A recently published chapter (here) describes the evolving global regulatory landscape in three major developing areas – real world evidence, health data, and AI/Machine Learning- across the key jurisdictions of the United States, Europe and China.
The landscape of digital health has changed dramatically in recent years, accelerated by the COVID-19 pandemic, which has demanded an increased reliance on technological tools to manage complex and multifaceted healthcare systems.
The field encompasses the concept of eHealth for managing healthcare delivery and health surveillance, as well as other digital health technologies, such as the internet of things, AI, big data, and robotics. These technologies will become more important in the way people manage their own health and in the way they receive care.
Digital health is the field of knowledge and practice associated with the development and use of enabling digital technologies to improve health. The digital health market was valued at over US$200 billion in 2022, and it is projected to expand at a compound annual growth rate of 18% from 2023 to 2030.
Pressure on healthcare delivery is becoming more critical as we enter a global recession, fuelled by inflationary pressures and geopolitical uncertainty. Moreover, all countries face major challenges to prepare their health and social systems for significant demographic shifts stemming from rising life expectancy. An aging population is correlated with certain complex health states, which can be medically challenging.
Digital tools can help assess the impact of higher chronic disease prevalence, design systems that will improve the quality of patient care, and evaluate the effectiveness of specific medical interventions. Digital transformations and other related analytical tools are also increasingly being applied to gain greater efficiency in basic and translational research by simplifying data collection, analysis, storage, and data mining.
The chapter is co-authored with my colleagues: Bo (Alice) Du, Julie Kvedar, Helen Ryan, Kellie Combs and Katherine Wang of Ropes & Gray’s Global Life Sciences & Healthcare Practice.
"Such sweeping technological and methodological advances are bringing about a sea change in the global regulatory environment. Regulators from around the world are rethinking their approaches, adopting regulatory models that are agile, iterative, and collaborative to address the considerable challenges posed by disruptive digital health technologies and methodological approaches."