On December 13, the National Supplementary Health Agency (ANS) published Normative Resolution 621/24 (RN 621/24), which establishes the rules for the creation and operation of an experimental regulatory environment (regulatory sandbox) in the supplementary health sector. RN 621/2024 is the result of Public Consultation 138/24, launched in October this year by ANS (more information here).

The regulatory sandbox is a controlled environment where participating legal entities can receive temporary authorizations to test new services, products, or regulatory solutions, provided they meet pre-established criteria.

At the federal level, this initiative is regulated by Complementary Law 182/21, which establishes the legal framework for startups and innovative entrepreneurship. According to the law, within a regulatory sandbox, public administration bodies and entities, individually or in collaboration, may choose not to apply to the regulated sector certain regulations under their jurisdiction .

During the 616th meeting held on December 16, 2024, the ANS Board of Directors approved a proposal for a public call for entities that manage discount cards for health services to participate in the process of regulating their activities, initially through the regulatory sandbox.

The ANS Board of Directors ( Dicol of ANS), in its 616th meeting held on December 16, approved a proposal for a public call for entities that manage discount cards for health services to participate in the process of regulating their activities, initially through the regulatory sandbox.

RN 621/24 main aspects

According to the new regulation, the main objective of the ANS regulatory sandbox is to encourage innovation in supplementary health by providing a controlled environment where new solutions can be developed and tested. Other purposes include:

  • Encouraging innovation;
  • Providing an environment that fosters the development of new products, services, and technologies;
  • Reducing costs and maturation time for developing services, products, technologies, or regulatory solutions;
  • Improving  ANS current regulatory framework; and
  • Promoting competition and reducing entry barriers in the supplementary health sector.

Regarding the admission of participants in the ANS’ regulatory sandbox, RN 621/24 stipulates that an initial participation notice must be issued, which must contain detailed information about:

  • Objectives;
  • Market segments;
  • Relaxed rules;
  • Deadlines;
  • Selection criteria;
  • Number of participants;
  • Geographic and/or volume and scale limitations;
  • Metrics for measuring expected benefits;
  • Identification of potential risks; and
  • Administrative sanctions.

The draft notice must be legally reviewed by the Federal Attorney's Office at ANS before being submitted for public participation.

Minimum eligibility criteria for interested companies include:

  • Demonstrating sufficient technical and financial capacity to develop the intended activity; and
  • Not being prohibited from participating in public tenders or receiving grants within the public administration.

For health plan operators, additional eligibility requirements include compliance with the submission of periodic information and not being under fiscal or technical management.

The selection of participants and the supervision of activities developed in the regulatory sandbox will be carried out by a specific sandbox committee, which will be established for each notice.

The committee will have a plural character, with representatives from more than one ANS directorate. It may also include invited members, provided they demonstrate sufficient technical competence and relevance to the object of the regulatory sandbox.

Temporary authorizations will be granted to participants with the signing of a specific admission term, after deliberation by ANS Board of Directors . The term must contain, at a minimum:

  • The name of the company or entity;
  • The authorized activity and the regulatory exceptions granted;
  • Conditions, limits, and safeguards aimed at protecting the health plan beneficiary and ensuring the proper functioning of health services, with the objective of mitigating risks arising from activities exempted from regulatory requirements;
  • The start and end date of the temporary authorization;
  • The set of information to be provided to the sandbox committee for monitoring the experiment;
  • The effects resulting from the end of the temporary authorization; and
  • The provision of administrative sanctions for non-compliance.

Participation in the regulatory sandbox can be terminated by the expiration of the term, at the participant's request, by cancellation of the authorization, or by obtaining definitive authorization from ANS.

In exceptional cases, the experiment execution period can be extended for up to 12 months, provided it is justified by the sandbox committee and authorized by ANS Board of Directors .

The Life Sciences & Health practice can provide more information on the topic.