Resonance Health provides FerriScan®, Cardiac T2* and HepaFat-Scan® via a unique service model. All patient MRI data is securely transferred to Resonance Health’s central Service Centre where it is analysed by our team of experts and a patient report is returned.
A patient requiring a FerriScan, Cardiac T2* or HepaFat Scan is referred to a previously approved Radiology Centre for an MRI scan. The Radiology Centre transmits the data to Resonance Health, via our secure data transfer system; FAST. The raw data undergoes a series of quality control checks and once deemed suitable, is analysed. A series of quality control and quality assurance checks are performed on the results and a report is made available for download by the Radiology Centre within a target turnaround time of two business days.
Our service model, utilising a central Service Centre with a team of experienced analysts, allows vigilant Quality Control and Quality Assurance measures to be performed for each and every analysis. As such, Resonance Health can assure the reliability and reproducibility of our results in accordance with our certified and regulatory cleared quality management system.
Quality Certification and Regulatory Clearance
Resonance Health Analysis Services has a company-wide commitment to quality management, and it is the responsibility of every employee, in every activity.
Our regulatory clearances, together with our quality commitment and certification, provide our customers with the confidence they demand from a medical service.
All aspects of our service provision are performed in accordance with our certified quality management system. From the recruitment and training of staff, to the receival of data and the quality control checking of results, documented procedures are followed and records retained.
A primary focus of the company is the continual improvement of the quality management system and the service we provide, through monitoring and actioning of customer feedback, internal audits, and a corrective and preventative action system.
Our quality management system is certified to the following international standard:
- ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.
In addition to this quality management system certification, Resonance Health Analysis Services has regulatory clearance to market the FerriScan and HepaFat-Scan analysis services worldwide, with the following regulatory clearances:
- Australia (Therapeutic Goods Administration - TGA)
- United States of America (Food and Drug Administration - FDA)
- Europe (CE Mark)
While Resonance Health maintains international regulatory clearances from the FDA, TGA and CE Mark, it is the responsibility of the customer to ensure that any services contracted comply with the regulatory requirements specific to their country.
Resonance Health has undertaken extensive measures to ensure the security of patient data. The measures include data and internet security, staff training, de-identification of patient data, quality control procedures, physical security systems within the Service Centre, and adherence to:
- Medical Technology Association of Australia (MTAA) Code of Practice
- AdvaMed – Advanced Medical Technology Association (USA) Code of Ethics
Resonance Health utilises its proprietary secure web-based system (FAST) for data upload, tracking, and result download. All data transfer to and from the FAST system is secured. Access to the system is restricted to authorised personnel by unique login IDs and passwords.
Resonance Health's infrastructure is compliant with:
- Health Insurance Portability and Accountability Act (HIPAA) (USA)
- Health Information Technology for Economic and Clinical Health (HITECH) Act (USA)
- Data Protection Act (UK)
- Australian Privacy Act 1988
Resonance Health is also a registered data controller in the UK registered with the Information Commissioner’s Office.
The FAST server is co-located in a professional high security hosting facility with maximum bandwidth broadband internet, dual PIX firewall for security, offsite backups, redundant power supply and 24x7 network support.