Our breakfast presentation series dedicated to AI continues. Join us for our next event on May 24, 2024 at 9 via Dante in Milan! Our partner, professor Camilla Ferrari of the University of Milan, will be speaking about the impact of AI on contracts.
Curious about past presentations on AI and AI liability? You may find below our slides (in Italian).
On March 2024, the Italian Data Protection Authority (“Italian DPA”) has issued a new digest (“Digest”) relating to the processing of personal data, whether or not concerning health data pursuant to section 9 of the GDPR, carried out through the utilization of platforms, accessible through apps or web pages (“Platforms”), that aim to facilitate connection between healthcare professionals (“HCPs”) and patients.
The use of such Platforms poses high risks to the protection and security of patients’ personal data, and in particular health-related data, given that the latter are subject to an enhanced protection regime set forth by section 9 of the GDPR.
The Digest seeks to summarize the applicable data protection rules that may be followed, and defines the roles of the parties, as well as the legal bases, applicable to (i) the processing of personal data of the users by Platform’s owners; (ii) the processing of HCP’s personal data by Platform’s owners; and (iii) the processing of health data of the patients by the Platform’s owner and by the HCPs.
Additional guidance is provided as to:
Lastly, the Digest includes a list of the most common measures that are taken by the data controllers to ensure an appropriate level of technical and organizational measures to meet the GDPR requirements, such as encryption, verification of the qualification of the HCPs that seek to enroll within the Platform; strengthened authentication systems, monitoring systems aimed at preventing unauthorized access or loss of data.
The Digest should be very welcomed by the Platform’s owners, as it now gives a reliable and complete legal frame that may be followed in order to set up a Platform in a way which is compliant with the GDPR principles.
On March 26, 2024 the Council adopted a new framework for a European digital identity (eID).
Background. In June 2021, the Commission proposed a framework for a eID that would be available to all EU citizens, residents, and businesses, via a European digital identity wallet (EDIWs). The new framework amends the 2014 regulation on electronic identification and trust services for electronic transactions in the internal market (eIDAS regulation n. 910/2014), which laid the foundations for safely accessing public services and carrying out transactions online and across borders in the EU. According to the Commission, the revision of the regulation is needed since only 14% of key public service providers across all Member States allow cross-border authentication with an e-Identity system.
Entry into Force. The revised regulation will be published in the EU’s Official Journal and will enter into force 20 days after its publication. The regulation will be fully implemented by 2026.
Digital Wallets. Member States will have to offer citizens and businesses digital wallets that will be able to link their national digital identities with proof of other personal attributes (e.g., driving license, bank account). Citizens will be able to prove their identity simply using their mobile phones.
EU-wide Recognition. The new EDIWs will enable all citizens to access online services with their national digital identification, which will be recognised throughout the EU. Uses of EDIWs include: opening a bank account, checking in in a hotel, filing tax returns, storing a medical prescription, signing legal documents.
The Right to Digital Identity. The fundamental purpose of the regulation is to establish the right to a digital identity for Union citizens and to enhance their privacy.
Main features of EDIWs. According to the new regulation:
• the use of EIDWs shall be voluntary and shall be provided directly, under mandate or recognition by a Member State;
• EDIWs shall enable the user to (1) securely request, store, delete, share person identification data and to authenticate to relying parties; (2) generate pseudonyms and store them encrypted; (3) access a log of all transactions and report to the national authority any unlawful or suspicious request for data; (4) sign or seal by means of qualified electronic signatures; (5) exercise the rights to data portability.
Privacy. Privacy will be safeguarded through different technologies, such as cryptographic methods allowing to validate whether a given statement based on the person’s identification data is true without revealing any data on which that statement is based. Moreover, EDIWswillhave a dashboard embedded into the design to allow users to request the immediate erasure of any personal data pursuant to Article 17 of the Regulation (EU) 2016/679.
