medical mobile apps: the regulatory story
TRANSCRIPT
Regulatory Story
Mobile Medical Apps (MMAs)
Mobile apps are everywhere
Is Pharma ready for its challenges?
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!
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.
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
Regulatory Enforcement Guidelines
FDA on MMA’s
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The reality is that apps can pose a serious threat to patients' health if and when it doesn't function as intended
Policymakers acknowledge
benefits of MMAs
Big step
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Payers starting
to reimburse apps
Monetary value
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Apps most heavily regulated by FDA:
Apps operating as medical devices that can directly affect a patient's health outcomes
© Nadja Bester
Apps least heavily regulated by FDA:
Low-risk info systems that transmit published health info / provide general education tools
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Apps least heavily regulated by FDA:
Disease-self-management tools that don’t provide
specific treatment / treatment suggestions.
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Apps least heavily regulated by FDA:
Patient tools to organise and track health information.
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Apps least heavily regulated by FDA:
Document, show, or communicate
potential medical conditions to HCPs.
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Apps least heavily regulated by FDA:
Apps that provide medication reminders
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Apps least heavily regulated by FDA:
Simple task automation for HCPs.
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Apps least heavily regulated by FDA:
Patients’ or providers’ interaction with personal health
records (PHR) or electronic health records (EHR).
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Grey areas in FDA’s MMA Regulation:
Apps that link to patients‘
medication ordering systems
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Grey areas in FDA’s MMA Regulation:
Clinical decision support (CDS) apps
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CDS used in conjunction
with certain products =
drug labelling
drug advertising and promotion rules apply © Nadja Bester
" 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
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" 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
When Pharma does MMAs,
it needs to get done RIGHT
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
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
Development of MMAs is in its infancy.
Innovation is the way of the future,
but in life sciences, think before you leap.
© Nadja Bester
Is it wanted?
Don’t develop an app you think someone needs.
© Nadja Bester
Is it legal?
Be ingenious but stay within bounds.
© Nadja Bester
Is it safe?
Don’t go messing with people’s lives.
They only have one.
© Nadja Bester
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
THANK YOU! Listening is a skill, and you rocked it!