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28JunDati anonimi e pseudonimi: cosa cambia per la ricerca dopo l’ultima sentenza della Corte UeIl Tribunale dell’Unione Europea si è espresso di recente sul tema della distinzione fra dati anonimi e pseudonimi. Il significato e l’impatto della sentenza sulla ricerca in ambito medico-scientifico
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28JunDigital Therapeutics: EFPIA recommendations for access to digital therapies in the EUThe European Federation of Pharmaceutical Manufacturers & Associations ("EFPIA") published a report on Improving access to digital therapeutics in Europe, aiming to promote a structured approach to the regulation of digital therapeutics ("DTx") on the European market.
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14JunNon-promotional communication: Boost for digital from the Farmindustria Code?The recent amendments to the Farmindustria Code on non-promotional drug interactions may boost pharmaceutical companies’ communication via digital and other channels.
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8JunData protection enforcement in the healthcare: What can we learn from it?In recent years, since the GDPR was fully implemented and inspections focused on enforcement of the new rules began, the Italian Data Protection Authority has focused on breaches of the rules applicable to processing health data in the context of the Electronic Health Record, the Health File, and online medical reports.
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31MayProcessing health data on online platforms: The Garante rules on fairnessWith order no. 368 of November 10, 2022, the Italian Data Protection Authority ruled that the provider of an online platform aimed at connecting healthcare professionals with patients was in breach of the personal data protection rules provided by the GDPR in processing data via their platform.
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22MayIntelligenza artificiale in azienda: le sfide della complianceIn qualsiasi settore si cerca di trarre valore dai dati personali che vengono trattati o di offrire servizi innovativi e personalizzati, e spesso lo si fa utilizzando l’IA. Questo pone importanti sfide in ambito privacy
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12MayDrug advertising: New directions from EuropeEurope is not making any revolutionary changes when it comes to the advertising of medicines.
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26AprThe metaverse in healthcare: What are the legal implications?Di fronte a così tante opportunità, il diritto si interroga su quali possano essere gli strumenti per gestire e regolare il fenomeno del metaverso nella sanità.
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17AprDelivering drugs to the public outside a pharmacy via a third party: Considerations on a recent ruling by the Criminal Court of CassationIt’s official: Under certain conditions it is not an offense for drugs—including prescription drugs—to be received by and distributed to the public, potentially even outside the pharmacy channel.
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28MarDecentralized clinical trials: Recommendation paper for the implementation of uniform procedures in the European Union publishedOn December 13, the European Commission (EC), the Heads of Medicines Agencies (HMAs), and the European Medicines Agency (EMA) published a document entitled Recommendation paper on decentralised elements in clinical trials (“Recommendations”) to provide Member States further and more detailed guidance on the implementation of procedures for conducting trials outside of traditional clinical trial centers.