Guidance for GDPR and proposal for an EU HTA regulation

The European Commission recently adopted two documents of relevance to health research:

  1. On January 24th 2018, the Commission published guidance to facilitate a direct and smooth application of the new General Data Protection Regulation (GDPR) which is going to be applied directly in the EU Member States as of 25 May 2018.

The guidance outlines what the European Commission, national data protection authorities, the national administrations and businesses/organisations should still do for completing the preparation to a successful application of the GDPR.

The Commission also launched a new practical online tool to help citizens, businesses, in particular SMEs, and other organisations to comply and benefit from the new data protection rules.

The Health Directorate in DG RTD together with DG CNECT and DG SANTE contributed to the elaboration of this online tool which has been designed as practical Q & As in order to provide some clarifications for the most commonly raised questions by our stakeholders regarding the data protection requirements in health research.

Please find below some questions of particular relevance (also) for health researchers like data minimization, purpose limitation, further processing, erasing of data, etc:

How much data can be collected?

Can data be used for another purpose?

Does personal data have to be deleted when asked?

How is consent for processing in research obtained?

  1. On February 2nd 2018, the European Commission adopted a proposal to reinforce cooperation amongst EU Member states in Health Technology Assessment (HTA).

The proposed Regulation on HTA covers new medicines and certain medical devices, focussing on the most innovative ones. It provides the basis for permanent and sustainable cooperation for assessing the added value of technologies in four main areas: 1) joint clinical assessments, 2) joint scientific consultations (advice to industry in the early stage of product development), 3) horizon scanning to identify emerging health technologies and 4) voluntary cooperation in all other HTA domains (e.g. collection of real-world data, HTA of public health interventions).

This proposal is welcome as it is expected to have important positive impacts on Research and Innovation for the benefit of the patients across Europe: 1) improve the availability of innovative health technologies for patients by reducing the timelines for market access, 2) stimulate innovations through improved business predictability and efficiency gains for industry.

Individual EU countries will continue to be responsible for making decisions on pricing and reimbursement.

The proposal will now be discussed by the European Parliament and the Council of Ministers. It is expected that once it is adopted, it will start applying three years after it enters into force