Malaphor: Digital Health Law in Canada

health + tech in law = mixing chalk + cheese

Class Actions for Misrepresentations of Privacy Practices

Since the reports of the large fines that have been issued under GDPR have started making the rounds in the last couple of years, I have seen an increase in concern about being compliant with privacy laws here in Canada. In particular, a couple of questions that I sometimes get asked are “What could happen if our company is not compliant with PIPEDA? Will the Privacy Commissioner come after us with huge fines?” It’s usually a surprise to the asker when I say that, relative to its European counterparts, the Privacy Commissioner has little power in privacy enforcement.

Privacy enforcement by class action
Privacy enforcement by class action
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How a COVID vaccine patent waiver could provide real world data on the value of patents

This week, President Biden expressed his support for a proposal before the World Trade Organization (WTO) for waiving certain patent protections for COVID vaccines. In summary, if the proposal goes forward, countries such as India and South Africa would be permitted to exempt the application of vaccine patents within their border without being subject to a trade complaint from other countries. I won’t go into further details of the proposal, if you are looking for one, check out the one at Ars Technica here.

Given the US’s history in pushing for increasing IP rights in bilateral or multilateral trade agreements over and above the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement standards that apply to all WTO members, Biden’s support for this vaccine patent wavier is a pretty big deal. Obviously, the companies that have developed and are selling these vaccines are resistant to the proposal.

Photo of a staff member of the USTR upon hearing President Biden supporting the vaccine patent waiver proposal
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Social Media Surveillance for Censorship

If you are familiar with the popular platform WeChat, then you’d know that there are differences in the app depending on whether you registered your account with a phone number from China or elsewhere. It was previously known that, due to Chinese censorship regulations, WeChat content was subject to surveillance and moderation. But it was thought that surveillance and content moderation applied only to China-registered accounts.

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UN Special Rapporteur makes health-data protection recommendations

In 2015, the Human Rights Council of the United Nations appointed its first Special Rapporteur on the right to privacy, Professor Joseph Cannataci. Under his mandate, Prof. Cannataci produced this Recommendation for health-data protection (the “Recommendation”), along with an Explanatory Memorandum (the “Memo”). (See also this page for other related documents.)

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It’s my health data!

In my last post, I wrote about some issues surrounding health data and data sets in the context of AI. Since then, I saw a couple of interesting items with respect to health data “ownership” that I wanted to share.

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Personalized medicine in the age of Big Data

Intuitively, medical treatment that is tailored to our individual physical needs makes sense. For example, the best treatment for me for a particular condition may not be the best for you.

This is the goal of personalized medicine. The scope of personalized medicine can be fuzzy, but the Centers for Disease Control and Prevention (CDC) states:

Precision medicine, sometimes called personalized medicine, is an approach for protecting health and treating disease that takes into account a person’s genes, behaviors, and environment. Interventions are tailored to individuals or groups, rather than using a one-size-fits-all approach in which everyone receives the same care.

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World Health Organization Digital Health Guidelines

Recently  the World Health Organization (WHO) published a guideline entitled “Recommendations on Digital Interventions for Health System Strengthening.” The guideline responds to the World Health Assembly Resolution on Digital Health, approved by Member States in 2018, which tasked the WHO to provide normative guidance on digital health. In particular, the Member States indicated that they were interested in employing digital health technologies to advance universal health coverage and other health aims of the Sustainable Development Goals.

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Is a wave of digital health patent litigation coming?

Representative drawing of Canadian Patent No. 2,233,794, entitled “ Method and apparatus for the management of medical files”

At least since the last century, the introduction of significant advances in technology is often accompanied by patent litigation. Many people will be aware of the numerous lawsuits brought in relation to computers or connectivity in the last couple of decades. However, they may not be aware that before that, there had been patent lawsuits in relationship to the incandescent light bulb, the electric steam iron and even zippers.

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Drug and medical device clinical trial information is now publicly available in Canada

Regulations made under Vanessa’s law target clinical trial information transparency for Canadian drug and medical device approvals.

On March 20, 2019, new regulations relating to clinical trial information transparency were published in the Canada Gazette, part II. There are two parts to the regulations, one part amending the Food and Drug Regulations to deal with the drug approval process, and one part amending the Medical Device Regulations, to address medical device approvals.

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Bill 74 – What’s in it for digital health?

On February 26, 2019, the Ontario government introduced Bill 74, The People’s Health Care Act, 2019, which would make drastic changes to the health care system. Schedule 1 of the Bill, The Connecting Care Act, 2019, (the “CCA”) provides most of the substance to the Bill.

In the Minister’s announcement for the Bill, the intent is to address the fragmentation and gaps in care. As a solution, the Bill contains multiple pieces (some of them controversial), but today I’ll be concentrating on the digital health aspects. Digital health seems to be an important part of the new healthcare system, but let’s take a closer look.

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