The rankings of The Legal 500 are out and this year Gitti and Partners’ life sciences practice has been recognized as a “Tier 2” firm, with Paola Sangiovanni as “Leading Individual”.
Check out the rankings here:
https://www.legal500.com/c/italy/industry-focus-healthcare-and-life-sciences/
A huge THANK YOU to our wonderful testimonials, but also to all of our clients, who help us get better year after year, and to our team, who makes working fun!
In the context of criminal proceedings for aggravated fraud for obtaining public funds (art. 640 bis of the Criminal Code) and for ideological falsity of the private party in a public deed (art. 483 of the Criminal Code), the Italian Supreme Court (ruling No. 3196/2024 Jan. 26, 2024) had the opportunity to reiterate some useful principles in the context of 231 Models:
•the legal representative of the entity, suspected or accused of the predicate offense, cannot appoint the entity’s defense attorney, due to the absolute prohibition of representation posed by Article 39 of Legislative Decree No. 231 of 2001. The incompatible representative cannot perform any defensive act in the interest of the entity and, if performed, must be considered ineffective. However, the entity may join the proceedings by replacing the representative who has become incompatible or by appointing an ad hoc representative.
•The Court must always make an independent determination of the administrative liability of the entity and this means that:
1)It is not necessary to make a final and complete finding of individual criminal liability of the natural person, but a mere incidental finding is sufficient.
2)The configurability of criminal liability of managers for 231 crimes is not sufficient to affirm the liability of the entity. The judge must carry out a judgment of the suitability of the 231 Model adopted, ideally placing it at the time when the offence was committed, in order to verify whether compliance with the 231 Model would have eliminated or reduced the danger of the occurrence of offences of the same kind as the one that occurred.
With Ministerial Decree dated December 29, 2023, the Italian Ministry of Health has established criteria and methods for feeding the fund dedicated to the governance of medical devices, the so-called “Fondo per il governo dei dispositivi medici” (Fund for medical devices governance, “Fund”).
Key Features
Companies are currently assessing whether the Fund can be challenged in court with arguments that may be similar to those raised in the so called “payback” litigation, which will see its day in Court (namely, the Italian Constitutional Court) on May 22, 2024.
The proposed Corporate Sustainability Due Diligence Directive, so-called CS3D, may set new rules binding large EU or non-EU companies aimed at preventing adverse impacts on the environment and human rights resulting not only from their own operations, but also from those of their business partners.
CS3D has been criticized for its strong impact on the whole supply chain. While only large companies are in scope, vendors of such obligated entities will need to comply with such entities’ policies inspired by CS3D.
What Are the Proposed Obligations?
New due diligence requirements are supposed to be established by CS3D and may subsequently be implemented by each member state. According to the text under discussion, companies will have to identify, prevent, stop, mitigate and account for the adverse impacts on the environment and human rights caused by their activities. In addition, they will need to have a plan to ensure that their business strategy is compatible with limiting global warming to 1.5°C in line with the Paris Agreementand the climate neutrality goals set by Regulation (EU) 2021/1119.
Which Companies are In Scope of CS3D?
CS3D would apply to European companies that:
It would also applty to third-country companies that:
When Will It Enter into Force?
CS3D is still under discussion. The proposal for the Directive was presented by the European Commission on February 23, 2022, and the Parliament adopted the amended text on December 14, 2023. The proposal must be formally approved by the Commission, the Parliament and the Council before it can officially enter into force.
Today, January 11, 2024, marks the entry into force of EU Regulation 2023/2854, better known as “Data Act”.
The new regulation sets forth new rules on B2B and B2C data access and provides a regulatory framework for sharing data generated by the use of connected devices and related services. In addition, the Data Act contains measures to restrain economic operators from abusing contractual imbalances in data-sharing contracts.
The new regulation’s declared goals are to:
Art. 50 of the regulation provides that the new set of rules shall apply from September 12, 2025; however, certain articles, shall apply at a later stage.
Law, Health & Technology 
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