The Covid-19 health emergency triggered an important development in the world of medicine in correlation with technology. At that time, the growth in the provision of telemedicine services skyrocketed, as well as the use of new technologies, including the Artificial intelligence.

Said development can be seen in topics ranging from a consultation with the doctor through a platform, to the possibility of obtaining a diagnosis or information related to the individual’s health through software or technological products. Some are common, such as smart watches that measure the pulse, pressure, temperature, among other functions, but there are also machines that transmit extremely complex information from a patient with precise data about a condition or disease.

What does the current legislation say?
In Mexico, there is little or no regulation of software as a medical device, within the General law of health and the Regulation of health products. In the same way, there is no clear definition of the scope that some of these types of devices and new technologies, used for medical purposes, have within the context of Mexican legislation. There are some precedents, such as the modification to the Official Mexican Standard (NOM) on good manufacturing practices for medical devicesbut a true regulation on the subject has not been achieved.

New technologies, such as the Artificial intelligencehave a direct correlation with the use of these devices and even the definition of possible issues in terms of determining health conditions and risks, so it is a situation in which there is no clarity about the scope that the use of these devices and technology will have in the field of human health.

In accordance with Alberto CamposPartner of the Life Sciences Industry Group of the Sánchez Devanny law firm, Artificial Intelligence really is a technological concept that, with the speed that it has developed and the infinite field of subjects that can be applied, is obviously not regulated in Mexico.

There are remote surgical procedures, through programs and machines, where the doctor is in another town or country, and they even obtain diagnoses through these technologies.

Current use of Artificial Intelligence in health
The most common way in which the Artificial intelligence It is through technological platforms, where the patient must enter all kinds of personal information, which, it is not known how far it will go, and are data that can be misinterpreted, if the person in charge of registering them does not have enough experience. For this reason, the human factor will continue to be extremely important, mainly for the integration of information.

In Mexico, there is a development and regulation, in relation to medical devices, particularly the General Health Law and the Regulation of Health Supplies they have a very general description of what a medical device is and are classified into three classes, depending on two factors, interaction with the body and safety.

The first type of devices are those that have very little interaction with the body, be it a thermometer or tongue depressor; the second type are those that have a more relevant relationship and are even inserted into the body, such as syringes.

Subsequently, there are the most risky devices, which are those that remain in the body within a certain period or indefinitely, an example may be a pacemaker. Within this list, contemplated in the law, software is not mentioned, since, when it was promulgated, it was not something that in practice will be used for these purposes.

According to the specialist, when a watch is used, it contains software, which will be fed with artificial intelligence, which can give an incorrect diagnosis, in which case there is no person responsible for the failure.

In legal terms, it is not clear who has responsibility for the product, as well as to what extent the health professional can use these tools to reach a medical conclusion. In the same way, the lack of regulation implies that there are obsolete provisions, an example of which is the doctor’s obligation to have a bunsen burner, when it is an object that is no longer used in the procedures.