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On 18 March 2023, Legislative Decree No. 26 of 2023 implementing EU Directive 2019/2161 was published in the Italian Official Journal.
After a long implementation process, the legislative decree will enter into force on 2 April 2023, amending and integrating the text of Legislative Decree no. 206 of 2005.
The new rules are intended to strengthen consumer protection when contracting, especially online, with traders. The new rules are also intended to fully harmonize consumer protection rules at European level by introducing greater transparency and more effective sanctions with regard to unfair commercial practices, unfair terms and distance contracts.

The Ministry of Health (MOH) has confirmed its intention to table the Health Information Bill (Bill) in the second half of 2023. Through the Bill, the MOH seeks to enable the collection of patients’ selected health data from healthcare providers and to allow healthcare providers to share patient information with one another in a safe and secure manner.

Following the implementation of the Healthcare Services Act in phases since January 2020, the Ministry of Health announced the first and second reading of the Healthcare Services (Amendment) Bill (Bill) on 6 February 2023 and 6 March 2023 respectively. If passed, most of the amendments as set out in the Bill will be implemented together with the second phase of implementation of the Healthcare Services Act in mid-2023.

Royal Decree 192/2023 on Medical Devices, which adapts Spanish national regulations to the provisions of Regulation (EU) 2017/745, was published on 22 March 2023. The new Royal Decree identifies the competent authority in Spain for medical devices, expands the scope of some of the provisions to new kind of products and introduces provisions regarding the manufacture of in-house products and the reprocessing of single-use products, among other significant changes.

On 21 March 2023, the Authority of Broadcasting and Electronic Information (ABEI) under the Ministry of Information and Communications released a white list specifying local service providers whose online websites and/or social networks are verified and suitable for online advertisements (“White List”). This is part of ABEI’s initiative to encourage brands and advertisers to prioritize displaying advertisements on non-violating websites.

On 13 March 2023, FDA issued a notice regarding guidance documents related to the COVID-19 pandemic, including which of the guidance documents will no longer be in effect after expiration of the declaration of the COVID-19 public health emergency (PHE). The notice followed a Department of Health and Human Services announcement on 9 February that it is planning for the declaration of the PHE to expire on 11 May 2023.