Christian López-Silva
Partner, Head of Healthcare and Life Sciences
Baker McKenzie
/
Expert Contributor

Digital Transformation, Health and Mexico’s Regulatory Framework

By Christian López-Silva | Mon, 05/10/2021 - 08:58

The digital transformation accelerated intensely with the COVID-19 pandemic. It was already a trend fully in motion, but the pandemic deepened and hastened many aspects due to the abrupt changes to our personal and professional lives.

This exploded particularly in the field of digital health, which is the point of interaction where the digital industry and the health industry meet and produce a rich variety of innovations. This interaction requires intense collaboration — so intense that some have identified a new form of systemic and strategic collaboration called hyper-hybridity

Is the law and regulation ready for these innovations in Mexico? I think we still have a long way to go, which can be seen as an opportunity.

We first need to know where we are. To do that, a first angle that may be useful in understanding and measuring the kind of interactions that are taking place in digital health is to look at the way in which physicians use digital technologies in their practices. This was precisely the object of a study in a recently published report, prepared by the Mexican Internet Association (AIMX), called "Digital Habits of the Medical Community." Its results are very revealing, which include the following:

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Those findings invite so many regulatory questions, including: (I) is telemedicine and its implications regulated in Mexico?, (II) are digital interactions with HCP regulated by the current codes of conduct?, (III) are medical apps regulated?, (V) when should a digital tool, including virtual assistants, that provides information to be used for diagnosing and treating a patient be regulated as medically relevant, as auxiliaries of a health service?, (vi) is the regulation of e-health records working?, (VII) are e-prescriptions fully allowed in our country?, (VIII) is the current advertising regulation adapted to this digital reality?, (IX) what aspects of virtual reality could constitute promotion and which ones advertising, and what is the relevance of that distinction?, (X) are there risks for companies in placing content about medical products in social networks? 

Noteworthy, the regulatory framework could be greatly improved not only by addressing the aforementioned innovations in the field of digital health, but also by adopting digital transformation in general. For that, we could look at some proposals put forward by key players in the digital health ecosystem. This would include those prepared and sent to the health regulator (COFEPRIS) by the Health Regulation Committee of the National Association of In-House Lawyers (ANADE) and by the Health Committee of the Mexican Association of Internet (AIMX). These proposals would include the following:

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Fortunately, the new head of COFEPRIS has been keen to re-open the dialogue with the regulated users. Consistently, the director of sanitary promotion has reassumed its role as liaison with private stakeholders. Thus, those proposals could find willing ears to listen. At the same time, in fact, the new head of COFEPRIS has taken digital transformation very seriously, already putting one digital topic at the top of a revamped agenda for this critical regulator: the full digitalization of their system of authorizations and notifications. That goal has been the Holy Grail for all regulated users and many past administrations and could demonstrate the huge transformational potential of going digital for a regulatory framework.

At the same time, there are other promising developments, made by different stakeholders. These include:

  1. An indication of the new administration at COFEPRIS that some of the regulatory questions identified above may be finally addressed, including an intention to regulate medical apps, through the incorporation of the concept of Software as Medical Device (SaMD) to the new Draft Technical Standard PROY-NOM-241 on Good Manufacturing Practices for Medical Devices.
  2. An indication by the industry that the draft of new Codes of Conduct will include provisions that foresee the new digital reality in the regulation of their interaction with Health Care Professionals (HCP).

There is, however, a long way to go, as most of the regulatory questions identified above do not yet have a clear answer. All stakeholders in Mexico will need to listen to each other and collaborate, in order to benefit in full from the promises of digital transformation and digital health.