Quantum medical technology research at ASU: Frequently asked questions
On this page: what qualifies as Quantum Medical Technology research, which federal agencies oversee it and the resources are available at ASU to support safe and compliant research.
What is Quantum Medical Technology Research?
Quantum Medical Technology Research encompasses the development of quantum sensing technologies for disease detection and treatment, with an emphasis on integrating these sensors into diagnostic tools and advancing their transition from laboratory research to clinical practice.
Which federal agencies fund this research?
NSF Bring Quantum Sensors to Fruition
National Institutes of Health Quantum Computing Challenge
NIH Quantum Research Activities
NIH National Center for Advancing Translational Sciences (NCATS)
National Science and Technology Council Quantum Initiative
National Research Council of Canada
Federal Ministry of Education – Germany
Which agencies regulate Quantum Medical Technology research?
As this is an emerging field of study, specific regulations have not been developed. 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 are relied upon.
Federal Trade Commission (FTC) Regulations: FTC provides guidance on consumer protection and advertising practices. For Quantum Medical Technology, key considerations include consumer labeling, data privacy, and advertising claims.
Food and Drug Administration (FDA) Regulations: FDA provides guidance on regulation of drugs, medical devices and related health products.
ISO13485 – Medical Device Quality Management: Provides guidance for medical devices to meet regulatory and customer requirements in safety and efficacy.
IEC60601 – Medical Electrical Equipment: Provides guidance for medical electrical equipment to meet safety and performance.
Health Insurance and Portability and Accountability Act (HIPAA): Federal law to protect sensitive patient and/or human subjects information. Key considerations for Quantum Medical Technology Research are protection of health information (PHI) that involve the use, creation, or disclosure of PHI.
What policies and resources does ASU have?
ASU Environmental Health and Safety: oversight and training.
ASU Office of Research Compliance: guidance for federal and state regulations.
What training is available?
Collaborative Institutional Training Initiative (CITI)
CITI is the online training platform used by ASU to meet the ethical and regulatory training requirements for research. CITI covers topics like human subjects’ protections, research security, information privacy and security, conflict of interest, responsible conduct of research, etc.
Log into CITIProgram.org through your organization (ASU) with your ASURITE, select “Add a Course” on MyCourses, select the one you want to take.
Looking for Specific Training
If you need guidance on specific training, please email [email protected], and we will work with you to find available options.
Are there dual-use concerns with this research?
Yes. Some Quantum Medical technologies and knowledge can be applied for both beneficial purposes (e.g., medicine, energy) and harmful purposes (e.g., weapons). The key consideration for areas of risk are cybersecurity, human enhancement technologies and advanced quantum sensing.
Are there export control concerns with this research?
Yes. Medical devices and related health products may be subject to custom regulations, export licensing requirements and compliance with international trade agreements or local regulatory bodies.
Sharing certain information with foreign nationals may not be allowed or require prior authorization from the federal agency.
Are there common terms and conditions that apply to Quantum Medical Technology research awards?
Yes. Quantum Medical Technology research awards will include specific research compliance and security requirements. Below are a list of common terms and conditions that may apply:
Participation
- Restrictions on foreign nationals (non-U.S. citizens or permanent residents).
- Foreign involvement may require prior sponsor approval.
- U.S. citizenship or lawful permanent residency may be required for certain research projects, especially those involving U.S critical technologies.
- Restrictions may extend to key personnel, students and technical staff.
- Restrictions may extend to Entities of Concern
- Security clearance may be required
Data, technology and export controls
- Research results, materials and technologies may be subject to:
- Export Administration Regulations
- International Traffic in Arms Regulations
- Sharing technical data with foreign nationals may constitute a “deemed export,” potentially requiring a license
- Sponsor review and approval may be required before publication (Publication Restriction)
- Classified and Controlled Unclassified Information must be safeguarded
- Restrictions may apply to conference presentations or international collaborations
Facilities, materials and security
- Requirements for use of secure labs and compliance with facility standards
- Access controls on quantum sensing and medical devices
- Periodic sponsor reviews to ensure compliance with safety and non-proliferation regulations
Legal and regulatory compliance
- Record-keeping obligations covering training, personnel access and export license determinations
- Explicit prohibitions on using research results for nefarious applications
- Specific terms regarding commercialization and U.S. economic benefits
- Human subjects
Who do I contact?
- General questions about quantum software/tools (e.g., access, functionality, support, safeguarding data): Contact your local IT support, Enterprise Technology ET Routing Matrix or the Get Protected team.
- Questions about the use of Quantum Medical Technologies I in research projects involving human subjects (e.g. IRB studies, etc.): Email the ASU IRB at [email protected]
Questions about US export controls related to research projects involving specific Quantum Medical Technologies: Email the Export Control team at [email protected]