Impact of Law No. 74-25 (New Penal Code) on the Dominican Health Sector
The promulgation of Law No. 74-25, which establishes the new Penal Code of the Dominican Republic, promulgated on August 3, 2025 and coming into force on August 3, 2026, represents one of the most relevant regulatory changes for the health sector in recent decades. Although the law does not create a specific medical liability regime, it incorporates multiple provisions that directly impact doctors, nurses, pharmacists, laboratories, clinics, hospitals and other health service providers.
The new legal framework strengthens the protection of patient rights, particularly in matters of informed consent, confidentiality of medical information, protection of personal and genetic data, biomedical research and institutional responsibility. 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 health professionals and the institutions in which they provide services.
Main Risks and Implications for the Healthcare Sector
1. Strengthening 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 for 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 can generate 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 medical 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 facilities 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 Penal Code criminalizes various behaviors that may lead to the criminal liability of healthcare professionals, including:
Issuing false medical certificates.
Conducting biomedical experiments without consent.
Unauthorized genetic studies.
Disclosure of confidential medical information.
Participation in assisted reproduction procedures outside of legal requirements.
Manufacturing, distributing, or dispensing adulterated, counterfeit, or harmful medications.
Improper administration of unregulated substances or treatments.
Certain actions related to abortion.
These provisions aim to punish serious conduct that violates the health, dignity, autonomy, or trust of the patient, 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 in management, 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 supplementary sanctions provided for by law.
This implies that the legal risk no longer falls exclusively on the healthcare professional, but also on the institution responsible for providing the service.
5. Compliance Programs
The law expressly recognizes the importance of compliance programs as mechanisms for preventing and mitigating criminal risks for legal entities.
Organizations that demonstrate the existence of effective policies for supervision, control, prevention, and risk management can 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.
Incident reporting and management channels.
Periodic compliance audits.
6. Liability for Omission and Duty to Act
Law 74-25 establishes criminal liability when a person with a legal duty to act fails to take the necessary measures to prevent a harmful outcome that they were capable of preventing.
For the healthcare sector, this principle may have implications in situations related to:
Timely patient care.
Application of clinical protocols.
Staff supervision.
Management of foreseeable risks.
Emergency care.
Monitoring of critical procedures.
The proper documentation of medical and administrative actions becomes even more important under this new legal framework.
7. Main Legal and Operational Consequences
In addition to prison sentences and fines, the Penal Code includes measures that can directly affect professional and institutional continuity, including:
Temporary or permanent disqualification from practicing healthcare professions.
Revocation of licenses and authorizations.
Temporary or permanent closure of establishments.
Restrictions on operating certain regulated activities.
These consequences make regulatory compliance management a strategic priority for healthcare organizations.
Priority Actions for Healthcare Institutions
With the entry into force of Law 74-25, it is recommended that healthcare organizations develop an adaptation plan that includes:
Updating informed consent forms and processes.
Reviewing confidentiality and data protection policies.
Auditing physical and electronic medical records.
Strengthening access controls to sensitive medical information.
Reviewing protocols for genetics, biomedical research, and assisted reproduction.
Training medical, administrative, and technical staff.
Implementing or strengthening regulatory compliance programs.
Reviewing emergency care and clinical supervision protocols.
Evaluating legal and operational risks associated with the new penal framework.
Strengthening clinical documentation and traceability processes.
Conclusion
Law No. 74-25 significantly transforms the liability framework applicable to the Dominican health sector. Its approach strengthens patient protection, raises standards of informed consent and confidentiality, expands the responsibility of institutions, and promotes a culture of regulatory compliance.
While Law 74-25 expands the criminal risks associated with certain conduct in the healthcare field, this does not imply that every adverse clinical outcome automatically generates criminal liability. The assessment of each case must consider the particular circumstances of the professional action and compliance with applicable standards.
In this new regulatory landscape, adequate clinical documentation, traceability of medical decisions, and evidence of protocol compliance acquire strategic importance for the legal protection of both patients and 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, so it is recommended to obtain professional advice before making decisions based on the measures described.
