GDPR

General Data Protection Regulation

GDPR The key elements of personal data

The GDPR applies to personal data. The GDPR stands for General Data Protection Regulation and applies in any information that can directly or indirectly identify a natural person (subject), and can be in any format.
The Regulation is placing a much stronger control on the processing of special categories of personal data, such as sensitive data, i.e health data but also includes a new guideline for processing data of genetic and biometric origin.

Personal data

Special categories of personal data

Broader scope

The GDPR applies to all EU organisations – whether profitmaking or commercial business, charity or public authority, private hospitals, doctors, laboratories etc – that collect, store or process the personal data of individuals residing in the EU, even if they’re not EU citizens.

Any Organisation based outside the EU that offers services or goods to EU residents, and monitor their behaviour or process their personal data, will be subject to the GDPR. So if there is an activity of Gross Border transfer of personal data those organisations are to adhere the EU GDPR. i.e.

Service providers (data processors) that process data on behalf of an organisation come under the remit of the GDPR and will have specific compliance obligations. An example might be a company that processes your personnel data or an internet provider offering Cloud data storage.

Data Subject Rights

Breach Notification

Under the GDPR, breach notification will become 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 will also be 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 from the data controller confirmation 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 subjects 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.

Data Portability

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 now, 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 organisational 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 principles

Personal data must be processed according to the six data protection principles:

Processed lawfully, fairly and transparently.
Collected only for specific legitimate purposes.
Adequate, relevant and limited to what is necessary.
Must be accurate and kept up to date.
Stored only as long as is necessary.
Ensure appropriate security, integrity and confidentiality.

Accountability and governance

You must be able to demonstrate compliance with the GDPR:

The establishment of a governance structure with roles and responsibilities.
Keeping a detailed record of all data processing operations.
The documentation of data protection policies and procedures.
Data protection impact assessments (DPIAs) for high-risk processing operations such as private hospitals, clinics diagnostical centers, etc..
Implementing appropriate measures to secure personal data.
Staff training and awareness.
Where necessary, appoint a data protection officer.

Data protection by design and by default

There is a requirement to build effective data protection practices and safeguards from the very beginning of all processing:

Lawful Processing

There are six available lawful bases for processing. No single basis is ’better’ or more important than the others – which basis is most appropriate to use will depend on your purpose and relationship with the individual.

The lawful bases for processing are set out in Article 6 of the GDPR. At least one of these must apply whenever you process personal data:

(a) Consent: the individual has given clear consent for you to process their personal data for a specific purpose.
(b) Contract: the processing is necessary for a contract you have with the individual, or because they have asked you to take specific steps before entering into a contract.
(c) Legal obligation: the processing is necessary for you to comply with the law (not including contractual obligations).
(d) Vital interests: the processing is necessary to protect someone’s life.
(e) Public task: the processing is necessary for you to perform a task in the public interest or for your official functions, and the task or function has a clear basis in law.
(f) Legitimate interests: the processing is necessary for your legitimate interests or the legitimate interests of a third party unless there is a good reason to protect the individual’s personal data which overrides those legitimate interests. (This cannot apply if you are a public authority processing data to perform your official tasks.)

The legitimate interests of the organisation

You must have a valid lawful basis in order to process personal data.
Most lawful bases require that processing is ‘necessary’. If you can reasonably achieve the same purpose without the processing, you won’t have a lawful basis.
You must determine your lawful basis before you begin processing, and you should document it. Take care to get it right first time – you should not swap to a different lawful basis at a later date without good reason.
Your privacy notice should include your lawful basis for processing as well as the purposes of the processing.
If your purposes change, you may be able to continue processing under the original lawful basis if your new purpose is compatible with your initial purpose (unless your original lawful basis was consent).
If you are processing special category data you need to identify both a lawful basis for general processing and an additional condition for processing this type of data.
If you are processing criminal conviction data or data about offences you need to identify both a lawful basis for general processing and an additional condition for processing this type of data.

The lawful basis for your processing can also affect which rights are available to individuals. For example, some rights will not apply:

However, an individual always has the right to object to processing for the purposes of direct marketing, whatever lawful basis applies.

Valid consent

There are stricter rules for obtaining consent:

Consent must be freely given, specific, informed and unambiguous.
A request for consent must be intelligible and in clear, plain language.
Silence, pre-ticked boxes and inactivity will no longer suffice as consent.
Consent can be withdrawn at any time.
Consent for online services from a child under 13 is only valid with parental authorisation.
Organisations must be able to evidence consent.

