A Brief Quantum Medicine Policy Guide

by Mauritz Kop, Suzan Slijpen, Katie Liu, Jin-Hee Lee, Constanze Albrecht & I. Glenn Cohen

 

I. Introduction: Harnessing Quantum and AI in Precision Medicine

The convergence of artificial intelligence (AI) and quantum technology (QT) in precision medicine promises to revolutionize healthcare by enabling hyper-personalized treatment.

Fundamentally, for our purposes, quantum technology leverages unique properties of quantum physics—such as superposition and entanglement—to solve problems beyond classical capabilities. Second-generation (2G) quantum technologies harness these principles to achieve quantitative (speed, fidelity) and qualitative (novel functionality) advantages over other methods. Quantum-classical hybrids (frameworks, algorithms or devices that integrate both quantum and classical computing resources such as qubits and digital bits) combine elements from both macroscopic and microscopic worlds to solve complex problems.

Potential applications range from individualized treatment plans powered by AI-enhanced real-time individual health monitoring to advancements in drug design using classical-quantum systems. Innovative explorations, such as stimulating individual neurons at the single-nanocrystal level and utilizing quantum dots for cancer imaging and drug delivery purposes, could benefit oncology research and lead to treatments for neurodegenerative diseases like Alzheimer’s and Parkinson’s thanks to these semiconducting nanoparticles ability to overcome the blood-brain barrier.

Quantum technologies can be utilized in or function as medical devices.

Newer, second-generation quantum technologies encompass computing, sensing, and networking, each offering use cases across areas like chemistry and healthcare. For example, quantum sensing enhances medical imaging resolution and precision in laser surgery. Quantum simulation allows unprecedented modeling of complex systems, accelerating drug discovery through analyzing molecular interactions.

Policymakers must learn from past experiences with AI, nanotechnology, nuclear, and genetics to responsibly manage the ethical, legal, socio-economic, and policy implications (ELSPI) that will be amplified by emerging technologies like Quantum Artificial Intelligence (QAI), Quantum Machine Learning (QML), and Quantum Large Language Models (QLLM). Robust testing is essential, as small flaws in autonomous code can exacerbate inequality, generate false claims, or cause harmful hallucinations. The dual-use nature of QAI—such as in gain-of-function research to develop pathogens for either civil or military purposes— necessitates a principled, human-centric approach in healthcare.

II. 2G Quantum Technology Healthcare Use Cases

First-generation quantum technologies like MRI have profoundly impacted healthcare. This section explores second-generation (2G) quantum use cases in healthcare, connecting them to broader initiatives like the United Nations Sustainable Development Goals.

Computing:

• De Novo Drug Discovery: Quantum computing could accelerate drug discovery by simulating molecular interactions and enhancing predictions of drug efficacy and side effects, leading to personalized medications.
• Personalized Medicine Design: Quantum-enhanced AI might analyze a patient’s genetic makeup, lifestyle, and environment to tailor treatments.
• Healthcare Operations Optimization: Quantum algorithms could optimize scheduling for hospitals, clinical trials, and surgeries, improving efficiency and patient care.
• Medical Imaging Enhancement: Quantum algorithms improve MRI data analysis for faster diagnosis and treatment planning, critical for acute conditions like strokes or traumatic brain injuries.
• Protein Synthesis and Genomics: Quantum computing aids in protein folding simulations, crucial for drug design.
• Genome Sequencing: Quantum computing reduces genome sequencing time, accelerating identification of genetic markers for quicker diagnoses.
• Drug Delivery Purposes: Quantum dots nanotransporters can assist targeted gene and drug delivery platforms in cancer treatments such as cancer molecular targeting.

Simulation:

• Simulating the Human Body: Quantum simulations model complex biological systems at individual or group levels, aiding in understanding disease mechanisms, predicting epidemics, and designing interventions.
• Drug Discovery and Development: Simulating molecular interactions improves drug development success rates and side effects.
• Protein Folding for Drug Design: Quantum simulations provide deeper and faster understanding of protein folding, assisting the drug development process.
• Quantum Virtual Reality Surgery: Precision surgery training method that uses quantum sensors for real-time tracking of movements during complex operations by a human surgeon in VR.

Cryptography:

• Quantum-Safe Patient Data Sharing and Storage: Quantum technologies such as Post Quantum Cryptography (PQC) and Quantum Key Distribution (QKD) can secure patient data, safeguard human identity, and provide secure channels for transmitting sensitive health information. These technologies can act as privacy enhancing techniques (PET) to ensure privacy and compliance with regulations like HIPAA and GDPR.

