HIPAA Compliance Checklist For Healthcare Software Development 2024

Companies providing health and human services are responsible for preventing unauthorized access to the personal data of a customer. When it doesn’t happen, organizations face strict penalties for HIPAA compliance infractions, reaching financial loss of up to $2,067,813 per violation.

Our HIPAA compliance checklist 2024 helps healthcare organizations and their business associates comply with HIPAA regulations. Achieving HIPAA compliance leads to customer security, trust, satisfaction, and a good company reputation. We composed this software HIPAA compliance checklist to help you understand what to rely on to stay HIPAA-compliant while building healthcare software.

What is HIPAA Compliance‌

HIPAA compliance is the process of adhering to regulations aimed to safeguard protected health information, also known as PHI. Protected Health Information (PHI) is healthcare data that belongs to an individual. PHI is the information that HIPAA compliance aims to protect and keep private.

What is included in PHI

HIPAA compliance is a continuing process that implements robust protections for data security, employee training, data encryption, risk assessments, reporting, and other security procedures. The HIPAA compliance process ensures that your organization is doing everything possible to protect the privacy of the individuals it serves.

In 2023, L.A. Care Health Plan was fined $1,300,000 for failing to comply with security measures, which led to unacceptable disclosure of sensitive patient information. The data breach happened due to insufficient safety measures and inadequate activity monitoring in information systems. This is just one of the millions of dollars in penalties levied by the Department of Health and Human Services (HHS) Office for Civil Rights annually.‌

You must check if your product is HIPAA-compliant if you:

• Design custom healthcare software for human services
• Implement software in medical organizations
• Create an EMR/EHR (electronic medical/health records) system
• Give any service to healthcare organizations

Otherwise, you are under the risk of losing millions of dollars, your reputation, and even your company.

Who has to be HIPAA-compliant

HIPAA compliance aims to regulate data security and protection in healthcare business. According to the U. S. Department of Health and Human Services, compliance standards apply to covered entities and business associates.

Covered entities

According to the U. S. Department of Health and Human Services, covered entities include healthcare providers, health plans, and healthcare clearinghouses.

Healthcare providers are the individuals and organizations that provide medical services. Healthcare providers have access, interact, and use patient PHI. They are directly engaged in creating and transmitting PHI through the performance of treatment or other procedures. Healthcare providers have to comply with HIPAA standards, policies, and procedures.

Examples of healthcare providers:

• Doctors
• Clinics
• Psychologists
• Psychiatrists
• Dentists
• Nursing Homes
• Pharmacies

Health plans are health insurance organizations that manage and pay for the medical care of a customer. Insurance companies deal with PHI, so they also have to prioritize achieving HIPAA compliance.

Health plans include:

• Insurance companies
• Health maintenance organizations
• Employer-sponsored health plans
• Government health insurance programs

Healthcare clearinghouses act as mediators in the healthcare system, particularly aimed at the information exchange between healthcare providers and health plans. Healthcare clearing houses are responsible for keeping PHI private, so HIPAA compliance is obligatory for them.

Business associates

Business associates are individuals and services cooperating with covered entities in a non-healthcare role but are still responsible for HIPAA compliance. Business associates come into contact with protected health information (PHI) from covered entities but are not engaged directly.

Examples of business associates include:

• Data storage organizations
• Software providers
• Accounting companies
• Legal services
• Consultants
• EHR platforms
• Third-party consultants
• Administrators
• Cloud service providers
• Attorneys

How to become HIPAA compliant

Meeting all HIPAA regulations needs a mix of internal procedures, appropriate technology, and strategic external relationships. Before discovering the specifics, let’s consider how to become HIPAA compliant from a strategic standpoint.

Implement protections

HIPAA compliance requires robust PHI safeguards, both physically and digitally. Physical PHI storage facilities should only be accessible to authorized people. Strong password and login safeguards should also be implemented to comply with HIPAA.

Create policies and procedures

The next step is to create and execute robust cybersecurity standards, policies, and procedures. Your administrative systems and processes should all be HIPAA compliant, as should your workforce. Also, ensure that your policy is well-documented and widely distributed within the organization.

Perform annual HIPAA risk assessment

Having annual HIPAA compliance risk check-ups guarantees confidence in your company security. A HIPAA risk assessment procedure should encompass all administrative, technical, and physical security measures implemented by your organization to ensure HIPAA compliance.

