the FDA in its regulatory review of digital health technology. This proliferation of digital health technologies and new reimbursement opportunities have attracted non-U.S.
companies to enter the U.S. health market and, in some cases, to establish digital health businesses in the United States. With regard to the FDA regulatory review of digital health technology, the Center of Excellence in Digital Health (which is part of the U.
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