On February 8, 2024, the U.S. Department of Health and Human Services (HHS) issued a final rule (Final Rule) updating federal “Part 2” regulations to more closely align the requirements applicable to substance use disorder (SUD) treatment records with the HIPAA privacy rule, and to make certain other changes. The regulations at 42
On December 13, 2023, the Office of the National Coordinator for Health Information Technology (ONC) issued its final rule entitled “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing” and known as “HTI-1” (Final Rule). Among other issues addressed in the Final Rule, ONC revised the information blocking rules to add clarity and to create a new information blocking exception. We outline these changes in further detail below. The information blocking provisions of the Final Rule will be effective 30 days after it is published in the Federal Register.Continue Reading ONC’s HTI-1 Final Rule Updates Information Blocking Regulations
On November 1, 2023, the U.S. Department of Health and Human Services (HHS) published a proposed rule titled “21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking” (the Proposed Rule). The Proposed Rule, if finalized, would create disincentives for health care providers that the HHS Office of Inspector General (OIG) determines have committed “information blocking” (as defined at 45 C.F.R. § 171.103).Continue Reading HHS Proposes Disincentives for Providers that Commit Information Blocking
On April 12, 2023, the U.S. Department of Health & Human Services (HHS) released a Notice of Proposed Rulemaking (Proposed Rule) that seeks to enhance safeguards of reproductive health care information through changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. The proposal is intended to align with President Biden’s Executive Order…
On November 28, 2022, the Department of Health and Human Services (HHS) issued a proposed rule to modify the confidentiality protections of Substance Use Disorder (SUD) patient treatment records under 42 CFR Part 2 (Part 2) to implement statutory amendments passed under Section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (42 U.S.C. 290dd-2). Comments are being accepted for 60 days from the date of publication.Continue Reading HHS Proposes Rule to Align Part 2 Records and HIPAA
Health care providers subject to the Information Blocking rules issued under the 21st Century Cures Act, Pub.L. 114–255, are reminded that such Information Blocking rules will apply to an expanded set of information beginning on October 6, 2022. The Information Blocking rules currently apply only to a limited portion of electronic health information (EHI) represented by the specific data elements identified in the United States Core Data for Interoperability version 1 standard (commonly referred to as USCDIv1). Effective October 6, 2022, the Information Blocking rules will apply to all EHI, which is defined as all electronic protected health information (as defined by HIPAA) to the extent that such electronic protected health information is included in a designated record set (also as defined by HIPAA), and excluding psychotherapy notes and information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative proceeding.Continue Reading REMINDER: October 6 Deadline for Information Blocking Rules Approaches
On February 28, 2022, the Office of the National Coordinator for Health Information Technology (ONC) issued data on information blocking claims received since April 5, 2021, the effective date of information blocking regulations enacted under the 21st Century Cures Act (Cures Act). As a reminder, in accordance with the Cures Act’s prohibition on certain information blocking practices, in 2020 ONC issued a pair of rules (available here and here) to implement information blocking regulations (now found at 45 CFR Part 171). Due to COVID-related delays, ONC ultimately set a compliance date for such regulations of April 5, 2021. ONC is now sharing preliminary data on the information blocking claims received for the first time.
Continue Reading ONC Information Blocking Data Show Majority of Claims Against Health Care Providers
On June 16, and then on July 6, 2021, Connecticut Governor Ned Lamont signed into law a pair of bills that together address privacy and cybersecurity in the state. As cybersecurity risks continue to pose a significant threat to businesses and the integrity of private information, Connecticut joins other states in revisiting its data breach reporting laws to strengthen reporting requirements, and offer protection to businesses that have been the subject of a breach despite implementing cybersecurity safeguards from certain damages in resulting litigation.
Public Act 21-59 “An Act Concerning Data Privacy Breaches” (PA 21-59) modifies Connecticut law addressing data privacy breaches to expand the types of information that are protected in the event of a breach, to shorten the timeframe for reporting a breach, to clarify applicability of the law to anyone who owns, licenses, or maintains computerized data that includes “personal information,” and to create an exception for entities that report breaches in accordance with HIPAA. Public Act 21-119 “An Act Incentivizing the Adoption of Cybersecurity Standards for Businesses” (PA 21-119) correspondingly establishes statutory protection from punitive damages in a tort action alleging that inadequate cybersecurity controls resulted in a data breach against an entity covered by the law if the entity maintained a written cybersecurity program conforming to industry standards (as set forth in PA 21-119).
Both laws take effect October 1, 2021.
Continue Reading Connecticut Enacts Legislation to Incentivize Adoption of Cybersecurity Safeguards and Expand Breach Reporting Obligations
In a rare move, the Department of Health and Human Services (HHS) has issued a warning to hospitals and health systems to prioritize the patching of a two-year-old vulnerability in picture archive communication systems (PACs). PACs are used for the exchange and storage of health scans and images, such as MRIs, CT Scans, breast imaging,…
On November 30 and December 2, 2020, the Department of Health and Human Services Office of Inspector General (OIG) published two final rules (available here: November 30 Final Rule and December 2 Final Rule) which modify the safe harbor regulations to the federal Anti-Kickback Statute (AKS) and codify a new exception to the Civil…