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How FRANCE will cope with the new
expectations of the citizens regarding

      e-health and Patient Record

Michèle THONNET

Mission pour l ’Informatisation du Système de Santé (MISS)


                          Barcelona February 2007
Agenda
Health & ICT
characteristics of the french system
policy, strategy and reform (1996-2006)
goal, projects and objectives
roll out and current situation
ePMR (DMP)
lessons learned
we are part of Europe … and of the world
Reforming the H system : a necessity
    ageing population
    chronic diseases evolution
    citizen demands & needs transfo
    increasing costs of research,
    equipments, examinations, treatment
    pandemia expansion
    lack or shortage of HCP
    mobility of citizens & patients, …
    economic model
ICT : necessary but not sufficient
    medical informatics
    telematics
    telemedicine
    e-Health
    p-health
    connected health
    e-inclusion
          the most visible target   the eHR ...
Visible part : an iceberg ?
 techno. is attractive, speaking about is usual
 but cultural changes are key
  – more difficult to envisage
  – need more time and continuous efforts
  – change professional exercice, patient view
  – reorganise the actors relationships & positions
  – destabilize the present « system »
 team work needs exchange & sharing info….
 the ePMR :only a good enabler & trigger tool
The French health system



          Some characteristics
France and health system
 540 000 Km2    60 M inhabitants

 life expectancy : 75,2 M 82,7 W

 Global Expenditure per capita 2000 €

 1,7 M jobs in Healthcare
A complex system
A multitude of actors
– health insurance (compulsory complementary )
– 300 000 professionals (120 000 doctors), 23 000
  pharmacies ,
  4 000 laboratories
– 4000 hospitals, 1,1 million employees (50 000
  doctors)

…with a very large autonomy
1- A system that deserves its
appreciative rating ...
The first in the world according to WHO
(2000)…


… but with important internal inequalities

– social


– geographical
2- a high cost
 The national expenditure of health
  – 148 billion €uros, 8.8% of GDP
 one of most expensive among the
 developed countries
 A growth regularly stronger than the GDP
    + 5,2 % in 2001, ...
 Presumptions of inefficiencies
  – adequacy of the offer compared to the needs
Public policies for e-health in France




Objectives of the authorities
Government’s guidelines
To develop the assets of a policy for
(public) health


By improving the overall effectiveness
   policy followed by the introduction of the
  ICT is a variation of that
The main goal

Make use of ICT and Internet to
rationalize the healthcare system
 – for a healthier population


   • => to improve the level and quality of care
   • => by controlling the costs
Three types of projects

a first stage : SESAM-Vitale : (Administration)
– administrative simplification for refunding health
  expenses

a « corner stone » project to improve the
doctor-patient relationship : (Medical)
– electronic health record (EHR)

public health issue : (Information)
– to manage the consequences of the availability of the
  information to public (education, protection)
Four main objectives

To facilitate the continuity and the
coordination of the health care :

– electronic health records :protected access and transmission

– telemedicine

To improve access to knowledge :

– online state of the art for the professionals ( KB, EBM)

– quality of e-health sites
Four main objectives (2)

better know the reasons for recourse and
evaluate the expenditure
– piloting information systems (reorga H System)


better and quicker refunding

– administrative simplification : SESAM-Vitale
A continuous voluntarist strategy


 important investments


 an impact on the whole population


  – 55 million smart cards handed over
The roll-out scenario
  Starting point
                   administrative simplification
    with SESAM-Vitale, (infrastructure needed)

  … but investments need to serve the other
  more general goals

   Structural role of technical tools : HCP cards,
Insurance cards (Vitale), Internet standards, RSS,...
Public policies for e-health in
                    France : about TRUST




   Confidence requirement is key

Health is not a product like others

Securing data confidentiality
A specific status for health information
 The European Legislation 24 October 1995 (art 8)

  – prohibits any data processing without the consent of the person
  – except for the data absolutely necessary to the health professional
  – or those related to the management of health services, required by
    people exercing under professional secrecy


 The french Medical Privacy Act (4 february 2002)

