As MedTech companies accelerate their digital transformation, the proliferation of connected medical devices is unlocking new possibilities for patient care, operational efficiency, and data-driven innovation. But with this connectivity comes a critical imperative: cybersecurity. Safeguarding these technologies isn’t just a technical concern—it’s a strategic priority that directly impacts patient trust, regulatory compliance, and long-term business resilience. As digital health tech surges forward, so does the urgency to secure it—because when medical devices are exposed, so are lives.
What is medical device cybersecurity?
Medical device cybersecurity involves safeguarding medical devices from cyberthreats and vulnerabilities. While the growing interconnectedness of medical devices and software is a major innovation in healthcare delivery, it also exposes these devices to data breaches, malware attacks, and other cybersecurity threats. Cybersecurity breaches can disrupt patient care, leading to negative health outcomes, and compromise the confidentiality of protected health information (PHI).
The current state of cybersecurity in the MedTech industry
In 2025, both medical device manufacturers and health delivery organizations (HDOs) are under more pressure than ever before to be vigilant against the unprecedented level of risk from cybersecurity threats facing the MedTech industry. Rising threats call for cyber defenses to be integrated at the earliest stages of medical device development, including regular software updates and thorough risk assessments. Compliance with the latest international standards is also crucial to maintaining security integrity.
And while AI can be used maliciously by bad actors, it can also aid in real-time threat detection and response with safeguards in place. Medical device manufacturers can leverage AI algorithms to analyze vast amounts of data in real time, identifying patterns and irregularities indicating cyberthreats. This proactive approach aligns with requirements imposed by regulatory standards like ISO 14971 and IEC 62304, which emphasize the need for integrated risk assessments and continuous monitoring throughout the medical device lifecycle.
The importance of cybersecurity in medical devices
The importance of cybersecurity in medical devices cannot be overstated, as devices increasingly rely on remote, wireless technologies and software. Hackers and other bad actors can more easily exploit vulnerabilities and gain access to sensitive PHI or even remotely commandeer device functions, directly putting patient lives in danger. There are relevant regional regulations in the US (HIPAA, CISA and NIST) and EU (GDPR, Cyber Resilience Act (CRA) and NIS2) that mandate strict cybersecurity measures to protect medical device software and PHI to alleviate the risks associated with the digital transformation of medical devices.
Impact on patient safety:
Medical devices with network connectivity—especially those that are implantable or deliver treatment—present unique cybersecurity challenges. Vulnerabilities such as outdated software, unpatched security flaws, or weak network configurations can expose these devices to remote hacking, data breaches, and even physical harm to patients.
- Implantable Devices: Pacemakers, insulin pumps, and defibrillators may be susceptible to unauthorized access, potentially allowing manipulation of dosages or cardiac rhythms, or exposure of sensitive patient data.
- Infusion Pumps: These systems, which administer fluids and medications, can be compromised if not properly secured, leading to incorrect dosing.
- Imaging Systems: MRI, CT, and X-ray machines—integral to diagnostics—can be targeted for vulnerabilities within the broader Internet of Medical Things (IoMT) ecosystem.
- Patient Monitoring Devices: Wireless monitors for vital signs like heart rate and blood pressure are at risk of data manipulation or breaches.
- Hospital Information Systems: These platforms, which manage patient records and clinical workflows, are vulnerable to ransomware and other cyberattacks that can disrupt care delivery.
The risks range from unauthorized data access to direct interference with treatment protocols. Addressing these vulnerabilities is not just a technical necessity—it’s a strategic imperative for safeguarding patient outcomes and maintaining trust in digital health innovation.
Privacy concerns and data protection:
Sensitive PHI gathered by medical devices is at risk when unauthorized access to patient data or device functions is enabled. HIPAA enforces the strict protection of PHI through measures such as data encryption, access controls, regular software updates, and monitoring potential vulnerabilities.
Evolving cyberthreats to medical devices:
The sophistication and enhanced connectivity of medical devices have only expanded the attack landscape available to cybercriminals and hackers. Connected medical devices that offer real-time monitoring and data collection have become pivotal tools in enhancing patient care, but they also require a heightened focus on cybersecurity to protect patient safety and PHI. Rigorous regulatory requirements and international standards, such as ISO 14971 and IEC 62304, mandate proactive risk management strategies, thorough documentation, and analysis of potential failures and cyberthreats to mitigate any negative impact on patient safety.
The introduction of AI into medical device technology and software also necessitates a focus on securing algorithms and data pipelines to prevent unauthorized access and potential manipulation. By incorporating AI-driven algorithms and machine learning models, medical device manufacturers and HDOs can proactively identify and neutralize cyberthreats before they escalate by utilizing the continuous monitoring and analysis of vast data streams through AI to swiftly detect anomalies and potential vulnerabilities. AI can also automate routine security tasks, allowing cybersecurity professionals to focus on more complex issues and strategic risk management.
How does the Omnibus Bill affect medical device OEMs?
The Omnibus Bill significantly affects medical device original equipment manufacturers (OEMs) by instituting stringent cybersecurity demands on the entire medical device lifecycle. Provisions in the Omnibus Bill are part of the Protecting and Transforming Cyber Health Care (PATCH) Act, which has important guidance for medical device manufacturers to be ready, willing, and able to identify and respond to postmarket vulnerabilities in their products within 90 days.
The Omnibus Bill's emphasis on cybersecurity reflects broader shifts in national security strategies, underlining the importance of securing critical healthcare infrastructure. It also provides support through the Cybersecurity and Infrastructure Security Agency (CISA), which offers resources to strengthen medical device supply chains, especially the necessity for OEM engagement in robust risk management practices.
