Trump Towers, Ofis Kule:2 Kat:18, No:12, Sisli, Istanbul, Turkey

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Regulatory Overview of Wearable Technologies in Healthcare

Wearable technologies, used in various sectors including health, fitness, security, gaming, fashion, etc., enable the continuous monitoring of human physical activities and behaviors, as well as physiological and biochemical parameters and are becoming a substantial part of daily life. This article aims to discuss regulations under Turkish law which may be applied to wearable technologies to monitor health and disease.

Wearable Technologies: Software as a Medical Device

With advancement of technology, software has rapidly become an essential part of human daily life and became an important part of healthcare products serving both medical and non-medical purposes. With this respect, use of software as a medical device (“SaMD”), which is on its own a medical device, is continuing to increase, and the subject is being addressed by global actors.

Wearable Technologies and Intellectual Property: Stand Alone Software and Software as Medical Devices

The EU Directive 2009/24/EC of the European Parliament and of the Council on the Legal Protection of Computer Programs (“Legal Protection of Computer Programs Directive”) sets out the provisions regarding the rights arising, the rights of the beneficiaries, the exclusive rights of the rights holder, limited rights and exceptions related to them, and the cases where the program users are permitted to convert the program back into source code.

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COVID-19 Outbreak: Revision on the Circular on Cargo Transport in Passenger Cabin of Aircrafts

The 2nd revision of the Circular UOD-2020/2G (“the Circular”) regarding the transport of cargo in the passenger cabin of aircrafts is published on April 29, 2020, by the Directorate General of Civil Aviation (“DGCA”) as part of the measures taken against COVID-19 in Turkey. The purpose of the Circular is to enable the transportation of the medical equipment internationally and to protect the market place of Turkey with regards to the cargo transportation.

Corona Outbreak: Extension of Judiciary Period Suspensions in Turkey

As per the Presidential Decree No. 2480 published in the Official Gazette No. 31114 dated April 30, 2020, judiciary period suspension stipulated under provisional article 1 of the Law Amending Certain Acts No.7226 published in the Official Gazette No. 31080 dated March 26, 2020 is temporarily extended with the exception of the mandatory administrative application periods stipulated under Public Procurement Law No. 4734, due to the Covid-19.

ICC Force Majeure and Hardship Clauses 2020 in the Wake of COVID-19

To respond the struggles experienced by the businesses in terms of contractual liabilities in the wake of COVID-19, International Chambers of Commerce (“ICC”) has updated the 2003 version of its force majeure and hardship clauses. With the recent update dated March 25, 2020, ICC aimed at bringing an equivalence for the parties’ legitimate expectations of performance that impinged due to COVID-19 outbreak.

Legal Update: E-Complaints for Procurements in Turkey

A new e-filing system has been established for complaints through Turkish Public Procurement Authority’s (“Procurement Authority”) Electronic Public Procurement Platform (“EKAP”). The launch of the e-filing aims to prevent the loss of rights resulted from procedural mistakes in in-person/in mail applications. In the announcement published on the official website of the Procurement Authority on April 29, 2020, it was stated that a training video and guidelines were published regarding the process.

Corona Outbreak: Update on the Pre-Authorization Process of Export Prohibited Goods

As per the new announcement published by the Turkish Medicines And Medical Devices Agency (“the Agency”), the previously published announcements on the pre-authorization application processes regarding the certain export prohibited products  have been updated and as of April 27, 2020, the applications to be made to the Agency shall continue in accordance with the new guide attached to the announcement.

Kustepe Mahallesi, Mecidiyekoy Yolu Caddesi, Trump Towers, Ofis Kule:2 Kat:18, No:12, Sisli Mecidiyekoy, Istanbul, Turkey

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