What's life sciences' take on the booming app industry? If regulatory has anything to do with it, it'll start with a whole lot of responsible development.

1. Regulatory Story
Mobile Medical Apps (MMAs)

2. Mobile apps are everywhere
Is Pharma ready for its challenges?

3. On a mission to breathe digitalife into
life sciences through technological –
and humanistic – empowerment of
patients, HCPs, and other healthcare
stakeholders.
www.nadjabester.com
Nadja Bester
Group Digital Marketing Associate
at Aspen Pharmacare
@NadjaBester
Hello!

4. Is Pharma ready for its challenges?
Our findings indicate
that the long-
expected mobile
revolution in
healthcare is set to
happen. Both
healthcare providers
and consumers are
embracing
smartphones as a
means to improve
healthcare.
Ralf-Gordon Jahns,
Head of Research at
researche2guidance.

5. MMAs and Their Regulatory Story
1 Stakeholders in MMAs
2 Which MMAs are Regulated, and How?
3 Risks Posed by MMAs
4 The Way Forward
© Nadja Bester

6. Regulatory Enforcement Guidelines
FDA on MMA’s
© Nadja Bester

7. The reality is that apps can pose a serious threat to
patients' health if and when it doesn't function as intended

8. Stakeholders in MMAs
PART ONE
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9. Policymakers
acknowledge
benefits of MMAs
Big step
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10. FDA released
final guidelines
Key Action
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11. Payers starting
to reimburse apps
Monetary value
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12. Doctors suggest
apps to patients
Adoption
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13. Patients use apps
to improve health
Drivers
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14. Which MMAs are
Regulated, and How?
PART TWO
© Nadja Bester

16. Apps most heavily regulated by FDA:
Apps operating as medical devices that can
directly affect a patient's health outcomes
© Nadja Bester

17. Apps least heavily regulated by FDA:
Low-risk info systems that transmit published
health info / provide general education tools
© Nadja Bester

18. Apps least heavily regulated by FDA:
Disease-self-management tools that don’t provide
specific treatment / treatment suggestions.
© Nadja Bester

19. Apps least heavily regulated by FDA:
Patient tools to organise and track health information.
© Nadja Bester

20. Apps least heavily regulated by FDA:
Document, show, or communicate
potential medical conditions to HCPs.
© Nadja Bester

21. Apps least heavily regulated by FDA:
Apps that provide medication reminders
© Nadja Bester

22. Apps least heavily regulated by FDA:
Simple task automation for HCPs.
© Nadja Bester

23. Apps least heavily regulated by FDA:
Patients’ or providers’ interaction with personal health
records (PHR) or electronic health records (EHR).
© Nadja Bester

24. Grey areas in FDA’s MMA Regulation:
Apps that link to patients‘
medication ordering systems
© Nadja Bester

25. Grey areas in FDA’s MMA Regulation:
Clinical decision support (CDS) apps
© Nadja Bester

26. CDS used in conjunction
with certain products =
drug labelling
 drug advertising and promotion rules apply  © Nadja Bester

27. "FDA intends to apply its regulatory oversight to only those mobile apps that
are medical devices and whose functionality could pose a risk to a patient’s
safety if the mobile app were to not function as intended. The FDA believes
that this subset of mobile medical apps poses the same or similar potential
risks to the public health as currently regulated devices if they fail to
function as intended.
"FDA Guidelines on Regulatory Enforcement Approach to Mobile Medical Applications
© Nadja Bester

28. Risks Posed by MMAs
PART THREE
© Nadja Bester

29. "If a mobile app is intended for use in performing a medical device function
(i.e. for diagnosis of disease or other conditions, or the cure, mitigation,
treatment, or prevision of disease) it is a medical device, regardless of the
platform on which it is run.
"FDA Guidelines on Regulatory Enforcement Approach to Mobile Medical Applications
© Nadja Bester

30. When Pharma does MMAs,
it needs to get done RIGHT

31. Case Study:
Pfizer’s Rheumatology Calculator
Recalled due to ‘buggy’ software
SAFEGUARD:
Software diagnosis =
EU Class IIA / FDA Class I
CDS apps  IEC 62304 standard requirements
© Nadja Bester

32. Case Study:
Janssen’s PASI MMA
Issued Raised:
Legal disclaimers:
• Not to rely on data
to make diagnoses
• MMA’s status on data collection
Technical details:
• Equation scores used
in MMA calculators
© Nadja Bester

33. The Way
Forward
PART FOUR
© Nadja Bester

34. Development of MMAs is in its infancy.
Innovation is the way of the future,
but in life sciences, think before you leap.
© Nadja Bester

35. Is it wanted?
Don’t develop an app you think someone needs.
© Nadja Bester

36. Is it legal?
Be ingenious but stay within bounds.
© Nadja Bester

37. Is it safe?
Don’t go messing with people’s lives.
They only have one.
© Nadja Bester

38. Is it the best way to build your brand?
Don’t develop MMAs for the sake of doing it.
Identify a real need, then have your app fill it.
© Nadja Bester

39. THANK YOU!
Listening is a skill,
and you rocked it!