Software - the unregulated medical device

Introduction

In Mexico, it is a basic constitutional principle that no activity or product can be restricted or limited unless a legal provision establishes such restriction or limitation. This principle has resulted in a number of complexities and legal gaps regarding products and activities of a technical nature, as Mexican law is rarely (if ever) as dynamic and fast moving as technology and innovation.

In recent years, one of the most visible technological advances has been in the software and app arena, and new apps are regularly being developed for almost every kind of activity. Many of these apps directly relate to human health – be that for the purpose of monitoring, diagnosing, preventing or even curing certain medical conditions.

Regulation of software and apps

In several jurisdictions, health-related software and apps are now regulated as medical devices. For example, in the 2014 report of the International Medical Device Regulators Forum (of which Mexico is not a part), 'software medical devices' were defined as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device".

This definition clearly establishes that 'software' that is not embedded in or part of a physical medical device is per se considered to be a medical device and should thus be subject to the corresponding control of and supervision by the competent authorities.

Under the Mexican General Health Law, products which have an effect on human health are classified as 'health bound materials'. These include:

• medicines;
• psychotropic substances;
• narcotics;
• raw materials used in the production of the above substances;
• medical devices;
• prostheses;
• orthoses;
• functional aids;
• diagnostic agents;
• dentistry materials;
• surgical materials;
• curation materials; and
• hygiene products.

Further, Article 262 of the General Health Law defines 'medical devices' as:

apparatuses, accessories or instruments with specific uses bound for medical attention, surgery or exploration procedures, diagnostic, treatment and rehabilitation and those bound for biomedical research; prosthesis, orthosis and functional aids as those products bound to substitute or complement a human body or organ function; diagnostics agents those materials and substances that may be used as an aid for other clinic or para clinic procedures; dentistry products as all materials and products that may be used for dental health; surgical and curation materials as those materials used in surgical praxis or for treatment of lesions; and hygienic products as those materials and substances that may be applied to the outer body or its cavities that have a preventive pharmacological action.

Notably, the above definitions refer only to physical goods that may be used for the treatment, prevention or diagnosis of medical or health-related conditions.

Thus, the purpose of these provisions is arguably to regulate physical products and not software. This is particulary true given that the law was enacted in 1984.

In this same regard, the General Health Law Regulations for Health-Related Materials establish that the production, sale and distribution of medical devices, prostheses, orthoses, functional aids, diagnostic agents and dentistry materials, among other things, is subject to sanitary registration or a marketing authorisation.

The regulations must be interpreted alongside the General Health Law as applying only to physical goods. This position is supported by Article 83 of the regulations, which qualifies the nature of these materials based on their risk level as follows.

Based on the above, software per se arguably cannot be considered to be a product or material which is subject to sanitary control upon its importation, sale, marketing or use in Mexico since it is, under the applicable statute, intellectual property which is subject to particular provisions and regulations.

In Mexico, software is regulated only by Articles 13(XI) and 101 of the Federal Copyright Law, in which it is defined as an "original expression in any manner, language or code that is a group of instructions with a determined sequence, structure and organization that has as its purpose the performance of a specific function by a computer".

Although an app may constitute software, it is not a physical material which falls within the scope of the products considered to be medical devices and thus is not subject to sanitary control by the health authorities.

Comment

The lack of regulation over software in Mexico has two main consequences:

• on the one hand, the import, sale and use of software is not subject to control by the health authorities and may be freely used and distributed via the Internet; and
• on the other hand, the fact that medical devices are freely distributed and used without any form of sanitary control may represent a health risk for end users.

Software may be used together with hardware, networks and people other than healthcare professionals; it is precisely these complexities and interactions that may result in inappropriate use or results, particularly when no attention is given to the particular patient or health problem.

Additional issues regarding the sanitary control of software derive from its:

• nature;
• rapid development;
• tendency to be updated; and
• distribution via the Internet or networks.

Based on the above, the Mexican health authorities face a challenging situation in which they must take all efforts necessary to avoid potential health hazards arising from the use of such software, while at the same time lacking the necessary legal framework that permits them to actually do so.

This article was first published by the International Law Office, a premium online legal update service for major companies and law firms worldwide. Register for a free subscription.