Mobile technology

Should medical smartphone applications be regulated?

By Rosie Lombardi

More than 1,500 medical smartphone applications designed specifically for use by healthcare professionals have been developed, and many more are being created. Despite the profession’s technophobic reputation, uptake of smartphones by physicians has been enthusiastic because so many useful apps are available. But concern is growing about the quality of these applications.

In the United States, the FDA is considering whether medical apps should be regulated to some degree or left to develop unfettered, according to Scientific American magazine. Adverse events resulting from medical applications and other health information technology have been reported to the agency. In one instance, allergy information for a patient failed to display on a clinical decision support app due to a programming error, and in another, results of a nuclear medicine study were saved in the wrong patient’s file when accessed using healthcare management software.

“Potentially anybody and everybody can develop a medical application. So it’s caveat emptor, as there are no standards in place,” says Dr. Mark Otto Baerlocher (pictured), Toronto-based co-developer of the Radiation Passport, an iPhone app that tracks radiation exposure levels in diagnostic testing.

Apple does retain some control over apps developed for its iPhone, says Baerlocher. For a fee, Apple provides a software development kit to create their apps, but reserves the right to approve or decline them once they’re developed.

“This process is to ensure that the apps are working properly and don’t crash. But in terms of ensuring that the information contained within medical apps is accurate, there is more variability – developers are ultimately responsible for ensuring the accuracy of their own apps,” he says.

The content development process for many smart phone medical apps is very similar to the one in place for printed material, says Dr. Peter Hudson, Colorado-based developer of iTriage, an iPhone and Android application that provides healthcare consumers with actionable information in acute-care settings.

The content for iTriage was developed by ER physicians and included feedback from nurses and other healthcare professionals, has been reviewed by specialists for each illness category and the final review was conducted by a public health expert, says Hudson.

“I don’t think there’s anything unique per se about content development, be it deployed to smartphones, web or literature,” he says.

Smartphone apps may be new terrain, but physicians should approach them with the same due diligence they use to evaluate other medical information, says Baerlocher.

“Evaluating an app is analogous to what physicians must do with medical research –  they must be able to evaluate various papers for validity, reliability, and accuracy. They need to look into the background and credibility of the developers, and try to find credible reviews of the app.”

Baerlocher says websites offering reviews of new apps by tech-savvy physicians are springing up to assist other physicians. iMedicalapps.com is one that is gaining prominence, and has several young physicians on its panel of reviewers.

Hudson doesn’t believe regulation by government entities is warranted or even possible. “The FDA would have to regulate everything from Dr. Spock’s handbook to medical textbooks. All of them have the same path to content generation that we used.”

Baerlocher agrees. “It would stifle innovation in this emerging and very useful area, as it would add delays and costs to medical app development.”

However, apps that actually track a patient’s physiological data are in a different category and do need some oversight, depending on how they’re used, says Hudson.

“I have a watch that tells me what my heart rate is when I ride my bike up the mountain. There are useful consumer tools like this out there, but the difference is that I’m not being prescribed hypertension medication or a regimen based on that data. If that type of data is communicated and used in critical decision-making by people who can prescribe treatments, that’s when you cross the threshold, in my opinion.”

Posted June 24, 2010