mHealthBelgium Belgian Platform for mobile applications · •Development of a vision and of a...

Minister van Sociale Zaken en VolksgezondheidMinistre des Affaires sociales et de la Santé publique

MAGGIE DE BLOCK

Minister van Sociale Zaken en Volksgezondheid,Ministre des Affaires sociales et de la Santé publique, Maggie De Block

mHealthBelgiumBelgian Platform for mobile applications

Vitalis-Gothenburg, Mai 2019

Etienne Maerien

eHealth advisor


2 important pillars in Belgian eHealth-ict landscape

07/05/2019- 2 -

Dedicated federal administration Inter-federal eHealth-roadmap


1st Pillar: the eHealth platform 07/05/2019- 3 -


www.ehealth.fgov.be/ehealthplatform/nl/reglementen07/05/2019- 4 -

Legal entity


10 Tasks

• Development of a vision and of a strategy for eHealth

• Organization of the cooperation between all governmental institutions which are charged with the coordination of the electronic service provision

• The motor of the necessary changes for the implementation of the vision and the strategy with regard to eHealth

• Determination of functional and technical norms, standards, specifications and basic architecture with regard to ICT

07/05/2019- 5 -


10 Tasks

• Registration of software for the management of electronic patient files

• Managing and coordinating the ICT aspects of data exchange within the framework of the electronic patient files and of the electronic medical prescriptions

• Conceptualization, design and management of a cooperation platform for secure electronic data exchange with the relevant basic service

07/05/2019- 6 -


10 Tasks

• Reaching an agreement about division of tasks and about the quality standards and checking that the quality standards are being fulfilled

• Acting as an independent trusted third party (TTP) for the encoding and anonymisation of personal information regarding health for certain institutions summarized in the law for the support of scientific research and the policymaking

• Promoting and coordinating programmes and projects

07/05/2019- 7 -


Infrastructure: Overall architecture

Basic services eHealth platformNetwork

Patients, health care providers, health facilities

VAD VADVAD

Suppliers

Users

eHealthportal

Health portal

VASSoftware

health facility

VASMyCareNet

VAS

Software HC provider

Site NIHDI

VAS

VADVADVAD

VAS

07/05/2019- 8 -


Approved means of authentication

Security codevia SMS, user-id + password

User-id + password

Weak

Security code on paper (paper token), user-id + password

Strong

eID + PIN-code with connected card reader

Security codevia mobile app, user-id + password

SIM card withPIN-code

eID + PIN-code with wireless card reader

07/05/2019 - 9 -


Basic services eHealth platform

Coordination of digital subprocesses

PortalIntegrated user and access management

Management of logsSystem for end-to-end encryption

eHealthBox

TimestampingEncryption andanonymization

Consultation of the National Register and the CBSS Registers

Reference directory (metahub)

07/05/2019- 10 -


Hubs & Metahub

• System to make medical data available between health care providers– consultation and operation reports– discharge letters– protocols of medical imaging and results of lab tests– SumEHRs, medication schedules, … in health vaults– ...

• Objective– linking regional and local exchange systems of medical data (hubs)– possibility for health care providers to retrieve and consult the

available electronic medical files regarding a specific patient, irrespective of • the location where these documents are stored • the location where the health care provider logs into the system

07/05/2019- 11 -


Hubs & Metahub - Scheme

4 hubsThe Collaborative Care Platform (in Dutch: Cozo)Flemish Hospital Network KU Leuven (in Dutch: VZN)Health Network of Wallonia (in French: RSW)Brussels Health Network (in French: RSB)

07/05/2019 - 12 -


Hubs & Metahub

• Situation 2019– system for sharing data and documents by general and

psychiatric hospitals and Labo via the following 4 hubs• the Collaborative Care Platform (in Dutch: Cozo)

• Flemish Hospital Network KU Leuven (in Dutch: VZN)

• Health Network of Wallonia (in French: RSW)

• Brussels Health Network (in French: RSB)

– reference to first-line documents (SumEHR, medication schedules...) via the 3 health vaults/metahub• Vitalink

• InterMed

• BruSafe

07/05/2019- 13 -


BEFORE: Hubs & Metahub07/05/2019- 14 -


A

CB

3. Retrieve data from hub A

4:

All data

available

Hubs & Metahub – since 2012

07/05/2019 - 15 -


A

C

B

InterMedBruSafe

Extramural data: vaults

07/05/2019 - 16 -


Hubs & Metahub

07/05/2019 - 17 -


Hubs & Metahub

07/05/2019 - 18 -


Data sharing consent07/05/2019- 19 -


Therapeutic/care relationships

• Definition: the relationship between a specific patient and one or more health care professionals involved in activities concerning diagnosis, prevention or care for the patient

• Examples of evidence of a therapeutic/care relationship– establishment of a GMF with a GP – consultation with an individual health care provider– hospitalization– supply of a medicinal product in a pharmacy– …

07/05/2019- 20 -


Access matrix07/05/2019- 21 -


Personal Health Viewer


Hubs & Metahub

07/05/2019 - 23 -


Approved means of authentication

Security codevia SMS, user-id + password

User-id + password

Weak

Security code on paper (paper token), user-id + password

Strong

eID + PIN-code with connected card reader

Security codevia mobile app, user-id + password

SIM card withPIN-code

eID + PIN-code with wireless card reader

07/05/2019 - 24 -


2nd Pillar: eHealth Roadmaps• 2012: round table was organized on the further digitization of the

health care sector– about 300 people in the sector participated – a concrete eHealth action plan was drawn up for 5 years: roadmap

2013-2018

• 2015 > update: roadmap 2.0 (2015-2018)– 20 action areas with concrete objectives

• 2019 > roadmap 3.0 (2019-2021) has been elaborated with a focus on, amongst others– operational excellence: availability, performance, quality, chain

supervision, usability, training… – applications for citizens– support for innovation– international standards & terminology – …

-


Roadmap eHealth 2.007/05/2019- 26 -

Mobile Health pilot-projects


AP 19 = mHealth: why?

