Consideration of Cybersecurity Risks in the Benefit-Risk Analysis of Medical Devices: Scoping Review
This review highlights a substantial gap between the recognition of cybersecurity risks in MDs and the guidance on their incorporation into the BRA. Standardized frameworks are needed to provide clear methods for evaluating cybersecurity risks and their impact on the safety and security of MDs.
Authors
- Christian Rosenzweig
- Max Ostermann (ORCID: https://orcid.org/0009-0004-7808-2701)
- Stephen Gilbert (ORCID: https://orcid.org/0000-0002-1997-1689)
- Pascal Werner
- Oscar Freyer (ORCID: https://orcid.org/0000-0003-3323-2492)
- Fatemeh Jahed
Institutions
- Fresenius (Germany) (DE)
- Johner Institut (Germany) (DE)
Publication Details
- Journal
- Journal of Medical Internet Research
- Published
- 2024-12-24
- DOI
- https://doi.org/10.2196/65528
- Citations
- 12
- Primary Topic
- Quality and Safety in Healthcare
- Type
- article
- Field-Weighted Citation Impact
- 11.31
Funders
- European Commission
- Bundesministerium für Bildung und Forschung
- Ministry of Food and Drug Safety
- National Institute of Standards and Technology
- HORIZON EUROPE Framework Programme