Stay Compliant with HIPAA Regulations in 2025
Since the 1990s, healthcare organizations and their business associates have followed HIPAA regulations to safeguard protected health information (PHI). While the core rules have remained largely unchanged, significant updates to the HIPAA Privacy Rule are scheduled for 2025, potentially adding complexity to compliance efforts.
Navigating HIPAA Privacy Rule and Regulation Changes in 2025
The Health Insurance Portability and Accountability Act (HIPAA) of 1996 has provided consistent regulatory guidance for decades. While the last major update occurred in 2013, the HIPAA regulations set to take effect in 2025 introduce significant changes, especially to the HIPAA Security Rule and HIPAA Privacy Rule.
To navigate 2025’s changes to the framework, organizations will need to know:
- How some changes to the Privacy Rule will impact data accessibility
- How the bigger overhaul of the Security Rule will shape infrastructure
- How shifts in governance and enforcement could impact covered entities
- How other, auxiliary changes to the framework can complicate compliance
Ultimately, the best way to achieve and maintain seamless HIPAA compliance in 2025 and beyond is to partner with a dedicated compliance advisor who’ll streamline the process for you.
Implications of 2025 HIPAA Privacy Rule Updates
While the HIPAA Privacy Rule has seen minor revisions over the years, its core principles have largely remained intact. That trend continues in 2025, the proposed updates primarily clarify existing requirements or expand upon current practices, rather than overhaul the rule entirely.
However, these adjustments carry important implications for how organizations manage communication and data accessibility.
These revisions have been years in the making. The Office for Civil Rights (OCR) within the Department of Health and Human Services (HHS) has been working to modernize the Privacy and Security Rules since at least 2018, when it issued a formal Request for Information (RFI).
This was followed by a Notice of Proposed Rulemaking (NPRM) in 2020, which introduced a range of proposed updates aimed at enhancing clarity, efficiency, and patient rights.
Specific Changes to Privacy Rule Requirements
The Privacy Rule is expected to undergo relatively minor changes to its priorities and reach, which may necessitate changes in the way HIPAA compliance is approached organizationally.
The most impactful proposed changes to the HIPAA Privacy Rule for 2025 are:
- Covered entities must enhance PHI access and transparency, allowing individuals to inspect their health records in person, take notes, and receive full documentation within 15 days—down from the previous 30-day requirement. Patients will have the right to inspect their PHI in person, take notes, and capture images for personal reference, increasing accessibility and transparency.
- Relatedly, covered entities will now be required to provide estimated fee schedules for PHI access, along with itemized estimates for individual requests. They must now notify individuals when they can access PHI without any charge, along with informing people of their rights to full documents from cases where only summaries have been offered.
- Greater care must be practiced when transferring and handling electronic PHI (ePHI), including limiting transfers to third parties to only electronic health records (EHR) and obtaining confirmation before allowing transfers of ePHI to direct provider sharing.
- There are subtle changes to certain definitions and permissions, such as more latitude for permitted uses and disclosures related to the Armed Forces’ requests. Covered entities will be provided more grace in determining when PHI sharing is justified to mitigate potential future harm, and the definition of “healthcare operations” has been expanded with respect to determining whether certain uses or disclosures are sound.
In addition, the HHS has set the groundwork for further changes related to these. For example, individuals identified in PHI will eventually have the ability to direct covered entities on how to share EHR, including coordinating sharing between providers that wasn’t previously allowed.
Ramifications of the 2025 HIPAA Security Rule Overhaul
The 2025 updates to the HIPAA Security Rule mark the most significant overhaul since the introduction of the HITECH Act. While the rule’s foundational principles remain intact, the new requirements introduce stricter controls on cybersecurity, risk management, and the protection of electronic protected health information (ePHI).
The goal of these updates is to enhance and modernize existing safeguards, closing long-standing gaps in the Security Rule’s coverage.
The revised rule offers deeper protections and broader applicability to address today’s evolving cyberthreats—challenges that were not fully anticipated when the Security Rule was last revised.
At its core, the HIPAA Security Rule builds on the Privacy Rule by establishing technical, administrative, and physical safeguards for securing PHI. The 2025 enhancements strengthen this foundation by requiring organizations to adopt more advanced controls, such as:
- Enhanced encryption and access management standards
- Comprehensive risk assessments tailored to modern digital infrastructure
- Ongoing monitoring and incident response planning
Organizations may need to install new technologies and update existing systems to remain compliant under these more rigorous expectations.
Key 2025 HIPAA Security Rule Requirements
On the whole, the Security Rule is expected to undergo relatively major updates that will impose more specific and direct requirements on applicable organizations than prior iterations have.
The most impactful proposed changes to the HIPAA Security Rule for 2025 are:
- Covered entities must now create and maintain an information technology (IT) asset inventory and network map, including updates to ensure accuracy every 12 months.
