La reutilización de la información de salud
con finalidades de investigación
Anna García-Altés
5 Aniversario MAR Biobanc
Barcelona, 13 de junio de 2016
Theory
Exposure to medicines among patients admitted for hip fracture and the casefatality rate at 1 year. A longitudinal study
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Exposure to medicines among patients admitted for hip fracture and the casefatality rate at 1 year. Study carried out reusing information
 The study “Hip fracture in population older than 65 years” has been published as part
of the annual report of the Results Center (“Central de Resultats”).
 Sample: 8.172 patients 65 years or older admitted for hip fracture
 Sources of information: pharmaceutical information, hospital discharge records, mortality
data, … Information anonymized by AQuAS.
 The one year mortality rate was 24,5% (CI amplitude: 1,9%).
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Main differences between studies
Study 1
Information
access
 From electronic health record with
patients’ informed consent. Difficult to
ensure the principle of proportionality
of the information.
Study 2

Anonymized information coming from
administrative registers. Principle of
proportionality of information is
ensured.
Sample size
 456 patients

8.172 patients
Mortality rate
 24,6% with a confidence interval
20,6% to 28,6% (CI amplitude: 7,9%)

24,5% with a confidence interval
23,6% to 25,5% (CI amplitude: 1,9%)
Time to carry
out the study
 More than 2 years
 Few weeks/ months
 Repeat the study from the beginning
 Few days
Time to
replicate the
study
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Questions for a Clinical Research Ethics Committee
 Is it necessary to use the electronic health record of 500
patients to do this study?
 Could the study be carried out reusing anonymized health
data?
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The international scientific community needs large
health datasets to boost research and innovation
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The European Commission considers the reuse of health
data as a key issue to redesign health systems
 The European Comission defines 5 recomendations to
reddress health policies in “Redesigning health in
Europe for 2020”.
 One of the recommendations is to promote the reuse of
the health data to:




