Introduction
The enactment of Law No. 74-25, which establishes the new Criminal Code of the Dominican Republic—enacted on August 3, 2025, and entering into force on August 3, 2026—represents one of the most significant regulatory changes for the healthcare sector in recent decades. Although the law does not create a specific medical liability regime, it incorporates numerous provisions that directly affect physicians, nurses, pharmacists, laboratories, clinics, hospitals, and other healthcare service providers.
The new legal framework strengthens the protection of patients' rights, particularly regarding informed consent, confidentiality of medical information, protection of personal and genetic data, biomedical research, and institutional liability. At the same time, it introduces greater regulatory compliance requirements for professionals and organizations in the sector.
The law introduces new criminal exposures for both healthcare professionals and the institutions in which they provide services.
Main Risks and Implications for the Healthcare Sector
1. Strengthening of Informed Consent
Law 74-25 gives special importance to informed consent in highly sensitive medical procedures, including:
- Biomedical research and experiments.
- Genetic studies.
- Assisted reproduction procedures.
- Medical interventions that involve significant risks to the patient.
Informed consent ceases to be a merely documentary requirement and becomes an effective guarantee that the patient has received sufficient, clear, and understandable information about the procedure, its risks, benefits, and available alternatives. The absence of adequate documentation and evidence of the information process may create criminal risks for the professionals and institutions involved.
2. Greater Protection of Medical Information and Sensitive Data
The law incorporates sanctions related to:
- Improper disclosure of confidential medical information.
- Unauthorized access to clinical records.
- Irregular use or processing of personal data through automated systems.
- Disclosure of genetic information without authorization.
- Conducting genetic studies without prior, free, and informed consent.
Consequently, healthcare centers must strengthen their information security systems, access policies, document custody protocols, and mechanisms for protecting clinical and genetic data.
3. Professional Conduct with Risk of Criminal Liability
The new Criminal Code criminalizes various conducts that may compromise the criminal liability of healthcare professionals, including:
- Issuance of false medical certifications.
- Conducting biomedical experiments without consent.
- Unauthorized genetic studies.
- Disclosure of confidential medical information.
- Participation in assisted reproduction procedures outside the legal requirements.
- Manufacturing, distribution, or dispensing of adulterated, counterfeit, or harmful medications.
- Improper supply of unregulated substances or treatments.
- Certain actions related to the interruption of pregnancy.
These provisions seek to penalize serious conduct that violates the health, dignity, autonomy, or trust of the patient, and not the legitimate practice of the medical profession.
4. Criminal Liability of Clinics, Hospitals, and Laboratories
One of the most significant changes introduced by Law 74-25 is the possibility of attributing criminal liability to legal entities when there are failures of direction, supervision, control, or regulatory compliance within the organization.
In this context, clinics, hospitals, laboratories, mental health centers, and pharmaceutical establishments may be subject to sanctions when certain infractions are committed within their organizational structure.
The consequences may include:
- Significant fines.
- Temporary or permanent closure of establishments.
- Revocation of licenses, permits, and authorizations.
- Suspension of operations.
- Other complementary sanctions provided for in the law.
This means that legal risk no longer falls exclusively on the healthcare professional, but also on the institution responsible for providing the service.
5. Regulatory Compliance Programs (Compliance)
The law expressly recognizes the importance of regulatory compliance programs as mechanisms for the prevention and mitigation of criminal risks for legal entities.
Organizations that demonstrate the existence of effective policies for supervision, control, prevention, and risk management may significantly reduce their legal exposure.
For the healthcare sector, this implies the need to implement formal compliance structures that include:
- Identification of criminal risks.
- Action protocols.
- Monitoring and supervision systems.
- Continuous training programs.
- Reporting and incident management channels.
- Periodic compliance audits.
6. Liability by Omission and Duty to Act
Law 74-25 establishes criminal liability when a person who has a legal duty to act fails to adopt the necessary measures to prevent a harmful outcome that they were able to prevent.
For the healthcare sector, this principle may have implications in situations related to:
- Timely patient care.
- Application of clinical protocols.
- Supervision of personnel.
- Management of foreseeable risks.
- Emergency care.
- Follow-up of critical procedures.
The proper documentation of medical and administrative actions takes on even greater relevance under this new legal framework.
7. Main Legal and Operational Consequences
In addition to custodial sentences and financial fines, the Criminal Code contemplates measures that may directly affect professional and institutional continuity, including:
- Temporary or permanent disqualification from practicing health professions.
- Revocation of licenses and authorizations.
- Temporary or permanent closure of establishments.
- Restrictions on operating certain regulated activities.
These consequences make the management of regulatory compliance a strategic priority for healthcare organizations.
Priority Actions for Healthcare Institutions
In view of the entry into force of Law 74-25, it is recommended that healthcare-sector organizations develop a compliance plan that contemplates:
- Updating informed consent forms and processes.
- Reviewing confidentiality and data protection policies.
- Auditing physical and electronic clinical records.
- Strengthening access controls to sensitive medical information.
- Reviewing protocols for genetics, biomedical research, and assisted reproduction.
- Training of medical, administrative, and technical personnel.
- Implementing or strengthening regulatory compliance programs.
- Reviewing emergency care and clinical supervision protocols.
- Assessing the legal and operational risks associated with the new criminal framework.
- Strengthening documentation and clinical traceability processes.
Conclusion
Law No. 74-25 significantly transforms the liability framework applicable to the Dominican healthcare sector. Its approach strengthens patient protection, raises the standards of informed consent and confidentiality, expands the liability of institutions, and promotes a culture of regulatory compliance.
Although Law 74-25 broadens the criminal risks associated with certain conducts in the healthcare field, this does not mean that every adverse clinical outcome automatically generates criminal liability. The assessment of each case must consider the particular circumstances of the professional's actions and compliance with the applicable standards.
In this new regulatory scenario, proper clinical documentation, the traceability of medical decisions, and evidence of compliance with protocols take on strategic importance for the legal protection of the patient as well as of healthcare institutions and professionals.
This summary is for informational purposes only and does not constitute legal advice. The application and impact of the provisions contained in Law No. 74-25 will depend on the particular circumstances of each case; therefore, it is recommended to obtain professional advice before making decisions based on the measures described.