デジタルヘルス

Digital health technology and artificial intelligence (AI) has prompted a major evolution of drug and medical device developments, the provision of healthcare, and how healthcare is received by patients. Products increasingly blur the boundaries between consumer technology and medical devices. Innovators in this field face unique challenges in navigating a fluid regulatory terrain and evolving privacy rules, as legislators and regulators race to keep up with the pace of technological development.

“Sidley’s life sciences practice is highly regarded on an international level. Clients seeking global support will benefit from the firm’s highly rated teams across Europe, Asia, and the USA.”
Chambers Global 2022, Multi-Jurisdictional: Life Sciences

Global companies achieving groundbreaking advances in healthcare seek Sidley’s advice on the complex and challenging legal issues they face in their day-to-day business operations. This includes pre-clinical development, evidence generation for market approval and pricing and reimbursement, post-market surveillance, patient and healthcare professional engagement, gathering and analysis of real-world evidence, pharmacovigilance, manufacturing and supply chain, commercial deals, advertising and promotion, data privacy and information security, and the use of AI.

Our deep understanding of the life sciences industry in general, digital health, and AI in particular, is grounded in a collaborative cross-office team that has years of experience working with regulators, service providers, drug and medical device manufacturers, clinical laboratories, genetic testing manufacturers, health technology and health IT companies, industry leaders in consumer technology, and investors in this space. Harnessing our collective knowledge, combined with the resources of the firm’s global network of lawyers across Europe, the United States, and Asia, we help our clients optimize their digital health business models and avoid pitfalls.

Clients comment on Sidley’s “knowledge of the industry and the legal framework” adding that “the firm really makes cases their own” and “act very elegantly before the courts.”
Chambers Global 2022, Multi-Jurisdictional: Life Sciences