CFM RESOLUTION No. 1,821 / 07 (Published in the D.O.U. of 23 November 2007, Section I, pg. 252) Approves the technical standards regarding the digitization and use of computerized systems for the safekeeping and handling the documents of the patients' medical records, authorizing the elimination of paper and the exchange of information identified in health. THE FEDERAL COUNCIL OF MEDICINE, in the use of the powers conferred by Law No. 3,268, of September 30, 1957, as amended by Law No. 11,000, of December 15, 2004, regulated by Decree nº 44.045, of July 19, 1958, and WHEREAS the physician has the duty to prepare a medical record for each patient he attends; WHEREAS the Federal Council of Medicine (CFM) is the certifying authority for physicians in Brazil (AC) and will distribute the CRM-Digital interested doctors, which will be a standard ICP-Brasil certificate; WHEREAS the support, diagnosis and therapeutic service units have their own documents, which are part of the medical records patients; CONSIDERING the growing volume of documents stored by the various types of health facilities, as defined by types of units of the National Registry of Health Establishments, of the Ministry of Health; CONSIDERING the advances in information and telecommunications technology, which offer new methods of storage and data transmission; CONSIDERING the content of CFM Resolutions No. 1,605, of September 29, 2000, and 1,638, of August 9, 2002; CONSIDERING the content of CFM Opinion No. 30/02, approved at the plenary session of July 10, 2002, which deals with medical records prepared in electronic means; WHEREAS the patient's medical record, in any storage medium, is the physical property of the institution where it is assisted - regardless of whether it is a health unit or office - who is responsible for keeping the document; WHEREAS the data contained therein belong to the patient and can only be disclosed with his authorization or that of his guardian, or for legal duty or just cause; WHEREAS the medical record and its data belong to the patient and must be permanently available, so that when requested by him or his legal representative, allow the provision of authentic copies of the relevant information; WHEREAS professional secrecy, which aims to preserve the privacy of the individual, must be subject to the rules established in the legislation and the Medical Code of Ethics, regardless of the means used to store data in the medical record, whether electronic or in electronic form. paper; CONSIDERING the provisions of the Certification Manual for Electronic Health Record Systems, prepared, according to the agreement, by the Federal Council of Medicine and Brazilian Society of Health Informatics; WHEREAS the legal authorization to dispose of paper depends on the fact that computerized systems for the safekeeping and handling of patient records fully meet the requirements of the “Safety guarantee level 2 (NGS2)”, established in the referred manual; WHEREAS all health information individually identified needs protection in its confidentiality, as it is a principle fundamental to the practice of medicine; CONSIDERING the statements contained in articles 102 to 109 of Chapter IX of the Code of Medical Ethics, the physician has an ethical obligation to protect professional secrecy; WHEREAS the provision of article 5, item X of the Constitution of the Federative Republic of Brazil, in articles 153, 154 and 325 of the Code Penal (Decree-Law No. 2,848, of December 7, 1940) and Article 229, item I of the Civil Code (Law No. 10,406, of January 10, 2002); CONSIDERING, finally, what was decided in the plenary session of 11/7/2007, RESOLVES: Article 1 Approve the Certification Manual for Electronic Health Record Systems, version 3.0 and / or another version approved by the Council Federal of Medicine, attached and also available on the websites of the Federal Council of Medicine and the Brazilian Society of Health Informatics (SBIS), respectively, www.portalmedico.org.br and www.sbis.org.br. Art. 2 - To authorize the digitization of the patients' medical records, provided that the way in which the digitized documents are stored obeys specific scanning standard contained in the paragraphs below and, after mandatory analysis by the of the Permanent Document Evaluation Commission of the medical-hospital unit that generates the archive. § 1 The scanning methods must reproduce all the information from the original documents. § 2 The digital files originating from the digitization of the patients' medical records must be controlled by a system specialized (Electronic Document Management - GED), which has, at least, the following characteristics: a) Ability to use an adequate database for the storage of digitized files; b) Indexing method that allows the creation of an organized archive, allowing the search in a simple and efficient way; c) Compliance with the requirements of “Security guarantee level 2 (NGS2)”, established in the Certification System for Registration Systems Electronic Health; Art. 3 - To authorize the use of computerized systems for the safekeeping and handling of patient records and for the exchange of identified information in health, eliminating the obligation to register on paper, as long as these systems fully meet the requirements security guarantee 2 (NGS2) ”, established in the Certification Manual for Electronic Health Record Systems; Art. 4 Do not authorize the disposal of paper when using only the “Security guarantee level 1 (NGS1)”, due to lack of protection