Healthcare and life sciences operate within one of Türkiye’s most closely regulated legal environments. A single matter may engage public law, professional rules, corporate and commercial arrangements, patient rights, data protection, insurance, product regulation and civil or criminal procedure. The applicable framework also depends on whether the client is a healthcare institution, professional, investor, life-sciences business, insurer, patient or international intermediary.

Bıçak Law Firm advises healthcare institutions and market participants on regulatory compliance, licensing, transactions, investigations and disputes. We also represent patients, healthcare professionals, insurers and foreign counsel in matters involving informed consent, medical records, alleged malpractice, regulatory enforcement and cross-border evidence. Our approach combines healthcare regulation with corporate law, administrative law, evidence, criminal procedure, data protection, cybersecurity and dispute resolution. The practice draws in particular on the founder’s academic and professional work in evidence, criminal procedure and human rights, together with the firm’s experience in cross-border representation, corporate advisory work and technology-related risk. We provide legal analysis and representation; we do not provide medical advice, select healthcare providers or guarantee regulatory or clinical outcomes.

The Turkish Healthcare Regulatory Environment

Healthcare in Türkiye is governed through legislation, regulations, administrative decisions, professional standards and judicial interpretation. The Ministry of Health and provincial health directorates oversee healthcare facilities and service delivery. The Turkish Medicines and Medical Devices Agency (Türkiye İlaç ve Tıbbi Cihaz Kurumu, or TİTCK) regulates medicinal products, medical devices, cosmetics and significant parts of the life-sciences market. Other important institutions include the Social Security Institution (SGK), the Türkiye Health Services Quality and Accreditation Institute (TÜSKA) and the Personal Data Protection Authority (KVKK).

The legal position cannot normally be determined by consulting one licence or one regulation. A healthcare provider may require an underlying facility licence, an activity permission specifying its authorised services, properly registered professionals and separate permission for particular units or activities. International health tourism introduces an additional authorisation layer. Product businesses must also distinguish conformity assessment, registration, market access, reimbursement and post-market responsibilities.

Because subordinate rules, guidance and authorised-provider lists change, current advice requires verification against consolidated legislation, the Official Gazette and the competent authority’s latest materials. A Ministry or TİTCK index is useful for discovering relevant instruments but does not, by itself, establish that a linked text is current.

Healthcare Regulation, Licensing and Operations

The first regulatory question is the correct classification of the proposed healthcare activity. Private hospitals, medical centres, polyclinics, private practices, physical-treatment and rehabilitation institutions, dental facilities, laboratories, ambulance services and specialist treatment centres are not governed by one common licence. The principal rules include the 2025 Private Hospitals Regulation, the 2025 regulation governing private outpatient institutions and the cross-cutting rules on inspection, quality and patient rights. We advise on:

• healthcare market entry and facility classification;
• Ministry planning requirements and preliminary permissions;
• premises, architectural projects and licensing applications;
• activity permissions, specialties, beds, units and medical devices;
• responsible-manager appointments and professional working documents;
• foreign healthcare professionals, equivalence and work authorisation;
• expansion, relocation, transfer, merger and operational restructuring;
• quality, patient-safety and record-management systems;
• regulatory inspections, corrective action and sanctions;
• objections and proceedings before the administrative courts.

Corporate registration or an activity code does not confer authority to deliver healthcare. Equally, a facility licence does not authorise every specialty, procedure, unit, device or professional. Proposed services and contractual arrangements must remain within the scope recorded in the relevant authorisation documents. Where an inspection identifies non-compliance, the response may involve corrective action, an administrative fine, restriction or suspension of activity, licence consequences or judicial review, depending on the governing provision and patient-safety risk.

Healthcare Transactions and Investment

Healthcare investments require regulatory due diligence in addition to conventional corporate review. The value and continuity of an undertaking may depend on its licensed capacity, physician positions, specialist units, approved premises and inspection history. A share or asset transaction does not necessarily transfer a public-law authorisation or cure an existing regulatory deficiency.

Bıçak Law Firm assists with acquisitions, investments, joint ventures, reorganisations and commercial arrangements involving healthcare businesses. The regulatory review is coordinated with the firm’s corporate, employment, real-estate, data-protection and dispute-resolution capabilities. Our work may include:

• reviewing licences, activity permissions and specialist authorisations;
• examining ownership, control and change-notification requirements;
• analysing inspection reports, sanctions and corrective periods;
• assessing premises, leases, zoning and approved-use documentation;
• reviewing employment and professional-service arrangements;
• preparing transaction documents and regulatory conditions precedent;
• advising on post-closing notifications and licence amendments;
• negotiating technology, supply, management and service agreements.

The legal structure must reflect the licensed activity and cannot transfer statutory clinical responsibilities to an unauthorised party.

