Security Aspects
In considering that mobile products incorporating clinical-decision support, there is a strong need of FDA supervision in order to protect the public health, sustain consumer confidence in mHealth products and encourage appropriate control.
Majority of mHealth Products are safe to use but some evidences indicates through independent evaluation that some apps do not works as claimed or they make mistakes. In 2012, Sanofi Aventis recalled its diabetes app because it was miscalculating insulin doses, which might lead to dangerously low or high blood glucose levels in diabetics.
The FDA’s true challenge is creating an administrative framework in order to prevent the market from being overloaded with products that are ineffective or unsafe with in house technical proficiency to supervise proceeding chain of mHealth products by approval fee for mHealth products like user fees for drugs; to achieve its attempt, the FDA may need to dedicate a center or office to control mobile applications and other software devices (Hamel, Cortez, Cohen, and Kesselheim, 2014, p.379). As mHealth products become more global and ambitious, FDA supervision will aid to preserve the public health, support user’s confidence in mHealth products, and encourage high-value innovations.
Ethical and social aspects
As it seems, smartphone applications have positive effects in our health life but they might have some ethical issues for elderly people who doesn’t have a technical knowledge to work with new technologies or even people who can’t afford to have one.