As the mid-February compliance deadline looms for new regulations aimed at aligning federal laws governing the confidentiality of substance use disorder records with HIPAA, treatment facilities supported by federal funding are facing crucial uncertainties. Legal expert Aleksandra Vold, a partner at the law firm BakerHostetler, emphasized that several significant questions remain unanswered as these changes come into effect.
Among the concerns are the timeline for enforcement actions by federal regulators, how to appropriately flag and safeguard these records when integrated with other electronic health data, and the implications of using these records for artificial intelligence initiatives. These regulatory updates pertain specifically to Part 2 of Section 42 of the Code of Federal Regulations. The U.S. Department of Health and Human Services (HHS) has designated the Office for Civil Rights (OCR) to oversee enforcement of these regulations. This agency, often criticized for being under-resourced, also bears the responsibility for enforcing HIPAA.
Recently, HHS OCR released new online guidelines that compile documents related to data privacy in mental health and substance use disorder contexts. However, these guidelines fall short of clarifying how the OCR plans to fulfill its new enforcement responsibilities or address other pressing issues.
Vold pointed out that while there are stringent measures designed to ensure compliance with Part 2, the practical ability of the HHS OCR to initiate breach investigations or enforce regulations remains uncertain. This is particularly relevant given recent staffing reductions at HHS and the agency’s continued focus on other HIPAA-related priorities.
In a detailed discussion, Vold addressed multiple key topics that warrant attention. These include the obligations surrounding breach reporting that involve records covered by Part 2, potential complications arising from the analytics and artificial intelligence applications using these records, and other critical compliance considerations related to the updated regulations.
Vold, who specializes in guiding healthcare systems, insurers, and technology firms through complex privacy, cybersecurity, and regulatory landscapes, provides insight into the impacts of unauthorized access incidents and how to navigate the evolving requirements in federal and state data privacy laws. Her experience stresses the importance of preparedness in a sector facing rapid regulatory changes.
As industry stakeholders brace for these developments, the urgency to clarify the associated compliance risks and actionable responses becomes increasingly critical.