NewPublicHealth Q&A: Joseph Kvedar on Regulation of Smartphone Apps
The Food and Drug Administration (FDA) has proposed guidelines for a small number of health-related smartphone apps the agency could oversee. The concern: medical apps that could present a risk to patients if they don’t work as intended. The FDA is proposing to regulate “medical apps,” including those that function like medical devices that diagnose, treat, cure or prevent disease. An example might be an app that turns a smartphone into an electrocardiography (ECG) machine to find out if a patient is experiencing a heart attack.
NewPublicHealth spoke with Joseph Kvedar, M.D, director of the Center for Connected Health in Boston about oversight of medical smartphone apps by the FDA.
NewPublicHealth: Are these proposed guidelines a good idea?
Dr. Kvedar: In many ways, this is good news because I think there has been a bit of a chill in the mobile health industry for some time now because people were unsure what the FDA would regulate. And a number of companies didn’t add innovations because they were worried that the mobile phone itself might become a focus for FDA regulation. So their proposal is that they will be regulating certain uses of mobile technology in healthcare. This is not a bad place to start. It’s an advisory looking for commentary, so we have the option and the opportunity to give them some of our feedback on this.
NPH: What do you think should be the guidelines for determining regulating vs. not regulating a type of app?
Dr. Kvedar: That’s a hard question. I think the FDA’s goal, and you can see it as you read through the actual advisory, is patient safety. It is going to mean a lot less free things, but if you look at the mobile health landscape now – there is very little quality control.
NPH: Could this delay introduction of new apps?
Dr. Kvedar: Sure. If you are a company that has a type of app that’s now in the proposed guidelines, this is going to cause you to stop and probably engage an attorney to give you an opinion on whether the app might be regulated. And that will absolutely delay certain products getting to the market place.
NPH: How do you think the industry will respond to regulation of at least some apps?
Dr. Kvedar: I think in the initial phases it will be viewed as a downside because most of the innovation in this space is coming from either privately-held companies or venture-funded start-ups, and they are all in a hurry, and so they will have to take a step back, take a breath, and decide what they want to do. But as it gets older, I think the industry will welcome the clarity because it just provides a rule set around which the industry can move forward.
NPH: Many health-related apps are free or cost very little. Do you think the proposed rule could raise the purchase price for some?
Dr. Kvedar: I do because the proposed rule is likely to be increased expenses for those apps that are ultimately regulated. Those costs could include the labor costs needed for the filing, the cost of the legal counsel that one needs and in some cases research to determine whether a particular app does or doesn’t fall under FDA regulation once the rules are released.