As many healthcare institutions start maintaining electronic medical records, healthcare data security becomes one of the most important aspects of data protection. The rapid growth in adoption of technology across medicine has brought along and introduced some gaps and legal concerns with health data protection, and thus paved the way for regulatory rules and guidance in this field.

Regulation on Processing and Privacy of Personal Health Data[1] ("Previous Regulation") was the first action taken by the Turkish authorities to regulate privacy of personal health data. This regulation was published in the Official Gazette of October 20, 2016. However, the Council of State ceased the execution of with its decision numbered 2016/10500 E. the Previous Regulation Even though an amendment to the Previous Regulation was published in the Official Gazette of November 24, 2017, the Council of State explicitly stated that a new regulation would need to be drafted in order to ensure full compliance with the laws, rather than making amendments to an annulled legislation and stopped the execution of this amendment as well.

To address this, Regulation on Personal Health Data[2] was enacted by the Ministry of Health ("Ministry") by taking into account of the applicable laws and procedures (such as the Law No. 6698 on Protection of Personal Data ("DPL"), secondary legislation, the Data Protection Board's decisions and guidelines) along with the Council of State's decisions and has come into effect on June 21, 2019.

The main purpose of the Regulation on Personal Health Data is to control and regulate the activities of real persons and legal entities that process personal health data related to the processes and applications carried out by the Ministry of Health (such as hospitals, health institutions etc.). Unlike the Previous Regulation, Regulation on Personal Health Data has a narrower scope and it covers the activities of real persons and legal entities under private law and legal entities under public law that process personal health data related to the processes and practices carried out by Ministry of Health.

Regulation on Personal Health Data has introduced new definitions such as open data, open health data, e-Pulse, KamuNET (public network for all public institutions), de-identification, personal data, destruction, erasure and demolishing of personal data, authority and masking. Besides these new definitions, Regulation on Personal Health Data removed "data processor" from the definitions and introduced the term "relevant user" which refers to the person who processes personal data within the organization of data controller or in accordance with the authorization and instructions received from the data controller, except for the person or unit responsible for the technical storage, protection and back-up of the data.

Accessing Personal Health Data

In order to prevent unlawful access to personal data, Regulation on Personal Health Data limits access to data to only required and authorized healthcare personnel. Pursuant to Article 6 of the Regulation on Personal Health Data, authorized personnel may access personal data, provided that the relevant access is within the scope of the health services offered to patient. As for patients who are signed up for the e-Pulse system (a system established by the Ministry of Health in accordance with the e-government practices, providing access to the health data of data subjects, physicians or third parties authorized by data subjects), since they determine the privacy rules to be applied to their personal data on their own, they are deemed to assume full responsibility for any loss or damages caused due to any breakdowns or malfunctions in the e-Pulse system.

Subparagraph (2) of the Article 7 of Regulation on Personal Health Data provides that de- identified data sent to central health data information system may only be utilized by the users authorized by General Directorate (Health Data Information Systems Directorate) upon the request of the head of the unit in accordance with personal data protection legislation. This use may solely be for the purposes of planning, management, financing and auditing healthcare services.

Access to Minor's Health Data

Under most jurisdictions, for a minor to obtain health care services, his/her parent or legal guardian must consent to such services. This is likely to be interpreted as parents are automatically entitled to disclose health care information regarding children. As per Article 8 of the Regulation on Personal Health Data, parents can access their children's health data through the e-Pulse system without consent. However Minors with discernment capacity may subject their parents' access to consent through the e-Pulse system, if they like to.

Access by Attorneys

Attorneys cannot access their client's personal data by enforcing a general Power of Attorney designated to provide them with broad authority. Regulation on Personal Health Data, requires that data subjects include a clear language in their powers of attorney specifically indicating that the attorney was granted power to access, process and obtain personal health data.

Concealing, Correction, Destruction and Transfer of Personal Health Data

Regulation on Personal Health Data requires a warrant issued by the judicial authorities in order to conceal the data regarding persons who were granted a protective order of confidentiality. Provincial health directorate is in charge of all technical and administrative measures to protect confidentiality of the persons and to make sure that the data is only available to the persons who are entitled to that information due to their duties.

Provincial health directorates are also regulated as the point of authority with respect to applications made for health data corrections. Data subjects who believe that an erroneous entry has been made regarding their health data are able to apply to provincial directorates for correction of such data. In case the health directorate finds that the error was made inadvertently, it sends an official request letter to General Directorate asking for correction of the health data generated.

As for the destruction of data, Regulation on Personal Health Data refers to principles set forth in Article 7 of the Regulation on the Erasure, Destruction or Anonymization of Personal Data ("Erasure Regulation") published in the Official Gazette of October 28, 2017.[3]

With respect to transfer of personal health data within the country and abroad, Regulation on Personal Health Data adopts the transfer rules listed under Articles 8/2/b and 28 of the Data Protection Law ("DPL"). In addition, Regulation on Personal Health Data requires a protocol indicating the data to be transferred within the scope of general principles and data security provisions of personal data protection legislation to public institutions and organizations. As per subparagraph (2) of Article 15, transfer of data is processed through KamuNET[4] when the technical infrastructure is available.

Processing for Scientific Purposes and Open Health Data

Regulation on Personal Health Data allows scientific studies on health data. For personal data to be utilized in such studies, data should be anonymized with official statistics for the purposes of research, planning or statistical operations. Moreover, Health Data Regulation authorizes use of personal health data for artistic, historical, literary or scientific purposes or within the scope of freedom of speech; provided that national defense, national security, public safety, public order, economical safety, privacy of private life or personal rights are not violated and the processing of data does not constitute a crime.

Data Security and Sanctions

Sections 6 and 7 of the Regulation on Personal Health Data refer to obligations and sanctions concerning data security regulated under DPL. Health Data Regulation requires that Personal Data Security Guideline prepared by Data Protection Board be taken into consideration while taking technical and administrative measures.

Article 21 of the Regulation on Personal Health Data imposes disciplinary measures on public officials who fail to comply with Health Data Regulation. Accordingly, public officials who are in violation of Regulation on Personal Health Data will be notified to the disciplinary authority to which they are associated with, and their license, if any, will be cancelled. Also, Articles 17 of 18 of DPL will be applicable for the crimes and minor offences committed against data protected under Health Data Regulation.

Health service providers who fail to send data to the central health data system in accordance with the procedures and principles determined by the Ministry of Health will be subject to disciplinary sanctions in accordance with the third paragraph of Article 11 of the Main Law No. 3359 on Health Services.

Overall, given the sensitive nature of healthcare data and cyber threats in the area of digital privacy, Health Data Regulation is a crucial instrument leveraging healthcare privacy and providing support for progressive universalization of data management.

This article was first published in Legal Insights Quarterly by ELIG Gürkaynak Attorneys-at-Law in September 2019. A link to the full Legal Insight Quarterly may be found here

[1] The Official Gazette dated October 20, 2016 (Last Access Date July 12, 2019).

[2] The Official Gazette dated June 21, 2019 (Last Access Date July 12, 2019).

[3] The Official Gazette dated October 28th, 2017 (Last Access Date July 12, 2019).

[4] A project developed by the Ministry of Transport and Infrastructure for the purposes of ensuring data communication between public institutions and organizations, conducting such communication on a virtual network closed to the internet, more secure against physical and cyber-attacks, minimizing cyber security risks, providing standards for the existing and to be installed secure closed circuit solutions and establishing suitable infrastructure for common applications.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.