HIPAA Compliance Checklist For Software Development: Tips For Maintaining HIPAA
Health technology is one of the markets that is rapidly expanding. The global healthcare IT industry is currently valued at $167.7 billion this year, with a CAGR of 17.9% predicted to reach $609.1 billion by 2030.
Do you want to create an app to help patients and healthcare providers? The first step is to ensure HIPPA compliance for your app. To guarantee that HIPAA compliant software development is completed accurately, it is crucial to focus on PHI confidentiality, integrity, and accessibility.
So, what is HIPPA compliance for software development, and how can you guarantee that your app obliges to these rules? Join Savvycom and let’s find out in our guide.
What is HIPAA Compliance?
The Health Insurance Portability and Accountability Act (HIPAA) is a federal law enforced in 1996 to ensure the safety and confidentiality of sensitive patient health information, also known as Protected Health Information (PHI).
This act sets out specific regulations and standards that healthcare providers, health plans, and healthcare clearinghouses are required to follow to protect PHI. It also applies to software vendors that develop solutions for the healthcare industry that handle, store, or transmit PHI electronically.
Protecting PHI and ePHI from unauthorized access, disclosure, alteration, or destruction is crucial in the healthcare industry. Compliance is vital in establishing trust and confidence among patients and medical providers.
Here are why your healthcare app should be HIPAA-compliant:
- Failure to comply with HIPAA may result in significant fines and brand reputation damage.
- Since HIPAA establishes clear criteria for handling and protecting PHI, it can help to prevent illegal access, use, or disclosure.
- By respecting HIPAA standards, you can help build patient trust and demonstrate that you value their privacy.
- Some healthcare providers and payers may only collaborate with HIPAA-compliant app developers. Compliance can broaden your potential consumer base and enhance income opportunities.
- HIPAA-compliant software can save you from costly fines, boost patient trust, and expand your potential consumer base. That is why your software must adhere to HIPAA compliance rules.
Who needs to follow HIPAA compliance?
The parties mentioned below are those mandated for HIPAA requirements:
- Healthcare providers
This category included doctors, nurses, psychologists, dentists, chiropractors, and other individuals or businesses who provide healthcare services. This covers hospitals, clinics, nursing homes, and other healthcare facilities. HIPAA requires healthcare professionals to safeguard patients’ health information, whether it is stored on paper or electronically.
- Health plans
Insurance companies, health maintenance organizations (HMOs), and other entities that pay for healthcare services fall into this category. Medicare and Medicaid are examples of both private and governmental health programs. HIPAA requires health plans to safeguard their members’ health information, such as medical records, insurance claims, and payment information.
- Healthcare clearing houses
These are entities that manage healthcare transactions for healthcare providers and health plans, including billing and claims processing. These may include companies that offer electronic health record (EHR) software or medical billing services. It is mandatory for healthcare clearinghouses to maintain the confidentiality and security of the healthcare data they handle, as per HIPAA regulations.
- Business associates
Individuals or businesses that provide services to healthcare providers, health plans, or healthcare clearinghouses, including access to patients’ health information, are considered business associates. Billing companies, IT support companies, and law firms that provide legal services to healthcare providers are all examples of business associates. HIPAA requires business partners to sign a contract with the covered company indicating that they will comply with HIPAA’s privacy and security obligations.
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Requirements Of HIPAA Compliance
HIPAA compliance refers to following the set of standards, rules, amendments, and legislation outlined by HIPAA. Generally, HIPAA has strict regulations with severe penalties while also offering flexibility in how the rules are applied, making it somewhat ambiguous.
1. HIPAA Privacy Rule
The Privacy Rule guidelines were established to safeguard the use and disclosure of medical records and other PHI, to enhance the flow of health data while preventing fraud and theft. Additionally, the rule gives patients certain rights pertaining to their health information, such as the ability to view, obtain a copy of, and request modifications to their records.
2. HIPAA Security Rule
The Security Rule mandates regulations to protect ePHI generated, received, used, or maintained by covered entities. As per the Security Rule, covered entities must establish “appropriate administrative, physical, and technical safeguards to maintain confidentiality, integrity, and security” of ePHI. Although HIPAA does not always specify exact or minimum requirements, reference to the NIST guide for implementing HIPAA is customary (note: a revision is forthcoming).
3. HIPAA Enforcement Rule
The Enforcement Rule outlines the procedures that the Department of Health and Human Services (HHS) follows to enforce HIPAA regulations, which includes determining responsibility and imposing penalties for non-compliance. Complaints or data breaches typically trigger investigations, but HHS can initiate an investigation without a specific cause.
4. Breach Notification Rule
HIPAA-covered entities and their business associates are required to comply with the Breach Notification Rule, which mandates the notification of a breach of unsecured PHI, regardless of whether it is paper-based or electronic. The HHS specifies the criteria to determine if a breach has occurred, including the type and amount of PHI involved, the kind of disclosure, whether the data was viewed, and the level of exposure risk. Furthermore, any breach that impacts over 500 residents must include a media notice and other necessary measures.
