Mobile healthcare, telemedicine, telehealth, BYOD

Policy News

FDA Provides Leeway for mHealth Technology Development

By Ryan Mcaskill

It is easy to see the impact that technology companies are having on healthcare. From global giants like Apple (Apple Watch, HealthKit, ResearchKit) and Google (Google Glass, Google Fit) to countless startups that are trying to launch new apps and devices, the technology world is pushing the boundaries of what is possible.

Many of these devices, apps and services are created with the goal of improving the quality of patient care. This happens to go hand-in-hand with the goals that the Affordable Care Act and other pieces of healthcare reform legislation are creating. The popularity of of these new technologies are also helping to craft future changes to the healthcare industry, as regulating bodies try to come up with the best ways to maximize potential, while ensuring a standard.

This is something that is seen in every industry, but the problem is that technology is often evolving at a faster pace than regulation can keep up. Because of this, governing bodies are often playing catchup.

Last month, reported on the ways that the Food and Drug Administration (FDA) could regulate mobile health technology. The organization has been responsible for regulating software and hardware in healthcare since the 1980s. In recent years, the organization has released the FDASIA Health IT Report which focuses on strategies based on the premise that risk and corresponding controls should focus on health IT functionality and not the platform or product name.

In a recent interview with Bloomberg Business, Bakul Patel, who oversees regulation of consumer-focused health products at the Food and Drug Administration, spoke about the new devices coming from Apple and Silicon Valley. His most interesting statement is that the FDA will give leeway to these companies to develop without aggressive regulations.

"We are taking a very light touch, an almost hands-off approach," Patel, the FDA's associate director for digital health, said in an interview. "If you have technology that's going to motivate a person to stay healthy, that's not something we want to be engaged in."

He added that these products have a long way to go before they will require “close scrutiny” for the agency. The FDA will closely monitor these emerging technologies and step in when the moment is right.

"We have to be confident in what we are getting," Patel said. "The trajectory is there and all signals are headed that way, but by the same token the research and science should get us that confidence. It boils down to will it work or not."


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