Improve access to this information by researchers.
Transfer research results into clinical practice
Create a culture of transparency.
Improve of health services by using benchmarking
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The reuse of information provides benefits for citizens
Improving the quality of care provided. It makes possible better
planning and provision of healthcare services, and increases the
quality of care received by citizens.
Improving the quality of research. There will be more cases to
analyze and researchers will improve their capacity of processing and
analysing data. This will improve the quality of research and the
efficiency (less time and costs).
Increasing the capacity to obtain competitive funds.
Accelerating innovation.
More capacity for planning and resource allocation.
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Examples of data reuse experiences
•The CPRD is a governmental, not-for-profit research service, jointly funded in 2012 by the
NHS National Institute for Health Research and the Medicines and Healthcare products
Regulatory Agency, a part of the Department of Health (UK).
• CPRD services are designed to maximize the use of anonymised clinical data for
observational research.
• BIFAP is an initiative which was presented in March 2015 consisting of a computerized
database of primary care medical records for drug studies and epidemiological. This
initiative is responsible of Spanish Agency for Medicines and Health Products and have de
support the autonomous communities of Aragon, Asturias, Canary Islands, Cantabria,
Castilla y León, La Rioja, Madrid, Murcia and Navarra and the main scientific societies
involved.
• In 2010 SIDIAP was created to promote research based on primary care clinical data
(eCAP project) and other complementary databases
There are other initiatives like Pharmo (Holland), care.data (United Kingdom) or PCORnet (USA).
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Key aspects of information reuse
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Quality and variety of information available
• Analysis of the purpose and proportionality of the information necessary to
conduct the study (principle of proportionality of the information)
Measures of information security
• Data transfer agreement. Contractual obligations and penalties.
Key aspects of the agreement
• you can only use the data for their intended purpose
• you can not link the data with other databases
• you have to delete the data after finishing the study
2
Data protection and anonymisation process
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• Anonymisation process for each study
• Anonymisation process is performed according to Article 29 of Data
Protection Working Party
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Anonymisation process
Anonymisation process is performed according to Article 29 of Data
Protection Working Party
*This Working Party was set up under Article 29 of Directive 95/46/EC. It is an independent
European advisory body on data protection and privacy. Its tasks are described in Article
30 of Directive 95/46/EC and Article 15 of Directive 2002/58/EC.
The main anonymisation techniques, namely randomization and generalization, are
described in this opinion. In particular, the opinion discusses noise addition, permutation,
differential privacy, aggregation, k-anonymity, l-diversity and t-closeness.
The opinion concludes that anonymisation techniques can provide privacy guarantees an
may be used to generate efficient anonymisation processes, but only if their application is
engineered appropriately – which means that the prerequisites (context) and the
objective(s) of the anonymisation process must be clearly set out in order to achieve the
targeted anonymisation while producing some useful data. The optimal solution should be
decided on 4 a case-by-case basis, possibly by using a combination of different
techniques, while taking into account the practical recommendations developed in this
Opinion.
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Option to opt-out
 ARCO rights (access, rectification, cancellation
and opposition). Control over personal data is
exercised through the ARCO rights. These give
the power to protect this information and to
exercise effective control. When personal
identifying information disappears (anonymized
data) no longer ARCO rights apply.
 Option to opt-out. Citizens may request that
their data is not used for biomedical
research.
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Overview and key figures of the Catalan healthcare system
•
46 million primary care visits per year
•
760.000 hospital discharges per year
•
60 million electronic health record documents
•
100.000 convalescence discharges per year
•
2.7 million visits to emergency units
•
140 million electronic prescriptions per year
63
369
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72
Hospitals
Primary care
teams
Mental health
centers
Convalescence
centers
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How is access to health information for research purposes?
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AQuAS facilitates access to anonymized information for research purposes
and improves data protection
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Security, privacy and ethical issues
 Code of ethics. The project has a code of ethics and transparency to ensure the
correct use of data.
 Data anonymization. AQuAS will implement and execute the process of data
anonymization, ensuring the highest security standards. The process consists on
removing information that identifies individuals or minimize the essential details of
the information or other variables that may lead to indirect identification.
 Approval of studies. Researchers should present a research protocol where they
have to specify the purpose of the study and have to contain internationally accepted
sections: background, objectives, methods, results, financing, main investigator and
ethical requirements.
o Approval of the request for an Ethics Committee for Scientific Research (CEIC).
o Names of studies are made public (name, date, authors and entities).
 Option of opting-out.
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The Bioethics Committee of Catalonia considers that this is an opportunity to
improve the quality and sustainability of the public health system
 The committee issued its report "Ethical Principles and Guidelines for the re-use of the
Catalan health system in research, innovation and evaluation", which examines the ethical
and privacy aspects the project.
 The committee concludes that respect ethical principles and ensuring compliance with
aspects of custody and data security and transparency in the implementation, must do
away any citizens's doubts about the project.
 In the report it is stated that many of the recommendations made by the committee
regarding ethical guarantees in data reuse are included in the reference documentation
project.
 The committee notes that only researchers of Catalan health public system can access
the data.
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Prominent researchers support the reuse anonymous data for
research purposes
Thirty-nine researchers from the main research centers in health
sciences in Catalonia have driven the document "The use of
information for research in health sciences" in which they
expressed their support to the reuse of anonymous data for research
and evaluation purposes
…La utilización de datos de salud anonimizados para finalidades de investigación y evaluación no es una actividad
que venga de nuevo; hace años que se lleva a cabo y no se puede dejar de hacer si no se quiere que la calidad de
la investigación y el bienestar de la ciudadanía se vean afectados. Dejar de aprovechar las oportunidades que ofrece
la reutilización de información para generar conocimiento con utilidad práctica puede suponer, socialmente hablando,
quedar atrás no solo en el ámbito de la investigación, sino también en lo que refiere a la transformación de la
realidad social y económica del país y en proporcionar a la ciudadanía mejores condiciones para el desarrollo
personal y colectivo. Estos argumentos deben hacer desaparecer las dudas que pueda tener la ciudadanía en
relación al uso de la información para la investigación en ciencias de la salud.
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The reuse of information…
Enables not to use personal health information if it is not strictly necessary
Increases the capacity of analysis, evaluation and decision-making,
improving the quality of health care for citizen
Boosts R + D + i
Enables Catalonia continue pioneering internationally in the field of
biomedical research and health sciences
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Practice
Before
I am a researcher working on a Catalan research center and I
need health data…
… does this data exist and is it
available in an administrative
registry?
… where and to whom should I
address?
… what if I need to link different
datasets?
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Before
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Now
 Initiative of the Ministry of Health of the Government of Catalonia
whose main objective is to facilitate research, innovation and
assessment through the re-use of the healthcare system
information.
 AQuAS will provide the R&D centers with anonymized information
from the Catalan healthcare system with the aim to facilitate research
and innovation.
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Legal framework
 AQuAS will be the organization providing for research the
information from the Catalan healthcare system
 Legal agreements (3) between the AQuAS and
o Health Department
o CatSalut
o Institut Català de la Salut
 Grant AQuAS access to health data from these three institutions
 AQuAS as a single contact point for research centers/projects
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Now
ICS
SCS
Departament de salut
Agreement of the three organizations to give access to health personal data
to AQuAS with the objective to link, anonimize and give data to Catalan
research centers
AQuAS
VISC+: opt-out, merging,
anonomization, risk analisys,
paperwork, specific data
preparation
Research centers
Formal procedure for data transfer
 Request
o a legal entity should be responsible for the data request
o the scientific goal of the research must be relevant to health
o the amount of information requested must be the necessary
needed to achieve this goal (AQuAS may assist the applicant in
the design of the data set)
 The resulting dataset must go through a re-identification risk
assessment process
 A legal agreement must be signed
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Legal agreement between AQuAS and research projects