  – transmission of personal information is authorized only between health
    professionals treating their mutual patients, and only with their prior
    consent (article L1110-4)
Confidentiality requirements
 To secure release and circulation of invoices
 (SESAM-Vitale)

  – authentification of the transmitter
  – signature of the person receiving benefits and the
    recipient
        choice of cards supports


 Soon significant volume of information will
 circulate
       necessity to invest in confidentiality
Confidentiality requirements

Two key issues to deal with, for the French
Government

– legislative : the Act of March 4th, 2002

– technical : smartcards, PKI, secured standardised network

Internet sites on e-health
– support self-regulation between bodies involved (users,
  professionals, economic actors)
                          the project « e-health quality »
A technical federator : infrastructure
  to exchange and share :The choice of Internet
  standard technologies, but protected

  for / with the HCP :The Health Professional Card
  (CPS)
  – (identify), authenticate, sign, coding


  for / the citizen :The recipient insurance card :
  – carte Vitale
Health Professional Card (CPS)
CPS
– an large roll-out ...
   • over 485 000 cards rolled-out
– a central role in the security of the system
   • authenticate the holder of the card :
      – identity HCP, qualifications, conditions of exercise
      – « Sésame » to reach to protected informations

   • electronic signature

   • protecting and coding messages
The health insurance card

The Vitale card

– easier
  • identify the holder :


– 55 million cards handed out to the citizens
Public policies for e-health in
                         France




The current situation
SESAM-Vitale
An increasing use :

– >80 million electronic invoices issued every
  month

– more than 65% of invoices

– 180 000 Professionals using the system

– a smooth and steady implementation
The electronic Patient Medical Record
ePMR . . . DMP


   An effective way to manage patient’s
   continuity of health care…

   … but which must offer all the
   guarantees of privacy
The role of the Authorities
   To support the development of the
   consensus
                finalities, contents, control of the uses

   To encourage experiments

   To build up the legislative framework

   To develop incentives, if necessary
Role and vision of the
                   Government

Three important innovations in the
law for the patient's rights

An important reform of the Health
Insurance

The ePMR (DMP)
The new law : three important innovations
  The new law : three important innovations


1- Direct access to personal medical
  informations (article L1111-7)

2 Securing confidentiality (article L1110-4)

3 Regulate by law the storage of personal
  EHR (article L1111- 8)
To enhance their development
The objective:

support the development of ePMR, used & shared

– information is produced by health professionals

– reviewed on line with strict conditions on the rights of access
  (ICT team)

– of which the use (and contents?) are controled by the patient

– which are stored securely under very strict conditions by
  accredited third party outside the premise of the MD
  (authorities)
13 August 2004 Act DMP (ePMR,...)
Coordination dossier ( 2007- implementation start)
– no replacment of the GP dossier
Strongly linked to the « patient act »
 – strict security policy & mechanisms
 – patient control on the access
   • authorised access for HCP habilited
   • direct access to medical data by patient
 – mandatory labelisation of the storage places,
   which are not allowed to accesss to medical data
Four question marks                ????

Optimal level of confidentiality

Identification of the patient

Control of the access by the patients

Technical options
The objectives of the ePMR (DMP)
 • to offer over 2007:
     –the same ePMR for all, under the control of
      the patient
     –an ePMR compliant to the law(s): improvment
      of the care ‘ circuit ’, avoiding iatrogeny &
      redondency of examination
     –with simplicity of access and usage
 • to allow the patient to choose his accredited
   medical storage « harbour »
 • to support the HC professionnals in order to
   populate the ePMR
Principle 1 : increase the existing value
& build upon experimentation
 Continuity of the approach
  – to build upon the outcomes of the experimentat.
  – to offer the same ePMR for all, useful & used
  – to associate all the actors to the management of
    the project (including industry)


 Structuration via a universal service
 -   simplicity of access, identification, managt
 -   Interoperability, evolutivity
The key factors of success
 • To join forces of all the concerned actors
    – Appropriation & usage of the developed tools
    – Convergence with the existing systems
    – Call for projects proposals
 • Cooperation with the industry
    – build up tools for populating easily the ePMR
      (services sub contracting to the market players)
        • concertations with the software editors for HCP
        • opening to the medical storage harbour when
          generalized
        • Cost containment
The approach :
Offer & open an ePMR to each one who ask
– create the infrastructure able to support this


