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Defining mHealth regulations?

  • 1.  Defining mHealth regulations?

    Posted 01-Aug-2019 12:38
    Edited by Lindsey Summers 05-Aug-2019 11:24

    Hello Everyone,

    A friend and colleague of mine is looking for some expertise around mHealth regulations and I thought this group would have insight. Any advice on this would be appreciated!

    Here is the text of the questions:

    Hoping to get some clarification from experts that are defining mHealth regulations. I am hoping to categorize and define the buzz words below, along with a specific examples/companies associated with each term. I gathered most of my initial information from these guidelines, but still have a few clarifying questions: https://www.fda.gov/medical-devices/digital-health/guidances-digital-health-content  Thank you for being the communication channel to ask the experts!

    1. Medical mobile app: I realize there are two classes under medical mobile app. Those the FDA "intends to exercise enforcement discretion" and those that are "the focus of FDA's regulatory oversight." Can someone please explain the line in the sand here? How would you qualify a program like Omada Health as it is helping to manage and prevent chronic diabetes, but not necessarily connected to a CGM? What about a company like My Strength that is delivering cognitive behavioral therapy to prevent acuity? Where do both of these companies fall?

    -Software as a medical device: How is this different from medical mobile app? Can you give a specific example?

    -Prescription digital therapeutic: Does this fall under medical mobile app?

    1. Does the FDA categorize communication platforms for physicians and patients (what an average person would consider general telemedicine) differently than mobile medical apps that send patient reported data to a provider and are usually condition specific?

    Definitions hoping to find specific companies/examples for:

    Telehealth

    Telemedicine

    mHealth

    Digital Health

    Prescription Digital therapeutics 

    Software as Medicine

    Mobile Medical App

    Please feel free to provide my personal information and to set up a phone meeting on my behalf as there may be some nuances that should be explained outside of email. 

    Here is her contact 415-235-1252

    ------------------------------

    Lindsey Summers, MBA
    Director, Pharmaceutical Consulting Division Green Key Resources, LLC
    Denver, CO
    Direct: 720.543.8692
    Mobile: 303.437.0391
    lsummers@greenkeyllc.com
    www.linkedin.com/in/lindseysummers

    http://www.greenkeyllc.com/ph/

    Regulatory Affairs / Medical Writing & Publications / Medical Communications & Information / Clinical Operations / Clinical Quality / Drug Safety / Data Management / SAS Programming / Biostatistics / Drug Development Project Management / Clinical Development / Medical Affairs & Monitoring / Epidemiology / Health Outcomes

    *Receive up to1500 for referring a colleague*

    Please note that in the state of California, Green Key conducts business under the name GK Pacific, LLC.
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