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 2013Miriam Ventura

Department of Bioethics, LABMECS-RISContato: miriam.ventura@iesc.ufrj.br

Panopticon of the Bentham

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

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 classifiedSECRET for reasons of security or public health orPERSONAL INFORMATION

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).

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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).

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.

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.

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

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.

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.

DIREITO AO ACESSO À INFORMAÇÃO - LEGISLAÇÃO ATUAL

Título Tipo Número Ano Origem Fonte Ementa

LEI Nº 12.527, DE 18 DE NOVEMBRO DE 2011 LEI FEDERAL 12.527 2011 LEGISLATIVO

D.O.U. DE 18/11/2011, P. 1(EDIÇÃO EXTRA)

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.

PORTARIA Nº 884, DE 13 DE DEZEMBRO DE 2011 PORTARIA 884 2011 EXECUTIVO - MS/SAS

DOFC I 14/12/2011 80 2ESTABELECE QUE O FLUXO PARA SOLICITAÇÃO DE CESSÃO DE DADOS DOS BANCOS NACIONAIS DOS SISTEMAS DE INFORMAÇÃO - SI, SOB GESTÃO DA SECRETARIA DE ATENÇÃO A SAÚDE - SAS

DECRETO Nº 7.724 DE 16 DE MAIO DE 2012 DECRETO DO EXECUTIVO

7.724 2012 EXECUTIVO - Presidência da República

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.

RESOLUÇÃO NORMATIVA - RN Nº 298, DE 13 DE JUNHO DE 2012

RESOLUÇÃO 298 2012 EXECUTIVO - MS/ANS

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.

PORTARIA Nº 1.583, DE 19 DE JULHO DE 2012 PORTARIA 1.583 2012 EXECUTIVO - MS/GM

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.

Fonte: Saúde Legis

Descritor: Informação

Período: 01/01/2002 a 15/08/2012

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