Telemedicine & e-Health Regulation

 Telemedicine & e-Health Regulation

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The digital transformation of healthcare offers unprecedented opportunities in Georgia, yet launching a telemedicine or e-health platform requires navigating a complex and evolving regulatory landscape. Our firm provides specialized legal counsel to health-tech innovators, clinics, and physicians, ensuring their virtual care operations are structured in full compliance with Georgian law. We deliver a comprehensive legal strategy that addresses every critical aspect, from physician licensing and the establishment of a valid patient-provider relationship to data security and the legalities of remote prescribing, allowing you to innovate with confidence.

Under the Law of Georgia on Medical Activities and the Law on Health Care, any form of medical service, including those delivered remotely, must adhere to the established professional standard of care. This means a telemedicine consultation must be conducted with the same level of diligence and thoroughness as an in-person visit. We help our clients develop robust clinical protocols and select secure technologies that meet this high standard. Furthermore, we provide clear guidance on licensing, ensuring that any physician providing care to patients in Georgia holds the appropriate state certificate to practice, which is a foundational requirement for all telehealth services.

Protecting patient data is a paramount legal and ethical obligation in digital health. All patient information processed through an e-health platform is classified as a special category of data under the Law of Georgia on Personal Data Protection. This imposes stringent security requirements, mandating the use of encrypted communication channels and secure data storage solutions. Our legal services include conducting data protection impact assessments, drafting comprehensive privacy policies and patient consent forms, and reviewing agreements with technology vendors to ensure the entire data lifecycle is secure and legally compliant.

Establishing a valid practitioner-patient relationship and obtaining informed consent are critical legal pillars for any telemedicine service. Before treatment can begin, the patient must be clearly informed about the identity and qualifications of the physician, the limitations of a virtual consultation, and their data privacy rights. We assist in designing a legally sound patient intake process that fulfills these requirements, creating a foundation of trust and transparency. This meticulous approach not only ensures compliance but also mitigates liability risks associated with remote medical practice.

The legal framework for prescribing medications through telemedicine is particularly nuanced. While electronic prescriptions are permissible, strict rules apply, especially concerning controlled substances which generally require a prior in-person physical examination. We provide precise legal opinions on what can and cannot be prescribed based on a virtual-only consultation, ensuring your platform’s prescribing policies align perfectly with the regulations set forth by the State Regulation Agency for Medical and Pharmaceutical Activities. By partnering with us, you gain a legal team dedicated to ensuring your innovative healthcare solution is not only successful but also impeccably compliant.

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