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28SepSunshine Act: Draft Decree for the Sanità Trasparente electronic register publishedNow available the draft decree and technical specifications envisaged by the Sunshine Act, establishing the structure and technical characteristics of the “Sanità Trasparente” electronic register, and the modalities for manufacturing companies to transmit notifications.
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15SepAI and machine learning in the medicine lifecycle: EMA publishes first draft of reflection paperThe first draft of EMA’s “Reflection paper” contains the authority’s latest considerations on the application of AI and machine learning methods in each phase of the medicinal product lifecycle.
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27JulWhistleblowing Decree: Key points for the pharmaceutical sectorLarge multinational companies are being called to assess the compatibility of existing reporting channels with the requirements of the new regulation published on March 15, 2023 on the Official Journal of the Italian Republic, implementing the EU Directive 2019/1937 on whistleblowing.
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10JulThe AI Act: What will the impact be on the medical device industry?The European Parliament approved the “AI Act” (June 14, 2023), a proposal for a regulation providing a uniform legal framework for the use of artificial intelligence in the EU.
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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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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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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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