5. Omnibus Rule
HIPAA’s Omnibus Rule, updated in 2013, is a set of modifications to the Privacy, Security, and Enforcement Rules. These changes are more stringent, making it difficult to avoid breach notifications, extending non-compliance liability to business associates, and implementing new privacy restrictions for using PHI.
HIPAA compliance checklist for software development
- User authorization
HIPAA Compliance hinges on a critical aspect of limiting PHI access solely to authorized individuals. This mandates the implementation of stringent user authentication and authorization mechanisms on the platform. This entails creating unique accounts for each user, enforcing robust passwords, and adopting multi-factor authentication. Additionally, platform administrators must be able to supervise user accounts, such as revoking access for inactive users and assigning access levels based on user roles.
- Remediation plan
The next crucial factor to consider is creating a remediation plan in case of a security breach. This involves outlining the steps to take if the system is compromised or data is leaked. The recovery plan should specify protocols for informing users and regulatory bodies, along with measures to address the root cause of the security breach.
- Emergency mode
It is essential for the platform to feature an emergency stop mode which enables authorized platform administrators to promptly access the PHI during unforeseen circumstances like security breaches or natural disasters. This mode should be restricted to only authorized personnel.
- Activity monitoring
To ensure the safety of sensitive information, the platform should have tools to oversee user activity and regulate access to PHI. This involves keeping audit logs that document all user actions pertaining to PHI access. Additionally, the platform should have means to observe network activity and identify any irregularities that could signal a security breach.
- Data backup
You must consistently create backups of your crucial data and store them securely to avoid potential loss, damage, or unauthorized access. Moreover, you need to frequently verify the accessibility and ability to restore your backup data when necessary.
Now, we will cover the practices to ensure your software’s HIPAA compliance:
|Point to consider and implement||Practices to fulfillment|
|Data access management||
|Product integrity||Separate the system infrastructure into two layers: a data layer and a system layer|
|Credible user authentication||
|Protected data transferring||
Steps to make software HIPAA compliant
Step 1. Solution design
In this initial phase, we collaborate with you to determine your project’s fundamental objectives and thoroughly grasp your business’s context.
Subsequently, we arrange a meeting with our Solution Team to delve further into your project and clarify your specifications. Our Solution Design team, comprising business analysts (BAs), a solution architect (SA), and a designer if required, will evaluate your application and preliminary details. This team works closely with you to specify your business requirements and provide a preliminary estimate for your project.
This comprehensive process guarantees that we comprehend your necessities entirely and provide a healthcare solution that satisfies your expectations.
Step 2: Analysis and planning
It’s important to take the time to properly analyze and plan before jumping into coding. This includes identifying the necessary technology and business requirements and developing a solid implementation plan. Additionally, it’s crucial to consider any HIPAA compliance needs that may apply.
Working with a business analyst can be helpful in collaboratively creating a comprehensive feature list. At Savvycom, our experienced BAs are adept at studying requirements and mitigating risks to ensure successful project outcomes.
Step 3: UI/UX design
The designer creates design layouts establishing the software’s user interface and interaction during this stage. It is crucial for the designer to ensure that the UI does not include any sensitive information and complies with HIPAA regulations.
Step 4: Healthcare software development
During this phase, the software’s functional components are designed and tested for compliance with HIPAA regulations. The software engineers work with secure coding practices to establish a framework that safeguards PHI against unauthorized access while guaranteeing data confidentiality, integrity, and availability. They also incorporate technical safeguards, such as access controls, encryption, and secure data transmission, to prevent any breaches.
Step 5: Release and support
Once the development phase is complete, it is critical to release and deploy the HIPAA-compliant software on relevant systems. This ensures smooth interaction with existing systems and proper functionality. The deployment process should be done in a way that minimizes any potential disruptions to ongoing operations.
When working with HIPAA-compliant software, it is critical to have access to post-development support. This entails having support ready to promptly resolve any issues or concerns that may occur, such as security incidents or compliance audits. It is also critical that the software provider provides frequent upgrades and maintenance to guarantee that the program stays HIPAA compliant and fits the evolving needs of healthcare companies.
Practices to maintain Persistent HIPAA Compliance
Wondering how to create HIPAA compliant software that can last for a long time? To ensure that your solution remains relevant and up-to-date, it’s essential to follow these procedures regularly:
- Infrastructure access management
It’s crucial to ensure employees can access the information and resources they need without violating HIPAA regulations. To achieve this, it may be necessary to restrict access to specific data and create accounts only for employees who require it.
- Cybersecurity practices implementation
Data protection is a vital component of the HIPAA Act. To do this, cybersecurity measures such as network security, virus protection, and improved access restrictions must be implemented.
- Access operation
Practice regularly reviewing and restricting access to sensitive information to prevent unauthorized access to data. It is important to manage employee accounts by removing inactive ones and restricting access to information that is not necessary for their work.
