Systems, devices and methods are disclosed for a prescription-regulated software application and an associated medical device. In some aspects, a smart medicine-injection device (e.g., smart insulin pen) is configured to be in communication with a patient's companion device (e.g., smartphone) having a software application (prescription app) that serves the patient as a complimentary medical device to the smart medicine-injection device, in which only certain features and functionalities of the prescription app are fully operable based on device pairing with the smart medicine-injection device to unlock medical device capabilities only available to the patient through prescription.