The Food and Drug Administration (FDA) plans on regulating medical apps soon. They have already proposed a series of guidelines that will be posted on Wednesday's Federal Register. Yes, the government is growing once again but this may be for the best since the health and medical apps the FDA will be targeting will be those used by medical professionals to evaluate their patients' symptoms.
The fields of medicine and technology have intertwined and are growing together at an amazing rate so it is important to know that someone is overseeing this drastic progress. When it comes to people's lives, it is doubtful that many would object to this kind of regulation.
Some of the medical apps that won't be regulated by the FDA will be those that consumers use regularly such as "apps that provide medical advice or count calories." Hopefully, everything will run smoothly and more apps will be created to save lives or at least to make the quality of patients' lives better.
© Evalynn J. Saeyang – Gather Inc. 2011
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Comments: 1
Medical apps are a small proportion of our medical devices. 50% of our medical devices and 80% of our pharmaceuticals are imported according to the FDA themselves in their report Pathway to Global Product Safety and Quality. They also said themselves that “The safety of America’s food and medical products remains under serious threat… it would take 9 years just to inspect every high-priority pharmaceutical facility alone, let alone those of lower priority.” The FDA is lacking in resources and manpower. The FDA’s budget was slashed recently by 258 million. This new set of regulations is only one instance of new regulations that are taking away resources from more important areas. This lack of resources has made the 2011 Food Safety and Modernization Act reactionary instead of preventative as the FDA will need to establish a myriad of partnerships, coalitions and improved intelligence-gathering techniques. Even then, resources will still be deployed on “data-driven risk analytics.” Hardly all-inclusive, hardly preventative. By overregulating this new field of technology and handing over monopolies to big pharma, we crush innovation. Many companies, especially small tech startups cannot afford the increased research. For example since 1968 about 41 less new pharmaceuticals have been approved each year according to the Independent Institute and even more aren’t even researched due to the costs associated.
Initially, for the first 86 years of FDA's existence, from 1906-1992the U.S. treasury department funded the FDA. In 1992 a law passed allowing pharmaceutical companies to provide funding for their own research that smaller companies could not put forth.
Once again the FDA kills growth and initiative in favor of Big Pharma.