The HIPAA Security Rule was originally promulgated over 20 years ago. While it historically provided an important regulatory floor for securing electronic protected health information, the Security Rule’s lack of prescriptiveness, combined with advances in technology and evolution of the cybersecurity landscape, increasingly indicate the HIPAA Security Rule neither reflects cybersecurity best practices nor effectively mitigates the proliferation of cyber risks in today’s interconnected digital world. On December 27, 2024, the HHS Office of Civil Rights (“OCR”) announced a Notice of Proposed Rulemaking, including significant changes to strengthen the HIPAA Security Rule (the “Proposed Rule”). In its announcement, OCR stated that the Proposed Rule seeks to “strengthen cybersecurity by updating the Security Rule’s standards to better address ever-increasing cybersecurity threats to the health care sector.” One key aim of the Proposed Rule is to provide a much clearer roadmap to achieve Security Rule compliance.
The Proposed Rule contains significant textual modifications to the current HIPAA Security Rule. While the actual redline changes may appear daunting, the proposed new requirements are aimed at aligning with current cybersecurity best practices as reflected across risk management frameworks, including NIST’s Cybersecurity Framework. For organizations that have already adopted these “best practices”, many of the new Proposed Rule requirements will be familiar and, in many cases, will have already been implemented. Indeed, for such organizations, the biggest challenge will be to comply with the new administrative requirements, which will involve policy updates, updates to business associate agreements, increased documentation rules (including mapping requirements), and the need for additional vendor management. For organizations that are still trying to meaningfully comply with the existing HIPAA Security Rule, or that seek to extend the Rule’s application to new technologies and systems handling PHI, the Proposed Rule will likely require significant investment of human and financial resources to meet the new requirements.
In the absence of a comprehensive federal data privacy law, state legislators continue to add to the often-contradictory array of laws aimed at protecting the security and privacy of their residents’ data. Very recently, Washington State’s My Health My Data Act was signed into law by Governor Jay Inslee in late April, Florida lawmakers passed Senate Bill 262 in early May, and the Tennessee Information Protection Act was signed into law earlier this month as well. While preparing this update, Montana’s enacted its Consumer Data Privacy Act on May 19th, which we will address in subsequent guidance due to its recency. These newly enacted state laws build upon the growing patchwork of laws enacted in California, Connecticut, Colorado, Virginia, and Utah, all of which we previously discussed here and here. Yet, among these state laws there is significant variety, including inconsistencies as to whether the laws allow for private rights of action, and whether the laws provide affirmative defenses and other incentives based on compliance with relevant best practices.
More than just New Year’s resolutions went into effect when the clock struck midnight on January 1, 2023. The California Privacy Rights Act (“CPRA”) and the Virginia Consumer Data Protection Act (“VCPDA”) are now effective in California and Virginia, respectively. These comprehensive data privacy laws, along with three other state laws going into effect this year, establish new and complex obligations for businesses. If your business has not taken steps to prepare for these privacy laws, it is high time to start that process to avoid violations and enforcement likely to follow later in the year. See below for a timeline of key dates.
Throughout 2021, we closely monitored the latest privacy laws and a surge of privacy, cybersecurity, and data asset management risks that affect organizations, small and large. As these laws continue to evolve, it is important for companies to be aware and compliant. We will continue to monitor these trends for 2022.
The attorneys of the Privacy, Cybersecurity & Data Asset Management group have written on a wide range of notable developments and trends that affect employers and health care providers. In case you missed any, we have assembled a recap of our top 10 blog posts of 2021, with links to each, below:
Blog Editors
Recent Updates
- Proposed Modernization of the HIPAA Security Rules
- In Confirmation Hearings, AG Nominee Pledges to Defend the Constitutionality of the False Claims Act
- A Primer on Executive Orders and a Preview of the Road Ahead
- At Long Last, DEA’s Remote Prescribing Rules 2.0 Are (Really) Here! (Pending Further Consideration by the Incoming Administration . . .)
- Massachusetts District Court Applies “But-For Causation” Standard, Dismisses AKS-Based FCA Case After Evaluating Facts and Circumstances of Independent Contractor Arrangements