1 Introduction Roger Kuan, Norton Rose Fulbright David Wallace, Johnson & Johnson Expert Analysis Chapters 7
10 Investing in Digital Health Thomas Kluz, Venture Lab NGK SPARK PLUG Jason Novak & Rachel Wilson, Norton Rose Fulbright The Global Landscape of Digital Health: A Comparative Regulatory Analysis of Real-World Evidence, Health Data, and Artificial Intelligence/Machine Learning in the United States, Europe, and China Lincoln Tsang, Kellie Combs & Katherine Wang, Ropes & Gray LLP 19 Data Protection and Data-Driven Digital Health Innovation Dr. Nathalie Moreno, Lydia Loxham & Harriet Bridges, Addleshaw Goddard LLP 25 Emerging Trends in the Global Regulation of Digital Health: Fragmented Frameworks Aiming to Catch up with Technological Advancement Eveline Van Keymeulen, Elizabeth Richards, Nicole Liffrig Molife & Oliver Mobasser, Latham & Watkins 33 Hospital Innovation Pathways in the USA, UK, Germany and France
Stephen Hull, Gilles Launay, Kirstin Ostoff & Louise Cresswell, Hull Associates LLC Q&A Chapters 41 Australia Norton Rose Fulbright: Bernard O'Shea & Rohan Sridhar 53 Austria Herbst Kinsky Rechtsanwalte GmbH: Dr. Sonja Hebenstreit 62 Belarus
Sorainen: Kirill Laptev & Marina Golovnitskaya 72 Belgium Quinz: Olivier Van Obberghen, Pieter Wyckmans, Amber Cockx & Hannah Carlota Osaer 82 Brazil Azevedo Sette Advogados: Ricardo Barretto Ferreira da Silva, Juliana Gebara Sene Santos Ikeda & Lorena Pretti Serraglio 90 China East & Concord Partners: Cindy Hu, Jason Gong & Jiaxin Yang 100 France
McDermott Will & Emery AARPI: Anne-France Moreau, Lorraine Maisnier-Boche, Caroline Noyrez & Julie Favreau
107 Germany McDermott Will & Emery Rechtsanwalte Steuerberater LLP: Jana Grieb, Dr. Deniz Tschammler, Dr. Claus Farber
& Steffen Woitz 117 India LexOrbis: Manisha Singh & Pankaj Musyuni 125 Israel Gilat, Bareket & Co., Reinhold Cohn Group:
Eran Bareket & Alexandra Cohen 134 Italy Astolfi e Associati, Studio Legale: Sonia Selletti, Giulia Gregori & Claudia Pasturenzi
146 Japan Nagashima Ohno & Tsunematsu: Kenji Tosaki & Masanori Tosu 153 Korea Lee & Ko: Jin Hwan Chung & Eileen Jaiyoung Shin 160 Mexico Baker McKenzie: Christian Lopez Silva, Carla Calderon, Marina Hurtado Cruz & Daniel Villanueva Plasencia 170 Portugal PLMJ: Eduardo Nogueira Pinto & Ricardo Rocha 178 Saudi Arabia Hammad & Al-Mehdar Law Firm: Suhaib Hammad & Ebaa Tounesi 186 Singapore Allen & Gledhill LLP: Gloria Goh, Koh En Ying, Tham Hsu Hsien & Alexander Yap 194 Spain Baker McKenzie: Montserrat Llopart Vidal & Javier Saladich Nebot 204 Taiwan Lee and Li, Attorneys-at-Law: Hsiu-Ru Chien, Eddie Hsiung & Shih-I Wu 212 United Kingdom Bird & Bird LLP: Sally Shorthose, Toby Bond, Emma Drake & Pieter Erasmus 221 USA Norton Rose Fulbright: Roger Kuan, Jason Novak & Susan Linda Ross Digital Edition Chapter
232 Predicting Risk and Examining the Intersection of Traditional Principles of Product Liability Laws with Digital Health
Eric Alexander, Gerard Stegmaier, Jamie Lanphear & Michael Rubayo, Reed Smith LLP
