Surgical Device Cybersecurity: Understanding AI and Medical Device Risks in Healthcare

Surgical and medical devices, plus AI is complex because regulations for this technology exist in different buckets, not one comprehensive rulebook. These buckets include healthcare privacy/security, cybersecurity, device safety, product compliance, etc. The various regulation types to be aware of and the reasons why each is relevant are essential when managing risk.

Healthcare privacy and security regulations: This is the starting point. In the United States, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the HIPAA Security Rule are the regulations that spell out expectations around the management and protection of electronic protected health information (PHI). While not directly a medical device regulation, HIPAA covers medical devices any time PHI is created, stored, transmitted, or integrated with other systems by a device. HIPAA knowledge is essential for IT professionals to know at a high level. This is especially true as it relates to implementing administrative, technical, and physical safeguards for device-connected systems like the safeguard categories (access control, audit logging, transmission security, incident response, etc. ), so you can show these systems were not the weakest link in the HIPAA environment because they were built without foundational enterprise security principles.

Medical device safety and cybersecurity regulations: Second in line are the medical device safety and cybersecurity regulations. In the United States, the Food and Drug Administration (FDA) regulates medical devices as safety-critical products. For many years, the medical device industry has struggled to find clarity from the FDA on how cybersecurity concerns are evaluated as part of device approvals. It has become clearer in recent years that cybersecurity is a recognized patient safety risk by the FDA. Cyber risk is an explicit expectation in both pre-market regulatory submissions as well as post-market guidance from the FDA, with expectations to continuously monitor, manage vulnerabilities, and coordinate disclosure. IT teams supporting regulated medical devices need to understand how security controls, patching practices, network architecture, and other decisions can impact the FDA position, regulatory status, and manufacturer obligations.

International medical device regulations: A third category is the increasing amount of international medical device regulations with explicit expectations for medical device cybersecurity. In the European Union, the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements for manufacturers include cybersecurity as part of the risk management and clinical safety expectations. Similar to the U.S. FDA, MDR/IVDR regulations require organizations to be able to demonstrate that known and foreseeable cybersecurity risks are identified, mitigated to an acceptable level, and monitored throughout the device lifecycle. For IT professionals in international environments, this means being aware of how cybersecurity decisions can impact regulatory approvals, audits, and market access.

Cybersecurity standards and frameworks: Cybersecurity standards and frameworks, while not often legally required, are a big influence on many of the regulators and audit requirements. Standards like IEC 62304 (medical device software), IEC 81001-5-1 (cybersecurity for health software), ISO 14971 (risk management), the NIST Cybersecurity Framework (CSF), and others are referenced or expected by regulators and auditors who verify HIPAA, device safety, international compliance, and device cybersecurity requirements. It is extremely useful for IT professionals to know how these standards map to practical technical controls that are implemented. While many auditors ask about what controls were implemented, they also frequently ask to see how risk decisions were made and documented.

Post-market surveillance and incident reporting: Finally, most of these regulations have some kind of post-market surveillance and incident reporting requirements. This includes detecting, assessing, and reporting cybersecurity events in a manner that could reasonably impact patient safety. Vulnerability disclosure programs, security researcher coordination, and even timelines for reporting to regulators when an event reaches a certain level of risk or severity, are all important for IT professionals to be aware of because they are often involved directly with the detection, investigation, containment, and evidence preservation for these events.

Procurement and third-party risk: With procurement requirements growing more stringent, it is important for IT professionals to be aware of the cybersecurity due diligence and evaluation that hospitals are expected to do for medical devices before buying a product, and periodically throughout its lifecycle in their environment. Understanding of a software bill of materials, patching commitments, end-of-life policies, and general vendor response capabilities are all a part of this, as IT professionals will often act as the intermediary between clinical stakeholders, procurement teams, and manufacturers.

What’s New with AI in Plastic Surgery & Medspa Industry: Trends, Risks, & Cybersecurity Considerations

What are applicable U.S. laws, regulations, and regulatory bodies for surgical devices, AI-enabled systems, and cybersecurity risk?

The following standards and requirements are particularly relevant for connected, software-driven, and AI-assisted surgical technology. Understand what the rule or standard is and why it matters for real-world medical device security and IT risk management.

Federal Food, Drug, and Cosmetic Act (FD&C Act)

WHAT: The FD&C Act is the foundational U.S. law that grants the U.S. Food and Drug Administration (FDA) regulatory authority over medical devices that are sold or used in the United States.

WHY: All surgical devices, including their software and AI-driven functionality, are subject to this law if they meet the legal definition of a medical device. Cybersecurity is considered as part of device safety and effectiveness, and security failures can become regulatory violations.

Section 524B: Ensuring Cybersecurity of Medical Devices

WHAT: Section 524B is an addition to the FD&C Act, which was included through the Consolidated Appropriations Act of 2023.

