The collection, generation, analysis, and use of health data have opened new pathways for patient care and treatment, particularly in the context of decentralized clinical trials, real-world data, and personalized medicine. Simultaneously, the increased volume of health data around the world has led to multifaceted legal questions around information security, privacy, regulatory, and technological issues. To help life sciences companies, investors, and healthcare and technology providers securely and effectively harness the value of data, Sidley’s lawyers draw upon the firm’s deep knowledge of global business and the burgeoning digital health landscape.
Working together across the firm’s global offices and practice areas, our lawyers monitor the changing data regulatory frameworks and developments in technology to counsel clients on regulatory strategy, data-driven policy, litigation, and transactional matters. We bring our multidisciplinary knowledge to bear in advising on a range of issues at the intersection of health technology and life sciences. In addition to information security and privacy, we advise on market access, competition, intellectual property, and product liability.
“… impressive capabilities across corporate, privacy and data security, product liability, and healthcare.”
Chambers Global 2022, USA: Life Sciences & Pharmaceutical Sector (International & Cross-Border)
How We Add Value
Digitalization in life sciences and the corresponding legal framework — including data privacy and cybersecurity laws — are constantly evolving, with case law and new statutes driving regulatory changes globally. This includes the utilization of Big Data, the Internet of Things, artificial intelligence (AI), wearables, facial recognition technologies, and biometrics. Privacy regulators will not hesitate to bring enforcement actions against any non-compliant use of data and such technologies.
Sidley is constantly monitoring developments in this space and benchmarking commercial practices in the marketplace to provide our global clients with the right legal solutions and technologies for critical business and data challenges. We have been actively involved in working with regulators and trade associations, preparing responses to various public consultations in the EU, the UK, and the U.S., and advising clients on how best to implement health and privacy-enhancing technologies (such as homomorphic encryption, federated analytics/learning, and multi-party computation) in line with information security and privacy requirements. Our lawyers advise on all aspects of cybersecurity risk, from proactive counseling and compliance assessments, to reactive cyber incident response.
Additionally, our team has been involved in many transactions and disputes involving technology and scientific research collaborations, as well as advising on the use of real-world data and secondary research, including consent-related issues, market access, and the use of novel technologies in clinical studies/investigations.
“Excellent practice recognized for its litigation strengths and compliance expertise, maintaining a respected incident response and data breach team. Offers advice to clients on a wide array of issues, including big data, cybersecurity and cross-border information flow matters.”
Chambers Global 2022, USA: Privacy & Data Security: The Elite