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Medical Device Cybersecurity Guidance for the Industry

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Medical device cybersecurity guidance

Connected medical devices are prime targets, jeopardizing patient health. Manufacturers must bake comprehensive cybersecurity into technologies across their entire lifecycle. Device connectivity enables efficient healthcare but also widens the attack surface. Companies must leverage security best practices to harden networked equipment against unauthorized access.

Proactive cyber-resilience is imperative. Flawed cybersecurity jeopardizes patient well-being and data privacy. Manufacturers must secure network-enabled devices and thwart vulnerabilities. Cyber guidance for manufacturers is crucial for protecting patient health and privacy.

Why Is Cybersecurity Guidance Needed?

Most medical devices today rely on software running on commercial off-the-shelf operating systems that can contain vulnerabilities, just like traditional IT systems targeted by cybercriminals.

Many legacy and outdated medical devices still deployed were developed without foundational security principles in mind.

Fundamental issues like unpatched operating systems, weak authentication mechanisms, lack of encryption, and poor network segmentation persist on many products currently used in healthcare environments.

If effectively exploited, cybersecurity weaknesses in medical equipment could directly impact patient health and safety by altering device functions or making them unavailable during critical interventions.

There are also serious privacy concerns if compromised systems allow unauthorized access to protected health information and susceptible medical data.


The threat of cyber attacks targeting medical devices and healthcare organizations continues to grow alarmingly.

Recent statistics highlight the rising risks and need for comprehensive security guidance:

  • Ransomware attacks on healthcare doubled in 2021, with 66% of businesses affected (Source)
  • 80% of healthcare data breaches in 2022 were related to hacker or IT-related incidents. [Source: Irdeto Insights]

These trends underscore why medical device manufacturers and healthcare delivery organizations need to make cybersecurity a top priority.

Compromised medical equipment could endanger patient safety if critical functions are disrupted. Unauthorized data access also severely impacts privacy.

9 Crucial Cybersecurity Guidance for Medical Devices Manufacturers

The FDA has released over 25 guidance documents, many aligned with those from international regulators like IMDRF, related to medical device cybersecurity. These aim to promote security across the product lifecycle.

Here, we will highlight seven key examples:

Guidance 1 – Content of Premarket Submissions for Cybersecurity

This guideline outlines extensive documentation manufacturers should submit to the pre-market demonstrating security measures implemented during design and development. This includes a detailed Software Bill of Materials, diagrams, threat models, risk analysis, and planned mitigations.

Guidance 2 – Post-market Management of Cybersecurity

This guideline details recommended ongoing practices post-deployment like vulnerability handling, incident response, coordinating disclosure, and user notifications. Proactive monitoring and rapid response are critical to address emerging issues.

Guidance 3 – Building Cybersecurity into the Quality System

This guideline strongly advises integrating security activities into existing quality assurance and risk management processes per FDA requirements. Security should be considered early and continually.

Guidance 4 – Wireless Devices and Radio Frequency Technologies

This guideline provides extensive tailored advice for securing wireless communications in devices like pacemakers and infusion pumps using proprietary protocols.

Guidance 5- Medical Device Data Systems, Medical Image Storage and Communications

This guideline discusses unique risks and highly specific controls for protecting sensitive images and health data stored or transmitted across the healthcare ecosystem.

Guidance 6 – Network Connected Devices and Hospital Networks

This guideline focuses on risks and defenses when connecting equipment to healthcare IT networks and medical record systems. Recommends approaches like network segmentation and securing all interfaces.

Guidance 7 – When Premarket Review is Needed for Software Changes

This guideline clarifies when cybersecurity software updates substantially affect safety and effectiveness, requiring additional regulatory submissions over a product’s lifetime as threats evolve.

Manufacturers can build comprehensive cybersecurity into their processes by thoroughly engaging with these and other recommendations throughout the product life cycle.

Collectively, they provide a pathway toward more resilient devices that will help protect patients and sustain trust in connected technologies revolutionizing healthcare.

Guidance 8 – Software as a Medical Device

The FDA acknowledges the unique considerations for manufacturers developing regulated medical software lacking hardware components.

This guidance outlines best practices for these technologies, including validating software requirements and architecture, ensuring code quality, and implementing cybersecurity controls tailored to the software-based risk profile. A rigorous approach is advised to ensure patient safety and data integrity.

Guidance 9 – Medical Device Cybersecurity Regional Incident Preparedness and Response

This FDA guideline stresses the importance of effective coordination between medical device manufacturers and healthcare delivery organizations when responding to cybersecurity incidents.

It provides recommendations on rapid threat information sharing, joint analysis, containment strategies, and efficiently deploying software updates across multiple affected entities.

A coordinated approach can help accelerate recovery and prevent the expansion of impacts during attacks.


Cybersecurity must be a central consideration when designing modern medical devices before deployment. Unauthorized access to medical devices could grant access to susceptible patient health data, violating personal privacy on a large scale.

Extensive guidance from bodies like the FDA provides a vital framework to build protections across the product life cycle.

Manufacturers have an essential duty to ensure medical equipment can withstand evolving threats, prioritizing patient safety and privacy in increasingly connected healthcare environments.


Dmitry Kurskov, Head of Information Security Department at ScienceSoft

An IBM Certified Deployment Professional, Dmitry has more than 20 years of practical experience as an information and cybersecurity systems architect. He manages the design and implementation of security policies and solutions within the company’s IT environment and oversees the delivery of managed security services to ScienceSoft’s clients. Dmitry advocates the consistency and continuous improvement of cyber defense as the key to resisting ever-evolving cyber threats. He has contributed greatly to aligning ScienceSoft’s security management system with ISO 27001.

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