Qure.ai and Global Medical Device Regulations
United States FDA:
Qure.ai’s qER (V2.0), qER-Quant and qXR-BT are US FDA 510(k) cleared.
- Qure.ai‘s qER (V2.0) product is US FDA 510(k) cleared as a radiological computer aided triage and notification software. The device is intended to assist hospital networks and trained medical specialists in workflow triage by flagging the following suspected positive findings of pathologies in head CT images: intracranial hemorrhage, mass effect, midline shift and cranial fracture. The 510(k) summary explaining qER’s performance and clinical benefits is publicly available here in FDA’s database.
- Qure.ai‘s qER-Quant product is US FDA 510(k) cleared as an automated Radiological Image Processing Software. It is intended for automatic labeling, visualization and quantification of following segmentable brain structures from a set of Non-Contrast head CT (NCCT) images: Intracranial Hyperdensities, Lateral Ventricles and Midline Shift.
The 510(k) summary explaining qER-Quant’s performance and clinical benefits is publicly available here in FDA’s database.
- Qure.ai‘s qXR-BT is US FDA 510(k) cleared as an automated Radiological Image Processing Software. It is intended to facilitate confirmation of the position of a breathing tube and an anatomical landmark on adult chest X-rays.
The 510(k) summary explaining qXR-BT’s performance and clinical benefits is publicly available here in FDA’s database
European Economic Area (CE)
Qure.ai’s qXRv3.1 and qERv2.0 EU products are Class IIa CE-certified medical devices. The CE mark is a certification that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.
The CE class IIa marking process includes a conformity assessment carried out by a European Notified Body (review of the technical file and clinical evidence supporting the device) and an audit of Qure.ai’s quality management system to the ISO 13485 standard.
Please contact email@example.com for information on Qure.ai’s device registrations in other countries.
Information Security and Privacy at Qure.ai
This section explains the measures that Qure.ai has implemented to secure healthcare data for our customers and partners and lays out the cybersecurity protections that make our AI products are safe for use.
Qure.ai complies with the United States Health Insurance Portability and Accountability Act by ensuring that any data is de-identified before it leaves a covered entity’s premises for cloud processing. On-premise deployments may not de-identify images, provided that data processing occurs entirely within servers that are operated and owned by the covered entity.
The EU general data protection regulation addresses questions of data security and confidentiality. It introduces measures to limit the amount of data collected, the purposes for which data is used, and the duration for which it is stored. Qure.ai is GDPR-compliant with respect to healthcare data as well as other data from users of our websites and portals. Qure.ai is audited annually by 3rd party auditors for compliance with GDPR.
ISO/IEC 27001 certified
ISO/IEC 27001 is a global information security standard requiring that an organization systematically examine information security risks, design and implement a coherent and comprehensive suite of information security controls and adopt a process to meet these needs on an ongoing basis. Qure.ai is ISO 27001 certified.
Certified Software Development Processes
Qure.ai is ISO 13485 certified. ISO 13485:2016 includes the protection of confidential data as well as the establishment and review of requirements for associated medical devices.
Qure.ai is IEC 62304 compliant. The IEC 62304 standard also provides IT security requirements.
Rigorous Cybersecurity Controls
Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. As a medical device manufacturer, Qure.ai is vigilant about identifying risks and hazards associated with our products and proactively mitigating these. Our cybersecurity team assesses vulnerabilities and threats to Qure.ai processing servers on a real-time basis and implements the appropriate control measures for both cloud servers and on-premise installations.
Cybersecurity audit reports are part of our FDA submissions and CE technical files and are evaluated by the US FDA and the European Notified Body as part of device clearance/certification.
Qure.ai also has substantial cybersecurity liability coverage, with 3rd party underwriters due diligence prior to policy issues.
Protected Data Communication
We have protected and encrypt data at every level, both at source and in transit.
- Communication (typical transfer of DICOM files) via our API and demo portal is encrypted.
- Communication with Qure.ai software deployed on-premise servers is similarly encrypted.
- Gateway servers are secured using the latest data protection technology.
- License managers are used to authenticate user credentials.
Secure Cloud Servers
Qure.ai uses cloud servers built by cloud hosting partners with the highest standards for privacy and data security (Amazon Web Services and Azure Cloud).
Transparent User Privacy Policies
Privacy policies for users of our website, demo portal, and apps are displayed to visitors who access these applications.
Please contact firstname.lastname@example.org for information on Qure.ai’s information security measures.