When Does Stand-Alone Software Qualify as a Medical Device in the European Union?—The Cjeu’s Decision in Snitem and What it Implies for the Next Generation of Medical Devices

Abstract

<jats:title>Abstract</jats:title> <jats:p>This contribution analyses the first decision by the Court of Justice of the European Union (CJEU) on the qualification and regulation of stand-alone software as medical devices. Referring to the facts of the case and the applicable European Union (EU) regulatory framework, the Court specifically found that prescription support software may constitute a medical device. This would even be the case where the software does not act directly in or on the human body. Yet, according to the CJEU, it is necessary that the intended purpose falls within one or more of the ‘medical purpose’ categories of the regulatory definition of ‘medical device’. The case has important implications, not only for specific legal debates, but it also signifies a paradigm shift with a rapidly increasing digitalisation of the health and life sciences. This highlights the demand for continuous debates over the necessary evolution of the regulatory framework applying to the interface of medical artificial intelligence (AI) and Big Data.</jats:p>

Ethical Considerations for Artificial Intelligence in Medical Imaging: Deployment and Governance

“…If a systematic error occurs because of inaccurate performance claims, obscured limitations, or failures of the system in intended-use cases, responsibility should be placed on those who trained, tested, and validated the AI device. The assignment of legal liability for harm is made more complex by the evolving legal status of AIMDs as regulated medical devices in the United States and Europe (51,52) and the unsettled requirements for premarket and postmarket disclosure. As we build a regulatory structure around AIMDs, the locus of liability for harm must be proactively addressed by lawmakers and regulators.…”

The borderline with medical devices in the current Spanish legal framework

“…• Dispositivos intrauterinos para liberación de medicamentos Los dispositivos intrauterinos para liberación de medicamentos, especialmente aquellos dedicados a la liberación de levonogestrel, se usan tanto como anticonceptivos como en afecciones (la bomba, la cánula, el reservorio, el sistema de adhesión, la zona de inserción, el monitor y el software), cuya función es la de control de la administración del medicamento, mientras que la responsable de la acción principal prevista, el manejo de la diabetes, es la insulina (120,121).…”

Place du numérique et de l’intelligence artificielle dans l’activité médicale. Éléments pour une réflexion commune entre médecins et entreprises

“…Product liability could apply insofar as an algorithm is integrated in a medical device or diagnostic. Both European and US courts and new regulations regard medical software as a medical device because of its intended use (258). Developers may, however, escape liability because in many cases the "actual uses" of a product differ from the "intended uses", even if some of the "actual uses" could have been foreseen (258).…”

“…Both European and US courts and new regulations regard medical software as a medical device because of its intended use (258). Developers may, however, escape liability because in many cases the "actual uses" of a product differ from the "intended uses", even if some of the "actual uses" could have been foreseen (258). Product liability may also not apply if an AI algorithm is construed as a service and not as a product.…”