Patient perspective
- Provide patient confidential access to a precise ovulation induction algorithm using the OIOL software algorithm via a Smart phone application (OVUNET App).
- Provide an assessment of patient health status utilizing automated responses to patient questionnaire items, external reports of ultrasound findings and relevant blood investigations to determine safety and appropriateness of utilization of the OVUNET System.
- Provide instruction to the patient regarding the need and timing of required telehealth consultations.
- Provide, within limitations, based on entered patient demographics and clinical data, a customized ovulation induction treatment regimen via the Smart phone App.
- Provide real time based direction to the patient regarding medication usage and the undertaking of investigations during the ovulation induction treatment regimen, and mapping of compliance with the regimen.
- Provide treatment summary to the patient via email following each treatment cycle.
- Provide, if required, a revised treatment regimen in a subsequent treatment episode to improve or enhance the patient’s response to the directed treatment regimen.
- Provide the option of telemedicine follow up with the OIOL clinical staff during or following treatment regimens.
Clinician perspective
- Provide notification to the clinician regarding planned use of the OVUNET App by patient.
- Provide notification to the clinician regarding patient completion of investigation requests, compliance and non-compliance with treatment regimens.
- Provide instruction to clinicians regarding need to enter investigation data into the OIOL algorithm.
- Provide options for the clinician to consider regarding prescription of medications to patients.
- Provide Internal audit data to allow for review of the OVUNET System performance across clinical and technical areas.
- Provide notification to Clinician of request by the patient for telemedicine consultation.
- Provide correspondence to the patient’s treating General Practitioner regarding her use of the OIOL Algorithm.
- Provide opportunity for appropriately qualified Specialists to purchase and provide OVUNET treatment vouchers to patients.
OVUNET has been designed and maintained in reference to the following Standards:
ARGMD - Australian Regulatory guidelines for medical devices
ISO 13485 - Medical devices- Quality Management Systems-requirements for regulatory purposes
ISO 14971 - Medical devices-Application of risk management to medical devices
IEC62304 - Medical device software- software lifecycle processes
The App, Website and related software are defined as Clinical Decision Support Software, and are notified to the Therapeutic Goods Administration. Ovunet is exempt from TGA regulation.
OVUNET is managed by a bespoke Quality Management System, exclusively designed in reference to ISO 13485.
OIOL follows Good Medical Practice Principals.
Ovunet Software and all intellectual rights are protected by copyright by its Owners.
