+

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