Building a Legal and Operational Framework for Healthcare 4.0

The healthcare industry faces a significant shift with Healthcare 4.0, but its adoption also presents substantial legal and operational challenges, as Mexico’s regulatory frameworks are not fully equipped to support this transformation. The ongoing evolution of technology needs continuous dialogue between public and private entities, while regulations must also adapt to keep pace with emerging advances and ethical considerations, experts say.

The Mexican health industry faces several operational challenges, including limited interoperability between systems, and the need for continuous training on technology, and cybersecurity, says Daniela González, Founder, Mina. The current approach to healthcare information systems requires careful management, as the sheer volume of data being generated demands more sophisticated methods for handling and sharing information between systems. “While technological infrastructure continues to evolve, the healthcare sector must prioritize securing and maintaining this infrastructure to ensure effective data management and patient safety,” she says.

Healthcare 4.0 aims to leverage advanced technologies and data-driven processes to improve patient care, enhance operational efficiency, and reduce costs. “The sector is moving toward an era of interconnected health systems, where data feedback, AI, and the Internet of Things (IoT) will radically change how individuals engage with their health,” says Jesús Hernández, President, Mexican HealthTech Association. “However, while Mexico has made strides in this area, there is still significant work to be done to fully capitalize on these technologies.”

One of the key benefits of the implementation of technology in healthcare services is increased access. “Digital transformation could bridge the gap in healthcare access for Mexico’s rural and underserved populations,” says Enrique Remezal, CEO, ICON Group. “Telemedicine, enabled by mobile devices, can connect patients with healthcare providers remotely, helping to alleviate geographic disparities in healthcare availability.” 

Mobile devices, along with other wearables like rings and watches, gather patient data to improve patient care, creating opportunities for developers to launch tools and solutions that enhance healthcare and prevention. “Data can move the industry’s efforts toward preventive care to reverse escalating healthcare costs and poor health outcomes,” says Francisco Martínez, Head of Digital Health, Automation, and AI at Mexico, Central America, and the Caribbean, Siemens Healthineers. By implementing new technologies, healthcare professionals will enhance their ability to implement these new models of care. 

However, reaping the benefits of Healthcare 4.0 requires a supportive regulatory environment, but Mexico has significant gaps in healthcare legislation. “There is a need for a comprehensive legal framework, especially concerning data management and the portability of medical records,” says Hernández. More robust regulations are necessary to ensure certainty for health tech startups, as without a clear legal foundation, investment in the sector will remain limited, he adds.

“The lack of comprehensive legal standards poses a risk to patient safety and impedes innovation in the sector,” warns Martínez. “Healthcare legislation must evolve to keep pace with technological advances, especially in areas like robotic surgery and multidisciplinary care, which can save lives.”

Regulations not only protect patients; they can also enhance the quality of care. “Regulation provides an added value in healthcare services, since verification by authorities guarantees that digital solutions hold medical value,” says Juan Luis Serrano, Partner, Sánchez DeVanny Eseverri. To realize a regulatory framework that benefits all players, from medical device suppliers to the patients themselves, collaboration between the public and private sectors is necessary. 

Some strides have been made in the development of regulation for Healthcare 4.0. Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) has recently published regulations for software as a medical device, which can pave the way for further legislation, says Martínez. 

More collaboration between the public and private sectors will be necessary as the need for healthcare services increases. “The need will become so great that within the second half of the next administration, collaborations will return, as the current system will not be able to handle the demand. This need will pave the way for collaboration and greater access to healthcare services,” says Hernández.