Digital Health is a complex system where ideas, trends, actions, and the ramifications that result, move at an ever-increasing rate of speed. In such an environment, it helps to have some level of consistency. A set of rules, some generally agreed-to guiderails, that can keep forward progress moving while still enabling innovation and achievement.
That is why the U.S. Food and Drug Administration (FDA) recently announced establishment of a new digital health unit. Through this new group, the FDA and its Center for Devices and Radiological Health plan to ramp up medical app and device offerings, with the stated purpose of centralizing and coordinating digital health information so that there is consistency in applying policies.
Bakul Patel, associate director of digital health for the FDA, explained that the primary responsibilities of those on the project include developing software and digital health technology to assist with pre-market submissions or devices, utilize experts, and incorporate metrics that will assist with review times and submission.
This comes as welcome news for the life sciences industry, as it promises to provide some valuable structure, consistency, and direction to the burgeoning digital health marketplace, from inception of ideas through development prior to commercialization.
Creation of this digital health unit follows prior FDA actions to address this growing tech market, such as establishing guidelines for wellness apps in 2016, and cybersecurity guidelines for medical devices.
Later this year, the FDA plans to begin hiring as many as 13 full-time employees from various private sectors with hopes of having them on board by the 2018 fiscal year.
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