Health IT

FDA assoc director of digital health: We are taking almost hands-off approach

For all the interesting technological developments coming out of the convergence of medical devices and […]

For all the interesting technological developments coming out of the convergence of medical devices and digital health, it’s also creating a growing gray area that becomes challenging to regulate in practice. Despite that, FDA associate director of digital health Bakul Patel asserted in a Bloomberg News service interview that the regulator has no plans to get tough on wearables aimed at consumer wellness.

“We are taking a very light touch, an almost hands-off approach…If you have technology that’s going to motivate a person to stay healthy, that’s not something we want to be engaged in.”

Bloomberg focused on the launch of the imminent launch of the Apple watch in reference to wearables. Although it possesses few healthcare applications in its initial version, future versions will work with Healthkit and ResearchKit — an open source platform that will develop apps with hospitals used for research on Parkinsons’s disease, asthma, cardiovascular disease, diabetes and breast cancer.

But Patel did caution that it’s important for companies like Apple to evaluate applications so make sure developers aren’t overpromising product benefits.

Apps that grabbed the attention of the Federal Trade Commission last month claimed in their marketing pitch to help users identify skin discolorations that could be cancerous without backing up those claims with scientific proof.

But the line between what’s a medical device that requires scrutiny and what’s a consumer facing health and wellness tool beyond the interest of regulatory oversight aren’t totally clear in practice because regulation seems patchy. More transparency on enforcement of its rules on digital health and how the FDA and FTC work together on these issues could reinforce confidence in the regulators’ approach.

Rock Heath managing director Malay Gandhi expressed concern in the article about companies the regulators aren’t targeting.

“I worry that there are going to be companies that are skirting the rules,” Gandhi said. “We have to see the enforcement, otherwise it creates a very uneven playing field between companies that are acting ethically and those that aren’t.”

[Photo credit: Police tape Caution from Flickr user Picture Perfect Pose]

Shares0
Shares0