5
Oct 22
Payback mechanism for medical devices in light of the Aiuti-bis Decree
On September 22, Law No. 142/2022 converting Decree-Law No. 115 of August 9, 2022 (the “Aiuti-bis Decree”) was published.
5
Oct 22
The new standards for territorial care and telemedicine services in accordance with Ministerial Decree 77/2022
On June 22, 2022, the decree of the Ministry of Health No. 77 on “Models and standards for the development of territorial care in the National Health Service” (the “Document”) was published in the Official Gazette.
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published in the Official Gazette
1
Sep 22
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of private healthcare facilities entered into force on 27 August
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of private healthcare facilities entered into force on 27 August
Guidelines for the implementation of the Electronic Health Record (EHR) to ensure dissemination, uniformity and accessibility of the EHR at national level now published in the Official Gazette
6
Jul 22
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.
