On April 27th, Bill n° 1998/20 was approved by the Brazilian Chamber of Deputies of Brazil is currently awaiting approval by the Senate. The proposal, which at this stage began to also encompass, in addition to telemedicine, offsite care in nursing, physiotherapy and psychology, authorizes and describes the practice of telehealth, defined as the modality of providing health services remotely through the use of technology in its broad sense.

The Bill also assigns to the relevant Federal Councils the responsibility for the supervision of the professional practice and the ethical regulation regarding the provision of such telehealth services. Some of them relates to healthcare professionals in general, while others are narrowed to doctors practicing medicine/telemedicine.

This Bill also gives room for regulation by the SUS and other relevant health regulatory bodies, as it has been expanding scope upon the digital health concept, not only telemedicine.

The Brazilian Federal Council of Medicine (in Portuguese, “Conselho Federal de Medicina” or “CFM”), through its Resolution n. 2,134/2022 – entering into last 5/5 –, regulates the practice of telemedicine and, in general, disciplines and safeguards 

• (i) the confidentiality, privacy and protection of the data and image of patients appearing on physical or electronic medical record (i.e., which shall meet all the representation, terminology and interoperability standards);
• (ii) the professional’s autonomy regarding the decision to use the telemedicine, as well as on when using it (i.e., including the first consultation, the medical assistance or the respective procedure), except concerning the medical treatment for chronic diseases and/or diseases which require a long-term monitoring, related to which the personal presence is required; 
• (iii) the patient’s and/or legal representative’s informed consent; 
• (iv) the possibility of telehealth’s exercising in the modalities of teleconsultation, teleinterconsultation, telediagnosis, telesurgery, telemonitoring or telesurveillance, teletriage and teleconsultancy; and
• (v) the patient’s and doctor’s full right to discontinue the telemedicine consultation/treatment and/or opt for the face-to-face modality; and (vi) the several mandatory information to be included in the medical reports, certificates and/or electronic medical prescriptions. 

The approval of the Bill, as well as the CFM’s regulation, denotes another official step towards the definitive regulation of telehealth in Brazil, in line with the countless advances and benefits that the practice of telemedicine has brought to the population, the professionals and the Brazilian healthcare market when it was temporarily instituted during the state of public calamity – now officially overcome –, at the time caused by the coronavirus pandemic.

As an example, it is known that, between 2020 and 2021, the telemedicine practice in Brazil exceeded the mark of 7 million appointments, performed by more than 52,200 doctors.

As it is well understood that pandemics are now a constant threat to humanity due to globalization, the life sciences and healthcare industry will play an increasingly important role in the global economy, now alongside technology, based on a philosophy of patient access and (as seen in the current developments around COVID-19 vaccines) readiness to collaborate with business competitors in service of the greater good (which also reinforce the reasons why digital health IPO’s and SPAC deals meant to health innovation raised billions only in 2021)

This reinforces the understanding that, considering the current and global backdrop, as well as the great expectation of greater expansion in the coming years – mainly with the advent of 5G and artificial intelligence -, this is the time for the stakeholders that make up the chain of healthcare services and systems worldwide to direct efforts in the development and strengthening of the digital health ecosystem in a timely, safe, and innovative way.

Besides, early indications already suggest that, given the inconstancy verified in this multifaceted market, sustainable strategies are needed for companies to effectively operate and thrive. This also rings a bell in the sense that the companies operating in this field through disruptive business models must protect and explore the opportunities that the technology offers behind their products and services. This is, by the way, a great investment hub, especially in this new era of informatization and data monetization – mainly in Latin America. 

Of course, the myriad of legal issues that digital health faces in the region is wide ranging but the process of incorporating it into business practices is still in early days. We believe much more development is to come, but even today the use of AI  and the Internet of Things (IoT), open source, high-quality, and deidentified data, in addition to a sustainable approach to expanding access to health, shows how the strongest healthcare players operating across Brazil and Latin America are addressing procompetitive risks and distinguishing themselves from the less agile pack. 

Much more to come soon.