The healthcare sector faces a significant threat from cybercriminals, with a concerning rise in attacks. A staggering 60% increase in cyberattacks against healthcare organizations was reported, reaching 1,426 attacks per week in 2022.
Maintaining strong cybersecurity is critical for your connected medical devices. These devices house sensitive patient data and connect to your broader systems, which means a breach on any device could compromise your whole organization. What’s worse is that hackers know this, and they’re exploiting medical device vulnerabilities every chance they get.
The impact of these attacks on connected medical devices in healthcare organizations is substantial. The cost of a data breach has surged by 42% in the last two years, making healthcare the industry with the highest data breach cost, averaging $10.10 million per incident, according to the Cost of a Data Breach Report.
One particularly costly attack is ransomware, which affects approximately 1 in every 42 healthcare organizations. This underscores the urgency for robust cybersecurity measures in medical devices and the healthcare sector to safeguard sensitive information and prevent financial losses.
Connected Medical Devices in healthcare stand out as a prime target for cybercriminals, and several factors contribute to this unfortunate distinction.
1. Network Entry Points for Attackers: IoMTs, including innovations like pacemakers, insulin pumps, x-rays, and defibrillators, represent significant advancements in this century. However, in certain instances, they can be likened to an open vulnerability that attracts cybercriminals to exploit hospital systems. Despite these devices typically not storing personal data, hackers can exploit them to infiltrate hospital systems. This unauthorized access can be utilized to breach the broader hospital network, either extracting valuable data or holding it hostage for ransom.
2. Medical Devices are Easy to Hack: The security of medical devices poses a considerable challenge for healthcare IT professionals due to the presence of many connected medical devices with varied specifications from various manufacturers. Although these devices might not always store substantial patient data, they can serve as vulnerable entry points for attackers aiming to access data-rich servers.
3. Harm Patients: The potential threat of criminals gaining access to connected medical devices and remotely causing harm to individuals is a concerning possibility. For instance, hackers could compromise a pacemaker, halting the patient's heart, or infiltrate an insulin pump to administer a lethal dose of medicine, resulting in the patient's death. While there haven't been reported cases of individual targeting, this issue demands significant attention as hackers can access medical devices to harm their targets remotely.
Without a proper cybersecurity plan and the necessary software defenses, healthcare organizations with connected medical devices face severe and potentially irreversible consequences, including the following.
1. Data Vulnerability in Medical Devices: Connected medical devices can contain sensitive patient information such as medical history, treatment plans, and personally identifiable information (PII). A single breach risks compromising patient privacy and reputation and threatens physical safety. Moreover, these attacks can introduce inaccuracies in diagnosis or treatment recommendations, jeopardizing patient safety and the overall effectiveness of healthcare delivery
2. Lead to DDoS Threats in Connected Medical Devices: A distributed denial-of-service (DDoS) can happen, which overwhelms the bandwidth or resources of a targeted system, rendering it unresponsive to requests. Regarding connected medical devices, DDoS attacks pose a significant risk, potentially resulting in severe patient harm. For example, an attack on a connected insulin pump might cause delays in insulin delivery or lead to overdoses, with potentially life-threatening consequences.
3. Malware and Phishing Threats: Malicious software (malware) poses a serious risk to medical devices, compromising patient data and introducing diagnosis errors. Additionally, phishing, often initiated through deceptive emails, is a common entry point for cybercrime. These attacks aim to trick users into revealing sensitive information or installing malware. It's crucial to address these threats to ensure the secure operation of medical devices, emphasizing vigilance against phishing attempts and implementing measures to mitigate malware risks.
Effectively incorporating, overseeing, and regularly updating your practice's connected medical devices within the framework of your comprehensive cybersecurity strategy is essential. This approach allows you to harness the advantages of medical IoT without exposing your practice to undue risks.
Implementing real-time monitoring for every connected medical device in your practice is imperative. This enables your security team to continuously assess for vulnerabilities or unusual activities that may indicate a device compromise. In an environment where numerous connected devices are used, employing an intelligent cybersecurity solution in medical devices is the only effective approach to managing the network proficiently.
Begin with a thorough risk assessment of the connected medical devices. This should include identifying potential vulnerabilities in the devices' software, hardware, and network connections. Regular assessments can help anticipate new threats and ensure the security of all aspects of the device ecosystem.
