AI & Machine Learning is Shaping the Future of Healthcare Delivery

The 21st Century Cures Act amended the term "device" to exclude clinical decision support software, which can deploy AI and ML technologies. While the requirements associated with the exclusion are rigorous, the legislation represents strong legislative support for the development of AI and ML healthcare technology. FDA has also cleared some AI-based medical devices, and there is no reason to believe this will not continue through 2018. Finally, FDA has embarked on an ambitous project to re-design its oversight of digital health technologies to focus more on the developer. This continues an effort by FDA to improve and accelerate its review process associated with digital health technologies, which included guidance on mobile medical apps.