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Is this application an fda regulated mobile medical application?
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I am working digital health technology such as mobile applications by writing a evaluation of mobile medical applications based on FDA Mobile Medical Application Guidelines. This case study will focus on AliveCor to review it adherence to the FDA guidance. I have attached the necessary files to be used for the case study and the rubrics is also below to follow:
The Case Study
Review the attached case study AliveCor-Iterating-the-Business-Model-in-a-Nascent-Market-FINAL.which provides background on a cardiac monitoring platform. In your assessment you should address the following key areas:
1. How would you evaluate the safety of the application outlined in the case study? Is this application an FDA regulated mobile medical application?
2. How would you construct a more robust study to assess the efficacy of the program? Provide additional commentary on the current approach and potential improvements to deployment by AliveCore. How could this platform be integrated into a healthcare system to impact behavior change?
3. Review the technology landscape. Are there other services or platforms worth considering? Is there an adequate evidence base to support their use? Find at least three competitive technologies.
You submission should be 4-6 pages double spaced with APA citation format. No cover sheet is necessary. Expect 3-4 external citations from either peer reviewed or grey literature is required. Peer reviewed literature is preferred to grey literature.
Please the attached files are the AliveCor files and the Rubric. Also attached is the FDA Mobile Medical Applications Guidelines link below use for mobile apps evaluation:
Please ensure no plagiarism and use double space and APA citation format.