Is an app that provides you with a daily reminder to take a pill the same as an app that a doctor uses to calculate the correct dosage for a prescription? Obviously not, but the FDA thinks they should be regulated the same way.
Just looking at the list of Health and Fitness Apps in the iTunes store, you can see how the market for these products has exploded over the last couple of years. Many of these would be subject to FDA evaluation.
According to the Health IT Now organization, regulatory structures governing mobile apps overlap among agencies and impose a confusing array of requirements. Take for example:
- On average medical devices that require FDA evaluation are available to patients in the U.S. a full two years after they were available to patients in Europe.
- Bringing a product to market through FDA requires an additional 72 months and $75 million
- FDA requirements account for 77 percent of the cost of bringing a medical device to market.
Health IT Now also believes that the FDA is seeking to perform oversight responsibilities more appropriately undertaken by the Office of the National Coordinator for Health IT, the Federal Trade Commission, and the Federal Communications Commission. They also state that the agency is “ill equipped to perform evaluation of software products used in information storage, capture, and sharing.”
Of course there should be regulations on an app that tells you how much insulin you need, in order to ensure it is safe and accurate. While the process is lengthy, it is costly to develop, and those costs are passed down to consumers, a truly medical app should be covered by most insurances. But that free app that records your daily calorie intake would also be subject to similar regulation, and all of the sudden it wouldn’t be so free anymore. Doesn’t really make a lot of sense, does it?
This isn’t necessarily an attack on the movement, but an opportunity to share some suggestions for revision. In a letter addressed to a Deputy Director of Policy for the FDA, there were recommendations for a resolution.
“While we applaud the FDA’s efforts to develop a regulatory framework for mobile health technologies, the concerns expressed by the various stakeholders highlights the need for additional clarity and depth of detail in the Agency’s approach. We urge FDA to exercise caution to ensure that its regulatory structure does not inhibit the development and use of mobile medical apps. We believe the Agency can balance the need for patient safety and the desire to promote innovation by modifying its guidance document such that it provides a clear, predictable, and appropriately tailored regulatory framework. We request the FDA move quickly to make the modifications necessary to achieve these goals, taking into consideration comments from all stakeholders.”
The Health IT Now Coalition promotes the rapid deployment of heath information technology. Health IT will benefit patients and health care consumers while supporting health practitioners to make smart decisions about patient care while promoting efficiency. For more information, visit www.healthitnow.org