Digital Health

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

In a new post on the Covington Digital Health blog, our colleagues discuss recently issued proposed rule to implement statutory amendments enacted by Section 3221 of the 2020 Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”).  Specifically, the proposed rule would harmonize certain provisions of the Confidentiality of Substance Use Disorder Patient Records under…

In a new post on the Covington Digital Health blog, our colleagues discuss a recent amendment to California’s Confidentiality of Medical Information Act (“CMIA”) that expands the scope of the law to cover mental health services that are delivered through digital health solutions and the associated health information generated from these services. …

Continue Reading California Expands the Scope of the CMIA to Cover Certain Digital Mental Health Services and Information