Data Privacy & Security

FTC Warns That Health Apps Must Notify Consumers of Data Breaches

Margaret Young Levi Data Privacy & Security , ,

By: Margaret Young Levi

On September 15, 2021, the Federal Trade Commission (FTC) issued a Policy Statement cautioning that health apps and connected devices that collect or use consumers’ health information must comply with the Health Breach Notification Rule and notify consumers when their health data is breached.

The Health Breach Notification Rule (codified at 16 C.F.R. § 318) protects individually identifiable health information created or received by vendors of personal health records. The Rule requires vendors of personal health records to notify U.S. consumers, the FTC, and sometimes the media when there has been a breach of security of unsecured identifiable health information. Persons that fail to comply with the Rule may be subject to monetary penalties of up to $43,792 per violation, per day.

The Health Breach Notification Rule became effective in 2009, but the FTC has not enforced it to date. However, because health care applications continue to proliferate and to collect increasingly personal and sensitive health information, the FTC issued this Policy Statement to place health apps on notice that the Rule will be enforced going forward and to clarify that they are considered to be “vendors of personal health records” covered under the Rule. 

The FTC explains that the developer of a health app or connected device is considered a “vendor of personal health records” under the Rule if it is capable of drawing information from multiple sources, such as a combination of direct inputting by a consumer, syncing with a consumer’s fitness tracker, or even interfacing with the phone calendar. The Rule does not apply to vendors of personal health records who are already covered by HIPAA. 

In addition, the FTC reminds vendors of personal health records that a “breach of security” is not limited to cyberattacks by third parties, but includes any acquisition of identifiable health information of an individual in a personal health record without the individual’s authorization.  The FTC states that “[i]ncidents of unauthorized access, including sharing of covered information without an individual’s authorization, triggers notification obligations under the Rule.” 

If a breach occurs, then health apps should examine state data breach notification laws to determine if they apply as well. 

A Supreme Development in Employer Computer Protection

WyattLLP Data Privacy & Security, Health Information Technology, HITECH Law ,

By: Courtney Samford, contributing author Blake Sims, Wyatt Summer Associate

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Employers commonly supply computer and work devices to employees and state that the electronics may only be used for business related purposes, and employers have always had the ability to discipline employees who violate computer use policies through improper use. In some Federal Court of Appeals Circuits, employers may have been able to rely on threats of criminal and civil liabilities under 18 U.S.C. § 1030 to further deter improper use. On June 3, 2021, however, an evenly split conservative-liberal majority of the Supreme Court reversed the Eleventh Circuit Court of Appeals in Van Buren v. United States, holding that an individual only violates the Section 1030 of Computer Fraud and Abuse Act “when he accesses a computer with authorization but then obtains information located in particular areas of the computer—such as files, folders, or databases—that are off limits to him.” Van Buren v. United States, No. 19-783 (Sup. Ct. June 3, 2021).

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HITECH Act Amendment: Using “Recognized Security Practices” May Lead to More Favorable HHS Review and Reduced Fines After Data Breach

Kathie McDonald-McClure Data Privacy & Security, HIPAA, HITECH Law , , , , ,

by Margaret Young Levi and Kathie McDonald-McClure

Congress amended the Health Information Technology for Economic and Clinical Health Act (HITECH Act) on January 5, 2021.  This Amendment requires the U.S. Department of Health and Human Services (HHS) to favorably consider whether covered entities and business associates have implemented specific security measures when making decisions regarding penalties and audits under the Health Insurance Portability and Accountability Act (HIPAA). 

Specifically, the Amendment mandates HHS to “consider whether the covered entity or business associate has adequately demonstrated that it had, for not less than the previous 12 months, recognized security practices in place” when HHS is making decisions to (1) decrease fines, (2) decrease the length and extent of an audit or terminate an audit, and (3) mitigate other remedies with respect to resolving potential violations of the HIPAA Security Rule. 

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Federal Agencies Warn of Cyberattacks on U.S. Hospitals

Kathie McDonald-McClure Cyber Security and Cyber Crime, Data Privacy & Security, Electronic Health Records, Health Information Technology , , , , ,

By Margaret Young Levi and Kathie McDonald-McClure

On October 28, 2020,  the Federal Bureau of Investigation (FBI), the U.S. Department of Health and Human Services (HHS), and the Cybersecurity and Infrastructure Security Agency (CISA) issued a Joint Cybersecurity Advisory warning hospitals and the health care community about coordinated ransomware attacks on hospitals designed to steal data and freeze hospital information systems for financial gain. 

Six U.S. hospitals fell victim to this attack on October 27th and the FBI, HHS, and CISA have credible information that more hospitals will be targeted in this attack. The ransomware behind these attacks is known as Ryuk, which utilizes TrickBot malware and other malware to execute the attack. The Ryuk ransomware is designed to allow the cybercriminals to stealthily access, map and move laterally across the victim’s network before encrypting critical data files and deleting connected backups.

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U.S. Department of Homeland Security Issues SAP Critical Vulnerability Alert

WyattLLP Cyber Security and Cyber Crime, Data Privacy & Security , , ,

Written by:  Kathie McDonald-McClure

On Monday, July 13, 2020, the Homeland Security Cybersecurity and Infrastructure Security Agency (CISA) issued a SAP cybersecurity alert, No. AA20-195A, regarding a critical vulnerability that an unauthenticated attacker could exploit through the Hypertext Transfer Protocol (HTTP) to take control of trusted SAP applications. CISA strongly recommends that organizations immediately apply patches, prioritizing internet-facing systems and then internal systems.  At least 15 SAP Java-based solutions are affected, including the SAP Supply Chain Management, the SAP Enterprise Portal, Central Process Scheduling and other widely used SAP applications.  See the Alert for the list of 15 affected SAP applications.