What’s missing from many health apps — medical expertise
■ The lead researcher of a study says apps have potential for improving pain management, but stricter oversight is needed. The FDA is considering some regulations.
By Pamela Lewis Dolan — Posted May 13, 2013
Many smartphone apps on the market offer tips, advice and treatments on how to deal with pain. But many are not backed by science or created with input from a medical professional.
This was the finding of a team of researchers from Ohio State University led by Lorraine Wallace, PhD, that analyzed 222 pain-related smartphone apps available for Android, iPhone and Blackberry devices. Of the apps that researchers reviewed, a third had no input from a health care professional. For another third, it couldn’t be determined whether there was professional input. Twenty-seven percent of the apps had obvious input from an MD or DO, and 8% had input from a nonphysician health care professional.
The health-related smartphone app market has exploded, with estimates ranging from 17,000 to more than 40,000 apps available. The problem with tracking an exact number of apps, as well as monitoring them, is that apps come and go quickly. New apps are launched daily, while others are taken off the market. This makes it nearly impossible for physicians to know which apps their patients are using, or whether they were developed by reliable sources. This is one reason the call for better monitoring of health-related apps has grown in recent months.
The Ohio State study, which has not yet been published, was modeled after one conducted in the United Kingdom in 2011 that examined 111 pain-related apps. Wallace said the British study found that most of the evaluated apps “had no real evidence of health care input, or sketchy information was provided.”
When she started her evaluation in the summer of 2012, Wallace found that not much had changed. She said the findings mirrored other studies that looked at health-related apps in general in finding a lack of input from the medical community.
Wallace, an associate professor at Ohio State University College of Medicine’s Dept. of Family Medicine, presented her findings at the annual meeting of the American Academy of Pain Medicine in April. Newly elected AAPM President Lynn Webster, MD, speaking to American Medical News after the meeting, said he sees mobile medicine playing a role in improving communication between physicians and patients, which would result in better pain management, with mobile apps being used as an alternative treatment option.
Dr. Webster said it’s therapeutic when patients feel they have access to their physicians. Mobile apps “appear to offer us a connection with patients that we never had before,” he said. He said real-time information and feedback could allow physicians to modify treatments much more easily.
Efforts to get more oversight
Wallace agrees that smartphone apps have great potential for improving pain management, but she said better oversight is needed. She said she did not do an in-depth review of each app to determine quality of the content, but the potential is there for an app to offer advice that might not be medically appropriate. For example, exercise is a common coping mechanism for pain that might be dangerous for some patients.
There have been efforts to get the Federal Drug Administration involved in app oversight. The agency has indicated that it is mostly concerned with clinical monitoring systems with a mobile component, but it has not published final guidance on how it will regulate the app market. Some app developers have sought FDA approval voluntarily. The agency has reviewed more than 100 apps that fall under the medical device definition. It has not said whether it has taken enforcement action against those that did not seek FDA approval.
The apps Wallace reviewed ran the gamut of pain diaries to therapeutic advice for pain sufferers. Although it seems clear the FDA would not regulate a pain diary app, it’s less clear if it would review apps that offered medical advice.
The National Institutes of Health is working to build an interdisciplinary team to study risks and benefits of mobile apps, according to an article by NIH Director Francis Collins, MD, in the July 2012 issue of Scientific American. “Mobile devices offer remarkably attractive, low-cost, real-time ways to assess disease, movement, images, behavior, social interactions, environmental toxins, metabolites and a host of other physiological variables,” wrote Dr. Collins. But “health researchers, technology developers and software designers must pull together to find ways of evaluating new technologies.”
Wallace said input from the medical community is crucial for a pain-related app, but it doesn’t guarantee that the app will be useful. She said patients must be involved in the evaluation process to determine if the apps are understandable and easy to use.
In the private sector, an app certification program was launched by Happtique, a mobile health application store. The group evaluates apps and makes them available to physicians to recommend to patients. The group developed standards for app developers that include guidelines on content, operability, privacy and security. The standards were developed with input from a variety of organizations, including patient advocacy, government, research and health care groups, such as the American Medical Association. The standards were used to launch a certification program in February.
Dr. Webster said the AAPM might be willing to take on the role of gatekeeper.
“Anything that can help physicians do a better job of treating their patients and patients receiving excellent care is something we would be interested in,” he said.
“The field of pain medicine is an interdisciplinary field, and I think that to employ other treatment modalities outside of medications or procedures is something we’re very much interested in,” he added. “And, personally, I am going to be looking into how the apps can be utilized and whether or not we should have some kind of review process of what makes sense, and what’s practical, and what the science says about them.”