Examine HIPAA violations

Mistakes happen, whether you discover them, an auditor, or authorities. If HIPAA violations are discovered, systems should be in place to undertake root cause analysis and remediation so that the problem does not reoccur.

HIPAA Compliance Checklist 2024

Step 1: Learn about four HIPAA rules

Maintaining HIPAA compliance effectively depends on a deep and adequate understanding of four HIPAA rules: the Privacy rule, the Security rule, the Omnibus rule, and the Breach notification rule. Organizations have to be aware of HIPAA requirements and keep up with the necessary technical standards in order to implement the needed safeguards, policies, and procedures. Keep reading to discover the detailed information on the rules.

Step 2: Find out which HIPAA rules apply to your company

Outlining relevant rules and standards results in clear and accurate limitations. It is essential to specify what category of organizations your company belongs to (covered entities or business associates). Based on the type of services your company provides, find out the rules you have to follow. For example, covered entities need to implement safeguards stated in the Privacy Rule to protect not only electronic PHI, but all PHI in general. So, get aware of the requirements relevant to your business while starting your HIPAA compliance journey.

Step 2: Assign a privacy officer

HIPAA compliance is simple to handle when assigned to a responsible person or department. A smart approach is to assign a privacy officer to supervise all compliance aspects. Privacy officer deals with the adequacy of the PHI use and disclosure. The officer is responsible for creating and applying PHI policies and procedures, working with patient requests for medical records access, and training employees on privacy HIPAA requirements.

Step 3: Assign a security officer

Having a security officer is vital for an organization. The security officer is responsible for safeguarding PHI, mainly electronic PHI (ePHI). The duties include specifying and applying security measures, like data encryption and access controls, to protect ePHI. The officer also manages risk assessments to detect vulnerabilities in the security system, and addresses data breaches and reports them to the Department of Health and Human Services if needed.

Step 4: Implement the required safeguards

There are the required standards you have to follow to achieve compliance. Each rule involves a range of policies and procedures. For example, the HIPAA Security Rule emphasizes three safeguards categories essential to protect PHI: administrative, physical, and technical. Their implementation results in a successful HIPAA compliance journey.

Step 5: Conduct regular HIPAA risk analysis

You have to apply a regular HIPAA risk assessment procedure. Organizations that follow HIPAA regulations conduct a security HIPAA audit regularly, making risk assessment continuous. This is necessary for achieving HIPAA compliance since it allows you to detect flaws and vulnerabilities to avoid data breaches and other cyber threats. The risk analysis also ensures that administrative, technical, and physical safeguards are effectively implemented, and that all relevant controls are in place.

Step 6: Hold documentation

The important part of a HIPAA compliance checklist is thorough documentation. All processes, policies, and procedures of PHI security should be registered and recorded in your company. HIPAA documentation should also involve keeping track of policies and procedures structure changes as they are updated, as well as the information on which entities and business associates you shared PHI with.

It is a smart decision to record all the HIPAA compliance activities to detect and mitigate security incidents instantly. At TechMagic, we practice having it all in one place to make HIPAA compliance requirements more apparent and beneficial in case of a data breach.

Step 7: Train employees on HIPAA policies and procedures

The important step in maintaining HIPAA compliance is to ensure that employees in your company are aware of the HIPAA compliance process and the policies they are obliged to follow. The overall HIPAA compliance awareness within a company results in the decreased number of HIPAA violations.

Step 8: Investigate violations and learn from them

If a HIPAA violation occurs, your business should investigate the reason why it happened. It is a chance to tighten security controls or update processes to ensure that such an occurrence does not turn out again. HIPAA violations point out the vulnerabilities and HIPAA non compliance aspects, so take them into account and enhance the HIPAA compliance process in your organization.

Step 9: Report data breaches and security incidents instantly

In case your company faces security incidents, a responsible person has to send a breach report to the Secretary of Health and Human Services during 60 days of the breach incident. It is necessary to follow the Breach Notification Rule, according to which a company is obliged to inform all the individuals whose PHI was disclosed. If a data breach touches more than 500 individuals, it is compulsory to let local media know about the incident.

Step 10: Always keep up-to-date on the HIPAA compliance policies and procedures

Never stop to monitor and update your HIPAA compliance process. Tracking the changes in rules, requirements and federal law will help you to avoid potential hipaa violations.

