The Government proposes a new act on the secondary use of health and social data. The aim is to ensure flexible and secure use of data by establishing a centralised electronic licence service and a licensing authority for the secondary use of health and social data.

1. 23.11.2017 Etunimi Sukunimi1
Secondary use of
health and social data
Government proposal of 26 October 2017

2. Abbreviations
23.11.2017 First name Surname2
• STM = Ministry of Social Affairs and
Health
• Kela = Social Insurance Institution of
Finland
• Tekes = National Technology Agency
• Sitra = Finnish National Fund for
Research and Development
• THL = National Institute for Health and
Welfare
• TK = Statistics Finland
• KL = Association of Finnish Local and
Regional Authorities
• VM = Ministry of Finance
• OKM = Ministry of Education and
Culture
• TEM = Ministry of Economic Affairs and
Employment
• OM = Ministry of Justice
• TSV = Office of the Data Protection
Ombudsman
• VRK = Population Register Centre
• ETK = Finnish Centre for Pensions
• Finpro – helps Finnish SMEs go
international, encourages foreign direct
investment in Finland and promotes
travel to Finland.
• SA = Academy of Finland

3. Primary and secondary use of personal data
Primary use
Use of data when
delivering services to
clients or patients
Secondary use
Knowledge management,
statistics, official
instructions, enforcement by
authorities, research,
development, innovations
etc.
health and
social data
26 October 20173

4. Government proposal for an Act on Secondary Use of
Health and Social Data and related legislation
Purpose of the proposal
• to create consistent up-to-date conditions for secure use of client data compiled from service
activities within healthcare and social welfare and other personal data related to health and
wellbeing
Scope of application
• statistics, research, development and innovation activities, education, knowledge management,
official instructions and enforcement, authorities’ planning and reporting duties
Objective
• to facilitate and speed up the process related to licences to use data and to essentially reduce the
administrative burden created by parallel licensing procedures.
• to better protect clients’ confidence and personal privacy Technological development has created
new conditions for secure handling and combining of sensitive client data and for combining it with
other personal data in a secure manner.
Means
• statutory right to use client data from health and social services for certain purposes
• one single licensing authority to decide on the use of data related to the health and social sector
• secure electronic environment and secure connections for controlled handling of released data
26 October 20174

5. Tasks of national strategies
and their connections to the current legislative reform
• Digitalisation, enabling legislation,
deregulation
• policies outlined in the Government
Programme
• Health and social services reform,
governance reform
• steering, oversight and monitoring
• Better well-being and health for
people through the means of, for
example, research and technology
and seamless joint access to health
and social data
• implementation of the research, development
and innovation growth strategy for the heath
sector
• Increase in data management and
electronic services
• Implementation of the strategy for
bringing health and social data
into use
• Innovation platforms and
ecosystems are being developed
• My Kanta (Omakanta), STM, Kela,
Tekes...
• service operator, STM, Sitra, THL,
TK, Kela,…
• Innokylä, STM, THL, KL, Soste ry,
Sitra
Etunimi Sukunimi23.11.20175

6. Changing a pile of ore into a national treasure –
use of health and social data
Use of
materials
Handling
of
materials
Materials
Development
and innovations Education
Information
management
Steering and
oversight
Planning,
surveys Statistics
PERMIT AUTHORITY AND SERVICE OPERATOR
Search for data:
Permits, ethical committees, data
protection
Data transfers:
Transfer, combination,
protection
OPERATIVE SYSTEMS WITHIN HEALTHCARE AND SOCIAL WELFARE
Bio banks
gene banks
Kanta-portal,
Omakanta
National
registers (THL)
Health&social
service stat.
Social-
economic data
Research
19.10.20176

7. NOW AFTER THE REFORM
ADDITIONALLY
Permit applications
separately to each data
controller
Data Protection
Ombudsman shall be
heard
Long-lasting
process
Data used for
scientific research
and statistics
Permit authority gives the permit to use the registers and is
responsible for the service: data management, combination and
transfer
Electronic permit portal for describing the data required (what, why,
where) and for saving permit applications
Permit authority shall ensure that the combined data is handled in
conformity with data protection legislation
Permits for combining registers will become unnecessary  smoother
and simpler process
Wider use of data: scientific research and statistics, development,
innovations, education and information management
In conformity with EU Data Protection Regulation
Data is handled in a secure use environment
Data controllers give advice on how to use the data
Data from an individual register through the
data controller or permit authority
19.10.20177

