The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCP) and their patients – aged 18 years and older – who haveprediabetes, diabetes, heart failure, high blood pressure, liver disease, kidney disease, and/or sleep apnea. The Welldoc App also supports weight management and mental wellbeing.The patient software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a HCP. The software also generates electronic reports intended for a HCP.The web-based HCP software allows HCPs to view patient health data and communicate directly with their patients.The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, bloodpressure monitors, activity trackers, and weight scales as well as self-reported health information. The software also performs retrospective analysis of CGM data which maybe used by people with diabetes and their HCP when determining therapeutic strategies.The software provides educational content to encourage behaviors which may help living well with cardiometabolic conditions based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity.The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replaceself-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
An application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.
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