Exploit all the established features from the
experimentations
– specifications & content, security & ergonomics issues
– capitalise on the proposed organisational changes


Avoid the ‘ blank page ’ syndrome
– « recovery » of the ePMR used for the experimentations
– mechanisms to (automatically) populate the ePMR
Programme control & mastering
• Involvment strategy
• Confirmation of the objectives
       – compliant to the law(s)   - simplicity
       – ergonomy                   - utility
• Master, control the follow-up of the
                             interoperability
• Visibility on costs & budget
• Respect of the announced planning
• Reinforcement of the resources of the
  structure in charge of          (GIP DMP)
Architecture
        Portail Portail
                               Accueils du portail :
                                         Portail Portail
                  patient PS hébergeur
        Identification
          2       3                        4       5
               Héberg
        SVA 2 SVA 3 Héberg
                           Héberge
                                          Portail
                                   Héberg Héberg



        Annuaires
                             ur          SVA 4 SVA 5
                          eur de   eur de         eur de        eur de
                                    DMP unique DMP
                                           de DMP




                                                                 droits
                                                                 Tables des
                                                                 ation
                                                                 Authentific
                           DMP                                   DMP
 Service                  agréé    agréé
                                              de
                                                        agréé   agréé
                                            référenc
                            2        3                    4       5
universel                                       e

                                              Aiguillage
          Services
        Assist Assist               de confiance uniques
                                                 Assist Assist
        ance 2 ance 3                Assistance ance 4 ance 5
                                    téléphonique                 Rése
                         SIH         DCC               LGC        au
                                                                données
                                                       (PS)
                                                              médicalement
                                           Producteurs de données utiles
                                                              détenues par
                                                               l ’assurance
                                                                  maladie
2006 experimentations:
                   13 regions, 17 sites
How to cope with e-health



 Some lessons learned
What happened so far ?
Objectives & goals
– unsatisfactory situation
designing a strategy : e-Health for Health
– reform supported by politicans
– need some legal framework
strongly linked to other policy regulations
(health & not health)
taking into account all stakeholders
The lessons learned so far
always more time than expected
– resistance to change, « daily routine »
– early adopters are not representative
always more expensive
– unexpected « borderline effects »
critical mass point is not easy to reach
– to be careful on incentives
do not underestimate
– the existing environment
– conditions & consequences of generalisation
How to increase the chances of success

 Define clear objectives

 – with explicit milestones to measure progress
 – based on consensual indicators


 Involvment of all stakeholders

 – early pre - consultation / concertation
The accompagnying measures
Rearrangment of existing measures

– to maximise integration of the new elements
– take advantage to reorganise & optimise
 (hospitals/clinics, specialists,GP, homecare)

Anticipate the needed changes
– on medical care, on personal behaviour
– on the HC system, on reimbursement, ...
A way to progress
design an iterative process
– existing adopted roadmap & context evolution


do not forget to nominate A pilot
– strong coordination & clear decisions


be precise in respective roles &
                             responsabilities
Clear objectives in an evolving world
Integrate the regional & national evolutions

avoid to focus too much on technical issues

anticipate
 – negative consequences of a new system or

 – changing in the existing forces balance
We are part of Europe & of the world

  Take into account the evolution of the
  other EU M.S. and other countries

  … to support citizen & patient mobility
  … to be « compliant » with other systems
  … to anticipate their potential impact on
  national (& regional ) HC system
Keep European and open on the world
  improve & facilitate the use of european &
                      international standards

  give no long term agreement to
                       proprietary products

  be present on international arena to
                        anticipate changes
The key basic components
Will & cooperation of all actors (citizen, govt,
patient, HCP, hosp., insurer, industry,
daily used added value services
standardised shared mutual services on
– security (id, authent, certif, PKI,e-signature,…)
– access (ergonomic, perf., available, direct. LDAP)
– modelling (RIM : HL7 V3) processes
– transformation (syntaxic format XML, CDA-XDS)
– terminology (semantic : ICD, MeSH, MedDRA, LOINC,
  SNOMED, GALEN, GO, FMA,...)
International collaboration : EU
Health is a national prerogative
but collaboration is a key issue patient mobility
volontarist coope. on INTEROPERABILITY
consensual defined priorities at EU level :
– non ambiguous ID (patient, HCP, hospital,
  service)
– patient record summary (minimum data set)
– secure data exchange flows
   • emergency data set / e-prescription
Thank you for attention