8. How to get a licence and the data?
Request for licence or data
via an electronic system
Release of data
• anonymous data
can be released as such
• pseudonyms / identifiable data
into a secure environment
Licensing authority
• grants the licence to use the material, or accepts the
request for information and gives an order to the service
operator
• notifies the decision to the person needing information
Data controllers
• advice service, data resource descriptions and release of data
for handling an application for licence or a data request,
releases the licensed data to the service operator
Service operator
• collects, combines, pseudonymises, anonymises the data
and releases it to be used in a secure electronic
environment maintained by the service operator or the
recipient
Person/operator
needing
information
26 October 20178

9. Impacts of the new Act
26 October 20179
Centralised licensing and
secure electronic environment
Enables individual use and
combining of data
Improved opportunities for
research and product
development
Faster access to
information, wider range of
purposes of data use
Effective treatments and
new medicines, e.g. for risk
groups
New business activities,
products and services

10. -26 October 201710
Who benefits from secondary use of health and social data
People,
clients of
health
and social
services
ICT
enter-
prises
Pharma-
ceutical
compa-
nies
Manage-
ment of
health
and
social
services
Startups
Healthcare
and social
welfare
professionals
Develop-
ment
organisa-
tions
Organisers
and
providers
of health
and social
services
National
economy
Research
institutions
and
universities
LEGISLATION ENABLES

11. 26 October 201711
Benefits for people
• more research data → better
functioning services, more
effective medicines
• better treatment and care when
data is easier available to
operators
• more effective health and social
services
• data is handled in a secure
environment and cannot fall in
the wrong hands

12. 26 October 201712
 anonymous information would not be subject
to licence
 one single authority would decide on licences
to use registers which contain client data from
health and social services
 more extensive data, easier access
 shorter waiting times and simpler processes
for accessing the data
 data is already compiled and homogenised
 stronger research and competence
Benefits for researchers

13. Benefits for organisers of health and social services
Data from service providers
can be used in real time
for knowledge management
Easier to create new service
innovations
Better possibilities to combine
health and social data,
wider knowledge basis
Easier to follow up, develop and
compare services and their impacts
Development leads towards a more
client-oriented service system and a
more individual care and service
culture
Better and more effective services,
well-functioning packages of health
and social services to clients (e.g. to
frequent users of services)
26 October 201713

14. 26 October 201714
• more research data
• more extensive data, access via one-stop
shop
• better innovation opportunities
• new areas for applications
• better opportunities to develop services
and business environments
• better opportunities for product
development
• easier to operate as an enterprise offering
health and social services
Benefits for enterprises

15. Revised, new and amended provisions
Personal Data Act, Act on the Openness of Government Activities,
Biobank Act, Communicable Diseases Act, Act on the Status and
Rights of Social Welfare Clients,
Act on the Investigation of the Cause of Death,
Act on Electronic Prescriptions
Act on Statistical Services of National
Research and Development Centre for
Welfare and Health Stakes
Act on National Personal Data Registers
for Health Care
Act on Secondary Use of Health and Social
Data
Revised Act on National Institute for Health
and Welfare
General Data Protection RegulationAct on the Electronic Handling of Client
Information in Healthcare and Social
Welfare
Act on Organising
Health and Social
Services
Legislation to be reformed: New acts:
Related legislation to be amended :
Act on National Institute for Health and Welfare
Regulation on Clinical Trials on Medicinal
Products
EU:
Other acts to be amended:
19.10.201715

16. Up-to-date data
Better availability of
combined data
Remote use
No need to transfer
sensitive data
Data will be used in a
secure and scalable
environment
Access to health and
social data via one-stop
shop: guides the user of
data, administrates
licences, maintains
metadata, ensures
information security and
gives user support
On request
Faster than ever
One single licensing authority
Consistent practices
DIGITAL SERVICE
PORTAL
Operation starts in stages at the beginning of 2018

17. 26 October 201717
 Working group prepared a proposal for the new act
 Legislative package circulated for comments in
autumn 2016, comments published on the website of
Innokylä
https://www.innokyla.fi/web/verkosto1598477/lakiluonnoksest
a-annetut-lausunnot-lokakuu-2016-
 Hearing in Swedish on 4 November
 Expert group edited the proposal on the basis of the
comments in autumn 2016
 Preparatory work by public servants, spring/summer
2017
 Government proposal submitted to Parliament in
autumn 2017
Stages of legislative
drafting