Data Protection

On June 6, the Texas Attorney General published a news release announcing that the Attorney General has opened an investigation into several car manufacturers.  The news release states that the investigation was opened “after widespread reporting that [car manufacturers] have secretly been collecting mass amounts of data about drivers directly from their vehicles and then

On May 31, 2024, Colorado Governor Jared Polis signed HB 1130 into law. This legislation amends the Colorado Privacy Act to add specific requirements for the processing of an individual’s biometric data. This law does not have a private right of action.

Similarly to the Illinois Biometric Information Privacy Act (BIPA), this law requires controllers

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:

  • Revised definitions:  The final rule includes changes to current definitions in the HBNR that codify the FTC’s recent position on the expansiveness of the HBNR.  Specifically, among other definition changes, the HBNR contains key updates to the definitions of:
    • “Personal health records (‘PHR’) identifiable information.”  In the final rule, the FTC adopts changes to the definition of PHR identifiable information that were included in the proposed rule to clarify that the HBNR applies to health apps and other similar technologies not covered by the Health Insurance Portability and Accountability Act, as amended, and its implementing regulations (collectively, “HIPAA”).  In the final rule, the FTC discusses the scope of the definition, noting that “unique, persistent identifiers (such as unique device and mobile advertising identifiers), when combined with health information constitute ‘PHR identifiable health information’ if these identifiers can be used to identify or re-identify an individual.”
    • “Covered health care provider.”  In the proposed rule, the FTC proposed adding a definition of “health care provider” to include providers of medical or other health services, or any other entity furnishing “health care services or supplies” (i.e., websites, apps, and Internet-connected devices that provide mechanisms to track health conditions, medications, fitness, sleep, etc.).  The final rule does not make substantive changes to this proposed definition but does contain a slight terminology change to “covered health care provider” to distinguish that term from the definition of “health care provider” in other regulations. 

Continue Reading FTC Issues Final Rule to Expand Scope of the Health Breach Notification Rule

On April 17, the Nebraska governor signed the Nebraska Data Privacy Act (the “NDPA”) into law.  Nebraska is the latest state to enact comprehensive privacy legislation, joining CaliforniaVirginiaColoradoConnecticutUtahIowaIndiana, Tennessee, Montana, OregonTexasFloridaDelawareNew Jersey,  New

On April 2, the Enforcement Division of the California Privacy Protection Agency issued its first Enforcement Advisory, titled “Applying Data Minimization to Consumer Requests.”  The Advisory highlights certain provisions of and regulations promulgated under the California Consumer Privacy Act (“CCPA”) that “reflect the concept of data minimization” and provides two examples that illustrate how

A new post on the Covington Inside Privacy blog discusses remarks by California Privacy Protection Agency (CPPA) Executive Director Ashkan Soltani at the International Association of Privacy Professionals’ global privacy conference last week.  The remarks covered the CPPA’s priorities for rulemaking and administrative enforcement of the California Consumer Privacy Act, including with respect to connected

On January 17, 2024, the European Data Protection Board (“EDPB”) published its report on the 2023 Coordinated Enforcement Framework (“CEF”), which examines the current landscape and obstacles faced by data protection officers (“DPOs”) across the EU.  In particular, the report provides a snapshot of the findings of each supervisory authority (“SA”) on the role of

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.

1: Health data holder

The term “health data holder” includes, among others, any natural or legal person developing products or services intended for health, developing or manufacturing wellness applications, or performing research in relation to healthcare, who:

  • in relation to personal electronic health data: in its capacity of a data controller has the right or obligation to process the health data, including for research and innovation purposes; or
  • in relation to non-personal electronic health data: has the ability to make the data available through control of the technical design of a product and related services.  These terms appear to be taken from the Data Act, but they are not defined under the EHDS.

In practice, this means that, for example, hospitals, as data controllers, are data holders of their electronic health records.  Similarly, pharmaceutical companies are data holders of clinical trial data and biobanks.  Medical device companies may be data holders of non-personal data generated by their devices, if they have access to that data and an ability to produce it.  However, medical device companies would not qualify as a data holder where they merely process personal electronic health data on behalf of a hospital.

Individual researchers and micro enterprises are not data holders, unless EU Member States decide differently for their territory.

2: Data sets covered by EHDS

The EHDS sets out a long list of covered electronic health data that should be made available for secondary use under the EHDS.  It includes, among others:

  • electronic health records;
  • human genetic data;
  • biobanks;
  • data from wellness applications;
  • clinical trial data – though according to the recitals, this only applies when the trial has ended;
  • medical device data;
  • data from registries; and
  • data from research cohorts and surveys, after the first publication of the results – a qualifier that does not seem to apply for clinical trial data.

Continue Reading EHDS Series – 2: The European Health Data Space from the Health Data Holder’s Perspective

On 20 February, 2024, the Governments of the UK and Australia co-signed the UK-Australia Online Safety and Security Memorandum of Understanding (“MoU”). The MoU seeks to serve as a framework for the two countries to jointly deliver concrete and coordinated online safety and security policy initiatives and outcomes to support their citizens, businesses and economies.

The MoU comes shortly after the UK Information Commissioner’s Office (“ICO”) introduced its guidance on content moderation and data protection (see our previous blog here) to complement the UK’s Online Safety Act 2023, and the commencement of the Australian online safety codes, which complement the Australian Online Safety Act 2021.

The scope of the MoU is broad, covering a range of policy areas, including: harmful online behaviour; age assurance; safety by design; online platforms; child safety; technology-facilitated gender-based violence; safety technology; online media and digital literacy; user privacy and freedom of expression; online child sexual exploitation and abuse; terrorist and violent extremist content; lawful access to data; encryption; misinformation and disinformation; and the impact of new, emerging and rapidly evolving technologies such as artificial intelligence (“AI”).Continue Reading UK and Australia Agree Enhanced Cross-Border Cooperation in Online Safety and Security

On February 28, the European Data Protection Board (“EDPB”) announced that EU supervisory authorities (“SAs”) will undertake a coordinated enforcement action in 2024 regarding data subjects’ right of access under the GDPR.  For context, the EDPB selects a particular topic each year to serve as the focus for pan-EU coordinated enforcement.

In 2023, regulators focused