The Health Insurance Portability and Accountability Act (HIPAA) is a U.S. law that protects patient health information.

Enacted in 1996, it sets rules for handling sensitive data to ensure privacy and security.

Non-compliance can result in penalties and operational issues. Bellwether helps organisations understand and meet HIPAA requirements.

What is HIPAA and Why It Matters

HIPAA Compliance Requirements

HIPAA compliance ensures that patient data remains private and secure while allowing healthcare providers to operate efficiently. HIPAA compliance is needed for covered entities (e.g., hospitals, clinics, insurers) and business associates (e.g., EHR vendors, billing services providers) handling PHI. The Security Rule and Privacy Rule are the core regulations for protecting PHI, especially in digital systems.

HIPAA Security Rule - Key Requirements

1. Administrative Safeguards:

   • Implement policies for managing ePHI security, like HIPAA risk assessments and training for staff who handle ePHI.

   • Assign a HIPAA compliance officer to oversee compliance.

   • Legal Reference: 45 CFR § 164.308 – Requires risk analysis and security management processes.

2. Physical Safeguards:

   • Secure facilities and devices storing ePHI, like locked server rooms or password-protected applications that access ePHI.

   • Restrict server room access to only authorized IT staff.

   • Legal Reference: 45 CFR § 164.310 – Mandates facility access controls and device security.

3. Technical Safeguards:

   • Use encryption, access controls, and audit logs to protect ePHI.

   • Ensure secure data transmission (e.g., via SSL).

   • Example: Enable end-to-end encryption for all patient video calls to prevent interception.

   • Legal Reference: 45 CFR § 164.312 – Requires encryption and access controls.

4. Breach Notification:

   • Notify affected individuals, the Department of Health and Human Services (HHS), and sometimes the media within 60 days of a breach affecting 500+ people.

   • Legal Reference: 45 CFR § 164.400-414 – Outlines breach notification rules.

Implementation of the mandates in the HIPAA Security Rule prevents data breaches, which are common in 2025 due to increased cyberattacks on healthcare systems. Assess your SaaS apps as well as on-premise hosted systems for encryption and access controls to meet these standards.

HIPAA Privacy Rule - Key Requirements

1. Patient Rights:

   • Patients can access their PHI, request corrections, and get an accounting of disclosures.

   • Providers must inform patients of their rights via a Notice of Privacy Practices.

   • Example: Provide patients a portal to view their medical records, complying with patient access rights.

   • Legal Reference: 45 CFR § 164.520 – Requires a Notice of Privacy Practices; 45 CFR § 164.522 – Grants rights to access and amend PHI.

2. Use and Disclosure Limits:

   • PHI can only be used or shared for treatment, payment, or healthcare operations (TPO) without authorization, unless permitted by law (e.g., public health reporting).

   • Other uses, like marketing, require patient authorization.

   • Example: You may share patient data with a lab for testing (allowed for treatment). But seek consent from the patient to share it for research purposes.

   • Legal Reference: 45 CFR § 164.502 – Limits uses and disclosures of PHI; 45 CFR § 164.508 – Requires authorization for non-TPO uses.

3. Minimum Necessary Standard:

   • Use or disclose only the minimum PHI needed for the purpose.

   • Example: A billing company only accesses patient payment details, not full medical histories, to process claims.

   • Legal Reference: 45 CFR § 164.502(b) – Enforces the minimum necessary rule.

4. Business Associate Agreements (BAAs):

   • Contracts with business associates must ensure they protect PHI.

   • Example: A Texas hospital signs a BAA with a cloud EHR provider to ensure data security.

   • Legal Reference: 45 CFR § 164.504(e) – Requires BAAs for business associates.

The Privacy Rule protects patient trust and prevents unauthorized data sharing. In 2025, with rising telehealth and SaaS apps, ensuring proper consent and limiting disclosures is critical.

Bellwether has developed a world-class Enterprise Risk Management framework for healthcare industry by combining functional, information security and legal expertise. Our HIPAA consulting clients range from start-ups to large enterprises.