Sensing:

• Real-Time Health Monitoring: Quantum sensors enable continuous monitoring of vital signs with unprecedented precision.
• Precision Laser Therapy: Quantum sensor-controlled lasers offer targeted treatments with minimal damage to surrounding tissues.
• Real-Time Genome Sequencing: Quantum sensors facilitate rapid genome sequencing for quicker diagnoses.
• Entangled Vision for Retinal Diagnostics: Quantum probes improve retinal imaging for early detection of eye diseases.
• Improved Clinical Pathology: Quantum technology known as optical metamaterial single-photon detectors can enhance Raman spectroscopy, an analytical technique in chemistry.

Quantum-driven healthcare innovations present quantum-specific regulatory challenges, discussed in more detail below.

III. EU Legal Requirements for Quantum-Powered Medical Devices

In the European Union, quantum-infused medical devices incorporating AI, classical data, and quantum systems are subject to a complex web of overlapping regulatory frameworks. There is no specific regulation for quantum technology in healthcare, though the European Declaration on Quantum Technologies acknowledges its importance. But there are sector-specific laws and technology-specific regulations for AI and data.

Devices must primarily comply with Regulations (EU) 2017/745 on Medical Devices and 2017/746 on In Vitro Diagnostic Medical Devices. The EU AI Act, proposed EU AI Liability Directive, and laws under the European Strategy for Data, such as the Data Governance Act, may also play roles. Obtaining a Conformité Européenne (CE) mark, which affirms the item’s conformity with European health, safety, and environmental protection requirements remains slow due to limited Notified Bodies with expertise in AI and quantum technologies.

Multidisciplinary teams can use tools like Quantum Impact Assessment (QIA) and Exploratory Quantum Technology Assessment (EQTA), and the Foresight, Understanding, and Response Matrix (FURM) to navigate legal complexities, but authorities must independently ensure compliance with applicable legislation.

IV. US Legal Requirements for Quantum-Powered Medical Devices

In the United States, some quantum-powered medical devices may be governed under the existing FDA regulatory framework. Depending on the device this might include good laboratory and clinical practices, registration and device listing, labeling, and post-market surveillance are likely governed by multiple regulatory bodies, each imposing its own set of requirements. In some instances, the FDA’s Regulatory Framework for AI/ML-Based Software as a Medical Device (SaMD) may also apply.

Some quantum-powered medical devices may also be governed by multiple other statutes and/or regulatory bodies, each imposing its own set of requirements. These might include the Health Insurance Portability and Accountability Act’s (HIPAA) privacy and security rules, the Federal Trade Commission (FTC) Regulations, the International Medical Device Regulators Forum’s (IMDRF) framework for risk categorization, and international standards like ISO 13485 and the IEC 60601 series.

Given the novel nature of quantum technologies, manufacturers should engage with the relevant agencies early in the development process to clarify regulatory expectations and ensure compliance with all applicable laws and regulations.

The regulatory landscape in the U.S. is dynamic, with recent cross-sectoral developments like the National Security Memorandum on quantum computing and the National Quantum Initiative reflecting the government’s active focus on quantum technologies.

V. Quantum-specific Considerations in Medical Device Regulatory Oversight

In general, regulatory regimes might be challenged by the design of quantum and AI powered medical devices. Compared to previous devices, quantum devices operate on fundamentally different principles, complicating safety and efficacy assessments. Standardized compliance norms may be insufficient to address quantum-specific risks, such as data security concerns. Quantum technology could disrupt existing encryption methods, resulting in what some call “Q-Day” necessitating ecosystem-level upgrades for data handling and privacy protection.

Given these challenges, regulators in the EU and the U.S. will need to change their practices to address key issues:

1. Developing Evaluation Protocols: Recognize unique behaviors associated with quantum phenomena which may not be fully addressed by existing FDA regulations focused on traditional devices and therapies, such as quantum explanations for subtle DNA changes (replication or repair mechanisms) that classical physics cannot explain.
2. Enhancing Risk Management Frameworks: Account for and ensure protection for human subjects from the unpredictability of quantum effects, starting with near-term applications like quantum simulation of drug metabolism.
3. Establishing Clinical Trial Guidelines: Create tailored clinical trial guidelines specifically for clinical trials of or involving quantum devices, given their novelty.
4. Setting Interoperability Standards: Ensure quantum devices are able to share and exchange information with existing healthcare systems.