 Think globally

 Act locally



       michele.thonnet@sante.gouv.fr

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Michele bcn02 2007

  • 1. How FRANCE will cope with the new expectations of the citizens regarding e-health and Patient Record Michèle THONNET Mission pour l ’Informatisation du Système de Santé (MISS) Barcelona February 2007
  • 2. Agenda Health & ICT characteristics of the french system policy, strategy and reform (1996-2006) goal, projects and objectives roll out and current situation ePMR (DMP) lessons learned we are part of Europe … and of the world
  • 3. Reforming the H system : a necessity ageing population chronic diseases evolution citizen demands & needs transfo increasing costs of research, equipments, examinations, treatment pandemia expansion lack or shortage of HCP mobility of citizens & patients, … economic model
  • 4. ICT : necessary but not sufficient medical informatics telematics telemedicine e-Health p-health connected health e-inclusion the most visible target the eHR ...
  • 5. Visible part : an iceberg ? techno. is attractive, speaking about is usual but cultural changes are key – more difficult to envisage – need more time and continuous efforts – change professional exercice, patient view – reorganise the actors relationships & positions – destabilize the present « system » team work needs exchange & sharing info…. the ePMR :only a good enabler & trigger tool
  • 6. The French health system Some characteristics
  • 7.
  • 8.
  • 9.
  • 10. France and health system 540 000 Km2 60 M inhabitants life expectancy : 75,2 M 82,7 W Global Expenditure per capita 2000 € 1,7 M jobs in Healthcare
  • 11. A complex system A multitude of actors – health insurance (compulsory complementary ) – 300 000 professionals (120 000 doctors), 23 000 pharmacies , 4 000 laboratories – 4000 hospitals, 1,1 million employees (50 000 doctors) …with a very large autonomy
  • 12. 1- A system that deserves its appreciative rating ... The first in the world according to WHO (2000)… … but with important internal inequalities – social – geographical
  • 13. 2- a high cost The national expenditure of health – 148 billion €uros, 8.8% of GDP one of most expensive among the developed countries A growth regularly stronger than the GDP + 5,2 % in 2001, ... Presumptions of inefficiencies – adequacy of the offer compared to the needs
  • 14. Public policies for e-health in France Objectives of the authorities
  • 15. Government’s guidelines To develop the assets of a policy for (public) health By improving the overall effectiveness policy followed by the introduction of the ICT is a variation of that
  • 16. The main goal Make use of ICT and Internet to rationalize the healthcare system – for a healthier population • => to improve the level and quality of care • => by controlling the costs
  • 17. Three types of projects a first stage : SESAM-Vitale : (Administration) – administrative simplification for refunding health expenses a « corner stone » project to improve the doctor-patient relationship : (Medical) – electronic health record (EHR) public health issue : (Information) – to manage the consequences of the availability of the information to public (education, protection)
  • 18. Four main objectives To facilitate the continuity and the coordination of the health care : – electronic health records :protected access and transmission – telemedicine To improve access to knowledge : – online state of the art for the professionals ( KB, EBM) – quality of e-health sites
  • 19. Four main objectives (2) better know the reasons for recourse and evaluate the expenditure – piloting information systems (reorga H System) better and quicker refunding – administrative simplification : SESAM-Vitale
  • 20. A continuous voluntarist strategy important investments an impact on the whole population – 55 million smart cards handed over
  • 21. The roll-out scenario Starting point administrative simplification with SESAM-Vitale, (infrastructure needed) … but investments need to serve the other more general goals Structural role of technical tools : HCP cards, Insurance cards (Vitale), Internet standards, RSS,...
  • 22. Public policies for e-health in France : about TRUST Confidence requirement is key Health is not a product like others Securing data confidentiality
  • 23. A specific status for health information The European Legislation 24 October 1995 (art 8) – prohibits any data processing without the consent of the person – except for the data absolutely necessary to the health professional – or those related to the management of health services, required by people exercing under professional secrecy The french Medical Privacy Act (4 february 2002) – transmission of personal information is authorized only between health professionals treating their mutual patients, and only with their prior consent (article L1110-4)