cool. Art. 5 As the “Security guarantee level 2 (NGS2)”, requires the use of a digital signature, and according to articles 2 and 3 of this resolution, use of the ICP-Brasil standard digital certificate is authorized, until the implementation of the Digital CRM by CFM, when 360 (three hundred and sixty) days for computerized systems to incorporate this new certificate. Art. 6 In the case of micro-film, microfilmed medical records may be disposed of in accordance with the specific legislation that regulates this area and after mandatory analysis by the Medical Record Review Committee of the medical-hospital unit that generates the file. Art. 7 Establish permanent custody, considering technological developments, for the medical records of patients electronically filed in optical, microfilmed or digitized media. Art. 8 - Establish a minimum period of 20 (twenty) years, from the last record, for the preservation of patients' medical records in support of paper, which have not been filed electronically in optical, microfilmed or digitized media. Art. 9 The attributions of the Permanent Document Evaluation Commission in all units that provide medical assistance and are holders of patient records files, based on the attributions established in the Brazilian archival legislation, can be exercised by the Medical Record Review Committee. Art. 10 ° To establish that the Federal Council of Medicine (CFM) and the Brazilian Society of Health Informatics (SBIS), by agreement will issue a seal of quality for computerized systems that are in accordance with the Certification Electronic Health Record, approved in this resolution. Art. 11 CFM Resolutions No. 1,331 / 89 and 1,639 / 02, and other provisions to the contrary, are hereby revoked. Art. 12 ° This resolution takes effect on the date of its publication. Brasilia, July 11, 2007 Edson de Oliveira Andrade Lívia Barros Garção President Secretary-General EXPLANATORY STATEMENT The patient's medical record, in any storage medium, is the physical property of the institution where the patient is assisted, health unit or office, which is responsible for keeping the document. Thus, the data contained therein belongs to the patient, which can only be disclosed with your authorization or that of your responsible, or due to legal or just cause. These data must be permanently available, so that, when requested by him or his legal representative, allow the supply of authentic copies relevant information. Today, there is an increasing volume of documents stored by the various types of health facilities, as defined by types of units of the National Registry of Health Establishments, of the Ministry of Health. The support, diagnosis and therapeutics have their own documents, which are part of the patients' medical records. In addition, advances in information technology and telecommunications offer new methods of storing and transmitting data. The provisions of the Certification Manual for Electronic Health Record Systems, prepared, according to the agreement, by the Federal Council of Medicine and the Brazilian Society of Health Informatics guarantees that, to eliminate paper, computerized systems for safekeeping and handling of patient records, fully meet the requirements of “Security Assurance Level 2 (NGS2)”. When meeting the “Security guarantee level 1 (NGS1)”, the computerized system already has a good level of security, however, the elimination of paper is only possible with the use of ICP-Brasil standard digital certificate, as determined by the legislation in force on the document in Brazil, described below. The legal validity of electronic documents as evidence is guaranteed in accordance with the provisions of articles 104, 212, 221, 225 and 421 of the Civil Code and in articles 131, 154, 244, 332 and 383 of the Code of Civil Procedure. Decree No. 3,587, of September 5, 2000, establishes rules for the Public Key Infrastructure of the Federal Executive Branch - ICP-Gov. Provisional Measure No. 2,200, dated August 24, 2001, instituted the Brazilian Public Key Infrastructure - ICP-Brasil and granted validity full legal status to public and private documents provided they have a certification (arts. 1 and 10); and Decree No. 3,872, of July 18, 2001, provides for the Brazilian Public Keys Infrastructure Management Committee - CG ICP-Brasil, its Executive Secretariat and Commission Executive Technician. Brazilian archival legislation regulates the custody, timing and classification of documents, including medical records. Law No. 5,433, of May 8, 1968, regulates the micro-filming of official documents through Decree No. 1,799, of January 30, 1996. Law 8,159, of January 8, 1991 (Law on Archives), provides for the national policy on public archives and provides other measures and Decrees No. 2,134, of January 20, 1997; 2,942, of January 18, 1999, and 4,073, of January 3, 2002, regulate it. Law 8,394, of December 30, 1991, provides for the preservation, organization and protection of private documentary collections of presidents of the Republic. Decree No. 1,173, of June 29, 1994, provides for the competence, organization and functioning of the National Council of Archives and the National Archives System. Decree No. 2,182, of March 20, 1997, establishes rules for the transfer and collection of federal public archival collections for the National Archives. Decree 2,910, of December 29, 1998, establishes rules for the safeguarding of documents, materials, areas, communications and information systems of a confidential nature. Decree No. 