Bioinformatics Integration with Biomedical Devices: Toward Smart Health Monitoring Systems - Regulatory and Ethical Considerations in Biomedical Devices

Abstract

This integrated field of bioinformatics and biomedical devices will revolutionize health monitoring such that health care, in the future, will not only be real-time, on the record, device on the person, and wireless enabled but rather personalized and predictive! This has allowed clinicians to generate, analyze and interpret enormous amounts of biological and physiological data within the human body with an unprecedented level of accuracy by merging the advanced bioinformatics tools with wearable and implantable biomedical devices. Such synergy lends itself to early disease detection, personalized treatment planning, and ongoing monitoring of health, resulting in improved patient outcomes and a greater emphasis on proactive healthcare. But the fast development of these kinds of smart health monitoring systems creates serious regulatory and ethical issues. The need for patient faith and fortifying medical standards makes it important for good ethical issues to be focused on such as: making sure of data privacy, securing informed consent and ensuring data integrity. Also, the regulatory frameworks around these technologies have to evolve, both to support innovation and to ensure safety and effectiveness. In this review article, we systematically characterize the landscape of integrated bioinformatics in biomedical devices, highlight notable technological innovations, and provide a critical overview of the regulatory and ethical permeations shaping their translational pathway. Through identification of possible opportunities and challenges, this paper intends to direct future research, policy evolution and clinical implementation strategies towards safer, more equitable and more efficient smart health monitoring/ trolling systems.