While AI-focused frameworks like the FDA’s SaMD criteria offer a starting point, they may not adequately support market entrance of multifunctional quantum devices, highlighting the need for flexible regulatory strategies to ensure successful integration of quantum technology

VI. A Comprehensive Approach to Quantum-specific Regulations of Medical Devices

A comprehensive approach to quantum-specific regulations of medical devices should combine three elements:

• Ex-Ante (Pre-Market) Regulation: Establish Regulatory Sandboxes for Quantum-AI Devices (RSQAD) to test technologies under regulatory supervision. Linked with innovation hubs like the Stanford Quantum Incubator, sandboxes provide a controlled environment for assessing safety and efficacy before broader market deployment, supporting development of rights-respecting technical standards linked to certification, verification, and performance benchmarking.
• Ex-Durante (Ongoing) Regulation: Both the FDA and European Commission must accommodate quantum complexities, possibly establishing specialized subcommittees such as those under the U.S. National Quantum Initiative Advisory Committee, consisting of quantum experts to address ELSPI considerations and conduct compliance audits.
• Ex-Post (Post-Market) Oversight: Implement a centralized registration database for quantum-AI medical devices to facilitate regulatory oversight, transparency, and market monitoring.

Regulatory frameworks must balance avoiding stifling innovation with ensuring public safety. A nuanced approach to ELSPI enforcement is needed, with regulations that are robust yet adaptive.

VII. Policy Recommendations: Balancing Innovation and Regulation

To realize the benefits of quantum-driven, personalized healthcare responsibly, the following guiding principles are proposed for healthcare policymakers:

1. Promote Quantum Literacy: Educate policymakers on quantum technologies.
2. Anticipate Societal Impact: Develop forward-looking, anticipatory policies.
3. Implement Quantum Technology Guidelines: Prioritize patient safety, data privacy, and equitable access by establishing Responsible Quantum Technology (RQT) frameworks tailored to healthcare.
4. Operationalize a Quantum Standards-First Approach: Prioritize quantum-specific standard setting, certification, benchmarking, and verification over sweeping, cross-sectoral regulations.
5. Adopt Ex Ante, Principles-Based Regulation: Embrace a forward-looking regulatory approach with flexibility to permit technological advancements without hindering innovation.
6. Employ Adaptive Regulations: Update regulatory frameworks to address quantum specific challenges, utilizing modular approaches and regulatory sandboxes.
7. Avoid Regulatory Fragmentation: Harmonize standards and regulations across jurisdictions.
8. Foster Institutional Plasticity: Evolve institutions like the FDA and EMA to accommodate quantum technologies.
9. Encourage Collaboration: Foster partnerships among researchers, policymakers, industry, and healthcare providers.
10. Consider the Long Term: Account for future generations in innovation decisions.

By adopting these principles, healthcare policymakers can support innovation while mitigating risks that could adversely affect stakeholders across the healthcare ecosystem.

VIII. Conclusion

As quantum technology and AI converge, the healthcare sector stands on the brink of unprecedented advancements. Quantum technologies promise to transform healthcare through advanced diagnostics, personalized medicine, improved clinical research, secure data management, and enhanced virtual experiences. With this potential comes the responsibility to guide these technologies toward beneficial outcomes while mitigating risks. By fostering global collaboration, setting harmonized quality and interoperability standards, aligning regulations with existing frameworks, and ensuring policymakers are well-informed, we can harness the power of quantum technology in medicine for the betterment of healthcare worldwide.

Cross-posted with the Stanford Center for Responsible Quantum Technology: https://law.stanford.edu/2024/12/06/a-brief-quantum-medicine-policy-guide/

Kop is the Founder and Executive Director of the Stanford Center for Responsible Quantum Technology, and a Stanford Law School TTLF Fellow; Slijpen is an attorney in the Netherlands; Liu is a Stanford Computer Science undergraduate and concert pianist; Lee is a Stanford educated human-computer interaction specialist and coloratura soprano; Albrecht is an MIT neuroinformatics graduate; Cohen is a professor at Harvard Law School where he directs Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. Cohen’s work was supported by a Novo Nordisk Foundation Grant for a scientifically independent International Collaborative Bioscience Innovation & Law Programme (Inter-CeBIL programme – grant no. NNF23SA0087056).