There are three types of consent:

1.1 Implied where the patient’s action or lack of action may clearly indicate their wishes (ie – holding out their arm to have a blood pressure recorded).
1.2 Verbal a patient may clearly state their consent for a procedure (ie – “yes, you can take blood from me”).
1.3 Written a patient signs a declaration that they consent to the procedure

For example a consent form for Hospitals should be clearly inform the patients

Information in language of choice (via written information or interpreter)
assess the patients’ understanding of information presented and choices available
always be cognisant of cultural sensitivities and taboos
the nature of their condition
the proposed treatment/procedure
The nature and risk that could reasonably be expected
alternatives to this treatment (including no treatment)

Privacy rights of individuals

Individuals’ rights are enhanced and extended in a number of important areas:

The right of access to personal data through subject access requests.
The right to correct inaccurate personal data.
The right in certain cases to have personal data erased.
The right to object.
The right to move personal data from one service provider to another (data portability).

Transparency and privacy notices

The first principle of data protection is that personal data must be processed fairly and lawfully. The GDPR says that in order for the processing to be fair, the data controller (the organisation in control of processing the data) has to make certain information available to the data subjects (the individuals whom the data relates to), so far as practicable:

who the data controller is;
the purpose or purposes for which the information will be processed; and
any further information which is necessary in the specific circumstances to enable the processing to be fair.

This applies whether the personal data was obtained directly from the data subjects or from other sources.

Organisations must be clear and transparent about how personal data is going to be processed, by whom and why.

Privacy notices must be provided in a concise, transparent and easily accessible form, using clear and plain language.

Data transfers outside the EU

The transfer of personal data outside the EU is only allowed:

Where the EU has designated a country as providing an adequate level of data protection;
Through model contracts or binding corporate rules; or
By complying with an approved certification mechanism, e.g. EU-US Privacy Shield.
Standard contractual clauses should provide for the technical and organisational security measures to be applied by data processors established in a third country not providing adequate protection, in order to ensure a level of security appropriate to the risks represented by the processing and the nature of the data to be protected.
Parties should make provision in the contract for those technical and organisational measures which, having regard to applicable data protection law, the state of the art and the cost of their implementation, are necessary in order to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access or any other unlawful forms of processing.
In order to facilitate data flows from the European Union, it is desirable for processors providing data-processing services to several data controllers in the European Union to be allowed to apply the same technical and organisational security measures irrespective of the Member State from which the data transfer originates, in particular in those cases where the data importer receives data for further processing from different establishments of the data exporter in the European Union, in which case the law of the designated Member State of establishment should apply.

Data security and breach reporting

Personal data needs to be secured against unauthorised processing and against accidental loss, destruction or damage.

The breach notification requirements outlined in GDPR Article 33 are aggressive —“The controller shall without undue delay and, where feasible, not later than 72 hours after having become aware of it, notify the personal data breach to the supervisory authority.”

Data breaches must be reported to the data protection authority within 72 hours of discovery.

Individuals impacted should be told where there exists a high risk to their rights and freedoms, e.g. identity theft, personal safety, patients records, etc.

Data Protection Officer (DPO)

Currently, controllers are required to notify their data processing activities with local DPAs, which, for multinationals, can be a bureaucratic nightmare with most EU Member States having different notification requirements. Under GDPR it will not be necessary to submit notifications / registrations to each local DPA of data processing activities, nor will it be a requirement to notify / obtain approval for transfers based on the Model Contract Clauses (MCCs). Instead, there will be internal record keeping requirements, as further explained below, and DPO appointment will be 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 e.g. private hospitals, clinics, or data relating to criminal convictions and offences.

Importantly, the DPO:

Must be appointed on the basis of professional qualities and, in particular, expert knowledge on data protection law and practices
Can 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.

The appointment of a DPO is mandatory for:

Public authorities;
Organisations involved in high-risk processing; and
Organisations processing special categories of data such as private hospitals, clinics, etc.

A DPO has set tasks:

Inform and advise the organisation of its obligations.
Monitor compliance, including awareness raising, staff training and audits.
Cooperate with data protection authorities and act as a contact point.

How SIZERRO, managing risk and compliance can help you get GDPR-ready

SIZERRO MANAGEMENT LTD, managing risk and compliance is a leading provider of risk management and compliance solutions, is at the forefront of helping organisations address the challenges of GDPR compliance.

We offer comprehensive solutions, services and expertise to help you meet your GDPR compliance objectives.
Since our inception in 2007 we are offering specific compliance services to the healthcare sector in the areas of Risk Management, Health and Safety compliance, Food Law compliance schemes, data compliance frames, IT and Security compliance, etc..

It applies to all companies processing and holding the personal data of data subjects residing in the European Union, regardless of the company’s location.

Sizerro Management Ltd, is engaged in various GDPR projects in the Health Care Sector.

