INTRODUCTION Contributed by: Sarah-Jane Dobson and Katrin Ruhl, Ashurst
• data interoperability and standardisation; and • the Internet of Medical Things (IoMT). These advancements are transforming the healthcare landscape, offering new opportuni- ties for improving patient care and operational efficiency. Several jurisdictions are undertaking reforms to address the evolving digital healthcare land- scape. On the EU level, the revised PLD aims to keep pace with new stakeholders and prod- uct types, overcoming the “black box” effect for consumers. In Switzerland, the “DigiSanté” ini- tiative aims to advance digitalisation within the healthcare sector. These reforms and initiatives reflect the ongoing efforts to create a more integrated and robust regulatory framework that can effectively man- age the complexities of digital healthcare tech- nologies.
In conclusion, digital healthcare offers signifi- cant benefits in terms of accessibility, efficiency and patient outcomes. However, the regulatory framework must evolve to keep pace with tech- nological advancements, address legal risks, and ensure the safety and privacy of patients. In the face of continuing digital progress, regard- less of the regulatory framework (or its introduc- tion), stakeholders will face uncertainties and will need to closely monitor the changing regulatory landscape. Moreover, even with existing and fur- ther developed liability regimes, the complexity of legal issues arising in the context of digital healthcare means liability determination for these products is particularly complex.
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