What is HIPAA?
In an effort to address issues of access to healthcare data, President Bill Clinton signed the Health Insurance Portability and Accountability Act (HIPAA) of 1996 into federal law. HIPAA involves a set of regulations that every healthcare business, sometimes referred to as a covered entity, must follow in order to keep protected health information safe and private.
What is HIPAA Compliance Software?
The U.S. healthcare industry operates on a very large scale, as virtually everyone will require some form of healthcare during their lifetime. Healthcare organizations manage a large amount of confidential patient medical records that must be protected from external threats with HIPAA-compliant security measures. When using compliance software, organizations can keep track of patient data and ensure that it’s being handled properly and is HIPAA-compliant.
How to Make Your Software HIPAA Compliant
If a data breach occurs in your healthcare software, it can have a negative impact on business operations and public reputation. Let’s take a look at the different steps an organization should go through to ensure your software is HIPAA-compliant.
Evaluate Risks Based on the Type of Data
Once you’ve identified where protected health information (PHI) is located in your software, you’ll need to conduct a comprehensive risk assessment to identify any vulnerabilities or weaknesses in your software’s security. This could involve analyzing potential threats, evaluating the likelihood and impact of those threats, and determining the risk level for each vulnerability.
Secure ePHI Data on Servers
Organizations must secure all electronic protected health information (ePHI) data on servers to protect against attacks and intruders. This can include measures like firewalls, intrusion detection systems, and regular security updates.
Ensuring access controls are in place to limit who can access your organization’s ePHI data is a necessary step. This includes measures like strong passwords, multi-factor authentication, and role-based access control.
Encrypt Data to Avoid Data Breaches
Selecting the right data encryption method that fits your needs is crucial. You need to create a strong encryption barrier to protect your data, ensuring only authorized users can access it. You’ll want to securely manage your encryption keys so that only trusted users can access the encrypted data, monitor for a potential data breach, and take action if any threats arise.
Data Backup and Implement Disaster Recovery
Organizations need to have a secure backup plan in place for data security. By creating regular backups of your data, including patient information, you can have a safe and secure copy of your data in a separate location. Whether it’s in the cloud or in a different physical location, make sure it’s secure and easy to access when you need it.
The backup data needs to be encrypted to keep it safe from prying eyes. Use strong passwords, authentication mechanisms, and other security systems to keep your backups locked down. It’s also important to continually review and update your backup and disaster recovery plan regularly to keep up with changes in your software, technology, and regulatory requirements.
Dispose of Old Data
Having a fully functioning, reliable data storage system that avoids HIPAA violations also involves making sure you properly dispose of old data. You’ll want to gather a team that is well-versed in HIPAA compliance and have them go through old data and determine if it needs to be disposed of. When securely disposing of the data, you will need to document the process and ensure all physical or digital remnants are destroyed.
Provide Authorized Access Only
For HIPAA compliance software, access management is like having a locked door with limited keys, ensuring that only the right people can enter and view sensitive health data. Access to protected health information is restricted to only authorized personnel who view or modify information based on their job responsibilities. This is typically done through strict access controls, where each user is granted access permissions based on their role and responsibilities within the organization.
These access controls can include measures such as role-based access control (RBAC), where users are granted access based on predefined roles, such as physician, nurse, or administrator. There’s also need-to-know access, where users are only granted access to the specific PHI necessary for their job responsibilities.
It’s important to ensure that access permissions are reviewed and updated regularly, as job roles and responsibilities may change over time. Additionally, access to PHI should be immediately revoked for users who no longer require it, such as when an employee leaves the organization.
Authenticate User Accounts
When users access medical software, they typically need to provide credentials to prove their identity. This process is known as authentication, and it helps ensure that only authorized users are granted access to PHI.
HIPAA compliance software typically requires strong authentication measures to protect PHI. This may involve implementing complex password requirements or even two-factor authentication (MFA), which requires users to provide additional verification beyond just a password, like a fingerprint scan or a smart card.
MFA adds an extra layer of security by making it more difficult for unauthorized users to gain access, even if they somehow obtain a user’s password.
Ensure Integrity and Audit
When ensuring integrity, you need to make sure the data within the medical software remains accurate, complete, and reliable. This can involve implementing measures such as data validation checks, error handling, and data backup procedures to prevent data from being altered or corrupted, unintentionally or maliciously.
The purpose of auditing is to detect and investigate any unauthorized or suspicious activities, as well as to provide a record of activity for compliance and accountability purposes. With HIPAA compliance software, auditing typically involves keeping track of who accesses PHI, when they accessed it, and what they did with it. This can be done through activity logs, audit trails, and other monitoring mechanisms.
Implement the Right Security Policies
When it comes to implementing security policies to ensure HIPAA compliance, it’s all about setting up the right rules and guidelines to protect sensitive health information. This might involve setting up strict access controls so that only authorized personnel have access to PHI based on their job responsibilities. For example, only those who need to view or modify PHI for their work should have access, and their access should be regularly reviewed and updated.
