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Taking Health on the Road


I delivered this presentation at the DTC National Conference in Washington DC. The presentation highlights the importance of mobile for people making decisions about their health and discusses how to …

I delivered this presentation at the DTC National Conference in Washington DC. The presentation highlights the importance of mobile for people making decisions about their health and discusses how to present information about FDA-regulated products in this important channel.

Published in Health & Medicine , Business
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  • 1. Taking Health on the Road Presented by Dale Cooke 22 April 2014
  • 2. 2 >  Rise & importance of mobile >  FDA mobile apps guidance >  Mobile medical device requirements >  Promotional labeling in mobile tactics >  Q&A Agenda
  • 3. Rise & importance of mobile
  • 4. Vatican 2005
  • 5. Vatican 2013
  • 6. Source: KPCB
  • 7. 7 91% of smartphone owners have their phone within arm’s length most of the time. (60% all the time)
  • 8. 8
  • 9. 9 of ALL children under two, are using mobile 38%
  • 10. 10 Mobile DRIVES of all internet traffic 28%
  • 12. 12 Consumers taking health on the road 10 20 28 61 75 95 15 29 45 2008 2009 2010 2011 2012 2013 Mobile health users Tablet health users Millions of consumers using mobile devices for their health SOURCE: Manhattan Research, The Cybercitizen Health™ (2013)
  • 13. 13 STUDY REPORT: Consumer Use of Smartphones for Condition Related Health Activities Prepared by
  • 14. 9 out of 10 would “take” an app if a physician prescribed it.
  • 15. 15 2xMore likely to ask for a brand by name 80%more likely to switch medications Mobile use at the moment of truth
  • 16. FDA mobile apps guidance
  • 17. 17 Medical DevicesAdvertising & Promotion What is this thing?
  • 18. 18 FDA is here to help DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf See also, Guidance-Finalized Released September 2013
  • 19. 19 MMA guidance Mobile Medical App (MMA) defined as: “a mobile app that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); and either is intended: • to be used as an accessory to a regulated medical device; or • to transform a mobile platform into a regulated medical device.” —FDA Guidance for Industry: Mobile Medical Applications, page 7
  • 20. 20 DH LifeBrands is also here to help
  • 21. 21 CDRH will focus its regulatory efforts on apps that: >  Are accessories to a regulated medical device >  Transform the mobile device into a medical device >  Perform patient-specific analysis and provide patient- specific treatment recommendations
  • 22. 22 “Some mobile apps may meet the definition of a medical device but because they pose a lower risk to the public, FDA intends to exercise enforcement discretion over these devices (meaning it will not enforce requirements under the FD&C Act)” —FDA Guidance for Industry: Mobile Medical Applications, page 4
  • 23. 23 Regulatory discretion FDA is asserting two things: 1.  FDA has the legal authority to enforce legal and regulatory requirements in that area. 2.  FDA will not use that authority.
  • 24. 24 Can we rely on this? —FDA Mobile Apps Twitter Chat, September 26, 2013
  • 25. 25 •  Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions; •  Provide patients with simple tools to organize and track their health information; •  Provide easy access to information related to patients’ health conditions or treatments; •  Help patients document, show, or communicate potential medical conditions to health care providers; •  Automate simple tasks for health care providers; or •  Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems. —FDA Guidance for Industry: Mobile Medical Applications, page 16
  • 26. Medical device requirements
  • 27. 27 > Medical device manufacturer registration > Class determination (I, II, or III) > Validated development environment and/or quality systems in place > Investigational Device Exemption filing requirements > 510(k) or PMA filing with FDA likely required > Postmarketing reporting requirements Meeting medical device requirements
  • 28. Promotional labeling in mobile tactics
  • 29. 29 Mobile apps can be advertising platforms (e.g., The New York Times app, Doximity) When the underlying app discusses health, the same rules apply >  Is it a medical device? >  Does regulatory discretion apply? >  Is your paid placement an advertisement or part of the app’s core functionality? Mobile apps as promotional platforms
  • 30. 30 Promotional labeling requirements Product Promotion Requirements >  Product Name Usage >  Fair Balance >  Indication Statement >  Adequate Provision (Directions for Use) >  MedWatch Statement >  Beware turning your app into a regulated device via promotion! Four Types of Communication > Reminder Ads > Product Promotions > Redirecting Communications > Disease Awareness Communications
  • 31. 31 But what about mobile promotion? Unique considerations for mobile promotion >  Device size >  Device variability >  Screen rotation >  Technology changes (Go away, Flash!) >  Screen takeover >  Touch screen interface >  Integration with the rest of the device (GPS, calendar, reminders, accelerometer, etc.)
  • 32. Questions? Dale Cooke VP/GD, Regulatory @PhillyCooke on Twitter
  • 33. 33 Dale Cooke VP/Group Director, Regulatory Dale Cooke is the head of the regulatory department for Digitas Health LifeBrands. He has worked with more than 30 pharmaceutical and medical device clients around the world from offices in Philadelphia, New York, Boston, San Francisco, and London. Dale advises clients on FDA enforcement actions and provides recommendations for compliance with FDA regulations, with a focus on issues involving the Internet and emerging technology. His insights have been featured in the Wall Street Journal’s Health blog, The Pink Sheet, MedAdNews, PharmExec, and others. Dale is an active member of the Regulatory Affairs Professionals Society (RAPS), Drug Information Association (DIA), Food and Drug Law Institute (FDLI), and the Alliance for a Stronger FDA. He also serves on the faculty of the University of California San Francisco’s American Course in Drug Development Regulatory Sciences program. Dale is the author of Effective Review and Approval of Digital Promotional Tactics, which is part of the FDLI’s primer series. He is regularly invited to speak at industry conferences on topics including FDA enforcement trends, best practices for review processes, global review practices, and life sciences use of social media. Dale earned his B.A. in Philosophy from Southern Methodist University and an M.A. in Analytical Philosophy from the University of Arizona and studied Epidemiology and Biostatistics at Drexel University’s School of Public Health and Healthcare Compliance at Seton Hall University’s School of Law.