In a move that many medical companies are applauding, the U.S. Food and Drug Administration (FDA) has issued final guidance for developers of
medical apps designed to perform the same functions, like diagnosing abnormal heart rhythms, as traditional medical devices. The overarching conclusion: the FDA won't bully medical app developers.
Among other tasks, mobile medical apps currently on the market can transform a smartphone into a mobile ultrasound device, or function as the "central command" for a glucose meter used by a person with insulin-dependent diabetes.
"Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health. "The FDA's tailored policy protects patients while encouraging innovation."
Focusing on Higher-Risk Apps
The FDA acknowledges that mobile apps have the potential to transform health care by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional health care settings, help consumers manage their own health and wellness, and also gain access to useful whenever and wherever they need it.
Because the majority of mobile apps pose minimal risk to consumers, the FDA aims to exercise enforcement discretion -- meaning it will not enforce requirements under the Federal Drug and Cosmetic Act. The agency will instead focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.
Specifically, the FDA will take a closer look at mobile medical apps that are intended to be used as accessories to regulated medical devices, such as that allow a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system on a smartphone or a mobile tablet.
The agency is also targeting mobile apps that transform a mobile platform into a regulated medical device, such as applications that turn a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
An Even-Handed Approach
"We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly," said Shuren. "Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products."
According to market research firm research2guidance, the market for mobile medical apps will climb to $26 billion by 2017. There are about 97,000 mobile health apps in major app stores like Apple's iTunes and Google Play.
"It's important that the FDA gets involved to make sure the apps aren't doing any harm. And it looks like they are taking a very even-handed approach instead of coming after it with a sledgehammer," Rob Enderle, principal analyst at The Enderle Group, told us. "Typically, government agencies don't care until something disastrous happens and then they overreact. This is a much better approach."
Posted: 2013-09-27 @ 12:55pm PT
In three previous blog posts, I have documented the appalling failure
of the FDA's approval process for medical devices that
multinational corporations have spent years developing.
Time after time, despite a protocol that requires extensive clinical
trials and "documentation" by these profit-crazy firms, the devices that
the FDA has enshrined as "safe and effective" have proven to be unsafe
and ineffective. Now the agency is going to handle mobile apps? Oh great -- more bungling. The agency says it will only review cell phone apps that are either moderate-risk (Class II) or high-risk (Class III).
Will someone please tell us which ones are HIGH RISK?? Does it seem
CRAZY to anyone but me that we are placing HIGH RISK medical devices in
the hands of any customer of any age, without proper education or
What could some smart young hacker do with a HIGH RISK medical app?
Are we at risk only if we own the phone and we're doing something,
knowingly, to ourselves? Or can someone with a "high-risk" app endanger
our health somehow -- by targeting another person's pacemaker, for
example, or shooting some kind of waves or rays in our direction? There's a bit of a backlog: Approximately 1,000 new programs are released each
month, and there will be 142 million annual downloads and 500 million worldwide users by 2016, according to a study published in the August issue of Insights into Imaging. The number of medical imaging-related apps in the marketplace has tripled since January, the European web site HealthCare Informatics reported last month.
This deluge cries out for oversight, but it also cries out, "Mission Impossible!"
"The FDA is taking a tailored, risk-based approach that focuses on the
small subset of mobile apps that meet the regulatory definition of
'device' and that are intended to be used as an accessory to a regulated
medical device, or transform a mobile platform into a regulated medical
device," it states on its web site. "Our focus (is) only on
the apps that present a greater risk to patients if they don’t work as
intended and on apps that cause smartphones or other mobile platforms to
impact the functionality or performance of traditional medical
"Risk-based approach" is such a nice way of putting it. How risky is too
risky? How many malfunctions, injuries and deaths are acceptable? The
FDA hasn't gotten that straight when it comes to big-time devices and
drugs, so one has to wonder how well they'll manage the apps issue. The
agency's focus is "only on the apps that present a greater risk to patients if they don’t work as intended." Greater than what? Than not having a phone
at all, and walking around with both hands free, like people did not so
long ago? And where were we -- and the medical establishment -- when
these bright, charming apps starting popping up and "impacting the
functionality" of the medical machinery we've come to rely upon?
The European HealthCare Informatics site studied the FDA's process of assessing
cell-phone medical apps, noting that it is only advisory -- "not a full
regulatory process." The site discovered that only a small minority of
the apps claims to have had a medical professional involved in the
development of its product. And it found that deceptive language is
widespread in the marketing of these apps. This is typical of how the imprimatur of the FDA is abused by profiteers, without penalty.
As of yesterday, 40 state attorneys general asked the FDA to regulate e-cigarettes.
They can't regulate everything. As far as I can tell, they can't regulate anything.