ARTICLE
3 September 2020

ICLG Digital Health 2020

O
OLIVARES
Contributor
Our mission is to provide innovative solutions and highly specialized legal advice for clients facing the most complicated legal and business challenges in Mexico. OLIVARES is continuously at the forefront of new practice areas concerning copyright, litigation, regulatory, anti-counterfeiting, plant varieties, domain names, digital rights, and internet-related matters, and the firm has been responsible for precedent-setting decisions in patents, copyrights, and trademarks. Our firm is committed to developing the strongest group of legal professionals to manage the level of complexity and interdisciplinary orientation that clients require. During the first decade of the 21st century, the team successfully led efforts to reshape IP laws and change regulatory authorizations procedures in Mexico, not only through thought leadership and lobbying efforts, but the firm has also won several landmark and precedent-setting cases at the Mexican Federal and Supreme Courts levels, including in constitutional matters.
Mexican legislation has not specifically defined "digital health".
Mexico Food, Drugs, Healthcare, Life Sciences
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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.

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ARTICLE
3 September 2020

ICLG Digital Health 2020

Mexico Food, Drugs, Healthcare, Life Sciences
Contributor
Our mission is to provide innovative solutions and highly specialized legal advice for clients facing the most complicated legal and business challenges in Mexico. OLIVARES is continuously at the forefront of new practice areas concerning copyright, litigation, regulatory, anti-counterfeiting, plant varieties, domain names, digital rights, and internet-related matters, and the firm has been responsible for precedent-setting decisions in patents, copyrights, and trademarks. Our firm is committed to developing the strongest group of legal professionals to manage the level of complexity and interdisciplinary orientation that clients require. During the first decade of the 21st century, the team successfully led efforts to reshape IP laws and change regulatory authorizations procedures in Mexico, not only through thought leadership and lobbying efforts, but the firm has also won several landmark and precedent-setting cases at the Mexican Federal and Supreme Courts levels, including in constitutional matters.
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