Turkey: Our General Health Data Is On Free Trade! Who Wants To Buy?

Not only governmental institutions but private entities and individuals are now authorized to execute agreements with the Social Security Institution ("SSI") to have access to general health insurance data on Turkish people, in consideration of course for a fee! But is it ethical to sell health data?

A Turkish physician started to collect bone-marrow samples from Turkish volunteers to create a database for patients who need a bone-marrow transplant. Once very popular, he succeeded to collect nearly 160,000 bone-marrow and blood samples through newspaper advertisings. However, things became very awkward when the Doctor and database went missing! It was discovered that the Doctor had fled the country and had taken the database along with all the data that he had collected. This deeply shocked public's conscience as this was the first health care related data scandal in Turkey. More recently, other like scandalous news has been revealed. The main opposition party, CHP, alleged that the current Administration's Ministry of Health sold the SSI database to an international pharmaceutical company in secrecy for a few million dollars. The SSI database contains all the health data of all citizens covered by Turkey's the general health. Though these alleged facts remain, they could not be conclusively proven, despite being a very popular topic, the case has not moved forward. And now, it seems that it will be possible to sell and purchase health data without any legal coincidences. In looking at the current state of the laws in Turkey, one might wonder how this can be possible? In 2012, the Ministry of Labour and Social Security has adopted the Regulation Security and Disclosure of General Health Insurance Data ("Regulation"). Basically, the Regulation made it possible for a local or international private company, to have access to the collective health data collected

by every public/private medical service provider in Turkey, so long as there was an executed contract with the SSI!

The Regulation was published in the Official Gazette No. 28350 on 11 July 2012. The Turkish Physicians Association and the Turkish Psychiatry Association collectively filed a lawsuit before the 15th Circuit of the Council of State of the Republic of Turkey, under file no. 2013/5986, claiming that the Regulation was unconstitutional and they requested a stay of execution and cancellation of some of its provisions. The Council of State found the claim of unconstitutionality valid and referred the case to the review of the Constitutional Court of the Republic of Turkey. Now, most recently on 22 April 2014, the Constitutional Court found the decision of the Council of State to be adequate and have started to review the merits of the case.

The peculiar thing about this administrative case is that the Council of State has abstained from issuing a stay of execution decision over the Regulation, unlike in other cases when it often issues an immediate stay of execution. This is why, currently although the case is pending before the Constitutional Court, the Regulation is still in full force and effect, and a stay of execution has not been issued. This lack of action, creates a large question mark, as to why the Council of State has not issued a stay of execution decision, despite the fact that it found the claim to be material enough to refer the case to the Constitutional Court's review. Up till now, the common practice had been for the Council of State to issue stay of execution decisions when it finds the claims serious enough and that there is danger of material damage or irrevocable consequences if a stay of execution decision is not issued over a given administrative transaction or Regulation. This change of approach, unfortunately, causes every patient within the Republic of Turkey who benefits from general health insurance to face the risk of an unauthorized disclosure of his/her personal health data, even if the disclosure is made on an anonymous basis.

The Turkish Psychiatry Association made a public announcement in its 2013 bulletin, Volume 16, No. 3, stating that they find the Council of State's decision to delay issuing a stay of execution decision to be illegal. The Turkish Psychiatry Association emphasized its intention to file another application to the Council of State to request an immediate stay of execution of the Regulation in order to avoid irreparable damage and to protect patient's rights.

The challenged Regulation has been issued within the framework of Article 78 of the Law No. 5510 on Social Securities and General Health Insurance1 Law ("Law No. 5510"). Article 78 of Law No. 5510 states that the Ministry of Labour and Social Security, following the suggestion of other relevant ministries, will determine the method for protecting health data from disclosure for persons covered under this law. fore Article 78 has been challenged because it grants unlimited legislative authority to the Administration which is contrary to the Turkish Constitution without identifying statutory limits.

Moreover, a Communiqué on the Insurance Check to Be Conducted by Banks and Public Administration and Information and Documents to Be Obtained from Agencies and Institutions ("Communiqué") has recently been issued. The Communiqué expands the scope of SSI's rights to demand and collect data from almost all kinds of institutions, including from Ministries, banks, sports federations, the Press and Publication Association (Basın İlan Kurumu), the Public Procurement Authority, the Turkish Tradesmen and Artisans Confederation, Turkish Travel Agencies Association, the Turkish Patent Institute and Higher Education Council (Yükseköğretim Kurulu)and even the İstanbul stock exchange. The said Communiqué was published in the Official Gazette No. 29026 on 10 June 2014 and will enter into effect on 1 August 2014.

The Regulation extends the scope of the SSI's power defined in Law No. 5510 to collect a greater extent of health data and clarified how the collected data could be used by SSI. It also gave authority

to the SSI to execute contracts with those wishing to have access to the data. The Regulation details which legal entities or individuals can apply to SSI to receive such data, and what sorts of information and/or documents can be delivered to them by the SSI.

