EU: Healthcare

Lord Patel Excerpts

Wednesday 11th January 2012 Lords Chamber

[Lord Patel]

My Lords, I want to speak about the data protection directive. It regulates the processing of any personal information, and has been transposed in the UK as the Data Protection Act. That legislation covers any activities that involve data processing. They are as diverse as marketing and internet transactions, routine administrative data collection and the use of health records for research and clinical practice.

Health research is therefore only one small aspect of the directive, but that complex legislation has had a major impact on how health data are used in studies. Properly controlled access to individuals’ health records is essential for health research. Health records enable researchers to identify patients to take part in clinical trials and to provide data for observational studies, such as those looking for associations between particular lifestyle choices and ill health. Researchers find the legislative framework for the use of health data complex and confusing. For example, they are uncertain how much protection now offered by exemptions for research on how they handle anonymised data, where the identity of individuals is masked.

The European Commission will put forward a new legislative proposal to replace the data protection directive at the end of January. That is expected to increase the rights of individuals, and it is highly likely that that will have an impact on how we use health data in research, even if that is unintended.

The Government recognise the importance of the use of patient data in research. I welcome the recent commitment to consult on changes to the NHS Constitution to create a system that will enable patients’ records to be used in research unless they opt out. This is therefore an exciting but also anxious time for the use of health data in research. We must make sure that changes to EU data protection legislation do not inadvertently hamper those plans. I am sure that the noble Earl will liaise with the Justice Department to ensure that that is not the case.