INSAFEDARE Project: Innovative Applications of Assessment and Assurance of Data and Synthetic Data for Regulatory Decision Support.

Digital health solutions hold promise for enhancing healthcare delivery and patient outcomes, primarily driven by advancements such as machine learning, artificial intelligence, and data science, which enable the development of integrated care systems. Techniques for generating synthetic data from real datasets are highly advanced and continually evolving. This paper aims to present the INSAFEDARE project's ambition regarding medical devices' regulation and how real and synthetic data can be used to check if devices are safe and effective.

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

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 architectures. In addition, the project will review best practice and identify gaps in the guidance, particularly the guidance stipulated by the medical device regulation and directives. Finally, the project will develop comprehensive methodology and tooling for the engineering of trustworthy networks of inter-operating medical devices, that shall have security-for-safety by design, with a strategy for device certification and certifiable dynamic network composition, ensuring that patient safety is safeguarded from malicious cyber actors and technology "accidents".

Structuring Clinical Decision Support Rules for Drug Safety Using Natural Language Processing.

Drug safety is an important aspect in healthcare, resulting in a number of inadvertent events, which may harm the patients. IT based Clinical Decision Support (CDS), integrated in electronic-prescription or Electronic Health Records (EHR) systems, can provide a means for checking prescriptions for errors. This requires expressing prescription guidelines in a way that can be interpreted by IT systems.

Converting Text to Structured Models of Healthcare Services.

The paper presents a concise method for transforming textual representations of healthcare services, to a structured, semantically unambiguous modelling language. The method is designed based on literature, as well as trial and error by the authors, using text descriptions of healthcare services. Employing the method can convert textual descriptions to structured graphical models, facilitating stakeholder collaboration on requirements analysis and simulation.