HIPAA Privacy Rule

HIPAA Privacy Rule is a set of national standards to prevent unauthorized access to medical records and identifiable health information of patients (together defined as PHI). It provides people with primary control over their health information. The rule applies to health plans, healthcare clearinghouses, and healthcare providers facilitating electronic health records and transactions. These organizations must have adequate constraints and conditions on using and disclosing PHI.

The Privacy Rule break example:

After a theft of a laptop containing ePHI of 1,391 individuals from an employee vehicle, a wireless health service provider had to pay $2.5 million to address suspected HIPAA Privacy Rules breaches. ‌At the time of the theft, there was an insufficient risk analysis procedure and inadequate management systems, according to the inquiry. Furthermore, the HIPAA Privacy Rule policies and procedures were in a draft form. The organization failed to develop clear and effective policies and procedures for safeguarding ePHI.

HIPAA Privacy Rule guidelines

Implement documented behavior standards

Compose the lists of training requirements and written consequences for HIPAA non compliance and ensure your employees are aware of all the rules and procedures.

Sign business associate agreements

When cooperating with a business associate, ensure you have detailed, up-to-date business associate agreements to shield your company from liabilities in case the business associates violate HIPAA regulations. While composing business associate agreements, make sure to mention all the required security measures to monitor PHI usage, disclosure, and other security incidents.

Procedure for filing complaints

Implement mechanisms that allow patients to register a complaint against a covered entity concerning HIPAA compliance. Remind patients that concerns may also be addressed to the HHS Office for Civil Rights.

Paperwork and record retention

Records of all privacy policies and procedures, practice notifications, complaints, remediation plans, and other documentation must be kept for six years after they are created. Despite the fact that the purpose of the Privacy Rule is to protect PHI, it also allows for information among providers who need to use it to deliver the best patient care possible using HIPAA compliance checklist.

HIPAA Security Rule

HIPAA Security Rule provides precise restrictions to prevent data breaches in the production, distribution, storage, and disposal of electronically protected health information (ePHI). Since HIPAA Security Rule implementation, the rule has been utilized to manage patient confidentiality in the face of evolving technologies. With the rise of cloud computing and distant document exchange, protecting ePHI is more vital than ever.

The Security Rule break example:

The OCR examined a health insurance company after hackers accessed the PHI of roughly 10.5 million people. The hackers accessed the provider computer system with a phishing email containing malware. The malware provided the organization with access to ePHI and stayed undiscovered for 9 months. ‌
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‌The corporation was penalized $6.85 million by the OCR for breaching the HIPAA Security Rule. ‌
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A multi-state case was also resolved for $10 million, as was a class action lawsuit for $74 million.

HIPAA Security Rule requires covered organizations to keep reasonable and necessary administrative, technical, and physical safeguards in place to secure electronic protected health information (ePHI). Some examples are:

• Ensure the confidentiality, integrity, and availability of all ePHI created, received, maintained, or transmitted
• Identify and protect against reasonably anticipated threats to the security or integrity of the information
• Safeguard against reasonably anticipated illegal uses or disclosures

To maintain the confidentiality, integrity, and security of electronically protected health information, the Security Rule in the HIPAA compliance checklist for software development requires sufficient administrative, physical, and technical safeguards.

Administrative safeguards

Administrative safeguards in HIPAA relate to rules and processes that clearly illustrate how the company and its employees have to comply with HIPAA while using and storing PHI.

Administrative safeguards aim to:

• Master employees skills on PHI security measures
• Address security incidents that put PHI under risk

Administrative safeguards involve:

• Risk audit evaluations
• Risk management policy implementation
• Assigning a privacy officer
• Third-party access to ePHI should be restricted
• Creating a backup plan in case of an emergency
• Employee cybersecurity training is available

Physical safeguards

Physical safeguards aim to ensure security of the physical devices which have access to PHI. Physical safeguards are necessary to avoid sensitive information breaches through the inefficient security of employees desktops and mobile devices.

Some examples of physical safeguards are:

• Making policies for the workstations use and placement
• Create policies and procedures for mobile devices usage
• Setting alarm and security systems

Technical safeguards

Technical safeguards relate to the measures used to protect against unauthorized access to ePHI.

Technical safeguards include:

• Access controls implementation
• Antivirus software
• Data encryption and decryption technologies
• Automatic log-off PCs and gadgets

HIPAA Omnibus Rule

HIPAA Omnibus rule, one of the most recent amendments to HIPAA, broadens the scope of regulated companies beyond Covered Entities. As a result of the present outcome, the covered entity will be held liable for any possible data security breaches committed by its business partners and subcontractors. It made blaming the partners for upping the safety requirements more difficult.

