Regulation of Telemedicine Units: First Steps

On September 2nd , 2024, the Portuguese Health Regulatory Entity (“ERS”) released the Supervisory Alert no. 7/2024, aimed at telemedicine healthcare providers.

In an innovative manner and given the noticeable growth in the use of telemedicine solutions, this Supervisory Alert finally comes to clarify the various obligations that must be observed by telemedicine healthcare providers when engaging and providing healthcare services to patients.

In this context, the ERS stresses out that telemedicine service providers must ensure that patients' rights are safeguarded at all times – better detailed in a Practical Guide, released together with the Supervisory Alert and available here. Thus, it is worth highlighting that the ERS clarifies that telemedicine providers must:

• Inform patients and obtain their consent for teleconsultations, therefore become clear that the provision of healthcare through electronic platforms does not undermine the obligation of obtaining the informed consent from patients.
• Maintain patient privacy, ensuring that the teleconsultation is conducted appropriately and with the same quality of care expected in an in-person consultation. In practical terms, this means the healthcare professional must ensure that the space where he/she provides the service from, as well as the space where the patient is located, have appropriate conditions, and ensure the patient's privacy.
• Provide patients with the necessary clinical information, as well as, whenever requested, issue proof of the patient's presence in the teleconsultation.
• Comply with the Guaranteed Maximum Response Times (“TMRG”) when providing services that require it, thus becoming clear that telemedicine healthcare providers have to ensure that they do not exceed the legally defined response times in Portugal.

Furthermore, whenever healthcare providers are unable to meet the TMRG, they must inform patients that they are entitled to an alternative quality service within an appropriate timeframe, through referral to another healthcare provider of the National Health Service (NHS) or from the contracted sector (i.e. with a protocol/convention with the NHS

Considering the above and recognizing that the regulation defining TMRG is tailored for the NHS and traditional in-person consultations, it remains to be explored and understood how this            regulation translates to healthcare providers operating within the realm of telemedicine.

The ERS takes this opportunity to even remind healthcare providers that compliance with the rules that govern the provision of healthcare is mandatory and subject to supervision, even when these are provided through telemedicine units. In this sense, the non-compliance with these requirements, including with the rules listed above, may lead to the application of fines.

As a remarking note, it is worth reminding that telemedicine units, despite being considered healthcare establishments and being subject to registration with the ERS and to the general obligations of healthcare providers, do not have a specific regime that they must observe in terms of technical and operating requirements. Therefore, this Supervisory Alert must be indeed considered a first and significant step in the regulation of the uncertainties still surrounding these units.