4 tips for mobile developers given at Health Refactored on May 14, 2013 on the federal mobile regulatory space.

1. +
anatomy of the (mobile) beast
Jess Jacobs. @jess_jacobs
Chair, FedTel Technology, Innovation, and Standards
May 14, 2013

2. +
How do I not feel like this guy?
It’s (really not) a trap!

3. +
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

5. +
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

6. +
Mobile Medical Apps (devices)
Displaying, Storing, or
Transmitting
Controlling connected
medical devices
Mobile platform
transformation
Interpretation of Medical
Device Data

7. +
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

9. +
4. The Government isn’t scary
(also, it’s filled with groupies)

10. +
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