The digital transformation is changing every industry. The healthcare industry is no different.
This advancement in healthcare is bringing new opportunities for innovation but also requires us to protect sensitive patient data.
Today, when data breaches are common, maintaining patient trust and sensitive medical records is crucial. That is why following HIPAA rules is not just a legal obligation but an ethical duty as well.
This blog is equipped with a checklist designed to provide the knowledge required to build secure, HIPAA-compliant healthcare applications.
What is HIPAA Compliance?
HIPAA stands for the Health Insurance Portability and Accountability Act of 1996. This federal law in the United States protects health information.
It sets rules for how to secure and manage protected health information (PHI). PHI includes personal data like your name, date of birth, biometric data, vehicle information, social security number, payment details, contact information, and photos.
Protecting PHI is more important than ever, especially as healthcare organizations increasingly use cloud computing and digital systems.
Understanding HIPAA Compliance's Relevance to Software Development
HIPAA is a U.S. law designed to protect sensitive patient data. Any business handling protected health information, including healthcare providers, insurers, and software developers, must comply with HIPAA regulations.
Software developers help ensure HIPAA compliance in healthcare software development by using security practices like data encryption, user authentication, access controls, and regular risk assessments. By focusing on compliance from the start, developers help healthcare businesses avoid legal issues and keep patient data safe.
HIPAA Privacy Rule
This rule sets national standards to protect patient health information (PHI). It controls how healthcare providers and other organizations can use and share PHI. It also gives patients rights over their own information.
The Security Rule
This rule focuses on protecting electronic PHI (ePHI). It sets standards for keeping data safe, both when it is stored and when it is sent. It requires administrative, physical, and technical measures to ensure the confidentiality, integrity, and availability of ePHI.
The Data Breach Notification Rule
This rule requires organizations to inform affected individuals, the Department of Health and Human Services (HHS), and sometimes the media if there is a breach of unsecured PHI.
The HIPAA Omnibus Rule
The HIPAA Omnibus Rule requires covered entities, business associates, and their subcontractors to protect patients' health information, known as Protected Health Information (PHI). These groups are directly responsible for keeping this information safe.
The rule increases fines for not following these requirements, which can be as high as $1.5 million for each violation, depending on severity. It also enhances patient rights by allowing individuals to request electronic copies of their health records and limiting some sharing of their health information.
Also, the rule specifies stricter measures for auditing and monitoring compliance with HIPAA security and privacy standards to ensure accountability in the healthcare system.
How HIPAA Compliance Impacts Software Development?
HIPAA compliance process affects software development significantly. Developers need to ensure compliance at every stage of the software development process. Key areas to consider include:
- Data Storage: Use secure databases and storage solutions to protect PHI.
- Data Transmission: Encrypt data when it is sent between systems and devices.
- Access Control: Create systems with strong access controls, such as role-based access and authentication.
- Audit Logging: Implement thorough logs to track who accesses data and when changes are made.
- API Security: Secure APIs to prevent unauthorized access to PHI.
- Data Minimization: Collect and use only the necessary data.
Who Needs to Comply with HIPAA?
HIPAA is important for all healthcare organizations, but it is not a one-size-fits-all rule.
The regulation distinguishes between two main groups: covered entities and business associates, each with different responsibilities.
HIPAA covered entities are the main healthcare providers. This group includes healthcare organizations, hospitals, doctor's offices, health insurance companies, and healthcare clearing houses. These organizations handle patient health information (PHI) directly and are responsible for protecting it.
Business associates are individuals or organizations that use or share PHI on behalf of a covered entity. This includes software developers making healthcare applications, cloud storage providers that handle patient data, and billing services.
In a nutshell, if you access, store, transmit, or manage PHI, you must address HIPAA compliance requirements and follow its rules.
HIPAA Compliance Software Development Checklist
Developing software for healthcare needs to follow HIPAA rules. This HIPAA compliance journey helps avoid fines and build trust with patients. Over 540 organizations reported health data breaches to the HHS Office for Civil Rights (OCR), which affected 112 million people. Here’s a quick HIPAA compliance software checklist.
1. Implement Secure User Authentication
HIPAA-compliant systems must ensure secure user login for all users. This includes even patients and health personnel. There are varied ways to implement secure user authentication, such as:
- Passwords-based authentication
- Biometric methods like fingerprints or facial recognition
- Multi-factor authentication
2. Incorporate Data Access Controls
Limiting who can access specific data in your application is critical for maintaining HIPAA compliance.
It is one of the most essential pointers to be followed in the hipaa compliance checklist in which software developers need to define clear access control policies to protect patient information from unauthorized access. This ensures that only authorized personnel can access protected health information (PHI).
These policies specify who can view certain data and what actions they can take with it. For instance, only specialized doctors may access sensitive health information.
The NIST Cybersecurity Framework provides a clear guide for protecting your organization’s data. So, to ensure HIPPA compliance, developers should follow this framework to implement effective cybersecurity measures.
