Health
Care Mobile Device Revolution
An FDA
letter in May admonished an Indian software developer that it needed FDA clearance
for its urinalysis app. This action sent a warning to other mobile health firms
that many medical marketing apps could be interpreted as medical devices.
The FDA's
action alone does not establish nor spell out which kinds of apps could be
regulated; and the FDA's final guidance on mobile health apps, due
this fall, will not settle some important issues in this area, which include:
· Differentiation
between disease-related and wellness-related apps. For instance, weight
loss/diet app that includes a calorie counter and a pedometer, for example,
doesn't need to be regulated if it's promoted for general wellness and fitness.
However, if that same app is marketed it to people with a specific disease,
such as diabetes, as a diabetes management tool, it can be interpreted as a
medical device.
· Accessories
(which will be defined/dealt with in separate guidance) used with a medical
device to enable it to operate--is defined as an accessory to the device and must
be regulated. An example includes software that connects a glucose meter to a
cellphone ‘could be’ defined as an accessory.
For a detailed
overview of mobile medical apps & the regulatory landscape, see article
below.
SOURCE: The
Speed of Innovation: Mobile Radiology Apps are Evolving at the Speed of
Imagination – But Can Regulators Keep Up?
American College
of Radiology, author: Chris Hobson (Feb 27, 2013)
Full article and
cites appear below.
Apple’s iPhone
kicked off the mobile device revolution just five years ago, and now there are
well over a million apps in existence. Tens of thousands of these apps are
designed to either improve or maintain user health, doing everything from measuring
blood pressure to monitoring a patient’s adherence to certain medical
treatments. A fraction of these medical apps are designed for radiologists,
transforming a smartphone or tablet into, for instance, a portable workstation
on which to perform occasional primary diagnoses.
The number of these mobile
medical apps is growing rapidly. According to Research2Guidance, a research
firm specializing in mobile technology, 500 million smartphone users will be
running health-related apps by the year 2015.1 Before a subset of these apps
can be marketed to the public, however, software developers must make their
existence known to the federal government. But with so many new tools being
developed so fast, some have begun questioning whether the government can regulate
them quickly and efficiently enough to avoid stifling innovation.
Regulations for the 21st Century Since health-related apps are being created at a breakneck pace, some software vendors worry that government oversight could slow the development process. The U.S. Federal Drug Administration (FDA) regulates medical devices, which include a subset of health-related apps known as “mobile medical apps.” Important benchmarks of the agency’s efficiency in regulating these devices and apps had steadily worsened over the past decade so, in 2011, the FDA laid out a plan of action that has improved the review process.2 Later that year, the agency put forth a draft guidance, to be finalized in 2013, that designated a small subset of mobile medical apps that the agency will oversee. In addition, the guidance outlined into which pre-established medical device categories mobile medical apps should be placed, further clarifying the process for developers. These categories are named Class I, Class II, and Class III. When evaluating the market readiness for mobile medical apps, the FDA applies a risk-based approach to classification: Class I represents apps that pose the least risk to a patient, while Class III designates the apps that carry the greatest risk. Apps that fall into Class I or Class II, which are deemed substantially equivalent in safety and effectiveness to an already legally marketed app, use what is called a 510(k) pathway, or a premarket notification, to gain FDA marketing clearance. In other words, these mobile medical apps do not represent a total departure from other apps already in existence that have proven safe and effective for users. Software developers who submit information about their apps for an FDA premarket clearance through the 510(k) pathway are usually notified within 90 days that their product meets the requirements, after which time they may proceed to market their product with the FDA’s clearance. If, on the other hand, the vendor is developing a Class III app, then they must apply for premarket approval (PMA). Class III apps are comprised of “those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.”3 PMA represents a more rigorous review process, and developers must demonstrate safety and effectiveness of their product to the FDA in order to receive approval to market it. This designation applies even if a similar app is already being legally marketed.
Innovation Under Threat? According to the FDA, all of the radiology mobile apps it has approved have fallen into the Class II category, which, explains David S. Hirschorn, MD, director of radiology informatics at Staten Island University Hospital, has caused little disruption in innovation. This is largely because, to his mind, the 510(k) process is so short. “Of the software vendors I’ve talked to, no one has said that the FDA is dragging its heels during the review process,” he notes, saying that the organization strives not to over-regulate medical apps. Indeed, the agency treads lightly when it comes to medical software. “With the exception of mammography,” he asserts, “states regulate the practice of medicine, not the FDA.”
