Talk by Miriam Ventura at the 1st Syposium on Big Data and Public Health (2013)

1. 1st Symposium on Big Data and Public Health
Data Access Policies
Access to Information, privacy, and health research in Brazil
Rio de Janeiro, 24 October 2013
Miriam Ventura
Department of Bioethics, LABMECS-RIS
Contato: miriam.ventura@iesc.ufrj.br

2. Panopticon of the Bentham

3. Access to public information in Brazil
is a fundamental citizen´s right
(constitucional law).
Public information is all information
produced by government or under
government custody.
AVAILABILITY, AUTHENTICITY AND
INTEGRITY ARE THE MAIN ATTRIBUTES
OF PUBLIC INFORMATION

4. Federal Law nº 12.527/2011 regulates the right of
access to public information, providing state duties:
 to efficiently manage government documents or those
under government custody.
 to make knowledge and consultation thereof available
TO ALL.
The Law ONLY ALLOWS RESTRICTIONS ON
ACCESS to information classified
SECRET for reasons of security or public health
or
PERSONAL INFORMATION

5. Federal Law n. 8.080/1990 regulates the state’s duties
vis-à-vis the right to health and the organization of public
healthcare services in Brazil, highlights citizens’ right to
information and the state’s duty to base its policies
and actions on health information and scientific
evidence.
Resolution nº 466/2012, of the National Council of Health,
regulates the research involving human subjects,
reaffirming the confidentiality of personal data, and only
exceptionally authorizing access without individual
consent after analysis by a research ethics committee
(nationwide system in charge of the ethical regulation of
research).
.

6. Brazil government available on the Internet a largest
national health databases containing records on
deaths, live births, hospital admissions and ambulatory
obtained directly from individual in the sphere of
individual care. The confidentiality of personal
information is preserved.
However, some research require access in databases
with identified information. The specific requirements
for access in databases with identified information
have been set by health system administrators and
ethical review boards (CEP/CONEP).

7. The constitutional provision is clear and applicable to any type of
information.
Detainers of information owe maximum respect for the individual
privacy and maximum transparency of acts involving the public
interest. (art. 5º, XXXII, art. 37 II do § 3º art. 216 e nº § 2º da
Constituição Federal Brasileira).
Personal information, even when its collection, storage, and use
are authorized by health legislation, does not lose its confidential
quality, and access to it requires the person’s consent, except in
two situations:
when “the person is physically or legally incapable, and solely and
exclusively for medical treatment” or
when the information is necessary “to produce statistics and
scientific research of evident public or general interest, as
provided by the law, while prohibiting the identification of the person
to whom the information refers”.
Brasil. Federal Law 12.527/ 2011.

8. ETHIC REQUIREMENTS FOR WAIVER OF CONSENT
The health system administrators and ethical review boards (CEP/CONEP)
reaffirming the confidentiality of personal data, and only exceptionally
authorizing access without individual consent.
The ethical review must specify :
a)whether the study seeks to answer a relevant public health question, with
clear benefits;
b)whether it is unfeasible to obtain consent from the subjects;
c)whether the research offers minimal risks;
d)whether the rights or interests of the persons will not be violated and their
privacy and anonymity will be preserved.
e) the safety measures to be adopted to prevent possible harm to the
persons involved and special measures to protect vulnerable groups and
avoid discrimination and social stigmatization.
Researchers should also be accountable for any and all undue use of
the data authorized by the consent.

9. NEW FACTS AND INSTITUTIONAL VALUES RELATED TO
INFORMATION:
The speed of technological progress has rendered various forms of
legal tutorship rapidly obsolete, and the more recent strategy has
focused less on purely technological data and more on other
normative points of reference such as the subject’s nature (public
versus private):
a) Concept of privacy and individual protection, shifting more recently
to the more complete notion of “data protection” including a virtual
dimension of protection of the “electronic body”, as a negative right to
freedom, i.e., to not use data from electronic files, and meanwhile of
positive freedom, of controlling one’s data in such records.
b) the purposes of the data collection, and
c) greater attention to new interactive technologies that expand
circulation and increase the power of information

10. The recent Law on Access to Information
provides both the legitimacy for this
consolidated public information policy
and the opportunity to expand the
discussions and reflections on public
information in health, besides improving
mechanisms to ensure such access in
this new democratic context with
technological advancements.

