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FTC Updates Health Breach Notification Rule

On July 1, 2024, the amendments to the Health Breach Notification Rule (HBNR) went into effect. First promulgated in 2009, the HBNR applies to vendors of personal health records — entities that are not covered by the Health...more

U.S. Protectionism in Health Data Flows

As privacy laws continue to proliferate in the U.S. and globally, there is one trend that companies, especially those operating in the health and pharmaceutical sectors, can no longer overlook. This is the trend towards data...more

Biden Administration Announces New Sensitive Data Restrictions

Overview - On February 28, 2024, the Biden administration released an Executive Order that would restrict “countries of concern” from accessing Americans’ sensitive personal data, including “genomic data, biometric data,...more

So, What’s “Consumer Health Data,” Anyway?

The U.S. privacy landscape has changed rapidly over the past few years. But the most significant recent changes relate to “consumer health data” — health information about identified or identifiable consumers that falls...more

Superior Court of California Prohibits Enforcing CPRA Regulations Until March 2024

On June 30, 2023, the Superior Court of California, County of Sacramento, Judge James Arguelles presiding, issued an order prohibiting the California Privacy and Protection Agency (the Agency) from enforcing regulations...more

Sephora Settles with California AG for $1.2M for Alleged CCPA Violations Relating to Third-Party Cookies and User-Enabled Opt-Out...

On August 24, 2022, California Attorney General Rob Bonta announced a settlement with Sephora for violations of the California Consumer Privacy Act (CCPA). The action places online consumer tracking, analytics and advertising...more

Zombie PHR Breach Rule Rises From the Dead

Yesterday, the FTC issued a policy statement announcing a new interpretation of the FTC’s 10-year-old “Personal Health Record Breach Notification Rule.” As the FTC acknowledges, this rule has never been enforced by the FTC....more

A New Dawn for International Data Transfers: Publication of the EDPB’s Updated Guidance on International Data Transfers

Last year’s European Court of Justice (ECJ) judgement in Data Protection Commissioner v Facebook Ireland LTD, Maximillian Schrems, C-311/18 (Schrems II) continues to have ramifications for cross border data transfers. The...more

New Tools for International Data Transfers: European Commission Adopts New Standard Contractual Clauses

In early June 2021, the European Commission adopted a new set of Standard Contractual Clauses for organizations to use to ensure compliance with the EU General Data Protection Regulation (GDPR) requirements for transfers of...more

Draft Standard Contractual Clauses Released by European Commission: New Clause Cause for Applause?

Following on from this week’s big announcement by the European Data Protection Board (EDPB) on its expectations for international data transfers after the European Court of Justice’s July 16 Schrems II decision, the European...more

European Data Protection Board Issues New Recommendations for International Data Transfers: Essential Guarantees, Supplemental...

On November 11, 2020, the European Data Protection Board (EDPB) issued two much-anticipated guidance documents, outlining the approach it expects organizations to take when transferring data out of the EU. Although these...more

What Is Involved in Clinical Trials and What Has Changed During COVID-19: A Brief Primer

Why Do Clinical Trials? Clinical trials are an important — and government-required — step on the way from an idea to a commercial medicinal product. All new pharmaceutical and biological products and most generic...more

OCR Enforcement Discretion Allows Business Associates to Disclose PHI for Public Health Purposes

On April 2, 2020, the Office for Civil Rights at the Department of Health and Human Services (OCR) announced that, effective immediately, they would exercise “enforcement discretion” regarding disclosures of COVID-19-related...more

How We Spent Our Summer Vacation or Summary of CCPA Amendments

The long anticipated amendments to the CCPA were passed by the California Legislature in early September and now await Governor Newsom’s signature. Some of the changes were “clean up” amendments to update cross references,...more

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