EMA is preparing a question-and-answer guidance document on the impact of EU data protection legislation on the secondary use of health data in support of the development, evaluation and supervision of medicines.
The aim is to help medicine developers, data providers and research bodies comply with EU data protection rules, and to help patients and consumers understand their rights and the existing safeguards to protect personal data.
EMA would like to gather input from patients, consumers and healthcare professionals as data contributors as well as from medicines developers, research-performing and research-supporting infrastructures and other data providers (e.g. payers of healthcare).
In the context of the General Data Protection Regulation (EU) 2016/679 (GDPR) and focusing on nine key topics outlined in the below discussion paper, EMA would appreciate to receive feedback on specific data protection questions on secondary data use.
The Agency will launch a targeted stakeholder consultation on the draft guidance in the fourth quarter of 2020. It aims to publish the finalised guidance in the first half of 2021.
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