Personalized medicine in the age of Big Data

Big Data may provide insights about treatments

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… Read more »

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… Read more »

Is a wave of digital health patent litigation coming?

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,… Read more »

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… Read more »

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… Read more »

‘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… Read more »

Health Canada’s Draft Guidance on SaMD shows the medical devices laws need to be updated for digital health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. According to the Draft Guidance Document, software will generally be considered SaMD if it has and performs one or… Read more »

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… Read more »