HIPAA: Compliance for Health Data – Frequently Asked Questions

What is HIPAA?

HIPAA (Health Insurance Portability and Accountability Act) is a 1996 U.S. federal law that protects the privacy and security of patient health information. It applies to all covered entities and business associates handling protected health information (PHI) of U.S. citizens, regardless of where the organisation is located.

What is Protected Health Information (PHI)?

PHI is any information in a medical record or health plan that can be used to identify an individual, including medical records, medical record numbers, lab reports, hospital bills, health insurance details, and treatment information. HIPAA defines PHI through 18 specific identifiers.

Who must comply with HIPAA?

HIPAA compliance is required for:

• Covered entities: Healthcare providers (doctors, clinics, hospitals), health plans (insurance companies), and clearinghouses

• Business associates: Third parties that handle PHI on behalf of covered entities, such as billing companies, cloud storage providers, or IT contractors

If these organisations process PHI of U.S. citizens, they must comply regardless of their location.

What is the difference between PHI and PII?

PHI (Protected Health Information): Specifically relates to healthcare data and requires stricter protection under HIPAA.

PII (Personally Identifiable Information): A Broader category of any data that identifies an individual (names, addresses, emails). PHI is a subset of PII.

All PHI is considered PII, but not all PII is PHI. PHI requires stricter protection because it directly impacts an individual’s health and privacy.

What are the key HIPAA rules?

HIPAA consists of five titles, with Title II covering:

• Privacy Rule: Establishes standards for protecting patient health information and grants patient rights

• Security Rule: Sets standards for securing electronic protected health information (ePHI) through administrative, physical, and technical safeguards

• Breach Notification Rule: Requires notification of individuals if their PHI is compromised

What does the HIPAA Privacy Rule cover?

The Privacy Rule establishes national standards to protect the privacy of individually identifiable health information. It dictates how covered entities can use and disclose PHI and grants patients specific rights regarding their health data.

What can covered entities use PHI for without authorisation?

Covered entities can use and disclose PHI without patient authorisation for:

• Treatment

• Payment

• Healthcare operations

For any other use, written patient authorisation is required.

What is the “minimum necessary” standard?

The minimum necessary standard mandates that only the necessary amount of PHI is used or disclosed in any given situation. Covered entities must develop procedures to limit the disclosure of PHI to what’s minimally required.

What patient rights does HIPAA grant?

Patients have the right to:

• Access their protected health information

• Request corrections if the information is inaccurate

• Receive a notice of privacy practices

• Request restrictions on how their PHI is used

• Request confidential communications

• Know how their information is used and disclosed

• Request an audit log of who accessed their records

What is the HIPAA Security Rule?

The Security Rule specifically addresses the protection of electronic protected health information (ePHI). It requires covered entities and business associates to implement administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of electronic protected health information (ePHI).

What are administrative safeguards under HIPAA?

Administrative safeguards include:

• Designating a Privacy and Security Officer

• Workforce training on HIPAA regulations and data security

• Access controls based on job functions

• Incident response plans

• Regular risk assessments

• Written policies and procedures

• Business associate agreements

What are physical safeguards under HIPAA?

Physical safeguards include:

• Limited physical access to facilities housing ePHI

• Secure storage methods

• Multi-factor authentication

• Policies restricting access to authorised personnel only

• Environmental controls (locks, cameras, etc.)

What are technical safeguards under HIPAA?

Technical safeguards include:

• Access controls and user authentication

• Encryption of ePHI in transit and at rest

• Audit controls to track access and modifications

• Data integrity controls

• Secure EHR systems with encryption

• Regular security risk assessments

What privacy notice must I provide?

Your privacy notice must explain:

• How you use and disclose PHI for treatment, payment, and healthcare operations

• Examples of disclosures requiring authorisation

• Patient rights under the Privacy Rule

• Your legal duties regarding PHI

• Contact information for your privacy officer

Provide this notice at the first service encounter and obtain written acknowledgement of receipt.

What user authentication must I implement?

HIPAA requires strong authentication mechanisms to verify the identities of both patients and providers. This includes:

• User login and logout controls

• Multi-factor authentication

• Secure password protocols

• Role-based access restrictions

Audit logs must track all access to PHI, including failed attempts and security violations.

What is a business associate agreement (BAA)?

A BAA is a written contract between a covered entity and a business associate that outlines how the business associate will handle PHI. The BAA must ensure compliance with HIPAA requirements and include provisions for protecting PHI and reporting breaches.

Must I appoint a HIPAA Compliance Officer?

The HIPAA Security Rule requires every covered entity to appoint a security officer to develop and implement policies for protecting ePHI. Organisations may also appoint a separate Privacy Officer. Large organisations may have separate officers for these roles.

What does a HIPAA Compliance Officer do?

A HIPAA Compliance Officer is responsible for:

• Developing and implementing comprehensive HIPAA compliance programs

• Creating privacy and security policies tailored to the organisation

• Conducting regular risk assessments and identifying vulnerabilities

• Developing employee training programs on HIPAA requirements

• Maintaining compliance documentation

• Ensuring business associate compliance

• Overseeing incident response and breach notification procedures

What training requirements does HIPAA impose?

