Cyber Resilience Act, medical devices and the AI Act – An integrated perspective on cybersecurity and AI in the healthcare industry
With the Cyber Resilience Act (CRA) and the upcoming AI Act, the EU is setting new requirements for IT security and the use of artificial intelligence (AI).
These regulations play a central role, particularly in the area of digital healthcare products, which include connected medical devices. The new regulations set standards that require an integrated safety strategy in order to make innovations such as AI in medicine safe and compliant.
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CRA and AI Act – safety standards for digital health products
The CRA aims to harmonize IT security standards for products with digital elements and sets strict requirements for networked devices and software. Among other things, it requires security updates, compliance with a secure standard configuration level and detailed documentation, such as a software bill of materials (SBOM).
The AI Act supplements these safety requirements with specific specifications for AI-supported systems and products that are classified as “high-risk”, which applies to many applications in medicine.
The combination of these regulations is intended to ensure comprehensive risk management for digital health products, especially when AI is used for diagnoses or patient-specific therapies.
Integration into the requirements of the MDR and IVDR
Medical devices, especially those that are based on AI or are networked, are already subject to the MDR and IVDR. However, the CRA and the AI Act create additional standards and requirements that are particularly important for manufacturers of digital health products. These must integrate the following aspects:
Overlaps and synergies – an integrated approach to security
Conclusion
With the CRA and the AI Act, the EU is creating a vision for the future of digital health that combines innovation and safety. Manufacturers of connected and AI-supported medical devices are required to adapt their development processes and implement new standards for cybersecurity and AI.
In this way, products can be created that meet the highest safety requirements and at the same time fulfill the demand for innovation in the healthcare sector.
