Our use case focused research explores how emerging quantum technologies, when combined with artificial intelligence (AI), could transform precision medicine, potentially providing hyper-personalized healthcare solutions. By leveraging quantum phenomena like superposition and entanglement, second-generation quantum technologies (2G QT) can tackle complex medical challenges beyond the reach of classical computers. These advancements, ranging from quantum computing and quantum-classical hybrids to quantum sensing and quantum networking, can enhance drug discovery workflows, improve diagnostic imaging, accelerate genome sequencing, and even enable real-time health monitoring.

For instance, quantum simulations may aid in modeling molecular interactions to produce more effective drugs, while quantum dots could deliver targeted cancer treatments or bypass the blood-brain barrier to help fight neurodegenerative diseases. Quantum sensors can also refine surgical precision and boost diagnostic accuracy.

However, these breakthroughs also raise ethical, legal, socio-economic, and policy (ELSPI) concerns, that will be amplified by emerging technologies like Quantum Artificial Intelligence (QAI), Quantum Machine Learning (QML), and Quantum Large Language Models (QLLM). The introduction of quantum medical devices raises significant regulatory questions, as existing frameworks are not fully equipped to handle quantum’s unique capabilities and risks. Drawing lessons from agentic AI, nanotechnology, spatial computing, genetics, and nuclear technology governance, policymakers must ensure responsible quantum oversight.

Neither the European Union nor the United States currently has dedicated regulations for quantum healthcare devices, though both rely on existing frameworks like the EU’s Medical Device Regulation, the EU AI Act, the Federal Trade Commission (FTC) Regulations, the FDA regulatory categories, and international standards like ISO 13485 and the IEC 60601 series. Moreover, import and export controls may apply. Both regions face quantum-specific concerns, including data security threats once classical encryption is broken (Q-Day), and the need for tailored clinical trial guidelines to account for quantum’s novel biological interactions.

The convergence of quantum technology and artificial intelligence could revolutionize precision medicine, offering hyper-personalized treatments and innovative solutions to longstanding healthcare challenges. Regulatory frameworks must balance avoiding stifling innovation with ensuring public safety. A nuanced approach to ELSPI enforcement is needed, with rights respecting technical standards linked to certification, verification, and performance benchmarking. Regulations should be robust yet adaptive with built-in agility and flexibility by utilizing modular approaches and regulatory sandboxes.

To manage these complexities, a combination of ex-ante, ex-durante, and ex-post regulatory approaches, as well as international standard-setting, adaptive guidelines, institutional plasticity, and multidisciplinary collaboration, is recommended. Our research offers quantum-specific considerations in medical device regulatory oversight and proposes 10 guiding principles for healthcare policy makers.

Ultimately, we advocate for proactive, flexible, and harmonized policy approaches. Policymakers should learn from previous technological experiences, promote quantum literacy, and adopt principles-based, forward-looking regulations. By doing so, they can support innovation while ensuring the safe, ethical, and equitable integration of quantum technologies into global healthcare.