  • 24. Confidentiality requirements To secure release and circulation of invoices (SESAM-Vitale) – authentification of the transmitter – signature of the person receiving benefits and the recipient choice of cards supports Soon significant volume of information will circulate necessity to invest in confidentiality
  • 25. Confidentiality requirements Two key issues to deal with, for the French Government – legislative : the Act of March 4th, 2002 – technical : smartcards, PKI, secured standardised network Internet sites on e-health – support self-regulation between bodies involved (users, professionals, economic actors) the project « e-health quality »
  • 26. A technical federator : infrastructure to exchange and share :The choice of Internet standard technologies, but protected for / with the HCP :The Health Professional Card (CPS) – (identify), authenticate, sign, coding for / the citizen :The recipient insurance card : – carte Vitale
  • 27. Health Professional Card (CPS) CPS – an large roll-out ... • over 485 000 cards rolled-out – a central role in the security of the system • authenticate the holder of the card : – identity HCP, qualifications, conditions of exercise – « Sésame » to reach to protected informations • electronic signature • protecting and coding messages
  • 28. The health insurance card The Vitale card – easier • identify the holder : – 55 million cards handed out to the citizens
  • 29. Public policies for e-health in France The current situation
  • 30. SESAM-Vitale An increasing use : – >80 million electronic invoices issued every month – more than 65% of invoices – 180 000 Professionals using the system – a smooth and steady implementation
  • 31. The electronic Patient Medical Record ePMR . . . DMP An effective way to manage patient’s continuity of health care… … but which must offer all the guarantees of privacy
  • 32. The role of the Authorities To support the development of the consensus finalities, contents, control of the uses To encourage experiments To build up the legislative framework To develop incentives, if necessary
  • 33. Role and vision of the Government Three important innovations in the law for the patient's rights An important reform of the Health Insurance The ePMR (DMP)
  • 34. The new law : three important innovations The new law : three important innovations 1- Direct access to personal medical informations (article L1111-7) 2 Securing confidentiality (article L1110-4) 3 Regulate by law the storage of personal EHR (article L1111- 8)
  • 35. To enhance their development The objective: support the development of ePMR, used & shared – information is produced by health professionals – reviewed on line with strict conditions on the rights of access (ICT team) – of which the use (and contents?) are controled by the patient – which are stored securely under very strict conditions by accredited third party outside the premise of the MD (authorities)
  • 36. 13 August 2004 Act DMP (ePMR,...) Coordination dossier ( 2007- implementation start) – no replacment of the GP dossier Strongly linked to the « patient act » – strict security policy & mechanisms – patient control on the access • authorised access for HCP habilited • direct access to medical data by patient – mandatory labelisation of the storage places, which are not allowed to accesss to medical data
  • 37. Four question marks ???? Optimal level of confidentiality Identification of the patient Control of the access by the patients Technical options
  • 38.
  • 39. The objectives of the ePMR (DMP) • to offer over 2007: –the same ePMR for all, under the control of the patient –an ePMR compliant to the law(s): improvment of the care ‘ circuit ’, avoiding iatrogeny & redondency of examination –with simplicity of access and usage • to allow the patient to choose his accredited medical storage « harbour » • to support the HC professionnals in order to populate the ePMR
  • 40. Principle 1 : increase the existing value & build upon experimentation Continuity of the approach – to build upon the outcomes of the experimentat. – to offer the same ePMR for all, useful & used – to associate all the actors to the management of the project (including industry) Structuration via a universal service - simplicity of access, identification, managt - Interoperability, evolutivity
  • 41. The key factors of success • To join forces of all the concerned actors – Appropriation & usage of the developed tools – Convergence with the existing systems – Call for projects proposals • Cooperation with the industry – build up tools for populating easily the ePMR (services sub contracting to the market players) • concertations with the software editors for HCP • opening to the medical storage harbour when generalized • Cost containment
