The document discusses guidelines for mobile medical applications, emphasizing the importance of understanding regulatory requirements from various agencies such as the FDA, FCC, and FTC. It outlines the differences between wellness apps and mobile medical apps, highlighting the upcoming FDA guidance on mobile medical apps. Additionally, the document reassures that government regulations are manageable and provides links to relevant resources.

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anatomy of the (mobile) beast
Jess Jacobs. @jess_jacobs
Chair, FedTel Technology, Innovation, and Standards
May 14, 2013

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How do I not feel like this guy?
It’s (really not) a trap!

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1. Know the Need

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2. Use Common Sense
 Communication: FCC
 No Jamming
 No Intercepting
 Meet technical specs
 Consumers: FTC
 No Crazy Claims
 Be careful what info you
collect from kids
 Don’t lose health info
 (HHS’s OCR)
 Competition: USPTO
 No infringement

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3. Know if you’re wellness app or a
mobile medical app
Device Not a Device
Diagnose, Cure, Mitigate, Treat,
Prevent a Disease/Condition.
General Wellness

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Mobile Medical Apps (devices)
Displaying, Storing, or
Transmitting
Controlling connected
medical devices
Mobile platform
transformation
Interpretation of Medical
Device Data

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The Future is getting clearer…
 FDA Mobile Medical Apps Guidance (MMA)
 Should be finalized by out September 2013.
 FDA Safety and Innovation Act 2012, Section 618
 FDA, FCC, ONC will coordinate on regulatory framework.
 Recently announced FACA membership

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But reality isn’t half bad
FDA
cleared
MMA a
year
20
Days to
get
cleared
by FDA
67
MMA
total.
Ever.
100

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4. The Government isn’t scary
(also, it’s filled with groupies)

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Resources
 FCC: http://www.fcc.gov/topic/health-care
 FTC: http://www.ftc.gov/
 FDA: http://www.fda.gov/medicaldevices/productsandmedicalprocedures/ucm255978.htm
 CMS: http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Meaningful_Use.html
 ONC: http://www.healthit.gov/policy-researchers-implementers/mobile-devices-roundtable-safeguarding-health-
information
 NIST: http://www.nist.gov/medical-devices-portal.cfm