Key regulatory frameworks and standards in medical device cybersecurity
IEC 62304 and software lifecycle:
IEC 62304 outlines the processes required for the safe design and maintenance of medical device software across its entire lifecycle and ensures compliance with US and international regulatory requirements. The standard is crucial for medical device manufacturers for its emphasis on the importance of embedding safety and security measures in the development phase to address cybersecurity risks and safeguard patient safety. By classifying software into three distinct safety classes—Class A (no injury possible), Class B (injury possible but not serious), and Class C (serious injury or death possible)—IEC 62304 helps manufacturers to implement appropriate risk management strategies.
ISO 14971 and risk management:
Managing cybersecurity risks in medical devices is an integral part of the overall risk management process, as outlined by ISO 14971:2019, the international standard that advocates for a thorough and systematic approach to risk management, patient safety, and device efficacy throughout the medical device lifecycle. Incorporating Association for the Advancement of Medical Instrumentation (AAMI) guidelines TIR57:2016 and TIR97:2019 can further assist medical device manufacturers in aligning their cybersecurity measures with existing risk management frameworks. Integrating cybersecurity risk management with ISO 14971 also involves both HDOs and regulators for a comprehensive approach to managing potential security breaches and developing strategies to remedy them.
IEC 81001-5-1 and cybersecurity risk management:
IEC 81001-5-1 builds upon the foundation of ISO 14971 by explicitly extending risk management principles to cybersecurity in health software and health IT systems. This standard provides a structured framework for identifying, evaluating, and mitigating cybersecurity risks throughout the software lifecycle—from design and development to deployment and maintenance. For MedTech executives, IEC 81001-5-1 represents a strategic opportunity to align cybersecurity practices with broader risk management and regulatory compliance efforts. By integrating this standard, organizations can proactively address vulnerabilities, enhance patient safety, and strengthen trust in connected medical technologies. The FDA’s guidance on Quality System Considerations and Content of Premarket Submissions provides complementary cybersecurity insights for medical device product teams.
ISO/IEC 27001 and information security management:
ISO/IEC 27001 is the globally recognized standard for establishing, implementing, maintaining, and continually improving an information security management system (ISMS). While not specific to MedTech, it is highly relevant for organizations leveraging platforms like Windchill+, ThingWorx, and other PTC solutions that manage sensitive product data, digital twins, and connected device ecosystems. By adopting ISO/IEC 27001, companies can ensure robust governance over data confidentiality, integrity, and availability—especially critical when integrating medical device data with enterprise systems or cloud-based platforms. This standard also supports compliance with broader regulatory frameworks such as GDPR and the Cyber Resilience Act, making it a strategic asset for digital health innovation and operational resilience.
FDA guidelines and recommendations:
The Food and Drug Administration (FDA), through its Center for Devices and Radiological Health (CDRH), plays a central role in safeguarding patient health and safety by addressing the cybersecurity risks associated with medical devices. Medical device manufacturers must address specific FDA requirements to ensure that any security issues can be swiftly identified and addressed before serious breaches occur. The FDA’s guidelines are not limited to traditional hospital or clinical settings but also extend to home care environments, as the wide spectrum of device users present unique challenges in maintaining cybersecurity within broad contexts.
HIPAA in medical device cybersecurity:
While HIPAA is a federal law primarily focused on the protection of sensitive patient data, its relevance applies to any medical device that processes or transmits sensitive patient information, which becomes more complex as medical devices increasingly rely on cloud and AI-driven platforms. Under the HIPAA Security Rule, HDOs are required to implement appropriate administrative, physical, and technical safeguards, such as policies and training, physical access restrictions, and enhances security of controls, to protect patient electronic protected health information (ePHI).
Selecting and implementing a medical device cybersecurity solution
Medical device manufacturers must navigate complex challenges when selecting and implementing a robust medical device cybersecurity solution that aligns with international standards and regulatory requirements. PTC’s unified digital thread can improve traceability across product and service lifecycle management, with a focus on both patient needs and compliance demands. Codebeamer is a comprehensive solution for medical device manufacturers, including features like requirements management, risk analysis, and test management, to manage cybersecurity risks and achieve compliance with FDA guidelines and standards like ISO 14971, IEC 81001-5-1, and IEC 62304. ThingWorx Foundation ensures robust cybersecurity by integrating vulnerability scanning, penetration testing, and continuous software component analysis. These measures, combined with manual and automated testing, reinforce compliance with industry standards and deliver a secure, trusted platform for medical device applications.
Software as a Service (SaaS) provides agility in overcoming the limitations of traditional IT infrastructures to respond to cybersecurity threats and optimize resource utilization. Windchill+, PTC’s award-winning PLM solution, is delivered via SaaS and offers integrated IP protection, vulnerability scanning, and ensured compliance through certifications and audits for enhanced medical device cybersecurity measures. PTC solutions provide a strong foundation for managing cybersecurity risks, helping medical device manufacturers prioritize patient health and safety while also adhering to regulatory demands. These efforts are further supported by alignment with ISO/IEC 27001, the global standard for information security management systems, which underpins PTC’s enterprise-wide commitment to data protection and risk mitigation.
Securing the Future of Digital Health Innovation
Cybersecurity in MedTech is no longer a siloed concern—it’s a foundational pillar of digital health strategy. As connected medical devices become more intelligent, personalized, and integrated into broader digital ecosystems, the responsibility to secure them grows exponentially. By aligning with global standards like ISO 14971, IEC 81001-5-1, and ISO/IEC 27001, and leveraging secure platforms like Windchill+, ThingWorx, and Codebeamer, medical device manufacturers can build trust, ensure compliance, and drive innovation with confidence.
To explore how PTC supports secure digital transformation across the product lifecycle, visit our Trust Center.
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