cybersecurity and medical devices Archives

Top 10 Healthcare Device Security Companies 2025

Chinmaya Choudhury / March 17, 2025

With the development of healthcare technology, there are new things to consider concerning patient safety, data security, and medical technology usability. Healthcare Device Security Companies, administrators, and policymakers must face, recognize, and understand these health IT challenges so that they can deal with the risks appropriately and promote safety in healthcare. In this blog, we will find out the top 10 Healthcare Device security Companies in 2025, identify the risks associated with healthcare technologies, and understand how to best evaluate the companies in selecting the right cybersecurity program. Risks with AI-Enabled Health Technologies Artificial Intelligence (AI) is increasingly used in the fields of diagnosis and treatment planning in health and patient care processes. These are AI-based systems developed to analyze and mine huge numbers of patient records and point out specific patterns in the data to support better medical decision-making. However, such systems rely upon the quality and completeness of these data; otherwise, they can be unreliable and inaccurate. The major issue with health technologies empowered by AI is the bias, misdiagnosis, and opacity associated with them. In case the training data used by AI models is incomplete or biased, it might result in wrong predictions, ultimately yielding improper recommendations for treatment. For instance, research carried out by the University of Michigan established that there was proof Black patients were 4.5% less likely to undergo medical tests for ailments than white patients with similar age, sex, medical symptoms, and triage level due to discriminatory training in the AI. AI systems will also be afflicted by “hallucinations” when the program generates untrue or misleading responses. AI will also have the challenge of varying its outputs in the face of new data or situations, producing shifting patterns in performance over time. Clinicians can also disproportionately trust AI findings without thoroughly recognizing the reasoning they use, expanding the likelihood of mistakes. To reduce these risks, human decision-making should remain at the center of healthcare processes: Unmet Technology Support Needs for Home Care Patients The switch to home health care has captured the spotlight with the patient’s voice strongly favoring it over hospital-based care, further driven by cost containment in health care. Many patients now manage their chronic conditions or make recovery from a procedure at home with medical device security like ventilators externally worn dialysis machines, or infusion pumps. Nonetheless, there is a great risk of an unaddressed challenge concerning the use of health IT in patient care at home due to inadequate technological provision. Patients and caregivers may struggle to set up or operate medical devices correctly, leading to medical errors and adverse events going undetected or device readings being misinterpreted. One study found that out of 606 incidents associated with infusion devices in private homes, 278 involved device malfunctions, 87 involved incorrect dosage administrations, 56 involved devices being programmed incorrectly, and 42 involved devices being set up incorrectly. Devices may also malfunction, causing care delays or patient harm. Additionally, technical malfunctions may go unresolved due to insufficient access to expert support. To use these devices safely, patients and caregivers must manage healthcare technology appropriately, including: What Makes a Strong Healthcare Cybersecurity Company? Most healthcare organizations will benefit from working with a cybersecurity solution vendor or managed security services provider (MSSP) to acquire the necessary capabilities for defending against today’s threats. What should your organization look for in a cybersecurity company? Look for firms that can assist you in addressing the most critical areas of data protection, access management, and risk detection. Where possible, identify one organization capable of serving all three requirements so that you can eliminate the complication of working with multiple vendors. In your assessment process, incorporate companies that provide 24/7 monitoring and incident response features. Attacks may occur at any moment, and they may grow quickly. You require a means of detecting and responding to attacks quickly. A cybersecurity provider’s solutions and services must also integrate seamlessly with your current IT infrastructure, either on-premises or in the cloud. Few healthcare organizations have the time or resources to do custom integrations or completely revamp their environment to fit new security features. Notably, look for a firm that specializes in healthcare device penetration testing experience. The firm’s employees must realize the need for HIPAA compliance. They should also know about what is new and growing, including threats to medical equipment and devices, so they can assist you better in preparing your organization. If your company is going for HITRUST Common Security Framework (CSF) certification, you’ll need to get a cybersecurity firm that can aid you in this endeavor. It can be time- and effort-intensive to gain HITRUST certification; you can simplify the process by collaborating with a knowledgeable partner. Top 10 Healthcare Device Security Companies 2025 Although there are many healthcare cybersecurity firms in the market, comparatively fewer can serve the needs of healthcare firms. A few of the top firms in that sector are: 1. Cloudticity Cloudticity is a cloud-based, healthcare-oriented MSSP that allows healthcare organizations to take full advantage of public cloud services while simplifying security, compliance, and management. Through the blending of extensive cloud and industry-specific knowledge with a complete set of managed and automated services, we assist healthcare organizations in avoiding data breaches, staying HIPAA compliant, and speeding up HITRUST certification. Cloudticity collaborates with leading cloud providers such as AWS, Azure, and Google Cloud, as well as cybersecurity leader Crowdstrike, whose Falcon™ platform prevents breaches. 2. CrowdStrike’s AI-driven platforms and features for security in healthcare include advanced endpoint protection, managed detection and response, IoT and IoMT protection, and incident response services in the areas of network security, cloud security, and security operations solutions, used by healthcare entities to lessen downtime from service interruptions. 3. Palo Alto Networks Palo Alto Networks assists healthcare organizations in reducing incident-induced service downtime by offering solutions in network security, cloud security, and security operations. 4. GE HealthCare seamlessly integrates security into its product line and offers consulting and managed monitoring services to protect devices, systems, and data. 5. Check Point