Ensure that devices have strong user authentication and strict access controls. Multi-factor authentication (MFA) should be standard practice, along with role-based access controls that ensure only authorized personnel can access device data and controls.
The FDA emphasizes maintaining authentication processes that do not disrupt patient care. It is crucial to evaluate and determine the appropriate level of security for each situation. Certain workflows, like transmitting blood pressure or temperature readings, may only necessitate a single level of security. In contrast, other workflows might mandate multiple authentication factors due to internal policies or government regulations.
Connected medical device software should be regularly updated to ensure compliance with evolving market requirements and enhance safety and performance. Failure to update may result in legal issues, including incorrect implementation of cybersecurity laws, challenges with personal data protection regulations, and non-compliance with usability requirements and Medical Devices European Regulations like the MDR.
In a scenario where cyber threats are increasingly prevalent, keeping software up-to-date is a preventive measure to mitigate risks. Each software update introduces new features that bolster security, and neglecting updates leaves systems vulnerable to known flaws that accumulate over time, posing a greater risk. We suggest comparing the SBOM every month against NIST or equivalent databases via tools such as Snyk.
Patients and healthcare providers need assurance that their data is handled securely. Implementing robust security measures in data transmission and storage builds trust in healthcare systems, encouraging the adoption and effective utilization of medical devices for improved patient care.
HIPAA establishes standards for safeguarding sensitive patient information. To comply, entities handling Protected Health Information (PHI) must implement physical, network, and safety measures. Non-compliance, even without a PHI violation, can lead to substantial fines. Actual violations may result in criminal or civil prosecution.
Therefore, to protect sensitive patient information, encrypt data both in transit and at rest, utilize secure communication protocols, and manage encryption keys securely. Additionally, ensure that any cloud or remote services used with the devices meet stringent security standards.
The extensive data handled by connected medical devices has exposed them to malicious attacks and cybersecurity breaches. Ensuring the safety and effectiveness of these devices requires robust cybersecurity protocols. Incidents have even caused interoperability issues between medical devices and hospital networks, posing risks to patients through delays in diagnosis and treatment.
Cybersecurity is essential for protecting patients, medical professionals, and manufacturers' reputations. Organizations must prioritize addressing cybersecurity concerns in medical devices to prevent harm, maintain trust among healthcare providers, and uphold industry standards.
Create a detailed cybersecurity policy specifically for medical devices, which includes procedures for monitoring, reporting, and responding to incidents. Training staff on cybersecurity guidelines and best practices is also crucial, as human error can often be a weak link in security.
[Recommended reading: Understanding FDA's Cybersecurity Guidelines for MedTech Firms]
BioT conducts regular and comprehensive risk assessments, vulnerability scanning, and penetration tests as part of its service, ensuring its platform is continuously evaluated for potential vulnerabilities. This proactive approach helps identify and mitigate risks before they can be exploited.
The platform employs robust authentication mechanisms and stringent access controls. BioT's infrastructure supports multi-factor authentication (MFA) and attribute-based access controls, ensuring that only authorized personnel have access to device data, its functionalities, and to patient data, thus maintaining the integrity and confidentiality of sensitive health data.
BioT's platform is designed to facilitate the seamless updating and patching of software and firmware for connected medical devices. This ensures that all devices operating on the BioT platform are protected against known vulnerabilities through the latest security patches, reducing the risk of cyberattacks.
BioT ensures data encryption in transit and at rest, safeguarding patient information. The platform utilizes secure communication protocols and robust key management practices. BioT's cloud services also adhere to the highest security standards, ensuring that all data storage and transmission meet rigorous compliance requirements.
BioT helps MedTech companies develop and enforce comprehensive cybersecurity policies tailored to their connected medical devices. The platform includes monitoring tools for real-time surveillance and incident response, and it provides the needed deliverables for regulatory submissions such as SBOM and DHFs. BioT's approach ensures that a thoroughly enforced policy covers all security aspects.
Connect with BioT-Medical today to explore innovative medical solutions. Benefit from our extensive experience and up-to-date knowledge of cutting-edge cybersecurity measures for connected medical devices. Connect with us today to initiate a conversation and explore how we can assist you. Reach out to us and contact our experts by filling out the form below.