On May 5, 2022, the Brazilian version of US’s Federation of State Medical Boards, called the Federal Council of Medicine (CFM), published Rule #2,314/2022 to regulate telemedicine in the country. The new rule was highly anticipated, considering that until now the topic was regulated by CFM’s outdated Rule #1643/2002, which was reinstated after the CFM revoked in 2018 its Rule #2,227/2018, issued to replace Rule #1643/2002, due to criticism by physicians and other healthcare professionals.
With its 22 articles, Rule #2,314/2022:
- Provided a classification of telemedicine practice into seven categories all containing definitions in the regulation: teleconsultation; teleinterconsultation; telediagnosis; telesurgery; telemonitoring; telescreening; and telecounselling (Article 5);
- Required the patient’s explicit consent for the use of telemedicine, as well as for the sharing of any of his/her data (Article 15);
- Relied on, and, thus, required respect to, physicians’s autonomy in deciding whether or not to use telemedicine considering the patient’s best interest (Article 4);
- Required the recording, storage and protection of patient’s data and interactions as per CFM’s current ethical standards and the General Data Protection Act (Statute #13,709/2018), under the responsibility of the attending physician, in the case of medical offices, or of the director/physician technically responsible for the company or institution (Article 3, paragraph 3).
The Rule #2,314/2022 has provisions like those of the 2018 rule. For instance, when Rule #2,314/2022 requires companies to only be registered before the Medical Board of the state where its headquarter is located, regardless if it provides telemedicine in other states (Article 17). Nevertheless, Rule #2,314 /2022 innovated in some of its provisions, bringing clarity to some hot topics such as:
- The first appointment no longer needs to be face-to-face, as it was required by the 2018 rule, although Rule #2,314 /2022 requires further appointments to include a face-to-face encounter (Article 6, paragraph 3);
- The requirement that physicians who wish to practice telemedicine inform their respective Medical Board (Article 17, paragraph 1);
- The recognition that telesurgery must be regulated in its own rule, which had already been done recently by CFM through Rule #2,311/2022.
One of the concerns not yet addressed by the new provision, however, relates to the technological and telecommunications infrastructure requirements for the practice of telemedicine. Despite the progress of 5G, with promises of significant improvement in the quality of service and experience of patients, CFM did not establish minimum technical interoperability standards for its proper functioning.
Finally, it should be noted that the new rule can still require some amendments, considering that it has some inconsistencies with Bill #1998/2020 that aims at governing telemedicine in Brazil and was recently approved by the House of Representatives, currently awaiting review by the Senate. As an example, contrary to the rule, the Bill does not require face-to-face appointments for medical follow-up. In fact, Bill currently provides that further regulations should not limit telemedicine unless absolutely necessary.
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