11/11/2025 3:02:36 PM Computer Says: You're Hired/Fired/Promoted By Edward Machin Suzanne Wilson As organisations increasingly use AI tools for a range of process improvement purposes, a range of human resources-specific use cases...
10/15/2025 11:15:37 AM What The Latest Clearview AI Judgment Tells Us About Behavioural Monitoring and Big Data Under the GDPR By Edward Machin Despite the fears of foreign organisations about the long-arm jurisdiction of European data protection laws, the extra-territorial...
9/9/2025 10:28:06 AM It's All Relative: Analysing The CJEU's Judgment On The Scope Of Pseudonymous Personal Data By Edward Machin David Peloquin In a decision with significant legal and operational ramifications for organisations of all shapes and sizes, the Court of Justice of the...
6/2/2025 10:37:37 AM 2025 Medtech Regulatory Affairs Roundtable: Key Takeaways By Katherine Wang On May 22, Ropes & Gray and McKinsey & Company co-hosted the 12th Medtech Regulatory Affairs Roundtable online. Around 40 Regulatory...
5/30/2025 8:50:37 AM Regulation of Laboratory Developed Tests in APAC By Katherine Wang Michael Purcell Daisy Bray Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed,...
4/23/2025 10:11:38 AM Regulatory Landscape for AI-enabled MedTech in APAC By Katherine Wang Michael Purcell Daisy Bray Regulation of artificial intelligence (AI) in Asia Pacific remains nascent, mostly governed by existing regulatory frameworks designed...
3/26/2025 4:24:06 PM The Data Act: Six Months to Go — But What To Do? By Edward Machin The Financial Times recently published a special report on the future of digital healthcare, comprising articles on ‘smart’ hospitals,...
3/14/2025 9:26:37 AM Promoting Medical Device Regulatory Harmonization: Key Takeaways from the 27th IMDRF Conference in Japan By Katherine Wang The 27th International Medical Device Regulators Forum (IMDRF) conference, held this week in Japan, gathered regulators and industry...
2/6/2025 6:08:06 PM Life Sciences Regulatory Outlook 2025: Areas to Watch in the U.S., EU, UK, and Asia By Kellie Combs Lincoln Tsang Katherine Wang Joshua Oyster Daisy Bray Pascale Stain Emily Fruchterman +4 more... Show less As a new administration takes office in the U.S., life sciences companies and investors are preparing for changes in the regulatory,...
1/14/2025 11:57:36 AM MHRA Launches the 2025 Pilot Real-World Evidence Dialogue Programme – Implementing Broader Data Strategy and Pro-Innovation Regulatory Framework By Lincoln Tsang Daisy Bray On 13 January 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) launched its pilot Real-World Evidence (RWE)...
1/9/2025 4:19:06 PM One Size Does Not Fit All: EU, UK, and U.S. Regulatory Developments in the Age of Precision Medicine By Joshua Oyster Hannah Kerr-Peterson Jessica Delalio Advances in precision medicine (also known as “personalized medicine”) have led to an improved understanding of mechanisms underlying...
7/19/2024 9:33:17 AM What Does the New Labour Government's Legislative Agenda Tell Us About the Future of Technology Regulation in the UK? By Edward Machin On Wednesday (17 July 2024), the UK’s newly formed government announced its legislative agenda for the upcoming parliamentary session. In...
5/5/2024 12:00:56 PM Challenges and opportunities: A global review of regulatory developments surrounding AI and machine learning as devices in healthcare settings By Lincoln Tsang My colleague, Greg Levine, who chairs our FDA regulatory compliance practice, and I had a very informative conversation in a webinar on...
3/28/2024 12:38:12 PM Regulatory compliance for life sciences advertising: Challenges and opportunities in a changing global environment By Lincoln Tsang Global growth in healthcare advertising The global advertising and promotion of healthcare products has seen consistent growth. In 2023,...
3/28/2024 12:34:13 PM Asia Pacific Medtech: Regulatory updates to have on your radar in 2024 By Katherine Wang Jenny Zhang With Asia continuing to be one of the major regions for innovative medical devices and pharmaceutical products, a recent APACMed town...
1/12/2024 3:38:18 PM Private capital: Life sciences regulatory and compliance trends and developments to consider in 2024 By Lincoln Tsang Hannah Kerr-Peterson Advances in science and technology, as well as an evolving regulatory and market access environment, continue to shape the life sciences...