HIPAA Compliance Requirements Checklist & Technical Requirements

December 12, 2024

Technology has triggered transformative changes in the medical industry, and we are ready to see automation in HIPAA compliance. It activates better decision-making among healthcare businesses, unveiling the full potential of predictive and prescriptive insights.

Maintaining HIPAA compliance in healthcare software development is imperative for data security, as it prevents organizations from unauthorized access to personal data.

Understanding the hyperconnected world with the HIPAA compliance requirements checklist helps business associates meet regulations. Attaining compliance augments customer trust, security, satisfaction, and overall regulation. 

This guide outlines essential requirements to ensure your software remains tech-driven and HIPAA-compliant, helping you confidently navigate the complexities of healthcare software development.

Who Comes Under the HIPAA-Compliant?

HIPAA-compliant covers essential categories to comply with. It covers covered entities and business associates.

1. Covered Entities

Healthcare providers deliver medical services and handle patient PHI. Examples include:

• Doctors
• Clinics
• Psychologists
• Dentists
• Pharmacies

2. Nursing homes

Health plans, like insurance companies and government programs, manage PHI. Health plans and healthcare providers share information as a mediator between healthcare providers and health plans.

Business Associates

These individuals or services work with covered entities in non-healthcare roles but still handle PHI. Examples include:

• Data storage companies
• Software providers
• Accounting firms
• Legal services
• Cloud providers

HIPAA Compliance Checklist for 2024

A HIPAA compliance checklist emphasizes critical security measures that your company needs to protect Protected Health Information (PHI). This document provides a ten-step checklist to assist you in successfully achieving compliance.

• Establish Security Management Standards  

Designate a privacy officer to lead your compliance efforts. This person will manage your compliance plan and ensure adherence to HIPAA Privacy and Security rules. Document every action taken to safeguard patient information. This documentation is crucial; it is the backbone of your compliance strategy.

• Assign Responsibility  

Assign an individual or division to manage HIPAA compliance. Centrally organizing duties reduces misunderstandings and guarantees no work is missed, making overseeing the compliance process more accessible and practical.

• Develop a Compliance Strategy  

Integrate your HIPAA compliance checklist into daily operations. Regular staff training on HIPAA rules should be conducted, and transparent data privacy protocols should be followed. Regularly assess risks to make protecting PHI an ongoing priority.

• Conduct Risk Evaluations  

Conduct a HIPAA risk assessment to find weaknesses in how you handle data. Administrative, physical, and technical precautions should all be evaluated. If gaps exist, develop a corrective action plan to address them quickly.

• Ensure IT Infrastructure Meets Standards  

Your IT infrastructure must be HIPAA-compliant. Use strong encryption and enforce tight access controls for PHI. Physical safeguards, such as critical card access systems and surveillance cameras, are essential for securing areas where PHI is stored.

• Maintain PHI Handling Technology  

Update the software on your medical devices. Antiquated technology is like providing cybercriminals with an unlocked door. Frequent upgrades and cybersecurity services guarantee robust system protections and help avert attacks.

• Investigate Violations  

If unauthorized PHI use occurs, investigate the cause. Most breaches stem from internal oversights rather than external hacks. Once you identify the issue, tighten controls and revise policies to prevent future incidents.

• Record Violations and Remediation Plans  

Document all violations and the steps taken to resolve them. This log is vital for compliance and provides clarity if a breach occurs. For each issue, outline a plan and timeline for correction, especially after audits.

Detailed Look at HIPAA Regulations: Major Principles

Let’s break down the four principal HIPAA regulations!

• HIPAA Privacy Rule

This rule shields patient data for insurers, employer-sponsored health plans, and healthcare providers. Disclosing PHI is strict but allowed with conditions only for appropriate purposes, such as billing and treatment. To comply, organizations should adopt security measures, provide patients with a Notice of Privacy Practices, and ensure access to their records.

• HIPAA Security Rule

This rule focuses on protecting electronic PHI. Organizations must safeguard PHI from security risks and ensure staff follows protocols. Based on risk evaluations, compliance entails both physical and technical measures.

• HIPAA Omnibus Regulation

The compliance standards include subcontractors, business associates, and healthcare providers. Business associates are exempt from most regulations. They establish policies regarding the use and disclosure of PHI.

• HIPAA Breach Notification Rule

Businesses must inform the Secretary of Health and Human Services within 60 days of discovering a breach. They must also notify the impacted parties and the local media about serious infractions.

How to Develop HIPAA-Compliant Web or Mobile Healthcare Apps

Creating HIPAA-compliant medical software involves several vital steps to protect sensitive data. Here are seven essential HIPAA compliance software checklists.

• Transport Encryption

Encrypt all electronic Protected Health Information (ePHI) before transmission. Use SSL and HTTPS protocols to secure data during transfers. Ensure your cloud provider supports robust encryption methods. Validate that HTTPS is appropriately set up and that passwords are stored as hash values for added security.

• Backup and Storage Encryption

Use secure backup services to protect data from loss. Ensure that only authorized personnel can access sensitive PHI. Store all data, including backups, securely using industry-standard encryption like AES and RSA. Managed cloud databases, like Amazon RDS, offer built-in encryption.

• Identity and Access Management

Implement strong identity management practices. Use unique passwords and never share them. Track access with system logs and enable Two-Factor Authentication (2FA) to verify user identities. Consider biometrics and Single Sign-On (SSO) for easier access while maintaining security.

