Digital Health

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted.  This article focusses on the obligations of data users; for an overview of the EHDS generally, see our first post in this series.

We expect the final text of the EHDS to be adopted by the European Parliament in April 2024 and by the EU Member States shortly thereafter.Continue Reading EHDS Series – 3: The European Health Data Space from the Health Data User’s Perspective

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted.  This article focusses on the obligations of data holders; for an overview of the EHDS generally, see our first post in this series.

We expect the final text of the EHDS to be adopted by the European Parliament in April 2024 and by the EU Member States shortly thereafter.Continue Reading EHDS Series – 2: The European Health Data Space from the Health Data Holder’s Perspective

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted.

We expect the final text of the EHDS to be adopted by the European Parliament in April 2024 and by the EU Member States shortly thereafter.Continue Reading EHDS Series – 1: Five Key Take Aways on Secondary Use of Health Data

While the EU GDPR regulates the international transfer of personal data, several recently enacted EU laws regulate the international transfer of non-personal data, which is any data that is not “personal data” under the GDPR.  In other words, these new laws apply to data that does not relate to an identified or identifiable natural person, including anonymized data and data about industrial equipment, significantly expanding the types of data subject to international transfer restrictions.  Some of this legislation has been enacted recently, and other legislation on this topic is making its way through the legislative process but has yet to be adopted.  In this blog post, we outline the current and forthcoming EU legislation on the international transfer of non-personal data.Continue Reading EU Rules Restricting the International Transfers of Non-Personal Data

Digital health apps are increasingly used in practice. They raise various questions under regulatory and data protection and data security laws. On November 6, 2023, the German Conference of the Independent Data Protection Supervisory Authorities (Datenschutzkonferenz, DSK), a national body which brings together Germany’s federal and regional data protection authorities, issued a paper about the GDPR’s application to cloud-based digital health applications (“health apps”) that are not subject to the German Digital Health Applications Ordinance (Digitale Gesundheitsanwendungen-Verordnung, the “DiGA Regulation”).Continue Reading German Data Protection Authorities Publish Paper on Cloud-Based Digital Health Applications

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.Continue Reading Italian Garante Issues Guidance on the Use of AI in the Context of National Healthcare Services

In May 2023, the Spanish Supervisory Authority (“SA”) issued a detailed guidance paper on GDPR compliance in the context of data spaces.  The paper acknowledges EU and Member State level initiatives for the creation of data spaces (such as the Data Governance Act, the proposed Data Act, and the proposed European Health Data Space) and provides insight into how the SA expects companies to meet their GDPR obligations when participating in those data spaces.Continue Reading Spanish Data Protection Authority Issues Guidance on Data Spaces

This quarterly update summarizes key legislative and regulatory developments in the first quarter of 2023 related to Artificial Intelligence (“AI”), the Internet of Things (“IoT”), connected and autonomous vehicles (“CAVs”), and data privacy and cybersecurity.Continue Reading U.S. AI, IoT, CAV, and Privacy & Cybersecurity Legislative & Regulatory Update – First Quarter 2023

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

On February 1, the Federal Trade Commission (“FTC”) announced its first-ever enforcement action under its Health Breach Notification Rule (“HBNR”) against digital health platform GoodRx Holdings Inc. (“GoodRx”) for failing to notify consumers and others of its unauthorized disclosures of consumers’ personal health information to third-party advertisers.  According to the proposed order, GoodRx will pay a $1.5 million civil penalty and be prohibited from sharing users’ sensitive health data with third-party advertisers in order to resolve the FTC’s complaint. 

This announcement marks the first instance in which the FTC has sought enforcement under the HBNR, which was promulgated in 2009 under the Health Information Technology for Economic and Clinical Health (“HITECH”) Act, and comes just sixteen months after the FTC published a policy statement expanding its interpretation of who is subject to the HBNR and what triggers the HBNR’s notification requirement.  Below is a discussion of the complaint and proposed order, as well as key takeaways from the case.Continue Reading FTC Announces First Enforcement Action Under Health Breach Notification Rule