The European Federation of Pharmaceutical Industries and Associations (EFPIA) has joined a new coalition that wants to ensure privacy laws in the EU do not unnecessarily restrict the exchange of personal health data and, by extension, opportunities to deliver optimal healthcare and to drive effective clinical and public-health research.
The multi-stakeholder Healthcare Coalition on Data Protection is built around a single cause: the need to “facilitate health-data processing for health purposes, in a reliable and responsible manner (with the highest respect for EU citizens’ fundamental right to data protection and privacy)”.
The Coalition aims to raise awareness of “the essential role” the processing and sharing of personal data plays in “improving effective, sustainable and innovative healthcare while supporting health research of significant public interest”.
In particular, this involves presenting a united front in the debate over the European Commission’s proposal for a General Data Protection Regulation, which was published on 25 January 2012.
The Coalition has a number of concerns about the proposal as it stands.
For example, the stakeholders want to make sure the principles of data protection do not apply to anonymised health data and that provisions on the use of pseudonymised (or key-coded) data recognise “the context and the risk of re-identification to ensure a risk-based approach”.
Other than EFPIA, the members of the Healthcare Coalition on Data Protection are the Council of European Dentists; the European Hospital and Healthcare Federation; the Federation of European Academies of Medicine; COCIR, which represents the radiological, electromedical and healthcare IT industry in Europe; Continua Health Alliance; the GSMA, representing the interests of mobile operators worldwide; and the Standing Committee of European Doctors (CPME).
The Healthcare Coalition on Data Protection makes five key recommendations which it believes would improve the proposed General Data Protection Regulation:
• Maintaining data-processing provisions for healthcare, research and “ultimately patient safety”.
• Clarifying definitions of health data to allow a workable and effective data-protection regime.
• Considering the potential unwanted consequences of the Right to be Forgotten (i.e., a provision that would give individuals the right to ask for data about them to be deleted).
• Avoiding excessive administrative burdens linked to impact-assessment obligations.
• Clarifying rules and definitions around the concept of consent.
With today’s information-based healthcare systems, “the availability of health data through the healthcare cycle is crucial for delivering quality care, clinical research, public health research, improving the quality of patient-centred healthcare services and reducing costs”, the Coalition states.
Information and communications technology, electronic health records and mobile technologies “are increasingly connecting all parts of the system, delivering more personalised ‘citizen-centric’ healthcare, which is more targeted, effective and efficient”.
To capitalise on these benefits, the Coalition argues, “it is vital that the EU strikes an appropriate balance between facilitating the secure use of health data for health purposes and patients’ rights to privacy”.