Regulations for the 21st Century Since health-related apps are being created at a breakneck pace, some software vendors worry that government oversight could slow the development process. The U.S. Federal Drug Administration (FDA) regulates medical devices, which include a subset of health-related apps known as “mobile medical apps.” Important benchmarks of the agency’s efficiency in regulating these devices and apps had steadily worsened over the past decade so, in 2011, the FDA laid out a plan of action that has improved the review process.2 Later that year, the agency put forth a draft guidance, to be finalized in 2013, that designated a small subset of mobile medical apps that the agency will oversee. In addition, the guidance outlined into which pre-established medical device categories mobile medical apps should be placed, further clarifying the process for developers. These categories are named Class I, Class II, and Class III. When evaluating the market readiness for mobile medical apps, the FDA applies a risk-based approach to classification: Class I represents apps that pose the least risk to a patient, while Class III designates the apps that carry the greatest risk. Apps that fall into Class I or Class II, which are deemed substantially equivalent in safety and effectiveness to an already legally marketed app, use what is called a 510(k) pathway, or a premarket notification, to gain FDA marketing clearance. In other words, these mobile medical apps do not represent a total departure from other apps already in existence that have proven safe and effective for users. Software developers who submit information about their apps for an FDA premarket clearance through the 510(k) pathway are usually notified within 90 days that their product meets the requirements, after which time they may proceed to market their product with the FDA’s clearance. If, on the other hand, the vendor is developing a Class III app, then they must apply for premarket approval (PMA). Class III apps are comprised of “those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.”3 PMA represents a more rigorous review process, and developers must demonstrate safety and effectiveness of their product to the FDA in order to receive approval to market it. This designation applies even if a similar app is already being legally marketed.
Innovation Under Threat? According to the FDA, all of the radiology mobile apps it has approved have fallen into the Class II category, which, explains David S. Hirschorn, MD, director of radiology informatics at Staten Island University Hospital, has caused little disruption in innovation. This is largely because, to his mind, the 510(k) process is so short. “Of the software vendors I’ve talked to, no one has said that the FDA is dragging its heels during the review process,” he notes, saying that the organization strives not to over-regulate medical apps. Indeed, the agency treads lightly when it comes to medical software. “With the exception of mammography,” he asserts, “states regulate the practice of medicine, not the FDA.”
But while the FDA
generally cannot regulate the practice of medicine, medical app manufacturers
do come under its purview. The agency distinguishes whether or not it has
oversight authority over a product based on a product’s intended use, which
largely depends on how a vendor markets it. Hirschorn illustrates the fine line
the FDA walks with an example: “If a magnifying glass is advertised as
something that can help you see small things, it’s not a medical device. If,
however, it’s advertised as helping you to see micro-calcifications in a
mammogram, then it’s a medical device,” and the agency has right of approval
over it.
Bradley
Merrill Thompson, general counsel of the mHealth regulatory coalition in
Washington, D.C.,agrees. While he would like to see the premarket notification
process for mobile medical apps cut down, he doesn’t believe that the FDA is
overly suppressing innovation. “The pace at which the agency moves is dependent
upon its available resources,” says Thompson. “It’s a balancing act between
speed and resources — it can only hire so many staff members without getting
more resources either from Congress or from user fees. The FDA has to go
through a deliberate product-approval process but also try to move as fast as
possible.
Time
Is of the Essence
Others, however, are not convinced that the FDA’s approval process paves the
way for innovation. Joel C. White, executive director of Health IT Now, in
Washington, D.C., states that the life cycle of many mobile apps is shorter
than the time it takes to go through the FDA approval process. “Some apps are
updated weekly, and in some cases daily,” he says. “Turnaround time will be
crucial to ensuring the latest, best information is available for providers to
treat patients.” He recommends a more hands-off approach to regulation: “At a
minimum, software that poses the least risk should fall outside the FDA review
process. Only when a product interacts with a variable like human physiology
should the FDA be involved.”
But there are steps developers can take to
reduce turnaround times, argues FDA policy advisor Bakul Patel. “One point I
can emphasize to help reduce frustration is the need to talk to us early in the
development of mobile medical apps,” he notes. “The FDA can discuss data needed
to show safety and effectiveness with developers so they can plan those requirements
into the development of the app. This can help developers to find the quickest
path to market, help them use resources more efficiently, and shorten review
times.”
Although finding the quickest route to market may be helpful for
developers, however, it is the end product — and the end users — that matter
most. In Hirschorn’s experience, radiologists tend not to suspect the safety of
the software they use, often assuming it is safe unless told otherwise. “They
focus more on the clinical task and less on the software itself,” he explains.
“As a consequence, though, they are very unnerved if they learn that what they
were shown by a computing device was not what they thought it was. This
implicit trust can lead to a strong distrust if the radiologist feels she has
been betrayed by the technology,” he says, emphasizing the need for government
oversight to ensure that products work as they should.
The rapidly changing
landscape of mobile medical app development is a cause of both optimism and
unease. By working with developers and vendors, the FDA is making an effort to
alleviate this concern. While innovation will only increase the speed at which
new technologies are born, spurring unimaginable new treatment options, the
public’s safety must also be taken into account. Radiologists would do well to
ensure that the apps they use are tested thoroughly so that their trust in the
technology remains strong.
ENDNOTES
1. Mikalajunaite, E. “500m people
will be using healthcare mobile applications in 2015.” Available at http://bit.ly/MobileAppStudy. Accessed Dec. 8, 2012.
2. U.S. Food
and Drug Administration. “Improvements in Device Review: Results of CDRH’s Plan
of Action for Premarket Review of Devices.” Available at http://bit.ly/FDAPlanOfAction. Accessed Dec. 9, 2012.
3. U.S. Food
and Drug Administration. “Premarket Approval (PMA).” Available at http://bit.ly/FDAPremarketApproval. Accessed Dec. 8, 2012.
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