anatomy of the (mobile) beast - health refactored
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anatomy of the (mobile) beast Jess Jacobs. @jess_jacobs
Chair, FedTel Technology, Innovation, and Standards
May 14, 2013
+How do I not feel like this guy?
It’s (really not) a trap!
+1. Know the Need
+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
+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
+Mobile Medical Apps (devices)
Displaying, Storing, or Transmitting
Controlling connected medical devices
Mobile platform transformation
Interpretation of Medical Device Data
+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
+But reality isn’t half bad
FDA cleared MMA a year
20Days to get cleared by FDA
67MMA total. Ever.
100
+4. The Government isn’t scary(also, it’s filled with groupies)
+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
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