The Future of Medical Device Regulation and Standards: Dealing with Critical Challenges for Connected, Intelligent Medical Devices

A Mkwashi, I Brass - PETRAS National Centre of Excellent in IoT …, 2022 - papers.ssrn.com
New digital technologies and systems, such as the Internet of Things (IoT) or Artificial
Intelligence (AI) tools that are typically implemented as software in medical devices or as …

Emerging digital technologies in patient care: dealing with connected, intelligent medical device vulnerabilities and failures in the healthcare sector

I Brass, I Straw, A Mkwashi, I Charles… - … National Centre of …, 2023 - discovery.ucl.ac.uk
The integration of the Internet of Medical Things (IoMT) and Artificial Intelligence (AI) into
clinical routines is significantly impacting organisational preparedness at the point of care …

MedSecurance Project: Advanced Security-for-Safety Assurance for Medical Device IoT (IoMT)

P Gallos, R DeLONG, N Matragkas… - Caring is Sharing …, 2023 - ebooks.iospress.nl
The MedSecurance project focus on identifying new challenges in cyber security with focus
on hardware and software medical devices in the context of emerging healthcare …

Risk Assessment and Classification of Medical Device Software for the Internet of Medical Things: Challenges arising from connected, intelligent medical devices

I Brass, A Mkwashi - Proceedings of the 12th International Conference …, 2022 - dl.acm.org
Although the medical device industry operates within a stringent regulatory environment, the
growing deployment of connected, intelligent medical devices (CIMDs) in the healthcare …

The evolving state of medical device cybersecurity

S Schwartz, A Ross, S Carmody… - Biomedical …, 2018 - meridian.allenpress.com
To advance patient care, medical devices are becoming increasingly connected and
interoperable. Although interconnectivity and interoperability may provide great benefits …

Cybersecurity and medical devices: Are the ISO/IEC 80001-2-2 technical controls up to the challenge?

S Anderson, T Williams - Computer Standards & Interfaces, 2018 - Elsevier
Medical devices, in the case of malfunction, can have tangible impact on patient safety. Their
security, in a world where the Internet of Things has become a reality, is paramount to the …

Challenges of new technology: Securing medical devices and their software for HIPPA compliance

BA Fiedler - Managing medical devices within a regulatory …, 2017 - Elsevier
The implementation of electronic health records, increased concern for patient
confidentiality, changes in how mobile stand-alone devices that store personal health …

[HTML][HTML] Learning from experience and finding the right balance in the governance of artificial intelligence and digital health technologies

S Gilbert, S Anderson, M Daumer, P Li, T Melvin… - Journal of medical …, 2023 - jmir.org
Artificial intelligence (AI) and machine learning medical tools have the potential to be
transformative in care delivery; however, this change will only be realized if accompanied by …

Cybersecurity, Data Protection, and Artificial Intelligence in Medical Devices

L Jelić - Inspection of Medical Devices: For Regulatory …, 2023 - Springer
This chapter gives an overview of the current cybersecurity issues in medical devices, risks
concerning the personal data use, and regulatory recommendations for medical devices …

New cybersecurity requirements for medical devices in the EU: the forthcoming European health data space, data act, and artificial intelligence act

E Biasin, B Yasar, E Kamenjasevic - Law, Tech. & Hum., 2023 - HeinOnline
In recent years, the healthcare sector has undergone a digital transformation due to medical
devices that rely on network connectivity and advanced technologies. These advances bring …