Some of our clients:

Hippocrateon Private Hospital
Archangelos Michael Hospice
Ledra Fertility Clinic and IVF
German Oncology Center
Aretaeio Private Hospital
St. Panteleimonas Clinic
Ygia Polyclinic Private Hospital
ΟΚΥπΥ
Royal Artemis Private Hospital

Apollonion Private Hospital
America Medical Center
Elias Elia – Limassol Eye Clinic
Evangelistria Private Hospital
St. Kosmas & Damianos Clinic
Eden Senior Resort
Clinic Dr. Panos Economou
AIMIS Healthcare Group

Mother and Child
European Private Hospital
Blue Cross Medical Center
St, George Private Hospital
Lito Private Hospital
Scalamed Medical Center
The Breast Center
Ophthalmos Eye and Laser Center

GDPR FAQs

When is the GDPR coming into effect?

The GDPR was approved and adopted by the EU Parliament in April 2016. The regulation will take effect after a two-year transition period and, unlike a Directive it does not require any enabling legislation to be passed by government; meaning it will be in force May 2018.

In light of a uncertain ‘Brexit’ - I represent a data controller in the UK and want to know if I should still continue with GDPR planning and preparation?

If you process data about individuals in the context of selling goods or services to citizens in other EU countries then you will need to comply with the GDPR, irrespective as to whether or not you the UK retains the GDPR post-Brexit. If your activities are limited to the UK, then the position (after the initial exit period) is much less clear. The UK Government has indicated it will implement equivalent or alternative legal mechanisms. Our expectation is that any such legislation will largely follow the GDPR, given the support previously provided to the GDPR by the ICO and UK Government as an effective privacy standard, together with the fact that the GDPR provides a clear baseline against which UK business can seek continued access to the EU digital market. (Ref: http://www.lexology.com/library/detail.aspx?g=07a6d19f-19ae-4648-9f69-44ea289726a0)

Who does the GDPR affect?

The GDPR not only applies to organisations located within the EU but it will also apply to organisations located outside of the EU if they offer goods or services to, or monitor the behaviour of, EU data subjects. It applies to all companies processing and holding the personal data of data subjects residing in the European Union, regardless of the company’s location.

What are the penalties for non-compliance?

Organizations can be fined up to 4% of annual global turnover for breaching GDPR or €20 Million. 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’ will not be exempt from GDPR enforcement.

What constitutes personal data?

Any information related to a natural person or ‘Data Subject that can be used to directly or indirectly identify the person. It can be anything from a name, a photo, an email address, bank details, posts on social networking websites, medical information, or a computer IP address

What is the difference between a data processor and a data controller?

A controller is the entity that determines the purposes, conditions and means of the processing of personal data, while the processor is an entity which processes personal data on behalf of the controller.

Do data processors need ‘explicit’ or ‘unambiguous’ data subject consent - and what is the difference?

The conditions for consent have been strengthened, as companies will no longer be able to utilise long illegible terms and conditions full of legalese, as the request for consent must be given in an intelligible and easily accessible form, with the purpose for data processing attached to that consent – meaning it must be unambiguous. 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. Explicit consent is required only for processing sensitive personal data – in this context, nothing short of “opt in” will suffice. However, for non-sensitive data, “unambiguous” consent will suffice.

What about Data Subjects under the age of 16?

Parental consent will be required to process the personal data of children under the age of 16 for online services; member states may legislate for a lower age of consent but this will not be below the age of 13.

What is the difference between a regulation and a directive?

A regulation is a binding legislative act. It must be applied in its entirety across the EU, while a directive is a legislative act that sets out a goal that all EU countries must achieve. However, it is up to the individual countries to decide how. It is important to note that the GDPR is a regulation, in contrast the previous legislation, which is a directive.

Does my business need to appoint a Data Protection Officer (DPO)?

DPOs must be appointed in the case of: (a) public authorities, (b) organizations that engage in large scale systematic monitoring, or (c) organizations that engage in large scale processing of sensitive personal data such as private clinics, private hospitals, doctors, medical centers, diagnostical centers (Art. 37). If your organization doesn’t fall into one of these categories, then you do not need to appoint a DPO.

How does the GDPR affect policy surrounding data breaches?

Proposed regulations surrounding data breaches primarily relate to the notification policies of companies that have been breached. Data breaches which may pose a risk to individuals must be notified to the DPA within 72 hours and to affected individuals without undue delay.

Will the GDPR set up a one-stop-shop for data privacy regulation?

The discussions surrounding the one-stop-shop principle are among the most highly debated and are still unclear as the standing positions are highly varied. The Commission text has a fairly simple and concise ruling in favour of the principle; the Parliament also promotes a lead DPA and adds more involvement from other concerned DPAs, the Council’s view waters down the ability of the lead DPA even further. A more in depth analysis of the one-stop-shop policy debate can be found here.