The purpose of this article is to bring together, in a punctual and systematic way, the necessary guidelines regarding the theme “safekeeping and archiving of images and reports” – based on existing legislation and opinions on the matter. Here are the most relevant topics:
The exams (films and reports), despite sometimes receiving different treatment, are an integral part of the patient's medical record, under the terms of CFM Resolution No. 1638/02 and CFM Opinion No. 10/09.
The custody of the medical record, in turn, is regulated by Resolution CFM nº 1.821, of 11/23/2007, which establishes, in its article 8, the minimum term of 20 (twenty) years for the preservation of the medical record in paper format that has not been microfilmed or digitized, and in relation to the custody of the digitized or microfilmed medical record, this must be permanent, as established in article 7 of the same Resolution.
The responsibility of the doctor and the service for the custody of the radiological exams ceases with their withdrawal by the patients. However, a copy of the issued report must be filed, and the delivery of the documents to the patient must always be formalized with a “withdrawal protocol”.
After digitizing the exams according to the rules established in Resolution nº 1.821/2007, it is possible to destroy the originals before the storage time has elapsed, provided that the computerized system fully meets the requirements of the Security Assurance Level 2 (NGS2), established in the Certification Manual for Electronic Health Record Systems, approved by the Federal Council of Medicine.
Article 86 of the Code of Ethics states that the doctor is prohibited from providing the medical report to the patient. In the same sense, the understanding contained in Opinion nº 26/2009 of the CRMPB, whose conclusion was for the obligatoriness of the elaboration of the medical report (under penalty of ethical illicit).
Alan Skorkowski
CBR legal advice