Digital Health 2023

Norton Rose Fulbright lawyers Roger Kuan, Jason Novak, Bernard O'Shea, Rohan Sridhar, Susan Ross and Rachel Wilson contributed several chapters to Digital Health 2023 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% over the next seven years to reach approximately US$833.44 billion by 2027. 

Chapter 2 | Investing in digital health

Authors: Jason Novak and Rachel Wilson, Norton Rose Fulbright and Thomas Kluz, Venture Lab NGK SPARK PLUG

Although the digital health market did not escape the 2022 venture-investing downturn, there is light ahead. As the sun emerges, digital health companies with strong value propositions and strategic milestone choices should be able to ride post-pandemic tailwinds through the incipient recession. Simultaneously, investors and investees must pay special attention to legal issues put front and center by the digital evolution of healthcare. 

Chapter 7 | Australia

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

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 27 | USA

Authors: Roger Kuan, Jason Novak and Susan Ross, Norton Rose Fulbright

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 information technologies that enable seamless integration and communication between patients, providers, payors, researchers and health information depositories.