- Data encryption
According to the HIPAA software development guidelines, data encryption is critical to security. It is suggested that data be encrypted during transmission and storage to ensure its security in case of a security compromise.
- Periodic verifications
It is critical to conduct routine audits to verify complete conformity to HIPAA standards for systems and processes. These audits must include extensive evaluations of policy and procedure, access control assessments, data encryption examinations, and other critical cybersecurity checks.
- Specialist training
Employees who work with medical information must be trained and made aware of HIPAA principles and requirements. Every employee must be trained on data security and related policies and comprehend the value of medical privacy.
- Long-term risk assessment
Finally, long-term risk assessment
is critical for meeting ongoing obligations. This includes regularly revising rules and procedures, reviewing policies and processes when the legislation changes, and continuously monitoring security systems for vulnerabilities.
HIPAA software compliance is a complex procedure requiring initial compliance and ongoing monitoring and support. Following these guidelines will assist you in maintaining continuing HIPAA compliance while also providing a high level of medical privacy protection. However, hiring a certified IT services provider with good domain experience is the most dependable method to make your software HIPAA-compliant and competitive for a long time.
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HIPAA stands for the Health Insurance Portability and Accountability Act, a U.S. federal law that sets the standards for protecting sensitive patient health information. HIPAA compliance refers to the process of adhering to these standards to ensure the privacy and security of patient data.
Software developers play a crucial role in ensuring that healthcare applications and systems handle patient data securely and in accordance with HIPAA regulations. Compliance helps maintain the confidentiality, integrity, and availability of sensitive health information, protecting patients' privacy rights and reducing the risk of data breaches.
Some important elements to include in a HIPAA compliance checklist for software development are:
- Implementing technical safeguards: This includes encryption, access controls, audit logs, and secure transmission of data.
- Conducting regular risk assessments: Identifying and addressing potential security vulnerabilities and risks in the software application or system.
- Ensuring physical security: Protecting the physical infrastructure where the software is hosted, such as data centers, with appropriate measures like access controls and monitoring.
- Establishing policies and procedures: Developing and enforcing clear guidelines for employees, contractors, and users regarding data handling, access controls, incident response, and training.
- Secure software development practices: Incorporating security measures throughout the software development lifecycle, including secure coding practices, vulnerability assessments, and penetration testing.
- Secure data storage and transmission: Implementing encryption and secure protocols when storing or transmitting patient data.
- Providing user authentication and access controls: Ensuring that only authorized individuals can access patient data and that access levels are appropriate for each user's role.
- Regularly updating and patching software: Applying security patches and updates promptly to address vulnerabilities in the software and its dependencies.
- Monitoring and auditing: Implementing systems to detect and investigate any unauthorized access or breaches, as well as conducting regular audits of the software and its security controls.
Are there any specific programming languages or frameworks that are recommended for HIPAA-compliant software development?
While HIPAA compliance requirements focus more on the implementation and security measures rather than specific programming languages or frameworks, developers should choose languages and frameworks that have good security track records and provide robust tools for data protection. Popular choices include Java, C#, Python, and frameworks like Spring, .NET, and Django.
HIPAA compliance assessments should be conducted regularly to ensure ongoing adherence to the regulations and to identify any new risks or vulnerabilities. The frequency of assessments may vary depending on factors such as the complexity of the software, changes in regulations, and the organization's risk management strategy. Typically, assessments are performed annually or whenever significant changes are made to the software or its environment.
Non-compliance with HIPAA regulations can result in severe consequences for organizations, including financial penalties, legal liabilities, reputational damage, and loss of trust from patients and partners. The penalties for HIPAA violations can range from fines of up to $1.5 million per violation category per year to criminal charges, depending on the severity and intent of the violation.
Yes, cloud-based software applications can be made HIPAA compliant. However, it requires careful selection of a cloud service provider (CSP) that offers appropriate security measures and complies with HIPAA regulations. The software development team must also implement additional safeguards to ensure data privacy and security when utilizing cloud infrastructure.
If a software application experiences a data breach involving patient information, the following steps should be taken:
- Identify and contain the breach: Immediately isolate affected systems and limit further unauthorized access.
- Notify the appropriate parties: This includes the affected individuals, the organization's legal and compliance teams, and, if necessary, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR).
- Investigate and assess the breach: Determine the scope of the breach, the information compromised, and the potential impact on affected individuals.
- Mitigate the breach and prevent future incidents: Address the vulnerabilities that led to the breach, implement corrective measures, and update security protocols to prevent similar incidents in the future.
- Comply with reporting requirements: Follow HIPAA guidelines for reporting the breach, including notifying affected individuals within a specified time frame.
HIPAA compliance is an ongoing effort that requires continuous monitoring, assessment, and improvement. Technology evolves, new security threats emerge, and regulatory requirements may change over time. Therefore, software developers must regularly review and update their compliance measures to stay current with HIPAA regulations and best practices.