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July 13, 2020

COVID-19 | Life Sciences & Healthcare - PM 983

Life Sciences & Healthcare

Impacts of PM 983 in Health
updated on Jul 13 at 11:54 am

On June 16, 2020, Provisional Measure No. 983 (“PM 983”) was published, which provides for electronic signatures in communications with public entities and health matters.

Specifically, on what concerns the impacts of the new standard on health issues, the documents subscribed by health professionals related to their area of activity became valid, for all purposes, if signed with an advanced or qualified electronic signature.

Until the edition of PM 983, only documents with qualified signatures were accepted, which are those that use digital certification processes such as the Brazilian Public Key Infrastructure (ICP-Brasil).

Thus, with the new standard, there is a relaxation and debureaucratization in the process of issuance of electronic documents by health professionals, a change that comes at a good time, considering the current quarantine and social isolation measures necessary to combat the new Coronavirus.

The hypotheses and criteria for the validation of these documents, however, will be specified in a specific act of the Ministry of Health or the Board of the National Health Surveillance Agency (ANVISA).

PM 983 also amended section 35 of Law No. 5,991/1973, which provides for the requirements for the issuance of prescriptions. Among other changes, a new wording was included, stating that prescriptions in electronic media will only be valid if they contain the professional's electronic signature, as well as if the requirements that will be provided for in ANVISA or Ministry of Health act, are met

An overview of PM 983 can be found, in Portuguese, at the link: MP 983 - Assinaturas Eletrônicas

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