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9OctFarmaci anticontraffazione: entro il 9 febbraio 2025 l’Italia deve adeguarsi al Regolamento Ue 2016/161Measures to combat counterfeit drugs work to prevent such drugs from entering the European supply chain. Delegated Regulation (EU) 2016/161 introduces new rules to halt counterfeit drugs from entering the European market and includes digital tools. As of February 9, 2025, Italy will have to comply with the provisions of the regulation, so there is not much time left to get in line with the new measures.
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25SepNew Aifa guidelines on observational studies and decentralized clinical trials: digital tools increasingly in focusUn agosto caldo sul fronte delle attività di ricerca. Aifa ha reso infatti disponibili due nuove linee guida, dedicate rispettivamente agli studi osservazionali e alle sperimentazioni cliniche sui medicinali. Le relative determine sono state pubblicate sulla Gazzetta Ufficiale del 20 agosto scorso.
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23SepNew Aifa guidelines on clinical trials between simplification and decentralizationCome anticipato in un articolo precedente, ci occuperemo ora delle linee guida approvate da Aifa lo stesso giorno di quelle sugli studi osservazionali e anch’esse pubblicate sulla Gazzetta Ufficiale del 20 agosto 2024, aventi ad oggetto la semplificazione e la decentralizzazione delle sperimentazioni cliniche dei medicinali.
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4SepIl caso Dabus: l’intelligenza artificiale non può essere designata come inventore in un brevettoL’uso dell’IA pone interrogativi sul piano della brevettabilità delle scoperte da questa generate e sulla possibilità di indicare l’IA come autrice delle invenzioni oggetto di protezione brevettuale. Può un’invenzione generata dall’IA essere oggetto di brevetto? Se la nuova scoperta tecnica è generata dall’IA chi dovrà essere indicato come inventore?
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9JulTrasparenza nelle sperimentazioni cliniche: le Revised Transparency Rules diventano applicabiliIl 28 giugno 2024, con il lancio di una nuova versione del portale dedicato, sono diventate applicabili le Revised transparency rules for the Clinical Trials Regulation (CTR) and its Clinical Trials Information System (Ctis), emanate da Ema nell’ottobre del 2023 (“Revised Rules”).
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11JunMedical research: Advance consultation with Data Protection Authority no longer requiredMedical research is one of the sectors most affected by rapid technological development and the increasing use of artificial intelligence systems.
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23MayOnline medicine sales and the processing of purchase data: The Court of Justice of the European Union rulesData related to purchasing non-prescription medicine sold online by an authorized pharmacy should not be considered health-related data under the GDPR.
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10MayArtificial Intelligence in health care: Impact of the new draft law approved by the Italian Council of MinistersThe Italian Council of Ministers approved a draft law on principles governing artificial intelligence, designed to provide an initial national framework for artificial intelligence systems.
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26AprItalian Data Protection Authority publishes rules for platforms (websites or apps) connecting patients and healthcare professionalsIn recent years, technology has revolutionized many sectors, including healthcare. Online platforms and apps that connect patients with healthcare professionals have made medical care more accessible, especially in settings where physical presence is limited or not possible. This evolution has also raised important issues concerning privacy and the protection of personal data.
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9Apr“Pharmacy of Services”: Simplification Decree expands the range of healthcare and telemedicine services pharmacies can provideThe new draft of the Simplification Decree, recently approved by the Council of Ministers, significantly expands the range of services that can be provided by pharmacies as part of the National Health Service.
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