Digital Health 2020

1 Digital Health and Health Care IT

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, and others).

1.2 What are the key emerging technologies in this area?

Many areas of health technology are rapidly developing in Mexico, such as: mobile apps; robots; 3D printing; telemedicine; machine learning; genome research; and drones and healthcare.

In relation to the above, 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 health care IT?

As a type of medical device aimed to be used by healthcare practitioners and patients, healthcare IT 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 healthcare IT. IT often involves the collection and/or transfer of data, and healthcare IT could involve the collection and transfer of sensitive data. The mechanisms of data protection in Mexico are discussed further below.

It is advisable that entities offering healthcare IT are aware of professional liability issues, and that they check whether their professional liability insurance covers things that go wrong when providing healthcare IT services, including providing services that require a medical licence or administering medical care.

2 Regulatory

2.1 What are the core health care regulatory schemes?

Although developing, the field of digital health is still relatively new in Mexico and its application in real-life settings is still limited. There are no specific healthcare regulatory schemes for digital health; the field is instead being covered by schemes which regulate medicinal products and medical devices, namely:

the General Health Law (in Spanish, "Ley...