In April, the Competition Bureau announced it had commenced a market study of Canada’s health-care sector to “better understand existing or potential impediments to innovation and choice, and possible opportunities for change, in digital health care.”
The Bureau will examine issues related to the approval of digital health products, including medical devices, hospital procurement and the ability of health-care providers to deliver digital care to patients, says Laura Weinrib, a partner at Blake Cassels & Graydon LLP in Toronto.
Billing codes, compensation for delivering digital health care, the scope of practice of health-care professionals, whether provincial health-care professional statutes are overly limiting and who can provide digital care have all been under the microscope, she adds. The Bureau will now accept comments on its study and make recommendations to the health-care sector.
“They’re aware that this is a hot topic,” Weinrib says, noting that, in the market study, the Bureau stated that COVID-19 had accelerated the use of digital health care. “The push toward digital health care, telehealth — those are the things that are here to stay.”
“COVID, particularly in health care, has accelerated the adoption of technology to deliver health care through telecommunications,” says Michael Watts, a partner at Osler Hoskin & Harcourt LLP in Toronto. “It’s resulted in an acceleration of investment and proliferation of the offerings and the technologies.”
In short, the digital revolution in the provision of health care has arrived, and it won’t be going away.
“In my view, we’re seeing two things: lots of new products and lots of activities in the M&A space,” says Sara Zborovski, a partner at Stikeman Elliott LLP in Toronto. Increased innovation and technology, combined with a more tech-savvy culture, and then the COVID-19 pandemic “have created this perfect storm,” she says.
“All of a sudden, we’re all way more comfortable doing things online, including people of all generations. We’re seeing a ton of new products, an increase in disease prevention technologies and lots of transactions in the M&A space.”
Hospital systems are now investing in secured Zoom systems, and in December 2019, Health Canada issued, for the first time, guidance on software as a medical device.
Telehealth virtual apps started appearing about eight years ago, says Watts. “You had a few companies making apps available on a 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.
“There’s been an acceleration and proliferation 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 artificial intelligence and data to be able to provide algorithms to help guide the regulated health professionals.
“All of that has created a significant proliferation and advancement of the telehealth 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 locations, funding models were limited.
Physicians could not bill health insurance 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 provinces 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.
These 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 software as a medical device, which came into effect in December 2019, “was in response to very outdated guidance as to how software was treated as a medical device,” says Weinrib.
The guidelines consider software a medical device when it’s intended for one or more medical purposes and “where the software acquires or processes or analyzes an image or somehow supports or provides recommendations 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 awareness 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 technology where health-care professionals can get data from software 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 products 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.
“They’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 hallmarks of these new processes is that they’re continuously evaluating evidence of safety.”
However, the relaxation of the regulatory requirements for approval of medical devices and drugs is a temporary measure that balances the risk of harm with risk to Canadians from the COVID pandemic. Once the pandemic is over, Health Canada will revert to its “normal process,” says Watts.
The future of health care
Remote doctor or pharmacy visits are not only safer but faster. Weinrib say she has had multiple video or phone consultations with doctors since the start of COVID and has found them very helpful, with no commuting time and wait times never more than five or 10 minutes.
While annual physical exams and some tests will still have to be in person, “telehealth will align with our general ‘new normal’ post-COVID,” says Zborovski, when those who can work from home more often will and perhaps keep life more straightforward.
Part of that will be an acceptance of the technology that allows someone to call their doctor online and show them an ailment such as a rash without having to go anywhere. Younger generations may already be close to that, while older generations may soon adapt as well. “As we get more secure platforms and become more comfortable with doing things and disclosing things online, I think we’ll see more and more,” Zborovski adds.The future of health care will lie in its provision through leveraging AI data, virtual technology and virtual devices to virtual diagnoses, says Watts.
“We’re struggling in terms of the cost of provision of caring for Canadians with chronic illnesses — and that’s in the home, it’s in the community; it’s not in the hospital,” he says, noting that the Canada Health Act focuses primarily on hospital services and those provided by physicians. Care in communities can be delivered cost effectively and via telehealth and leveraging technologies in the home.
“COVID accelerated all of that,” he says, “but also because it clearly highlighted that it’s not safe to go to a hospital to receive care unless you really need to go.”