New Guidelines on Web Scraping

June 20, 2024Legal newsGDPR, italy, law, privacyLeonardo Moscati

Pursuant to Article 57(1)(b) of the GDPR, on May 20, 2024 the Italian Data Protection Authority (“Italian DPA”) adopted guidelines [LINK] on web scraping, with the aim of providing guidance to operators of websites and online platforms, acting in Italy as data controllers of personal data made available online to the public.

Web scraping is defined by the Italian DPA as the massive collection of personal data from the web for the purpose of training generative artificial intelligence models. Specifically, whenever such phenomenon involves the collection of traceable information – linked to an identified or identifiable natural person – a data protection issue arises with reference to the identification of an appropriate legal basis for the processing of such data.

According to the guidelines, the assessment of the lawfulness of web scraping must be carried out on a case-by-case basis. Personal data are made available on the web as a result of a primary level processing by operators of online platforms as data controllers. Only then, third parties – often web robots or “bots” – may gather such data for different purposes while scraping the web. This is the reason why the Italian DPA addresses its guidelines to operators of online platforms: they are, in fact, the only ones able i) to more easily evaluate how data are used after being scraped from their platforms and ii) to implement measures on their platforms that may prevent or mitigate web scraping activity for purposes of training algorithms.

Possible precautions or enforcement actions identified by the Italian DPA are the following:

Creation of restricted areas, which can only be accessed after registration. In this way, certain personal data would be removed from public availability;
Inclusion of ad hoc clauses in the terms of service of the online platform expressly prohibiting the use of web scraping techniques;
Monitoring network traffic to detect any abnormal flow of data and adopting limits as countermeasures;
Direct intervention on bots (e.g. insertion on websites of CAPTCHA checks or monitoring log files to block undesirable users).

Such measures should be adopted by the data controller after an independent assessment – in compliance with the accountability principle, which increasingly appears to govern new data protection legislation and strategies. At any rate, the Italian DPA acknowledges that, albeit useful, none of these measures can be expected to entirely prevent web scraping from happening.

Processing Health Data: the Most Recent Amendment to Italian Privacy Code

May 31, 2024Legal newsdata protection, GDPR, healthcare, innovation, Italian Data Protection Authority, italy, law, privacyLeonardo Moscati

The Italian “Privacy Code” (Legislative Decree No. 196/2003), which governs data protection in Italy together with the European GDPR, has recently been amended.

Law No. 56/2024, further implementing the National Recovery and Resilience Plan, intervened on section 110 of the Privacy Code, which deals with the processing of health-related data for the purposes of medical, biomedical or epidemiological scientific research.

Section 110 provides that consent of the data subject for the processing of health-related data for the purpose of medical, biomedical or epidemiological scientific research is not required when:

the research is carried out on the basis of legal provisions or European Union law, when processing is necessary for scientific research or statistical purposes, provided that an impact assessment is carried out pursuant to sections 35 and 36 of the GDPR; or
informing the data subject is impossible or involves a disproportionate effort, or would render impossible or seriously jeopardise the attainment of the purposes of the research.

In such cases – before the latest amendment – the data controller had to:

1) take appropriate measures to protect the rights, freedoms and interests of the data subject;

2) obtain a favorable opinion of the competent ethics committee; and

3) consult the Italian Data Protection Authority prior to processing.

The obligation to consult the Italian Data Protection Authority has now been repealed. Thus, there is no need to apply for the Authority’s clearance prior to processing health-related data (in those cases where consent of the data subject is not required under section 110 of the Privacy Code).

This amendment may have a significant impact especially on retrospective studies for which informing data subjects is particularly burdensome. The data controller will, in fact, be able to proceed without the Authority’s permission. Nonetheless, the data controller will still have to comply with specific guarantees and ethical rules issued by the Authority – as specified by the amended section 110.

On the one hand, the amended section 110 seems to favor accountability and to soften the procedural requirements in processing health data for research purposes, making the overall procedure quicker. When it comes to “secondary use” of health data, the accountability approach should be considered strong enough to protect data and favorably welcomed, as it moves in the same direction of the European Health Data Space – which intends to provide a reliable and efficient system for the re-use of health data in areas as research and innovation.

On the other hand, though, the Italian Data Protection Authority has already issued some interim guarantees, specifying that data controllers – when processing health data related to deceased or non-contact subjects – must carry out and publish an impact assessment, pursuant to section 35 of the GDPR, notifying it to the Authority. It remains to be seen how the amendment will be handled by the Authority in practice: the effects of the simplification provided by the new version of section 110 may be diminished if the guarantees set forth by the Authority generate equally articulate procedures.

