The healthcare sector brings together a large number of different actors within the same ecosystem: hospitals, medical centres, clinics, laboratories, imaging centres, physicians, healthcare professionals, medical device companies, pharmaceutical and biotechnology firms, digital health start-ups and private healthcare providers. The defining feature of the sector is that commercial activity and human health are part of the same process. Legal relationships in healthcare should therefore be assessed not only from the perspective of contract or company law but also in terms of patient rights, professional liability, personal data protection, health legislation, consumer law and criminal law.

The legal risks that arise in the provision of healthcare can vary according to the nature of the service. The relationship between a private hospital and a patient, the professional liability of a physician, a laboratory’s obligations concerning test results, a medical device company’s product liability or the personal data processing of a digital health app cannot all be assessed within the same area of law. For this reason, when building a legal structure in the healthcare sector, it is important to analyse in detail the business model, the type of service and the relationship established with the patient.

Legal Structure and Patient Rights in Healthcare Institutions

Legal Structure of Private Hospitals, Medical Centres and Clinics

The activities of private healthcare institutions are subject to many administrative and private law rules. From the establishment of a healthcare institution to its day-to-day operation, permits, licences, staff, patient admission, service contracts, advertising and promotion, data security and medical record processes should be assessed from a legal perspective.

In private hospitals, medical centres or clinics, matters such as the following can form the core of the healthcare business’s legal infrastructure:

Establishment and operating permits
Licensing and authorisation processes
Contracts with physicians and healthcare staff
Patient admission and information documents
Service contracts
Medical device and supply contracts
Laboratory and outsourcing relationships
Patient record and archive systems
Internal procedures and regulatory compliance

Patient Rights and Informed Consent

One of the most important topics in healthcare law is informing the patient adequately and understandably about the medical procedure to be performed. The patient must be able to make a decision with an understanding of the nature, possible risks, alternatives and consequences of the treatment or intervention.

The informed consent (aydınlatılmış onam) process should not be seen merely as having a form signed. What information was given to the patient, how clear that information was and whether the patient was genuinely able to form a decision all matter.

The scope of the duty to inform may be assessed in more detail, especially for surgical procedures, cosmetic interventions, interventional treatments and procedures with particular risks.

For healthcare institutions, standardising the information and consent processes, documenting them and updating them according to the medical procedure to be performed are an important part of legal risk management.

Malpractice and Medical Liability

Physician Liability and Malpractice Disputes

A significant proportion of disputes arising from healthcare services concern the professional liability of physicians and healthcare institutions. In claims of medical error, commonly referred to as “malpractice” (malpraktis), a negative outcome alone does not give rise to legal liability.

The assessment should examine whether the medical method used complied with current medical standards, whether the necessary care was taken, whether the patient was properly informed and whether there is an adequate causal link between the harm suffered and the medical treatment.

In malpractice disputes, headings such as the following may be important:

The diagnostic process
The choice of treatment method
Surgical intervention
Administration of medication
Follow-up and monitoring processes
Informed consent
Keeping of medical records
Distinguishing a complication from a medical error

The Distinction Between a Complication and a Medical Error

One of the most critical assessments in healthcare law is determining the difference between a complication and a medical error. Certain outcomes that are medically foreseeable, or that cannot be entirely prevented despite the necessary care being taken, may qualify as complications.

By contrast, legal liability may arise where there is a departure from standard medical practice, the necessary precautions are not taken or the duty of professional care is not fulfilled.

In healthcare disputes, therefore, the outcome should not be looked at in isolation; the period before the intervention, the way it was performed and the follow-up process should be examined together.

Legal Liability in Cosmetic and Plastic Surgery

Cosmetic procedures have particular significance in healthcare law. In cosmetic operations, the fact that the patient receives the service with the expectation of a certain appearance or result can give rise to different legal debates when the contractual relationship is assessed.

In cosmetic interventions, the main subjects of legal disputes may include:

The result promised to the patient
Before and after photographs
Informed consent
The likelihood of complications
The need for revision
Advertising and promotional content

In promotions made through social media in particular, the statements used must not be misleading, no guaranteed results may be promised and patient images must be used lawfully.

Liability for Compensation in Healthcare Services

Where it is alleged that a medical intervention has caused pecuniary or non-pecuniary damage, compensation claims may arise. The scope of these claims can vary depending on the specific circumstances of the case.

Bodily injury, treatment costs, loss of earning capacity, economic losses and claims for non-pecuniary damage can form different heads of compensation.

In assessing compensation, fault, damage and the causal link must be considered together. In addition, the liability of the healthcare institution, the physician and other healthcare workers may need to be assessed separately according to their role in the incident.

