Clinics get fined not for clinical mistakes but for a forgotten periodic report — healthcare compliance is a marathon of dozens of recurring tasks each year.
Licences: still valid?
Top of the checklist: the facility’s operation licence and each staff member’s practice licence (5-year term under the Law on Medical Examination and Treatment 2023). Track every expiry, remind 3–6 months ahead, and process renewals with continuous-education certificates. Staff practising on expired licences expose both practitioner and facility to penalties.
Periodic reports to regulators
Medical facilities must file health statistical reports periodically with regulators (Department/ Ministry of Health): care volumes, hospital infections, medical incidents, drug and equipment use. Late or false reporting draws administrative fines. Assign one owner for reporting and keep filing evidence.
Commonly forgotten compliance items
- Equipment calibration: X-ray, lab and measuring devices need periodic inspection — using overdue equipment is a violation.
- Fire safety: drills and system maintenance under Law 55/2024.
- Environment: a valid medical-waste disposal contract and environmental reports.
- Tax and labour: full tax filing and payment (Tax Administration Law 108/2025); employment contracts and social insurance for staff.
Frequently Asked Questions
What must medical facilities report periodically?
Statistical reports on care activities, infection control, medical incidents, drug and equipment use — filed with health authorities per prescribed schedules, with details per Ministry guidance.
What if a practice licence expires before renewal?
The practitioner must stop clinical work until renewed. The facility must arrange a qualified substitute; knowingly using expired-licence staff penalizes both.
What is a healthcare compliance audit — is it mandatory?
An independent review of the facility's legal compliance (licences, reports, procedures). Not legally mandatory, but an effective risk tool — catching issues before inspectors do.
This article has been quality-reviewed by the FLAW AI Legal Council
