Clinical trials and pharmacovigilance: Spanish Code of Conduct leads the way in data management
In an effort to expand the regulatory framework with self-regulatory instruments, the Spanish Data Protection Authority recently approved a “Code of conduct for the processing of personal data in the field of clinical trials and other clinical research and of pharmacovigilance” supported by Farmaindustria, the national trade association for the pharmaceutical industry in Spain.
Draft EMA guidelines on transparency in clinical trials: Protecting commercially confidential information
On April 7, 2022, the EMA published draft guidelines on the transparency of information uploaded to the Clinical Trial Information System for the specific purpose of giving operational guidance on the management of commercially confidential information and personal data
The new decree on non-profit studies: Data and results may now be sold
On February 16, 2022, more than two years later than planned, the Ministerial Decree of November 30, 2021, containing measures to facilitate and support the development of nonprofit clinical trials of medicinal products and observational studies, as well as to regulate the transfer of data and results of nonprofit trials for registration purposes, was finally published in the Official Gazette.
Published Decree of Health Ministry providing measures to enhance no-profit clinical trials and to regulate transfers of data and results of no-profit studies for registration purposes
New national guidelines on telerehabilitation
Last October, the State-Regions Conference approved a document submitted by the Ministry of Health containing national guidelines for the delivery of telerehabilitation services by healthcare professionals.
Health data and digital healthcare: MedTech Europe Recommendations
On June 16, 2021, the European trade association representing the medical technology industries named MedTech Europe published a document containing recommendations for maximizing benefits from use of health data collected via medical devices.