Work

Workshop Insights: Navigating Cybersecurity Regulations for Device Manufacturers and Healthcare Operators

Year: 2024

Type: conference-paper

Abstract: Both the manufacture and use of medical devices are heavily regulated, but stakeholders have a varying level of maturity, and often struggle to comply with rules and regulations. This paper reports on an empirical elicitation activity that sought to enumerate the challenges faced by (particularly smaller) device manufacturers and device operators (typically hospitals), with a goal to informing the creation of tools that these stakeholders can use to address the challenges. The stakeholders completed a brief survey, and then participated in two focus group sessions delving into perceived challenges. The results confirm a need for increased collaboration between manufactur-ers and operators, and improved guidance material to ease complying with relevant regulations

Source: Zenodo (CERN European Organization for Nuclear Research)

DOI: 10.5281/zenodo.13868996

Authors: Skytterholm, Andrea Neverdal, Flå, Lars Halvdan, Jaatun, Martin Gilje

Institution: SINTEF

Language: English

Topic: Healthcare Regulation

Subfield: Health Information Management

Field: Health Professions

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green

Funder: European Commission