The FDA Thinks Your Smartphone May Be A Medical Device

The Food and Drug Administration (FDA) has delivered on its promise to issue guidelines this year regarding “medical apps” that are being developed and issued daily across the United States. A press release regarding the Draft Guidance for Industry and Food and Drug Administration Staff—Mobile Medical Applications was posted yesterday and the proposed regulations can be found in their entirety here.

The draft has been issued to encourage feedback from manufacturers, health care providers, and others on how the FDA’s proposal may support the balance between promoting innovation and assuring safety and effectiveness. A good summary of the draft can be found here. The FDA is seeking public input on this approach. Once posted, comments can be submitted for 90 days online or in writing to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The FDA has focused on three primary segments of how to distinguish regulated “apps” and “manufacturers”—(i) mobile platform, (ii) mobile app, and (iii) mobile medical application. According to this summary, a mobile platform is a commercial off-the-shelf computing platform “with or without wireless connectivity” that is handheld. Mobile apps are software that can be run on a mobile platform or a Web-based software application that is designed for the mobile platform. Finally, a mobile medical app is one that meets the definition of “device” according to the FD&C Act, but also must be “used as an accessory to a regulated medical device” or “transform a mobile platform into a regulated medical device.”

Here are some examples of regulated mobile medical apps:

• Apps that use a mobile platform to upload electroencephalograph (EEG) recordings and automatically detect seizures


• Apps that use the built-in accelerometer or other similar sensors in a mobile platform to monitor the user's movement (useful in connection with measuring heart rates and detecting sleep phases, sleep apnea, falls, or other motions related to other conditions or diseases)

On the other hand, the FDA does NOT consider mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness to be mobile medical apps for purposes of these regulations. Examples of such apps include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness.

For nothing short of real entertainment, frequent the FDA Web site for the public comments over the next 90 days.

The Death of Common Sense: How Law is Suffocating America

What: The Death of Common Sense: How Law is Suffocating America, by Phillip K. Howard (Random House, 1994).

Why: Legal issues can be some of the most frustrating an entrepreneur encounters. A broader understanding of the context in which these issues arise is useful, although not necessarily liberating.

It happens all too often. An entrepreneur comes up with a great business idea. The business plan is a work of art. Investors are lining up to provide capital. Just a few details to check with the lawyers—and then the details take on a life of their own. We lawyers frequently take the blame, sometimes deservedly so, but more often than not we’re just the messengers. The real problem is a statute, an ordinance or a regulation that provides detailed guidance as to what must be done, but unfortunately what the law requires just makes no sense under the circumstances.

Philip Howard, a practicing lawyer in New York City, recognizes this scenario all too well. In the 15 years since The Death of Common Sense first appeared, he has written two more well-received books pointing out flaws in our legal system and has founded an organization, Common Good, dedicated to restoring common sense to American law. All of this is built on the basic premise that in seeking to legislate fairness for all, we have elevated procedure over substance, replaced sound judgment with mind-numbingly detailed laws, and created “a system of regulation that goes too far while it also does too little.”

Take, as one egregious example, the Occupational Safety and Health Administration. Volumes of regulations set out precise, objective rules meant to advance worker safety. So much law, in fact, that the law no longer offers a clear guide, but is essentially unknowable except in bits and pieces. And those enforcing the bits and pieces exercise no judgment in doing so, which leads to arbitrary enforcement, enforcement that requires that hugely expensive but unnecessary modifications be made, enforcement that misses real problems and focuses on paperwork. The result? “Safety in the American workplace has been largely unaffected by OSHA.”

But government still tries to detail the fix for every problem with absolute precision. That’s how we end up with a Department of Defense that, in 1994, spent “more on procedures for travel reimbursement ($2.2 billion) than on travel ($2 billion).” Does anyone really think things have changed for the better since then?

So where did we go wrong? Howard traces this to the turbulent 1960s, the emerging regulatory state and the rise of legal rationalism—the belief that everything can be figured out in advance and problems avoided through detailed lawmaking—and the glorification of process. We now argue “not about right and wrong, but about whether something was done the right way.”

Howard’s proposed solution could be called “Back to the Future.” Return to a system of law that establishes rules and guidelines that are “subservient to broader principles,” and allow those enforcing the law to use their judgment—their common sense—to make an exception whenever a rule in a particular case leads to a result inconsistent with the principle. Principle, not rules, should control. The focus should be what is right and reasonable, “not the parsing of legal language.”

Reading this against the background of current events, it’s hard not to wonder whether now is an opportune time to implement this idea. On the other hand, it just may be that this is the only time we might be able to do it, and doing it may be critical to rebuilding our economic infrastructure. As they say, some food for thought.