claims. Let Theranos Inc., the much-maligned maker of a new
blood-testing technology, be a lesson. The Palo Alto, Calif.-based
company launched to much fanfare (its technology shrouded in
much secrecy) in 2003, and gained a lot of media attention as
much for its young, promising CEO Elizabeth Holmes as its supposedly ground-breaking blood testing technology. Today, many
news outlets have reported that most of the claims made by
Holmes and Theranos were exaggerated and perhaps even false.
New, exciting technologies in the consumer space often follow a
path of media-aided hype fueled by an air of mystery around the
technology itself; there is no room for that in medical technology,
where the device or software is created to help patients manage
diseases or physicians perform life-saving tasks.
The FDA is operating in a somewhat deregulatory climate due
to pressures to lower review times and not stifle innovation in
the United States, pushing device makers to bring their devices
to market overseas first. However, just because the FDA is giving
mobile developers some latitude does not mean the FTC is not
paying strict attention. In 2011, the commission settled with mar-
keters of the AcneApp and Acne Pwner, mobile apps that were
marketed for treating acne by emitting colored lights from smart-
phones. The settlements forbid the marketers from making acne-
treatment claims about their mobile apps, or any other devices,
in the absence of substantiating scientific evidence. Then in 2015,
the FTC barred marketers of the MelApp and Mole Detective
mobile apps from making any representation that the apps could
detect or diagnose melanoma, identify risk factors of melanoma,
or increase users’chances of detecting melanoma in its early stag-
es, in the absence of substantiating scientific evidence. Later that
year, the FTC settled with the developer of the UltimEyes app,
which was marketed as“scientifically shown” to improve vision.
The company agreed to pay a $150,000 fine and to stop making
the vision improvement claims.
The most legally conservative approach, according to recent
FDA guidance and FTC activity, is to avoid any claim that an app
is designed to diagnose, cure, prevent, or mitigate a specific disease. Low-risk apps that promote general health and wellness
will likely avoid regulation, but as always, consulting with the
FDA will help ensure a device is on the right track—because, as
befits the space, mobile health regulation moves fast and changes regularly.
A Global Perspective
In February this year, the European Commission (EC) issued a
draft that seeks to revoke the medical device status of proan-thocyanidin (PAC)-based cranberry products for the treatment
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