The Omnibus Rule break example:

The city of New Haven reported a patient data breach after a terminated employee used their login credentials to access a work computer and transfer ePHI data onto a USB drive. ‌
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‌‌According to OCR, the city failed to protect HIPAA omnibus rule in various ways. At the time of their termination, the city had not deactivated the former employee login credentials. Employees were also not provided individual login passwords to track their system activities and contacts with ePHI.‌
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‌In addition, the company failed to conduct a risk assessment to identify possible risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI. As a result, the city committed to a remedial action plan and paid over $200,000 in financial penalties.

The Omnibus Rule states that any unauthorized use or disclosure of personal health information is a breach. This has undoubtedly increased reported data breaches each year.

HIPAA Breach Notification Rule

HIPAA Breach Notification Rule outlines the steps to take in case of a data breach. This guideline considers that no system is completely secure and that it is preferable to have a clear strategy for what to do in an emergency. Breach Notification Rule specifies how affected patients should be notified and what efforts should be taken to reduce the damage.

The Breach Notification Rule break example:

A specialist clinic had to pay $150,000 to address suspected HIPAA breaches. An unencrypted thumb drive containing the ePHI of around 2,200 people was taken from the car of a clinic employee. ‌
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‌The inquiry discovered that, as part of its security management approach, the clinic had not properly or completely examined the possible threats and vulnerabilities to the confidentiality of ePHI. ‌
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‌In addition, the clinic failed to meet the Breach Notification Rule requirements for documented rules and procedures and personnel training.

The procedures of the HIPAA Breach Notification Rule

Plan for notifying affected persons

Affected patients must be notified in writing about what has happened to their data within 60 days.

Plan for public transparency

If a data breach affects more than 500 people, the impacted organization is required to make a public statement through key local media.

Deadline in two months

The legislation requires that the results of a data breach be disclosed within 60 days.

Notify the Secretary of Health

If the event impacts more than 500 or more persons, covered entities must inform the Secretary as soon as possible and no later than 60 days after the breach. If it impacts less than 500 persons, the deadline is extended until the end of the year or annually.

All healthcare organizations that store, use, or transmit PHI are responsible for ensuring that the appropriate HIPAA compliance controls are in place and that the policies and procedures are recorded and updated to comply with HIPAA requirements.

Real use case of HIPAA Compliance at TechMagic

In this part of the HIPAA Compliance checklist, we describe a success story of our client on increasing the effectiveness and security of a product.

Our client is a USA-based connected healthcare pioneer with over 60 speciality care locations that provide complete injury treatment to patients injured in accidents. Putting the patient in the center stage, our client uses an advanced online platform to close the communication gap between the doctor, the patient, the insurance company, and the lawyer.

Initial context

For 15 years, we have been working and scaling up together. Since then, we've steadily shifted from paper to digital document flow, putting together all information about patients and related accidents.

We assemble a team of .NET and Vue.js tech specialists consisting of three software engineers, two QA specialists, an architect/CTO and a project manager. In regular meetings, we discuss future improvements and new features development while tracking and managing their development progress in Jira.

Our team concentrated on platform development to give users - both doctors and patients - the possibility to record, store and exchange any information, starting with patient data and ending with a detailed treatment plan after the accident, billing and payment details, and documents for the insurance company and employer.

Step by step, our engineers add innovative features for a multi-functional platform, such as a built-in calendar for appointments, an application to fill in initial patient information and integrate the platform with third-party providers, like telecom or transportation providers.

Challenges

The system operates with an immense volume of data, including appointment details, diagnosis clarifications, treatment plans, medical and insurance reports, recipes, medical certificates on sick leaves, and patient personal information. A lot of data is interdependent. The major challenge with the further growth of the platform is to manage it correctly between the users and to arrange it in clear and readable documents for other end users and state authorities.

For product security, we followed the HIPAA security compliance checklist:

• Restricted the extent of critical PII/PHI data exposure
• Limited the number of devices that may currently login to a single account and configure the session expiration time
• Managed data transfer between users and the server
• Managed permissions for different roles - doctors, back office employees, call-center staff
• Isolated database access with role-based authentication that only accepts connections from the internal network
• Applied e-signature authentication
• Detected unknown application login attempts and access limiting for suspect users
• Strengthened password guidelines
• Conduct regular long-term storage backups and stringent access controls for sensitive data to keep track of activities

With our proficiency in developing integrations, EHR systems, custom healthcare solutions, and competence in building HIPAA-compliant software, we successfully handled all project challenges.

