What I learned week 11
What I learned week 11
Unfortunately, I was not
able to attend Tuesdays speaker for I had a work obligation and there were no
assigned readings. I was however at Mina Hernandez’s discussion about the
intersection of insurance and healthcare. Mina works at Hanover Insurance as an
underwriter and developer of their health care section. There are four main
categories in which they provide insurance to. There are medical devices,
pharmaceuticals, digital health and contract research.
This
really opened my eyes because when I think of healthcare I mainly think of just
drugs and medical devices, and that’s really all we’ve talked about so far, so
it’s interesting to dive into these two unique aspects of the healthcare world.
Especially digital health because we live in such a technology driven world
that digital health is all around us. The broad scope of digital health includes categories such as mobile
health i.e. cellphone fitness apps, health information technology, wearable
devices i.e. Fitbit, telehealth and telemedicine, and personalized medicine. I have
a mobile health app on my phone called MyFitnessPal. This app tracks my
calories, shows exercise moves, acts as a food diary and provides me tips and
tricks to staying healthy. I thought to myself, with technology changing
so fast, how does the FDA keep up in regulating all these new advancements? I
did a little bit of research and found that “The 21st Century Cures Act
(12/13/2016) clarified FDA's regulation of medical software. The new law
amended the definition of "device" in the Food, Drug and Cosmetic Act
to exclude certain software functions. The FDA is currently developing draft
guidance for public comment to help industry and FDA staff understand how the
21st Century Cures Act affects FDA's oversight of medical device software (U.S
Food & Drug Administration).” The
use of technologies such as smart phones, social networks and internet
applications is not only changing the way we communicate, but is also providing
innovative ways for us to monitor our health and well-being and giving us
greater access to information. Together these advancements are leading to a
convergence of people, information, technology and connectivity to improve
health care and health outcomes. I also wasn’t as familiar
with contract research. A contract research organization is
an organization that provides support to the pharmaceutical, biotechnology, and
medical device industries in the form of research services
outsourced on a contract basis.
I also expanded my knowledge this week on medical
devices. Mina taught us about the three classes of medical devices, which I
found to be very interesting. The FDA created these classes as well as the
official definition: A medical device is any apparatus,
appliance, software, material, or other article—whether used alone or in
combination, including the software intended by its manufacturer to be used
specifically for diagnostic and/or therapeutic purposes and necessary for its
proper application. The higher the class, the more dangerous and higher risk
the medical device. FDA classifies medical devices based on the risks
associated with the device. Devices are classified into one of three
categories—Class I, Class II, and Class III. Class I devices are deemed to be
low risk and are therefore subject to the least regulatory controls. For
example, dental floss, examination gloves and elastic bandages. Class II
devices are higher risk devices than Class I and require greater regulatory
controls to provide reasonable assurance of the device’s safety and
effectiveness. For example, powered wheelchairs, acupuncture needles, infusion
pumps and air purifiers. Class III devices are generally the highest risk
devices and are therefore subject to the highest level of regulatory control.
Class III devices must typically be approved by FDA before they are marketed.
For example, replacement heart valves, defibrillators, and implants.
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