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Consideration of Cybersecurity Risks in the Benefit-Risk Analysis of Medical Devices: Scoping Review
Oscar Freyer1, Fatemeh Jahed1, Max Ostermann1
1Else Kröner Fresenius Center for Digital Health, Dresden University of Technology, Dresden, Germany.
Journal of Medical Internet Research
|December 24, 2024
Summary
This review found that while cybersecurity risks in medical devices (MDs) are recognized, there
Area of Science:
- Medical Device Cybersecurity
- Regulatory Science
- Risk Management
Background:
- Connected medical devices (MDs) offer benefits but introduce significant cybersecurity risks.
- Regulatory frameworks in the EU and US require cybersecurity risks to be assessed in the benefit-risk analysis (BRA) for MD approval.
- Current guidance on systematically evaluating and integrating these cybersecurity risks into the BRA is limited.
Purpose of the Study:
- To conduct a scoping review of legal frameworks, guidelines, and standards.
- To identify how cybersecurity risks are considered in the benefit-risk analysis (BRA) for medical devices (MDs).
- To cover regulations in the United States, Canada, South Korea, Singapore, Australia, the United Kingdom, and the European Union.
Main Methods:
- A systematic literature search using PRISMA-ScR guidelines was performed across 10 databases.
- Searches included terms like "cybersecurity," "benefit/risk," and "risk-benefit" in July and September 2024.
- Data from 34 included documents (regulations, standards, reports, guidelines) were extracted and analyzed.
Main Results:
- Out of 150 documents, 34 met the inclusion criteria, comprising regulations, standards, technical reports, and guidance documents.
- Most documents acknowledged cybersecurity risks, but lacked detailed methods for their integration into the benefit-risk analysis (BRA).
- A comprehensive and standardized approach for evaluating cybersecurity risks within the BRA was not found.
Conclusions:
- A significant gap exists between acknowledging cybersecurity risks in medical devices (MDs) and providing guidance for their inclusion in the benefit-risk analysis (BRA).
- There is a need for standardized frameworks to guide the evaluation of cybersecurity risks and their impact on MD safety and security.
- Clearer methods are required for assessing cybersecurity risks to ensure the safety and security of medical devices.
Keywords:
benefit-risk analysisconnected medical devicescybersecuritypatient safetyregulationrisk managementvulnerability assessmentMore Related Videos
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