Changes to the Health Breach Notification Rule Include Regulations for Health Apps

Written by: Margaret Young Levi and Casey Parker-Bell (Wyatt Summer Associate)

Vendors who maintain personal health records will soon be subject to amended rules for notifying customers of data breaches. The Federal Trade Commission (“FTC”) has issued a Final Rule, finalizing changes to the Health Breach Notification Rule (“HBNR“) first issued in 2009 (the “2009 Rule”). The Final Rule clarifies the HBNR’s application to apps and other new technologies in the healthcare industry.

New technology, like fitness trackers and other direct-to-consumer health tech and wearable apps, have increased the amount of health data collected from consumers. There is a growing concern that some companies are disclosing or selling individuals’ personal health data for marketing and other purposes, while not subject to protections under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). “We are witnessing an explosion of health apps and connected devices, many of which aren’t covered by HIPAA, collecting vast amounts of sensitive consumer health information.” said Samuel Levine, Director of the FTC’s Bureau of Consumer Protection. “The proposed amendments to the new rule will allow it to keep up with marketplace trends, and respond to development and changes in technology.” The FTC has announced this Final Rule to address these new technologies.

The Final Rule’s Changes to the HBNR

The HBNR requires vendors of personal health records (“PHRs”) to notify individuals, the FTC, and, in some cases, the media of a breach of unsecured PHR identifiable health information. The HBNR also requires third-party service providers of personal health records to provide notifications. After seeking comments on proposed changes to better protect consumer who use PHRs, the FTC finalized the following changes to the HBNR:

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Kentucky Enacts New Consumer Data Privacy Act

Written by: Margaret Young Levi, Kathie McDonald-McClure and Drayden Burton (Wyatt Summer Associate)

On April 4, 2024, Governor Andy Beshear added Kentucky to the growing list of states with comprehensive data privacy legislation by signing House Bill 15 into law. The Kentucky Consumer Data Protection Act (“KCDPA”) will become effective on January 1, 2026. The KCDPA creates rights for Kentucky consumers as well as imposes requirements on certain businesses that handle consumer data.

What rights does the KCDPA create for consumers?

The KCDPA provides “consumers,” which it defines as natural persons residing in Kentucky who are acting solely in an individual context, with a swathe of rights concerning their personal data. These rights mirror the laws of other states that have passed similar legislation. These rights include:

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LabMD Appeals; Court Grants Temporary Stay

lab_specimensIn a recent blog post entitled “FTC Issues Final Order and Data Security Lessons in LabMD Case,” we discussed the Federal Trade Commission (“FTC”)’s Final Order in the LabMD case.  The FTC found that LabMD failed to provide reasonable and appropriate security for its customers’ personal information and that this failure caused (or was likely to cause) substantial consumer harm constituting an unfair act in violation of the law.  It  ordered LabMD to implement a number of compliance measures, including creating a comprehensive information security program, undergoing professional routine assessments of that program, providing notice to any possible affected individual and health insurance company, and setting up a toll-free hotline for any affected individual to call.  Although LabMD has closed its doors and has limited resources to comply with the FTC’s Final Order, it appealed the Final Order to the U.S. Court of Appeals for the Eleventh Circuit.  At the same time, it sought a stay from the FTC, which would halt these compliance measures pending the court’s review. The FTC denied the stay, so LabMD then asked the Eleventh Circuit to grant the stay.

On November 10, 2016, the Eleventh Circuit granted LabMD’s motion to stay enforcement of the Final Order pending appeal.  A copy of the court’s Order granting the stay is available here.  When issuing the stay, the court found that there existed a serious legal question as to Continue reading