Key legal aspects of implementing digital therapeutics (DTx) in Turkiye

According to the Medical Device Regulation (Tıbbi Cihaz Yönetmeliği), devices, implants, material, instrument, equipment, software and etc. designed for the purposes of following, shall be characterized as medical devices: 

• Diagnosis, treatment, monitoring, prediction, prognosis, therapy or mitigation of disease; 
• Diagnosis, monitoring, treatment, mitigation or compensation of injury or disability; 
• Providing information through in vitro testing of human body samples, including organ, blood and tissue donations; 
• Devices for the prevention or support of pregnancy; and 
• Products specifically designed for cleaning, disinfection, or sterilization of medical devices. 

As a result, DTx designed for the diagnosis, treatment, monitoring, prediction, prognosis, or mitigation of disease or another purpose indicated above, is characterized as medical device.  

In principle, medical devices may be utilized by both healthcare professionals and laypersons. However, specific provisions may restrict the use of particular medical devices to certain healthcare professionals or healthcare institutions. In this respect, secondary regulations have to be considered after the classification of the medical device. 

As DTx creates and uses health data, data protection and data security are one of the areas of key concern. Any medical software to be offered on Turkish market will need to comply with local requirements in this regard.  

Pursuant to the Turkish Data Protection Law, data relating to health are sensitive characterized as sensitive personal data. Processing of sensitive personal data without the explicit consent of the data subject is prohibited under Turkish Data Protection Law.  

Please also note that personal data cannot be transferred abroad without the consent of the data subject. In this respect, the Data Protection Law does not bring forth data localization requirements on Türkiye resident data controllers. This means that, as per the Data Protection Law, in principle, Turkish companies can send personal data abroad, if they comply with the terms of the Law. In the presence of the exceptional circumstances listed in the Data Protection Law and provided that there is adequate protection in the foreign country to which the personal data will be transferred, or in the absence of adequate protection, provided that the data controllers in Türkiye and the relevant foreign country undertake an adequate protection and the Data Protection Board’s permission is obtained, the personal data may be transferred abroad without the explicit consent of the data subject. 

Nevertheless, a circular, namely the Presidential Circular on Information and Communication Security Measures numbered 2019/12 (“Circular”), is in effect in Türkiye, which relates to how personal data shall be stored. 

Based on the terms of the Circular, critical information, and data such as population, health, contact registration information, genetic and biometric data should be stored safely within Türkiye. The Circular does not directly target companies operating in the private sector, except for those operating critical infrastructures, which consist of electronic communications, energy, water management, critical public services, transportation and banking and finance. Considering that the health data is considered as critical data, the Circular may apply to public institutions and organizations as well as private entities in the health sector that operate the systems where the critical data are processed or stored. 

In general, in order to be placed on the market or put into service, medical devices must be properly supplied, properly installed, properly maintained and used in accordance with their intended use. 

It is prohibited to use information (e.g. text, names, trademarks, images and figurative or other signs in the labelling, instructions for use, placing on the market, placing into service and advertising/promotion of devices) that may mislead the user or patient about the intended use, safety and performance of the device. 

Additionally, if the manufacturer is not established in Türkiye or EU Member States, the manufacturer will need to appoint an authorized representative in Türkiye in order to place the device on the market. 

Devices specified in the annex to the Regulation on the Sales, Advertising and Promotion of Medical Devices (Tıbbi Cihaz Satış, Reklam ve Tanıtım Yönetmeliği) products such as band-aids, plasters, cotton, surgical masks, dental prosthesis care products may be freely advertised to consumers.  

However, pursuant to the Regulation on Medical Device and Sales Advertising and Promotion, devices that are sold, adapted, or applied only in hearing aid centres, custom-made prosthesis and orthosis centres or opticianry establishments or dental prosthesis laboratories, and devices that are foreseen to be used or applied exclusively by healthcare professionals or require application in medical device sales centres cannot be advertised to consumers. Therefore, DTx designed for the diagnosis, treatment, monitoring, prediction, prognosis, or mitigation of disease or another purpose indicated in 1.a) - as it is characterized as medical device - cannot be freely advertised to consumers. 

Going further, devices outside this scope may only be advertised to consumers on the internet where the device is sold. 

In terms of misleading advertising, no advertising activities can be carried out in a way that may harm the patients and environmental health and threaten their safety. In addition, the devices may not be advertised in a way that would lead to unfair competition or harm the interests of the user, or by providing untrue, misleading, exaggerated, or unverified information. 

