The Impact Of Artificial Intelligence On Medical Innovation In Europe And United States

In a recent article published in Intellectual Property & Technology Law Journal, and expanding on our previous post, we discuss the legal and regulatory implications of applying artificial intelligence (AI) to the EU and US healthcare and life sciences sectors.

AI software, particularly when it involves machine learning, is being increasingly used within the healthcare and life science sectors. Its uses include drug discovery (e.g., software that examines biological data to identify potential drug candidates), diagnostics (e.g., an app that analyses real-time data to predict health issues), disease management (e.g., mobile-based coaching systems for pre- and post- operative care) and post-market analysis (e.g., adverse event data collection systems).

Given the healthcare and life science sectors are highly regulated, the development and use of AI requires careful scrutiny of applicable legal and regulatory obligations and any ongoing policy developments. The article discusses how AI may contribute to the research and development of health products, to the care and treatment of patients, and the corresponding legal and regulatory issues surrounding such technological advances.

In Europe, depending on its functionality and intended purpose, software may fall within the definition of 'medical device' under the Medical Devices Directive. However, classification of software is fraught with practical challenges because, unlike classification of general medical devices, it is not immediately apparent how the legal parameters apply. The European Commission has published guidelines to interpret the Directive's requirements, but these are not legally binding (although were recently endorsed by the Advocate General of the Court of Justice of the European Union, as discussed in our advisory). The new EU Regulations adopted on April 5, 2017, which come into effect on May 26, 2020, will widen the scope of the regulatory regime considerably, and will require all...

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