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Approaches to PersonalisedMedicine in Finland:Status Report
Tallinn 26.10.2015
Liisa-Maria Voipio-Pulkki MD PhDDirector of Health Care Group, CMOMinistry of Social Affairs and HealthFinland
Phases of the economic and needs pressure
Pensions on the increase
Increasing need of care
2010
Economic burden
Building phase of the welfare society
70 children and elderly per 100 persons in working age
50
60
70
80
indeksi
50
60
70
80indeksi
40 40
203020202000199019801970 2040year00
Situation in October 2015
10/29/2015Name Surname
3
Maritta Korhonen4 29.10.2015
Large reforms for Finnish healthcare are coming- what has happened since January 16th, 2015?
� New government => new outlines for the social and healthcare reform, major changes in division of public power between municipalities & state; major changes in taxing policies and social & hc funding
� Fiscal constraints, unemployment on the increase
� Refugee & migrant groups beyond all expectations
� New national social and health ICT strategy
� New outline for a national genome strategy
� Biobank activities face some practical challenges, including consent and data privacy issues
Etunimi Sukunimi5 29.10.2015
Social welfare and health care reform in the new Government Programme
� Prime Minister Juha Sipilä’s GovernmentProgramme was published in May 27th 2015
� Responsibility of all social and health services will be given to 5-19 regional authorities by 2019
� Main targets:
– reducing socioeconomic inequity
– improving cost containment
� Main tools:
– full integration of primary, secondary and tertiary health care as well as public health services with social services
– maximal digitalization of all services
� Joint strategy created and implemented by 3 ministries– Min. Employment and the Economy
– Min. Social Affairs and Health
– Min. Education and Culture
� For the first time the strategy examines the health sector from the perspective of innovation and business growth.
� Use of health data and genomic information for drug development and personalized medicine
National Health Sector Growth Strategy for Research and Innovation activities
6
More information: http://www.tem.fi/files/40138/TEMrap_16_2014_web_09062014.pdf
10/29/2015
© TEM / INNO 2008
Strategy: Finland´s goals
7
Finland´s goal is to be an internationally renowened forerunner in health sector research and innovation, investment and new business acitivities while benefiting peoples´s health, welfare and capacity to act.
This means that Finland is:
• The source and user of versatile and high quality scientific research and therefrom derivied inventions and innovations.
• A dynamic operating environment for new companies in the field and a reliable partner for the international growth of companies.
• An attractive target country for health sector investment.• A model country for consolidating a sustainable healthcare
system with innovative activities.
Building Blocks of PM in Finland
10/29/2015 Name Surname8
Y O U R T E S T B E D F O R N E X T G E N E R A T I O N R E A S E A R C H & I N N O V A T I O N
NATIONAL REGISTERS
Etunimi Sukunimi10 29.10.2015
National archive of health information
� ePrescription
– Provides medication summary and enables a fully electronic prescription – dispensing – reimbursement process
� eArchive
– Centralised active and real-time data store + legal archive
– Allows sharing of data between healthcare providers securely and with patient consent
� eAccess
– Citizens can view their own prescriptions and electronic records
� National services are accessed through local systems
– Implement same interoperability standards also in local systems (HL7 V3 CDA R2)
Etunimi Sukunimi11 29.10.2015