WHY: Manufacturers are now required to provide specific cybersecurity information in premarket submissions to the FDA.

FDA Cybersecurity and AI Guidance Documents

WHAT: The FDA has issued guidance on how it interprets cybersecurity and AI requirements for medical devices. Key examples include: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Draft Guidance on AI-Enabled Device Software Functions and Lifecycle Management

WHY: These documents describe how the FDA expects device software to be secured throughout its lifecycle. Recent drafts directly address AI-specific risks like data poisoning, model drift, adversarial inputs, and unauthorized model updates.

Health Insurance Portability and Accountability Act (HIPAA)

WHAT: HIPAA is the primary U.S. law that governs the privacy and security of protected health information.

WHY: If a surgical device stores, processes, or transmits any patient data, then it becomes part of the HIPAA security perimeter. That includes networked devices, robotic surgery platforms, and AI systems that may handle or infer patient information. HIPAA requires administrative, technical, and physical safeguards as well as incident response and breach notifications.

Health Information Technology for Economic and Clinical Health Act (HITECH)

WHAT: HITECH is a law that strengthens and builds on HIPAA’s data privacy and security requirements.

WHY: HITECH increases the financial and legal stakes for cybersecurity failures involving electronic protected health information. AI-assisted surgical technologies that connect to hospital networks are now part of that enforcement landscape.

21st Century Cures Act

WHAT: This law includes clarifications about how software, including clinical decision support, is regulated under U.S. medical device law.

WHY: Some software functions are not regulated, but many AI-enabled features are still regulated as medical device software. AI that drives surgical decisions or device behaviors will likely be under FDA oversight, along with associated cybersecurity expectations.

Federal Trade Commission Act Section 5

WHAT: Section 5 of the FTC Act makes unfair or deceptive acts or practices illegal. This is the law that the Federal Trade Commission (FTC) enforces.

WHY: If a medical device manufacturer makes exaggerated or misleading statements about the security or safety of its AI or connected systems, the FTC can bring enforcement actions even when the FDA or HIPAA do not apply. Marketing claims about cybersecurity must be supported by reality.

State Privacy and Cybersecurity Laws

WHAT: States have begun to pass their own data privacy and cybersecurity laws, such as the California Consumer Privacy Act and proposed healthcare-specific cybersecurity laws in states like New York.

WHY: Surgical devices that collect or transmit patient data could also be subject to state-level requirements in addition to federal law. Rules at the state level tend to emphasize risk assessments, reasonable safeguards, and breach reporting.

NIST Cybersecurity Framework and NIST AI Risk Management Framework

WHAT: Risk management frameworks that have been developed by the National Institute of Standards and Technology and are frequently cited by regulators and auditors.

WHY: While not laws, these frameworks are often used to demonstrate reasonable security and defensible decision-making. They are especially valuable for AI risk where specific regulations have not yet been finalized.

FDA Post-Market Surveillance and Reporting Requirements

WHAT: FDA requirements that mandate device manufacturers to monitor their products after release and to report any adverse events, including cybersecurity incidents.

WHY: Cyber incidents that impact device performance or patient safety may require mandatory reporting under Medical Device Reporting rules. Vulnerabilities that are discovered post-deployment can still have regulatory repercussions.

ANSI AAMI Consensus Cybersecurity Standards

WHAT: Consensus standards like ANSI AAMI SW96 that define cybersecurity best practices for medical devices.

WHY: Standards are not laws, but they are frequently referenced by regulators and are now expected in premarket submissions. Following them helps demonstrate alignment with industry-accepted practices.

Key Takeaways for IT and Security Leaders for Laws and Regulations

FDA rules center on safety and cybersecurity throughout the device lifecycle.
HIPAA and HITECH govern patient data protection when devices connect to clinical environments.
FTC and state laws plug gaps related to privacy, security claims, and consumer protection.
NIST frameworks and consensus standards are helpful for showing reasonable, defensible security decisions.

The FDA has ramped up cybersecurity expectations for medical devices in recent years. Strong legal authority applies to connected devices and AI-enabled systems. Surgical technology is part of the FDA ecosystem, so cybersecurity risk is now fundamentally entangled with patient safety and regulatory compliance. Knowing how these laws and standards fit together is critical to risk management and meeting current expectations for reasonable security.

What are Some Use Cases & Cybersecurity Applications for AI in Surgical Devices?

Contemporary surgical devices are networked, software-defined, and AI-enabled, allowing vendors to improve patient outcomes and introducing new cyber risks to health systems. It is incumbent upon IT and clinical teams to appreciate both aspects of the issue.

Use Case: Robotic-Assisted Surgery Platforms

Platforms (such as da Vinci® or equivalent robotic surgical systems) that enable a surgeon to perform minimally invasive, high-precision operations are ubiquitous today. AI models can consume intraoperative information to assist with the stabilization of hand motions and with optimizing tool trajectories.