the sorry state of pharma mobile health apps & what to do about it

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© 2015 Pharmaguy™ The Sorry State of Pharma Mobile Health Apps & What To Do About It PharmaGuy Social Media in the Pharmaceutical Industry 21 - 22 Jan 2015 * London, UK

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© 2015 Pharmaguy™

The Sorry State of Pharma Mobile Health Apps & What To Do About It

PharmaGuy

Social Media in the

Pharmaceutical Industry21 - 22 Jan 2015 * London, UK

© 2015 Pharmaguy™2

The Sorry State of Pharma Mobile Apps

#1: Low Functionality

16,000+ Consumer

Health Apps90%

Score

Below 40

© 2015 Pharmaguy™3

The Sorry State of Pharma Mobile Apps

#2: Low Number of Downloads

© 2015 Pharmaguy™4

The Sorry State of Pharma Mobile Apps

#3: Undocumented, Untested Efficacy

“At the moment,” said Carolyn Gauntlett,

Senior Innovation Consultant with IMS Health,

“we have a profusion of healthcare apps with

undocumented efficacy and basically existing

in a vacuum of scientific evidence.”

Janssen PASI Calculator did not cite the source used to perform calculations

Pfizer’s Rheumatology Calculator App recalled via “Dear Doctor” letter because of a “bug in the app ... gives wrong results.”

Were these apps tested and certified by a third-party?

© 2015 Pharmaguy™5

The Sorry State of Pharma Mobile Apps

#4: Unreliable eHealth Data Management

“Ambitious app designs are being stuck down by internal medical/legal

reviews because of concerns about the storage and use of healthcare data,”

said Gauntlett.

© 2015 Pharmaguy™6

1. Develop “FDA Approved” Apps

2. Submit to 3rd-Party Ratings and/or Certification

3. Involve Patient Advocates

4. Adopt Self-Regulatory Industry Guidelines

5. Consider Alternative Roles in the mHealth Market

What To Do About It

© 2015 Pharmaguy™

Easy entry into

mHealth offers

incredible opportunity

for innovation in

healthcare; however,

the open market comes

with certain concerns...

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Who’s Your App Developer?

© 2015 Pharmaguy™8

WARNING!

Silicon Valley developers are novices when it comes to FDA regulations

Anne Wojcicki, CEO of 23andMe, creator of “Spit for Science,” for example, ignored FDA for the sake of preserving the “customer experience.”

FDA Regulation?

© 2015 Pharmaguy™

Most Apps Won’t Require FDA Regulation

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© 2015 Pharmaguy™10

Independent Ranking/Certification:

#FAIL?

IMS Health mentions

“certifications” as part

of its mHealth App

ranking process. But

certification programs

are tricky, resource

intense, and prone to

failure.

© 2015 Pharmaguy™11

#mHealthPharma Tweet Chat

“Having patient's perspective ...

from the very beginning is key

to achieve success.”

“Get grassroots patients to help

design, then they will be more

likely to download, use and

promote.”

“Give the patient what they

want instead of what pharma

wants to give them.”

“Industry rarely co-creates tools

collaboration w/actual patients.

If they did, apps will improve,

guaranteed.”

© 2015 Pharmaguy™12

A Formula for Patient-Centric mHealth Apps

Quality mHealth App = Satisfy Patients’ Needs§ +

Transparency + Reliable Health Data Management*

§Satisfy Patients’ Needs =

Useful Functionality + Efficacy

*Reliable Health Data Management =

Good Privacy Practices + Data Security

© 2015 Pharmaguy™13

To get the perspective of patient

advocates, Pharma Marketing

News accessed the Truvio health

consumer influencer panel in

August, 2014. Truvio is powered

by the WEGO Health Activist

Network of more than 100,000

opted-in and vetted consumer

health influencers from more than

130 health conditions and topics.

Involve Patient Advocates

We asked: “In your opinion, what can the pharma industry do to ensure

that the mobile apps it develops meet the highest possible ethical

standards? Should the industry develop mhealth Guiding Principles? If

so, what organizations/individuals should help develop such

principles? If not, why not?”

© 2015 Pharmaguy™14

“Patient advocates have the patients' best

interests at heart and, know what patients

would feel comfortable with and what they

wouldn't. They would be the ones that

would be familiar with what a person with a

chronic illness is going to want in an

application.”

“Pharma can show some real

leadership here and build some

trust with patients by getting in

front of this before they are

made to do it.”

“The more mobile health apps are able to

do things for us, the more a need arises to

have guiding principles. Who better to

come up with these and enforce them than

the big pharma companies who developed

the apps?”“While I do think developing a

set of standards for mobile

health apps is very wise, I don't

think it should be developed by

pharma in any way.”

“My suggestion is that the major patient advocate associations ... convene a

pharmaceutical round table ... to look at these apps, and to give some

guidance to the drug industry. But I'd hate to see the consumer friendly nature

of this be so over-regulated that we end up with nothing.”

Some Comments from Patient Activists

© 2015 Pharmaguy™15

Full Disclosure

Assure Accuracy

Informed Consent

Good Privacy Practices

Data Security Assurance

Regulatory Compliance

HIPAA Compliance (where applicable)

PhRMA mHealth Guiding Principles?

Should PhRMA pro-actively develop “Guidelines for Mobile Health Apps

Developed by the Pharmaceutical Industry” in much the same manner

as it developed DTC advertising guidelines?

Based on eHealth Code of Ethics

© 2015 Pharmaguy™16

Pharma mHealth Best Practices Survey

Should Pharma

develop best

practices or self-

regulatory

guidelines for

developing

trustworthy

mHealth apps for

consumers and

physicians?

© 2015 Pharmaguy™

Get Out of the App Publishing Business

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© 2015 Pharmaguy™

The Sorry State of Pharma mHealth Apps; http://bit.ly/mobcat-pmn1304-02

“Leaky” Pharma Mobile Apps; http://bit.ly/LeakyPharmaApps

Many Smartphone Apps Lack Privacy Policies; http://bit.ly/PharmaAppPrivacy

Pharma mHealth App Best Practices Survey; http://bit.ly/PharmaMoSurvey

Patients Demand High Quality mHealth Apps; http://bit.ly/pmn1307-01

#mHealtMobile Chat Takeaway; http://bit.ly/mHeathChat

LinkedIn Debate; http://bit.ly/LinkedInDebate

eHealth Code of Ethics; http://www.virsci.com/code0524.pdf

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Resources

© 2015 Pharmaguy™19

Thank You!

http://bit.ly/PGpioneer