As connected healthcare devices become more pervasive and critical to patient outcomes, the cyber risks tied to their design, production, and deployment grow exponentially. In its latest white paper, the U.S. Food and Drug Administration (FDA) takes a proactive stance with a detailed “Cybersecurity Risk Management Playbook” aimed at medical device manufacturers and their supply chain partners.
The playbook outlines a structured, collaborative approach to identifying and mitigating cybersecurity threats across the product lifecycle—from design to distribution.
The FDA emphasizes that cyber resilience must be “engineered into” devices at the earliest phases of development. According to the report, “Cybersecurity risk management should begin during product concept and continue throughout the total product lifecycle (TPLC).”
The shift toward a secure-by-design philosophy reflects broader federal cybersecurity guidance and is echoed in frameworks from U.S. CISA and NIST.
“The FDA’s playbook is a clear signal that governance, risk, and compliance (GRC) practices must evolve beyond checkbox HIPAA compliance,” said Hemanth Tadepalli, Cybersecurity and Compliance Engineer at May Mobility. “Sophisticated adversaries like APT41 and UNC1878 have already targeted healthcare systems through third-party suppliers. Embedding cybersecurity into every phase of the device lifecycle is essential not just for resilience, but for regulatory alignment and patient safety.”
A core theme of the playbook is the shared responsibility between device manufacturers and their supply chain partners. The document encourages coordinated vulnerability disclosure (CVD) programs and third-party risk management protocols to ensure transparency.
“No single entity can manage these risks alone—collaborative action is required across the device ecosystem,” the report cites.
The FDA includes detailed examples of risk assessment matrices, threat modeling tools, and response planning templates (see complete checklist below). These are meant to guide organizations in both assessing potential vulnerabilities and responding to incidents quickly and effectively.
“Advanced persistent threats like Volt Typhoon and APT29 are actively probing the healthcare sector, not just for data theft, but to disrupt critical infrastructure,” Tadepalli added. “The FDA’s emphasis on secure-by-design, coordinated disclosure, and continuous post-market monitoring brings cybersecurity risk management in line with the realities of today’s threat landscape—and complements HIPAA, HICP, and NIST CSF with enforceable expectations.”
The playbook doesn’t shy away from the real-world consequences of insecure devices. From disrupted hospital operations to patient safety risks, the FDA links cyber threats directly to care delivery. From the report: “The inability to access or trust the integrity of device data can delay procedures, increase costs, and most critically, place patients at risk.”
This white paper complements existing frameworks such as NIST’s Cybersecurity Framework (CSF) 2.0; FDA’s pre-market and post-market cybersecurity guidance; and HHS’s 405(d) Health Industry Cybersecurity Practices (HICP).
It reflects a trend toward regulatory expectations for continuous cybersecurity assurance, not just point-in-time compliance.
Some cybersecurity vendor experts offered their perspectives:
Nivedita Murthy, Senior Staff Consultant at Black Duck: “Hardware devices in general are tricky to embed security in but not as complex. However, with medical devices the biggest challenge has been that the underlying devices and components included still use legacy ports and protocols to establish connections. These connections are usually unencrypted or allow users access to manipulate information. A lot of these devices communicate with each other using the old protocols and to upgrade one component you need to ensure all others are upgraded to the latest secure protocol. To understand the size of this problem one just needs generate a hardware bill of materials of all components used in a medical device and look into the details on how varied it is in terms of producers and age. “
“With rapid advancement in digitalization including the medical industry, vendors need to remember that the old software world is gone, giving way to the new set of truths defined by AI and global software regulations. As an industry , there is a need to unleash innovation by defining new ways to manufacture these devices keeping in mind security and technological advancements in the era of accelerating risk. Adhering to some of the standard network security best practices as also required in FIPS standards would help a long way in advancing and improving the security posture in this field.”
Nathaniel Jones, Vice President of Threat Research at Darktrace: “As OT becomes more integrated with IT systems, it presents more opportunities for attackers. OT security is strongest when supported by robust IT security, requiring coordination between IT and OT teams to defend the entire network. By adopting good cyber hygiene, proactively securing your digital estate, and addressing any vulnerabilities before they can be exploited, organizations will be much better equipped to defend their networks against increasingly opportunistic threat actors.”
John Gallagher, Vice President at Viakoo: “Clearly the shift by malicious hackers to target IoT/OT devices has brought new requirements to the lines of business, such as manufacturing, healthcare, physical security, facilities, etc…, that are responsible for managing and securing such devices. Compared to traditional manufacturing or physical security workers, employers will pay a premium in these departments in their race to secure their non-IT devices. As threats become more cyber-physical in their impact, faster incident response and forensics will drive employers to recruit security professionals who can operate outside of the traditional IT space.”
Medical device cybersecurity risk management checklist
Design and development
- Incorporate cybersecurity risk management into the Total Product Lifecycle (TPLC)
- Conduct threat modeling during product concept and design phases
- Apply secure-by-design principles and security architecture reviews
- Evaluate software and firmware components for known vulnerabilities
Supply chain risk management
- Map all supply chain partners and third-party software dependencies
- Establish supplier cybersecurity requirements and SLAs
- Require Software Bill of Materials (SBOM) from vendors
- Perform periodic security audits of critical suppliers
Risk assessment and monitoring
- Perform regular risk assessments and gap analyses
- Use risk assessment matrices to evaluate likelihood and impact
- Implement tools for continuous vulnerability scanning
- Track threat intelligence feeds relevant to device usage
Testing and validation
- Conduct security testing (e.g., fuzzing, static/dynamic analysis)
- Validate firmware and update mechanisms for tamper resistance
- Perform red team exercises to simulate attacker scenarios
Disclosure and response
- Create a Coordinated Vulnerability Disclosure (CVD) policy
- Set up a dedicated process for handling security findings
- Develop a documented Incident Response Plan (IRP)
- Test incident response plans with tabletop exercises
Clinical and operational preparedness
- Train clinical and operational staff on device cybersecurity hygiene
- Plan for device downtime or compromise scenarios
- Ensure business continuity plans include device-dependent workflows
Post-market and regulatory compliance
- Monitor device performance and cybersecurity posture after deployment
- Report incidents and vulnerabilities as required under FDA or HHS guidance
- Align cybersecurity program with NIST CSF and HICP practices