The Internet of Medical Things (IoMT) represents the most explosive growth sector in healthcare, reaching a projected $814.28 billion by 2032. Expanding from $47.32 billion in 2023, IoMT boasts an unprecedented annual growth rate of 38.5%.
From patient monitoring systems and diagnostic equipment to infusion pumps and imaging technologies, connected medical devices enhance patient outcomes, improve operational efficiency, and reduce costs while elevating safety standards. The number of IoMT devices used by hospitals is expected to double from 3.21 million in 2021 to 7 million by 2026, signaling that this technology is far beyond pilot programs to become a fundamental component of modern healthcare operations.
However, the growth of IoMT creates a critical paradox: the same technology that enables life-saving innovations also introduces unprecedented security vulnerabilities. The emerging vulnerabilities create operational risks, threatening downtime, reputational damage, or legal troubles. Furthermore, unchecked vulnerabilities create safety-critical flaws that threaten patient data, outcomes, and in some cases, life.
The healthcare industry receives 100% to 200% more cyberattacks annually than any other sector.
Just this year, the January 2025 Frederick Health ransomware breach resulted in the theft of 934,000 patient files, including NHS numbers and clinical notes. Days later, the FDA issued safety alerts for Contec CMS8000 and Epsimed MN-120 monitors, identifying vulnerabilities that could allow unauthorized remote access and data leakage.
These incidents represent only the visible portion of a significantly larger security challenge. The immense value of protected health information (PHI), combined with the safety-critical nature of medical devices, creates an attractive target for cybercriminals seeking financial gain, operational disruption, or notoriety.
Healthcare environments compound these cybersecurity challenges through inherent vulnerabilities. Legacy systems, built for maximum uptime and longevity, often lack modern security features yet cannot be easily replaced due to regulatory requirements and operational constraints. For example, an electronic health record (EHR) system installed decades ago would lack modern security measures; however, replacing it costs millions of dollars and risks system-wide outages and loss of sensitive patient data. While legacy systems present ongoing challenges, complete replacement is rarely feasible. With legacy systems deeply entrenched in safety-critical operations, the key lies in developing integration strategies that allow new technologies to work seamlessly with existing infrastructure without introducing additional vulnerabilities or operational disruptions.
As healthcare environments incorporate increasing numbers of IoMT devices, traditional IT update methods that worked for conventional computer systems prove inadequate for managing these specialized medical technologies. The unique characteristics of IoMT devices make conventional update approaches time-consuming and error-prone, often resulting in inconsistent deployment across device fleets — leaving some devices vulnerable while others receive protection.
Additionally, the uptime requirements for safety-critical systems prevent traditional maintenance windows, making it difficult to implement security updates without risking patient safety. Extended downtime during updates compromises patient care while creating operational disruptions. The complexity of coordinating updates across diverse device types and vendors often results in delayed or deferred security patches, leaving healthcare organizations exposed to known vulnerabilities.
Healthcare organizations relying on traditional update mechanisms face mounting threats to patient safety, regulatory compliance, and operational continuity as the connected healthcare ecosystem continues to expand.
Despite these security and modernization challenges, the business drivers transforming healthcare delivery make IoMT adoption essential. Connected medical devices enable continuous patient monitoring, providing healthcare professionals with real-time data streams supporting proactive interventions. Remote monitoring capabilities extend this visibility beyond hospital walls, allowing clinicians to detect deteriorating conditions early and prevent costly emergency interventions.
IoMT devices greatly expand healthcare access by facilitating remote care delivery, allowing patients to receive quality healthcare services without frequent hospital visits. Smart cardiac monitors and continuous glucose monitors enable real-time sharing of physiological data with specialists across the globe, facilitating remote consultations and second opinions without requiring patient travel. Furthermore, connected medication dispensers ensure treatment adherence through automated reminders and dosage tracking. In the coming years, AI-powered diagnostic tools integrated with IoMT devices will become a prominent method to provide preliminary assessments and flag critical conditions for immediate specialist review.
From an operational perspective, connected medical devices streamline clinical workflows through innovative applications like smart hospital beds that automatically adjust positioning based on patient movement patterns and pressure point data, and IoMT-enabled instruments that provide real-time feedback on procedure progress. Connected imaging equipment can instantly share diagnostic results with radiologists anywhere in the world, while smart infusion pumps automatically adjust medication delivery based on patient response data. Wearable sensors for hospital staff track possible disease exposure and ensure compliance with hand hygiene protocols. At the same time, AI-integrations analyze patterns across thousands of connected devices to predict patient deterioration hours before traditional monitoring would detect changes.
To realize the benefits of IoMT while mitigating risks, healthcare and medical device OEMs must implement medical-grade over-the-air (OTA) update strategies. Medical-grade OTA updates require foundational security architecture, including:
Deployment strategies must also account for the sensitive nature of healthcare operations. Delta updates significantly reduce network traffic by transmitting only differences between current and target software versions rather than complete system images—critical in healthcare environments where network bandwidth may be limited or shared across multiple systems. Gradual deployment strategies enable organizations to deploy updates across device fleets in phases, allowing careful monitoring and validation at each stage before expanding to larger groups.
Instant recovery capabilities through A/B partition systems provide automated rollback from failed updates, ensuring medical devices remain operational even when updates encounter problems. In healthcare settings where device availability directly impacts patient safety, automated rollback prevents device failures and ensures the continuous operation of critical medical equipment.
A proper OTA update solution must address immediate security concerns while simultaneously accommodating regulations, such as the US FDA, the NIS2 directive, and HIPAA requirements.
The regulatory environment governing medical device cybersecurity is constantly evolving. The US FDA's requirements for premarket approval submissions, like 510(k), establish clear mandates for secure update capabilities and require cryptographically signed and verified updates with comprehensive documentation. HIPAA's technical safeguards align directly with robust OTA update capabilities, requiring access control, audit mechanisms, authentication procedures, and transmission security measures.
The NIS2 Directive expands cybersecurity requirements for EU healthcare organizations, mandating comprehensive cyber risk management measures and stringent incident-reporting processes. The EU Medical Device Regulation (MDR) enforces strict controls on ongoing post-market surveillance and comprehensive documentation that aligns with audit logging from robust OTA update capabilities.
Organizations must anticipate future regulatory changes by integrating secure-by-design components that can accommodate new security standards, reporting requirements, and operational procedures as they emerge.
The massive growth trajectory of IoMT, alongside extensive regulations and emerging vulnerabilities, makes clear that secure and robust OTA updates are essential for protecting patients and their data while providing intelligent, connected care. Organizations that proactively implement comprehensive medical-grade OTA update infrastructure will lead the growth of connected healthcare, improving patient outcomes while ensuring safety and regulatory compliance.
As IoMT continues to gain prominence in healthcare delivery, the question isn't whether to embrace connected medical devices, it's how to implement them securely. The convergence of exponential market growth, escalating cyber threats, and evolving regulatory requirements demands a strategic approach to medical device security that puts patient safety at the center of every technology decision.