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09 October 2019
In today's world, technology develops rapidly and it generally takes the legislature some years to catch up. This is particularly true in the healthcare industry, where regulations are struggling to keep up with the development of health-related technology.
This situation has put Mexico in a difficult position. On the one hand, health-related technology (eg, apps) is widely available to the general population through mobile phones and the Internet. Further, various international agreements and treaties permit the free use of a diverse range of technologies. However, as a developing country, Mexico faces numerous challenges with regard to the applicable legal framework, as it cannot quickly and efficiently regulate the use of emerging technologies.
Additional challenges have arisen due to the government's general austerity policy for all government activities and bodies. Thus, the health authorities have struggled to implement legal provisions to govern the use of technology for health-related purposes. This austerity policy has, to a considerable extent, slowed down and in some cases completely stalled the activities of the authorities which regulate health matters.
In Mexico, telemedicine is not specifically regulated by the laws which govern health-related services (ie, the General Health Law and its Regulations for Health-Related Services). The General Health Law and the associated regulations were enacted in 1984 and 1986, respectively, and although they have been the subject of diverse amendments since then, none of these have concerned telemedicine.
The health authorities have attempted to regulate the diverse use of technology in health-related matters in an isolated manner by issuing Mexican official standards (NOMs), Mexican standards (NMXs) and other administrative guidelines, many of which were not developed in accordance with the applicable legal requirements and thus have no binding effect.
The NOMs that regulate health services (and, to some extent, those provided through remote access (ie, telemedicine)) include:
However, none of these NOMs explicitly regulate the provision of telemedicine services in Mexico. Instead, they contain references to some of the concepts and services that may be associated with telemedicine and, in a broader sense, telehealth.
Likewise, many of these NOMs were issued several years ago and have not been amended to reflect technological advances in the healthcare field.
One of the main aims of telemedicine is to provide medical services in an efficient manner by removing the need for medical professionals to be physically present or for service providers to have specific premises. In turn, this speeds up the process and cuts costs.
Likewise, telemedicine allegedly concentrates a range of medical expertise in one place, creating a hub from which high-quality medical attention can be more efficiently rendered by a diverse range of professionals to patients located in remote areas or places where specialist services are unavailable.
Notwithstanding the above, telemedicine poses unique risks and challenges, particularly with regard to patients in jurisdictions that lack sophisticated regulatory provisions or a reliable regulating authority, as is the case in many places throughout Mexico.
Some of the issues that may arise in relation to the provision of telemedicine services include:
To render telemedicine services, parties predominantly require:
Although these requirements seem obvious, there are no compulsory provisions in Mexican law which set out clear requirements for the provision of telemedicine services (eg, the protocols to be followed, what information must be preserved, requirements pertaining to the necessary premises or equipment or the specific training required of medical or health professionals).
Most provisions regarding the rendering of health-related services in Mexico concern the obligation to have physical premises where specific equipment is available and which may be used only for specific types of service (with numerous limitations and restrictions). The most relevant of these provisions are included in various NOMs, including:
These NOMs, together with many other provisions, establish that all health-related services must be provided at a specific premise and be overseen by medical professionals. As such, they do not provide for the possibility of services being provided remotely by way of communication technologies.
In general, the requirement to operate from a physical premise involves a number of considerations not only from a physical or infrastructural perspective, but also from a regulatory and administrative perspective. For example, to operate premises where health-related services will be carried out, service providers must enlist an individual who is responsible for sanitation. Among other things, this person will be responsible for:
These requirements pose a significant challenge to the provision of telemedicine in areas where it is impossible to have premises that duly comply. Thus, from a legal perspective, telemedicine is not a viable alternative for providing services to certain demographics.
These NOMs even establish different categories of medical office from which basic medical attention or services can be provided, each of which is subject to different requirements. Under such model, services cannot be provided via telemedicine with regard to specific medical specialities unless these minimum requirements are met.
Thus, telemedicine as an alternative for the less privileged is unfeasible and would represent a lack of legal certainty for the individuals or legal entities rendering such services in Mexico.
On 21 December 2015 PROY-NOM-036-SSA3-2015 was published in the Federal Official Gazette. This proposed NOM aimed to regulate remote medical services and included a number of specific provisions which, although incomplete, signified a first step towards the specific regulation of telemedicine services.
However, on 27 April 2018 the cancellation notice for this NOM was published in the Federal Official Gazette, once again leaving a major gap in Mexico's regulations.
In order to provide telemedicine, service providers require devices which enable them to communicate with patients and obtain the necessary information regarding patient health.
Under Mexican law, devices used to provide medical services must be authorised by the competent authorities and have obtained the corresponding marketing authorisations. Likewise, under the applicable provisions, it could be argued that health-related services can be provided by using only the devices specifically contemplated in such provisions or devices that meet the applicable requirements.
Medical devices are generally regulated by the General Health Law and the Goods and Services for Health Purposes Regulations. In addition, other provisions set out particular requirements for these types of goods, which are not limited to medical devices per se, but may include medical-related materials.
In general, these requirements are contemplated in NOMs, NMXs and other guidelines issued by the competent authorities.
Notably, some of the devices commonly used by medical professionals to render telemedicine services remotely are software or apps that the patient can access via:
Just as telemedicine is not specifically regulated in Mexico (and could even be considered to contravene the specific provisions regarding health-related services), the use of software or apps for certain health-related purposes is not considered to constitute the use of a medical device subject to regulation or control by the competent authorities.
In Mexico, software (including apps) is not considered a medical device under the General Health Law and its regulations, despite recent attempts by the authorities to start regulating software bound for medical purposes and consider it a per se medical device subject to administrative controls through the issuance of NOMs and other guidelines (for further details please see "Software – the unregulated medical device").
On 14 June 2019 the draft PROY_NOM-241-SSA1-2018 (good manufacturing practices for medical devices) was published in the Federal Official Gazette. This draft NOM, which may replace NOM-241-SSA1-2012, includes software within the definition of a 'medical device'. However, such definition is arguably a mere point of reference and not an actual definition of the concept as it is to be regulated.
In addition, the new draft NOM establishes that in order to use software which constitutes a medical device, users must provide:
However, the way in which software is currently regulated is incompatible with this definition, as all provisions regarding medical devices (including their use, registration and authorisation) have been issued in connection with or apply to physical goods for patient use (either over, on or in their body) and not a non-physical product (eg, software), the import, marketing and use of which would go beyond the scope of the Mexican authorities regulation.
The final NOM will hopefully address these matters in more detail and provide some formal guidance on the way in which the authorities will interpret the term 'devices'.
At present, it appears that the provision of telemedicine services in Mexico is impossible due to the requirements pertaining to the premises where health-related services must be rendered. Arguably, one of the most relevant considerations in this regard is the fact that the actual provider of the service may not be located in Mexico and may instead render services from a foreign jurisdiction. In such cases, Mexican law could be considered inapplicable.
In addition, one of the biggest challenges of providing telemedicine services is the need for remote communication technology (ie, the Internet) and specific software or apps which patients can download onto any general-use device (eg, a phone or computer) without the need to interact with a medical or health professional.
More situations in which health-related services are provided through devices may arise in the near future. In turn, this may lead to an increase in associated legal issues arising from, among other things:
For further information on this topic please contact José Alberto Campos Vargas at Sanchez-DeVanny Eseverri SC by telephone (+52 55 5029 8500) or email (email@example.com). The Sanchez-DeVanny Eseverri SC website can be accessed at www.sanchezdevanny.com.
The materials contained on this website are for general information purposes only and are subject to the disclaimer.
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