eDeliveries from pharmaciescompared to reimbursed prescriptions
years 2009–2015
reimbursed prescriptions
Million prescriptions
2009 2010 2011 2012 2013 2014 2015
ePrescriptions
Pharmacies31.03.2012
Public health care31.03.2013
Private health care31.12.2014 (>5000 res/v)
2014
ePrescription
for 3,64 M
persons (pop 5,4 M)
8.10.2015
Etunimi Sukunimi12 29.10.2015
Public healthcare providers
6.9.2011
Other national services
Kanta services
ePrescription service
Dispensations
Patient data repository
Health records, structured (CDA R2 L3)
Metadata
Consent and will management
Opt-ins and opt-outs
Organ donation wills
Living wills
National code server
Code lists and terminologies
Form and document structures
Pharmacies (~800)
Hospital districts (20)
Primary care org. (192)
Private healthcare providers (4000)
Patient summary management
Diagnoses
Lab
Radiology
Procedures
Vaccinations
Physical findingse
pS
OS
NC
P
Swedish epSOS NCP
Risks Medication
Other NCPs not yet connected
Healthcare and social care organizations register
Radiology DICOM studies
IHE
X
DS
IHE
X
DS
-I
Pharmacies register
PrescriptionsRenewals
Logs
Logs
Health and care plan
Patient data management service
Certification services Health care professionals register
Pharmaceutical database
Health records, legacy (CDA R2 L1)
Health care professionals
My KantapagesCitizens (> 5 000 000)
Web services for HCPs
Kan
tam
ess
agin
g la
yer
Aged 18 and
older
Main standards
• HL7 V3: CDA R2 Level 3 and Medical Records
• IHE IT-I Profiles • W3C XML DSig• WS Addressing, WS-I• TLS, X.509
Personal Health and Social Record
APPS
mHealth
OwnCare
SelfCare
Etunimi Sukunimi13 29.10.2015
All visits
Different visitors
8.10.2
015
20112010 20142012 2013
Monthly visits and different visitors in My Kanta service
2015
Etunimi Sukunimi14 29.10.2015
Patients can check how their personal information is used
� Patients can check the use and release of their personal healthinformation.
� Through the eAccess portal, patients can monitor whichorganisations access or process their personal information and to which organisations the information is released.
� Patients can also request the register authority to detail whohave accessed and processed the data.
Y O U R T E S T B E D F O R N E X T G E N E R A T I O N R E A S E A R C H & I N N O V A T I O N
Regulation by
national authorities
• professionality, quality
standards
KEY DRIVERTHE BIOBANK ACT OF 2013 WITH THREE IMPORTANT PRINCIPLES
Protection of
donors’ rights
• informed consent;
optout procedure for
retrospective samples
• privacy protection
and sample
pseudoymization
• donors right to know
the usage of samples
Promotion of
research and R&D
• broad consent
• permission to link biobank
specimens with information
from hospital databases and
national registries
• all raw data resulting from
the biobank material will
return to the biobank for
future biobank research
purposes
KSSHP
• Background: biobank law 2013, BBMRI_ERIC agreement by the state of Finland
• Health Growth Strategy
• 2014:
• Terveyden ja Hyvinvoinnin Laitos THL (THL Biopankki)
• TYKS ERVA ja Turun yliopisto (Auria Biopankki)
• HYKS ERVA ja Helsingin yliopisto/FIMM (HAMC Biopankki)
• Laaja alueelinen biopankki
• Projektien biopankit HUB ja FHRB
• Latest additions:
• Pohjois-Savon SHP ja Itä-Suomen yliopisto
• Pohjois-Pohjanmaan SHP ja Oulun yliopisto
• Pirkanman SHP ja Tampereen yliopisto
• Keski-Suomen SHP ja Jyväskylän yliopisto
BBMRI.fi
Clinical data
Genomic medicine in the
service of better health and
health care
Official launch date:
June 11th, 2015
By the year 2020, genomic data will be effectively used in healthcare and in the
promotion of health and wellbeing
to achieve population health benefits
Why do we need a genomics strategy?
