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How do you balance technological progress and cyber risk in MedTech?

To benefit and protect patients in today’s healthcare landscape, we need cutting-edge technologies coupled with robust security frameworks.


In brief

  • Connectivity of medical devices and healthcare applications has revolutionized patient care – but also opened the door to cyber threats.
  • The healthcare industry finds itself at a crossroads, tasked with balancing the needs of medical progress and cyber resilience.
  • Collaboration among manufacturers, healthcare providers and cybersecurity experts is imperative.

As medical devices morph from simple instruments to interconnected marvels, the ability to remotely monitor and manage health conditions has brought undeniable benefits, such as transforming mere heartbeat regulators into devices that transmit valuable patient data wirelessly. This increasing connectivity of medical devices to the Internet and each other is collectively known as the Internet of Medical Things (IoMT).

A range of healthcare applications have revolutionized patient care, diagnostic processes and data management. Healthcare applications are diverse and include electronic health record (EHR) systems, telemedicine platforms, diagnostic tools and patient monitoring applications. However, alongside these advancements, challenges related to data privacy and safety have also emerged, especially for life-sustaining devices and connected applications. The very connectivity that propels positive advances also brings forth a critical concern: vulnerability to cyber threats. This aspect necessitates a comprehensive approach to data protection and cybersecurity compliance.

Cybersecurity thus takes center stage as vulnerabilities could disrupt patient care, hinder operations, compromise sensitive patient data and even jeopardize lives. The revolution driven by IoMT and healthcare applications has reshaped how healthcare is delivered, monitored and managed. In the pursuit of a harmonious healthcare landscape, a symbiotic relationship between innovation and security must be established. Against this background, MedTech companies must seamlessly integrate cutting-edge technologies with robust security frameworks. This builds trust in their digital solutions, places patients at the center of their business model and empowers patients with control over their data.

There are many cybersecurity threats affecting medical devices. In this article, we share EY’s standpoint regarding three primary challenges: security vulnerabilities, compliance with data protection regulations and ransomware.

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Chapter

Security vulnerabilities

Why it is important to develop a comprehensive cybersecurity strategy.

Amalgamating cutting-edge devices with older legacy systems generates additional complexity within the MedTech landscape. While modern medical devices may be designed with cybersecurity in mind, existing devices often lack essential security features, making them more susceptible to cyber threats, including data breaches.

Expensive mistakes
Average cost of a data breach in 2023

The implications of these vulnerabilities are significant; the average cost of a data breach in 2023 is estimated to be around USD 11 million (Source: IBM). These “legacy medical devices” necessitate a tailored cybersecurity approach, particularly those that have exceeded their intended lifespan. The challenge is compounded by the fact that older devices may not be equipped to receive regular security updates, rendering them more vulnerable to exploitation. Malicious actors could leverage these vulnerabilities to gain unauthorized access, compromise device functionality or manipulate patient data.

To address these vulnerabilities, a comprehensive cybersecurity strategy is essential. Beyond encryption and authentication mechanisms, establishing monitoring based on behavioral analytics is critical. This approach enables the detection of anomalous patterns in device behavior, allowing for swift responses to potential threats. Furthermore, a robust vulnerability management process is crucial. This involves conducting regular end-to-end platform penetration testing, identifying vulnerabilities, and prioritizing their remediation. Additionally, robust patch management ensures that devices are up to date with the latest security patches, minimizing the risk of exploitation. By combining encryption, authentication, behavioral analytics, vulnerability management and patch management, MedTech companies can enhance their cybersecurity posture and protect patient data.

The MedTech industry stands at a pivotal juncture, tasked with striking an equilibrium between medical progress and cyber resilience. The journey demands unwavering commitment to security-by-design principles, continuous vigilance and a collective resolve to navigate this transformative era securely. Manufacturers, healthcare providers and cybersecurity experts must collaborate to identify and resolve vulnerabilities, share best practices and create a unified front against cyber threats.

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Chapter

Compliance with data protection regulations

How legal provisions help protect patient data and build trust in healthcare.

The importance of data protection regulations cannot be overstated in the realm of healthcare. Regulations such as the General Data Protection Regulation (GDPR) in the European Union, the Health Insurance Portability and Accountability Act (HIPAA) in the United States, and similar laws around the world ensure the meticulous handling of patient data while upholding privacy standards. The consequences of data breaches and unauthorized access extend beyond financial losses, eroding patients’ trust in the healthcare system.

Therefore, MedTech companies and healthcare institutions must prioritize the implementation of stringent security measures. Regular security audits and vulnerability assessments play a pivotal role in identifying and mitigating potential risks. Through mitigation strategies, organization can minimize the impact or likelihood of potential vulnerabilities and threats. By implementing safeguards, protocols and practices, organizations can prevent risks from materializing or mitigate their negative effects. Strong encryption, routine security assessments, robust access controls and comprehensive implementation of data protection principles contribute to the holistic protection of patient data.

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Chapter

Ransomware threats

What you can do to mitigate the risk of malicious intentions.

One of the most pervasive threats facing the healthcare sector is ransomware. Cybercriminals often use enticing tactics to lure unsuspecting users into clicking on malicious links or downloading infected files, leading to the encryption of critical data. To counter ransomware requires a comprehensive approach that combines technological solutions with investments in human awareness.

Several measures are commonly used to combat ransomware threats. Regular data backups play a crucial role in enabling swift recovery from ransomware attacks. These backups should be stored offline and regularly tested to ensure their integrity. Furthermore, implementing multi-layered security measures, such as robust firewalls, intrusion detection systems and up-to-date anti-malware software, significantly reduces the attack surface and strengthens defenses against ransomware attacks.

Despite technological advancements and sophisticated security measures, human actions remain a significant vulnerability.

However, it is essential to recognize that even the most advanced technology is only as secure as the weakest link in the chain. In many cases, this weak link is human behavior. Despite technological advancements and sophisticated security measures, human actions remain a significant vulnerability. Social engineering tactics, such as vishing or phishing, can exploit this vulnerability and compromise security. This emphasizes the need for comprehensive cybersecurity awareness training across all levels of an organization.

Furthermore, in the context of ransomware, a well-designed and regularly tested incident response plan is of paramount importance. The plan should outline the steps to be taken in the event of a ransomware attack, ensuring a swift and coordinated response to mitigate its impact. This plan should encompass isolating affected systems, notifying relevant stakeholders and collaborating with law enforcement agencies, if necessary. Moreover, a critical aspect of an incident response plan is the ability to quickly restore data from secure backups, minimizing downtime and reducing the incentive for cybercriminals to proceed with their ransom demands.

By educating employees about potential risks, enabling them to recognize suspicious activities and promoting responsible online behavior, organizations can effectively fortify this weak link and enhance their overall cybersecurity posture. This combination of technological measures, employee training and a robust incident response plan tailored to combat ransomware threats forms a comprehensive defense against the increasingly prevalent and damaging ransomware attacks.

Summary

As the healthcare industry grapples with the challenges posed by interconnected medical devices, it is important to address the evolving landscape of MedTech and cybersecurity. The journey toward a secure healthcare landscape requires not only cutting-edge technologies but also robust security frameworks that prioritize patient safety and data protection. By establishing monitoring based on behavioral analytics, adopting vulnerability management and patch management practices, conducting regular end-to-end platform penetration testing and implementing a well-designed incident response plan tailored to ransomware threats, the MedTech sector can fortify its defenses against emerging cyber threats.

Acknowledgements

We thank Clementine Bittar and Iuliia Simonova for their valuable contribution to this article.

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