GDPR - General Data Protection Regulation
The GDPR is a regulation that will come into force from 25th May 2018. Its intention is to strengthen data protection for individuals across the European Union. The GDPR strengthens the controls that organisations (data controllers) are required to have in place over the processing of personal data, including pseudonymised data.
The ICO helpdesk is available for all GDPR queries, Tel 0303 123 1113
Many of the GDPR main concepts and principles are much the same as those in the current Data Protection Act (DPA), so if you are complying properly with the current law then most of your approach to compliance will remain valid under the GDPR and can be the starting point to build from. However, there are new elements and significant enhancements, so you will have to do some things for the first time and some things differently.
The ICO have issued useful guidance on preparing for GDPR in their 12 steps to take now document.
Many thanks to the GDPR working group in compiling these resources for practices. The group consists of;
- Alison Lowerson - Practice Manager, Long Bennington
- Julie Walsh - Practice Manager, Ruskington Medical Practice
- Terri Zeferino - Practice Manager, Moulton Medical Centre
- Debbie Herd, Practice Manger, Munro Medical Centre
- Nick Turner, Practice Manager, Billinghay
We are by no means experts in GDPR but have pulled together the resources to help other practices.
The ICO helpdesk is available for all GDPR queries, Tel 0303 123 1113
Step 1 - Awareness
You should make sure that all your practice members are aware that the law is changing & they need to know about GDPR. They need to appreciate the impact this is likely to have and identify areas that could cause compliance problems under the GDPR.
It will be useful to add GDPR as an item to your practice meeting agenda.
Julie Walsh - Practice Manager at Ruskington Medical Practice has created a presentation for practice staff that you may find useful. A copy may be downloaded here.
Alison Lowerson, Practice Manager at Long Bennington, has also created a staff presentation that can be downloaded here.
Debbie Herd, Practice Manager at Munro Medical Centre also provided a staff presentation. Click here to download
ICO Posters, stickers & e-learning
Step 2 - Information you hold
You should document what personal data you hold, where it came from and who you share it with. You may need to organise an information audit across the organisation or within particular areas. The GDPR requires you to maintain records of your processing activities.
Data processing registers
(Pick your favourite!)
An alternative example spreadsheet to complete may be downloaded here
Data Retention Schedule
Step 3 - Privacy Notice - Communicating privacy information
You should review your current privacy notices and put a plan in place for making any necessary changes in time for GDPR mplementation.
Under the GDPR there are some additional things you will have to tell people. For example, you will need to explain your lawful basis for processing the data, your data retention periods and that individuals have a right to complain to the ICO if they think there is a problem with the way you are handling their data. The GDPR requires the information to be provided in concise, easy to understand and clear language.
Examples of privacy notices are available to download below;
Step 4 - Individuals' rights
You should check your procedures to ensure they cover all the rights individuals have, including how you would delete personal data or provide data electronically and in a commonly used format.
The GDPR includes the following rights for individuals:
- the right to be informed;
- the right of access;
- the right to rectification;
- the right to erasure;
- the right to restrict processing;
- the right to data portability;
- the right to object; and
- the right not to be subject to automated decision-making including profiling.
On the whole, the rights individuals will enjoy under the GDPR are the same as those under the DPA but with some significant enhancements. If you are geared up to give individuals their rights now, then the transition to the GDPR should be relatively easy.
Right to erasure - It is extremely difficult to envisage the circumstances when this right would apply to medical records. The right to erasure applies only in specific circumstances, for example, when the processing is no longer necessary or when the processing has been unlawful. It is extremely unlikely that these circumstances will be relevant in a health context.
Step 5 - Subject access requests
You should update your policies & procedures on how you will handle requests to take account of the new rules;
- In most cases you will not be able to charge for complying with a request
- You will have a month to comply, rather than the current 40 days
- You can refuse or charge for requests that are manifestly unfounded or excessive
- If you refuse a request, you must tell the individual why and that they have the right to complain to the supervisory authority and to a judicial remedy. You must do this without undue delay and at the latest, within one month.
Don't forget to update your fees list in your waiting room & on your website.
If your practice handles a large number of access requests, consider the logistical implications of having to deal with requests more quickly.
You could consider whether it is feasible or desirable to develop systems that allow individuals to access their information easily online.
Step 6 - Lawful basis for processing personal data
You should identify the lawful basis for your processing activity in the GDPR, document it and update your privacy notice to explain it.
You will also have to explain your lawful basis for processing personal data in your privacy notice and when you answer a subject access request.
The lawful bases in the GDPR are broadly the same as the conditions for processing in the DPA. It should be possible to review the types of processing activities you carry out and to identify your lawful basis for doing so. You should document your lawful bases in order to help you comply with the GDPR’s ‘accountability’ requirements.
Step 7 - Consent
You should review how you seek, record and manage consent and whether you need to make any changes. Refresh existing consents now if they don’t meet the GDPR standard.
You should read the detailed guidance the ICO has published on consent under the GDPR and use the consent checklist to review your practices.
Step 8 - Children
You should start thinking now about whether you need to put systems in place to verify individuals’ ages and to obtain parental or guardian
consent for any data processing activity.
Step 9 - Data breaches
You should make sure you have the right procedures in place to detect, report and investigate a personal data breach. Some organisations are already required to notify the ICO (and possibly some other bodies) when they suffer a personal data breach.
The GDPR introduces a duty on all organisations to report certain types of data breach to the ICO, and in some cases, to individuals. You only have to notify the ICO of a breach where it is likely to result in a risk to the rights and freedoms of individuals – if, for example, it could result in discrimination, damage to reputation, financial loss, loss of confidentiality or any other significant economic or social disadvantage.
A breach must be reported to the ICO no later than 72 hours after the data controller becomes aware of it.
Step 10 - Data Protection by Design and Data Protection Impact Assessments
It has always been good practice to adopt a privacy by design approach and to carry out a Privacy Impact Assessment (PIA) as part of this.
However, the GDPR makes privacy by design an express legal requirement, under the term ‘data protection by design and by default’. It
also makes PIAs – referred to as ‘Data Protection Impact Assessments’ or DPIAs – mandatory in certain circumstances.
A data protection impact assessment (DPIA) is mandatory when practices engage in new data sharing arrangements or where new technologies are being used. A DPIA must include a description of the processing, an assessment of the proportionality of the processing in relation to the purpose, an assessment of the risks posed and how the risk will be mitigated. This assessment must be carried out by the practice.
Step 11 - Data Protection Officer
You should designate someone to take responsibility for data protection compliance and assess where this role will sit within your organisation’s structure and governance arrangements. All practices which provide services under an NHS contract are public authorities, therefore it is mandatory that they designate a DPO.
Designation is a decision to be made by the practice. The DPO is expected to monitor compliance, however, responsibility for compliance remains with the data controller and data processor. Large practices and multi-practice groups are likely to have in-house DPOs but smaller practices may prefer to designate external DPOs that could for instance be provided by a Clinical Commissioning Group, Business Services Organisation.
The LMC have been in discussion with NHS England & the CCGs about appointing a central DPO for practices. Discussions are still ongoing, however in the interim most practices seem to be appointing their Caldicott Guardian as DPO.
Step 12 - International
This will generally not apply to GP practices.
If your organisation operates in more than one EU member state, you should determine your lead data protection supervisory authority and
Compliance with GDPR is essential as fines under the GDPR are up to a maximum of 20 million Euro or 4% of turnover.