Legal and Regulatory Framework for AI Solutions in Healthcare in EU, US, China, and Russia: New Scenarios after a Pandemic

settings Order Article Reprints Open AccessReview Legal and Regulatory Framework for AI Solutions in Healthcare in EU, US, China, and Russia: New Scenarios after a Pandemic by Filippo Pesapane 1,* [ORCID] , Daniele Alberto Bracchi 2, Janice F. Mulligan 3, Alexander Linnikov 4, Oleg Maslennikov 5, Maria Beatrice Lanzavecchia 6, Priyan Tantrige 7 [ORCID] , Alessandro Stasolla 8, Pierpaolo Biondetti 9,10, Pier Filippo Giuggioli 2, Enrico Cassano 1 [ORCID] and Gianpaolo Carrafiello 9,10 1 Breast Imaging Division, IEO European Institute of Oncology IRCCS, 20141 Milan, Italy 2 Agnoli e Giuggioli Law Firm, University of Milan, 20122 Milan, Italy 3 California Law Firm of Mulligan, Banham & Findley, San Diego, CA 92101, USA 4 Department of World Economy and International Business of the Faculty of International Economic Relations, Financial University under the Government of the Russian Federation, 123112 Moscow, Russia 5 Information Technology and Digital Economy Department, Ivanovo State University of Chemistry and Technology, 153000 Ivanovo, Russia 6 Isolabella Law Firm, 20122 Milan, Italy 7 Interventional Radiology, King’s College Hospital NHS Foundation Trust, London SE5 9RS, UK 8 UOC Neuroradiologia Diagnostica ed Interventistica, A.O.S. Camillo Forlanini, 00152 Rome, Italy 9 Diagnostic and Interventional Radiology Department, Fondazione IRCCS Ca Granda—Ospedale Maggiore Policlinico, 20122 Milan, Italy 10 Department of Health Sciences, University of Milan, 20122 Milan, Italy * Author to whom correspondence should be addressed. Radiation 2021, 1(4), 261-276; https://doi.org/10.3390/radiation1040022 Received: 9 August 2021 / Revised: 10 October 2021 / Accepted: 11 October 2021 / Published: 15 October 2021 Download Versions Notes Simple Summary We offer an overview of the state of regulation of AI in healthcare in the European Union, the United States of America, the China, and the Russian Federation and future strategies to make AI applications safe and useful. Abstract The COVID-19 crisis has exposed some of the most pressing challenges affecting healthcare and highlighted the benefits that robust integration of digital and AI technologies in the healthcare setting may bring. Although medical solutions based on AI are growing rapidly, regulatory issues and policy initiatives including ownership and control of data, data sharing, privacy protection, telemedicine, and accountability need to be carefully and continually addressed as AI research requires robust and ethical guidelines, demanding an update of the legal and regulatory framework all over the world. Several recently proposed regulatory frameworks provide a solid foundation but do not address a number of issues that may prevent algorithms from being fully trusted. A global effort is needed for an open, mature conversation about the best possible way to guard against and mitigate possible harms to realize the potential of AI across health systems in a respectful and ethical way. This conversation must include national and international policymakers, physicians, digital health and machine learning leaders from industry and academia. If this is done properly and in a timely fashion, the potential of AI in healthcare will be realized.