HIPAA Challenges in 2025

In 2025, the rise of telehealth, artificial intelligence (AI), and cloud-based systems introduced new complexities for HIPAA compliance, with fines for violations reaching up to $1.5 million per incident.

One major challenge is securing electronic PHI (ePHI) in cloud-based and AI-driven systems.

The HIPAA Security Rule (45 CFR § 164.312) requires encryption and access controls, but many organizations struggle to implement these in cloud platforms or AI tools used for diagnostics or patient analytics. The increasing use of Internet of Things (IoT) devices, like remote patient monitors, further complicates compliance, as these devices often lack robust security, risking violations of the Security Rule’s technical safeguards.

Another challenge is ensuring proper patient consent and data sharing under the HIPAA Privacy Rule (45 CFR § 164.502).

With telehealth and third-party vendors (e.g., EHR platforms, billing services), organizations must maintain Business Associate Agreements (BAAs) and obtain patient authorization for non-treatment uses, like research. Today's focus on AI-driven analytics heightens this risk, as organizations may inadvertently use PHI for unauthorized purposes without clear consent, requiring robust consent management systems.

Compliance with breach notification requirements (45 CFR § 164.408) also poses challenges, as cyberattacks are more frequent in 2025.

The Security Rule mandates notifying affected individuals and the Department of Health and Human Services within 60 days of a breach affecting 500+ people. Many organizations, especially smaller SaaS providers, lack formal breach response plans, leading to delays.

Bellwether’s readiness assessments can help organizations develop breach protocols and align with HIPAA, ensuring continuous compliance.

HIPAA compliance - A Brief Summary

What is HIPAA

HIPAA is a federal law in the United States defining the data protection requirements of Protected Health Information (PHI). HIPAA applies to healthcare providers, health plans, clearinghouses, and their business associates, including Vendors and SaaS providers handling PHI. HIPAA compliance ensures data security and patient trust.

Security and Privacy

The Privacy Rule controls how PHI is used and shared, requiring measures like patient consent and access controls. The Security Rule sets standards for protecting electronic PHI (ePHI) through technical, physical, and administrative safeguards, such as encryption and risk assessments.

Who Must Comply

HIPAA applies to covered entities like healthcare providers and their business associates, including SaaS providers. Global organisations handling PHI in the U.S. must also comply. Bellwether supports various entities to meet these requirements.

Vendor Due Diligence and Contracts Review

We assess your third-party vendors (also known as Business Associates/BAs) to ensure they have the same level of protection that is mandated by the HIPAA in both data security and data privacy domains. Signing a Business Associate Agreement (BAA) with vendors who process PHI is mandatory.

Training & Awareness

Employee-focused training modules need to be designed and delivered to all employees and contracts who handle PHI in the organization.

Breach Notification

In case of a breach of PHI, either accidental or intentional, HIPAA requires that the organization needs to notify the patients/individuals to whom the PHI belongs to. Apart from notifying individuals, the organization also has to notify the Office of Civil Rights (OCR) under the Department of Health and Human Services (HHS)

Our experienced HIPAA consultants can drive your Risk Management program

Need a HIPAA Compliance Consultant?

Bellwether has developed a world-class Enterprise Risk Management framework by combining functional, information security and, legal expertise. Our HIPAA compliance consulting clients range from start-ups to large enterprises.

Get in touch today to talk to a HIPAA Compliance Consultant and explore the ways to manage your enterprise risk and uncover value.

HIPAA - Lead Consultant

The author heads the practice of Cybersecurity and Data Privacy Compliance at Bellwether. At Bellwether, he has been advocating the core principles of EU-GDPR like data minimization, purpose limitation, explicit consent and privacy by design and default. Apart from delivering end-to-end consulting engagements in the DPDP Act, 2023, EU-GDPR, HIPAA, PCI-DSS, FDA 21 CFR part 11, NIST CSF, he leads data privacy and infosec consulting practice at Bellwether with a team of experienced consultants in the field of global data privacy regulations.

LinkedIn: https://in.linkedin.com/in/balu0103