FDA Rolls Out New Guidelines for Medical Network Device Security

As medical devices become more sophisticated and the Software as a Medical Device (SaMD) business grows in popularity, it is critical to ensure that your medical equipment is cyber-secure. Because of the huge volumes of health information and data, such as patient health, product performance, or data from other devices linked to the same network, the healthcare business has long been a target of cyber assaults. Due to the increase in cyber assaults on medical devices, the FDA (U.S. Food and Drug Administrator) released a Guideline for cybersecurity in medical devices manufacturers on how to secure their devices from assaults. In this blog, we will discuss the importance of cybersecurity, the guidelines of the FDA, and how to protect IoMT (Internet of Medical Things). Understanding the Cyber Threats of Medical Devices Many healthcare assaults utilize phishing and the establishment of persistent threats within networks and devices in order to attack when the potential benefits are greatest. 327 data breaches have been reported since the beginning of 2023. According to research, that statistic has grown more than 104% from 160 breaches as of mid-2022 and shows “no signs of abating.” In 2023, cyberattacks targeted more than 40 million individual patients, representing a 60% rise year on year for the first six months. According to the report, there were five breaches of at least 3 million data each in the first half of 2023, compared to a single breach of 2 million records last year. Healthcare business associates are also in danger, accounting for 14% of all reported breaches and increasing from 22 in mid-2020 to 82 this year. According to the study, this is a 273% increase. Talk to our Cybersecurity Expert to discuss your specific needs and how we can help your business. Schedule a Call FDA Cybersecurity Guidelines for Securing Medical Network Devices While the new guidance is similar in structure and content to the previous version, it adds two new substantive sub-sections to the original security risk management section: A new appendix identifying which specific documentation elements recommended for inclusion in premarket submissions will also apply to IDE submissions, Several cybersecurity term definitions. September 26, 2023: The FDA supports the establishment and use of a “Secure Product Development Framework,” or “SPDF.” This defines as a collection of activities that limit the number and severity of vulnerabilities in products across the device lifecycle. The SPDF is meant to be the core structure which manages cybersecurity risk, and focuses on three main elements: security risk management security architecture cybersecurity testing The guideline also mentions IEC 81001-5-1, a health software reference standard, as a viable framework to explore developing the SPDF. To assist in showing device safety and efficacy, the FDA Cybersecurity Guidance continues to suggest including a security risk management report in a premarket submission. The revised guidance’s modified security risk management section includes two new sub-sections, the first of which is on “Cybersecurity Risk Assessments.” The guideline acknowledges that cybersecurity risks are difficult to foresee and that previous data or modeling cannot estimate and quantify the possibility of an incident occurring. As a result, a cybersecurity risk assessment should concentrate on the exploitability of vulnerabilities existent within a device or system, as well as those that anticipates to exist in the context of use. The FDA recommends that the cybersecurity risk assessment include not only the risks and controls identified in the threat model but also the methods used for scoring such risks before and after mitigation, as well as the associated acceptance criteria, as well as the method for transferring security risks into the safety risk assessment. The risk management section also includes a new section on “Interoperability Considerations,” which addresses cybersecurity concerns that may arise from interoperable functionality. This includes interfaces with other medical devices and accessories and other functions. The guidance states that properly implemented cybersecurity controls will help ensure the safe and effective exchange and use of information. It also advises device manufacturers to assess whether additional security controls beneath common technology and communication protocols such as Bluetooth and network protocols are required to ensure safety and effectiveness. The guidance advises device manufacturers to consider the appropriate cybersecurity risks and controls that associates with interoperability capabilities and ensure they are in the document. According to FDA requirements, all cybersecurity efforts must be well documented and traceable, including records of risk assessments, security controls, testing findings, and mitigation plans. This paperwork must provide useful information for post-market monitoring and risk management. The FDA emphasizes the need to regularly monitor and analyze cybersecurity threats throughout the lifespan of a device. Manufacturers are expected to have mechanisms in place to identify, respond to, and mitigate cybersecurity events in a timely manner, assuring the device’s continuous safety and efficacy. These recommendations define the material necessary for premarket filings, ensuring manufacturers present enough documentation of their cybersecurity risk management strategies. This comprises documentation of risk assessments, security controls, testing findings, and a cybersecurity risk management plan for the device. The FDA is asking for an SBOM (Software Bill of Materials), which is a complete inventory of all software components that utilizes in a medical device, including those generated by the maker and those developed by third parties. An SBOM helps device makers and users discover possible security threats in a timely way, hence facilitating risk management processes. The Mandates of Cybersecurity in Medical Devices FDA Testing, like other aspects of product development, uses to show the efficacy of design controls. While software development and cybersecurity are closely related disciplines, cybersecurity controls necessitate testing that extends beyond standard software verification and validation activities. This is a need in order to demonstrate the effectiveness of the controls in a proper security context. This demonstrates that the device has a reasonable assurance of safety and effectiveness. A manufacturer requires to create and maintain processes for validating the device design. This verification must ensure that the design output satisfies the criteria of the design input. A manufacturer requires to create and maintain processes

cybersecurity and medical devices

Top 10 Healthcare Device Security Companies 2025

FDA Rolls Out New Guidelines for Medical Network Device Security

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