Institutional Liability of Healthcare Institutions

In healthcare services, liability does not always rest solely with the physician who performed the procedure. The hospital or healthcare institution may have its own obligations regarding organisation, selection of staff, technical infrastructure, equipment, hygiene, the record system and patient safety.

For example, failing to have adequate equipment, shortcomings in staff organisation, or not reviewing laboratory or imaging results in time may give rise to the institutional liability of the healthcare institution.

Health Data and Digital Health

Health Data and the KVKK

The healthcare sector is one of the most sensitive areas in terms of personal data protection. Patients’ diagnostic information, laboratory results, prescriptions, imaging records, surgical information and genetic data may fall within special categories of personal data (özel nitelikli kişisel veri).

For this reason, compliance with the Law on the Protection of Personal Data No. 6698 (KVKK) in healthcare institutions should not be limited to a general privacy policy. It should be clearly determined for what purpose the data is processed, who can access it, in which systems it is stored and under what conditions it is shared with third parties.

In the processing of health data, headings such as the following are particularly important:

The duty to inform
Processing of special categories of personal data
Retention of patient files
Electronic health records
Laboratory and imaging data
Doctor-patient communication systems
Transfers of data abroad
Data breach management

Patient Photographs and Social Media Use

The spread of social media use in the healthcare sector has created significant legal risks in relation to sharing patient photographs and treatment processes.

The fact that a patient’s face is not visible does not automatically mean that the shared content is no longer personal data. A photograph, information about the procedure, a date or other elements may make the person identifiable.

For this reason, especially in cosmetic clinics, dental practices and similar healthcare institutions, the use of before-and-after images should be assessed in light of personal data protection, patient privacy and the promotion rules that apply in healthcare.

Digital Health and Telemedicine

With the development of digital health services, remote consultations, online advice, mobile health apps and AI-supported health platforms are becoming increasingly common.

Telemedicine and digital health services are an area where healthcare law and IT law intersect. Which healthcare services may be provided during a remote assessment of a patient, how patient information will be transmitted, the security of digital systems and how medical records will be kept are all important.

In this area, the following in particular may be the subject of legal assessment:

Remote healthcare service contracts
Mobile app terms of use
Electronic consent processes
Security of patient data
Data storage in cloud systems
Online appointment and payment systems

Artificial Intelligence and Health Technologies

AI systems are used in various healthcare applications, from analysing imaging results and predicting disease risk to clinical decision support and patient monitoring.

However, the question of who is liable if a recommendation made by an AI system is wrong may give rise to new legal debates. The liability of the physician, the hospital, the software developer and the medical technology manufacturer should be assessed separately according to the features of each case.

In AI applications, the following are among the legal issues of growing importance:

Use of health data as training data
Explainability of algorithmic decisions
Liability for incorrect results
The limits of a physician’s reliance on AI output
Liability of the software provider

Medical Devices, Pharmaceuticals and Clinical Trials

Medical Devices and Product Liability

Medical devices used in the healthcare sector can directly affect patient health. Surgical devices, implants, imaging systems, laboratory equipment and digital health devices can create different responsibilities for the manufacturer, the distributor, the healthcare institution and the user.

If a medical device is faulty or defective, product liability, manufacturer liability and the healthcare institution’s liability for its use may be assessed together.

In contracts relating to medical devices, it is important to clearly regulate matters such as maintenance, technical service, calibration, training, warranty and liability in the event of a malfunction.

Pharmaceutical Law and Relationships with Pharmaceutical Companies

The pharmaceutical sector is one of the areas of healthcare law subject to special regulation. The manufacture, licensing, promotion and distribution of medicines and relationships with healthcare professionals can give rise to different legal obligations.

For pharmaceutical companies, the limits on advertising and promotion, scientific collaborations with physicians, clinical trials and personal data processes are of particular importance.

In claims of harm caused by the use of a medicine, the product’s side effects, the duty to inform and the way the product was used should be assessed together.

Clinical Trials and Information Processes

Clinical trials are scientific activities that can have direct consequences for human health. Informing participants, obtaining their consent and protecting research data therefore require a high degree of legal care.

In clinical trials, the headings that need to be assessed from a legal perspective may include in particular:

Informing the participant
Informed consent
Processing of personal health data
Liability of the trial sponsor
Insurance obligations
Ethics committee processes

Health Tourism and the Limits of Promotion

Health Tourism and Relationships with International Patients

The growth of health tourism in Türkiye has led to new relationships in which healthcare law and international law intersect. When foreign patients come to Türkiye for treatment, different contracts may be formed between the healthcare institution, the patient, the health tourism intermediary and other service providers.

