The field of artificial intelligence (AI) is stretching the boundaries of conventional med-tech regulation, and several regulatory agencies are working to cut that Gordian knot. Marc Lamoureaux, director of digital health at Health Canada’s (HC) medical device directorate, said on a Sept. 21 webinar that legislation passed in 2019 gives the agency a “regulatory sandbox” in which to experiment with AI regulation, a mechanism he said may bring these algorithms to market much more rapidly than would otherwise be the case.

The digital medicine company Physiq Inc. has received a contract from the NIH to develop an artificial intelligence (AI)-based index that can provide an early warning that a patient with COVID-19 is in decline and needs medical treatment. The index, called the COVID-19 Decompensation Index (CDI) Digital Biomarker, will run on Physiq’s existing Accelerateiq computing platform, analyzing physiological data from FDA-cleared wearable devices to create a personalized baseline for patients who have tested positive for COVID-19.

Israeli startup Olive Diagnostics Pvt. Ltd. is aiming to disrupt at-home urinalysis testing with a hands-free, noninvasive, artificial intelligence (AI)-based solution that provides remote diagnostics by detecting urine’s molecular composition. K2, as the device is called, attaches easily to the toilet rim to generate secure, personalized diagnostic data that directly links to a mobile app.

Fitbit Inc. and Apple Inc. picked up the pace in their race to put health monitoring apps on wrists everywhere with Fitbit gaining 510(k) clearance from the U.S. FDA for its new ECG app for the Fitbit Sense and Apple revealing the blood oxygen sensor built into its Series 6 watch this week. The new apps join a growing array of technological advances that permit wearable devices to track and record a range of health metrics.

LONDON – After years of progressing at snail’s pace, COVID-19 has forced through a rapid adoption of digital tools across the spectrum of health in the U.K., from general practitioner appointments, to hospital referrals, elderly care homes and community nursing. “At game changing speed” the health and care system, “has gone from one extreme to another,” said Harpreet Sood, a general practitioner in inner city London and board member of Digitalhealth London.

TORONTO – “With COVID-19 it’s not been an easy time to raise capital.” In virtually the same breath Joshua Liu, CEO of Toronto-based health-tech startup SeamlessMD Inc. credited the pandemic with nudging investors to spend CA$4 million (US$3 million) to grow his company’s cloud-based patient engagement app, boosting a library of digital plans for surgery, cancer and chronic care and adding machine learning-based risk prediction to remote patient monitoring.

The BioWorld Artificial Intelligence price-weighted index, which includes biopharmaceutical companies, medical devices and health care services companies, has climbed in value and is currently up almost 37% year-to-date.