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.

NEW DELHI – Artificial intelligence (AI) is increasingly gaining a foothold in India's health care landscape, with investors pouring money into the new technology, companies developing products and regulators looking to come up with much-needed rules.

The FDA's regulation of artificial intelligence (AI) is divided by product center for reasons that are obvious, but precisely what that regulation will look like is anything but. As the FDA's Center for Devices and Radiological Health (CDRH) goes through the comment period for its discussion draft for AI, other nations are starting their own efforts in this space. The American agency's efforts may foreshadow the approaches employed in other nations.

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.

Recognizing that the age of artificial intelligence (AI) has arrived and, with it, the potential to transform everything from health care to transportation and manufacturing, U.S. President Donald Trump issued an executive order earlier this year that launched the American AI Initiative.

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.

HONG KONG – With an aging population and a shortage of doctors, Japan is now working to develop artificial intelligence (AI)-based medicine faster than any other country in Asia.

PERTH, Australia – It's likely that Australia will not draft separate guidance or regulations for software applications that use artificial intelligence or machine learning (AI/ML) for drug development or medical devices.

HONG KONG – South Korea is actively working to expand its artificial intelligence (AI) capabilities in health care, but outdated regulations and concerns over privacy and profit sharing are proving to be significant stumbling blocks.