MDLIVE Health Coaching (the software) is Software as a Medical Device (SaMD) intended to be used by individuals – aged 18 years and older – who have hypertension (high blood pressure), who have prediabetes, who enroll in the weight management program, or who enroll in the mental well-being program. The software is intended to help people with hypertension or prediabetes, or enrolled in weight management or mental well-being programs manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to provider-assisted treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates electronic reports intended for a healthcare provider. The software provides secure transfer, storage, and secondary display of data from devices such as blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. The software provides educational content to encourage behaviors that may help living well with hypertension, prediabetes, managing weight, or managing mental well-being, 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 replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
An individual software program or group of programs, routines and/or algorithms, that are used together with a mobile phone (cell phone) or other communication device to function as a medication reminder. It is intended for medical purposes to provide alerts to patients and healthcare providers for predetermined medication dosing schedules. It may also enable the delivery of information about medications, such as indications for use, dosing, side effects, and even photographs of different pills.
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