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Should They Be Regulated?



Patients today can download more than 40,000 mobile apps that offer health, fitness, and medical information-some of which (whether specific to oncology or not) could be solutions to improving patient care and cutting health care costs. How do you (as clinician) decide which ones to use? Or, perhaps the question should be, how do you (as clinician or as patient) decide which ones to trust?


Adam Landman, MD, Chief Medical Information Officer for Health Information Innovation and Integration and an emergency medicine physician at Brigham and Women's Hospital BWH, and two colleagues tackled the topic in a recent Viewpoint article in the Journal of the American Medical Association (doi:10.1001/jama.2014.2564). And, in an interview with OT for our new "3 Questions on[horizontal ellipsis]" blog (, Landman explained further what oncologists should know.

ADAM LANDMAN, MD. AD... - Click to enlarge in new windowADAM LANDMAN, MD. ADAM LANDMAN, MD

Some mHealth apps are currently regulated-which ones?

"The FDA recently released a document that provides guidance on mobile health apps ( The position they're taking is that apps that act as either a medical device or an accessory to a medical device will need to obtain FDA approval.


"What does that mean? If you have a sensor or a phone that's acting as a thermometer, or as a blood pressure monitor, those would need to go through an FDA clearance or FDA approval process. Other apps-the ones that track events, retrieve medical content, or allow patient and medical providers to communicate-would not necessarily need to go through the FDA approval process."


So, do you think the FDA should have more regulatory authority over these apps?

"No, we're not pushing for additional FDA regulations. [horizontal ellipsis] But, we as health care providers need a trusted source for information on mHealth apps. We're looking for something similar to a nutrition label on a food product. That nutrition label looks the same on every food item, so you can get a clear, independent, and accurate review of the content of what's in that food.


"We need something like a nutrition fact label or food label for mobile health apps. We want physicians and patients to be able to look at an app and understand where the content is coming from. Is it JAMA content that's been peer-reviewed? Or is it content coming from someone who might not be a board-certified clinician? What's the source of that information? What's the credibility and validity of it?


"There are lots of models for how this might get done. One is having non-profit, non-governmental organizations play a role in evaluating the quality of mobile health apps. If you look at the Health on the Net Foundation (HON Foundation,, they play this role for websites. We might even want to set recommendations-such as consensus recommendations from a multidisciplinary group-for appropriate privacy and security settings for mHealth apps, and for content. How does the content get verified? What is that process?"


What can health care providers do now?

"We need more involvement from health care providers to develop the uses for these apps and to help design solutions that meet their needs and workflow-and even to develop content for the apps. We need to pay attention to making trusted sources of information available on these apps.


"And more importantly, we need robust evidence for the impact and effectiveness of mHealth interventions. Those are two areas where oncologists and oncology nurses could play two roles: in app development and evaluation."


Sorting Out the Options



Despite the proliferation of mobile medical apps, many physicians have been slow to prescribe them to patients, and the slow pace is particularly notable among oncologists. So said Graham Colditz, MD, DrPH, Associate Director of Prevention & Control at the Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis. "At the moment we aren't seeing as much use in oncology," he said in an interview.


But the growing popularity of medical apps, coupled with increased demand from consumers, may soon change that, noted Robert Miller, MD, Oncology Medical Information Officer at Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and Editor-in-Chief of Cancer.Net, the American Society of Clinical Oncology's patient site.


Moreover, the growing use of mobile medical apps by patients will ultimately have an impact on how oncologists use or prescribe the apps, he said: "Fifty-six percent of U.S. adults have smart phones and 19 percent of them use medical apps. We should recognize that patients more and more will be using medical apps."

ROBERT MILLER, MD. R... - Click to enlarge in new windowROBERT MILLER, MD. ROBERT MILLER, MD

Don Dizon, MD, Director of the Oncology Sexual Health Clinic at Massachusetts General Hospital Cancer Center, said the slow pace in adopting mobile medical apps is also due in part to the rapidly rising role of electronic health records (EHRs) and the fact that most oncologists currently do the bulk of their work on PCs rather than on tablets or smartphones.


In addition, he said, the nature of the disease-vast, complex, and with scores of subcategories-makes it more challenging for developers to build IT solutions like cancer apps tailored to specific types of cancer, unlike ailments such as diabetes, high blood pressure, or heart disease.

DON DIZON, MD. DON D... - Click to enlarge in new windowDON DIZON, MD. DON DIZON, MD

Colditz, who two years ago developed a health tracker mobile app called Zuum, which is designed to make it possible to do self-assessments of risks for six common diseases, agreed, saying that the variations of different treatment measures for each form of cancer has likely contributed to the fragmentation of the market for oncology mobile apps.


In addition, the ongoing transition to EHR has replaced the need for many of these mobile apps for physicians, placing many of the clinical tools at their fingertips, Dizon noted.


But Miller said the opposite is true for consumers, and patients will increasingly be looking to their oncologists for guidance. "We are a society that has embraced mobile technology, and patients will likely lead the way. Physicians are interested in technology, but right now their attention is being pulled in several different ways. They have EHRs, and the idea that they would need a secondary app is not that appealing to most doctors."


Miller noted that many of the consumer-targeted medical mobile apps on the market have to do with diet, fitness, and exercise. Such apps could be an important part of an oncologist's arsenal for helping patients fight cancer: "As oncologists we need to be more supportive of patients when they're trying to lose weight and exercise more," he said.