Our Services

Get 15% Discount on your First Order

[rank_math_breadcrumb]

week 3 Informatics replies

Top of Form

Ashley Evans

Health Care Informatics-DAX-DL01

Prof. Deborah Crevecoeur

Discussion Week 3

“The FDA’s mobile medical apps policy does not
 regulate the sale or general consumer use of smartphones or tablets” (I.Sim, 2019). The FDA’s mobile medical apps policy does not
 consider entities that exclusively distribute mobile apps, such as the owners and operators of mobile application stores to be medical device manufacturers. This is beneficial due to the FDA’s mobile medical apps policy does not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by the FDA.

However, the FDA regulates mobile medical apps through a systematic approach that ensures their safety and effectiveness. This process includes identifying medical apps, categorizing risks, and implementing a regulatory framework that encompasses pre-market review and post-market monitoring. This approach strikes a balance between fostering innovation and protecting public health. “By establishing quality standards and raising awareness, the FDA plays a vital role in encouraging the development of dependable mobile medical apps that serve the public interest while minimizing the potential risks of their usage” (FDA.gov, 2022).

Software functions that qualify as a device can be implemented on mobile platforms, other general-purpose computing platforms, or as part of the functionality or control of a hardware device. The FDA’s policies, which are platform-independent and function-specific, are consistently applied across different platforms. The term “software functions” encompasses mobile applications (apps).

How does the FDA regulate device software functions?

The FDA applies the same risk-based approach to device software functions as the agency uses to assure safety and effectiveness for other medical devices.

In conclusion, mobile apps can help people manage their own health and wellness, promote healthy living, and gain access to useful information when and where they need it. These tools are being adopted almost as quickly as they can be developed. Users include health care professionals, consumers, and patients.

The FDA encourages the development of mobile medical apps (MMAs) that improve health care and provide consumers and health care professionals with valuable health information. The FDA also has a public health responsibility to oversee the safety and effectiveness of medical devices including mobile medical apps.

References

Device software functions and mobile medical applications. (2022, September 29). U.S. Food and Drug Administration. 

Sim, I. (2019, September 4). 
Just a moment... Just a moment… 

Bottom of Form

Edited by Ashley Evans on Sep 18, 2024, 4:42:30 PM


Share This Post

Email
WhatsApp
Facebook
Twitter
LinkedIn
Pinterest
Reddit

Order a Similar Paper and get 15% Discount on your First Order

Related Questions

CLINICAL 514 DISCUSSION #6

Anything in this color is answers Module 6 Discussion     Weekly Clinical Experience 6 Describe your clinical experience for this week. · Did you face any challenges, any success? If so, what were they? Treating pregnant patients and their needed follow up. · Describe the assessment of a patient,

NUR 514 DISCUSSION 6

Module 6 Discussion   Female Patient Cases 4 For this Discussion, your instructor will assign you a case number. Case 3  Cases You work in a women’s health clinic. Many come lower abdominal discomfort. with Chronic Pelvic Pain (CPP). Questions for the case · Discuss and described the pathophysiology and

Advance Psychiatric

Please follow APA format, add citations and references within 5 years old. Document will be verified for plagiarism and AI use. Thank you!  Instructions: 1. Identify a clinical healthcare problem in mental health care. These problems can be either from your clinical site location, personal clinical experiences, or a review

Comprehensive Integrated Psychiatric Assessment

  Comprehensive Integrated CComprehensive Integrated Psychiatric Assessment Comprehensive Integrated Psychiatric AssessmenPsychiatric Assessment  Many assessment principles are the same for children and adults; however, unlike with adults/older adults, where consent for participation in the assessment comes from the actual client, with children it is the parents or guardians who must make

APN Business Planning

Discuss the process of Advanced Practice Nurse (APN) business planning from a system approach.

assistant

Nursing Program Clinical II – SIM 4 – Case Studies *to be done early in the semester Case Study 1   Scenario P.M., 24-year-old house painter, too ill to work the past 3 days. Arrived at your outpatient clinic with his girlfriend, he seems alert but acutely ill, with an

advanced pathophysiology

See attached  document for instructions APA format 7th edition. Please cite at least 3 credible sources. Patient is a 45-year-old male presenting with an acute onset of pain that began in his legs and has since spread to his lower back. The pain is rated 9/10 and described as deep,

Gerontology Power Point Presentation

Case Presentation-PowerPoint Presentation Develop a PowerPoint presentation on a clinical case for a 75-year-old female patient with Restless Legs Syndrome. 1. Provide information about the incidence, prevalence, and pathophysiology of the disease/disorder to the cellular level. 2. Educate advanced practice nurses on assessment and care/treatment, including genetics/genomics—specific for this disorder.

final disc

Now that you are in your final course in your program, it is time to turn in earnest to preparing for certification and licensure. You will need to take and pass a national FNP certification exam.  Once certified, you will then be eligible to apply for licensure as an advanced

Nursing Assignment

Nursing Program Clinical II – SIM 4 – Case Studies *to be done early in the semester Case Study 1   Scenario P.M., 24-year-old house painter, too ill to work the past 3 days. Arrived at your outpatient clinic with his girlfriend, he seems alert but acutely ill, with an

home work

Competency This deliverable will allow you to demonstrate your ability to clearly discern between valid and invalid arguments. Instructions Consider the following arguments All chickens have feathers. This animal has feathers. Therefore, this animal is a chicken. All chickens are green. No green birds eat pickles. Therefore, no chickens eat

Help with Research

See outline.  For your Final Assignment (Due in Module 7), you will use everything that you have learned in this course. You will select, analyze and appraise a quantitative study of your choice that uses one of the following designs: · Survey Research · Correlational Research · Experimental Research ·

NR 449 W5D

  This area provides you with an opportunity to reflect on what you have learned and what concepts you still need further exploration on.  Answer 1 question. Include a short summary of what has been learned, and include question(s) that are still unclear.   Post your answer to 1 of

SAM

Now that you have engaged with the learning resources in this module, you are ready to apply the principles of improvement science to your own practice setting – whether in a direct or indirect care role.  This assignment focuses on connecting real-world healthcare improvement needs with benchmarking, the Plan-Do-Study-Act (PDSA)

nursing

Post a response including the following: Identify the gap in knowledge (in the research article) and the gap in practice (in the QI study) presented in the articles provided. Explain how the practice-focused question emerged in the DNP EBP project. Review Chapter 4 in Bissett et al., (2025). Evaluate the

Pharmacology

Write a research paper in regards to a drug or drug therapy and explain in detail about the study and why it is important. Include the following criteria: Subject: Beta blocker therapy post myocardial infarction MI Example these topic Beta-blockers are a standard part of post-MI therapy because they provide