Artificial intelligence in medical device software and high-risk medical devices - a review of definitions, expert recommendations and regulatory initiatives.

Introduction: Artificial intelligence (AI) encompasses a wide range of algorithms with risks when used to support decisions about diagnosis or treatment, so professional and regulatory bodies are recommending how they should be managed.

Areas Covered: AI systems may qualify as standalone medical device software (MDSW) or be embedded within a medical device. Within the European Union (EU) AI software must undergo a conformity assessment procedure to be approved as a medical device.

Cybersecurity of medical devices: new challenges arising from the AI Act and NIS 2 Directive proposals.

Cyberattacks on the IT infrastructure of hospitals, electronic health records or medical devices that have taken place during the COVID-19 pandemic reaffirmed how crucial it is to ensure cybersecurity in the healthcare sector. Medical devices are regulated in the European Union (EU) through vertical product-specific legislation, such as the Medical Device Regulation (MDR), among others. The MDR foresees safety requirements implying cybersecurity obligations for medical device manufacturers.

Covid-19 Response From Global Makers: The Careables Cases of Global Design and Local Production.

Makerspaces-informal shared spaces that offer access to technologies, resources and a community of peer learners for making-across the globe initiated a rapid response to the lack of medical hardware supplies during the global pandemic outbreak in early 2020 caused by the Corona virus (COVID-19). As our health systems faced unexperienced pressure, being close to collapsing in some countries, and global supply chains failing to react immediately, makers started to prototype, locally produce and globally share designs of Open Source healthcare products, such as face shields and other medical supplies. Local collaboration with hospitals and healthcare professionals were established.