Medical Law and Regulations in the Field of Cosmetic Services

Legal Services and Consultations for the Medical and Aesthetic Sector

The firm provides legal services and legal consulting on:

• Registration of healthcare institutions for inpatient and outpatient care; dental centres, laboratories and aesthetic centres;
• Administrative procedures and representation before the National Health Insurance Fund; regional health inspectorates; the Executive Agency “Medical Supervision”, the Ministry of Health and the Bulgarian Drug Agency;
• Consultations on legal matters in the field of healthcare;
• Preparation of framework agreements for the provision of medical services, informed consent templates, general terms and internal rules;
• Legal assistance and representation in relation to complaints or signals submitted by patients and arising disputes;
• Procedural representation in court proceedings;
• Legal assistance in claims for damages from torts against healthcare institutions and medical specialists;
• Consultations regarding the use of medical, laser and energy-based equipment;
• GDPR consultations and protection of personal data and health information;
• Preparation of GDPR documentation (policies, internal rules, notices on personal data processing);
• Consultations regarding video surveillance in medical centres or cosmetic studios and the processing of sensitive personal data;
• Consultations regarding regulations for medicinal products and medical devices;
• Clinical trials and regulatory compliance;
• Advising foreign pharmaceutical companies entering the Bulgarian market;
• Comprehensive assistance during inspections by control authorities;
• Legal structuring and risk management for medical and aesthetic businesses

Aesthetic Medicine and Plastic Surgery

The so-called “Aesthetic medicine” and cosmetic services are among the sectors with the highest regulatory and reputational risk. The new regulatory requirements place serious emphasis on the distinction between a cosmetic procedure and a medical activity, the qualification of specialists, informed consent and the protection of patients.

The attorneys and lawyers at G&P Law advise aesthetic centres, laser centres, aesthetic medicine clinics and plastic surgery clinics in relation to:

• Regulatory requirements for performing the relevant medical procedures;
• Regulations regarding laser and medical equipment;
• Preparation of contract templates and informed consent forms;
• Representation in complaints/signals and court disputes;
• Advertising and marketing practices;
• Protection of personal data;
• Internal rules and compliance procedures;
• Legal risk management.

We place particular focus on the prevention of legal disputes, protection of the business and the development of effective documentation and internal procedures aligned with the applicable legislation and regulations, as well as strategies for effective communication with the respective patients or users of cosmetic services.

G&P Law provides practically oriented legal solutions and legal assistance for businesses in the field of medical law and healthcare regulations, with a focus on regulatory compliance, risk management and protection of clients’ interests.