Artificial intelligence is transforming biotechnology so rapidly that existing regulatory frameworks designed decades ago can no longer keep pace with the science. From AI-designed viruses that fight antibiotic-resistant bacteria to CRISPR gene-editing therapies, the convergence of computational power and biological engineering is creating capabilities that regulators never anticipated, forcing policymakers worldwide to fundamentally rethink how they govern these technologies.

Why Are Biotech Rules Falling Behind AI Innovation?

The challenge isn't simply that AI is advancing quickly, though it is. The deeper problem is that AI, CRISPR gene-editing, and synthetic biology are converging in ways that traditional regulatory structures cannot address. Most laws are organized around specific technologies, organisms, or activities considered separately. But when a novel biological capability emerges from combining multiple technologies that regulators have traditionally overseen independently, the existing rulebook breaks down.

Consider the recent breakthrough in AI-designed viruses. Researchers used artificial intelligence to create bacteriophages, which are viruses that exclusively kill bacteria, and these novel viruses rapidly overcame antibiotic-resistant strains of E. coli. This is genuinely promising for fighting antibiotic resistance, a major public health threat. Yet the same tools that enable this medical advance could potentially be misused or create unforeseen risks that current regulations were never designed to anticipate.

This is known as the "dual use" problem: the same technology that solves a problem can sometimes create new ones. For regulators and policymakers, the task becomes far more complicated than simply deciding whether a technology is "safe" or "dangerous." They must find ways to support useful research while identifying and managing risks that can be reasonably anticipated, even when those risks may be difficult to predict, detect, or contain.

How Are Governments Updating Their Biotech Governance?

Several countries are recognizing that rigid, one-size-fits-all approaches no longer work. New Zealand is currently grappling with this challenge through its proposed Gene Technology Bill, which would replace parts of a 30-year-old regulatory framework developed under the Hazardous Substances and New Organisms Act. Rather than treating all gene technologies identically, the new system would take a more flexible, risk-proportionate approach.

Under this emerging model, lower-risk gene-editing technologies would be exempt from regulation, while activities deemed to pose greater risks would remain subject to controls. This approach demonstrates that biotechnology governance and regulation do not have to restrict innovation; instead, they can be designed to enable beneficial research while maintaining appropriate oversight.

Other nations are adopting similar strategies:

• Australia: The Gene Technology Act 2000 provides a framework for managing risks from gene technology, with a dedicated gene technology regulator overseeing these risks while other agencies regulate specific products, including medicines and agricultural products. However, regulatory gaps remain, particularly regarding the editing of the human genome.
• United States: The Coordinated Framework for the Regulation of Biotechnology brings together several agencies, each retaining its own regulatory role. The biotechnology's classification determines which agency is responsible, though gaps exist; for example, a CRISPR-edited mushroom designed to be "brown resistant" fell outside the U.S. Department of Agriculture's oversight because it did not meet the agency's definition of a regulated article.
• European Union: Traditionally taking a cautious approach with rules described as "among the strictest in the world," the EU has adopted new rules since CRISPR's advent, creating simpler pathways for lower-risk technologies while maintaining greater oversight for more complex ones.

This shift across multiple regulatory systems shows that even highly protective frameworks recognize the need to evolve alongside biotechnology.

What Role Is the FDA Playing in AI-Enabled Medical Devices?

In the United States, the Food and Drug Administration (FDA) is taking a proactive approach to AI governance in the medical device space. On August 18, 2026, the FDA issued a discussion paper on considerations for regulating generative AI (GenAI)-enabled medical devices, seeking public feedback on risk assessment, premarket evaluation, postmarket monitoring, and other regulatory topics.

"Artificial intelligence is transforming medicine, and the United States must lead in shaping how this technology is developed and used safely and responsibly," said Acting FDA Commissioner Kyle Diamantas.

Kyle Diamantas, Acting FDA Commissioner

The FDA's Digital Health Center of Excellence is leading this effort, which aligns with the Trump Administration's key priority to harness AI to accelerate the delivery of innovative medical products to market. The discussion paper outlines a possible two-axis framework for risk assessment and describes a potential approach to premarket evaluation built on the concept of competency assessment, inspired by how physicians are trained and evaluated.

This competency assessment approach would consist of two components: non-clinical device benchmarking and clinical confirmation to evaluate whether a GenAI-enabled medical device performs as intended before reaching patients. The paper also describes several potential approaches to risk-proportionate postmarket monitoring and discusses considerations around foundation models and agentic AI systems, which are AI systems designed to take autonomous actions toward specific goals.

"Patients and clinicians deserve a regulatory approach that keeps pace with the rapid innovation of digital health technologies," said FDA Center for Devices and Radiological Health Director Michelle Tarver.

Michelle Tarver, M.D., Ph.D., FDA Center for Devices and Radiological Health Director

Steps for Stakeholders to Engage in AI Governance Development

The regulatory landscape for AI in biotechnology and medical devices is not fixed; it is actively being shaped through public input and stakeholder engagement. Here are key ways that interested parties can participate in this evolving process:

• Submit FDA Feedback: Device manufacturers, clinicians, consumers, researchers, and the public can submit feedback on the FDA's discussion paper under docket FDA-2026-N-7874 on Regulations.gov by October 19, 2026. This input will directly inform the development of a regulatory framework for GenAI-enabled medical devices.
• Participate in National Policy Discussions: Countries like New Zealand, Australia, and the European Union are actively debating how to update their biotechnology governance frameworks. Researchers, industry representatives, and civil society organizations can engage with these policy processes to ensure that regulations reflect both scientific reality and public values.
• Support Flexible Regulatory Approaches: Advocate for governance systems that distinguish between different levels of risk, allowing beneficial research to proceed while subjecting high-risk activities to greater scrutiny. This approach, adopted by the EU and proposed in New Zealand, has proven effective at balancing innovation with safety.

What Happens When Regulation Lags Behind Science?

The consequences of regulatory lag can be significant. When rules fail to keep pace with technology, several problems emerge: beneficial innovations may be delayed or blocked by outdated restrictions; genuine risks may go unmanaged because regulators lack clear authority or guidance; and public trust in both the technology and the regulatory system can erode if people perceive that oversight is inadequate or incoherent.

"Generative AI-enabled medical devices are poised to reshape the health technology landscape, and the FDA has an important responsibility to provide thoughtful leadership for this new era," said Rick Abramson, Director of the FDA's Digital Health Center of Excellence.

Rick Abramson, M.D., Director, Digital Health Center of Excellence

The goal, according to experts and policymakers, is not to choose between innovation and regulation, but to develop governance that can recognize emerging risks without sacrificing the potential benefits biotechnology has to offer. This requires regulatory systems that remain flexible enough to accommodate technologies as they continue to evolve, while maintaining clear safeguards for research, managing known risks, and allowing governments to distinguish between activities that pose different levels of harm.

As AI continues to reshape biotechnology and medical device development, the regulatory frameworks governing these fields will determine whether society can harness their benefits while managing their risks. The window for policymakers to act thoughtfully is narrow; the science will not wait for the rules to catch up.