Elisabetta Biasin

• Law
• Researcher at KU Leuven

With the recent and evolving regulatory frameworks regarding the usage of Artificial Intelligence (AI) in both drug and medical device development, the differentiation between data derived from observed (‘true’ or ‘real’) sources and artificial data obtained using process‐driven and/or (data‐driven) algorithmic processes is emerging as a critical c...

The European CORE-MD consortium (Coordinating Research and Evidence for Medical Devices) proposes a score for medical devices incorporating artificial intelligence or machine learning algorithms. Its domains are summarised as valid clinical association, technical performance, and clinical performance. High scores indicate that extensive clinical in...

Cybersecurity of medical devices has become a concrete concern for regulators and policymakers in the European Union and United States. Following the COVID-19 pandemic, there has been an increase in cyber-attacks on critical healthcare infrastructures and their IT systems, which have suffered service disruptions and put patients’ health and safety...

Social media (SoMe) has witnessed remarkable growth and emerged as a dominant method of communication worldwide. Platforms such as Facebook, X (formerly Twitter), LinkedIn, Instagram, TikTok, and YouTube have become important tools of the digital native generation. In the field of medicine, particularly, cardiology, attitudes towards SoMe have shif...

The regulation of cybersecurity for medical devices keeps evolving in the European Union (EU). In the past few years, new pieces of legislation have been added to the initial framework for medical device cybersecurity, including the Medical Device Regulation, the General Data Protection Regulation and the Cybersecurity Act. The Artificial Intellige...

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 med...

The Italian National Health Service is adopting Artificial Intelligence through its technical agencies, with the twofold objective of supporting and facilitating the diagnosis and treatment. Such a vast programme requires special care in formalising the knowledge domain, leveraging domain-specific data spaces and addressing data governance issues f...

Medical devices and artificial intelligence systems rapidly transform healthcare provisions. At the same time, due to their nature, AI in or as medical devices might get exposed to cyberattacks, leading to patient safety and security risks. This book chapter is divided into three parts. The first part starts by setting the scene where we explain th...

On 11 March 2020, the World Health Organization declared a pandemic of the COVID-19 coronavirus disease that was first recognized in China in late 2019. Among the primary effects caused by the pandemic, there was the dissemination of health preventive measures such as physical distancing, travel restrictions, self-isolation, quarantines, and facili...

The Data Act proposal of February 2022 constitutes a central element of a broader and extremely ambitious initiative by the European Commission to regulate the data economy. CiTiP’s Data Act White Paper, which is based and expands on a coordinated series of blog posts published by CiTiP during the summer of 2022 (https://www.law.kuleuven.be/citip/b...

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...

Regulators have been more permissive for medical devices compared to their drug and biologic counterparts. While innovative products can thereby reach consumers more quickly, this approach raises serious public health and safety concerns. Additionally, the nature of medical devices is rapidly changing, as software has become as important as hardwar...

This article details a correction to the article: Biasin, E. and Kamenjašević, E., 2020. Open Source Hardware and Healthcare Collaborative Platforms: Common Legal Challenges. 'Journal of Open Hardware', 4(1), p. 7. DOI: https://doi.org/10.5334/joh.31

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,...

Open collaborative platforms to share open source hardware project designs are a growing paradigm. In the healthcare sector, platforms-such as Careables.org, Patient Innovation, Makers Making Change-are becoming a popular means to share knowledge and create healthcare solutions. Users of these platforms, however, might be unaware of the legal requi...