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12 www.lexpert.ca Feature non-insured basis," meaning the cost of using the apps was not covered by health insurance. Since that time, a number of companies, including major telecoms such as TELUS, have bought up those initial startups. "ere's been an acceleration and prolif- eration of the telecommunication apps," Watts says, "and then you marry that with the wearable and diagnostic technologies that can be matched with the virtual apps, the proliferation and exploitation of arti- ficial intelligence and data to be able to provide algorithms to help guide the regu- lated health professionals. "All of that has created a significant proliferation and advancement of the tele- health apps." Provincial telehealth guidance and funding On the provincial front, says Weinrib, "we've had a revolution in telehealth as a result of COVID," owing to its convenience. Although patients had used it in remote loca- tions, funding models were limited. Physicians could not bill health insur- ance plans for the professional services they provided to their patients through telehealth, says Watts, because of the "very restricted payment of telehealth services through the Ontario Telemedicine Network." As a result of the COVID-10 pandemic, the prov- inces reviewed their earlier, more stringent requirements for insured physician services delivered via the apps since remote visits are safer, he says. Ontario, for one, enacted new billing codes for providing remote advice, and Alberta has already announced its plan to continue funding remote care in many circumstances, says Weinrib. ese temporary billing codes now exist across Canada, with some provinces allowing for variances of compensation for telehealth, says Watts. Telehealth applications should be compliant across Canada, "so most of the larger providers have taken steps to comply with the provincial legislation and the provincial health insurance plan for each of the provinces." And federally, the government of Canada is investing heavily in telehealth, to the tune of an estimated $241 million. Software as a medical device Health Canada's revised guidance on so- ware as a medical device, which came into effect in December 2019, "was in response to very outdated guidance as to how soware was treated as a medical device," says Weinrib. e guidelines consider soware a medical device when it's intended for one or more medical purposes and "where the soware acquires or processes or analyzes an image or somehow supports or provides recommenda- tions to health-care professionals or patients about prevention or diagnosis or treatment of a disease," says Zborovski. "We're seeing a lot of disease state aware- ness apps and disease prevention apps and taking it to the next step, [such as] apps that allow health-care professionals to review and analyze data remotely," she adds. "So not only are they getting data from the patient, but now we're seeing lots of tech- nolog y where health-care professionals can get data from soware that's attached to something," such as a dialysis machine. "It allows for even more types of remote health-care services to be provided," Zborovski says. "I think that'll also continue to push the envelope." Health Canada opens new pathways When it became clear that there was an urgent need for medical devices and personal protective equipment, Health Canada was "able to pivot at a speed that we have never seen before" in approving drugs and medical devices, says Weinrib. Some of these approvals were for prod- ucts approved in other countries and didn't provide an automatic path for approval in Canada but simply a quicker one. Health Canada provided more flexible standard labelling requirements. For example, where labels on certain products may not have been bilingual, they could be approved temporarily. "ey've been nimble in a way that we haven't seen before and in all areas: in inspections, in approving new devices and dealing with shortages of old devices [and] in approving new drug products," says Weinrib. Although there may have been more recalls for some of these products, "one of the "The COVID situation is what created this real perfect storm. All of a sudden, we're all way more comfortable doing things online, including people of all generations." "The push toward digital health care, telehealth — those are the things that are here to stay. We've had a revolution in telehealth as a result of COVID." Sara Zborovski STIKEMAN ELLIOTT LLP Laura Weinrib BLAKE CASSELS & GRAYDON LLP

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