Malaphor: Digital Health Law in Canada

health + tech in law = mixing chalk + cheese

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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‘Right to Repair’ legislation for electronic products is introduced in Ontario – could it be circumvented by anti-circumvention?

On February 21, 2019, Bill 72, Consumer Protection Amendment Act (Right to Repair Electronic Products), 2019 was proposed and carried through first reading at the Ontario Legislative Assembly. This proposed law is similar to ones that have been introduced in many states in the United States, following a movement started in 2016 (read about the origins of the Ontario bill in the article by MobileSyrup here). The movement is mainly based on the principle that one should have the right to fix their own things (electronic products) or choose the repairperson. Of course, there’s also the desire for saving money as well as to reduce waste.

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Health Canada’s Draft Guidance on SaMD shows the medical devices laws need to be updated for digital health

About a year after it convened a Scientific Advisory Panel with respect to Software-as-a-Medical-Device (SaMD), Health Canada has now released a Draft Guidance Document for public comment until March 29, 2019.

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World Health Organization Digital Health Symposium to be held February 6-8, 2019

The World Health Organization, Europe Region, is holding a symposium on the “Future of Digital Health Systems” February 6-8, 2019. Certain sessions will be streamed via a link available through the page below.

http://www.euro.who.int/en/health-topics/Health-systems/pages/news/news/2019/2/what-you-need-to-know-about-digital-health-systems

Health Canada has commenced a public consultation on its Draft Guidance Document for “Pre-market Requirements for Medical Device Cybersecurity.”

With all the recent reports on the hacking of pacemakers, it’s timely that Health Canada confirms that it “considers cybersecurity a component of the medical device’s design and life-cycle that can impact safety and effectiveness.” The Draft Guidance appears to address both IVDD and non-IVDD devices. Interestingly, however, the Draft Guidance focuses on pre-market/pre-license application activities, and explicitly excludes actual post-market activities. Perhaps Health Canada is waiting for changes to the Medical Devices Regulations it announced earlier this year to strengthen post-market surveillance and risk management of devices before releasing another Draft Guidance on such activities.

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