Technical safeguard controls: These prevent or respond to unauthorized access, use, or changes to your information system. This involves using tested hardware, software, and networking devices.
Operational controls: These manage healthcare system functions and restrict access to information based on user roles.
Recommended Read: Why Node.JS for Healthcare App Development is the Smart Choice?
3. Implement the Essential Policies and Procedures
To protect patient health information (PHI) and follow HIPAA rules, developers need to implement specific policies and procedures in healthcare systems. Here are some key ones:
For the HIPAA Privacy Rule, you should establish a record retention policy, allow patients to prevent access to their PHI and confidential communication, and create a workers’ compensation policy.
For the HIPAA Security rules, you can set up policies for password creation and use, disaster recovery, access management, and risk management.
For the Breach Notification rule, you should include an internal notification policy, guidelines for notifying about privacy breaches, an incident response policy, and a mitigation policy.
4. Secure Data Transmission
Healthcare providers and their partners must protect patient health information (PHI) by encrypting it when it is sent over networks and when it is stored on portable devices like hard drives and USB drives.
Technical safeguards are crucial in securing data transmission, ensuring that electronic protected health information (ePHI) is protected from unauthorized access and alterations. These safeguards, which are part of HIPAA security compliance, include measures like antivirus software and encryption to maintain the confidentiality, integrity, and security of sensitive patient data.
The HIPAA Security Rule allows the use of encryption methods that require a passphrase or key file and requires that backup media be encrypted by default. Developers must use standard encryption methods when sharing sensitive patient information over a network.
5. Encrypt Backup and Storage
The HIPAA Security Rule requires companies to encrypt all electronic protected health information (ePHI) stored on mobile phones or desktop computers. This means you must ensure that any sensitive information kept on a user's device is encrypted.
Additionally, ePHI must be backed up according to a written emergency plan, though specific encryption methods for backups are not detailed. The HHS Office for Civil Rights requires that electronic protected health information stored on application servers or shared drives also be encrypted.
6. Ensure Data Integrity
Keeping data integrity is crucial for following HIPAA rules. It is one essential aspect of the HIPAA Privacy Rule. This requires covered entities to create policies and procedures to protect the privacy and accuracy of both PHI and electronic protected health information.
To meet the requirement for data accuracy, your healthcare application must protect PHI and ePHI from loss, destruction, tampering, unauthorized access, and both accidental and intentional destruction.
7. Create a Breach Reporting Plan
Under HIPAA’s breach notification rule, developers must prepare a report plan for any breach affecting 500 or more individuals to the Secretary of Health and Human Services within 60 days.
Breaches affecting fewer individuals should be reported within 60 days after the end of the calendar year.
Having a clear internal plan for breach reporting is crucial when building HIPAA compliant software. It can ensure your HIPAA compliance by quickly detecting breaches and responding appropriately.
8. Train on HIPAA Compliance Procedures
HIPAA compliance training is required for organizations covered by the law. For this, you can appoint a dedicated staff member as the HIPAA Compliance, Privacy, and Security Officer.
The purpose of this training is to:
- Lower the chances of policy violations and non-compliance.
- Strengthen security measures and practices throughout the organization.
- Communicate data security, physical security, and privacy policies and procedures to all employees.
- Limit access to Protected Health Information (PHI) to only those employees who need it for their jobs.
9. Conduct HIPAA Activity Audit
Under HIPAA rules, organizations must keep a log called the Activity Audit Log (AAL). This log should record detailed information about all employees' access to electronically protected health information. It must include both allowed and unauthorized access by these employees.
The main purpose of an activity audit is to show that actions were done according to set standards or guidelines. Organizations often use activity audits alongside other audits, like financial audits, but they can also be done on their own.
10. Perform HIPAA Risk Assessments and Management
To stay compliant with HIPAA, healthcare software must be regularly checked for security risks. A risk assessment identifies issues in data storage, access controls, and security policies.
After identifying risks, there should be a plan to handle any security incidents, privacy, or administrative issues. By continuously monitoring and improving safety measures, organizations can protect patient data, minimize compliance risks, and build trust with healthcare partners and patients.
11. Manage Business Associates
Managing business associates is a critical aspect of HIPAA compliance. These are individuals or organizations that provide services to covered entities and have access to protected health information (PHI). To ensure HIPAA compliance, covered entities must manage their business associates effectively.
Business Associate Agreements: A Business Associate Agreement (BAA) is a contract between a covered entity and a business associate that defines how they will work together. The BAA must state that the business associate must follow HIPAA regulations, including the Security Rule, Privacy Rule, and Breach Notification Rule. It must also detail the business associate's role in protecting personal health information (PHI).
Managing Business Associates with Access to PHI: Covered entities must ensure their business associates can access protected health information (PHI) and follow HIPAA rules. This includes:
1. Checking business associates before signing a contract.
2. Ensuring business associates have strong security measures to protect PHI.
3. Keeping an eye on business associates to ensure they follow HIPAA rules.
4. Dealing with any security incidents or breaches involving business associates.
Also Read: Use of Artificial Intelligence in Healthcare
Why Should Your Healthcare App Be HIPAA-Compliant?