In the context of health tourism, matters such as the following are legally important:

Contracts with foreign patients
Intermediary agreements
Treatment fees
Patient information documents
Consent forms in foreign languages
Advertising and promotional activities abroad
International transfers of personal data
Disputes with foreign patients

In particular, in complication or compensation disputes that arise after a foreign patient has returned to their home country, the questions of governing law and the competent authority should be assessed separately.

Limits on Advertising and Promotion in the Healthcare Sector

Advertising and promotional activities in healthcare are subject to stricter rules than in other commercial sectors. Statements by healthcare institutions or healthcare professionals that may steer patient demand, are misleading or promise guaranteed results can create legal risk.

Posts on websites, social media accounts, Google profiles and other digital channels need to be prepared with attention to the line between information and advertising.

In particular, expressions implying superiority or guaranteed results, such as “definite result”, “guaranteed”, “the best” or “the most successful”, need to be assessed carefully in light of the legal rules applicable in healthcare.

Employees, Commercial Contracts and Health Insurance

Healthcare Workers and Employment Law

Hospitals and healthcare institutions are businesses with high levels of employment. Relationships with doctors, nurses, technicians, patient advisers and other employees can raise different issues under employment law.

Shift patterns, on-call systems, overtime, occupational health and safety, employees’ confidentiality obligations and the termination of employment contracts can be of particular importance in the healthcare sector.

Whether physicians work as independent practitioners, company partners or employees can also directly affect the legal nature of the contract.

Commercial Contracts in Healthcare Institutions

The day-to-day operation of a healthcare institution relies on a large number of supply and service contracts. Different contracts may be concluded with medical device companies, suppliers of medicines and consumables, laboratories, cleaning companies, software companies and technical service providers.

These contracts need to set out clearly the service standard, product safety, technical support, data security, confidentiality, payment terms and limits of liability.

Health Insurance and Relationships with Private Hospitals

Private health insurance and supplementary health insurance play an important role in financing healthcare services. Agreements between insurance companies and healthcare institutions, pre-authorisation (provizyon) processes and service fees can give rise to different legal relationships.

Situations such as whether a particular treatment of the patient is covered by insurance, whether an additional fee may be charged, or the insurance company refusing pre-authorisation can be assessed under both insurance law and healthcare law.

Criminal Proceedings, Evidence and Risk Management

Criminal Law Proceedings Arising from Healthcare Services

Some healthcare disputes may not be limited to compensation. Gross negligence, forged documents, unlawful sharing of data, unauthorised provision of healthcare services or certain medical practices can also have consequences under criminal law.

In criminal investigations, medical records, reports by court-appointed experts (bilirkişi) and the technical features of the incident are of great importance. When assessing whether a medical outcome gives rise to criminal liability, fault and the causal link must be examined in detail.

The Importance of Evidence and Medical Records in Healthcare Disputes

In healthcare law disputes, medical records are often one of the most important sources of evidence. The patient file, surgical notes, nursing observation records, laboratory results, imaging records, consent forms and electronic system records can show how the events unfolded.

Incomplete records, or records that were altered afterwards, can directly affect the legal assessment. It is important for healthcare institutions to manage their record and archive processes properly in order to protect both patient rights and the institution’s legal security.

Preventive Legal Risk Management in the Healthcare Sector

In healthcare law, the most effective approach is to identify legal risks at an earlier stage rather than only mounting a defence after a dispute has arisen. Updating patient consent documents, reviewing the contracts of healthcare workers, organising KVKK processes and carrying out legal checks on digital health systems can reduce significant risks that may arise later.

As medical processes change in a healthcare institution, as new devices or software come into use and as new service models are developed, the legal infrastructure also needs to be adapted to these changes.

Legal Advice in the Healthcare Sector

The healthcare sector is one of the specialised fields in which legal assessment requires technical medical knowledge and legislation to be read together. Although physician liability, patient rights, health data, health tourism, medical devices, digital health systems and the commercial relationships of healthcare institutions may appear unrelated, they can become directly linked within the same chain of services.

As Attorney Ezgi Çalışkan, I approach legal processes in the healthcare sector not only on the basis of the dispute that has arisen, but by assessing patient relationships, the medical record system, contracts, personal data protection and digital health infrastructure together. In this field, where legal risks change as the nature of healthcare services changes, establishing the right legal framework before services are provided can be decisive for patient rights as well as for the legal security of healthcare professionals and institutions.