Digital Health Regulation in Mexico: Hits, Opportunities

Mexico has an urgent need for regulation in the healthcare sector after the pandemic exacerbated digitalization and the adoption of new technological innovations, agreed industry experts during the panel “Digital Health Regulation in Mexico: Hits and Opportunities.”

Digihealth is in a unique position as it combines tech and healthcare to give Mexican citizens access to health services and digital technologies, said Juan Luis Serrano Leets, Partner- Life Sciences, Sánchez Devanny. However, despite the significant impact it has on companies, medics and patients, regulation is lacking, he added.

Because digihealth merges health and information, its regulation must not only focus on health regulation but also on information technologies to avoid skipping important steps such as technological neutrality, said Christian López-Silva, Partner, Head of Pharmaceuticals and Life Sciences, Baker Mckenzie. To do so, regulation identifies sanitary risks and prepares for potential eventualities.

Regulation in digital health also brings different concerns at different levels. In mobile apps, for example, companies and regulators must distinguish between medical purposes and wellbeing purposes. These small distinctions require smart regulation and different levels of intervention depending on circumstances. Mexico usually relies on authorizations and notifications but the system must realize that not everything requires an authorization. A modern regulatory framework that follows risk analysis can determine what actually requires authorization and what does not.

Regulatory concerns are increasingly prominent considering that digital health is expected to grow 10 percent in the next five years in Mexico due to greater access to mobile devices and the pandemic’s acceleration of technology, said Víctor Sánchez, CEO, Pragmatec. This phenomenon is creating new ways of providing healthcare that were previously not even imagined. Under these circumstances, regulation will impact not only the final user but also doctors who trust that the technologies have passed regulations and companies who invest in the health sector. Technological innovations brought by Industry 4.0, AI, big data, IOT and digihealth must be addressed federally as well as by state.

Sanitary regulation also promotes innovation, said Sánchez, but it must arrive at the right time. Setting regulations too early can break the cycles of generation of new knowledge. But if set too late, new applications can run into issues with formerly developed technologies. Therefore, regulation should be considered in intermediary steps once prototypes are ready and readjustments can be made, said Sánchez.

Regulation is a necessity because digihealth is here to stay, said Fabiola Fajardo, Strategic Consultant, Alitea. But digihealth is only a tool and as such it needs to be regulated. Digihealth will impact companies by affecting the interoperability between the public and private sector, the capacity of reimbursement with insurance companies and the impact perceived by investors. For doctors, digihealth will mean a temporary workload increase that has long-term benefits and increases demand for services at decentralized clinical practices.

A regulatory framework will bring benefits not only for innovation in digihealth but also in the infrastructure of telecommunications, according to Fajardo. Germany’s 2019 Digital Healthcare Act, considered a pioneer in the matter, provides an example to follow with fast-track evaluation to show its effect in the sector.

Digihealth must be regulated to guarantee its quality and efficiency, said Andrea Arozamena, Healthcare Linkage Leader, GS1. Not having a clear regulation opens the door to products without assurance and security, but the regulation process should flow in the same direction as the operation, said Arozamena. GS1 has observed poor communication between the government and the industry. Uniting efforts and following international examples facilitate the flexibility to innovate by allowing demonetization, democratization and dematerialization in access to digihealth.

This technology brings numerous benefits to the sector such as empowerment and increased accessibility geographically, said Gabriela Lerma Valencia, Contract Sales & Medical Solutions BU Director, IQVIA. However, it is necessary for patients and doctors to have guarantees regarding the use of their data. It is also necessary to have a regulation that ensures all players are well informed regarding regulated markets, telemedicine, prescriptions and digital file management, among other areas.

Challenges in the road to implement digihealth include the cultural transformation to adopt these digital solutions, poor interoperability, lack of information regarding the use of these technologies, literalizing digital information and limited accessibility due to the discrepancy between the public and private sectors. For patients in the public sector, there are other types of challenges: problems related to storage, data property and security. However, the implementation of further technologies such as AI can be a strong tool in overpassing these hurdles.