Mobile medical apps and hardware add-ons present a golden opportunity to make modern medicine more accessible, effective, and affordable. In fact, this could be our best chance to retool healthcare. But to make the most of it, we must ensure that entrepreneurs are free to innovate and that physicians and patients enjoy the widest choice of apps.

The FDA’s plan to regulate medical apps will only discourage investment and limit choices. By burdening developers with confusing rules and bureaucratic procedures, the FDA will drive up costs, add delays, and prevent potentially game changing products from getting off the launch pad.

Wireless gadgets offer the mobility and low price points that up to now have been sorely lacking in healthcare technology. They also lower the entry barriers for entrepreneurs with fresh ideas. Smartphones and tablet computers are relatively inexpensive platforms that come loaded with processing power, memory, and connectivity and feature developer friendly operating systems. The huge installed base of wireless gadgets offers a ready market, and online app stores provide convenient distribution. If the FDA leaves developers free to experiment, then we will surely witness an explosion of innovative, money saving products and services.

Dinosaur attitudes
Government agencies are often last to understand new technologies. When the FDA looks at wireless devices, it sees yesterday’s medical products repackaged to evade its oversight. This defensive attitude was on display in the FDA’s 2011 press release announcing draft guidelines for medical apps. The FDA emphasized that it is seeking to regulate only the “small subset of mobile medical apps” that work with devices that are already regulated or that transform wireless gadgets into devices that are already regulated. So what’s all of the fuss about?

Actually, medical apps and hardware add-ons are not the same old products in new packages. They are new tools with unique benefits. Consider Mobisante, a developer of smartphone and tablet based ultrasound imaging systems. These systems sell for a fraction of the price of the ultrasound machines found in large hospitals. Mobisante’s products are not intended to replace the high end machines. They are designed to extend the benefits of ultrasound imaging to locations such as small clinics and field hospitals.

FDA regulations create unnecessary obstacle courses for anyone bringing new medical devices to market. MIM Software introduced an app that displays diagnostic images on the iPhone in 2008 but was forced by the FDA to pull it from the market. After more than two years, including studies of the app’s performance under different lighting conditions, the company was finally granted approval. But the FDA stipulated that the app should be used “only when there is no access to a workstation.” Apparently, the FDA does not trust the judgment of trained medical professionals. But what makes FDA staff so much smarter?

Even supporters of medical app regulations urge the FDA to quit stalling and publish its final guidelines. The mHealth Regulatory Coalition, which speaks for some developers of mobile health technology, warns that uncertainty discourages investment. It should also question the propriety of a government agency putting products through the wringer when it still hasn’t told developers the rules. The coalition claims that medical app regulations are “deregulatory” because the FDA could have regulated even more types of health apps. That’s like politicians who call a smaller increase in this year’s national budget a “cutback.” No matter how it’s spun, regulating medical apps expands the FDA’s empire.

Too much power
The FDA is already too powerful. Most reasonable people agree that drugs and implants should be regulated because these products pose safety risks to ordinary consumers. But medical apps aren’t ingested or implanted and are typically used by tech savvy professionals and early adopters. Requiring FDA approval defeats two key benefits of medical apps: quick time to market and the ability to fix bugs and add features in a timely manner via downloadable updates.

The FDA was established to ensure safety but through mission creep has acquired the authority to judge effectiveness. However, we’ve learnt that specific drugs can be effective for specific people, so it’s counterproductive to evaluate drugs based on overall effectiveness. It makes even less sense to assess the effectiveness of medical apps because they are new and rapidly evolving.

FDA regulations favor large corporations over start-ups. Small developers often lack the resources and experience needed to win FDA approval. Big corporations engaged in multiple development efforts can spread the costs around. And large corporations often lobby government agencies to ensure that new regulations are in sync with their products and strategies.

None of this means that the FDA can’t play a positive role. The FDA could work with app developers, physicians, and patients to promote high standards, voluntary testing, and accountability. Rather than imposing regulations on all developers, the FDA could serve as a watchdog, taking action only when warranted.

Physicians and patients don’t want medical apps that meet stodgy government standards—they want medical apps that deliver exciting new capabilities at attractive prices. Developers free from constraints will give them what they want and retool health care for the 21st century.

Ira Brodsky is author of The History and Future of Medical Technology.