Digital Health 2024

Norton Rose Fulbright lawyers Roger Kuan, Jason Novak, Apurv Gaurav, Nathanael Green, Bernard O'Shea, Rohan Sridhar, Brian Chau, Véronique Barry, Vanessa Grant, and Sarah Pennington contributed several chapters to Digital Health 2024 International Comparative Legal Guide, published by GLG, which is a leading global platform for legal reference, analysis and news. Kuan also served as a contributing editor for the publication.

Chapter 1 | Introduction

Authors: Roger Kuan, Norton Rose Fulbright and David Wallace, Johnson & Johnson

The rapid convergence of digital technologies with healthcare over the past five years (even prior to the COVID-19 pandemic) has transformed how healthcare is delivered to the masses. The promise of digital technologies continues to transform the healthcare delivery model from a traditional model based on a “one-size-fits-all” practice of medicine that was characterized by a provider-centric approach with information silos, to a new model that is focused on patient-centric treatment personalization with high data accessibility and utilization. The result is a highly personalized healthcare system that is focused on data-driven healthcare solutions and individualized delivery of therapeutics and treatments to patients using information technologies (IT) that enable seamless integration and communication between patients, providers, payors, researchers and health information depositories. A November 2020 report by Precedence Research published on GlobeNewsWire indicates that the global digital health market is poised to grow at a compound annual growth rate of around 27.9 percent over the next seven years to reach approximately US$833.44 billion by 2027.

Chapter 2 | A new era of investing and diligence in healthcare solutions

Authors: Jason Novak and Nathanael Green, Norton Rose Fulbright and Dr. Milad Alucozai, Box One Ventures

Investing in emerging biotech and healthcare companies is a unique venture that requires knowledge and understanding of both the technology and the team behind the science. Here, we address themes for what makes a startup-investor team productive and how these themes lead to valuable companies. These themes should be considered by investors and founders alike (and their legal counsel) to consider each role in the bigger picture. This helps both sides’ understanding of what their counterpart considers and how they can shape their strategy to maximize the team’s output.

Chapter 3 | Australia

Authors: Bernard O’Shea and Rohan Sridhar, Norton Rose Fulbright

In Australia, digital health is an umbrella term referring to a range of technologies that can be used to treat, diagnose and monitor patients and collect and share a person’s health information.

Similar to other jurisdictions, the term “digital health” is still developing as technologies evolve. At one end of the spectrum, the term includes the delivery of telehealth services, while at the other end, the term connotes mobile apps and software as a medical device (SaMD) used to deliver personalized and individualized medicine, with digital medical devices lying somewhere in between.

While digital health is not a defined legislative term, the government has taken steps to define telehealth in order to include these services under the subsidized Medicare arrangement during the COVID-19 pandemic, and the national regulator, the Therapeutic Goods Administration (TGA), regulates some digital health technologies as medical devices.

Chapter 7 | Canada

Authors: Vanessa Grant, Brian Chau, Véronique Barry, Sarah Pennington

In Canada, “digital health” is generally defined as health technologies that improve access to healthcare information, facilitate diagnosis and treatment, and improve patient access to care. Digital health technologies include stand-alone software applications, integrated hardware, and software platforms, and medical devices (MDs) that include software and artificial intelligence (AI). Key emerging digital health technologies in Canada include wireless MDs, mobile medical apps, SaMD, and AI, among others. The core issues arising alongside these technologies include how they are to be categorized and regulated; concerns around the collection, handling, and protection of data and personal information in the digital age; and the scope of intellectual property rights available to protect digital health technologies.

Chapter 25 | USA

Authors: Roger Kuan, Jason Novak and Apurv Gaurav Norton Rose Fulbright

In the United States, digital health is a technology sector that is a convergence of high technology with healthcare. The result is a highly personalized healthcare system that is focused on data-driven healthcare solutions, individualized delivery of therapeutics and treatments to patients powered by IT that enable seamless integration and communication between patients, providers, payors, researchers and health information depositories.

The core legal issues associated with digital health in the US include patentability, data privacy and compliance with the Health Insurance Portability and Accountability Act (HIPAA), US Food and Drug Administration (FDA) regulatory compliance, healthcare provider licensing and issues connected with patient referrals and anti-kickback statutes.