HIPAA 2025: The End of Self-Declared Compliance - What Health Tech Companies Must Do Now

When it comes to compliance, there are two kinds of companies: those that claim to be HIPAA compliant… and those that prove it.

HIPAA 2025 is about to separate the two.

For years, companies handling Protected Health Information (PHI) could simply self-declare HIPAA compliance. There were no audits, no real proof. Just a statement.

And that’s changing.

The newly proposed HIPAA Security Rule aims to move from self-declaration to "proven compliance," requiring health tech companies to demonstrate cybersecurity safeguards through audits, real-time monitoring, and continuous risk assessments.

What Is HIPAA 2025 and Who Will Be Affected?

This shift mirrors the latest FDA’s cybersecurity guidance, but it extends beyond FDA-approved medical devices. Any digital health technology handling PHI will be impacted, including:

→ Wellness apps and wearable health trackers

→ Medical SaaS platforms and cloud-based health solutions

→ Connected medical devices and IoT health tech

→ Telehealth and remote patient monitoring systems

While still a proposed rule, the message is clear: regulators are pushing for stronger healthcare cybersecurity standards, and companies need to start preparing now.

HIPAA Security Rule 2025: From Self-Declared to Proven Compliance

What’s changing?

Under the current HIPAA Security Rule, companies only need to claim compliance. There’s no built-in requirement for continuous audits or proof of security safeguards.

What’s coming with HIPAA 2025?

The 2025 proposal will enforce "proven compliance", meaning, organizations must provide evidence of security measures and be ready for audits at any time.

So, what are the key proposed requirements?

1. Mandatory Annual Compliance Audits – Companies must document security safeguards every year.
2. Regular Vulnerability Scanning & Penetration Testing – security assessments will become a legal requirement.
3. 24-Hour Reporting for Revoked PHI Access – Any changes in PHI access must be reported within 24 hours.
4. 72-Hour Disaster Recovery Requirement – Cloud-based health systems must be fully restorable within 72 hours in case of a cyberattack or outage.
5. Comprehensive Network Mapping & Asset Management – Organizations must document PHI data flows and cybersecurity risks in real time.

This shift means health tech companies will need to move from passive security policies to active, continuous compliance monitoring.

Why Medical SaaS & Health Tech Providers Are Most at Risk

Unlike traditional medical devices, cloud-based health solutions face constant cybersecurity threats that make them especially vulnerable under HIPAA 2025. These include:

1. API Exposure – Cloud-based health platforms rely on REST APIs, MQTT, and FHIR, each a potential attack point.
2. IoT & Device-to-Cloud Communication – Connected medical devices continuously transmit PHI, making real-time encryption and endpoint security critical.
3. Third-Party Integrations – Many platforms integrate with EHRs, AI analytics, and cloud services, increasing vulnerabilities.
4. Remote Access Risks – PHI is accessed by manufacturers, clinicians, and patients, creating multiple security gaps.

Cyberattacks in healthcare are on the rise. And HIPAA 2025 is designed to enforce stricter security controls, but compliance will become significantly more complex.

How to Prepare for HIPAA 2025 Compliance?

With the upcoming changes, this question comes naturally. Here are 3 steps that can get you started:

1. Strengthen security and real-time monitoring

→ Automate SBOM monitoring – Track third-party vulnerabilities in real time to meet security documentation requirements.

→ Apply zero-trust architecture – Require Multi-Factor Authentication (MFA), Attribute-Based Access Control (ABAC), and secure API protocols (OAuth 2.0).

→ Deploy real-time threat monitoring – Use dashboards to detect unusual API activity, login attempts, and data traffic anomalies.

2. Focus on compliance and audit readiness

→ Maintain complete audit logs for security incidents, risk assessments, and compliance documentation.

→ Conduct vulnerability scans every six months and penetration tests annually.

→ Ensure PHI encryption with HIPAA-compliant AES-256 encryption (at rest and in transit).

3. Build a disaster recovery plan and security documentation

→ Ensure full system recovery within 72 hours.

→ Maintain detailed records of PHI data flows and security risks.

→ Prepare for mandatory annual compliance audits.

How BioT Helps Health Tech Companies Achieve "Proven Compliance"

Preparing for HIPAA 2025 will require significant investment in cybersecurity, compliance automation, and audit readiness. But BioT makes it more simple.

Here’s why leading Health Tech companies choose us:

1. End-to-End Compliance – BioT is pre-certified for HIPAA, GDPR, ISO 27001, IEC 62304, and SOC II Type II, reducing regulatory burden.
2. Proven Compliance as a Service – BioT’s platform provides continuous monitoring and automated audit reporting, ensuring real-time readiness.
3. No Code / Low Code / Pro Code Development – The BioT SaMD Developer Studio allows companies to build compliant applications 90% faster without DevOps overhead.
4. Automated SBOM Monitoring – BioT tracks and documents third-party vulnerabilities in real time, ensuring SBOM compliance.
5. Regulatory-Aware Analytics – BioT enforces PHI data governance at the database level, ensuring proper access controls.
6. 24/7 Security & Compliance Monitoring – Ensuring continuous vulnerability assessment and automatic compliance documentation.

Why wait when you can prepare for HIPAA 2025 now?

HIPAA 2025 is set to be the most significant compliance shift in years. While still a proposal, the move from self-declaration to proven compliance is inevitable.

Companies that start preparing now will avoid last-minute stress and stay ahead of e regulatory expectations.

Want to ensure full HIPAA 2025 compliance? Let’s talk!

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FAQ: HIPAA 2025 & Health Tech Compliance 

Q1: What is HIPAA 2025?

A: HIPAA 2025 is a proposed update to the HIPAA Security Rule that will require proven cybersecurity compliance instead of self-declaration. It emphasizes audits, real-time monitoring, and risk assessments.

Q2: Who needs to comply with HIPAA 2025?

A: Any company that handles Protected Health Information (PHI)—including cloud-based medical platforms, telehealth services, connected health devices, and wellness apps.

Q3: What are the new audit and security requirements?

A: The proposed rule mandates annual audits, biannual vulnerability scans, real-time PHI monitoring, and disaster recovery plans that restore services within 72 hours.

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