Wednesday, 28 March 2012

Protection of medical records of patients in clinical trials

The subject of the protection of personal data of EU citizens was also under debate yesterday by the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA). They have adopted a joint guidance document  and principles document to increase transparency as to when regulators may release certain medical data in response to access to documents requests (European medicines regulators agree a common, Europe-wide approach for the identification of commercially confidential information and personal data). This initiative is supposed to help the authorities to cope with requests for access to clinical and safety data contained in a marketing authorisation application. From the consumer perspective, it is important that these guidelines determine how to protect personal data (as defined by the EU Directive 95/46/EC) if it can lead to the identification of a person. It is especially applicable to personal data relating to experts, staff or patients that are taking part in, e.g., clinical trials whose data should be redacted before releasing.

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