In Australia and the US, those who make medical apps are about to feel the effects of game-changing regulations. The Therapeutic Goods Administration (TGA) and the US Food and Drug Administration (FDA) recently released separate sets of guidelines concerning mobile medical and health apps, recommending that many be subject to an approval process.
There are plenty of health-based apps on the market that measure such things as heart rate, blood pressure, blood sugar and amount of calories burned in a day. Apps that simply provide measurements are categorised as “low risk” and likely to continue without more regulation in both countries.
The apps being targeted by the new regulations are those that diagnose or treat illness, injury or disease or those that engage in “prevention, monitoring, treatment or alleviation of disease.” For example, an app that creates an electronic health record would be low risk, while one that instructs you to take a certain dose of a certain drug would be deemed to require regulation.
How Regulation Can Benefit App Developers
We see both positives and negatives for app developers. The main benefit is that regulation should provide much needed clarity to the app market. Previously, there were no guidelines for medical apps, which resulted in a lot of guesswork and possibly a few inappropriate apps hitting the market.
Another problem with having no real guidelines is that it can often steer investors away from apps that may or may not be outlawed in the future. It can be hard enough to find investors sometimes without the looming spectre of an app being quashed before it ever gets to market. Developers of apps that will be classified as “low risk” will have an easier time getting investors.
For those apps that will be subject to approval, though, there is still too much “gray area.” For example, medical software that just collates information wouldn’t be subject to regulation, but what about those that generate alerts or probability ratings based on that information? If an app, for example, alerted users that a certain set of measurements predisposed one toward a condition such as diabetes, it may then be subject to regulation, especially if an incorrect decision based on the alert represents a risk to patients.
Sometimes, the amount of risk represented by an app is dependent upon the context in which it is utilised. For example, a heart rate monitor for exercise would not require regulation, while the same monitor would require regulation if used to manage exertion in an exercise program for cardiac patients or to monitor anomalies in the heartbeat.
Another risk determinant will be whether the app is being used by consumers to self-diagnose or by qualified medical professionals. Apps can be made for medical professionals to manage treatment of various diseases and conditions and can tell doctors or patients when to decrease or increase dosage of medication.
All in all, we think a good set of firm guidelines will be beneficial to app developers and to the public.
The biggest potential problem we see happening is for regulatory agencies to be overwhelmed by the sheer number of apps on the market. There are approximately 750,000 medical apps on Google Play and 900,000 at the Apple App Store.
Imagine the paperwork nightmare as government agencies in Australia and the US scramble to investigate over a million apps. Obviously, they won’t all need regulation but the situation could bring the medical apps industry to a screeching halt and deny opportunity to both app developers and consumers alike to benefit from medical apps.
Medical Apps: the Diagnosis
We would be negligent if we didn’t caution app builders and developers to be very leery of medical apps until the governments of both countries have had an opportunity to develop their regulation and approval systems. That being said, there is still plenty of room for apps that won’t fall in the classification of “high risk” to consumers.
Apps that measure sport performance or track exercise are still OK and there will always be a market for them if they are created, developed and marketed correctly. It’s the same formula we recommend over and over: find a problem or need and develop a niche product for that need. As long as your app isn’t “playing doctor,” you should be able to steer clear of government regulation.
However, we recommend making sure that your app does not fall into any “gray areas” before the development stage.
If You Are Ready…
If you have an idea for an Android or iOS mobile app and would like to talk to us about development, call us: 1300 650 253.