Medicine in the Dark Ages, Part 2. Smartphone Apps Must be FDA-Approved!

It sounds absurd, but FDA wants to pre-approve simple medical apps—making them impossibly expensive.

Cell phone health apps are a growing industry, as more and more people use them to take ownership over their own health. They could even be the next big thing in the health revolution. Thousands of medical apps are now flooding the market, and they’re doing some amazing things—everything from counting calories or calculating your body mass index to measuring your blood pressure and blood sugar levels and, if desired, sending the readings to your doctor.
Between one-third and one-half of adults in America consult health-related blogs and social networks, visit health product ratings websites, or use health apps. The medical app market is projected to grow 25% annually—more than many other segments of the app market.
But now FDA wants to regulate (i.e., stifle) medical apps. Guidelines, allegedly requested by Congress but really sought by the agency, are expected by the end of the year. Whatever the guidelines say, we already know that:

• Having to get FDA approval will not only inflate price of individual apps, it will also delay the development of new and potentially crucial apps by months or even years.
• FDA doesn’t have the technical expertise to regulate mobile phone apps in the first place. Joel White, executive director of Health IT Now Coalition, puts it this way: “The issue here is that they’re really using a process for approval of these mobile apps that was basically created when the 5¼” floppy disk was the latest technology.”
• Pre-approval interferes with consumers’ ability to become educated about and take a proactive part in their own health, freezing health technology in the “dark ages.”
• Given the FDA’s bias against alternative medicine, a pre-approval process for apps will very likely ensure that we won’t see many that are focused on natural health. An app, for example, that measures daily recommended intake for vitamins and minerals would adhere to the standards of conventional medicine (such as the ultra-low vitamin D recommendations from the IOM report) rather than the nutrient standards recommended by integrative physicians.
• FDA could very easily violate First Amendment freedom of speech rights by predetermining what is and is not suitable for viewing. For example, if an app were to cite peer-reviewed science on the benefit of a nutritional supplement for a disease, the FDA will likely, given their track record with food companies, use that citation as the basis for denying approval. We are concerned this may open the door for FDA to regulate online forums and blogs where people share their clinical experiences.
• New and small businesses that do not have the finances necessary to weather an FDA approval process will be disproportionately hurt.

We will update you once HHS finishes its work and presents its recommendations to Congress at the end of the year. Enjoy your freedom while you can.