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New regulations needed for growth of mobile medical technologies

By JOEL WHITE, UPI Outside View Commentator   |   April 1, 2013 at 12:12 AM   |   Comments

ALEXANDRIA, Va., April 1 (UPI) -- As the U.S. deficit continues to rise and the sequester cuts take effect, it is time that U.S. lawmakers consider all areas of spending for cost-cutting solutions.

Luckily, when it comes to healthcare, technologies that reduce costs and expand the accessibility of services is already available. But to take full advantage of these benefits, there needs to be a change in the regulatory policies that foster the growth of the mobile medical industry.

The U.S. House Energy and Commerce Committee, with jurisdiction over health technologies and their regulators, recently had a series of hearings on how a framework might be constructed to advance both patient safety and innovation. This came on the heels of a letter from the committee to the Food and Drug Administration asking why the agency has yet to finalize a draft memo on how the federal government might regulate mobile medical apps and the devices that power them.

An important question raised in the committee letter is: If mobile apps are medical devices as the FDA suggests, would they be subject to the device tax included in President Obama's signature health reform law?

In the letter, the congressmen wrote: "The popularity of mobile medical applications reflects the desire of many Americans to use technology to actively engage in their own health. The abilities of smartphones and wireless devices to perform complex health and medical functions are increasing and the use of mobile medical applications is becoming more common."

Estimates indicate that the number of smartphone consumers using mobile medical apps will grow to 500 million by 2015. The popular demand for these applications highlights a market driven explosion in the use of health information technology in ways that enhance care outcomes, promote self-management, improve safety, and lower health costs. Consumers and healthcare providers want to be engaged in improving health and well-being, and ensuring the best, most attentive care possible.

There is the valid concern that mobile medical applications could pose patient safety risks and that they should be subject to strict consumer protections. I agree, but I disagree that the FDA is the best agency to protect consumers.

Right now, in Medicare and Medicaid, physicians, hospitals and other healthcare providers, are using technologies not certified by FDA but that are being used to more effectively and efficiently deliver care to patients.

These technologies are certified by private entities that have been accredited by independent bodies. They are experts at testing and developing software and ensure the products do what they say they can do.

Conversely, FDA likely doesn't have the in-house expertise to test and certify medical software. In a request for proposal last year, FDA solicited experts with expertise in this field.

In addition, and considering the time it takes FDA to review and approve a product, why wouldn't we adopt a model that relies on the experts to speed consumer products to market? I am concerned the increased cost and time associated with the FDA approval process would likely impede creation and use of mobile apps altogether, resulting in a loss for patients and healthcare providers.

To improve patient safety and to promote innovation, we should realize that the benefits of a new regulatory framework for health information technology and particularly mobile medical applications, far outweigh the dangers of slow, inconsistent and costly federal guidelines. This will require bold congressional action. But we, as consumers, should demand law makers act decisively.

Mobile medical applications offer one of the most effective avenues for the distribution of innovative health resources. The use of these technologies is already saving lives and improving the quality of life for millions of patients and has the ability to have an even bigger impact in the near future.

We have the right technologies; now all we need is for our lawmakers to strike the right regulatory balance.

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(Joel White is executive director of the Health IT Now Coalition.)

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(United Press International's "Outside View" commentaries are written by outside contributors who specialize in a variety of important issues. The views expressed do not necessarily reflect those of United Press International. In the interests of creating an open forum, original submissions are invited.)

© 2013 United Press International, Inc. All Rights Reserved. Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI's prior written consent.
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