• Upcoming technology• Need for new framework

• Quality• Privacy• Evidence

• Goal = integrate mHealth applications in Belgian healthcare system


AP 19 = mHealth: evolution

Q3 2016

call for pilot projects with 5 themes

•Stroke

•Cardiovascular care

•Diabetes

•Mental health

•Chronic pain

Q2 2017

start pilot projects

Q2 2018

end evaluation + validation model to be defined


Mobile health app’s - validation pyramid

M3Requires M2 Positioned within Belgian health system Conditional financing (expert committee)

M2Requires M1Validated by administrations (or trusted third parties) Security - AuthenticationInteroperability Scientific evidence (publications)

M1CE certified as Medical deviceGDPR compliantBelgian privacy law compliant

BE mHealthValidation

CostBenefitTriple Aim

CE Medical device

07/05/2019 - 29 -


)

inspirationHapptique (FR)


31

Agoria paves the way for all technology-inspired companies in Belgium that increase our quality of life through the development and application of technological innovations.

BeMedTech is the Belgian Federation of themedical technology industry, the members are suppliers or distributors of medical devices (no pharma).


AP 19 = mHealth: evolution

Q3 2016

call for pilot projects with 5 themes

•Stroke

•Cardiovascular care

•Diabetes

•Mental health

•Chronic pain

Q2 2017

start pilot projects

Q2 2018

end evaluation + validation model to be defined

Q3 2018

launch mHealthBelgium

25/01/2019

platform live


mHealthBelgiumplatform

• www.mhealthbelgium.be

• In 3 languages: NL – FR – EN

• Information for

– Broad public

– Health care professionals

• List of validated apps

– No full market scan

– Company driven

33

http://www.mhealthbelgium.be/


……

……

Ministre des Affaires sociales et de la Santé publique, et de l’Asile et la Migration

MAGGIE DE BLOCK

Communiqué de presse

Vous cherchez une bonne application de santé ? mhealthBelgium vous aide à vous y retrouver

BRUXELLES, 25/01/2019. – Aujourd’hui, les premières applications de santé validées par les autorités publiques ont été publiées sur la plateforme www.mhealthbelgium.be.

Maggie De Block, ministre de la Santé publique : « Les applications peuvent apporter une plus-value aux patients et aux prestataires de soins. Le problème est que l’offre est tellement vaste qu’il est difficile de savoir si une application est fiable ou pas. Cette plateforme doit aider les citoyens et les prestataires de soins à s’y retrouver : à terme, ils auront un aperçu de toutes les applications validées par les autorités. »

Les quatre premières applications validées ont été publiées aujourd’hui sur la plateforme mhealthBelgium.be : il s’agit d’une application qui permet de détecter les troubles du rythme cardiaque, une application de convalescence destinée aux patients ayant subi une opération au genou ou à la hanche, une application visant à améliorer le suivi des patients atteints d’un cancer pendant leur chimiothérapie et une application permettant de suivre les personnes souffrant de troubles du sommeil et respiratoires.

Modèle de validation

Les applications répondent aux critères du niveau 1 du modèle de validation des autorités. Cela signifie qu’elles disposent du marquage CE, qu’elles sont conformes à la réglementation relative aux dispositifs médicaux et qu’elles répondent également aux normes européennes en matière de partage de données.

Le modèle de validation compte trois niveaux en tout (pour en savoir plus, cliquez ici).

Prestataires de soins et entreprises

La plateforme s’adresse non seulement aux citoyens, mais aussi aux prestataires de soins et aux entreprises. Les prestataires de soins y retrouveront de bonnes applications qu’ils pourront recommander sans crainte à leurs patients. Les entreprises pourront quant à elles y notifier leurs applications auprès des autorités afin de les faire valider.


I am a mobile medical IT-solution & CE-marked

STAKEHOLDER INTERACTION& TIMING

I am safely connected

RIZIV / INAMI

eHealth platform

FAGG / AFMPS Now active

I show clinical evidence & health economic impact





RIZIV / INAMI

eHealth platform

FAGG / AFMPS

Under developmentFull mode from Sept 2019

Now active






RIZIV / INAMI

eHealth platform

FAGG / AFMPS

case by case

Under developmentFull mode from Sept 2019

Now active



Situation now: 6 apps in level M1

+4 in pipeline


Future

• Platform▶ Further development with M2 test services

▶ Improve flows and enrich content (but keep it simple)

• Communication▶ Reach out & spread the word

▶ More apps on platform in different levels

▶ Connect via other websites / tools e.g. personal health viewer


Personal Health Viewer

Validatedmobile Health app’s


DATA

• Innovation in healthcare is data-driven▶ Clinical evaluation: validation

▶ Proof health-economic value

• Access to data is crucial !!▶ facilitate the re-use of many existing data resources in healthcare and avoid

silos

▶ Dataforbetterhealth.be

Future


DataforBetterHealth.be

mHealthBelgium Belgian Platform for mobile applications · •Development of a vision and of a...

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