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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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11JulPortolano Cavallo announces the appointment of Enzo Marasà as partnerWith Enzo Marasà's appointment, the number of partners rises to 20, showcasing the firm's strong and consistent expansionArticle filed under: EU and Competition Law
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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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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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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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6JunPortolano Cavallo doubles down on private equity with partner Gianpaolo Scandone joining as co-leadThe firm’s Private Equity practice to be led by partners Gianpaolo Scandone and Andrea GrittiArticle filed under: Private Equity
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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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