相关论文: On Medical Device Cybersecurity Compliance in EU
Smart healthcare, an integral element of connected living, plays a pivotal role in fulfilling a fundamental human need. The burgeoning field of smart healthcare is poised to generate substantial revenue in the foreseeable future. Its…
The Solid specification aims to empower data subjects by giving them direct access control over their data across multiple applications. As governments are manifesting their interest in this framework for citizen empowerment and…
Providing security to Health Information is considered to be the topmost priority when compared to any other field. After the digitalization of the patient's records in the medical field, the healthcare/medical field has become a victim of…
[Context and motivation]: Understanding and interpreting regulatory norms and inferring software requirements from them is a critical step towards regulatory compliance, a matter of significant importance in various industrial sectors.…
The safety and clinical effectiveness of medical devices are closely associated with their specific use in clinical treatments. Assuring safety and the desired clinical effectiveness is challenging. Different people may react differently to…
One of the main issues of every business process is to be compliant with legal rules. This work presents a methodology to check in a semi-automated way the regulatory compliance of a business process. We analyse an e-Health hospital service…
The European Cybersecurity Certification Scheme for Cloud Services (EUCS) is one of the first cybersecurity schemes in Europe, defined by the European Union Agency for Cybersecurity (ENISA). It aims to encourage cloud providers to…
Medical Artificial Intelligence (AI) involves the application of machine learning algorithms to biomedical datasets in order to improve medical practices. Products incorporating medical AI require certification before deployment in most…
The rapid development of Industry 4.0 technologies requires robust and comprehensive standardization to ensure interoperability, safety and efficiency in the Industry of the Future. This paper examines the fundamental role and functionality…
Protecting embedded security is becoming an increasingly challenging research problem for embedded systems due to a number of emerging trends in hardware, software, networks, and applications. Without fundamental advances in, and an…
The demand of transparency of clinical research results, the need of accelerating the process of transferring innovation in the daily medical practice as well as assuring patient safety and product efficacy make it necessary to extend the…
Background: Medical device development projects must follow proper directives and regulations to be able to market and sell the end-product in their respective territories. The regulations describe requirements that seem to be opposite to…
As electronic data becomes the lifeline of modern society, privacy concerns increase. These concerns are reflected by the European Union's enactment of the General Data Protection Regulation (GDPR), one of the most comprehensive and robust…
Cybersecurity, which notoriously concerns both human and technological aspects, is becoming more and more regulated by a number of textual documents spanning several pages, such as the European GDPR Regulation and the NIS Directive. This…
There is a compelling demand for the data integration and exploitation of heterogeneous biomedical information for improved clinical practice, medical research, and personalised healthcare across the EU. The area of paediatric information…
Complying with the European Union (EU) perspective on human rights goes or should go together with handling ethical, social and legal challenges arising due to the use of biometrics technology as border control technology. While there is no…
Vessels cybersecurity is recently gaining momentum, as a result of a few recent attacks to vessels at sea. These recent attacks have shacked the maritime domain, which was thought to be relatively immune to cyber threats. The cited belief…
The European Union introduced the Digital Services Act (DSA) to address the risks associated with digital platforms and promote a safer online environment. However, despite the potential of components such as the Transparency Database,…
Since GDPR went into effect in 2018, many other data protection and privacy regulations have been released. With the new regulation, there has been an associated increase in industry professionals focused on data protection and privacy.…
The realization of digital preservation in compliance with legislation is extremely important, especially in a sensitive domain like healthcare, where guaranteeing document reliability, authenticity, integrity and readability over time is…