Is this you? As a journalist, you can create a free Muck Rack account to customize your profile, list your contact preferences, and upload a portfolio of your best work.
Claim your profile
Articles by Max Jerman
New EU Wastewater Treatment Fees on Producers of Pharmaceutical and Cosmetic Products
Yesterday, the European Parliament approved a new (recast) Urban Wastewater Treatment Directive (“UWWTD”) that will impose new additional costs on producers marketing pharmaceutical and cosmetic products in the European Economic Area by the end of 2027. Some studies suggest that the costs that producers would have to collectively pay could be around €1 billion per Member State.
New EU Wastewater Treatment Fees on Producers of Pharmaceutical and Cosmetic Products
Today, the European Parliament approved a new (recast) Urban Wastewater Treatment Directive (“UWWTD”) that will impose new additional costs on producers marketing pharmaceutical and cosmetic products in the European Economic Area by the end of 2027. Some studies suggest that the costs that producers would have to collectively pay could be around €1 billion Euro per Member State.
Italian Garante Issues Guidance on the Use of AI in the Context of National Healthcare Services
On October 12, 2023 the Italian Data Protection Authority (“Garante”) published guidance on the use of AI in healthcare services (“Guidance”). The document builds on principles enshrined in the GPDR, national and EU case-law. Although the Guidance focuses on Italian national healthcare services, it offers considerations relevant to the use of AI in the healthcare space more broadly. We provide below an overview of key takeaways.
Italian Garante Issues Guidance on the Use of AI in the Context of National Healthcare Services
On October 12, 2023 the Italian Data Protection Authority (“Garante”) published guidance on the use of AI in healthcare services (“Guidance”). The document builds on principles enshrined in the GPDR, national and EU case-law. Although the Guidance focuses on Italian national healthcare services, it offers considerations relevant to the use of AI in the healthcare space more broadly. We provide below an overview of key takeaways.
Italian Garante Issues Guidance on the Use of AI in the Context of National Healthcare Services
On October 12, 2023 the Italian Data Protection Authority (“Garante”) published guidance on the use of AI in healthcare services (“Guidance”). The document builds on principles enshrined in the GPDR, national and EU case-law. Although the Guidance focuses on Italian national healthcare services, it offers considerations relevant to the use of AI in the healthcare space more broadly. We provide below an overview of key takeaways.
Italian Data Protection Authority publishes guidance on the use of AI in health space (Italy)
The Italian Data Protection Authority has issued recommendations on how data protection principles should be interpreted with respect to the use of artificial intelligence (AI) in health services.
AIFA publishes new Q&As on manufacture and import of active substances (Italy)
AIFA has updated its guidance regarding authorisation and registration procedures for manufacturing and importing active substances.
AIFA launches new forum to enhance dialogue with stakeholders (Italy)
The Italian Medicines Agency (AIFA) has launched AIFA Incontra, a forum to encourage dialogue between AIFA and stakeholders.
New procedure applicable to renewal of nationally authorised medicinal products (Italy)
The Italian Medicines Agency has announced new procedural requirements for the renewal of nationally authorised medicines.
New priorities and objectives for the AIFA (Italy)
The Permanent Conference for Relations between the State, Regions and Autonomous Provinces of Trento and Bolzano will see discussion on several matters of interest to pharmaceutical companies, including pricing and pharmacovigilance.
New transparency rules in Italy
The Ministry of Health is reviewing submissions made to a consultation on the draft decree implementing the Sunshine Act.
WIPO proposes new Patent Disclosure obligations on Genetic Resources: What impact for companies?
Today, the World Intellectual Property Organization (“WIPO”) finished the preparatory session for the draft International Legal Instrument Relating to Intellectual Property, Genetic Resources and Traditional Knowledge Associated with Genetic Resources (the “Instrument”), which will be discussed and adopted at a diplomatic conference in 2024.
WIPO proposes new Patent Disclosure obligations on Genetic Resources: What impact for companies?
Today, the World Intellectual Property Organization (“WIPO”) finished the preparatory session for the draft International Legal Instrument Relating to Intellectual Property, Genetic Resources and Traditional Knowledge Associated with Genetic Resources (the “Instrument”), which will be discussed and adopted at a diplomatic conference in 2024.
Italian government announces intention to publish draft decree introducing a public register and implementing the Sunshine Act (Italy)
The Italian government announced that it will publish a draft decree establishing a public register to implement Sunshine Act provisions.
Ministry of Health sets out registration and retention obligations of Unique Device Identifiers for in vitro diagnostic medical devices (Italy)
A Ministry of Health Decree lays down registration and retention obligations regarding Unique Device Identifiers for in vitro diagnostic medical devices.
Pharmacies not permitted to deliver medicinal products to public via smart lockers (Italy)
The Ministry of Health has clarified that pharmacies must not distribute medicinal products to the public using smart lockers.
Pricing and reimbursement: updated procedure for negotiations following a centralised marketing authorisation variation (Italy)
The Italian Medicines Agency has published updated guidance on negotiating the price and reimbursement status of medicinal products following a marketing authorisation variation.
Ministry of Health sets out requirements for sites to conduct clinical investigations on medical devices (Italy)
A Ministry of Health Decree establishes requirements for sites to be deemed suitable for clinical investigations of medical devices.
Government proposes to further postpone payment of the payback requests for medical devices (Italy)
The Italian government has proposed amendments to Law Decree 51/2023 which include the introduction of a new legislative framework for managing public expenditure on medical devices by 2026.
Show More
loading
Actions
Is this you?
As a journalist, you can create a free Muck Rack account to customize your profile, list your contact preferences, and upload a portfolio of your best work.Get in touch with Max
Contact Max, search articles and posts on X, monitor coverage, and track replies from one place.
Learn more about Muck Rack