Health Regulatory Sandbox: What to Expect in 2025

At the beginning of February, the National Supplementary Health Agency (ANS) approved the public notice to implement a regulatory sandbox in the supplementary health sector. In other words, for 2025, one of the sector's biggest expectations is centered on the proposal of an experimental regulatory environment to test new health plan models, focusing exclusively on elective consultations and exams.

Structured based on the regulations outlined in Normative Resolution 621, published by the agency in December 2024, the idea is that these new models will help address the low availability of individual and family health plans. According to ANS, in 24 out of the 27 federal units, these types of plans represent less than 10% of the total subscribed plans.

"The initiative seeks to expand Brazilians' access to health plans, reducing unmet demand and promoting the diversification of available products. In addition to increasing the supply of plans, the proposal could attract a younger audience, which has been distancing itself from the sector due to the high costs of traditional coverage," explains Rogério Scarabel, a lawyer specializing in the health sector, former president of the National Supplementary Health Agency (ANS), and partner at M3BS Advogados.

Regarding young people, the expectation is that around 10 million new beneficiaries within this age group will be included through this pilot project. For example, in 2023, ANS data indicated a decline of:

• 11% in the number of beneficiaries aged 15 to 19;
• 17% in the 20 to 24 age group;
• and 18% among those aged 25 to 29.

Therefore, Scarabel reiterates that "the inclusion of this new group would not only strengthen the sector’s balance but could also encourage greater adherence to preventive practices, promoting more consistent health habits from an early age and reducing the need for more complex treatments in the future."

Although the focus is on individual and family plans, ANS has also authorized collective plans by membership, but under the following conditions:

• with a waiting period;
• without portability;
• with hierarchical access;
• with a co-participation model limited to 30%;
• and bonuses for beneficiaries with longer enrollment periods, for those participating in care pathways, and for those allowing data integration with the SUS.

Sandbox in Brazil

In Brazil, experimental regulatory environments are still in their early stages, and the regulatory bodies of each sector are responsible for structuring their respective testing areas.

For example, while in July 2024, the Superintendence of Private Insurance (SUSEP) published the notice for the 3rd edition of the sandbox for private insurance, the health sector was still trying to reach a consensus on what should be included in the regulations.

Thus, in December 2024, ANS released its first normative resolution establishing rules for the sandbox in the supplementary health sector, in addition to clarifying its main objectives.

The document highlights that the regulation allows legal entities to test new services, products, or technologies specifically designed to meet the demands of supplementary health.

Furthermore, the new regulation also emphasizes other objectives, such as:

• “Reducing costs and the maturation time required to develop services, products, technologies, or regulatory solutions within supplementary health;
• Improving the existing regulatory framework at ANS;
• Promoting competition and lowering entry barriers in the supplementary health sector.”

In practice, ANS is relaxing the rules, allowing new health solutions to be developed and tested over a two-year period. After this period, if the project delivers the expected results and gains approval for continuation, the operators can decide whether to discontinue the product or introduce it to the market.

In cases where the plan is discontinued, beneficiaries will have the right to portability to another operator, a measure that mitigates potential risks for users.

Additionally, the emergence of new products is expected to stimulate innovation and increase competition among operators —particularly in regions where coverage and services are not sufficiently efficient or accessible.

Challenges of the sandbox in healthcare

Although the possibilities and rules are beginning to take shape, challenges still remain.

According to Scarabel, “the possibility of beneficiary portability to the new plan may encourage the migration from corporate plans, significantly reducing revenues for providers (such as hospitals and clinics) and suppliers (such as pharmaceutical companies and the medical device industry),” the expert points out.

Among other risks, coverage limits may lead to confusion, dissatisfaction, and even an increase in legal disputes within the sector, depending on how the commercialization process unfolds. In this regard, the new health plan model excludes coverage for oncology, dialysis, and ASD (Autism Spectrum Disorder) treatments. However, it is still considered a better alternative than discount cards and the exams provided by SUS (Brazil's Unified Health System).

Additionally, there is a concern regarding collective plans, as “the requirement that plans be collective by membership may make it difficult for individuals who are not part of professional associations or unions to enroll. In this sense, the proposal does not directly address the indicated barrier to commercialization,” says Rogério Scarabel.

Finally, for the objectives of the experimental regulatory environment to be achieved, the expectation is that ANS will further strengthen the regulations, closely monitor the results, and be prepared to make adjustments as new needs arise. All of this should be carried out with the support of public consultations and hearings.

“The documents have not yet been made available, but it is clear that the success of the sandbox will depend on clear regulations and a thorough analysis of the results after the testing period. If well implemented, the proposal could bring significant benefits to the market, democratizing access to health plans and promoting a more sustainable model,” the lawyer concluded.

A public consultation on the topic will be open from February 18 to April 4, and a public hearing will also address these issues on February 25.

But where did the regulatory sandbox come from?

Disruptive ideas are tempting. However, when it comes to health and money, caution is necessary. After all, are all innovations truly beneficial? Do they always translate into better clinical outcomes for patients? Do they genuinely help operators and service providers reduce costs or optimize bureaucratic processes?

The need to answer these questions gave rise to the regulatory sandbox — or simply experimental regulatory environment in portuguese. Used across various sectors such as information technology, transportation, finance and healthcare, this "sandbox" refers to a safe space, removed from existing regulations, where high-complexity projects can be tested and validated.

Developed in the United Kingdom in 2016, experimental regulatory environments were initially structured to meet the needs of fintechs, which required a space to validate new financial technologies. Since then, several countries have followed suit, including Brazil, Canada, Singapore, Australia, and the United States.

In 2020, a report by the World Bank Group indicated that 57 countries had already adopted the model, leading to the existence of 73 experimental regulatory projects worldwide at that time.

Since then, numerous "sandboxes" have been created to validate innovations. However, in Brazil’s healthcare sector, experimentation spaces have remained more of a concept than a reality. With ANS’s latest initiatives, experimental regulatory environments in healthcare are starting to gain safer conditions, helping to consolidate these spaces.