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FTC Health Breach Notification Rule Update: 6 Things You Should Know

The Federal Trade Commission (FTC) has updated its Health Breach Notification Rule that applies to non-HIPAA, consumer health data. Among the revisions, the FTC expanded or introduced key definitions and modified the...more

Cybersecurity Incidents and Ransomware Attacks: Cybersecurity and Infrastructure Security Agency (CISA) Proposes Reporting Rule

The Cybersecurity and Infrastructure Security Agency (CISA), a division of the Department of Homeland Security, has proposed a rule that would govern whether, when, and how companies in critical infrastructure sectors report...more

Top 4 Cybersecurity Takeaways from 2023

The average cost of a data breach has reached an all-time high of $4.45 million, according to IBM. Regulatory requirements, scrutiny, and enforcement have continued to expand. As we kick off 2024, here are the key action...more

Global Authorities Ramp Up Medical Device Cybersecurity Expectations: What Medical Device Companies Need to Know

The last year has seen a multijurisdictional regulatory push for increased cybersecurity standards for medical devices. The new approaches, issued by regulatory authorities in the United States (U.S.), the United Kingdom (UK)...more

The DOJ’s Focus on Clinical Trial Enforcement: An Ounce of Prevention Is Better Than an Enforcement Action Cure

In early April, the U.S. Department of Justice (DOJ) Civil Division’s Consumer Protection Branch (CPB) published its first-ever “Recent Highlights” report. The report provides background on the CPB, highlights from its recent...more

What Critical Infrastructure Should Do: Mandatory Cybersecurity Incident Reporting for Critical Infrastructure is Coming and CISA...

The Cybersecurity and Infrastructure Security Agency (“CISA”) released a “Sharing Cyber Event Information” Fact Sheet on April 7 that may preview its implementation of the new federal government cyber incident reporting...more

Playtime is Over for Apps Collecting Health‐Related Data – FTC Announces Intent to Enforce Health Breach Rule

The Federal Trade Commission ("FTC") recently announced its intent to "vigorously" enforce its 2009 Health Breach Notification Rule (the "Rule") via a policy statement that sheds light on the Rule's scope. The policy...more

Cybersecurity and Privacy Threats and Risks for Life Sciences and Healthcare Companies

Attacks on the life sciences and healthcare sectors (healthcare providers and health technology, medical device, pharmaceutical and biotechnology companies) increased significantly in the last year, including at the World...more

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