  • 42. The approach : Offer & open an ePMR to each one who ask – create the infrastructure able to support this Exploit all the established features from the experimentations – specifications & content, security & ergonomics issues – capitalise on the proposed organisational changes Avoid the ‘ blank page ’ syndrome – « recovery » of the ePMR used for the experimentations – mechanisms to (automatically) populate the ePMR
  • 43. Programme control & mastering • Involvment strategy • Confirmation of the objectives – compliant to the law(s) - simplicity – ergonomy - utility • Master, control the follow-up of the interoperability • Visibility on costs & budget • Respect of the announced planning • Reinforcement of the resources of the structure in charge of (GIP DMP)
  • 44. Architecture Portail Portail Accueils du portail : Portail Portail patient PS hébergeur Identification 2 3 4 5 Héberg SVA 2 SVA 3 Héberg Héberge Portail Héberg Héberg Annuaires ur SVA 4 SVA 5 eur de eur de eur de eur de DMP unique DMP de DMP droits Tables des ation Authentific DMP DMP Service agréé agréé de agréé agréé référenc 2 3 4 5 universel e Aiguillage Services Assist Assist de confiance uniques Assist Assist ance 2 ance 3 Assistance ance 4 ance 5 téléphonique Rése SIH DCC LGC au données (PS) médicalement Producteurs de données utiles détenues par l ’assurance maladie
  • 45. 2006 experimentations: 13 regions, 17 sites
  • 46. How to cope with e-health Some lessons learned
  • 47. What happened so far ? Objectives & goals – unsatisfactory situation designing a strategy : e-Health for Health – reform supported by politicans – need some legal framework strongly linked to other policy regulations (health & not health) taking into account all stakeholders
  • 48. The lessons learned so far always more time than expected – resistance to change, « daily routine » – early adopters are not representative always more expensive – unexpected « borderline effects » critical mass point is not easy to reach – to be careful on incentives do not underestimate – the existing environment – conditions & consequences of generalisation
  • 49. How to increase the chances of success Define clear objectives – with explicit milestones to measure progress – based on consensual indicators Involvment of all stakeholders – early pre - consultation / concertation
  • 50. The accompagnying measures Rearrangment of existing measures – to maximise integration of the new elements – take advantage to reorganise & optimise (hospitals/clinics, specialists,GP, homecare) Anticipate the needed changes – on medical care, on personal behaviour – on the HC system, on reimbursement, ...
  • 51. A way to progress design an iterative process – existing adopted roadmap & context evolution do not forget to nominate A pilot – strong coordination & clear decisions be precise in respective roles & responsabilities
  • 52. Clear objectives in an evolving world Integrate the regional & national evolutions avoid to focus too much on technical issues anticipate – negative consequences of a new system or – changing in the existing forces balance
  • 53. We are part of Europe & of the world Take into account the evolution of the other EU M.S. and other countries … to support citizen & patient mobility … to be « compliant » with other systems … to anticipate their potential impact on national (& regional ) HC system
  • 54. Keep European and open on the world improve & facilitate the use of european & international standards give no long term agreement to proprietary products be present on international arena to anticipate changes
  • 55. The key basic components Will & cooperation of all actors (citizen, govt, patient, HCP, hosp., insurer, industry, daily used added value services standardised shared mutual services on – security (id, authent, certif, PKI,e-signature,…) – access (ergonomic, perf., available, direct. LDAP) – modelling (RIM : HL7 V3) processes – transformation (syntaxic format XML, CDA-XDS) – terminology (semantic : ICD, MeSH, MedDRA, LOINC, SNOMED, GALEN, GO, FMA,...)
  • 56. International collaboration : EU Health is a national prerogative but collaboration is a key issue patient mobility volontarist coope. on INTEROPERABILITY consensual defined priorities at EU level : – non ambiguous ID (patient, HCP, hospital, service) – patient record summary (minimum data set) – secure data exchange flows • emergency data set / e-prescription
  • 57. Thank you for attention Think globally Act locally michele.thonnet@sante.gouv.fr