11. The international experience suggests that this
discussion should consider “the roots of power
based on the availability of information and its real
detainers” and not shape regulation on the
traditional and insufficient political and legal forms
of “counter-power and control” , but to seek
alternatives that allow all the potential of
information and new information technologies in
the protection of real subjects, from a perspective
of expanding the possibilities for “redistribution of
social and legal powers”, thereby legitimizing and
ethically and legally justifying the right to access
public information.
Rodotá S. A vida na sociedade da vigilância – a privacidade hoje. Rio de
Janeiro: Renovar; 2008.

12. Fonte: Saúde Legis
Descritor: Informação
DIREITO AO ACESSO À INFORMAÇÃO LEGISLAÇÃO ATUAL
Título
LEI Nº 12.527, DE 18 DE NOVEMBRO DE 2011
Período: 01/01/2002 a 15/08/2012
Tipo
LEI FEDERAL
PORTARIA Nº 884, DE 13 DE DEZEMBRO DE 2011 PORTARIA
DECRETO Nº 7.724 DE 16 DE MAIO DE 2012
DECRETO DO
EXECUTIVO
RESOLUÇÃO NORMATIVA - RN Nº 298, DE 13 DE RESOLUÇÃO
JUNHO DE 2012
PORTARIA Nº 1.583, DE 19 DE JULHO DE 2012
PORTARIA
Número Ano
Origem
Fonte
12.527 2011 LEGISLATI D.O.U. DE
VO
18/11/2011,
P.
1(EDIÇÃO
EXTRA)
Ementa
REGULA O ACESSO A INFORMAÇÕES PREVISTO NO
INCISO XXXIII DO ART. 5º, NO INCISO II DO § 3º DO ART.
37 E NO § 2º DO ART. 216 DA CONSTITUIÇÃO FEDERAL;
ALTERA A LEI Nº 8.112, DE 11 DE DEZEMBRO DE 1990;
REVOGA A LEI Nº 11.111, DE 5 DE MAIO DE 2005, E
DISPOSITIVOS DA LEI Nº 8.159, DE 8 DE JANEIRO DE
1991; E DÁ OUTRAS PROVIDÊNCIAS.
884 2011 EXECUTIV DOFC I 14/12/2011 80 2
ESTABELECE QUE O FLUXO PARA SOLICITAÇÃO DE
O CESSÃO DE DADOS DOS BANCOS NACIONAIS DOS
MS/SAS
SISTEMAS DE INFORMAÇÃO - SI, SOB GESTÃO DA
SECRETARIA DE ATENÇÃO A SAÚDE - SAS
7.724 2012 EXECUTIV
OPresidênci
a da
República
298 2012 EXECUTIV
OMS/ANS
1.583 2012 EXECUTIV
O MS/GM
D.O.U. DE
16/05/2012,
P. 1
(EDIÇÃO
EXTRA).
RETIFICAÇÃ
REGULAMENTA A LEI Nº 12.527, DE 18 DE NOVEMBRO
DE 2011, QUE DISPÕE SOBRE O ACESSO A
INFORMAÇÕES PREVISTO NO INCISO XXXIII DO CAPUT
DO ART. 5º, NO INCISO II DO § 3º DO ART. 37 E NO § 2º
DO ART. 216 DA CONSTITUIÇÃO.
DISPÕE SOBRE MECANISMOS DE TRANSPARÊNCIA
ATIVA E PASSIVA NO ÂMBITO DA AGÊNCIA NACIONAL
DE SAÚDE SUPLEMENTAR - ANS, INSTITUI O SERVIÇO
DE INFORMAÇÃO AO CIDADÃO - SIC DA ANS,
CLASSIFICA EM GRAUS DE SIGILO INFORMAÇÕES EM
PODER DA ANS E DISPÕE SOBRE O SEU
TRATAMENTO; E DÁ OUTRAS PROVIDÊNCIAS.
DISPÕE, NO ÂMBITO DO MINISTÉRIO DA SAÚDE E
ENTIDADES A ELE VINCULADAS, SOBRE A EXECUÇÃO
DA LEI Nº 12.527, DE 18 DE NOVEMBRO DE 2011, QUE
VERSA SOBRE A LEI DE ACESSO À INFORMAÇÃO, E
DO DECRETO Nº 7.724, DE 16 DE MAIO DE 2012, QUE A
REGULAMENTA.

13. Thanks!