HHS Proposed Rule Aligns Regulation on Confidentiality of Substance Use Disorder Treatment Records with HIPAA

by Kathie McDonald-McClure

On November 28, 2022, the Secretary for the United States Department of Health & Human Services (HHS) released a Proposed Rule to amend the requirements in Title 42, Part 2, on confidentiality of substance use disorder (SUD) patient records in federally assisted Part 2 Programs.  Part 2 protects the confidentiality of SUD patient records (which generally include alcoholism, alcohol abuse, and drug abuse treatment and prevention records) by restricting the circumstances under which Part 2 Programs or other lawful holders can disclose such records.

Section 3221 of the CARES Act of 2020, enacted by Congress on March 27, 2020, in response to the COVID-19 pandemic, in effect, had amended Title 42, Part 2, to align it with HIPAA but also required HHS to implement these amendments in the Part 2 regulation through the rule-making process. The 260-page Proposed Rule, in sum, would incorporate requirements and definitions from the HIPAA rules into the 40-year-old Part 2 regulation, including HIPAA’s consent, disclosure, de-identification, unsecured PHI and breach notification requirements, as well as HIPAA penalties for noncompliance.

Part 2 Compliance Challenges. For years, providers who are subject to both HIPAA and Part 2’s separate privacy requirements for SUD records have had to grapple with identifying and segregating SUD records that are subject to Part 2 from records that are subject only to HIPAA. In the Proposed Rule, HHS acknowledges that this has contributed to ongoing operational and compliance challenges for providers. HHS notes several examples of this challenge, including the following:  

For example, once a HIPAA covered entity or business associate disclosed PHI to a person who was not a covered entity or business associate, the information was no longer protected by the Privacy Rule, and thus the Privacy Rule’s limitations on uses and disclosures did not apply. In contrast, Part 2 strictly limited the re-disclosure of Part 2 records by any individual or entity that received a Part 2 record directly from a Part 2 program or other “lawful holder” of patient identifying information, absent written patient consent or as otherwise permitted under the regulations.

(Proposed Rule, pp. 19-20.)

SUD Treatment De-Stigmatization & Coordination. HHS additionally notes that the continued segregation of Part 2 Program SUD records sets these records apart in ways that perpetuate the stigma surrounding a person with SUDs.

Prior to passage of the CARES Act, Congressional hearings on the Opioid Crisis had already highlighted the need for HHS to promulgate regulations modifying the confidentiality requirements for Part 2 records to align with HIPAA. Testimony before Congress was that SUD records were being withheld in ways that inhibit care coordination between providers of a person’s mental health and physical health, conditions that are inextricably linked. In the HHS Announcement of the Proposed Rule, Secretary Becerra says, “This proposed rule would improve coordination of care for patients receiving treatment while strengthening critical privacy protections to help ensure individuals do not forego life-saving care due to concerns about records disclosure.” 

Summary of Changes. Some of the most significant changes would include:

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Apache Log4j Vulnerability in Java Applications May Pose Risk to Confidential Company and Personal Information

By: Kathie McDonald-McClure

On December 11, 2021, the United States Cybersecurity & Infrastructure Security Agency (CISA), issued a Statement regarding what it called a “critical vulnerability affecting products containing the log4j software library”.  This Statement emphasizes that end users are reliant on their vendors to inform them about the vulnerabilities and to develop patches to protect against the vulnerabilities.   Separately, CISA established a webpage for Apache Log4j Vulnerability Guidance that CISA is continually updating to impart further guidance and vendor information as they become available.  End users should be on the lookout for critical patches from their vendors.

According to the CISA Guidance, the Log4j vulnerability is being widely exploited by a growing set of malicious actors to steal information, launch ransomware attacks, or conduct other malicious activity such as taking over a company server to mine cryptocurrency.  At least 10 major technology vendors have issued statements that one or more of their products have been affected by the Log4j vulnerability: Cisco, IBM, VMware, Amazon Web Services (AWS), Fortinet, Broadcom, ConnectWise, HCL Connections, N-Able, and Okta.[1] On December 15, 2021, the Microsoft 365 Defender Threat Intelligence Team reported that a new family of ransomware, called Khonsari, is being deployed via the Log4j vulnerability on non-Microsoft hosted servers.

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KRONOS Payroll Ransomware Attack Implicates Potential Data Breach Notification Obligations

By: Kathie McDonald-McClure

UKG, Inc., a company that provides payroll support services known as KRONOS for many U.S. companies, began notifying its customers on December 12, 2021, that the KRONOS Private Cloud (KPC) had been attacked by ransomware.  (See UKG Kronos Private Cloud Status Updates.) The KPC products include Workforce Central, TeleStaff, Healthcare Extensions and Banking Scheduling Solutions. UKG reports that the KPC solutions may be unavailable for “several weeks.”  Affected companies are diligently working to find alternative solutions to process their payrolls in the interim. UKG has created a KPC Incident Resource Hub to assist customers impacted by the KPC disruption in services.

The American Hospital Association (AHA) reported that the ransomware attack has impacted many hospitals and health systems that rely on KRONOS for timekeeping, scheduling and payroll.  John Riggi, AHA’s Senior Advisor for Cybersecurity and Risk, said, “A lack of the availability of those services could be quite disruptive for health care providers, many of whom are experiencing surges of COVID-19 and flu patients. … This attack once again highlights the need for robust third-party risk management programs that identify mission-critical dependencies and downtime preparedness. … [W]e urge all third-party providers that serve the health care community to examine their cyber readiness, response and resiliency capabilities.” 

In addition to the immediate payroll issues, if the ransomware attack compromises employee personal information, then it may trigger a data breach notification for these employers under state breach notification laws. 

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