HIPAA’s Security Rule has remained largely unchanged in its core structure since the early 2000s. A major update now marks the most significant revision in more than a decade.
Multiple pressures pushed regulators to act. Ransomware attacks and credential-based intrusions have escalated across healthcare.
Cloud adoption, AI deployment, telehealth growth, and use of connected devices have also changed how protected health information moves through modern systems.
Numbers alone show the scale of the problem.
- 725 breaches affected more than $275 million records in 2024
- Total impact reached roughly 82% of the U.S. population
Regulators now aim to align HIPAA with modern cybersecurity practices. Earlier compliance models allowed broad discretion in how safeguards were applied. New requirements point to a more prescriptive model built on enforceable technical controls.
- Proposed in January 2025
- Finalization expected in May 2026
- Compliance window likely to be about 180 days after publication
A Shift Toward Mandatory Security Controls
A fundamental change sits at the center of the proposed rule. “Addressable” safeguards are expected to disappear, meaning organizations will no longer have wide latitude to decide which safeguards are optional in practice.
Earlier HIPAA expectations allowed covered entities and business associates to decide if certain controls were reasonable and appropriate in their environment.
Proposed revisions move away from that model by making all safeguards mandatory.
Compliance is no longer framed as a policy exercise alone. Security controls must be implemented, tested, maintained, and proven to work in practice.
Documentation still matters, but written policies without operational proof will no longer be enough.
Core Proposed Changes in the 2026 HIPAA Security Rule
Major revisions point to a compliance model built on measurable action. Each proposed area increases pressure on organizations to show real technical control over systems that handle ePHI.
Mandatory Encryption Requirements
Encryption of electronic protected health information, or ePHI, would become mandatory both at rest and in transit.
Earlier HIPAA language treated encryption as an addressable safeguard in some contexts. Proposed revisions remove that flexibility.
Email encryption is also expected to become effectively mandatory when PHI is transmitted. Regulatory intent is clear.
Ambiguity around what counts as “reasonable and appropriate” is being reduced in favor of direct technical requirements.
Enhanced Risk Analysis and Continuous Monitoring
Risk analysis is moving into a more formal and recurring structure. Periodic review is no longer enough under the proposed model.
Annual Security Risk Assessments will become a direct requirement with less flexibility around timing. Additional obligations are expected to include annual compliance audits and independent risk assessments intended to improve objectivity.
Organizations will need to show that controls remain active, are tested on a regular basis, and continue to function as intended.
- Annual Security Risk Assessments
- Annual compliance audits
- Independent risk assessments
- Continuous monitoring instead of periodic review only
- Documentation that proves controls are active, tested, and maintained
Stronger Identity and Access Management
Identity and access management is becoming a core enforcement issue. Credential theft remains a leading cause of healthcare breaches, so access controls are receiving much closer regulatory attention.
Multi-factor authentication, or MFA, is expected to become mandatory across systems that handle ePHI. Proposed changes also place greater focus on least privilege access and role-based access controls.
- MFA across systems handling ePHI
- Least privilege access
- Role-based controls
- Audit logs
- Real-time anomaly detection
Startup teams will need tighter access governance across employee accounts, contractor access, privileged roles, cloud systems, and connected applications.
Supply Chain and Vendor Risk Accountability
Vendor oversight is no longer a secondary issue. Business associates and outside partners can create direct compliance exposure for healthcare startups.
Oversight of business associates is expected to expand in a meaningful way. Audit results may need to be shared with covered entities, creating greater transparency between healthcare organizations and their vendors.
Risk inheritance is a major issue in healthcare. One weak link in a partner environment can create direct consequences for the startup and its customers.
Technical Testing and Security Validation
Security testing is moving closer to the center of compliance. Paper reviews and policy statements alone will not satisfy the proposed direction.
Annual penetration testing is expected to become mandatory. Regular vulnerability scanning, often biannual or continuous, will also play a larger role.
- Annual penetration testing
- Regular vulnerability scanning
- Identification of exploitable weaknesses in live environments
- Proof that defenses work under realistic conditions
A clear message is emerging. Security programs must prove that defenses work in practice.
Asset Inventory and Network Visibility
Visibility is becoming a baseline requirement. Organizations cannot secure systems they cannot identify, and they cannot control data flows they cannot map.
A full inventory of all assets that touch ePHI is likely to become mandatory, including AI tools and cloud-based systems. Network mapping of ePHI data flows is also expected to become mandatory.
- Full asset inventory
- Inclusion of AI tools
- Visibility into cloud systems
- Network mapping of ePHI data flows
Fast-moving startup environments will find this especially difficult because cloud resources, APIs, and third-party integrations can change quickly.
Incident Response and Reporting Modernization
Incident response expectations are moving toward faster action and greater operational discipline. Prevention alone is no longer enough.
