Health, Pharmaceuticals and Medical Devices

Depending on the type of institution, the legal framework for planning, licensing, operating permits, staff and physical conditions is assessed. Legal support is provided for application documents, correspondence with authorities, changes in activity and inspection processes. Not every healthcare institution is subject to the same permit regime.

In a share or asset sale, licenses and permits, real estate rights, debts, contracts, staff relations and existing disputes are reviewed. Confidentiality agreements, letters of intent and sale agreements are addressed together with the required approvals, handover, transition period and post-closing responsibilities.

Powers of representation and signature, management decisions, partnership relations, contract standards and a legal follow-up calendar are organized. For investors abroad, transaction follow-up and reporting within the scope of authority can be provided. Representation on, or taking a role in, the board of directors is assessed separately in terms of liability and conflict of interest.

Patient complaints handled within the institution, keeping incident records, preserving evidence, notifying insurers and directing matters to legal review are organized. Rather than altering clinical or financial records after the fact in a manner inconsistent with the facts, record integrity is maintained.

Contracts of physicians and other healthcare professionals, pay and working arrangements, confidentiality, non-compete and termination provisions are reviewed. In outsourcing relationships such as laboratory, imaging, maintenance, software and other services, duties, authority and liabilities are clarified; the actual nature of the relationship is assessed rather than relying only on the name given to the contract.

In international health tourism activities, the role of the institution, its authorization certificate and the obligations that apply are reviewed. Support is provided for applications, contracts, patient information, registration and inspection processes. The authority and responsibilities of a treating institution and of an intermediary company are addressed separately.

The scope of treatment, information and translation, payment, transport and accommodation-related services are clarified in contracts. The parties’ obligations in complications, additional procedures, patient complaints and communication after return to the home country are assessed; no commitment is given as to the medical outcome.

Websites, social media, patient reviews, use of images, campaign wording and promotion through third parties are assessed. Patient consent and the lawfulness of the promotion are reviewed separately. The rules that apply to activities aimed at domestic and international health tourism are also determined separately.

Applicable law, competent authority, service of documents, evidence and translation needs are assessed. Representation within the scope of authority is provided in legal proceedings in Türkiye; for matters involving foreign law or representation abroad, the need for coordination with authorized advisers in the relevant country is determined.

Notices, appropriate legal grounds, explicit consent where required, access authorizations, retention and destruction, service provider agreements and data breach processes are assessed. Transfers abroad, remote access and cloud use are reviewed separately. It is not assumed that every data processing activity must rest solely on explicit consent.

Authorization, user information and the roles of service providers are reviewed in remote health services and platform models. Software licensing, access, data portability, exit from the system and cyber incident responsibilities are addressed. In AI-supported applications, human oversight and assessments where medical device status is at issue are also carried out separately.

Depending on the classification of the product, registration, permit, market placement, promotion and traceability obligations are reviewed from a legal standpoint. Supply, servicing, warranty, product safety, recalls and liability disputes are assessed. Technical conformity and quality testing require the work of competent specialists.

Agreements between sponsors, researchers, institutions and other parties are reviewed with regard to the legal dimension of ethics and administrative permits, information provided to volunteer participants, data sharing, publication and intellectual property rights. Legal services do not replace scientific evaluation or ethics committee approval.

Information and consent documents relating to medical intervention, access to records, patient complaints and rights in the course of care are assessed. The consent form is reviewed together with the specific procedure and the explanations given; it is not treated as a document that alone removes all responsibility.

Inspection reports, requests for a defense statement, sanction decisions and notification dates are reviewed. Administrative applications, litigation and interim legal protection options are assessed. The conditions of criminal and disciplinary proceedings and the required permit procedures are addressed based on the file.

Documents relating to patient fees, refund requests, private health insurance, Social Security Institution (SGK) contracts and deductions are reviewed. The competent authority, route of application, mediation requirement and time limits are determined. Depending on the circumstances of the specific case, support is also provided for violence against healthcare workers and other criminal law applications.

Incident reports, camera footage, witnesses and medical documents are reviewed. Complaints, criminal investigations, lawsuits and protective measures suited to the specific incident are followed. The respective functions of internal reporting and judicial applications are determined separately.