No data will be provided by the Agency that may identify or
make an individual identifiable
 Not to carry any action that might identify or make an individual
identifiable
 Delete any personal information that may have been included
accidentally whithin the dataset and inform the Agency
 Not to transfer the data to third parties without the express written
consent of AQuAS
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Reidentification risk assessment
 Statistical Disclosure Control
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Risk control measures
 Aggregation
o Provide ages in ranks
o Replace diagnoses with an index
Data suppresion
Dataset not to be delivered
o In house processing
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Available datasets
 Diagnosis in primary
care, hospital, social
health and mental health
 Life styles
 Morbidity (risk factors)
 Clinical procedures
 Mortality




Radiological image
Non radiological image
Results of lab tests
Specific registries of
pathologies: Alzehimer
disease, cancer, heart
attack, stroke, etc.
 Drugs prescription
 Drugs dispensation
Available
clinical
activity
information
Available
pharmaceutical
information
Available
specific
information
More
information
to be
included in
the mid and
long-term
New datasets
roadmap (TBD)




Genomics
Proteomics
Clinical trials
Emergency activity
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Available data
Sociodemographic
data: DOB, sex,
country of birth, d/a
CMBD-AP and eCAP:
visits, lifestyle,
vaccinations, etc.
Mortality registry:
cause of death
Drug registries
CMBD-HA: 4
diagnostics, 10
procedures
Medical image
CMBD-MH and
CMBD-LTC
Invoices
Specific registries: MI,
stroke, nosocomial
infections,
arthroplasties,
alzheimer, etc.
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Real example 1
Case-control study to identify diseases and comorbidities associated to
CPAP in patients with sleep apnea and CPAP treatment
CPAP
eCAP, CMBD-AP, CMBD-HA,
CMBD/LTC, and drug prescription
non- CPAP
eCAP, CMBD-AP, CMBD-HA,
CMBD/LTC, and drug prescription
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Real example 2
Effectiveness of double antiaggregation on MI-EST patients
MI registry
Drug prescription, CMBD-HA,
mortality registry
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Real example 3
Changes in metabolic control of type 2 diabetes 2007-2013
eCAP, CMBD-HA, drug prescription, mortality registry
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Real example 4
Air pollution and autism spectrum disorders in children
Date and place of birth
Children ASD from CMBD-MH
Date and place of birth
Children non-ASD
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Thank you!