Reporting windows of about 72 hours are likely to become part of the new framework. Formal incident response plans, faster detection methods, and clear escalation processes are also expected.
- Approximately 72-hour reporting expectations
- Formal incident response plans
- Faster detection and escalation
- Readiness for cyber resilience, not only prevention
A healthcare startup must be prepared to identify an incident quickly, determine scope, contain impact, notify the right parties, and preserve evidence for later review.
What This Means Specifically for Healthcare Startups
Healthcare startups are likely to feel these changes immediately. Compliance obligations are becoming more expensive, more technical, and more visible to customers, investors, and partners.
Higher Barriers to Entry
Compliance now requires more infrastructure, more process control, and more ongoing oversight. Earlier entry paths into healthcare may no longer be realistic for startups with weak security foundations.
- Encryption
- MFA
- Monitoring
- Security testing
- Documentation
- Vendor management
- Audits
- Security personnel
Market readiness now comes with a much higher baseline.
Security as a Competitive Differentiator
Strong security posture can create a business advantage.
Hospitals, health systems, payers, and enterprise buyers are likely to place more value on vendors that can demonstrate readiness early, while working with experienced partners such as Netpeak.us can further strengthen market positioning and visibility.
Compliance is no longer only a legal issue. For many healthcare startups, it becomes a business enabler.
Shift Toward Security by Design
Security is moving closer to the architecture level.
Teams will need to build controls into infrastructure, software design, deployment pipelines, and operational workflows early in product development.
Architecture decisions made early will have direct compliance consequences later.
Why Healthcare Cybersecurity Is Different
Healthcare security is difficult because healthcare systems are highly interconnected and interdependent. Electronic health record platforms, IoT medical devices, cloud services, analytics tools, APIs, and vendor platforms all interact across one environment.
Simple compliance checklists do not work well in systems with constant change. Risk shifts as systems shift. New integrations, product features, user roles, and devices can alter exposure quickly.
- Interconnected digital ecosystems
- Dependence on external vendors and platforms
- Sensitive patient data moving across multiple systems
- Clinical operations tied to uptime and availability
- Fast-changing technology stacks that can create hidden risk
Regulatory changes signal a move toward adaptive, risk-based security models. Protection of ePHI now depends on how systems operate in practice, not only on how policies are written.
Practical Steps to Prepare Now
Preparation should start before the final rule is published. Early action can reduce implementation pressure and limit the chance of rushed compliance work later.
Conduct a Gap Analysis
A structured gap analysis should compare current safeguards against expected administrative, technical, and physical requirements.
Missing capabilities, weak processes, and documentation gaps should all be identified early.
- Review of administrative safeguards
- Review of technical safeguards
- Review of physical safeguards
- Identification of missing controls
- Creation of a phased remediation plan
Implement Mandatory Encryption Early
Encryption should be deployed early for data at rest and data in transit. Email and messaging workflows should also be reviewed to remove insecure communication channels.
- Encrypt stored ePHI
- Encrypt ePHI in transit
- Secure email transmission
- Remove insecure communication methods
Waiting until final publication may create unnecessary operational pressure.
Strengthen Identity and Access Controls
Access controls often produce fast risk reduction and will likely be central to future enforcement. Early investment in IAM can close important gaps before audits and technical testing begin.
- Deploy MFA across all systems handling ePHI
- Enforce least privilege access
- Use role-based permissions
- Conduct regular access reviews
- Remove unnecessary accounts and privileges
Build a Continuous Risk Management Program
Annual review alone is not enough under the proposed direction. Ongoing visibility into system activity, vulnerabilities, and user behavior is becoming essential.
- Annual Security Risk Assessments
- Ongoing vulnerability scanning
- Monitoring tools integrated into daily operations
- Review of alerts and audit logs
- Review of anomalous access activity
Continuous risk management will matter more than periodic compliance review.
What Is Still Uncertain
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Important details are still unresolved because the proposal remains at the Notice of Proposed Rulemaking stage.
Timing could shift, and some final provisions may change before publication.
- Enforcement rigor
- Final compliance deadlines
- Degree of flexibility for smaller organizations
Core direction still appears unlikely to change. Requirements are moving toward mandatory, prescriptive, and measurable security controls.
Organizations should avoid waiting for perfect certainty before taking action.
Adapt Early or Face Greater Risk
Proposed 2026 changes redefine HIPAA compliance as technical, continuous, and enforceable.
Earlier checkbox-style approaches are being replaced by operational security expectations tied to tested controls and measurable outcomes.
Healthcare startups now face a clear choice. Early preparation can reduce compliance pressure, improve buyer trust, and strengthen market readiness.
Delay can create compressed implementation timelines, higher costs, and greater regulatory exposure.
