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23OctDrug advertising: New rules on advertising for over-the-counter and non-prescription medicines (OTC and SOP)The Italian Ministry of Health updated the guidelines regulating the use of media to publish advertising messages regarding OTC and SOP: a good step in terms of streamlining and simplification of the applicable regulatory framework. Thanks to Denise Moretti for collaborating on this article
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23OctThe digital caregiver: Insights from the 4th AFI Patient DayCon il termine caregiver si intende una persona che presta assistenza quotidiana a chi non è autosufficiente. Può trattarsi, a seconda dei casi, di un familiare del paziente o di una persona retribuita (il/la cosiddetto/a badante).
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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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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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