FDA Commissioner Scott Gottlieb (@SGottliebFDA) wants to create a Center of Excellence on Digital Health “to establish the regulatory paradigm, build new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices. To modernize and expand its existing capabilities to ensure the cybersecurity of medical devices, the FDA would enhance its ability to coordinate device-specific responses to cybersecurity vulnerabilities and incidents. The FDA also would implement the modern, agile information technology systems necessary to support this new regulatory paradigm, foster and review breakthrough device innovations, and leverage real-world evidence. Implementing these regulatory innovations and information technology improvements are essential for advancing software-based technologies to improve the health and quality of life of patients while assuring critical safeguards as the current regulatory framework is not well-suited for driving the development of safer, more effective software-based devices, including the use of machine learning and artificial intelligence.” Whoa … https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596554.htm#FDAPreCert
