This document discusses ensuring patient safety and transparency of information in mobile health (mHealth) applications. It summarizes the benefits of mHealth, such as reduced healthcare costs and increased access to care. However, it also outlines risks like privacy breaches, inaccurate medical advice, and inappropriate clinical actions. The document proposes a quality and safety certification for mHealth apps in Andalusia to promote transparency and minimize risks. It advocates for an open data model and integration of certified apps within the public health system to optimize clinical processes while engaging citizens and entrepreneurs.

1. “Ensuring Patient Safety and Transparency of Information”
Javier Ferrero Álvarez-Rementería
javier.ferrero@juntadeandalucia.es
20th January 2016
Unlocking the Potential of Mobile Health in Europe:
Removing Barriers to the Empowerment of Citizens

2. Andalusian Public Health System
Andalusia
The andalusian public health service
Andalusia
Surface: 87.597 Km2
Population: 8.302.323 hab.
+ 21 M tourists/year
Primary Care Centres
Public Hospitals
Healthcare Professionals
Pharmacies
1.514
48
102.000
3.602

3. Andalusian Public Health System
95 M appointments/year
121 M e-prescriptions/year
8.24 M individual eHR
Professional
competences
Process
Management
Clinical
Management
eHR
The andalusian public healthcare model
Patient-centered model

4. Fundación pública perteneciente a la Consejería de Salud
encargada de promover y desarrollar políticas de calidad y
seguridad en el Sistema sanitario público de Andalucía
www.juntadeandalucia.es/agenciadecalidadsanitaria
The Andalusian Agency
for Healthcare Quality
The Andalusian Agency for Healthcare Quality

5. Luca Bruno /AP
mHealth: Introduction

6. Michael Sohn /AP
mHealth: Introduction

7. Gutenberg Moment
Eric Topol
January 2016
Healthcare is having its ‘Gutenberg
Moment’, right now.
This is driven by the adoption of
smartphones and is going to continue to
disrupt the common paternalism in the
doctor-patient relationship
mHealth: Benefits…

8. mHealth: Benetifs…
Huge benefits…
 500 million people will use apps by 2015
 100.000 m€ savings in European Budget by adoption of mHealth in 2017 (1)
 18% Healthcare cost reduction per capita in Europe and
up to 35% in chronic patients in 2017
(1) GSMA 2013. Socio-economic impact of mHealth: An assessment report for the European Union
(2) Adam Cohen, Google european responsible for strategy and communitary services, press release 6/5/15
81% (2)
75%

9. Starting with appointments…
644.012 citizens
792.204 downloads
3.318.486 APPointments
Savings: 0,65 Eur/appointment*
* With respect to an appointment through phone call
Dec’13 – Jun’15:
mHealth: Benefits

10. Ensure that technology is safe and
optimized to improve patient safety
“Optimizing the safety benefits and
minimizing the unintended consequences of
health IT is critical.”
December 2015
Fifteen years after To err is human…
mHealth: Patient safety

11. Lewis T, Wyatt J “mHealth and Mobile Medical Apps: A Framework to
Assess Risk and Promote Safer Use” J Med Internet Res 2014 Sep; 16
(9): e210
• Loss of privacy
• Poor quality patient data
• Inaccurate or out or date content
• Lack of feedback or failsafe
mechanism
• Inappropiate app usage
• Poor clinical decision
• Inappropiate clinical action
•…
Different types or risk
mHealth: Risks…

12. 3 out of 4 apps fail at detecting
more than 30% of melanomas…
mHealth: Risks

13. mHealth: Risks

14. 11600 downloads
Cost 1,99$
Net income (detracting Apple’s fee) 16158$
Conciliation fine 14294$
mHealth: Risks

15. mHealth: Risks

16. mHealth: Regulation
The need for “regulation”

17. mHealth: Regulation
The need for
“regulation”