Effectively Implemented “231” Model Exempts Italian Company from Criminal Corporate Liability

May 29, 2024Legal news231 model, italy, Legislative Decree 231/2001Filippomaria Leone Valle

A recent decision of the Milan Court exempted an Italian company from criminal charges under law 231, even while it found its employees guilty of a 231 financial crime.

The Court held that the company’s managers abused of their override powers to systematically ignore internal control systems. Nonetheless, the court found that the company had effectively implemented its compliance 231 model, although such model was fraudulently circumvented by the managers.

The Court confirmed, as already established in the Impregilo case, that the occurrence of a crime does not automatically prove the non-completeness and non-effectiveness of a company’s compliance program. A separate analysis of the compliance program must instead be carried out, even if a crime has occurred and individuals are found guilty.

Under Italian law 231, companies are liable for employees’ crimes when the crime is committed in the interest or to the advantage of the company. Such 231 liability can be lifted if the company has effectively implemented a compliance program aimed at preventing such crime. Despite the incentive built in in 231 law for companies to set up and effectively implement a compliance program, past case law has not been generous in granting such exemption from liability. The recent Milan court case may open a new path.

AI Breakfasts Continue

May 8, 2024Events, Legal newsAI, AI and contracts, Camilla Ferrari, Intelligenza Artificiale, Responsabilità da Intelligenza ArtificialePaola Sangiovanni

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).

life-sciences-practice-group-presentation-on-ai-legislation-eng Download

life-sciences-practice-group-presentazione-su-ia-e-responsabilita-ita Download

Processing of personal and health data through apps and online platforms aimed at connecting HCPs and patients: the new digest of the Italian DPA

April 15, 2024Legal newsAPP, data, data controller, data processor, data protection, data subject, Data Transfer, dpa, dpia, garante, gdpd, GDPR, hcp, health, health data, healthcare, heath app, innovation, Italian Data Protection Authority, italy, law, privacy, regulationFrancesco Stelio Clerici

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:

The necessity for the Platform’s owner to carry out (and periodically update) a data protection impact assessment (DPIA) pursuant to section 35 GDPR, since the use of Platforms determine a “high risk” processing of personal data, as such kind of treatment automatically meets the criteria issued by the European Data Protection Board for the identification of the list of data processing that may be deemed subject to the duty to perform a DPIA;
Which information notices should be provided, by who and to whom, as well as the contents that such information notices should have in each case, according to sections 13 and 14 GDPR;
The specific rules applicable to cross-border data transfers and data transfer to third countries.

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.

A New European Digital Identity

April 5, 2024Legal newsdigital wallet, digital-identity, EU Commission, european digital identity, GDPR, privacy, regulation, technologyLeonardo Moscati

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.

Tier 2!

March 28, 2024Eventslegal 500, life sciences Italy, rankingsPaola Sangiovanni

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!

Corporate Liability Under Legislative Decree No. 231/2001: Latest Developments

March 25, 2024Legal news231, criminal liability, fraud, italy, law, public fundsLeonardo Moscati

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.

The Italian Government Fund for the Governance of Medical Devices

February 23, 2024Legal newsFondo per il governo dei dispositivi medicii, health, healthcare, italy, medical device, medical devices, Ministry of Health, news, paybackFilippomaria Leone Valle

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

Annual payment obligation. Companies manufacturing or distributing medical devices, large medical equipment and in vitro diagnostic medical devices must pay a sum equal to 0.75% of the company’s previous year turnover from the sale of such devices to the National Health Service, net of VAT.

Annual Declaration Requirement. Companies must submit an annual statement to the Ministry of Health regarding:
- The estimated amount of 0.75% of the above-mentioned turnover.
- The company’s previous year turnover to the National Health Service, net of VAT;
Use of the Fund. The Fund will be used for various activities related to Health Technology Assessment and governance of medical devices (including the management of the National Price Observatory, the vigilance system and the market surveillance system).
Deadlines and next steps. The first deadline for compliance with the fund regulations is set for December 31, 2024.

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.

Law, Health & Technology

A blog by the life sciences group of GITTI and PARTNERS Studio Legale Associato (www.grplex.com). Our views on healthcare, new technologies, and their interactions with the law.