Ana Trana
FNU
Professor: Deborah Crevecoeur
The FDA does oversee certain features of mobile devices like smartphones and tablets, as well as mobile applications used for healthcare, but this oversight is precise and focused. The agency specifically targets mobile medical apps that qualify as medical devices under the Federal Food, Drug, and Cosmetic Act—those that aim to diagnose, treat, mitigate, prevent, or cure diseases or health conditions. While devices such as smartphones and tablets are generally not regulated unless marketed for medical functions, the FDA doesn’t directly regulate mobile app stores; instead, it concentrates on the applications themselves (FDA, 2020).
FDA Regulation and Public Benefit
The FDA’s regulation of mobile medical applications is advantageous for public health, ensuring these apps comply with safety and efficacy standards. By enforcing these criteria, the FDA reduces the risks linked to apps that may provide inaccurate diagnostic or treatment information. For instance, an app that tracks heart rates or blood glucose could pose serious risks if it incorrectly reports data. To protect users, the FDA mandates that high-risk apps undergo a premarket review to assess their safety and effectiveness prior to consumer access (Tarricone et al., 2021).
Additionally, the FDA fosters innovation by offering clear guidance on which apps are subject to regulation. Low-risk applications, such as those encouraging healthy habits or fitness tracking, typically fall outside FDA oversight. This clarity aids companies in developing these tools while ensuring that high-risk applications, particularly those related to diagnosis or clinical decision-making, receive the necessary evaluation (Wilbanks & Friend, 2020).
Mobile App Stores and Regulation
The FDA does not regulate mobile app stores like Google Play or the Apple App Store; however, some argue that it should. Given that app stores are the main distribution channels for mobile medical apps, applying regulations could help ensure that only safe and effective applications are available to consumers. This could mean requiring app stores to verify FDA approval before listing apps in their marketplaces. While this might enhance consumer protection, it could also delay the release of new apps and hinder innovation. Therefore, a balanced strategy is essential to protect public health while encouraging advancements in mobile healthcare.
References:
Food and Drug Administration. (2020). Policy for device software functions and mobile medical applications. U.S. Department of Health and Human Services. https://www.fda.gov/media/80958/download
Tarricone, R., Petracca, F., Cucciniello, M., & Ciani, O. (2021). Mobile health divide between clinicians and patients in a post-COVID-19 world. The Lancet Digital Health, 3(9), e537–e538. https://doi.org/10.1016/S2589-7500(21)00131-5
Wilbanks, J. T., & Friend, S. H. (2020). First, we need access: Revisiting FDA regulation of health information technology. JAMA, 323(1), 23–24. https://doi.org/10.1001/jama.2019.19326
- WE OFFER THE BEST CUSTOM PAPER WRITING SERVICES. WE HAVE DONE THIS QUESTION BEFORE, WE CAN ALSO DO IT FOR YOU.
- Assignment status: Already Solved By Our Experts
- (USA, AUS, UK & CA PhD. Writers)
- CLICK HERE TO GET A PROFESSIONAL WRITER TO WORK ON THIS PAPER AND OTHER SIMILAR PAPERS, GET A NON PLAGIARIZED PAPER FROM OUR EXPERTS
QUALITY: 100% ORIGINAL PAPER – NO ChatGPT.NO PLAGIARISM – CUSTOM PAPER
Looking for unparalleled custom paper writing services? Our team of experienced professionals at AcademicWritersBay.com is here to provide you with top-notch assistance that caters to your unique needs.
We understand the importance of producing original, high-quality papers that reflect your personal voice and meet the rigorous standards of academia. That’s why we assure you that our work is completely plagiarism-free—we craft bespoke solutions tailored exclusively for you.
Why Choose AcademicWritersBay.com?
- Our papers are 100% original, custom-written from scratch.
- We’re here to support you around the clock, any day of the year.
- You’ll find our prices competitive and reasonable.
- We handle papers across all subjects, regardless of urgency or difficulty.
- Need a paper urgently? We can deliver within 6 hours!
- Relax with our on-time delivery commitment.
- We offer money-back and privacy guarantees to ensure your satisfaction and confidentiality.
- Benefit from unlimited amendments upon request to get the paper you envisioned.
- We pledge our dedication to meeting your expectations and achieving the grade you deserve.
Our Process: Getting started with us is as simple as can be. Here’s how to do it:
- Click on the “Place Your Order” tab at the top or the “Order Now” button at the bottom. You’ll be directed to our order form.
- Provide the specifics of your paper in the “PAPER DETAILS” section.
- Select your academic level, the deadline, and the required number of pages.
- Click on “CREATE ACCOUNT & SIGN IN” to provide your registration details, then “PROCEED TO CHECKOUT.”
- Follow the simple payment instructions and soon, our writers will be hard at work on your paper.
AcademicWritersBay.com is dedicated to expediting the writing process without compromising on quality. Our roster of writers boasts individuals with advanced degrees—Masters and PhDs—in a myriad of disciplines, ensuring that no matter the complexity or field of your assignment, we have the expertise to tackle it with finesse. Our quick turnover doesn’t mean rushed work; it means efficiency and priority handling, ensuring your deadlines are met with the excellence your academics demand.