18. Most commonly used criteria in International health Apps awards…
• Social impact and value for end users
• Innovation, creativity and originality
• Functional prototype to be tested.
• Economical and finantial viability
• Quality of content
• Ease of use: navigation and orientation
• Quality of design: stetic value of graphics, music and sounds
• Functionalities
• Technical quality: performance, stability, …
Jury usually composed by marketing, mobility, technology, business, consulting
profiles… but…
mHealth: Quality acknowledgement

19. mHealth: Andalusian strategy for quality and safety in mobile health
Andalusian strategy in mHealth
2012
2013
www.calidadappsalud.com

20. https://ec.europa.eu/digital-agenda/en/news/journal-mhealth-available
mHealth: Andalusian strategy for quality and safety in mobile health

21. http://www.calidadappsalud.com/distintivo-appsaludable
- Free.
- For any health app: private and public, national or international.
- Self-assessment and Assessment methodology.
mHealth: Quality and safety certification
A labelling system for mobile health apps in
order to promote a reliable and safe use,
minimizing risks.

22. mHealth: Quality and Safety certification

23. mHealth: Quality and Safety certification

24. Recommendations aimed to:
- Reinforce liability of app contents.
- Inform about app responsibles.
- Explain about sources of information and scientific evidence.
- Declare sources of funding, as well as coflicts of interests.
- Ask for a patient safefy risk management and notification methodology
www.calidadappsalud.com
Block 2: 11 recommendations
Transparency of information and patient safety
mHealth: Quality and Safety certification

25. Only a few apps… but
a strict and rigurous
schema
mHealth: Quality and Safety certification

26. (1) GSMA 2013. Socio-economic impact of mHealth: An assessment report
for the European Union
research2guidance: Global Mobile Health Market Report 2010-2015
mHealth: Perspective of use within HCPs

27. 2013 - 2014
mHealth: Piloting integration and personalisation

28. Andalusian mHealth
Corporate Repository
Certification
Integration
Pertinence
Personalization
Commercialization
Clinical Process
Optimization
3rd party apps
2014-2016
mHealth: Integration and personalisation
Open Data Model
Large scale deployment

29. mHealth Service hub for citizens
Currently
1.000.000 users
mHealth: Personalisation
Reimbursement models with up to 8,5 Millions users

30. A new (wider) integration model is needed…
• Currently, interoperability
model is based on
international standards (HL7,
IHE, Dicom…)
• A very high specialisation
level is required.
• Unreachable and
unaffordable for mobile and
R+D+i initiatives
mHealth: Open data model

31. Public Procurement: “Open data” model
Enterpreneurs
SMEs
mHealth: Open data model
Self-registry web portal
API management

32. https://www.youtube.com/watch?v=Z1b8yGuZyk0
“…getting the most complete list of medicines … improving
adherence and reducing mistakes…”
https://www.youtube.com/watch
?v=dwkRCNauQQI
mHealth: Some examples (patient safety)
“…the more
questions… the
least risks…”
“…engaging
patients…prechir
urgical
verification lists”
“…first… do not
harm”
https://www.youtube.com/
watch?v=iLEDQ4lKOos

33. mHealth: Open Innovation
Challenges… why not?

34. Challenges… why not?
mHealth: Open Innovation
Hackathon
http://www.juntadeandalucia.es
/agenciadecalidadsanitaria/reto
-msspa/
https://www.youtube.com/watch?v=JJjIN_GDfS0

35. …from a public HCP point of view…
 Urgent to raise awareness on quality and safety in mHealth
 More (interoperable) certification initiatives and not so many popular app
crowded directories
 From a public HCP point of view, far from blocking, regulation is an innovation
enabler
 Easy to build up some mHealth services with a quick ROI
 Necessary to connect - and optimise - clinical processes to mHealth services
 Delicate to talk about clinical open data, but it is possibly the only way to
catch up with citizen demands
mHealth: Some conclusions

36. www.calidadappsalud.com
@CalidadAppSalud
facebook.com/CalidadAppSalud
Thank you very much!
javier.ferrero@juntadeandalucia.es