Life Sciences and Regulated Healthcare Products

Our practice extends to medicinal products, biotechnology, medical devices, in vitro diagnostic devices and other regulated healthcare products. We assist manufacturers, marketing-authorisation holders, authorised representatives, importers, distributors, technology businesses, research organisations and investors throughout the product lifecycle. This work is anchored in the current materials of TİTCK and, where reimbursement is concerned, SGK. Relevant work includes:

• TİTCK licensing, registration and regulatory procedures;
• medical-device classification and conformity questions;
• company, document and product registration within the Product Tracking System (ÜTS);
• clinical trials, clinical investigations and ethics processes;
• distribution, supply, manufacturing and quality agreements;
• pricing, reimbursement and market-access strategy;
• promotion and interactions with healthcare professionals;
• pharmacovigilance, device vigilance and safety reporting;
• product withdrawal, recall and field-safety measures;
• market surveillance and regulatory enforcement;
• product liability, intellectual property and commercial disputes.

Registration in an administrative system should not be confused with a substantive TİTCK approval or a guarantee of safety, effectiveness or clinical outcome. The precise obligations depend on product classification, the economic operator’s role and the applicable transitional and technical rules. For further information, see our publication on Medical Device Rules and Regulations in Turkey, which is being updated to reflect the current regulatory framework.

Health Data, Digital Health, Cybersecurity and Artificial Intelligence

Medical information is special-category personal data under Turkish law. Healthcare institutions and technology businesses must address lawful processing, professional confidentiality, access controls, information security, retention, patient rights and transfers to service providers or recipients abroad.

We advise on health-data governance, medical-record access, processor arrangements, cloud and software contracts, remote healthcare, digital platforms, connected devices and cross-border data transfers. This work builds on the firm’s wider data-protection and cybersecurity practice, including its published analysis of Turkish cybersecurity law. We also assist with incident response and the allocation of responsibility among healthcare providers, technology suppliers and other parties.

Artificial intelligence introduces further questions concerning data quality, transparency, clinical oversight, discrimination, device classification and professional accountability. The use of an algorithm or decision-support system does not remove the duties of the healthcare institution, professional or product operator. Governance should address the intended use, human supervision, validation, documentation, security and response to adverse outcomes.

Turkish health-data compliance is principally determined by Law No. 6698, the Personal Health Data Regulation and applicable sector rules. Foreign regimes such as HIPAA may become relevant to a particular international relationship, but they do not replace Turkish law.

Healthcare Advertising and Communications

Healthcare communication is subject to stricter limits than ordinary advertising. Different rules govern healthcare services, medicines, medical devices, cosmetics and health claims. We review websites, social-media accounts, paid campaigns, professional profiles, patient testimonials, before-and-after materials, price communications and international-patient marketing. The applicable analysis begins with the 12 November 2025 Regulation on Promotional and Informational Activities in Healthcare Services and then considers any product-specific or professional rules. Our advice addresses professional titles, comparative or superiority claims, inducements and statements suggesting guaranteed results.

Patient consent to the use of an image or testimonial does not by itself make its publication lawful. Data-protection, patient-confidentiality, professional and healthcare-advertising requirements must be considered together. Providers may also remain responsible for content distributed by agencies, influencers, intermediaries or related companies.

Patient Rights and Informed Consent

Patient rights form part of regulatory compliance and professional liability. Patients are entitled to appropriate information and to make treatment decisions within the limits of the law. Institutions must also protect dignity, privacy, confidentiality and access to records. Informed consent is a communication and decision-making process, not merely a signature on a standard form. Its adequacy may depend on the nature and urgency of the intervention, material risks, alternatives, the patient’s capacity, the timing and clarity of the explanation and the evidence showing what was discussed. Language and communication needs are particularly important in international-patient matters, but the legal effect of any deficiency must be assessed on the individual facts. We advise patients and providers on information and consent procedures, refusal of treatment, minors and protected adults, record access, confidentiality, discharge, referral, continuity of care and patient complaints.

Medical Malpractice and Healthcare Disputes

An unsuccessful treatment, an adverse event and legally actionable medical malpractice are not the same. A sound assessment requires the treatment record, the applicable professional standard, causation, the consent process and the nature of the alleged harm to be examined together. Independent medical expertise is often essential.

Bıçak Law Firm represents patients, healthcare professionals, institutions and insurers in medical and healthcare disputes. The firm’s established focus on evidence and procedure is important at the preliminary stage, when incomplete records or an unsupported theory of causation can distort the entire claim. Our work may include:

• preliminary legal and evidential assessment;
• obtaining and preserving medical records, imaging and communications;
• coordinating independent expert review for legal proceedings;
• analysing informed-consent and documentation issues;
• identifying the proper defendant, forum and procedural route;
• pursuing or defending compensation claims;
• mediation, settlement negotiations and litigation;
• insurance notification, coverage and recovery issues;
• related administrative or criminal proceedings.

