HIPAA applies if your organization handles Protected Health Information (PHI) in the U.S. healthcare system.

• If you provide healthcare services (e.g., hospital, clinic, insurer), you’re a Covered Entity.

• If you process or store PHI on behalf of those entities (e.g., SaaS platforms, digital health apps, labs, AI healthtech companies), you’re a Business Associate. Subcontractors of Business Associates also fall under HIPAA requirements.

Sekurno helps by assessing how PHI flows through your systems, identifying whether you are a Covered Entity, Business Associate, or subcontractor, and mapping out the specific compliance obligations tied to your role.

Organizations subject to HIPAA must:

• Implement administrative, technical, and physical safeguards to secure PHI.

• Maintain audit-ready documentation, including risk assessments and security policies.

• Establish and enforce Business Associate Agreements (BAAs) with all vendors handling PHI.

• Implement breach notification procedures and ensure timely reporting of incidents.

• Provide ongoing security awareness training for staff and contractors.

Sekurno supports organizations in meeting these responsibilities by creating practical policies and controls tailored to your environment, drafting and managing BAAs, setting up breach notification procedures, and delivering targeted security training so compliance is not only achieved but embedded in daily operations.

The timeline depends on company size and maturity:

• Startups and early-stage firms: typically 3–4 months, due to smaller environments and fewer integrations.

• Mid-sized and scaling organizations: usually 6–8 months, as vendor ecosystems and data flows are more complex.

• Enterprises (e.g., when expanding into the U.S. market, launching a healthcare product line, or acquiring a company handling PHI): may require up to 12 months, with extensive remediation, cross-departmental coordination, and large vendor networks.

Sekurno streamlines this process through a readiness assessment and a phased, business-aligned roadmap.

Costs depend on the complexity of your environment and how PHI is managed. Key factors include:

• Number of systems, applications, and vendors processing PHI.

• Availability and maturity of existing security policies, controls, and documentation.

• The extent of remediation required to align with HIPAA safeguards.

A small startup with limited systems may achieve compliance efficiently, while a larger or globally distributed organization may require more resources to cover vendors, integrations, and cross-departmental processes.

Sekurno designs the program to be scalable and cost-efficient, ensuring investment aligns with your business model and growth stage.

HIPAA compliance is an ongoing program, not a one-time initiative. Organizations must:

• Conduct annual risk assessments and policy updates.

• Perform continuous monitoring of PHI systems.

• Provide regular staff training.

• Oversee vendor compliance through BAAs.

Sekurno helps organizations maintain compliance continuously, reducing risk and ensuring long-term trust.

HIPAA does not provide an official government-issued certification. Compliance is demonstrated through implementing the required safeguards, maintaining documentation, and being prepared for audits or investigations.

To support this, Sekurno conducts a post-implementation readiness assessment and issues a Statement of Compliance. This serves as recognized evidence of your HIPAA alignment and can be shared with partners, clients, and regulators to build trust and credibility.

The first step is a gap assessment to establish your baseline. When partnering with Sekurno, preparation is straightforward:

• Assign an accountable person to oversee compliance internally.

• Prepare available documentation, such as security policies and vendor details.

• Be ready for structured interviews to map PHI flows, vendor dependencies, and current controls.

Sekurno uses this information to design a custom roadmap and lead the compliance implementation.

Non-compliance carries serious consequences:

• Fines: up to $1.5M per violation category per year.

• Breach notifications: mandatory disclosure of incidents.

• Legal liability: lawsuits, class actions, government investigations.

• Business impact: many hospitals, insurers, and investors require proof of HIPAA compliance before engaging.

If PHI is compromised, HIPAA’s Breach Notification Rule requires organizations to:

• Notify affected individuals without unreasonable delay (and no later than 60 days after discovery).

• Inform the U.S. Department of Health and Human Services (HHS).

• Notify the media if the breach affects more than 500 individuals in a state or jurisdiction.

• Document all breaches, even those involving fewer than 500 individuals, for annual reporting.

Failure to follow these steps can significantly increase penalties and reputational harm.

Sekurno helps by building an incident response and breach notification process tailored to your organization, so you’re prepared to act swiftly and remain compliant in the event of a breach.

HIPAA establishes a strong U.S. healthcare baseline and complements other global frameworks, reducing duplication and supporting international expansion:

• GDPR: Both frameworks emphasize protecting personal data. They overlap in areas such as data privacy, breach reporting, consent, and data subject rights, making HIPAA a natural extension for companies already GDPR-compliant.

• ISO 27001: HIPAA’s Security Rule aligns closely with ISO 27001’s requirements for an Information Security Management System (ISMS) — including risk assessments, access controls, incident response, and continuous monitoring. Organizations with ISO 27001 in place already meet many HIPAA safeguards.

• FDA / EU MDR: While HIPAA governs data privacy and security, FDA and EU MDR regulations focus on the safety, quality, and effectiveness of medical devices and diagnostics. HIPAA complements them by ensuring that devices and platforms also meet data protection and cybersecurity requirements, strengthening trust in regulated products.

Sekurno helps organizations build a scalable compliance infrastructure where HIPAA becomes the foundation for integrating additional regulatory requirements. This approach ensures that future frameworks can be added efficiently — without duplicating controls, documentation, or processes — reducing overall costs, minimizing operational friction, and enabling faster readiness for new markets.