MBYS Requirement for Clinics: What Does the New Regulation Say?
In Türkiye, collecting, transmitting, and auditing health data securely and in a standardized format is no longer just "best practice" — it's now a clear legal obligation. So, who is required to use MBYS (Practice/Medical Information Management System), what is its legal basis, and is there a penalty for non-compliance?
What Is MBYS?
Software infrastructure that keeps clinical data standardized and transmits it to e-Nabız/USS.
Diagnoses, procedures, processes… all sent as a package.
It's also monitored through KDS (Data Quality System) reports. Success rate and error codes are checked regularly.
Who Is It Mandatory For?
Private practices
Medical centers
Single-specialty centers
Oral and dental health clinics
In short, private healthcare institutions providing outpatient diagnosis and treatment services must use an MBYS-compliant system.
What Is the Legal Basis of the MBYS Requirement?
Law: Additional Article 19 of Law No. 3359. This grants the Ministry authority regarding the processing and notification of personal health data. Healthcare personnel notifications also fall within this scope.
Regulation: Regulation on Health Information Management Systems (dated 25.08.2022). It defines the standards, registration, and procurement procedures for SBYS/MBYS. It requires the use of systems that are registered and on the "active" list.
Is There a Penalty for Non-Compliance?
Yes. Under Additional Article 11 of Law No. 3359, healthcare institutions and organizations that "fail to properly keep the records determined by the Ministry or fail to fulfill the notification obligation" face an administrative fine of "at least 50,000 TL" and "2% of the previous month's gross service revenue." (The lower limit and rate were updated with the amendment made in 2024.)
Note: While some professional organizations continue legal debates in practice (objections/annulment lawsuits, etc.), the legislation remains in effect, and Provincial Health Directorates can carry out audit and enforcement processes.
Quick Compliance Checklist
Registration status: Is the software you use on the Ministry's active list?
Data flow: Are e-Nabız/USS packages being sent regularly? Are the rates in KDS clean?
KVKK & Disclosure: Are the texts up to date according to Additional Article 19? Are the purpose, legal basis, and retention period clear?
Permissions & Logs: Who has access to which data? Are access records kept?
Personnel notification: Have HR processes been arranged in accordance with Additional Article 19?
Simplify Your MBYS Compliance with Dr2Connect
Dr2Connect is a free clinic management platform that brings clinical processes together under one roof.
MBYS integration: Workflows that make it easier to comply with e-Nabız/USS standard package submissions and to track KDS reporting.
Role-based access and logging: User permissions and access records for KVKK (Turkish Data Protection Law) and internal audits.
Appointments, billing, CRM: Combining different systems and managing data from a single source.
Important: Dr2Connect is currently the only free clinic software with MBYS integration. This provides a significant advantage, especially for newly opened clinics or those aiming for cost optimization.