Related papers: On Medical Device Cybersecurity Compliance in EU
The advancement in the healthcare sector is entering into a new era in the form of Health 4.0. The integration of innovative technologies like Cyber-Physical Systems (CPS), Big Data, Cloud Computing, Machine Learning, and Blockchain with…
Prognostic and diagnostic AI-based medical devices hold immense promise for advancing healthcare, yet their rapid development has outpaced the establishment of appropriate validation methods. Existing approaches often fall short in…
Understanding the importance that the electronic medical health records system has, with its various structural types and grades, has led to the elaboration of a series of standards and quality control methods, meant to control its…
The healthcare infrastructure requires robust security procedures, technologies, and policies due to its critical nature. Since the Internet of Things (IoT) with its diverse technologies has become an integral component of future healthcare…
The GDPR grants data subjects certain rights, like the right to access their data from companies, but in practice multiple problems exist with exercising these rights such as unknown data holders or interpreting the received data. Small and…
Increased levels of digitalization in society expose companies to new security threats, requiring them to establish adequate security and privacy measures. Additionally, the presence of exogenous forces like new regulations, e.g., GDPR and…
The EU GDPR is a landmark regulation that introduced several rights for individuals to obtain information and control how their personal data is being processed, as well as receive a copy of it. However, there are gaps in the effective use…
A smart city is a place where existing facilities and services are enhanced by digital technology to benefit people and companies. The most critical infrastructures in this city are interconnected. Increased data exchange across municipal…
The General Data Protection Regulation (GDPR) requires an organisation that suffers a data breach to notify the competent Data Protection Authority. The organisation must also inform the relevant individuals, when a data breach threatens…
This article presents the current state of ML-security and of the documentation of ML-based systems, models and datasets in research and practice based on an extensive review of the existing literature. It shows a generally low awareness of…
Growing interdependencies between organizations lead them towards the creation of inter-organizational networks where cybersecurity and sustainable development have become one of the most important issues. The Environmental Goods and…
As artificial intelligence (AI) technologies increasingly enter important sectors like healthcare, transportation, and finance, the development of effective governance frameworks is crucial for dealing with ethical, security, and societal…
In April 2021, the European Commission published a proposed regulation on AI. It intends to create a uniform legal framework for AI within the European Union (EU). In this chapter, we analyze and assess the proposal. We show that the…
Computational Law has begun taking the role in society which has been predicted for some time. Automated decision-making and systems which assist users are now used in various jurisdictions, but with this maturity come certain caveats.…
Biocybersecurity is a novel space for the 21st century that meets our innovations in biotechnology and computing head on. Within this space, many considerations are open for and demand consideration as groups endeavor to develop products…
Mobile health (mHealth) applications (apps) have gained significant popularity over the last few years due to its tremendous benefits, such as lowering healthcare cost and increasing patient awareness. However, the sensitivity of healthcare…
Wearable devices like smartwatches, wristbands, and fitness trackers are designed to be lightweight devices to be worn on the human body. With the increased connectivity of wearable devices, they will become integral to remote healthcare…
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…
Small and medium-sized enterprises (SME) have become the weak spot of our economy for cyber attacks. These companies are large in number and often do not have the controls in place to prevent successful attacks, respectively are not…
The new General Data Protection Regulation (GDPR) will take effect in May 2018, and hence, designing compliant data protection policies and system architectures became crucial for organizations to avoid penalties. Unfortunately, the…