What are their roles?

The national government must first have a digital strategy with a multiyear budget designed to usher all citizens and businesses into the digital age. It also should provide communications infrastructure, set goals for rolling out digital administration, and ensure there is a pool of professionals with adequate training in related fields that businesses and government organizations can draw from. It is also the government’s responsibility to promote and pass the laws needed to ensure legal certainty for all involved.

The ministry of health and directors of the health system, which are responsible for the overall health strategy, should create and implement the digital health strategy as a tool for achieving the country’s health objectives. Their role includes setting objectives and goals and allocating the necessary financial and human resources.

Hospitals and primary care centers should make sure the DT brings value to patients and professionals. They also should implement clinical information systems and promote responsible use of information. It is therefore crucial for them to have a voice in decisions and to encourage professionals to participate in decision-making processes as well.

Health professionals should be involved in establishing requirements and semantic definitions based on their clinical information needs. They should also support technology uptake and propose innovations that help improve the DT.

Citizens and patients should be familiar with their health information, participate in designing the tools they will use, defend their rights, verify the DT’s value, and advocate for necessary legislative changes.

The regulatory framework

Governance for digital health requires laws and standards that define the roles and responsibilities described above and that facilitate the use of technologies and digital practices in the sphere of health. There are different conceptual frameworks that lay out the type of regulations needed to advance digital health. For example, the IDB’s Regulatory framework for Digital Health in Latin America and the Caribbean, identifies five key areas for implementing EHRs:

• Matters specific to EHR: what information EHRs should contain, and EHR’s legal status.
• Protecting patient data and secondary use of health information: which uses are permitted and which are prohibited.
• Actions by health professionals: who can access EHR’s information, what is its legal status, and the scope of its use.
• Role of patients in relation to their health data: whether patients can modify their data and whether they need to give consent for its use.
• Health and interoperability standards: the standards that should be followed so the information is understandable in all the different context where it is used.

The IDB’s mapping exercise in the above report shows that only 10 LAC countries have regulatory frameworks that cover more than 75% of these areas. Meanwhile, seven countries address 50% to 75%, and the rest less than 50%. The IDB’s interactive platform provides detailed information on the laws and regulations of the countries in the region. The platform can be used to draw comparisons between countries and access the texts of the different regulations.

In the daily routine

Beyond laws and regulations, governance encompasses and shapes the day-to-day culture and behavior of the ecosystem of people and institutions and the arrangements they need to make to digitally transform the sector. At this grassroots rather than legislative level, an example is the governance structure of the community developing the open-source EHR system in the state of Bahia in Brazil. This structure defines roles and responsibilities for decisionmaking and developing AGUse, an opensource electronic health record system.

Two characteristics of the DT in health are particularly relevant to governance. First, the transformation involves many actors from different spheres that have traditionally worked in isolation. Second, it is an ongoing and long-term process. The success of any exploration depends on all participants moving forward together in harmony and in the same direction to reach the destination, and good governance is the key to achieving this.