The regulatory framework for health software in Peru
Developing software for the health sector in Peru involves navigating a set of technical and legal standards that do not exist in other sectors. Non-compliance can not only generate financial penalties: in some cases it can compromise patient care and the security of sensitive data.
The MINSA (Peruvian Ministry of Health) and the National Health Superintendency (SUSALUD) are the main regulatory entities. Any health information system that operates in authorized establishments must align with its technical guidelines.
Technical Standard for Clinical History (NTS N°022)
NTS N°022-MINSA/DGSP establishes the requirements for clinical history in the Peruvian health system. Although it was published with physical formats in mind, its principles apply to the electronic format: integrity, confidentiality, availability and traceability of records.
An electronic health record (EHR) system must guarantee that each modification is recorded with date, time and responsible user. Information cannot be deleted; It can only be corrected by leaving traceability of the original record.
- Log of accesses and modifications (audit trail)
- No data deletion; only corrections with traceability
- Unique identification of the patient
- Minimum structure of the EHR according to the technical standard
- Digital signature of the health professional
Personal Data Protection Law (Law 29733)
Health data is considered sensitive data under Law 29733. This implies additional obligations for those who process it: explicit consent of the owner, reinforced security measures and strict limitations on the use and transfer of that information.
Medical software must incorporate from the design (privacy by design) the mechanisms to comply with this law: access control by role, encryption of data at rest and in transit, and documented procedures for access requests, rectification and cancellation of data.
- Encryption of data at rest (AES-256 minimum)
- Communications encryption (TLS 1.2+)
- Role Based Access Control (RBAC)
- Patient consent record
- Documented procedure for ARCO rights
- Data Retention and Deletion Policy
Turn this article into a technical decision
Tell us your context and we will send back the recommended next step for your business.
Interoperability: the great challenge of the sector
One of the biggest problems of the Peruvian health system is the fragmentation of information: a patient has records in the MINSA hospital, in his private clinic, in the insurance company and in his family doctor, without any of these systems talking to the others.
The international standard for healthcare interoperability is HL7 FHIR (Fast Healthcare Interoperability Resources). Although its adoption in Peru is still incipient, it is the path towards which the country's digital health policy points. Developing software with FHIR integration capabilities today means being prepared for tomorrow's requirements.
Infrastructure requirements and availability
An electronic health record system cannot have prolonged outages. In a medical emergency, lack of access to patient history can be critical. Healthcare systems require service level agreements (SLAs) with high availability: typically 99.5% or higher.
The infrastructure must provide for redundancy, automatic backups, disaster recovery plans (DRP) and graceful degradation capability: in the event of a partial failure, the system must continue to operate with reduced functionality rather than going down completely.
- Minimum SLA of 99.5% availability
- Automatic backups with retention of at least 7 years
- Documented and tested disaster recovery plan
- Cloud infrastructure (AWS, GCP or Azure) with multiple availability zones
- 24/7 monitoring with automatic alerts
UX Best Practices for Medical Software
The technically best EHR system can fail in practice if healthcare professionals do not adopt it. Usability in medical software is critical because users (doctors, nurses, administrative staff) use it under pressure and with limited time.
Best practices include: workflows adapted to the type of specialty, rapid registration of information with predefined templates, contextual alerts (allergies, drug interactions) without overwhelming with irrelevant notifications, and tablet access for visiting doctors.
- Flows validated with end users before development
- Maximum time of 2 clicks to access critical information
- Dark mode and font size adjustment for older users
- Mobile compatibility for use in the room or home visit
- Training and support included in the implementation plan
Where to start if you have a clinic or office
The first step before any development is to map the current processes: how patients are registered, how the medical history is maintained today, how appointments and collections are managed. With this diagnosis, it is possible to design a solution that gradually digitizes without interrupting the operation.
At Alaz we develop management systems for clinics and offices in Peru, in compliance with MINSA and data protection regulations. If you are considering digitizing your institution's medical records, we can help you understand the requirements and design the appropriate solution.
