[intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals...]: Medical Device Definition
The Food and Drug Administration (FDA) recently approved a radiology application for Apple’s mobile devices. The software application is made by MIM Software and is marketed by the company as a mobile diagnostic tool. And, therefore, it required FDA approval. This first approval is a small step and a giant leap in the right direction for the health care market in a country where standards evolve through competition in the marketplace rather than through the diktat of the government, though a Worldwide Web Consortium (W3C) or National Institute of Standards and Technology (NIST) approach of public-private stakeholder standards making can considerably benefit the process.
The health care industry, in its adoption of information technology, requires the development of standards for electronic health records (or EHR) and for extending the provisions of the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) to the new world of health care information technology or health IT, besides, of course, the potential for cross-border provisioning of health services.
It is not yet clear, however, if the evolution of standards can reduce health care costs, despite the potentially large economies of scale because of the persistent market inertias introduced by the health care industry interest groups. Therefore, it seems as though the purpose of mobile or mHealth is lost on the health care industry.