On February 8, 2017 Paola Sangiovanni will be speaking at this webinar organized by FAST on the new EU Regulation on medical devices:
If you are interested in learning about this topic, consider registering here:
See you there!
Year 2017 already brought to us some exciting change. The beginning of the year is also the perfect time for appraisals of the past and resolutions for the near future. Whether we see it as a welcome enhancement of personal data rights or simply as another burdensome European set of requirements, 2016 delivered the new European General Data Protection Regulation (Regulation EU 2016/679, “GDPR”). Already 233 days passed since GDPR entered into force and 498 days are left until the new Regulation will start to apply on May 25, 2018. Roughly, one third of the time given to comply with the new regulatory framework has already gone by. Then, perhaps, the beginning of 2017 can be a good chance to ask ourselves what has already been done in the first 233 days and what still needs to be done in the future 498 days in order not to miss May 2018’s deadline.
The GDPR imposes a much more burdensome level of compliance requirements to companies acting as data controllers and data processors.
Some of them require the assessment and preparation of organizational and implementing measures that need to be put in place well in advance of May 2018.
- Data controllers and data processors must appoint a data protection officer (“DPO”). The controller and the processor shall ensure that the DPO is involved, properly and in a timely manner, in all issues which relate to the protection of personal data. The controller and processor shall support the DPO in performing his/her tasks by providing resources necessary to carry out those tasks and access to personal data and processing operations, and to maintain his/her expert knowledge. The controller and processor shall also ensure that the DPO does not receive any instructions regarding the exercise of those tasks. Furthermore, the DPO shall not be dismissed or penalized by the controller or the processor for performing his tasks and shall directly report to the highest management level of the controller or the processor.
- Data protection by design and by default will have to be implemented. The data controller: (i) both at the time of the determination of the means for processing and at the time of the processing itself, must “implement appropriate technical and organizational measures, such as pseudonymisation, which are designed to implement data-protection principles, such as data minimization, in an effective manner and to integrate the necessary safeguards into the processing in order to meet the requirements of [the GDPR] and protect the rights of data subjects” and (ii) “to implement appropriate technical and organizational measures for ensuring that, by default, only personal data which are necessary for each specific purpose of the processing are processed”.
- A data protection impact assessment must be carried out. Such impact assessment must contain: a systematic description of the envisaged processing operations and the purposes of the processing, including, where applicable, the legitimate interest pursued by the controller; an assessment of the necessity and proportionality of the processing operations in relation to the purposes; an assessment of the risks to the rights and freedoms of data subjects; the measures envisaged to address the risks, including safeguards, security measures and mechanisms to ensure the protection of personal data and to demonstrate compliance with GDPR.
- Data controllers must guarantee the effectiveness of the data subject’s right to be forgotten and right to portability. This requires an assessment of the adequacy of the technical and organizational instruments currently available and, possibly, their improvement. More specifically, data controllers must be able to fulfill: (i) in relation to the right to be forgotten, their obligation to “take reasonable steps, including technical measures, to inform controllers which are processing the personal data that the data subject has requested the erasure by such controllers of any links to, or copy or replication of, those personal data”; (ii) as regards to the right to portability, their obligation to allow the data subjects to effectively exercise their right to “receive the personal data concerning him or her, which he or she has provided to a controller, in a structured, commonly used and machine-readable format and have the right to transmit those data to another controller”.
- Data controllers shall notify personal data breaches to the relevant supervisory authority without undue delay and, where feasible, not later than 72 hours after having become aware of it. This imposes on controllers the preparation of appropriate notification forms, as well as organizational measures to guarantee adequate resources to complete such task.
- The mandatory content of the written contract between the data controller and the data processor requires a revision of all such contracts. They shall include, inter alia, the obligations of the processor to: process the personal data only on documented instructions from the controller, including with regard to transfers of personal data to a third country or an international organization; ensure that persons authorized to process the personal data have committed themselves to confidentiality or are under an appropriate statutory obligation of confidentiality; delete or return all the personal data to the controller after the end of the provision of services relating to processing, including copies; make available to the controller all information necessary to demonstrate compliance with the obligations under GDPR; allow for and contribute to audits, including inspections, conducted by the controller or another auditor mandated by the controller.
- Information notice forms currently in use will need to be revised. In fact, information to be provided to data subjects must include, inter alia: the contact details of the DPO; the legal basis for the processing; the fact that the controller intends to transfer personal data to a third country or international organization and the existence or absence of an adequacy decision by the Commission; the period for which the personal data will be stored, or if that is not possible, the criteria used to determine that period; the existence of the right to data portability; the existence of the right to withdraw consent at any time for processing based on consent; the existence of the right to lodge a complaint with a supervisory authority; the existence of automated decision-making, including profiling.
- Data controllers and data processors must keep record of processing activities under their responsibility. Records to be kept by data controllers shall contain all of the following information: the name and contact details of the controller and, where applicable, the joint controller, the controller’s representative and the DPO; the purposes of the processing; a description of the categories of data subjects and of the categories of personal data; the categories of recipients to whom the personal data have been or will be disclosed including recipients in third countries or international organizations; where applicable, transfers of personal data to a third country or an international organization, including the identification of that third country or international organization and the documentation of suitable safeguards; where possible, the envisaged time limits for erasure of the different categories of data; where possible, a general description of the technical and organizational security measures. Records to be kept by data processors shall include: the name and contact details of the processor or processors and of each controller on behalf of which the processor is acting, and, where applicable, of the controller’s or the processor’s representative, and the DPO; the categories of processing carried out on behalf of each controller; where applicable, transfers of personal data to a third country or an international organization, including the identification of that third country or international organization and the documentation of suitable safeguards; where possible, a general description of the technical and organizational security measures. Data controllers and data processors shall therefore dedicate and organize resources to be able to start keeping such records.
All this may appear daunting. Nevertheless, 498 days are more than enough to take all necessary steps, if we let one of our New Year’s resolutions be to timely walk the road to compliance with the GDPR.