Digital tool use is growing, and rapidly. To keep up with these changes, the Food and Drug Administration released a Digital Health Innovation Action Plan over the summer. It aimed to redesign medical device regulation to effectively address new tools, while also making way for innovation in the field.The FDA quickly followed up the plan with several initiatives, including the launch of its Digital Health Software Precertification Pilot Program, which looks to fast-track the development and uses of digital health technologies. The FDA chose nine companies to participate in the program in September, including Fitbit, Samsung and Apple, among others.Now, to close out the year, the agency has released three policy documents that will shape future health IT oversight and innovation.We recognize that our regulations play a crucial role in the efficient development of such technologies. Therefore, our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation, FDA Commissioner Scott Gottlieb said in a statement. Moreover, we must always lean in the direction of enhancing access to more information not restricting information flow given the ability of reliable information to positively impact daily life.

Source: Click here

Share this article

Facebook Comments