- Risk assessments must now include detailed evaluations of IT asset inventories and network maps, identifying and mitigating anticipated PHI security threats.
- Covered entities will need to develop formalized, written procedures for contingency planning, including a complete, prioritized restoration of impacted data within 72 hours.
- Covered entities will need to conduct Security Rule audits, system-wide security reviews, and penetration tests every 12 months, along with vulnerability scans every six months.
- All PHI will need to be encrypted at all times, both in storage (“at rest”) and in transit.
- Covered entities will need to implement multi-factor authentication (MFA), network segmentation, and anti-malware to ensure the integrity and confidentiality of PHI.
- Portable devices handling PHI must implement encryption, remote wipe capabilities, and access controls to prevent unauthorized data exposure.
- Patches and software updates will need to be implemented in a timely manner.
- Any unnecessary or extraneous software will need to be removed from PHI systems, and unused network ports will need to be disabled in accordance with risk analysis.
- Covered entities will need to verify business associates’ cybersecurity measures every 12 months, ensuring that any systems in contact with PHI are fully HIPAA compliant.
What these changes reflect is an alignment with consensus best practices that are enshrined in other cybersecurity frameworks and regulations. Some organizations may be subject to HIPAA alongside these other rules, in which case compliance will entail mapping between rulesets.
Increased HIPAA Audit Coverage and Enforcement in 2025
One of the most significant developments in HIPAA compliance for 2025 is the anticipated rise in Office for Civil Rights (OCR) audits and investigations. While HIPAA does not require formal certification, covered entities and business associates must demonstrate compliance when incidents occur—or face serious consequences.
Historically, the Department of Health and Human Services (HHS) has deprioritized proactive audits since around 2017. However, in 2025, the OCR is expected to shift toward more frequent and expansive audits, focusing on:
- A broader range of HIPAA requirements in each review
- Stricter enforcement of the HIPAA Privacy and Security Rules
- Higher financial penalties for non-compliance or lack of preparedness
This increase in audit activity reflects the OCR’s growing emphasis on preventive enforcement rather than reactionary measures after a breach or violation has occurred.
To balance these stricter oversight measures, HHS has also proposed initiatives to support financially constrained healthcare organizations, helping them adopt and maintain HIPAA-compliant protections.
Auxiliary Changes to Protected Information Classes
Another kind of change impacting HIPAA in 2025 is the inclusion of different data types under the banner of PHI, along with extended protections due to the socio-political climate we’re in.
In particular, two subsets of personal information are now under tighter control via HIPAA:
- Substance Use Disorder (SUD) records – Previously governed separately—are now fully protected as PHI under HIPAA, ensuring stricter confidentiality measures This is the result of collaboration between OCR and the Substance Abuse and Mental Health Services Administration (SAMHSA), who have worked to integrate SUD into HIPAA since 2022.
- Reproductive health information – HIPAA now classifies reproductive health records—including procedures, contraceptive use, and related treatments—as specially protected PHI, restricting their disclosure for legal investigations. In particular, these records are not to be shared for the purposes of civil, criminal, or administrative investigations that persecute recipients for seeking out care. Even if a use or disclosure would normally be permitted by the Privacy Rule, it may not be in this case.
The upshot is that organizations will need to account for additional kinds of data in their PHI safeguards. In the case of reproductive health information, greater care needs to be taken to ensure this specific class of data is not shared under circumstances that other PHI could be.
How to Ensure Seamless, Long-term HIPAA Compliance
For organizations seeking HIPAA compliance for the first time, or those looking to continue complying with the rules after these changes are implemented, HIPAA advisory is critical.
By working with a trusted implementation and assessment partner, covered entities and business associates alike can review and adjust their existing controls, or implement completely new ones, like the newly required asset and network map, to ensure they meet HIPAA’s new rules.
In addition, working with an advisory partner is one of the best ways to navigate complicated regulatory compliance environments where multiple frameworks may apply simultaneously.
In these cases, implementing an omnibus framework such as the HITRUST CSF is one of the best ways to streamline all requirements and minimize costly overlap. HITRUST certification allows organizations to “assess once, report many” and cover all regulatory bases efficiently.
Optimize Your HIPAA Compliance Practices Today
In 2025, changes to HIPAA revolve around the big-ticket rework of the Security Rule. There are other considerations, and the higher stakes of increased audit enforcement make it even more critical for covered entities and business associates to be on top of their compliance.
But the biggest practical difference will be meeting the new, imposing security requirements efficiently.
RSI Security has helped countless organizations prepare for, achieve, and maintain HIPAA compliance. We’ve worked with this framework since well before the implementation of the HITECH Act, and we’re committed to helping organizations rethink their cyber defense in a holistic way.
The right way is the only way to protect your data, and we’ll help you do just that.
Stay ahead of HIPAA breaches, download our HIPAA Checklist and close your compliance gaps today.