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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 focusThe AIFA issued two new guidelines, focusing, respectively, on observational studies and clinical trials for medicinal products.
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23SepNew Aifa guidelines on clinical trials between simplification and decentralizationAs mentioned in our other article, this article deals with the guidelines approved by the AIFA on the same day as those on observational studies. They were also published in the Italian Official Gazette on August 20, 2024. The guidelines concern simplification and decentralization of clinical trials of medicines.
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4SepThe DABUS Case: Artificial Intelligence Cannot Be Designated as an Inventor on a PatentArtificial intelligence (AI) plays a fundamental role in the life sciences sector. AI offers the opportunity to facilitate various processes. For example, it can be used to analyze and process large quantities of health data that in turn may facilitate the discovery of new drugs, improve diagnostics, and customize treatments. It also can be used to automate laboratory processes and manage clinical trials, saving time and resources.
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9JulTransparency in clinical trials: Revised transparency rules take effectThe revised transparency rules (“Revised Rules”) for the Clinical Trials Regulation (CTR) and its Clinical Trials Information System (CTIS), issued by the EMA in October 2023, took effect on June 28, 2024, with the launch of a new version of the dedicated portal
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11JunMedical research: Prior consultation with the Data Protection Authority is no longer requiredMedical research is one of the areas most affected by rapid technological development and increased use of artificial intelligence (AI) 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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