Related papers: On Medical Device Cybersecurity Compliance in EU
Connected Medical Devices (CMDs) have a large impact on patients as they allow them to lead a more normal life. Any malfunction could not only remove the health benefits the CMDs provide, they could also cause further harm to the patient.…
The European Union (EU) has long favored a risk-based approach to regulation. Such an approach is also used in recent cyber security legislation enacted in the EU. Risks are also inherently related to compliance with the new legislation.…
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.…
A new Cyber Resilience Act (CRA) was recently agreed upon in the European Union (EU). The paper examines and elaborates what new requirements the CRA entails by contrasting it with the older General Data Protection Regulation (GDPR).…
While procedures prevail on the European market for the greater good of its citizens, it might be daunting when trying to introduce a product, whether innovative or not. In the current world, Cyber-Physical Systems (CPSs) are ubiquitous in…
Safety is becoming cybersecurity under most circumstances. This should be reflected in the Cybersecurity Resilience Act when it is proposed and agreed upon in the European Union. In this paper, we define a range of principles which this…
The European Union (EU) has been pursuing new cyber security policies in recent years. This paper presents a short reflection of four such policies. The focus is on potential incoherency, meaning a lack of integration, divergence between…
Because digital devices and systems are widely used in all aspects of society, the risk of adversaries creating cyberattacks on a similar level remains high. As such, regulation of these aspects must follow, which is the domain of…
Despite the immense potential of AI-powered medical devices to revolutionize healthcare, concerns regarding their safety in life-critical applications remain. While the European regulatory framework provides a comprehensive approach to…
Manufacturing of medical devices is strictly controlled by authorities, and manufacturers must conform to the regulatory requirements of the region in which a medical device is being marketed for use. In general, these requirements make no…
In this chapter, we review how the EU cybersecurity regulatory framework impacts providers of cloud computing services. We examine the evolving regulatory treatment of cloud services as an enabler of the EU's digital economy and question…
The EU General Data Protection Regulation (GDPR), enforced from 25th May 2018, aims to reform how organisations view and control the personal data of private EU citizens. The scope of GDPR is somewhat unprecedented: it regulates every…
The role of software in society has changed drastically since the start of the 21st century. Software can now partially or fully facilitate anything from diagnosis to treatment of a disease, regardless of whether it is psychological or…
In this paper, we investigate the implications of the General Data Privacy Regulation (GDPR) on the design of an IoT healthcare system. On 25th May 2018, the GDPR has become mandatory within the European Union and hence also for all…
Within the healthcare environment, mobile health (mHealth) applications (apps) are more and more important. The number of new mHealth apps has risen steadily in the last years. Especially the Covid-19 pandemic has led to an enormous amount…
The increasing popularity of machine learning approaches and the rising awareness of data protection and data privacy presents an opportunity to build truly secure and trustworthy healthcare systems. Regulations such as GDPR and HIPAA…
The Cyber Resilience Act (CRA) is a new European Union (EU) regulation aimed at enhancing the security of digital products and services by ensuring they meet stringent cybersecurity requirements. This paper investigates the challenges that…
The enactment of the General Data Protection Regulation (GDPR) in 2018 forced any organization that collects and/or processes EU-based personal data to comply with stringent privacy regulations. Software organizations have struggled to…
Understanding how data quality aligns with regulatory requirements in machine learning (ML) systems presents a critical challenge for practitioners navigating the evolving EU regulatory landscape. To address this, we first propose a…
Background: The integration of the General Data Protection Regulation (GDPR) and the Medical Device Regulation (MDR) creates complexities in conducting Data Protection Impact Assessments (DPIAs) for medical devices. The adoption of…