The processing of special category personal data (including health data e.g. vaccination status, blood type, health conditions etc) was a common topic before the COVID-19 pandemic (the “pandemic”), with various resources published that explored this topic.
For example, the European Data Protection Board (“EDPB”) published an adopted opinion on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation* (“GDPR”) (23January 2019), the Information Commissioner’s Office (“ICO”) posted a blog on why special category personal data needs to be handled even more carefully (14 November 2019) and the ICO published guidance on the lawful basis for processing special category data compliance with the GDPR (November 2019).
The pandemic has brought about a number of data protection considerations, all of which were already in existence but exacerbated by the pandemic (employee monitoring, contact tracing, workforce shift from office to home etc.) One that is more prevalent than ever before is the processing of health data, this piece aims to cover some key data protection themes and practical insights into the processing of health data.
Health data, a subset of special category personal data by its very nature comes with an increased risk profile. When processing this data type, not only are there legislative data protection requirements, the expectation of good clinical governance practices but also regulatory body considerations too.
For example, the NHS Care Quality Commission have in place a code of practice on confidential personal information, the NHS Health Research Authority have in place GDPR guidance specifically for researchers and study coordinators and technical guidance for those responsible for information governance within their organisation and the NHS more generally, has in place it’s Data Security and Protection Toolkit (the “Toolkit”). The Toolkit is an online self-assessment tool that enables organisations to measure and publish their performance against the National Data Guardian’s ten data security standards. The Toolkit covers records management and retention, training and awareness, system vulnerability management and crisis management to name a few.
The above is all on a national level (UK), on an international level, there are data protection laws which specifically cover health data such as HIPAA in the US, the Patient Data Protection Act in Germany, and various provincial health data privacy laws in Canada such as the Health Information Act in Alberta.
Whilst the previous paragraph highlights the complexities of processing health data whether on a national and international level in comparison to other data types, there are a number of mitigations that organisations can put in place to adequately reduce the risks associated with processing this type of data. Mitigations such as Data Protection Impact Assessments (“DPIAs”), updated privacy notices and appropriate security measures amongst other things should all be considered.
Many organisations that never historically processed health data may now do so as a result of the pandemic…
Covering your bases
The first base that must be covered when processing data is ensuring that an appropriate legal basis has been established for each data processing activity, so for example if health data is processed for employee monitoring and research, a legal basis for both of these activities will need to be established. Legal bases can include for the performance of a contract, for legitimate interests** of the organisation and/or in order to perform a legal obligation. Where processing of health data is concerned an additional category under Article 9 of the UK GDPR must be met. In the healthcare context, applicable additional categories may include explicit consent, health or social care purposes, public health purposes and/or archiving research and statistical purposes.
Many organisations that never historically processed health data may now do as a result of the pandemic or alternatively organisations that processed health data pre-pandemic may now be doing so in larger amounts, organisations that fit either side of the coin should also assess the extent to which their privacy notice(s) have been updated and/or need to be updated in order to make data subjects aware any applicable data processing changes and to comply with transparency obligations.
Next, large scale processing of health data may pose a ‘high risk to the rights and freedoms of natural persons’ and in such cases, will trigger the requirement of a DPIA. In order for a DPIA to have value, it is important for organisations to ensure that the DPIA is assessed and considered early on to ensure privacy by design and default is incumbent of any system or processing activity.
A DPIA will assess the likelihood and severity of harm related to the processing activity in question and should the DPIA identify a high risk with no available mitigations, consultation with the ICO will be needed. The ICO has set out a 9-step lifecycle for the DPIA, all of which should be considered before any data processing has taken place:
- Identify a need for a DPIA;
- Describe the processing;
- Consider consultation;
- Assess necessity and proportionality;
- Identify and assess risks;
- Identify measures to mitigate risk;
- Sign off and record outcomes;
- Integrate outcomes into plan; and
- Keep under review.
Internally, organisations should have appropriate technical and organisational measures in place which reflects the risk presented. In relation to technical measures, appropriate internal controls and security measures should be utilised. Organisations may wish to consider a myriad and combination of controls to ensure that health data has the best level of protection, this may include end to end encryption for data both in transit and at rest, role-based access within organisations and the adoption and accreditation of industry recognised security standards such as ISO 27001.
In respect of organisational measures, it may be apt for training and awareness sessions to be implemented with tailored training administered to employees that will doing data processing activities and a robust policy suite in place which covers key circumstances such as data breaches and business continuity.
A specific data processing activity that may be utilised more in the wake of the pandemic is that of data sharing between organisations for information and research purposes. In the England, the soon to be implemented GP Data Sharing Scheme aims to improve and create a new framework for creating a central NHS digital database from GP records and the UK’s Department of Health and Social Care (“DHSC”) has recently published a draft policy paper titled ‘Data saves lives: reshaping health and social care with data’. The policy covers the aspiration of the DHSC to introduce new legislation as part of the Health and Care Bill (currently at Committee stage) to encourage data sharing between private health providers and the NHS and have more guard rails around the sharing of data generally through mandating standards for how data is collected and stored.
With data sharing as evidenced by the above, is something that will be advocated for and welcomed in due course, it is important that organisations have in place the appropriate contractual and practical measures to protect data as data in motion is when it is most vulnerable. Contractual measures include ensuring data sharing and/or transfer agreements are in place which cover all necessary contractual provisions and provide adequate assurances as to the data sharing/transfer arrangements. The NHSX has published a template Data Sharing Agreement which has been labelled as suitable for use by all health and care organisations and includes risk management, legal basis and confidentiality and privacy provisions amongst other things. Practical measures include conducting due diligence checks on all organisations which may be in receipt of data as part of the data sharing process (including third parties) and anonymising/ pseudonymising data. The ICO has put in place a comprehensive data sharing checklist which invites organisations to consider data minimisation, accountability and data subject rights.
The pandemic has changed the world that we knew it in more ways than one and in the context of processing of health data, what seems to be certain is that the processing of health data is on the rise. As such, organisations should continue to monitor guidance and developments in this area and ensure data protection principles are at the core of all data processing activities as a first port of call.
* EDPB guidelines are no longer directly relevant to the UK data protection regime and are not binding under the UK regime.
** A legitimate interest assessment should be considered when relying on legitimate interest as a lawful basis.
Olivia Wint is a seasoned data protection professional, with over five years experience in this area. Olivia has worked in a range of sectors including local authority, third sector, start-ups and the Big 4 advising on all aspects of data protection compliance.