Conclusion

One of the most important aspects of bespoke healthcare software development is compliance with HIPAA and other industry rules, regulations, and standards.

“Every Covered Entity and Business Associate that has access to PHI must ensure the technical, physical and administrative safeguards are in place and adhered to, that they comply with the HIPAA Privacy Rule to protect the integrity of PHI, and that – should a breach of PHI occur – they follow the procedure in the HIPAA Breach Notification Rule.”

It’s important to know how your medical organization may be affected. Our HIPAA compliance software checklist will help you stay aware of efficient and reliable patient health information protection.

As you can see, many steps are involved in the HIPAA compliance technology checklist. It is needless to say, staying up-to-date on the latest HIPAA requirements is crucial. Even with a HIPAA compliance summary, acquiring complete compliance is a lengthy process — where the HIPAA provider comes in.

For 8+ years, TechMagic has delivered healthcare software development services to help healthcare startups become HIPAA compliant and meet all HIPAA regulations. If you plan to have a healthcare software development product that may be subject to HIPAA requirements, contact us and we will guide you across all security standards and software development.

HIPAA compliance resources

And if there is one thing we have learned about maintaining HIPAA compliance, you should always stay up-to-date on the latest HIPAA compliance requirements. So, there is a list of HIPAA compliance and security measures resources to monitor updates on HIPAA compliance in 2024:

• Official HHS CSC HIPAA Website
• Calculated HIPAA
• Center for Disease Control
• FAQs about the Disposal of Protected Health Information
• Business Associate Contracts and Business Associates FAQs
• Privacy, Security, and HIPAA
• Security Rule Guidance Material
• Special Topics in Health Information Privacy

FAQs

1. What is a HIPAA compliance checklist??

   A HIPAA compliance checklist is a useful instrument that helps organizations get aware of the steps they have to follow to protect the identifiable health information of their customers and achieve compliance with the Health Insurance Portability and Accountability Act (HIPAA). The compliance checklist can be used by covered entities and business associates.

2. How to follow a HIPAA compliance checklist?

   Ensure that data security measures are HIPAA-compliant and follow our HIPAA compliance checklist with all administrative, physical, and technical safeguards, Security, Privacy, Breach Notification and Omnibus Rules.

3. Who is this HIPAA compliance checklist for?

   This HIPAA compliance checklist is useful for you if you are a Privacy Officer, Security Officer, or any representative of a covered entity or business associate groups aiming to keep up with a compliance checklist.

4. What does HIPAA compliance mean?

   HIPAA compliance refers to adherence to the standards and procedures of the HIPAA Privacy, Security, Breach Notification, and Omnibus Rules.

5. Why is maintaining HIPAA compliance important?

   Is it essential to follow the ultimate HIPAA compliance checklist as HIPAA compliance protects vulnerable patient data and proclaims security measures to prevent unauthorized access, use, or disclosure of PHI. This results in patient security, satisfaction and trust.

6. What are the consequences of not maintaining HIPAA compliance?

   As for healthcare providers, the consequences of not following the HIPAA compliance requirements are security incidents resulting in criminal charges, financial penalties, reputational damage, corrective action plans or suspension and termination of right to provide health and human services. As for patients, in case of neglecting the HIPAA compliance requirements by a medical organization, they at risk of becoming victims of their personal vulnerable data disclosure.

7. What are the HIPAA rules?

   The HIPAA rules are Security Rule, Privacy Rule, Breach Notification Rule, and Omnibus Rule.

8. Who must comply with the HIPAA Security Rule?

   All the individuals and organizations that have access to identifiable health information and known as covered entities or business associates must comply with the HIPAA Security Rule.

9. What are covered entities and business associates?

   Covered entities include healthcare providers, health plans, and healthcare clearinghouses. Business associates involve people and organizations having access to PHI while cooperating with covered entities in a non-healthcare role.

10. Is employee training necessary under HIPAA?

    Yes, employee training is compulsory for any covered entity and business associate that deals with PHI.

11. Can I get a fine for an unintended HIPAA violation?

    Yes, you can get a fine for an unintended HIPAA violation. It doesn’t matter if HIPAA violations are unintentional or not, they lead to severe consequences. PHI is sensitive data, and its disclosure could result in identity theft or insurance fraud. That is why it is essential to follow our HIPAA compliance checklist.