HIPAA requires:

• Ongoing training for all employees handling PHI

• Training on current HIPAA guidelines and organisational policies

• Documentation of training completion

• Regular updates to reflect regulatory changes and emerging threats

• Staff understanding of their HIPAA responsibilities

What risk assessments must I conduct?

Covered entities must:

• Conduct regular systematic evaluations to identify potential vulnerabilities

• Evaluate where PHI could be exposed or mishandled

• Encompass both administrative and technical safeguards

• Document findings and prioritise risks

• Develop mitigation strategies for identified vulnerabilities

What is a HIPAA breach?

A breach is an unauthorised acquisition, use, or disclosure of PHI that compromises the security or privacy of the information. Not all unauthorised access constitutes a breach; only that which is likely to compromise security/privacy.

What is the breach notification timeline?

Covered entities must notify affected individuals without unreasonable delay but no later than 60 calendar days after discovery of a breach. Media notification and notification to the Secretary of Health and Human Services may also be required.

What must be included in breach notification?

Breach notification must include:

• Date of the breach

• Date it was discovered

• Description of the breach and information involved

• Steps individuals should take to protect themselves

• What the covered entity is doing to investigate and prevent recurrence

• Contact information for questions

What penalties apply for HIPAA violations?

Penalties vary based on violations:

• Civil penalties: $100 to $50,000 per violation

• Criminal penalties: Up to $250,000 fines and 10 years imprisonment for serious violations

• Healthcare providers may face criminal prosecution by the Department of Justice

What are common HIPAA violations?

Common violations include:

• Failing to conduct organisation-wide risk analysis

• Inadequate workforce training

• Improper access controls

• Failure to encrypt ePHI

• Inadequate business associate agreements

• Insufficient breach notification procedures

• Poor documentation of compliance efforts

How does HIPAA compare to GDPR?

Key differences:

• HIPAA: U.S. healthcare law; risk-based approach; applies to covered entities and business associates

• GDPR: EU law; applies to any organisation processing EU residents’ data; includes the right to deletion; requires a Data Protection Officer in certain cases

HIPAA and GDPR have minimal overlap despite both protecting health data. If you process both U.S. PHI and EU health data, you must comply with both laws.

Is HIPAA International?

HIPAA is limited to U.S. healthcare entities but applies to any organisation processing U.S. PHI, regardless of location. If your international organisation processes U.S. citizen health data, you must comply with HIPAA.

How does GDPRLocal help with HIPAA compliance?

GDPRLocal provides guidance on HIPAA compliance for health data, helping organisations:

• Understand covered entity and business associate requirements

• Develop privacy and security policies

• Conduct risk assessments

• Implement administrative, physical, and technical safeguards

• Establish business associate agreements

• Manage breach notification procedures

• Ensure staff training and compliance documentation

What’s the difference between a Privacy Officer and a Security Officer?

Privacy Officer: Handles patient rights and confidentiality policies, manages access authorisations and patient requests, and ensures Privacy Rule compliance.

Security Officer: Focuses on technical safeguards, encryption, access controls, and system monitoring to implement Security Rule requirements.

Both roles work together to conduct risk assessments and ensure compliance.

Must I encrypt ePHI?

Yes. Encryption is considered one of the most effective technical safeguards under HIPAA. ePHI must be encrypted both in transit (during transmission) and at rest (when stored).

What backup procedures must I have?

HIPAA requires:

• Backup procedures to prevent data loss

• Version control systems for electronic documents

• Regular testing of backup and recovery processes

• Secure storage of backup data

• Documentation of backup procedures

Can I share patient data with other healthcare providers?

Yes, but only for treatment purposes without explicit authorisation. Sharing for payment and healthcare operations is also permitted under the Privacy Rule without patient authorisation. All other sharing requires written patient authorisation.

What retention requirements apply to PHI?

Organisations must establish clear retention policies for PHI. Retain records only as long as necessary to meet legal requirements or operational needs, then securely delete them. Documentation of retention policies and deletion procedures is required.

What should I do if there’s a HIPAA breach?

Immediate steps:

• Contain the breach and assess the scope

• Determine if notification is required

• Investigate the cause and contributing factors

• Notify affected individuals within 60 days

• Document all breach-related activities

• Implement corrective measures to prevent recurrence

• Report to the Secretary of Health and Human Services if required

Do patients have the right to access their medical records?

Yes. Patients have the right to access their medical records and can request a copy. Covered entities must provide access in a timely manner, typically within 30 days. Entities can charge reasonable copying and administrative fees.

Can patients request corrections to their records?

Yes. Patients have the right to request amendments to PHI if they believe it’s inaccurate or incomplete. Covered entities must consider the request and respond within 60 days.

What are the online platform compliance requirements for HIPAA?

Online healthcare platforms must:

• Use strong authentication and user access controls

• Provide clear privacy notices

• Obtain patient consent according to HIPAA requirements

• Encrypt all ePHI in transit and at rest

• Maintain detailed audit logs

• Implement backup and integrity controls

• Train staff on platform-specific HIPAA requirements