Regulatory Compliance in Digital Health: Country-by-Country Guide for LATAM (2026)

Every country in Latin America has its own digital health regulations. If you operate in one country, you need to know yours. If you operate in several, you need to understand them all. Non-compliance doesn't just generate fines — it can shut down your clinic.

This guide consolidates the most important regulations from the 6 main digital health markets in LATAM.

Regulatory landscape by country

Peru

Regulation	Requirements
RENHICE (National Electronic Health Records Registry)	Standardized HL7 CDA R2 format for electronic health records
Law 30024	Creation of RENHICE and mandatory interoperability
DS 009-2017-SA	RENHICE regulations with technical specifications
Data Protection Law (29733)	Informed consent, health data security
RM 116-2024-MINSA	Telemedicine and telemonitoring regulation

2026 status: RENHICE in progressive implementation. Private clinics must be prepared for interoperability.

Colombia

Regulation	Requirements
Resolution 866 of 2021	Electronic health record interoperability
Law 2015 of 2020	Mandatory interoperable electronic health records
Resolution 3100 of 2019	Health service accreditation (includes technology requirements)
Law 1581 of 2012	Personal data protection (applies to health data)
Law 2200 of 2022	Telehealth regulation

2026 status: Interoperability in implementation. Clinics must generate and share standardized electronic health records.

Mexico

Regulation	Requirements
NOM-024-SSA3-2012	Electronic clinical record requirements
NOM-004-SSA3-2012	Clinical record requirements (paper and digital)
LFPDPPP	Federal Law for Protection of Personal Data Held by Private Parties
NOM-035-SSA3-2012	Health information requirements

2026 status: NOM-024 in effect. Private clinics must comply with electronic clinical record requirements if implemented.

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Chile

Regulation	Requirements
Law 20.584	Patient rights and duties (includes clinical record access)
Law 20.285	Transparency and public information access
Law 19.628	Personal data protection
DS 41/2012	Clinical records regulations
Law 21.180	State digital transformation (impacts public health)

2026 status: Electronic clinical records expanding. Telemedicine regulation consolidated post-pandemic.

Argentina

Regulation	Requirements
Law 26.529	Patient rights, clinical records
Law 27.553	Electronic prescriptions and teleconsultations
Law 25.326	Personal data protection
Resolution 21/2019	Digital clinical record standards

2026 status: Electronic prescription widely adopted. Digital clinical records expanding.

Ecuador

Regulation	Requirements
Organic Health Law	General framework for health services
Ministerial Agreement 5216	Unified clinical record
LOPDP (2021)	Organic Law for Personal Data Protection
Ministerial Agreement 090	Telemedicine regulation

2026 status: Electronic clinical records in early adoption phase. Telemedicine regulated post-pandemic.

Comparative table: what each country requires

Requirement	Peru	Colombia	Mexico	Chile	Argentina	Ecuador
Mandatory EHR	✅ Progressive	✅ Mandatory	⚠️ Optional with standard	⚠️ Regulated	⚠️ Expanding	⚠️ In process
Interoperability	✅ RENHICE	✅ Res. 866	⚠️ Partial	⚠️ Partial	⚠️ Partial	❌ Not yet
Electronic prescription	✅ Active	✅ Active	✅ Active	✅ Active	✅ Law 27.553	⚠️ Partial
Telemedicine	✅ Regulated	✅ Law 2200	✅ Regulated	✅ Regulated	✅ Law 27.553	✅ AM 090
Data protection	✅ Law 29733	✅ Law 1581	✅ LFPDPPP	✅ Law 19.628	✅ Law 25.326	✅ LOPDP

The 5 risks of non-compliance

Fines: Depending on the country, from $5,000 to $500,000 USD for data protection violations.
Temporary closure: Health authorities can suspend operations for accreditation non-compliance.
Lawsuits: Patients can sue for inadequate handling of their health information.
Insurance exclusion: Insurers may exclude clinics that don't meet documentation standards.
Loss of accreditation: Accrediting bodies increasingly require standardized digital systems.

How an integrated system facilitates compliance

A system like Davix facilitates compliance because:

Standardized electronic health records that meet each country's documentation requirements.
Electronic signature with legal validity for consents and prescriptions.
Complete traceability of who accessed what information and when.
Cloud backup with encryption meeting data protection standards.
Interoperability via DICOM and HL7 standards to connect with national systems.

Frequently asked questions

Can I use the same system across multiple LATAM countries?

Yes, if the system is configurable by country. Davix allows configuring the specific regulatory requirements for each market.

What if I operate on paper and want to comply with digital regulations?

Complying with digital regulations doesn't always require completely abandoning paper immediately, but you must prepare. The implementation guide helps you make the transition.

Do regulations apply to small clinics?

Yes. In most countries, data protection and clinical documentation regulations apply regardless of establishment size.

Conclusion

Regulatory compliance in digital health across LATAM is a moving target, but the trends are clear:

Electronic health records are becoming mandatory across all of LATAM.
Electronic prescriptions are already the norm in most countries.
Data protection has specific laws in all 6 major markets.
Interoperability is the next regulatory frontier.
An integrated system simplifies compliance instead of complicating it.

Check Davix pricing or schedule a demo to evaluate how to comply with your country's regulations.