Drones: a revolution that flies for the healthcare industry

/ / Legal x-rays

Drones have recently attracted a lot of attention not only regarding their specific military use but also for other purposes, such as amusement, artistic, cultural etc. The use of drones in many developing countries serves humanitarian aims as these small aircrafts help carry medicine or blood to isolated areas. However, it is important to answer whether their use is legally regulated and if so, what is the current legal context. Consider the following answers:

1) Does harmonized European legislation exist in relation to the use of drones?

The European Union (EU) does not currently regulate the civilian use of remotely piloted aircraft (RPA) with a mass of 150 kg or less; regulation 216/2008 on Common Rules in the Field of Civil Aviation, only covers aircraft whose mass is above that size. It is worth noting that a European Aviation Safety Agency (EASA) has been established in 2003 with the mandate to issue rules and approve airworthiness standards. Given, therefore, the absence of a harmonized EU legislation, drones whose mass is less than 150 kg may be regulated at a Member State level.  Indeed, several Member States, including, France, Italy, Germany, Denmark etc. have already adopted national rules. However, given the existence of different national rules on criteria and conditions for the operation of drones and related safety issues, operators comply with the national rules applied in in each EU Member State and must apply for a separate authorization, if such is required.

2) What about Greece?

On September 30 2016, a new Regulation for the flight of drones (Unmanned Aircraft Systems – UAS), was issued in Greece, as approved by Decision no Δ/ΥΠΑ/21860/1422 of the Greek Civil Airport Service. This Regulation sets for the first time specific rules under which the flight of drones can be allowed. The provisions of the Regulation shall come into force on January 2017 and will apply to all drone categories, as itemized in the Regulation. Flights shall be allowed in aerial spaces which will be segregated from aerial spaces used by manned aircrafts. Moreover, the operator’s liability is regulated along with safety measures she or he must take in advance. Finally, it is explicitly stated that any transfer of dangerous materials is strictly forbidden.

Aero models, unmanned aircrafts that are used for military or other government purposes by the respective public authorities as well as tethered or free balloons are excluded from the scope of the above Regulation.

3) What about the protection of personal data which may also be transferred through drones?

The Regulation foresees that in case any data processing takes place when drones are used, such processing must be in compliance with Greek law no 2472/1997 for the protection of personal data. In particular, the Greek Civil Airport Service, must notify the Hellenic Personal Data Authority for any issue which may rise regarding the protection of personal data while using drones. In case of breach of the current legislation sanctions will be imposed.

It is worth noting, that in case sensitive personal data is being transferred via drones, the operators must take strong safety measures in order to protect its privacy and must also apply, if necessary, for a permission which will be granted by the Hellenic Personal Data Authority, as foreseen in law no 2472/1997.

Our law firm’s comment:

Given that the use of drones in the healthcare industry in order to transfer medicines and blood, has substantially grown in the past few months, we expect to see how some specific rules will be enacted, especially regarding the protection of sensitive personal data transferred through drones (such as blood samples with reference to the patients’ names), as well as specific safety measures which will ensure safe transfer of such goods, always aiming to address patient needs. The adoption of the new Regulation sets for the first time in Greece basic ground rules for drone flight and transport, rules that should better be part of detailed considerations for businesses and organizations willing to engage with faster supplier streams or even, at some point, B2C deliveries.