Health Privacy

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

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On May 16, 2024, Alabama enacted a genetic privacy bill (HB 21), which regulates consumer-facing genetic testing companies.  HB 21 continues the recent trend of states enacting genetic privacy legislation aimed at regulating direct-to-consumer (“DTC”) genetic testing companies, such as in Nebraska and Virginia, with more than 10 states now having similar laws on the books. Continue Reading Alabama Enacts Genetic Privacy Bill

Last month, the Federal Trade Commission (“FTC”) announced its enforcement action against telehealth firm, Cerebral, Inc. (“Cerebral”), for its alleged unauthorized disclosures of consumers’ sensitive personal health information and other sensitive data to third parties for advertising purposes in violation of the FTC Act.  The complaint also alleges that Cerebral violated the Opioid Addiction Recovery Fraud Prevention Act (“OARFPA”), and the Restore Online Shoppers’ Confidence Act (“ROSCA”), which permits the court to order permanent injunctive relief, civil penalties, and other monetary relief for actions in violations of specific sections of the FTC Act, the OARFPA, and the ROSCA.  According to the proposed order, Cerebral must pay more than $7 million in civil penalties and consumer refunds.  In addition, Cerebral will be banned from using or disclosing consumers’ personal and health information (including online identifiers, such as IP addresses or other persistent identifiers) for advertising and must obtain consumers’ affirmative express consent before disclosing such information to outside parties.

Below is a discussion of the complaint and proposed order.Continue Reading FTC Announces Health Privacy Enforcement Action Against Telehealth Company, Cerebral

On April 26, 2024, the Office for Civil Rights (“OCR”) at the U.S. Department of Health & Human Services (“HHS”) published a final rule that modifies the Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) under the Health Insurance Portability and Accountability Act (“HIPAA”) regarding protected health information (“PHI”) concerning reproductive health. We previously covered the proposed rule (hereinafter, “the NPRM”), which was published on April 17, 2023. The final rule aligns closely with the NPRM.Continue Reading HHS Modifies Privacy Rule to Support Reproductive Health Care Privacy

On Friday, April 26, 2024, the Federal Trade Commission (“FTC”) voted 3-2 to issue a final rule (the “final rule”) that expands the scope of the Health Breach Notification Rule (“HBNR”) to apply to health apps and similar technologies and broadens what constitutes a breach of security, among other updates.  We previously covered the proposed rule, which was issued on May 18, 2023.

In the FTC’s announcement of the final rule, the FTC emphasized that “protecting consumers’ sensitive health data is a high priority for the FTC” and that the “updated HBNR will ensure [the HBNR] keeps pace with changes in the health marketplace.”  Key provisions of the final rule include:Continue Reading FTC Issues Final Rule to Expand Scope of the Health Breach Notification Rule

In March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  Although the text has not yet been formally adopted by all the European institutions, a number of interesting points can already be highlighted.  This article focuses on the governance and enforcement of the EHDS; for an overview of the EHDS generally, see our first post in this series.

The final text of the EHDS was adopted by the European Parliament on 24 April 2024 and is expected to be formally adopted by the European Council in the coming months.Continue Reading EHDS Series – 5: European Health Data Space Governance, Enforcement and Timelines

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 focuses on the implications for “wellness applications” and medical devices; for an overview of the EHDS generally, see our first post in this series.

The final text of the EHDS was adopted by the European Parliament on 24 April 2024 and is expected to be formally adopted by the European Council in the coming months.Continue Reading EHDS Series – 4: The European Health Data Space’s Implications for “Wellness Applications” and Medical Devices

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