Ch 19 Managing Medical Devices within a Regulatory Framework

What is it about?

The impact of digital technology platforms to deliver health information and their efficacy to produce positive patient results also comes with the challenge of incorporating innovative solutions driven by consumers into the overall health system. However, the growing commercial success of mobile health application does not guarantee positive clinical outcomes if content are not based on scientific evidence, analyzed with statistical methods, or have some medical value for physician use that can be applied to decision-making for patient evaluation, diagnosis, rehabilitation, pharmaceutical recommendations or other treatment options. Therefore, this document provides information on digital health regulation and the impact of digital technology on the internal and external Health Information Technology environment.

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Why is it important?

The objective is to prompt the development of policy and procedures that streamline patient information despite existing obstacles inherent in managing digital technology and their software.