Balanced Regulation Is Crucial for Digital Health

Mexico’s healthcare system is complex and has struggled with regulatory challenges. The advent of digital health tools has opened new challenges for all industry players amid the epidemiological and demographic transition the country is experiencing. Under these circumstances, regulators have a challenging but essential task to tackle. 

As the use of digital health platforms becomes increasingly prevalent, Mexican authorities must be careful not to over-regulate but also not to under-regulate digital health tools, says Julio Sánchez y Tepoz, Partner, Health Sanitary Consulting: “Regulation is necessary, but it must be balanced with market dynamics. If we overregulate, we risk slowing down innovation. We need to adopt a health risk model and establish public policies that safeguard human rights above all.”

The regulation of healthcare and health-related products and services has a long history in Mexico, dating back to the early 20th century. In 1906, the first law regulating pharmaceutical products was established and in 1917, the first national health code was published, which established the guidelines for public health activities in the country. However, it was not until the 1980s when Mexico began to implement significant changes to its healthcare and health regulation systems, says Sánchez y Tepoz. 

The General Health Law passed in 1984 established health prevention as a policy objective for the country. In 2004, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) was established as the main regulatory body for healthcare and health-related products and services.

Since then, the Mexican government has been working to improve the regulation of healthcare and health-related products and services, implementing various reforms to address the challenges and issues in the sector, says Sánchez y Tepoz. These efforts have included improving the regulatory framework for medical devices, establishing guidelines for research on human subjects and developing regulations for tobacco products, among other policies.

Digital health, which refers to the use of technology to improve healthcare delivery and outcomes, encompasses a wide range of digital tools, from mobile health applications and wearable devices to telemedicine platforms and electronic health records. Regulation of digital health is important and must take into account a health risk model, which is “the probability of occurrence of an exogenous adverse event that can cause damage to the life or health of people,” says Sánchez y Tepoz. In this sense, every tool and different part of the value chain must be regulated separately, according to the risk model. “The regulator has great challenges, and one of them is to understand what technological solutions represent in terms of health,” he adds.

Actions

While regulation of digital health tools already exists, it must be better informed, says Sánchez y Tepoz. In addition, several challenges remain, from training of professionals to education of patients and cybersecurity. Digital tools have the potential to improve the entire healthcare system but Sánchez y Tepoz explains that certain actions must be taken, including:

1. Develop public policies for digital health that are based on a health risk model.

2. Address the digital divide by establishing public-private partnerships that promote the efficient use of information technologies in healthcare.

3. Provide training and digital mentoring to healthcare workers to support the adoption of digital health tools.

4. Strengthen the legal and regulatory framework for the operation of digital health components.

5. Document and establish public policies and private self-regulation solutions to potential issues related to the "new digital identity," "overuse," "privacy and security," and "new content and social relations" that arise from the use of digital health technologies.