Digital Health 2022

• Published date: 08 March 2022
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Biotechnology & Nanotechnology
• Law Firm: OLIVARES
• Author: Mr Abraham Diaz and Ingrid Ortiz

1 Digital Health

1.1 What is the general definition of "digital health" in your jurisdiction?

Mexican legislation has not specifically defined "digital health". However, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and other private and public entities are already addressing the matter in various aspects (i.e. regulation, guidelines, analysis, forums, etc.).

Nevertheless, a definition generally accepted in Mexico - although in constant evolution - is that digital health is a concept that incorporates Information and Communication Technologies, into sanitary assistance products, services and processes, as well as into organisations and institutions that may improve the health of individuals.

1.2 What are the key emerging digital health technologies in your jurisdiction?

Many areas of digital health technologies are rapidly developing in Mexico, such as: portable and ingestible devices; mobile health apps; artificial intelligence (AI); robot health carers; medicine applied robots; 3D organ printing; blockchain; telemedicine; machine learning; genome research; drones; augmented and virtual reality; and electronic records and big data, among others. As stated above, these technologies are in constant evolution.

In relation to the above, the most recent advances in digital health in Mexico have been mainly applied to three diseases: ischaemic heart disease; breast cancer; and diabetes. For example, with advances in the genetic analysis of diabetes, Mexican doctors and scientists may be able to predict which students within a student population are likely to develop diabetes, and therefore intercept with preventative measures that will save many costs in the future.

1.3 What are the core legal issues in digital health for your jurisdiction?

As a type of medical device aimed to be used by healthcare practitioners and patients, digital health has safety, quality and effectiveness implications. This is currently regulated by COFEPRIS, which grants marketing authorisations to products that are safe and effective.

Data protection is another important issue in the field of digital health. IT often involves the collection and/or transfer of data, and digital health could involve the collection and transfer of sensitive data. As a matter of fact, digital health is becoming more and more intrusive as it evolves, which is in itself a reason why the proper handling of personal information, especially the sensitive information, must be a core...