Activities to be carried out for healthcare professionals or employees working in the field of medical devices within healthcare institutions and organizations about the scientific and medical properties of medical devices are considered as promotion. 

Pursuant to the Article 18 of Regulation on the Sale, Advertising and Promotion of Medical Devices; in promotions, healthcare professionals or technical staff working in the field of medical devices within healthcare institutions and organizations cannot be encouraged by giving money or gifts, providing any material gain or promising a benefit or reward for the prescription, use, purchase or recommendation of the device, and incentives cannot be requested or accepted by healthcare professionals or technical staff working in the field of medical devices within healthcare institutions and organizations. Disciplinary proceedings shall be initiated against relevant people working in the field of medical devices within healthcare institutions and organizations who act contrary to this provision. 

Please note that if these incentives are given to a public official, it may constitute a bribery offense under the Turkish Criminal Code. Pursuant to the Turkish Criminal Code, a person who, directly or through intermediaries, provides benefits to a public official or another person to be nominated by the public official, in order for the public official or nominated person to do or not to do a task, shall be punished with imprisonment from four to twelve years. 

The Regulation on the Sale, Advertising and Promotion of Medical Devices regulates the promotion of medical devices to healthcare professionals and technical staff within healthcare institutions and organizations. 

In order to sell and promote medical devices, medical devices must comply with the legislation. Devices cannot be promoted to persons other than healthcare professionals and technical staff working in the field of medical devices within healthcare institutions and organizations. Therefore, DTx, which qualifies as a medical device under Turkish law (please refer to 1.a)) cannot be promoted to laypersons. 

Therefore, it is possible to promote medical devices to healthcare professionals and technical staff working in the field of medical devices.  

However, we would like to point out that, pursuant to our legislation, in promotions, healthcare professionals or technical staff working in the field of medical devices within healthcare institutions and organizations cannot be encouraged to prescribe, use, purchase or recommend the device by giving money or gifts, providing any material gain or promising a benefit or reward. It is also prohibited for healthcare professionals or technical staff to request and accept incentives. We therefore do not recommend collaborating with healthcare professionals and technical staff for the sale and promotion of medical devices. 

In this respect, we evaluate that it would be beneficial to support and encourage university and industry cooperation agreements in the medical device sector. 

Only sales centres (satış merkezleri) authorized in accordance with the relevant legislation may sell medical devices in Türkiye. Pursuant to the Article 26 of the Regulation on the Sale, Advertising and Promotion of Medical Devices, placing medical devices on the market or to keep them on the market through direct sales or through newspapers, radio, television and telephone sales addressed to consumers are prohibited. 

Please note that apart from providing products directly to the sales centres, you could promote your medical devices to distributors that act as an intermediary between your institution and authorized sales centres. Pursuant to the legislation on medical devices, an authorized distributorship certificate will be issued by the manufacturer companies for the importers. Companies that obtain this certificate are authorized by the manufacturer company and can sell and/or distribute the relevant products or product groups. As a separate note, the authorized distributorship certificate is required for registration in the Product Tracking System (Ürün Takip Sistemi) where medical devices are registered.

Possible payors could be both private sector companies, real persons and public institutions. 

Due to the rapid growth in the software sector and as it is one of the most profitable sectors, non-refundable grants are provided to entrepreneurs in the field of information and technology.  

Venture capital firms and angel investors may provide funding to new businesses as financial support. Please keep in mind that as your business gets the capital it needs to bootstrap its operations, in return, investors may ask for a share in your business.

The Ministry of Trade (Ticaret Bakanlığı) aims to lead sustainable economic growth by making trade more competitive, fast, and secure, and by promoting high-tech, high value-added exports. The way to achieve this goal is to follow innovations such as e-commerce, software, and artificial intelligence, which will soon transform the world economy, and to spread export awareness and exports to the grassroots. 

So as to achieve this goal, the Ministry of Trade offers incentives for companies operating in software and related sectors. Please be informed that grants for the software sector are available for Turkish companies that plan to operate abroad. Moreover, Turkish companies in the software sector can also apply for grant support from the Ministry of Trade for company promotion, advertising, and marketing expenses to be made abroad. 

State support is provided under certain conditions for the allocation of specific devices such as ventilation devices, oxygen therapy devices (oxygen concentrator, oxygen cylinder and cap, oxygen therapy devices with portable components), home ventilator, and battery powered wheelchair. Since the support provided is frequently updated within the scope of the Health Implementation Communiqué (Sağlık Uygulama Tebliği), it is necessary to check the updated list.  

Please note that currently, DTx is not classified as a reimbursed medical device under Health Implementation Communiqué.