3 Questions on…

Answers straight from the experts on the latest news and topics in oncology

Wednesday, April 16, 2014

3 Questions on… Why (and How) to Regulate Mobile Health Apps
With ADAM LANDMAN, MD, of Brigham and Women’s Hospital


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 BWH, and two colleagues tackle the topic in a recent JAMA Viewpoint article (doi:10.1001/jama.2014.2564). And, in an interview with OT, Landman shares more on what oncologists should know.


1. 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 either act as a medical device or as 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.”


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


“No, we’re not pushing for additional FDA regulations. … But, we as healthcare 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?”


3. 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.”