Health data

On 1 July 2024, Germany has enacted stricter requirements for the processing of health data when using cloud-computing services. The new Section 393 SGB V aims to establish a uniform standard for the use of cloud-computing services in the statutory healthcare system which covers around 90% of the German population. In this blog post, we describe the specific…

On May 16, 2024, the CNIL launched a public consultation on all of its health data standards.  Interested stakeholders are encouraged to participate by completing a questionnaire (available in French here) by July 12, 2024.

French law has specific requirements for the processing of health data.  In particular, it generally requires that the processing…

On May 9, 2024, the Italian data protection authority (“Garante”) published a decision identifying the safeguards that controllers must put in place when processing health data for medical research purposes, in cases where data subjects’ consent cannot be obtained for ethical or organizational reasons.

The Garante’s decision follows a recent legislative development, enacted by Law n. 56 of April 29, 2024, and effective as of May 1, 2024, which amended, among other things, Article 110 of the Italian Privacy Code.  The amendment removes the obligation to submit a research program and related data protection impact assessment (“DPIA”) for prior consultation to the Garante, in cases where it is impossible or disproportionately burdensome to contact the concerned individuals.  

We provide below an overview of the legal framework and the safeguards identified by the Garante.Continue Reading Italian Legislator and Regulator Update Rules on Processing of Health Data for Medical Research

The French Public Health Code requires that certain service providers hosting health data hold a specific “HDS” certification.  In order to obtain this certification, providers must comply with the requirements set out in the “HDS” certification standard.  On May 16, 2024, France officially published an updated version of this “HDS” certification standard.

  1. Key Changes

The…

On 24 January 2023, the Italian Supervisory Authority (“Garante”) announced it fined three hospitals in the amount of 55,000 EUR each for their unlawful use an artificial intelligence (“AI”) system for risk stratification purposes, i.e., to systematically categorize patients based on their health status. The Garante also ordered the hospitals to erase all the data they obtained as a consequence of that unlawful processing.Continue Reading Italian Garante Fines Three Hospitals Over Their Use of AI for Risk Stratification Purposes, Establishes That Predictive Medicine Processing Requires the Patient’s Explicit Consent

With the rollout of COVID-19 vaccination programs across the EU and the UK, employers are faced with questions about whether or not they are legally permitted to ask employees about their vaccination status and, if so, how that information may be used.

Employers may wish to inquire about the vaccination status of their employees in order to comply with their general obligation to ensure a safe workplace and minimize the risk of exposure to COVID-19.  This raises privacy issues under the General Data Protection Regulation (“GDPR”), because employees’ vaccination status falls within a special category of personal data that concerns the health of individuals (Art. 9(1)).  This category is subject to more stringent data protection measures due to the sensitive and personal nature of data, and can only be processed in very limited circumstances (Art. 9(2)).Continue Reading COVID-19: Processing of Vaccination Data by Employers in Europe

On May 19, 2021, the Italian Supervisory Authority (“Garante”) fined a physician €5,000 for publishing a patient’s medical records without obtaining that patient’s specific consent to do so.  As background, the physician downloaded medical records about a patient she treated at a local hospital from the hospital’s online archive system, including images taken during surgery.  The physician used these records for a presentation at a medical conference, and also included them as documentation supporting a scientific research paper she submitted for a competition hosted by a surgeons’ association.  The physician’s paper was ultimately selected as the winner of that competition, resulting in the publication of her work on the association’s website.
Continue Reading Italian Supervisory Authority Fines Physician for Secondary Use of Patient Data Without Specific Consent

In February 2021, the European Commission (“Commission”) released a report on European Union (“EU”) Member States’ laws governing the processing of health data.  The report discusses three general types of health data uses:

  • primary use for health care services;
  • secondary use for public health purposes; and
  • secondary use for scientific research purposes.

For each of these general purposes, the report assesses real-world use cases.  For example, for health care services, the report considers e-health applications, among others.  For public health purposes, the report considers pharmacovigilance and product approvals.  The section on scientific research purposes, meanwhile, considers issues such as research by public bodies, sharing of data with third-party researchers, and the use of genetic data.Continue Reading European Commission Publishes Report on EU Member States’ Rules in Relation to Health Data

On February 2, 2021, the European Data Protection Board (“Board”) responded to questions submitted by the European Commission (“Commission”) on the application of the General Data Protection Regulation (“GDPR”) to health research.  The Board also announced that it is currently working on guidelines on the processing of personal data for scientific research purposes, which it aims to publish in the course of 2021.
Continue Reading European Data Protection Board Answers Commission’s Questions on Health Research

On March 28, 2020, the “Federal Act for the Protection of the Population against an Epidemic of National Significance” (Bevölkerungsschutzgesetz) went into effect.  The law forms part of an emergency legislative package introduced by the German government in response to COVID-19.

The law amends the Social Code V (SGB V)…