GDPR at Aesculape CRO
At Aesculape CRO, we have always been committed to protecting data privacy to support our customers and partners. Our commitment to handling data meticulously with a robust respect for privacy is at the core of what we do, we so were well positioned to embrace the EU Gerenal Data Protection Regulation (GDPR) from 25 May 2018.
It was our focus on privacy and data protection that led us to closely follow the development of the regulation. We have followed the progress of member state GDPR implementation laws and guidance throughout all our preparations for GDPR. This knowledge has been aplied to Aesculape CRO business operations where we are handling personal data within the scope of GDPR.
Our customers and partners can be confident that our operational policies and processes are not only GDPR-ready but also supportive of their requirements.
An overview of the main changes under GDPR and how they differ from the previous directive
The aim of the GDPR is to protect all EU citizens from privacy and data breaches in today’s data-driven world. Although the key principles of data privacy still hold true to the previous directive, many changes have been proposed to the regulatory policies; the key points of the GDPR as well as information on the impacts it will have on business can be found below.
Increased Territorial Scope (extraterritorial applicability)
Arguably the biggest change to the regulatory landscape of data privacy comes with the extended jurisdiction of the GDPR, as it applies to all companies processing the personal data of data subjects residing in the Union, regardless of the company’s location. Previously, territorial applicability of the directive was ambiguous and referred to data process ‘in context of an establishment’. This topic has arisen in a number of high profile court cases. GDPR makes its applicability very clear – it applies to the processing of personal data by controllers and processors in the EU, regardless of whether the processing takes place in the EU or not. The GDPR also applies to the processing of personal data of data subjects in the EU by a controller or processor not established in the EU, where the activities relate to: offering goods or services to EU citizens (irrespective of whether payment is required) and the monitoring of behaviour that takes place within the EU. Non-EU businesses processing the data of EU citizens also have to appoint a representative in the EU.
Organizations in breach of GDPR can be fined up to 4% of annual global turnover or €20 Million (whichever is greater). This is the maximum fine that can be imposed for the most serious infringements e.g.not having sufficient customer consent to process data or violating the core of Privacy by Design concepts. There is a tiered approach to fines e.g. a company can be fined 2% for not having their records in order (article 28), not notifying the supervising authority and data subject about a breach or not conducting impact assessment. It is important to note that these rules apply to both controllers and processors – meaning ‘clouds’ are not exempt from GDPR enforcement.
The conditions for consent have been strengthened, and companies are no longer able to use long illegible terms and conditions full of legalese. The request for consent must be given in an intelligible and easily accessible form, with the purpose for data processing attached to that consent. Consent must be clear and distinguishable from other matters and provided in an intelligible and easily accessible form, using clear and plain language. It must be as easy to withdraw consent as it is to give it.
Data Subject Rights
Under the GDPR, breach notifications are now mandatory in all member states where a data breach is likely to “result in a risk for the rights and freedoms of individuals”. This must be done within 72 hours of first having become aware of the breach. Data processors are also required to notify their customers, the controllers, “without undue delay” after first becoming aware of a data breach.
Right to Access
Part of the expanded rights of data subjects outlined by the GDPR is the right for data subjects to obtain confirmation from the data controller as to whether or not personal data concerning them is being processed, where and for what purpose. Further, the controller shall provide a copy of the personal data, free of charge, in an electronic format. This change is a dramatic shift to data transparency and empowerment of data subjects.
Right to be Forgotten
Also known as Data Erasure, the right to be forgotten entitles the data subject to have the data controller erase his/her personal data, cease further dissemination of the data, and potentially have third parties halt processing of the data. The conditions for erasure, as outlined in article 17, include the data no longer being relevant to original purposes for processing, or a data subject withdrawing consent. It should also be noted that this right requires controllers to compare the subjects’ rights to “the public interest in the availability of the data” when considering such requests.
GDPR introduces data portability – the right for a data subject to receive the personal data concerning them – which they have previously provided in a ‘commonly use and machine readable format’ and have the right to transmit that data to another controller.
Privacy by Design
Privacy by design as a concept has existed for years, but it is only just becoming part of a legal requirement with the GDPR. At its core, privacy by design calls for the inclusion of data protection from the onset of the designing of systems, rather than an addition. More specifically, ‘The controller shall… implement appropriate technical and organizational measures… in an effective way… in order to meet the requirements of this Regulation and protect the rights of data subjects’. Article 23 calls for controllers to hold and process only the data absolutely necessary for the completion of its duties (data minimisation), as well as limiting the access to personal data to those needing to act out the processing.
Data Protection Officers
Under GDPR it is not necessary to submit notifications / registrations to each local DPA of data processing activities, nor is it a requirement to notify / obtain approval for transfers based on the Model Contract Clauses (MCCs). Instead, there are internal record keeping requirements, as further explained below, and DPO appointment is mandatory only for those controllers and processors whose core activities consist of processing operations which require regular and systematic monitoring of data subjects on a large scale or of special categories of data or data relating to criminal convictions and offences. Importantly, the Data Protection Officer:
- Must be appointed on the basis of professional qualities and, in particular, expert knowledge on data protection law and practices
- May be a staff member or an external service provider
- Contact details must be provided to the relevant DPA
- Must be provided with appropriate resources to carry out their tasks and maintain their expert knowledge
- Must report directly to the highest level of management
- Must not carry out any other tasks that could results in a conflict of interest.