Devices

More FDA Regulation of Health Apps Needed: Study

Researchers say the FDA policy for health and wellness app regulation is ethically problematic and the agency should take much more responsibility to regulate all such apps. Writing online in the journal Bioethics, the researchers say that FDA currently does not regulate health and wellness apps that are not intended for medical use, leaving prevention of harm to consumers primarily to developers and app stores.

“We argue that FDA’s duties to prevent harm and maintain accountability to the American public require that they play a much stronger role,” the researchers write. “We also discuss concerns about efficiency and fostering innovation, and argue that while they should help shape FDA regulation of health and wellness apps, they do not justify complete absence of FDA involvement.”

The authors conclude that the new FDA Digital Health Center of Excellence “has the potential to expand their regulation of health apps without sacrificing regulatory efficiency or innovation. As it has been described, the Center will consist of experts from both FDA and private industry. The Center should ensure that accountability remains with FDA while also utilizing the skills and natural gatekeeping role that companies like Google and Apple play in society.”

The article says that while the researchers want to see FDA review expanded beyond apps explicitly intended for medical use, the authors admit they find it difficult to state with confidence where exactly an FDA expanded role should end. “Yet,” they write, “from the fact that it is difficult to say just where the expansion should end, it does not follow that there is no reasonable limit to the expansion…. One option for establishing an appropriate class of apps for review is for FDA to require developers to submit an application if they expect consumers will use their device for medical purposes, even if it is not the intended usage. FDA could also request feedback from app marketplaces on harmful apps they have identified to help inform the development of review criteria.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome