healthcare

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

Wyatt Data Breach & Notification, Data Privacy & Security, Electronic Health Records, FTC Enforcement, Health Information Technology, HIPAA , , , , , , , , , , ,

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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CMS Issues Updated Guidance on Texting Patient Orders

Margaret Young Levi Cyber Security and Cyber Crime, Data Privacy & Security, Electronic Health Records, Health Information Technology, HIPAA, Privacy & Security , , , , , , , , , ,

By: Margaret Young Levi

On February 8, 2024, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum entitled Texting of Patient Information and Orders for Hospitals and CAHs (the 2024 Memo), which provides updated guidance to State Survey Agency Directors.  This 2024 Memo now permits the texting of patient orders among members of the hospital care team—if the texting is accomplished on a secure platform that protects the privacy and integrity of the patient information. 

This new guidance updates CMS’ previous memorandum entitled Texting of Patient Information among Healthcare Providers in Hospitals and Critical Access Hospitals (CAHs) (the 2017 Memo), which permitted texting patient information if done through a secure platform, but prohibited texting of patient orders regardless of the platform utilized.

Even though texting of patient orders through a secure platform is now permitted by CMS, that does not mean it is recommended.  CMS still prefers that providers enter their orders into the medical record via computerized provider order entry (CPOE) or even a handwritten order because of concerns about medical record retention, accuracy, privacy and security, etc. as set forth in the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Medicare Conditions of Participation (CoPs), and, if applicable, The Joint Commission (TJC) standards discussed below.

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