• Integrity

Data must be safeguarded from unauthorized alterations and verified by digital signatures. Regular backups and strict access controls help maintain HIPAA compliance.

• Disposal

Properly dispose of outdated backups and decryption keys. Ensure that data is permanently deleted from all locations when no longer needed.

• Business Associate Agreement

Host ePHI on servers with a signed Business Associate Agreement. This ensures that the hosting company complies with HIPAA standards.

HIPAA Compliance Certification 101

Getting HIPAA compliance certification for software enables organizations to comply with the Health Insurance Portability and Accountability Act’s provisions for shielding patient health information (PHI). 

HIPAA regulations call for frequent assessments and instruction on privacy policies. Organizations can decide how often to conduct this training, usually every six months to a year.

Third-party vendors typically provide any certification. Although certification does not ensure audit success, it does demonstrate the organization’s efforts to protect PHI and provides beneficial staff training. 

HIPAA Compliance Certification Benefits

• Get Up to Speed: Certification helps organizations create effective processes for protecting PHI. This training is essential if anyone on your staff is unfamiliar with HIPAA.

• Gain Client Trust: Displaying a certification emblem on your website can reassure clients that you take data security seriously.

• Minimize Liability: Although certification doesn’t stop audits, it does assist your staff in adhering to best practices. This may lessen the effects of data breaches and safeguard your company’s assets and good name.

HIPAA Compliance Technical Requirements Simplified

HIPAA’s Technical Safeguards include five essential standards, each vital to protecting electronic protected health information (ePHI).

• Access Controls

Access controls ensure that only authorized personnel can access ePHI. Covered entities must establish policies to manage who can view or use this information. There are four essential requirements:

• Audit Controls

The audit controls standard mandates mechanisms to log access and activity in systems using ePHI. This is crucial for detecting unauthorized access. Automated audit systems can help prevent breaches in real time, especially with advancements in cloud technology.

• Integrity Controls

Integrity controls require organizations to protect ePHI from unauthorized changes. This means preventing accidental data entry errors or deletions. The standard emphasizes verifying that ePHI remains unaltered without permission.

• Authentication Controls

Authentication controls verify the identity of individuals accessing ePHI. Each user must have a unique password or PIN. Additional verification methods, such as electronic signatures or biometrics, enhance security.

• Transmission Security

Transmission security protects ePHI during electronic communication. Although earlier standards were less stringent, modern technology allows for more robust protections, like email encryption and other transmissions.

HIPAA Rules: A Basic Comprehension

Principal regulations of the HIPAA govern how businesses manage patient information. These rules are:

• The Privacy Rule
• The Security Rule
• The Breach Notification Rule
• The Omnibus Rule

Each rule has specific requirements that help protect patient information.

• HIPAA Privacy Regulation

The Privacy Rule describes what constitutes ePHI, its safeguards, and required security precautions. It sets the national standard for patient privacy. This includes any identifiable patient data, including:

• Past, present, or future health conditions
• Care records
• Payment records for healthcare

Under this rule, organizations can only share private health information in specific situations, like care, research, or legal needs. Entities must implement particular procedures and paperwork to comply.

HIPAA Privacy Rule Checklist

To follow the Privacy Rule, organizations should:

• Designate a privacy officer.
• Create written policies and procedures.
• Train staff on privacy practices.
• Obtain patient consent for disclosures.
• Maintain safeguards for protected health information (PHI).
• Review requests for PHI.
• Respond to patient requests for access to their PHI.
• Notify patients of any breaches.
• Assign unique identifiers for individuals.
• Set protocols for sharing PHI with others.

• The HIPAA Security Rule

ePHI protection is the primary goal of the Security Rule. It establishes standards for how to safeguard this data through:

• Administrative Safeguards: Policies and procedures affect ePHI, including employee training.
• Physical Safeguards: Security for physical access to computers and data storage.
• Technical Safeguards: Security measures for technology, like encryption and network security.

HIPAA Security Requirements Checklist

To meet the security rule, organizations must:

• Conduct a risk analysis.
• Implement security policies.
• Limit ePHI access to authorized individuals.
• Encrypt and store ePHI securely.
• Have procedures for responding to security incidents.
• Train staff on security policies.
• Regularly review security measures.
• Prepare backup plans in case of emergencies.
• Verify that outside vendors adhere to security requirements.
• Perform audits to verify compliance.

• The Breach Notification Rule under HIPAA

Data breach, when outlined in the Breach Notification Rule, organizations must acknowledge that no system can be completely safe. Here’s what they must do:

• Notify individuals affected by the breach in writing.
• If more than ten people are affected and contact info is missing, use public notices instead.
• Provide notifications within 60 days of discovering the breach.
• Alert the local media when over 500 individuals are affected.
• Notify the Secretary of Health if more than 500 persons are impacted.

• The Omnibus Rule of HIPAA

The Omnibus Rule signifies the accountability of Covered Entities for the actions of their business affiliates. They must adjust their compliance protocols to account for this commitment.

RichestSoft Helps Your Organization Become HIPAA Compliant

Consider using a data masking solution to enhance your HIPAA compliance. RichestSoft Continuous Compliance helps your IT teams automatically find and mask protected health information (PHI), ensuring the data meets HIPAA’s requirements on priority.