It's important for healthcare apps that handle Protected Health Information (PHI) to follow HIPAA rules. These rules protect patient data, ensure that the app follows the law, and build trust with users.
If an application does not comply, it can lead to heavy fines, data breaches, and reputational harm. On the contrary, a HIPAA-compliant healthcare app that meets legal standards can improve data security.
HIPAA compliance in healthcare software development brings a myriad of benefits to the healthcare industry. Take a look at a few of them below:
Key Benefits of HIPAA Compliance
- Keeping compliant helps you avoid large fines and legal issues from HIPAA violations.
- Prevent penalties that can cost thousands to millions of dollars for each violation.
- Reduce the risk of data breaches, unauthorized access, and security problems.
- Strong encryption, access controls, and good risk management in healthcare software keep sensitive patient data safe.
- Secure platforms improve user confidence and make healthcare providers and patients more likely to use them.
Ensuring HIPAA compliance in software development is about more than just following the rules. It's about creating a secure and trustworthy healthcare application that protects patient privacy and builds trust. So, in order to take benefit of the healthcare applications and streamline administrative workflows, it is essential to hire developers from a reliable partner.
Types of Healthcare Apps Need to Meet HIPAA Compliance
When talking about healthcare software development, it is crucial to follow the HIPAA compliance process. There are certain types of applications are required to achieve HIPAA compliance as a matter of regulatory necessity. This includes:
- Electronic Health Records (EHR) Systems help healthcare providers keep track of patient records.
- Telemedicine Apps let you have virtual doctor visits, store your medical records, and share your health information securely.
- Medical Billing and Insurance Apps manage patient payments, claims, and insurance details.
- Wearable Health Devices collect health data and share it with your doctors.
- Healthcare Chatbots or smart assistants that give medical advice and manage patient information.
- Pharmacy and Prescription Apps help you track medications, renew prescriptions, and communicate with your healthcare provider.
However, along with this, there are several types of apps that do not mandatorily require to be HIPAA compliant. This includes general wellness and fitness apps, mental health self-help apps, and health monitoring apps without PHI storage.
Key Practices We Follow For HIPAA-Compliant Software Development
At "Your Team" in India, we focus on HIPAA compliance in our healthcare software development. We use strong security measures to keep sensitive patient data safe while ensuring smooth functionality.
- Privacy by Design: We include security and compliance from the beginning of the development process. This makes data protection a main priority, not an afterthought.
- Regular Security Updates: Our team consistently monitors healthcare systems for threats and quickly applies necessary fixes. We also perform regular updates to keep our systems safe from weaknesses.
- Security Testing: We regularly test our software to identify security risks, if any. This helps us keep our software strong against cyber threats.
- Role-Based Access Control: We restrict data access based on user roles. This reduces the chance of unauthorized users exposing sensitive health information.
- Detailed Compliance Records: We maintain comprehensive records of our compliance efforts, audits, and security measures. This ensures transparency and a quick check on every regulatory requirement.
Conclusion
Ensuring compliance with HIPAA regulations in software development is crucial for safeguarding patient information and fulfilling legal obligations. Adhering to these standards protects sensitive data and also builds trust in healthcare solutions.
The key practices for creating HIPAA-compliant healthcare software include conducting risk assessments, implementing strong data security, managing access by user roles, and performing regular audits. Each of these practices contributes significantly to the security of confidential health information.
At Your Team in India, we focus on developing healthcare software that meets HIPAA requirements. Our skilled developers use best practices to create secure, scalable, and compliant healthcare applications.
Partner with us to build healthcare app solutions that prioritize global quality standards!
Frequently Asked Questions
Healthcare applications that collect, store, or share personal health information (PHI) and work with healthcare providers or insurers must follow specific rules. However, general wellness apps that don’t handle PHI usually do not need to comply.
HIPAA regulations are designed to protect patient privacy and the security of health information. These rules focus on key areas like privacy, security, and management in healthcare. This provides guidelines for keeping medical information private and ensures that health records are handled, shared, and managed safely in today’s digital world.
HIPAA compliance refers to the law that protects the privacy and security of your medical information. This information is called protected health information. It includes many types of personal health details that covered entities or their business associates collect or share, whether in electronic, paper, or spoken form.
HIPAA violations can lead to penalties, both civil and criminal. Civil penalties depend on how severe the violation is and can range from $100 to $50,000. Criminal penalties apply to people who intentionally misuse patient health information, which may result in heavy fines or prison time of up to 10 years.
Following the IT HIPAA checklist helps protect the security, privacy, and confidentiality of Protected Health Information (PHI) in healthcare. It enforces strict rules for how this information is stored, shared, and accessed in healthcare applications.
Use the IT HIPAA checklist and conduct a HIPAA risk assessment. Perform security audits, enforce encryption and access controls, and ensure that business associate agreements (BAAs) are in place with vendors. Also, consult compliance experts to confirm that you are following HIPAA-compliant software requirements.
4.8 out of 5 by