The procedure differs according to whether treatment was provided by a private institution, a public hospital, a university facility or an individual professional. Court jurisdiction, preliminary applications, limitation periods and liability standards must therefore be determined claim by claim. Further discussion is available in Medical Malpractice in Turkish Law.

Investigations, Enforcement and Professional Responsibility

Healthcare incidents may lead to several parallel processes. A Ministry inspection, professional inquiry, civil claim, insurance review and criminal investigation can concern the same underlying event but apply different legal tests and evidential standards. We assist healthcare institutions, professionals, executives and affected patients in:

• Ministry and provincial health directorate inspections;
• internal investigations and document preservation;
• allegations involving unauthorised practice, billing, records or data;
• professional and disciplinary proceedings;
• Professional Responsibility Board procedures where applicable;
• administrative fines, activity restrictions and licence measures;
• prosecutor and criminal-court proceedings;
• coordinated civil, administrative and criminal-case strategy.

The founder’s long-standing academic and professional focus on evidence and criminal procedure is particularly relevant where clinical records, electronic data, expert reports and witness accounts must be evaluated across several proceedings. Early preservation and controlled review of evidence can materially affect the legal response. This capability also assists foreign counsel and insurers seeking a Turkish-law assessment that separates clinical questions from the applicable legal and procedural tests.

International Patients and Health Tourism

Türkiye’s international-health-tourism framework regulates authorised healthcare providers and intermediary organisations. Health-tourism authorisation is additional to the provider’s underlying facility and activity permissions; it does not expand the authorised clinical scope or constitute a government guarantee of treatment quality. We advise providers and intermediaries on authorisation, international-patient contracts, advertising, data transfers, payment structures, invoicing, patient communications and post-treatment processes. We also represent foreign patients and families in disputes concerning treatment, consent, medical records, complications, billing and alleged malpractice.

International matters may involve several countries, languages, insurers, experts and legal systems. Bıçak Law Firm regularly works with foreign individuals, law firms, diplomatic missions and international professional contacts, allowing the Turkish proceedings and evidence requirements to be explained in an internationally intelligible form. The engagement must nevertheless distinguish legal representation from medical referral or clinical coordination. For a detailed overview, see International Medical and Health Tourism Law in Türkiye.

Cross-Border Representation and Evidence

Foreign patients and institutions do not always need to be physically present in Türkiye for preliminary legal work. Subject to the nature of the mandate and applicable formalities, we can review documents remotely, explain procedural options and coordinate representation under a Turkish power of attorney. Cross-border matters may require:

• collection and preservation of Turkish medical records;
• certified translation and assessment of foreign documents;
• use of foreign medical reports in Turkish proceedings;
• coordination with foreign counsel, insurers and claims handlers;
• identification of defendants and insurance arrangements;
• service, evidence and enforcement planning.

We focus on the legal and evidential requirements of the case. We do not select clinicians, arrange treatment or endorse the healthcare provider involved.

How Bıçak Law Firm Assists

Our medical and healthcare law services include:

• healthcare regulatory and licensing advice;
• facility compliance, inspections and administrative proceedings;
• healthcare transactions and regulatory due diligence;
• pharmaceutical, biotechnology and medical-device matters;
• health-data, digital-health, cybersecurity and AI advice;
• healthcare advertising and communications review;
• patient-rights and informed-consent advice;
• medical-malpractice assessment and litigation;
• internal, regulatory and criminal investigations;
• insurance, reimbursement and billing disputes;
• international-health-tourism compliance and disputes;
• cross-border evidence and representation;
• compliance programmes and professional training.

Each instruction is scoped according to the client, regulated activity, evidence and procedural stage. Where medical expertise is required, the legal analysis should be supported by an appropriately qualified independent expert.

Related Medical and Healthcare Law Insights

Our existing English-language resources include:

• International Medical and Health Tourism Law in Türkiye
• Medical Malpractice in Turkish Law
• Medical Device Rules and Regulations in Turkey
• Personal Injury in Türkiye for Foreign Nationals
• Holiday Food Poisoning Claims in Türkiye

This knowledge base will be expanded with focused publications on healthcare-facility licensing, life sciences, healthcare advertising, health data and foreign healthcare professionals.

Contact Bıçak Law Firm

Healthcare institutions, life-sciences and medical-technology businesses, professionals, investors, insurers, patients and foreign counsel may contact Bıçak Law Firm with a concise description of the issue, the relevant parties, important dates and the documents presently available. This allows us to conduct conflict checks and identify the appropriate initial scope of legal review. Bıçak Law Firm provides legal advice, representation and dispute-resolution services. We do not provide medical advice, recommend healthcare providers or guarantee regulatory, financial or clinical outcomes.