The EU Cyber Resilience Act: What It Means for Digital Health

The European Union’s Cyber Resilience Act (CRA) represents a significant step towards improving cybersecurity across the bloc. For digital health companies, this regulation introduces new challenges but also provides an opportunity to strengthen trust and security in a rapidly evolving industry. In this article, we’ll explore what the CRA is, why it matters, and how it will impact the digital health sector.

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What is the Cyber Resilience Act?

The Cyber Resilience Act, proposed by the European Commission in September 2022, aims to set a common framework for cybersecurity across connected devices and software. It is designed to address the increasing risks posed by the proliferation of smart devices and connected technologies, which are frequently targeted by cyber-attacks.

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Under the CRA, manufacturers, importers, and distributors of digital products in the EU will be held to stricter cybersecurity requirements. The Act applies to all products with digital elements, from simple applications to complex systems like medical devices or telehealth platforms.

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By enforcing these standards, the CRA seeks to:

• Reduce vulnerabilities in digital products.
• Improve the overall security of the digital ecosystem.
• Boost consumer trust in connected technologies.

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Why Does It Matter to Digital Health?

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The digital health sector relies heavily on interconnected technologies, including wearable devices, telemedicine platforms, and mobile health apps. These innovations improve patient care and efficiency but also present unique security risks.

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Healthcare data is among the most sensitive types of information, making it a prime target for cybercriminals. A breach not only exposes patient data but can also disrupt critical healthcare operations, leading to potentially life-threatening situations.

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The CRA ensures that cybersecurity is treated as a priority from the design stage (also known as “security by design”) rather than an afterthought. For digital health companies, this means incorporating robust security measures into their products before they reach the market.

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Key Impacts on Digital Health Companies

1. Increased Accountability
   Digital health companies will need to demonstrate compliance with the CRA, including documentation of their cybersecurity measures. Non-compliance could lead to penalties, product recalls, or removal from the EU market.
2. Mandatory Risk Assessments
   Under the CRA, organisations must conduct regular risk assessments to identify and address potential vulnerabilities in their products. This applies not only to new devices but also to updates or patches for existing systems.
3. Greater Focus on Supply Chain Security
   Digital health solutions often rely on third-party components or integrations. Companies will need to ensure that all elements of their supply chain meet CRA requirements, adding another layer of oversight and responsibility.
4. Innovation in Secure Design
   To meet the CRA’s demands, manufacturers must adopt a proactive approach to security, embedding it into the product lifecycle from conception to deployment. This is an opportunity to differentiate your products in a competitive market.

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Preparing for the CRA: Practical Steps

1. Understand Your Obligations
   Familiarise yourself with the requirements of the CRA and how they apply to your products. Review the European Commission’s documentation and seek guidance from legal or cybersecurity experts if necessary.
2. Implement Security by Design
   Start incorporating cybersecurity considerations at the design phase of product development. This includes secure coding practices, regular testing, and comprehensive documentation of your efforts.
3. Review Your Supply Chain
   Ensure that all suppliers and third-party vendors are compliant with the CRA. Consider conducting regular audits or requiring certification from your partners.
4. Invest in Training
   Educate your teams on the importance of cybersecurity and the specifics of the CRA. Employees at all levels, from developers to senior management, should understand their role in maintaining compliance.
5. Leverage Standards and Certifications
   Align with existing frameworks such as ISO 27001 or Cyber Essentials, which can help streamline compliance efforts and demonstrate your commitment to security.

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The EU Cyber Resilience Act is more than a regulatory hurdle; it’s an opportunity for digital health companies to enhance their security posture and build trust with consumers and regulators alike. By adopting a proactive approach to cybersecurity, organisations can not only meet the CRA’s requirements but also position themselves as leaders in secure digital health innovation.

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Start preparing now to ensure your products are ready for the challenges—and opportunities—that the Cyber Resilience Act will bring.

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Need Help Navigating Cybersecurity in Digital Health?
At Periculo, we specialise in guiding digital health companies through the complexities of cybersecurity compliance. Whether it’s preparing for the CRA or achieving ISO 27001 certification, we’ve got you covered. Contact us today.