Why FDA's role in mHealth oversight must be 'robust'

The U.S. Food and Drug Administration should be given robust oversight regarding mobile healthcare products and technology, states an article published July 24 in the New England Journal of Medicine. Such a role, authors Nathan Cortez, J.D., I. Glenn Cohen and Aaron S. Kesselheim, M.P.H. say, will not hinder innovation but may be a necessary linchpin for safe mHealth tools, devices and platforms.

The article also offers up what its authors term a radical approach--the creation of a brand-new process and postmarketing surveillance for mHealth products and software. They claim that forcing mHealth technology to fit into current FDA oversight parameters could be problematic.

Cortez (pictured) serves as associate dean for research and an associate professor of law at Southern Methodist University, while Cohen is a health law policy professor at Harvard Law School. Kesselheim is an associate physician at Brigham and Women's Hospital in Boston and an assistant professor of medicine at Harvard Medical School.

"As mHealth products become more ubiquitous and ambitious, targeted FDA oversight will help to protect the public health, sustain consumer confidence in mHealth products, and encourage high-value innovations," the authors say. "In our view, Congress must recognize that robust FDA oversight is not necessarily incompatible with innovation in the mHealth industry. In fact, the industry's long-term potential may depend on it."

In an email to FierceMobileHealthcare Cortez elaborated on his opinion.

"I do think mHealth apps are becoming more ambitious--trying to do more--and it's important for FDA to ensure that these products are relatively safe and work as claimed," Cortez told FierceMobileHealthcare. "The FDA's 510(k) process should provide some gatekeeping for new products, but that process doesn't always work well. That said, I think the agency has done a good job of identifying riskier mHealth products that should be cleared before being marketed."

The article arrives as debate regarding mHealth regulatory requirements is in full swing among healthcare organizations, federal agencies and lawmakers.

For instance, Federal Trade Commissioner Julie Brill recently said that she supports new laws for boosting healthcare data privacy and protection measures, but that her agency is not considering any new regulations. The FDA, lawmakers and mHealth advocacy groups--including the mHealth Regulatory Coalition--have long been discussing regulatory oversight. The coalition believes Congress must play an integral role in ensuring FDA guidance on mHealth apps.

Cortez and his colleagues recommend that the FDA update earlier guidance on its quality system regulations to encompass mHealth software. They also propose that Congress permit third-party validation of safeguards specific to mHealth.

"The true challenge, however, is creating a regulatory framework that encourages high-value innovation while also preventing the market from being overcome with products that are ineffective or unsafe," they say. "The FDA's premarket and postmarket authorities are essential to these goals. If Congress passes legislation, it should update the FDA's authority to better fit mHealth and preserve the FDA's discretion to address emerging risks."

For more information:
- read the NEJM article

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