+anatomy of the (mobile) beastJess Jacobs. @jess_jacobsChair, FedTel Technology, Innovation, and StandardsMay 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 Clai...
+3. Know if you’re wellness app or amobile medical appDevice Not a DeviceDiagnose, Cure, Mitigate, Treat,Prevent a Disease...
+Mobile Medical Apps (devices)Displaying, Storing, orTransmittingControlling connectedmedical devicesMobile platformtransf...
+The Future is getting clearer… FDA Mobile Medical Apps Guidance (MMA) Should be finalized by out September 2013. FDA S...
+But reality isn’t half badFDAclearedMMA ayear20Days togetclearedby FDA67MMAtotal.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/pr...
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Anatomy of the (mobile) Beast - Health Refactored

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

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Anatomy of the (mobile) Beast - Health Refactored

  1. 1. +anatomy of the (mobile) beastJess Jacobs. @jess_jacobsChair, FedTel Technology, Innovation, and StandardsMay 14, 2013
  2. 2. +How do I not feel like this guy?It’s (really not) a trap!
  3. 3. +1. Know the Need
  4. 4. +2. Use Common Sense Communication: FCC No Jamming No Intercepting Meet technical specs Consumers: FTC No Crazy Claims Be careful what info youcollect from kids Don’t lose health info (HHS’s OCR) Competition: USPTO No infringement
  5. 5. +3. Know if you’re wellness app or amobile medical appDevice Not a DeviceDiagnose, Cure, Mitigate, Treat,Prevent a Disease/Condition.General Wellness
  6. 6. +Mobile Medical Apps (devices)Displaying, Storing, orTransmittingControlling connectedmedical devicesMobile platformtransformationInterpretation of MedicalDevice Data
  7. 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
  8. 8. +But reality isn’t half badFDAclearedMMA ayear20Days togetclearedby FDA67MMAtotal.Ever.100
  9. 9. +4. The Government isn’t scary(also, it’s filled with groupies)
  10. 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

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