Intended for healthcare professionals

Head To Head

Should the FDA regulate mobile medical apps?

BMJ 2013; 347 doi: (Published 29 August 2013) Cite this as: BMJ 2013;347:f5211
  1. Bradley Merrill Thompson, attorney1,
  2. Ira Brodsky, consultant 2
  1. 1Epstein Becker & Green, 1227 25th Street, NW, Washington, DC 20037, USA
  2. 2Datacomm Research, St Louis, MO, USA
  1. Correspondence to: B M Thompson bthompson{at}, I Brodsky ibrodsky{at}

Bradley Merrill Thompson says regulation of certain medical apps is essential for patient safety, but Ira Brodsky believes unfettered development could see the reinvention of healthcare

Yes—Bradley Merrill Thompson

How could a diehard Republican attorney like me who gets hired by companies to oppose over-regulation by the US Food and Drug Administration actually favor regulation and not get fired by his clients? The answer is simple: by using cold, hard logic—instead of ideology—to examine the case for regulating higher risk medical apps.

What are higher risk medical apps?

Let me be clear: I am not suggesting that the government regulates low risk apps that do things like count calories. Indeed, most so-called health and wellness apps would never be regulated.

Instead, we should look at two higher risk categories of “mobile medical apps,” the phrase the FDA has coined for the higher risk apps it proposes to regulate. The first includes those apps that accessorize a traditional medical device—for example, an iPad app through which a doctor can help directly manage a patient’s implanted pacemaker or defibrillator to control heart rhythms. The second category includes apps that work on a standalone basis, not tethered to a medical device. An example in this category is an app used by radiologists to view medical images on a tablet that might include algorithms to analyze the images for potential cancerous lesions. The risks in both cases seem relatively clear.

Why regulate them?

Here is the main point: we and the rest of the developed world decided to regulate products such as these long ago. This is not a new question. Ever since the Medical Device Amendments of 1976, Congress has regulatory obligations on such products designed to make sure that each product that rolls off the assembly line is safe and effective and meets certain quality standards. Why did Congress do that? At least two reasons.

The first obviously is risk. Congress decided that certain products engendered so much risk that caveat emptor and the product liability system were not enough to assure that the product would be safe and effective. Congress created a risk based system that imposed a rigorous premarket approval process on the riskiest of these products but allowed lower risk medical devices to go to market after the manufacturer had simply self assured the implementation of a quality system.

The second reason is bad people. We live in a world where, unfortunately, some people are willing to hurt other people for money. They will cut corners, even when higher risk medical products are involved. So Congress wanted law enforcement that was more sophisticated in science matters than the local policeman or even the FBI to protect us from bad people in the medical product space.

Under the existing regulatory scheme, software used to program pacemakers and defibrillators and to view and analyze medical images has long been regulated. Such software carries significant patient risk, so why would we stop regulating it just because we can now do those things on a cell phone?


Somewhere, someone started the rumor that the proposed guidance that the FDA published in 2011 is designed to enlarge the agency’s regulatory sphere. But actually the opposite is true. As already explained, FDA currently regulates mobile medical apps, having cleared over 100 apps and brought enforcement action against one that lacked clearance. Rather than expanding its domain, the proposed guidance is intended to deregulate some of those apps.

By law, a guidance document cannot expand FDA authority. Rather, guidance documents were created in the mid-1990s so that people in industry can read the regulatory requirements in plain English without having to hire an attorney. And in this case, the FDA went further in the draft guidance and said it actually had no interest in regulating some apps the statute would otherwise cover, such as those used by consumers to manage disease. That deregulation would be a huge step forward for mobile health.

Let’s also be clear what the FDA regulation means. It does not equate with FDA approval of a product. FDA regulates many medical devices that it does not approve. Instead, for those apps, FDA imposes some general controls such as the use of a quality system to ensure the developer’s final product is safe and effective.

Does FDA regulation impede innovation? Yes, to some degree. And that’s why FDA regulation ought to extend only to those apps that truly engender high risk. That is also why FDA’s regulatory scheme is risk based so that lower risk medical apps can avoid FDA review.

Bottom line

It is absolutely true that this new technology should not be approached in the same manner as its much more pedestrian forefathers. The FDA needs to modernize its regulatory approach. The agency’s decades old approach of looking at individual products no longer makes sense in an era where medical devices are woven together into systems. We need a new approach to regulation more tailored to the needs of 21st century medical technology.

No—Ira Brodsky

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 healthcare for the 21st century.


Cite this as: BMJ 2013;347:f5211


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

  • Competing interests: The authors have read and understood the BMJ policy on declaration of interests and declare that Epstein Becker & Green represents numerous organizations with an interest in mobile health and that BMT serves as the general counsel of the mHealth Regulatory Coalition.

  • Provenance and peer review: Commissioned; not externally peer reviewed.

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