INTRODUCTION Contributed by: Sarah-Jane Dobson and Katrin Ruhl, Ashurst
trigger certain regulatory requirements such as certifications (eg, the CE mark for medical apps available on the EU market). The use and application of digital healthcare is prevalent globally, although it varies from coun- try to country. Telemedicine has become particu- larly prominent, especially during the COVID-19 pandemic. The integration of AI and machine learning is rapidly advancing, with a focus on improving diagnostic accuracy and patient out- comes. Some countries are very advanced in integrating digital technology into healthcare settings, while others have more fragmented systems that are not yet mainstreamed or inter - connected with each other. The different jurisdic- tions therefore have varying regulatory regimes on digital technology. Digital healthcare brings numerous benefits, including enhanced accessibility, efficiency and patient outcomes by enabling remote consul- tations, real-time data collection and AI-driven diagnostics, while also improving interoperability and data sharing among healthcare providers. The benefits of digital healthcare to patient care can be broadly divided into two groups: individu- al treatment improvement and the overall “great- er good” for patient treatment and research. The experience of patients is generally improved with better access to healthcare (reduced need for in-person visits), having greater control over their health data, and smoother transition and access to health data from any location. Health- care professionals benefit from enhanced clinical decision-making, improved diagnostic accuracy, streamlined workflows and more efficient patient care – eg, by everyone, everywhere benefiting from complete sets of data, particularly in urgent situations.
The overall benefit for all is facilitating access to health data for researchers and innovators to improve treatment and to research and develop strategies against diseases. While there are initial investment costs in tech- nology and infrastructure, digital healthcare has the potential to reduce long-term healthcare costs significantly through improved efficiency, early disease detection, remote monitoring and telemedicine. Legal Framework There is no universal regulatory definition of digi- tal healthcare, and in most instances no bind- ing definitions exist within national frameworks. However, practically speaking, digital health- care is broadly understood as an umbrella term encompassing various digital technologies used to improve health. The World Health Organiza- tion (WHO) defines digital health as “the field of knowledge and practice associated with the development and use of digital technologies to improve health”. Similarly, the European Com- mission defines digital health as “a set of tools and services that use information and com- munication technologies (ICTs) to support and improve all stages of healthcare, from preven- tion and diagnosis to treatment, monitoring and management of health conditions”. The new European Health Data Space (EHDS) Regulation provides certain definitions related to personal electronic health data. The regulatory framework for digital healthcare has, for the most part, been developed separate- ly by each country and often lags behind techni- cal progress. Broadly, liability regimes applicable to digital healthcare are more developed (largely as these are general product liability regimes) than bespoke regulatory regimes that address specific digital healthcare issues. For exam-
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