Monthly Archives: April 2024

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

Legal news, , , , , , , , , , , , , , , , , , , , , ,

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

Legal news, , , , , , ,

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.