Medical Devices

Securing increasingly connected medical infrastructure

Securing increasingly connected medical infrastructure

The Challenge: As Connectivity Increases, So Does Cybersecurity Risk

 

As if the healthcare industry weren’t already being stretched to its limits, an increasing number of cybersecurity attacks have taken advantage of the sector’s growing connectivity.

Digital health solutions have been widely adopted throughout the Asia-Pacific region - as demonstrated by adoption rates of 94% in Singapore, 89% in China and 60% in Japan. This widespread adoption has also broadened opportunities for cybercriminals, who constantly probe for weaknesses through which they can steal clients’ private medical information for profit, or worse, conduct ransomware attacks that cost hospitals not only revenues but lives as well.

A lack of harmonized standards for medical device cybersecurity has contributed to this collective vulnerability. Organisations are unaware of cybersecurity requirements based on regulations. As a result, 82% of health systems reported experiencing some form of Internet of Medical Things (IoMT) cyberattack, with ransomware making up 34% of all reported attacks. Organisations are unaware of cybersecurity requirements based on regulations.

This rising incidence of high-profile attacks has brought down serious political and regulatory scrutiny on connected health devices. To avoid both cyberattacks and regulatory penalties, medical device manufacturers must demonstrate cybersecurity compliance with regional and global standards and regulations, like the European Union's (EU) Medical Device Regulation (MDR)In Vitro Diagnostic Regulation (IVDR), and ISO 81001-5-1 covering cybersecurity for health software. 

Medical device manufacturers and healthcare providers alike have their work cut out for them. They must demonstrate measures for medical device cybersecurity and ongoing compliance with regulations, at a volatile time when reliability and security matter most.

 

We Understand Your Needs

With literal lives hanging in the balance, you as a medical device manufacturer must proactively address the following issues, in order to address cybersecurity risk and stay ahead of the technology curve in the long run.

1. Meeting stringent industry requirements

Because the health sector has spent less on cybersecurity relative to others, manufacturers and providers often lack the resources to invest in medical device cybersecurity management systems. Additionally, the wide health data infrastructure’s geographic distribution throws up another cybersecurity compliance roadblock.

2. Ensuring business continuity with cyber-resilience measures

Planning for unscheduled interruptions is essential in the medical field. Lives depend on connected health infrastructure even during power interruptions or force majeure events. Healthcare providers must set emergency planning and cyber-resilience measures to ensure continuing services in worst-case scenarios.

3. Deriving competitive advantage from medical device cybersecurity

Breaches could lead to expensive vigilance activities and field safety actions; negative publicity can damage trust and cost millions in regulatory penalties. Integrating medical devices into an IT infrastructure without compromising customer data is needed to increase business opportunities and foster loyalty.

 

Why choose TÜV SÜD for Medical devices?

TÜV SÜD’s extensive regulations and standards knowledge prepared you for the future, allowing you to implement and scale up digital technologies throughout your medical facility, without compromising operations or data integrity.

 

Whether you want to minimise your risk profile, or gain access to international standardisation committees, TÜV SÜD can provide the right level of service for your needs, supported by a global team of over 750 healthcare and medical device testing experts, engineers, and medical doctors.

Our customers count on our industry accreditations and our industry expertise to help their testing run smoothly, stay informed about the new regulatory requirements, and reduce time-to-market for their medical devices.

Our global customer base and past references attest to the high quality of TÜV SÜD’s service, and the trust our customers place in TÜV SÜD. After all, we’re not just a brand: we’re a partner in our customers’ businesses, working alongside them to anticipate and capitalise on technological developments.


Cybersecurity Challenges for Your Medical Devices

Medical Devices iconAdding connectivity to existing/new products

More healthcare providers require devices to be connected to the internet, including pre-existing equipment. Adding connectivity to legacy equipment should be done with caution, based on a careful assessment of business goals, patient needs, connectivity-associated risks and available technology.

 

Medical Devices icon Ensuring profitability of new smart products

Consider whether new smart products are worth the cost of adoption. Appraise long-term maintenance and eventual device replacements. For device manufacturers, show that the value of your products exceeds perceptions of premium price, ongoing support costs, and any attached subscription-based services.


 

Medical Devices icons

Securing compliance with updated standards and regulations

Cybersecurity compliance requirements can pose challenges when you are looking to explore new markets. Every region has its own specific requirements (which often change on short notice), and you need to fully understand each region’s regulations and compliance procedures.

 

Medical Devices iconMitigating additional cyber risks

As WiFi, Bluetooth and ethernet connections become essential parts of medical infrastructure, you have to implement proactive cybersecurity throughout the whole life cycle of the medical device to protect against attacks. This safeguards sensitive patient data, allow access to authorised personnel, and comply with regulations.

 

Medical Devices icons Strengthening position as enabler

As a medical device manufacturer, your ability to deliver value to your customers depends on continuing innovation, underpinned by a regimen of continual product development, testing, certification and maintenance.

 

 

 

Understand the importance of vulnerability scan and penetration testing in medical devices in our FAQ.

 

TÜV SÜD APPROACH

 

  • Assessments / Testing

    Our testing process puts products through a comprehensive medical devices industry assessment, and a battery of tests that cover the full design and production cycle including (but not limited to):

    Contact us for MHS Testing Services

  • Knowledge Services

    Our experts can ensure the safety, security, profitability and sustainability of medical devices, installations, and infrastructure with third-party engineering and test services that address medical device cybersecurity issues. SecureSafety combines our conventional safety services with additional expertise in OT security.

  • Managed Services

    idgard by Uniscon is a software-as-a-service (SaaS) platform that secures digital communication and collaboration between partners and customers. The platform uses internationally patented sealed cloud technology to generate virtual datarooms and maximum-level protection for content collaboration.

  • Certification and Testing

    Medical device manufacturers depend on TÜV SÜD as certification enabler, relying on its testing and certification services to support compliance with a broad range of international standards, including (but not limited to):

    • IEC/TR 60601-4-5 Medical Electrical Equipment – Safety-related technical security specifications
    • IEC 81001-5-1 Health software and health IT systems safety, effectiveness and security
    • IEC 62304 Medical device software - Software life cycle processes
    • ISO/IEC 27001 Information security management systems
    • UL 2900-2-1 Software Cybersecurity for Network-Connectable Products
    • Penetration tests in accordance with OWASP IoT
    • CSA Cyber Essentials mark
    • CSA Cyber Trust mark
  • Training

    We deliver classroom-based and online programmes that cater to your specific requirements. Our classes cover and deliver:

    • Functional training that establishes a cybersecurity foundation for medical devices
    • Certification courses for Information Security Auditors and Officers (ISO 27001) 
    • The foundation for medical device security knowledge—Information Security: Security Awareness, Cybersecurity Risk Management and Cybersecurity regulatory requirements

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