Another important aspect is regular employee training to ensure that everyone is aware of the security policies, understands their role in protecting PHI, and knows how to handle sensitive information securely. This can include:
- Clear procedures and guidelines for handling PHI
- Training on identifying and reporting potential security incidents
- Avoiding phishing attempts
- Safely transmitting PHI.
Implement a Remediation Plan
A remediation plan is a set of actions and strategies designed to address and resolve identified issues or deficiencies in a system, process, or environment. A remediation plan for HIPAA compliance software would outline the steps and measures needed to correct any non-compliant areas and ensure that the software aligns with HIPAA requirements.
A typical remediation plan can involve the following:
- Identifying the specific areas of non-compliance within the medical software, such as weak access controls, inadequate encryption, or incomplete documentation.
- Prioritizing the issues based on their severity and potential impact on patient data, focusing on the most critical areas that need immediate attention.
- Implementing the necessary changes to bring the medical software into compliance with HIPAA regulations. This can include updating configurations or implementing security measures.
- Testing and verifying the remediation measures to ensure that the issues have been adequately addressed and that the medical software now complies with HIPAA requirements.
- Along with documenting the changes, companies need to regularly review and update the software to maintain HIPAA compliance with HIPAA regulations and make adjustments to the remediation plan as needed.
HIPAA Rules Every Healthcare Software Must Adhere to
Healthcare providers rely on the companies who are building HIPAA-compliant software to ensure their medical software follows the following HIPAA rules in order to avoid data breaches and protect their patient data. These HIPAA rules include:
HIPAA Privacy Rule
The privacy rule sets standards for protecting the privacy of patient’s PHI. It requires healthcare organizations to implement policies and procedures to safeguard PHI and limit its use and disclosure to only those who have authorized access. It also gives patients certain rights, such as the right to access and request changes to their own PHI.
HIPAA Security Rule
Focusing on the security of ePHI, the HIPAA security rule requires healthcare organizations to implement measures to ensure the confidentiality, integrity, and availability of ePHI through access controls, encryption, and audit controls. It also mandates organizations to conduct risk assessments and implement administrative safeguards to protect against potential security breaches.
HIPAA Enforcement Rule
The Enforcement Rule sets the standards for how HIPAA violations are dealt with and the severity of the consequence. This rule also makes sure that healthcare organizations are educated and equipped to follow the rules. It provides guidance on best practices and offers training and resources to help healthcare providers comply with HIPAA regulations.
Breach Notification Rule
This rule outlines the requirements for healthcare organizations to notify affected individuals, the Department of Health and Human Services (HHS), and occasionally the media in the event of a breach of unsecured PHI. It requires organizations to promptly investigate and report any unauthorized access or disclosure of PHI to affected individuals and regulatory authorities.
How to Become HIPAA-Compliant as a Software Company?
There are a handful of critical steps to becoming a HIPAA-compliant software company. From creating a team to handle the compliance process to ensuring your company stays up-to-date with any changes to the regulations. Included in the HIPAA compliance checklist is:
Plans for Remediation
The first step in planning for remediation is to put together a team of healthcare software developers, business associates, legal professionals, and compliance experts. Next is to conduct a thorough risk assessment to identify any vulnerabilities in your systems and processes. With a strong team of experts, you can implement remediation measures, fix any issues, and ensure the documentation process is working correctly.
Documentation Processing
When it comes to processing documentation, it’s important to make sure that all the information you collect about someone’s health or medical history is handled with care, following the rules and regulations set by HIPAA.
sManagement of Business Relationships
In order to effectively manage your business relationships according to HIPAA compliance, keep in mind the following:
- Understand who you’re dealing with: Note what their role is and what kind of information you’ll be sharing. For example, will these partners be covered entities or business associates?
- Establish clear expectations and agreements: Make sure you’re on the same page with your business associates when it comes to handling PHI.
- Keep it secure: Just like in business relationships, you need to ensure that any PHI shared between you and your partners is protected, encrypted, and stored securely.
- Continue to monitor: You need to keep an eye on how things are going and make sure everyone is still in sync with HIPAA requirements.
Security
When we talk about security rules for HIPAA compliance software development companies, we’re referring to the measures and safeguards in place to protect the privacy and security of PHI that is stored, transmitted, or processed by medical software.
This involves implementing various technical, administrative, and physical safeguards to ensure the confidentiality, integrity, and availability of PHI. For example, a telemedicine software development company can:
- Use encryption to protect patient health data as it’s transmitted over networks
- Employ strict access controls to limit who can view or modify PHI
- Regularly monitor and audit their systems for vulnerabilities
- Have disaster recovery plans in place to quickly respond to any potential security incidents.
Just like any good software, HIPAA compliance is an ongoing process. Stay up-to-date with any changes or updates to the regulations, and make sure your compliance measures evolve accordingly.
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How Geneca Can Help
If you’re ready to leverage HIPAA compliance software for your custom healthcare solution, reach out to Geneca today! By partnering with Geneca, you’ll have access to a team of developers and analysts with extensive understanding and experience in the healthcare industry. Get your questions answered during a free consultation!