Ensuring Patient Safety and transparency of information

“Ensuring Patient Safety and Transparency of Information”

Javier Ferrero Álvarez-Rementería

[email protected]

20th January 2016

Unlocking the Potential of Mobile Health in Europe: Removing Barriers to the Empowerment of Citizens

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

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

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

Luca Bruno /AP

mHealth: Introduction

Michael Sohn /AP

mHealth: Introduction

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…

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%

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

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

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…

3 out of 4 apps fail at detecting more than 30% of melanomas…

mHealth: Risks

mHealth: Risks

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

mHealth: Risks

mHealth: Risks

mHealth: Regulation

The need for “regulation”

mHealth: Regulation

The need for “regulation”

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

mHealth: Andalusian strategy for quality and safety in mobile health

Andalusian strategy in mHealth

2012

2013

www.calidadappsalud.com

https://ec.europa.eu/digital-agenda/en/news/journal-mhealth-available

mHealth: Andalusian strategy for quality and safety in mobile health

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.

mHealth: Quality and Safety certification

mHealth: Quality and Safety certification

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

Only a few apps… but a strict and rigurous

schema

mHealth: Quality and Safety certification

(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

2013 - 2014

mHealth: Piloting integration and personalisation

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

mHealth Service hub for citizens

Currently 1.000.000 users

mHealth: Personalisation

Reimbursement models with up to 8,5 Millions users

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

Public Procurement: “Open data” model

Enterpreneurs

SMEs

mHealth: Open data model

Self-registry web portal API management

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…prechirurgical verification lists”

“…first… do not harm”

https://www.youtube.com/watch?v=iLEDQ4lKOos

mHealth: Open Innovation

Challenges… why not?

Challenges… why not?

mHealth: Open Innovation

Hackathon

http://www.juntadeandalucia.es/agenciadecalidadsanitaria/reto-msspa/

https://www.youtube.com/watch?v=JJjIN_GDfS0

…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

www.calidadappsalud.com @CalidadAppSalud

facebook.com/CalidadAppSalud

Thank you very much!

[email protected]