Hospital Compliance — the Legal Map
The lawful operation of a hospital, clinic or other medical facility in Georgia is built on several layers of the Law on Health Care: legal status and functions, the licensing and permit regime, employment of personnel, the body protecting patients' rights, and the technical regulation of high-risk activity. This page describes these layers on the basis of the law's exact norms — what the facility's income structure must look like, which activity requires which document, and what follows from a breach of the regulation.
From a compliance perspective, documentary precision is valued most: the licence or permit, the list of employable personnel, the ethics commission and the notification form are each a separate compliance object, and neglecting them can go as far as suspension of the activity.
Status and Functions of a Medical Facility
A medical facility is a legal person of an organisational-legal form allowed by Georgian legislation that carries out medical activity in the prescribed manner. The law sets a special financial criterion: the share of income from medical activity in the facility's financial resources must be at least 75%, and at least 75% of the average annual value of the fixed assets on its balance must be earmarked for performing the medical functions. Income from services performed under internal standards and from other economic activity — 100% of it compared with the previous year — remains at the facility's disposal, and the remuneration fund must constitute at least 30% of the income.
The functions of medical facilities are: determining the patient's state of health; prophylaxis and/or treatment of diseases, rehabilitation of patients, palliative care; obstetric activity; pharmaceutical activity; pathologico-anatomical examination of corpses and forensic medical examination; and the carrying out of epidemiological control measures. A facility is obliged to provide emergency medical care to a patient in the cases provided for by law, to observe the standards, rules and norms regulating medical and pharmaceutical activity, and to ensure equal accessibility of the facility for persons with disabilities.
Licence, Permit and Personnel
In the sphere of medical activity, the document confirming the respective right — a licence and/or permit — is issued by the ministry. The carrying out of medical activity subject to a licence and/or permit under Georgian legislation is impossible without the appropriate document. The list of health-care personnel entitled to employment and holding appropriate education is approved by the minister — who may be employed in a facility is thus determined centrally.
The Ethics Commission and High-Risk Activity
To ensure the protection of patients' rights and the norms of medical ethics, a medical ethics commission is created in the facility; the grounds for its creation are determined by legislation. The second layer is high-risk medical activity carried out on an outpatient or day-clinic basis: it is regulated by a technical regulation and subject to mandatory notification to the ministry. The list of such activities and the technical regulation are adopted by government decree, and the regulation contains requirements concerning medical equipment, instruments, hygienic conditions and the maintenance of medical documentation.
Compliance with the regulation is checked by selective control — three times a year. Where an inspection reveals violations endangering human life or health or the epidemiological situation, the ministry's competent body may fully or partially suspend the high-risk activity until the conditions of the regulation are met. The suspension decision remains in force if, within 24 hours of its adoption, the body submits a motion to the court to confirm the suspension — failing which the decision is deemed revoked and the activity restored. After the violations are eliminated, upon the provider's application the body checks compliance on site within 5 working days and adopts a decision; in case of refusal, the substantiated decision is immediately handed to the interested party and can be appealed in court.
An important exemption exists: where a provider carries out an activity covered by its licence/permit, its licensing conditions encompass the requirements of the technical regulation, and the activity is carried out at one factual address, it may operate without notification. The notification form may be filled in electronically and must contain the name of the activity, the person's identification data, address and contact information.
Frequently Asked Questions
What share must medical activity have in the facility's income?
At least 75% — both in financial resources and in the average annual value of fixed assets. The remuneration fund must constitute at least 30% of the income.
Who issues licences and permits?
The ministry issues the licence and/or permit in the sphere of medical activity; carrying out regulated activity without them is prohibited.
What is the regime of high-risk medical activity?
Outpatient or day-clinic high-risk activity is regulated by a technical regulation and subject to mandatory notification to the ministry; control is selective, three times a year.
Can the activity be suspended for violations?
Yes — where life, health or the epidemiological situation is endangered, provided the body applies to the court within 24 hours; otherwise the suspension is deemed revoked.
Is an ethics commission mandatory?
Yes — a medical ethics commission is created in the facility to protect patients' rights and the norms of medical ethics.
How We Help on Legal.ge
The Legal.ge team handles the legal compliance of medical facilities: assessing the observance of status and financial criteria, preparing licensing and notification documentation, establishing ethics commissions, and defending facilities in suspension and sanction cases. Contact us for a full compliance assessment of your clinic.