� To take full advantage of the potential benefits of the genomics era
� Fostering research and innovation policies
� Mainstreaming genomic technologies in the Finnish health system
� Ensuring equitable access to and rational use of the technologies
19
Y O U R T E S T B E D F O R N E X T G E N E R A T I O N R E A S E A R C H & I N N O V A T I O N
EARLY SETTLEMENT • 2000-10 000 years ago
• South and Coast
LATE SETTLEMENT• 16th century
• multiple bottle necks
EXPANSION • 18th century – population 250 000
• Today – population 5.4 million
EARLY
SETTLEMENT
LATE
SETTLEMENT
10/29/201521
By the year 2020, genomic data will be effectively used in healthcare and in the promotion of health and wellbeing
� Ethical principles and legal framework are available for the application of genomics
� Genomics research is integrated into healthcare
� Healthcare workforce have the knowledge and skill to apply genomic information
� Informatics infrastructure is in place for effective application of genomics
� Genomic information is widely used in healthcare to meet the needs of individuals and the population
� People understand and are able to make effective use of genomic information to improve their own health
� In genomics, Finland is an attractive research and innovation environment for collaboration and investment
Y O U R T E S T B E D F O R N E X T G E N E R A T I O N R E A S E A R C H & I N N O V A T I O N
THE 200K
Genome wide genotype data
73 000
Genome or exome sequences
>26 000
NATIONAL
BIOBANKExtensive health,
phenotype,
metabolomic data
Population cohorts
Disease specific
collections
200 000 individuals
4% of the population
REFERENCE DATABASE
POPULATION SPECIFIC CHIP/GENOTYPING
IMPUTATION
SISU-PROJECT
SEQUENCING INITIATIVE SUOMI (FINLAND)
DNA and RNA Analyses
Clinical
measurements & imaging
Functional imaging
Microbiome
Lifestyle data
Family history
Metabolomics
Reference database
Dream BigNational
health registries
Y O U R T E S T B E D F O R N E X T G E N E R A T I O N R E A S E A R C H & I N N O V A T I O N
DIGITAL HEALTH HUB:
A NATIONAL OPERATOR FOR HEALTH AND WELLBEING DATA
DIGITAL
HEALTH HUB
2017
NATIONAL
PHR
NATIONAL
GENOME
DATABASE
NATIONAL
PATIENT DATA
ARCHIVE (KANTA)
OPEN AND
OTHER DATA
SOURCES
DATA SOURCES:
SERVICE
PROVIDERSHEALTHCARE MEDICAL
RESEARCH
OTHER
RESEARCH
DATA USERS:
“One-stop-service”
National Operator
National Operator for Health and Well-being Informationcombined with new legislation on the secondary use of sensitive health data and other sensivite personal information 2015-
25
Data Creation
“My Kanta” / personal
online service for
medical details
EHR database
Bio-
banks
Integrated and analysed data
Standard interfaces
Customized interfaces
Ecosystem and Partner Network
• Public Research Institutes
• Private Research Institutes
• Pharmaceutical Industry
• Healthcare
Information Enrichment and Increased Customer Value
Revenue Stream
Utilization of Information
KanTa
Genome
-database
Other data sources
Value Added Services
Data anonymization
Individual
Benefit
1 3Data Gathering and
Refining
2
Individual
• Individual
Analytic services
End-user applications
Services containing anonymized data
Etc.
Audit Trail and Securing Information Reliability
• National Centres of Expertise
4
Sitra • 28.9.2015
What next?
10/29/2015Name Surname
26
Individualized systems medicine (ISM)
System medicine approach:- Data integration- Repeated sampling- Feedback to clinic- Learning system
Pemovska et al. Cancer Discovery, on-line Sep 20, 2013
Active Client: New role in client-oriented
service process modelling
29.10.201528
Visits Episode Visit Visit Visits
Active role of the client Health gain
Primary care Special care Home care
Service plans and good practices maximice effectivity/
indicators for quality and effectivity
Functional capacity of the client, Social networks and Culture
Patient dataPatient data
Business opportunities in digital health
Environmental
data
Environmental
data
Health dataHealth dataLifestyle data Lifestyle data
Genetic dataGenetic data
Early detection of diseases
Wellbeing services
Health promotionHealth promotionSelf-monitoring and careSelf-monitoring and care
Diagnostics industry
Personalised healthcare
Personalised healthcare
Pharma industry
Social media Game industry
Software industry
BioIT industry
Big data
Biobanks
Remote care
Clinical decision support
Population health management
Global digital health market EUR 47 bn in 2018
Sensors
DM 1381236
Y O U R T E S T B E D F O R N E X T G E N E R A T I O N R E A S E A R C H & I N N O V A T I O N
Ministero della Salute
Rogowski et al, Nature Reviews in Genetics, 2009
Regulatory nightmare or protection of patient privacy and safety?