3.505, of June 13, 2000, instituted the Information Security Policy in public administration bodies and entities federal. Decree No. 4,553, of December 27, 2002, provides for the safeguarding of confidential data, information, documents and materials from intersecurity of society and the State; Decree No. 4,915, of December 12, 2003, provides for the Archive Document Management System - Siga. Conarq Resolution No. 7, of May 20, 1997, provides for procedures for the elimination of documents within the scope of the organs and entities belonging to the Public Power. Conarq Resolution No. 22, of June 30, 2005, provides for guidelines for the evaluation of documents in health institutions. NBR ABNT No. 10,519 / 88, of October 1, 1988, sets the conditions required for the rationalization of Brazilian, public and establish precepts capable of guiding the action of those responsible for the analysis and selection of documents, with a view to deadlines for safekeeping and / or disposal. There are also more provisions in the legislation on the subject: Law 8,935, of November 18, 1994, regulates art. 236 of the Federal Constitution, providing for notary and registry services and provides for the use of electronic filing by notary and registry services. Law 9.492, of September 10, 1997, of definite competence, regulates the services related to the protest of titles and other debt documents and establishes in its art. 41 that “For the services provided for in this Law, Notaries may adopt, regardless of authorization, computer systems, microfilming, electronic image recording and any other means of reproduction ”. Law No. 9,503, of September 23, 1997, establishes the Brazilian National Traffic Code and determines that traffic departments must keep on file, for 5 (five) years, the documents referring to the driving, registration and licensing of vehicles, with the offices make use of microfilming technology or magnetic media. Law 9,800, of May 26, 1999, allows the parties to use a data transmission system to practice procedural acts, that is, sending petitions via e-mail, subject to certain requirements. Law No. 9,983, of July 14, 2000, changes Decree-Law No. 2,848, of December 7, 1940. Law 10,259, of July 12, 2001, provides for the institution of special civil and criminal courts within the scope of Federal Justice and its Article 8 standardizes electronic subpoena in the civil area for all legal entities governed by public law. Decree No. 660, of September 25, 1992, institutes the Integrated Foreign Trade System - Siscomex. and authorizes importers / exporters to use the issuing of documentation, related to foreign trade, through electronic processing of online data and images and magnetic media. Decree No. 2,954, of January 29, 1999, establishes rules for the drafting of normative acts within the powers of the Government Executive. Decree No. 3,714, of January 3, 2001, provides for the transfer of documents by electronic means referred to in art. 57-A of the Decree No. 2,954, of January 29, 1999. Decree No. 3,779, of March 23, 2001, adds provision to art. 1 of Decree No. 3,714, of January 3, 2001, which provides for remittance of documents by electronic means. Decree No. 3,996, of October 31, 2001, provides for the provision of digital certification services within the scope of public administration federal. Decree No. 4,414, of October 7, 2002, amends Decree No. 3,996, of October 31, 2001, which provides for the provision of digital certification within the federal public administration. Ordinance No. 1,121, of November 8, 1995, of the Ministry of Labor, provides for the computerization of the employee registry and other data related to the employment contract (use of electronic storage of documents in the labor area). Resolution No. 1, of September 25, 2001, of the Management Committee of ICP-Brasil, approves the Declaration of Certification Practices of AC- Raiz da ICP-Brasil. Resolution No. 4, of November 22, 2001, of the Management Committee of ICP-Brasil, changes the Statement of Certification Practices of AC Raiz da ICP-Brasil. Resolution No. 13, of April 26, 2002, of the Management Committee of ICP-Brasil, changes the Declaration of Certification Practices of the Root CA of ICP- Brazil (certifying authority), establishing the link between the Root pair of ICP-Brasil, the criteria and procedures for keys and their holder. Resolution No. 19, of May 8, 2003, of the Management Committee of ICP-Brasil, approves the electronic model Revalidation of Registration Data and New Certificate Request, as dealt with in Resolution No. 1, of September 25, 2001, of the Management Committee of ICP-Brasil. Opinion No. 16, of November 4, 1997, of the National Education Council, provides for electronic archiving on CDs or other means, school documents of educational institutions (Ministry of Education) which in its art. 1st. provides that: “The archiving of school documents, from educational institutions, will observe the following modalities: (c) on diskette or CD-ROM obtained by system computerized". With this, the Federal Council of Medicine recognizes the importance of using computerized systems for the storage and handling of medical records of patients and for the exchange of information identified in health, as well as the digitization of medical records on paper, as an instrument of modernization, with consequent improvement in patient care. It is the duty of the CFM to guarantee the physician ample legal support in the use systems, which is why it publishes this Resolution.