Who can receive data from SSI? According to the Regulation, any public institutions as well as private sector legal entities and individuals can apply to the SSI to receive general health data collected by the SSI. These entities/persons will execute an agreement with the SSI in order to have access to the health data that will be shared. SSI is authorized to share health data with the applicants in electronic or other magnetic record formats.

What kind of data can be received from SSI? Only general health data that is anonymous and which does not directly or indirectly identify individuals can be received from the SSI. The Regulation defines "health data" as any kind of data collected with respect to health services provided and financed to persons and their dependents covered under the Turkish general health. Personal health data collected by medical service providers cannot be shared with third parties without the explicit consent of the covered person or events permitted by law. The Regulation lists several categories of data that the SSI cannot disclose. This includes such disclosures as those which will hinder national security, data regarding members of the National Intelligence Agency and their dependents, data from covered persons that contains personal information and data that includes brand, trademark, or corporate identity that may hinder competition law principles. Similarly, data regarding medical service providers may be disclosed without specifying the entity's name, or if it does not directly or indirectly identify the relevant entity, and may merely state the geographical area. That being said, some of the entities are exempt from the stated limitations. For instance, public prosecutors, courts, the Presidency of the Court of Accounts, SSI supervisors, auditors, health policy makers and/or persons who have access to the health information, public investigators or inspectors are exempt from these provisions. How does the disclosure process work, and how is the contract executed? Public institutions, private sector entities and individuals may file a written application to the SSI to receive access to the health data. The application describes the reasons why access is being requested, how the data will be used and the legal grounds entitling access. SSI can decide to share the data based on the legal grounds entitling such access or via execution of a contract as authorized under the Regulation. The SSI will coordinate the data sharing. Data access requests will be subject to the SSI's pre-approval. If the pre-approval is granted, the applicant will be invited by the SSI to execute a data sharing contract. The said contract will be signed by the President of the SSI, or authorized SSI staff. Beyond these requirements, the Regulation fails to specify any other specific content or clauses that should be contained in the contract to be executed. Data is to be shared in an encrypted manner through electronic or magnetic means such as a CD, DVD, hard disk, USB.

How much does it cost to access the SSI data? Nothing, if it is a simple request that does not require special analysis and the applicant intends to use the data in an university project or for publication in a public administration statistical bulletin covered under the general budget of the State, Ministry of Labour and Social Security or its affiliated institutions. If however, the application does not meet the abovementioned criteria, it is implied that a fee will be paid following the execution of data sharing contract. However, the Regulation is silent on how the pricing for the data request is determined.

IP rights over SSI data? It may seem odd, but yes the Regulation does look to protect SSI's IP rights over that of the patients' health data privacy rights. The Regulation states that every time any receiver accesses the health data contained in the database they must indicate that it is SSI's resource. The SSI is also entitled to demand compensation from the user any time the data is accessed and credit is not given naming the SSI as the source of the data which is being accessed. Any liabilities? The Regulation does not foresee any liability for the SSI. But, the Regulation does state that the receiver has legal,

financial and criminal liability that may arise from accessing the data by any unauthorized persons or disclosing the data and/or its usage for purposes that fall outside the agreed upon scope of use.

How to ensure fair competition? The Regulation includes very limited information on this issue. It is not clear how the issue will be resolved if two entities apply for access to the same category of information, and whether a tender will be launched, or if the data will be disclosed to every applicant that requests it. The Regulation merely states that the data which includes trademark, brand, product name or corporation name may be disclosed to any relevant corporation. In addition, it is possible to disclose the data to entities, institutions and third parties provided that the limits are explicitly specified, and the applicant obtains a decision from the Competition Board confirming that the intended data use is not against fair competition, and provided that the notarized explicit consent is approved and granted. Moreover, the Regulation does not define what sort of "limits" there may be on the data? Other issues arise due the potential disclose such as why would a competitor grant such a notarized consent to its adversary? Whether now different corporations will be able to start selling each other their consents? Additionally, it is vague whether the receiver can sell it again, and disclose it to a third party, or even grant a sub-license over the data disclosed to the SSI receiver.

The human right to privacy as well as national security vs. SSI's ability to find a new financing resource by sale of collective data! Since 2009, the Republic of Turkey has witnessed extensive reforms in the healthcare sector, including e-health reforms, the introduction of performance appraisals for physicians and the institutionalization of the family physician. All of these reforms have faced criticisms while sparking public debate, while the issue of data protection remains an area that lacks a solid legal basis despite such reforms. For instance, a draft data protection law has been pending before the Parliament for many years and still cannot seem to reach the Parliament for action. The quick enactment of this Regulation may be interpreted as a means to simply provide funding for the SSI budget. It seems that the right to privacy, the issue of the government's collection and selling of the personal health data, - even if anonymously sold by governmental entities - will continue to be a hotly contested and debated subject matter for years to come.

Footnotes

1 Published in the Official Gazette No. 26200 on 16 June 2006.

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.

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