The hype surrounding artificial intelligence (AI) can make it sound like the technology has all the answers. But from a scientific perspective, one of the technology's biggest strengths is that it can ask better questions.

Information technology has been promising for decades, largely since the advent of electronic medical records, to improve and streamline health care as it has multiplied productivity in countless other industries. In addition to the long-standing problems with EMRs, more recently there have been early disappointments with the latest iteration of IT focused on artificial intelligence and machine learning, as big players like IBM Watson and Google have tended to over-promise and under-deliver with algorithms that are poorly matched to the data or the patient need.

The U.S. Supreme Court's decision in Alice earlier this decade has closed the door on many drug and device patents involving artificial intelligence, as such claims are likely to be dismissed as abstract ideas, which means they can't get through what's become the patent eligibility rabbit hole of Section 101 of the Patent Act.

While regulatory science can lag behind technology advances, the FDA has for the past few years been exploring ways to harness the potential of artificial intelligence (AI) to streamline drug development and the approval process. A nexus for its efforts is the Information Exchange and Data Transformation (INFORMED) initiative anchored in the agency's Oncology Center of Excellence (OCE). At its inception in 2016, INFORMED was designed to tap into the power of big data and advanced analytics to improve disease outcomes.

BEIJING – With home-grown artificial intelligence (AI) medical devices under priority review, mainland China is quickly putting together a regulatory framework to more rapidly tap into the power of AI to develop devices and drugs.